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Out GILD @ $70.75 at the EOD.
GILD
Best close in > 3 mo. Only 2nd close above $57 -- $57.25.
BMY
Not answering your question, but interesting article if you haven't seen it:
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Why Shares of Pure Storage Dropped Today
Motley Fool
Shares of Pure Storage (NYSE: PSTG) slumped on Thursday after the company's fourth-quarter results were overshadowed by weak guidance. The stock was down about 11% at 2:40 p.m. EST.
So what
Pure Storage reported fourth-quarter revenue of $227.9 million, up 52% year over year and a few million dollars above the average analyst estimate. Pure Storage added 450 customers during the quarter, bringing its total customer count to 3,000. Notable customer wins include video-streaming company Hulu and restaurant chain Subway.
Image source: Pure Storage.
Non-GAAP EPS came in at a loss of $0.02, up from a loss of $0.12 during the prior-year period and $0.06 higher than analyst expectations. The company lost $42.9 million, or $0.21 per share, on a GAAP basis, a slight improvement compared to the prior-year period.
While Pure Storage continued its streak of revenue and earnings beats, the company's guidance for the first quarter was disappointing. It expects to produce revenue between $171 million and $179 million, up just 25% year over year at the midpoint and well below analyst expectations of $201.7 million.
Now what
Pure Storage expects to produce $1 billion of revenue this year, right in line with the average analyst estimate, but the weak first-quarter guidance will require growth to pick up as the year goes on. CEO Scott Dietzen sees opportunities going forward:
Pure Storage is delivering the data platform for the cloud era, helping customers put data to work for their businesses. This year, Pure expects to reach $1 billion in revenue -- a remarkable achievement and evidence that we're only just getting started. We could not be more excited about the opportunities ahead.
Shares of Pure Storage are now down about 50% since peaking soon after the company's IPO in late 2015. With growth expected to slow during the first quarter, and with profitability nowhere in sight, investors are clearly losing patience.
10 stocks we like better than Pure Storage
When investing geniuses David and Tom Gardner have a stock tip, it can pay to listen. After all, the newsletter they have run for over a decade, Motley Fool Stock Advisor, has tripled the market.*
Timothy Green has no position in any stocks mentioned. The Motley Fool has no position in any of the stocks mentioned. The Motley Fool has a disclosure policy.
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https://whotrades.com/feed?pinned=3670375&showMore=1&utm_source=maxsocial&utm_content=feed
PSTG
Dividend remains at 0.39
BMY
Lot of good info in that article -- thanks.
GILD
Smiley face here, but I sold yesterday. Generally I post when I leave a stock, but didn't want to dampen the rally.
Who would believe after the good data dropping the pps last week, a Seeking Alpha article, though well written, would bring the biggest volume in a year? Sold early and could have bought back but never thought it had the sustained momentum. Totally out of character for IDRA.
Will be back in. Congratulations to all with the faith.
IDRA
Bristol-Myers Squibb Expands Focus on Precision Medicine with Investment and Planned Collaboration with GRAIL on Blood-Based Cancer Screening
By Business Wire, March 01, 2017, 08:10:00 AM EDT
Companies to enter a research collaboration that utilizes GRAIL's future analytics tools to inform research, advance diagnostics and improve patient outcomes
NEW YORK--(BUSINESS WIRE)--
Bristol-Myers Squibb Company (NYSE:BMY) announced today its equity investment and plans for a research collaboration with GRAIL Inc., a life sciences company whose mission is to detect cancer early when it potentially can be cured. By combining the power of high intensity cancer DNA sequencing, leading edge computer science and large clinical studies into a diagnostic platform, GRAIL aims to develop highly sensitive blood tests that detect cancer in its early stages to enable earlier intervention with targeted therapies.
As an investor, Bristol-Myers Squibb will gain early access to GRAIL's comprehensive clinical trial databases that may serve as a rich resource for understanding tumor genomics. Additionally, Bristol-Myers Squibb and GRAIL have agreed to principal terms of a research collaboration that would enable Bristol-Myers Squibb to examine its clinical data using GRAIL's analytic tools to inform research and development decisions, guide strategies to advance point of care companion diagnostics and potentially improve selection, care and management of patients through more targeted treatments.
"A key enabler of our Immuno-Oncology strategy is to leverage precision medicine to speed the selection of the most effective combinations of therapies for patients," said Francis Cuss, MB BChir, FRCP, chief scientific officer, Bristol-Myers Squibb. "GRAIL's future innovation potential is significant. Liquid biopsies hold the potential to support much earlier intervention and better define individual patient characteristics that may enhance treatment decisions."
Bristol-Myers Squibb has a diverse early portfolio of Immuno-Oncology mechanisms it's evaluating across a broad range of tumors and modalities, with 10 investigational I-O molecules in the clinic and ongoing registrational trials in 14 tumor types.
About Bristol-Myers Squibb
Bristol-Myers Squibb is a global biopharmaceutical company whose mission is to discover, develop and deliver innovative medicines that help patients prevail over serious diseases. For more information about Bristol-Myers Squibb, visit us at BMS.com or follow us on LinkedIn, Twitter, YouTube and Facebook.
Bristol-Myers Squibb Forward-Looking Statement
This press release contains "forward-looking statements" as that term is defined in the Private Securities Litigation Reform Act of 1995 regarding the research, development and commercialization of pharmaceutical products. Such forward-looking statements are based on current expectations and involve inherent risks and uncertainties, including factors that could delay, divert or change any of them, and could cause actual outcomes and results to differ materially from current expectations. No forward-looking statement can be guaranteed. Among other risks, there can be no guarantee that the clinical studies discussed in this release will be successfully developed or approved for any of the uses described in this release. Forward-looking statements in this press release should be evaluated together with the many uncertainties that affect Bristol-Myers Squibb's business, particularly those identified in the cautionary factors discussion in Bristol-Myers Squibb's Annual Report on Form 10-K for the year ended December 31, 2016 in our Quarterly Reports on Form 10-Q and our Current Reports on Form 8-K. Bristol-Myers Squibb undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events or otherwise.
View source version on businesswire.com: http://www.businesswire.com/news/home/20170301005876/en/
Source: Bristol-Myers Squibb
Read more: http://www.nasdaq.com/press-release/bristolmyers-squibb-expands-focus-on-precision-medicine-with-investment-and-planned-collaboration-20170301-00690#ixzz4a50VqWUD
Rumors that Starboard is in Gilead.
http://www.starboardvalue.com/overview/
GILD
Long bullish SA article:
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Idera Pharmaceuticals' Well-Funded And Growing Pipeline Of Potentially Blockbuster Drug Candidates Offers Significant Upside
Feb. 27, 2017 4:15 PM ET| About: Idera Pharmaceuticals, Inc. (IDRA), Includes: GSK, IONS, MRK, PFE, SNY
Leny Hettmansperger
Leny HettmanspergerFollow(651 followers)
(approx 10 charts/ tables missing)
Summary
Idera starts 2017 with a clear strategy; it is well-funded, has a robust and growing pipeline, and expects to deliver powerful near-term catalysts.
The company begins the year with over $100M in cash, which is enough to advance its diverse pipeline well into the second half of 2018.
The company's lead drug candidate IMO-2125 for refractory melanoma continues delivering blockbuster-like results starting from the pre-clinical stage to the current Phase 1/2 clinical trials.
Idera is working aggressively to expand the indications for IMO-2125 to address a variety of cancer and solid tumors in conjunction with well-known checkpoint inhibitors suck as Merck's KEYTRUDA.
The company, a pioneer in antisense technology, has developed a 3rd Generation Antisense technology platform, which is expected to be unleashed in 2H 2017.
Idera Pharmaceuticals (NASDAQ:IDRA) is a clinical-stage biopharmaceutical company developing novel nucleic acid based therapies for the treatment of certain cancers and rare diseases. Idera's proprietary technology involves using a TLR-targeting technology to design synthetic oligonucleotide-based drug candidates to act by modulating the activity of specific TLRs. In addition to its TLR programs, Idera has created a 3rd Generation Antisense technology platform using its proprietary technology to inhibit the production of disease-associated proteins by targeting RNA.
2016 - A Transformational Year
Idera entered 2016 after having presented positive clinical data from the ongoing Phase 1/2 trial of its then lead drug candidate IMO-8400 in patients with Waldenstrom's macroglobulinemia at the 57th Annual Meeting of the American Society of Hematology (ASH) (December 5, 2015, in Orlando, Florida). The report initially lifted the stock price to $4.4/share following the presentation. But after the initial excitement, the stock deflated gradually until September 26, 2016, when it quickly jumped to over $3 again as seen in the chart below:
The report that the company's Toll-like receptor (TLR) 9 agonist drug candidate IMO-2125 demonstrated promising clinical activity in patients with metastatic melanoma and was well tolerated was the reason for the September 26, 2016, spike. IMO-2125 was evaluated in combination with ipilimumab on patients who have failed prior PD-1 therapy,
Per the company, the patient population in those studies had minimal options and low expectation of clinical response with ipilimumab treatment alone. The most striking result was that three of the four patients with cutaneous melanoma were responders with one Complete Response (CR) and 2 Partial Responses (PR).
Idera CEO Vincent Milano commented:
"We have completed extensive pre-clinical work in a broad scope of tumor types to test the hypothesis of intra-tumoral administration of IMO-2125 inducing a meaningful effect on the tumor microenvironment and potentiating local and systemic tumor regression in patients. This work gave us confidence to test the ability of IMO-2125, beginning with this current study in PD-1 refractory metastatic melanoma patients."
CEO Milano continued:
"We are energized by the early results from this ongoing trial and have been solidifying our plans to accelerate the program as we believe there is a clear path to bring IMO-2125 to melanoma patients who have not benefited from checkpoint inhibition alone and open an opportunity to establish IMO-2125 as the agent of choice to activate the tumor microenvironment and potentially improve outcomes for patients."
"Following a full strategic review, we have decided to prioritize the IMO-2125 program and explore strategic options for IMO-8400 in B-cell lymphoma."
I believe it was the last sentence that confused and turned investors off. Some investors expressed their dismay on message boards for dropping the more clinically-advanced IMO-8400 for up-and-coming IMO-2125, often referring the company's management as "wishy-washy."
The press release stated that the company was suspending the clinical development of IMO-8400 for B-cell lymphomas, including studies in Waldenstrom's macroglobulinemia (WM) and Diffuse Large B-Cell Lymphoma (DLBCL), and that it will explore strategic options in these indications. However, the company confirmed that development of IMO-8400 in dermatomyositis will continue going forward.
In short, as part of its TLR (Toll-like receptor) drug-development platform, Idera develops TLR antagonists and agonists that regulate the activity of targeted TLRs. A TLR antagonist, such as IMO-8400, inhibits the immune response, while the TLR agonists, such as IMO-2125, stimulate the immune response.
In retrospect, this was the right decision at the right time. Clearly, management decided to focus its cash and resources on its potential blockbuster IMO-2125 drug candidate, based on the preclinical and clinical successes to date.
On November 11, 2016, Idera reported translational data supporting the mechanism of action of IMO-2125. No dose limiting toxicity has been observed and activity in patients with metastatic melanoma unresponsive to PD-1 therapy has been promising. Joanna Horobin, Idera's chief medical officer, commented:
"We hypothesized that the intratumoral injection of IMO-2125 into a single tumor lesion would stimulate dendritic cells to produce interferon and the downstream immune cascade in the tumor microenvironment, resulting in the recruitment and activation of tumor-killing T-cells in both the injected and non-injected tumors."
"When combined with a systemic checkpoint inhibitor, this change in the tumor microenvironment was expected to affect tumor responses in both injected and distant tumors."
Idera is clearly not a "one-trick pony." In late 2015, the company announced a collaboration agreement with GlaxoSmithKline (NYSE:GSK) whereby GSK agreed to pay Idera $2.5M up front and promising as much as $100 million more in development milestones in exchange for the rights to an undisclosed number of early-stage treatments targeting kidney disorders. Additionally, Idera could receive as much as 5% if any resulting products generate over $500M annual sales. Key to this collaboration is Idera's 3rd Generation Antisense (3GA) technology. By using this technology, Idera will be able to design drug candidates that will interfere with RNA communication and thus alter genetic expression. This way, therapies will be tailored to treat diseases resulting from gene defects.
Regarding this technology platform, Sudhir Agrawal, founder, and president of research at Idera, commented:
"Our in-depth understanding from our pioneering work in antisense technology along with our insights into the interaction of nucleic acids with Toll-like receptors has allowed us to design this unique technology platform to fully realize the potential of antisense technology. We are continuing to conduct preclinical studies with multiple 3GA candidates in house and with our collaborators (GSK, etc.), with a goal of advancing this technology to clinical development."
Idera is recognized as a pioneer of the antisense technology. Dr. Agrawal, (and a co-author) published the first-ever paper describing the antisense approach in the New England Journal of Medicine in 1987. The research described a way to "silence" disease-causing genes using synthetic DNA. Several biotech companies were born because of this discovery.
Another significant and transformational 2016 event was the November 28, 2016, announcement that Idera had granted privately-owned Vivelix Pharmaceuticals exclusive worldwide rights to the non-malignant gastrointestinal disorder candidate IMO-9200. Per the agreement, Vivelix paid Idera $15M upfront. Additionally, Idera could receive up to $140M in payments tied to achieving development, regulatory, and sales milestones for IMO-9200. Vivelix also agreed to pay escalating royalties on global net sales of the compound up to low double digits. Furthermore, Vivelix agreed to pay development, regulatory sales, and milestone payments totaling up to $52.5M toward potential backup compounds to IMO-9200. Idera may also receive up to low double digits of net global revenues. Including back-up compounds, this licensing agreement could generate over $200M for Idera long term.
2017 - An Inflection Year
Idera starts 2017 with a clear strategy; it is well-funded, has a robust and growing pipeline, and plans to deliver powerful near-term catalysts as will be seen later in this article.
In the company's 3Q 2016 financial results, Idera reported that it had cash, cash equivalents, and investments totaling $53.4M. With the October 2016 public offering that resulted in net proceeds of $48.9M and the $15M November upfront payment received from Vivelix, Idera is starting 2017 with over $100M in cash. This amount of cash will provide a runway well into mid-to-late 2018 to advance the company's exciting pipeline (see slide below). Much of the discussion in this article will be focused on the blockbuster potential of Idera's IMO-2125 drug candidate.
During the January 11, 2017, presentation, at the 35th Annual J.P. Morgan Healthcare Conference, CEO Milano was extremely bullish about 2017 and IMO-2125 in particular. He started by saying that 2017 will be an "incredibly pivotal year for Idera." The CEO then went into describing the primary mechanism of action of IMO-2125, which is to improve the tumor micro-environment so that a check-point inhibitor could more effectively attack tumors. As seen in the following slide, intratumoral injection of IMO-2125 is able to change the environment in local tumors, and can also free-up and help proliferate cancer fighting T-cells. This in turn can cause systemic tumor regression by enabling the check-point inhibitor to maximize its tumor-destruction work.
CEO Milano became clearly emotional when he talked about the complete response of a 68-year old refractory-melanoma patient. This patient had run out of options, and was even referred to a hospice. As we all know, the purpose of hospice care is to take care of people in the last phases of a disease that cannot be cured. CEO Milano explained that upon the patient's wife desperate request for one more try, he was enrolled in the program. This patient received six 8-mg IMO-2125 doses and four doses of check-point inhibitor ipilimummab (IPI). The patient showed a dramatic positive response, and a few months later he was declared CR.
The well-known English idiom "a picture is worth 1,000 words" is very appropriate at this point. The following slide shows the patient's pre-therapy status on the left, and where the treatment was applied with a yellow arrow, along with several tumors (red arrows). It can be seen clearly on the right images that the local, as well as the distant tumors, completely disappeared during the six-month check-up:
Many of us have lost a beloved family member to cancer, and have seen similar pictures. It is wonderful to know that treatments like this will be making a significant difference in people's lives, and their families, in a not-too-distant future.
On February 24, 2017, Idera presented an update on the dose-escalation phase of the ongoing IMO-2125 Phase 1/2 clinical trials. Marc Uemura, M.D. from the University of Texas, MD Anderson Cancer Center, presented an update on the clinical and translational findings from the ongoing trial in a poster entitled: "Intratumoral (i.t.) IMO-2125, a TLR9 agonist is active in combination with ipilimumab in PD-(L)1 refractory melanoma (RM)."
Mark Cornfeld, M.D., Idera's medical lead, oncology, commented on the study:
"We are very pleased to have achieved successful completion of all our objectives in the Phase 1 portion of this trial which established safety across all doses tested, and demonstrated preliminary evidence of clinical activity, including durable responses of over one year in two of the evaluable patients so far."
"At this point we have very clear justification to further the development of IMO-2125 and we'll soon be moving to the phase 2 portion of the trial, which will expand to multiple centers. Additionally, we are undertaking a parallel development pathway for IMO-2125 in combination with pembrolizumab and while that is not the focus of this presentation today, we are making good progress with safety and dose evaluation in that arm."
The poster presentation concluded:
The combination of IMO-2125 and ipilimumab is tolerable at all dose combinations studied and has clinical activity in PD-1 refractory melanoma.
There is evidence for immune activation in both the injected and distant tumor biopsies that correlates with clinical outcome.
Further investigation of the IMO-2125 + ipilimumab combination in PD-(L)1 refractory melanoma is warranted; the planned Phase 2 expansion will begin soon.
Dose escalation of IMO-2125 + pembrolizumab (Merck's (NYSE:MRK) KEYTRUDA) is also ongoing
Idera also announced the acceptance of two abstracts at the upcoming American Association for Cancer Research (AACR) 2017 Annual Meeting being held April 1-5 in Washington DC.
On Wednesday, April 5, 2017, Dr. Cara Haymaker of MD Anderson Cancer Center will present an update on the translational data outcomes in a poster presentation entitled, "Translational evidence of reactivated innate and adaptive immunity with intratumoral IMO-2125 in combination with systemic checkpoint inhibitors from a Phase 1/2 study in patients with anti-PD-1 refractory metastatic melanoma."
Also on April 5, Daqing Wang, Ph.D., principal scientist, Idera Pharmaceuticals, will present new IMO-2125 pre-clinical data in a poster entitled, "Local treatment with novel TLR9 agonist IMO-2125 demonstrates anti-tumor activity in preclinical models of pancreatic cancer."
Notice that the second presentation reflects the aggressive push by Idera to expand the indications for IMO-2125, presumably this time with Merck's KEYTRUDA (pembrolizumab) working together on pancreatic cancer.
The company has established an aggressive path forward to accelerate and maximize the benefits of the IMO-2125 program in the refractory melanoma indication. As soon as practical during 1H 2017, Idera plans: 1) To begin meetings with the FDA regarding end of Phase 1; 2) perform dose-selection and initiation of Phase 2 in 2Q2017; and 3) discuss with the FDA plans to finalize Phase 3 design.
The following slide shows the path forward to expand IMO-2125 indications beyond melanoma. The slide that follows shows the long-term expansion opportunities that would increase the addressable market from 20K to 160K patients and beyond:
2017 Catalysts And Milestones
I put together the following slide to highlight the major catalysts and milestones envisioned by the company for the remainder of 2017 and the beginning of 2018:
As seen at the bottom of the slide, the company plans to hold an R&D day during the second half of 2017 (TBA).
As can be seen from the above discussion that there are many reasons for Idera's investors to share CEO Milano's enthusiasm calling 2017, "an incredibly pivotal year for Idera."
Institutional and Insider Ownership
Institutional ownership is growing strongly with the largest institutions having increased their holdings substantially, led by Baker Brothers. Vanguard Group, Broadfin Capital, and Blackrock Fund Advisors. There are also several new institutions, and increasing positions are outnumbering decreasing positions by a 12 to 1 margin.
Insider buying has been persistent with no insider sales in the last 12 months.
Management Team and BOD
A company success relies heavily in the quality of the management team. Idera's management has been fortified significantly in the last three years.
On December 1, 2014, the company announced the hiring of Vincent Milano as CEO. Mr. Milano was a former CEO of ViroPharma, which was acquired by Shire Pharmaceuticals (NASDAQ:SHPG) for $4.2 billion. He is an industry veteran with an excellent record of accomplishments in the areas of commercializing and approval of several successful products. CEO Milano brought with him several close associates from ViroPharma including Elizabeth Eberhardt as VP of oncology team, Clayton Fletcher as Sr. VP business development & project management, and Robert Doody Jr., as VP investor relations and corporate communication.
Mr. Milano replaced company founder Dr. Sudhir Agrawal as CEO. Mr. Agrawal in turn was named president of research. Dr. Agrawal is a serial inventor and his name appears as author or contributor in over 300 patents in several areas of drug development.
Idera's Board of Directors is admirable for a company with a market cap of less than $300M. It brings decades of experience with members representing Baker Brothers, Sanofi (NYSE:SNY), GlaxoSmithKline, Genzyme, Pfizer (NYSE:PFE), Schering-Plough, and ViroPharma.
Analyst Opinions and Coverage
Three analysts covering IDRA have an average "Buy" rating on the stock with an average price target of $5/share. Price targets range from $4 to $6/share. On Friday, February 24, 2017 Wedbush reaffirmed its "Outperform" rating on IDRA stock and maintained its $6/share price target.
Risks and Uncertainties
1) Like most clinical-stage biotechs failure to meet top line results in any of the clinical programs underway would be a major setback.
2) Significantly higher than forecasted cash burn that would require equity raises before mid-2018, as expected.
3) Loss of key talent to the competition.
4) Decisions to out-license drug candidates can come back to haunt you. Longer Idera investors still remember with disgust when the company licensed its earlier generation antisense technology to the then Isis Pharma (NASDAQ:IONS). Isis eventually became a $5B plus thanks in part to Idera's technology.
5) Lack of focus on drug development strategies that could end up being costly and would turn away investors. The last two items are less of a concern now that the company has assembled a top-notch management team and BOD.
Conclusions
If we assume that Idera currently has more than $100M in cash, the market is valuing the company at only about $140M. This to me is extremely undervalued when considering:
Idera's extensive and potentially powerful pipeline, featuring IMO-2115 not only in refractory melanoma, but also in several other indications per the company's expansion plans.
Drug candidate IMO-8400 for dermatomyositis will complete Phase 2 enrollment in 2H 2017.
The 3rd Generation Antisense (3GA) technology platform will begin generating several drug candidates starting this later year. The catalyst table lists several key milestones around 3GA scheduled for 2H 2017.
The low valuation completely ignores the rich collaboration agreements with GSK and Vivelix, both in the 3GA area.
Finally, there could be an announcement of a collaboration to out-license IMO-8400 for B-cell Lymphoma indications which is Phase 2-ready.
The cash on hand provides a comfortable runway well into the second half of 2018 assuming cash burn stays in the $10-15M quarterly range.
In terms of a fair valuation, I don't feel comfortable coming up with one at this point since there are so many moving parts. But I will agree with the average of the three analysts covering IDRA, or a $5/share price target.
As a shareholder I am very enthusiastic about the make-up of the management team and the BOD. Its vision and decisiveness is reflected in the September 26, 2017, decision to focus on the development of IMO-2125 instead of the more advanced IMO-8400 program because of its blockbuster potential.
It is also encouraging to see that the institutional interest in the stock is on the upswing with some big names increasing their stake substantially like Baker Brothers, The Vanguard Group, and Blackrock Fund Advisors. Another positive is the persistent insider buying and lack of insider selling in the last 12 months.
As with any investment in the market, especially in the highly volatile biotech area, investors should take their time analyzing the Risks and Uncertainties detailed in the company's most recent 10-Q and 10-K filings.
Disclosure: I am/we are long IDRA.
I wrote this article myself, and it expresses my own opinions. I am not receiving compensation for it (other than from Seeking Alpha). I have no business relationship with any company whose stock is mentioned in this article.
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http://seekingalpha.com/article/4050165-idera-pharmaceuticals-well-funded-growing-pipeline-potentially-blockbuster-drug-candidates
IDRA
Bristol-Myers: Activist Investor Overload
Feb. 26, 2017 6:14 AM ET|21 comments| About: Bristol-Myers Squibb Company (BMY)
Activist StocksPremium Research »Follow(3,534 followers)
Long/short equity, deep value, special situations, growth
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Summary
BMY not only has two activist investors, but two.
JANA Partners has shaken up the board, but Carl Icahn is looking for something more aggressive.
BMY might finally be on the auction block.
Bristol-Myers Squibb (NYSE:BMY) has quickly become one of the hottest names in pharma after attracting two big name activist investors. To start, Barry Rosenstein's JANA Partners settled with BMY this week to add three independent members to the board. BMY also rolled out a $2 billion accelerated buyback plan, also a result of the discussions with JANA.
Now, Carl Icahn has revealed a stake in the drug company, suggesting it might be a buyout target. And with the newly positioned board, that could be sooner than later. The major theses lie in either getting BMY bought out, or convincing BMY to make strategic acquisitions or investing in its business to diversify operations beyond its blockbuster cancer drug Opdivo.
The company is heavily concentrated, which might be appealing to an acquirer looking to get an immediate stronghold in the immuno-oncology space. This also comes as BMY shares are relatively cheap, haven fallen 25% from the $75 a share price tag we saw just last year.
(chart missing)
Possible buyers?
The likes of Pfizer (NYSE:PFE), which has been on the hunt for a major buyout for a number of years after failing to snag Allergan (NYSE:AGN) last year, could be the prime buyer. But even if the $200 billion market cap drug company PFE doesn't step up, there's the opportunity for Novartis (NYSE:NVS), Johnson & Johnson (NYSE:JNJ) or Merck (NYSE:MRK) to step in and make an offer for BMY.
BMY dominates the immunotherapies space, which includes drugs that use the body's own immune system to fight cancer. And as I've said before, BMY remains an undervalued play in immuno-oncology. BMY still has a valuable drug portfolio, one that's likely attractive to other drug companies. This is a big activist target, with a $90 billion market cap.
But even without a buyout, BMY is an interesting standalone company, with a relatively strong portfolio that includes phase 2/3 clinical trials. And the other benefit of oncology is that it tends to demand higher prices / higher margins.
Icahn is no stranger to the pharma space. However, he has taken BMY by surprise, with a stake that's unclear. JANA owns less than 1% and has been pushing for management oversight changes, which includes board change. Change that it's gotten. Icahn, on the other hand, is a fan of mergers and acquisitions. In the end, the M&A in pharma slowed down a bit in 2017, but oncology is still bustling and, at the same time, consolidating. But the oncology sector has remained a hot area for consolidation. BMY has plenty of suitors, and two activists - one with the ear of the board - that will likely help get a deal done sooner rather than later.
Disclosure: I/we have no positions in any stocks mentioned, and no plans to initiate any positions within the next 72 hours.
I wrote this article myself, and it expresses my own opinions. I am not receiving compensation for it (other than from Seeking Alpha). I have no business relationship with any company whose stock is mentioned in this article.
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http://seekingalpha.com/article/4049769-bristol-myers-buyout-bound#alt1
BMY
From the PR:
"We are very pleased to have achieved successful completion of all our objectives in the Phase 1 portion of this trial which established safety across all doses tested, and demonstrated preliminary evidence of clinical activity, including durable responses of over one year in two of the evaluable patients so far," stated Mark Cornfeld, M.D., Idera's Medical Lead, Oncology. "Additionally from a scientific standpoint, we've established proof of mechanism through our translational effort which has gone well beyond the norm compared to what is typically done in oncology drug development."
Continued Cornfeld, "At this point we have very clear justification to further the development of IMO-2125 and we'll soon be moving to the phase 2 portion of the trial, which will expand to multiple centers. Additionally we are undertaking a parallel development pathway for IMO-2125 in combination with pembrolizumab and while that is not the focus of this presentation today, we are making good progress with safety and dose evaluation in that arm."
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IDRA
Idera Pharmaceuticals Presents Update from Ongoing Phase 1 Dose Escalation Clinical Trial of Intratumoral IMO-2125 in Combination with Ipilimumab in Metastatic Melanoma Patients Refractory to Anti-PD-1 Treatment at the 2017 ASCO-SITC Clinical Immuno-Oncol
By GlobeNewswire, February 24, 2017, 11:30:00 AM EDT
Results Demonstrate IMO-2125 plus ipilimumab combination is tolerable at all dose levels studied and has demonstrated durable clinical activity in PD-1 Refractory Melanoma
ORLANDO, Fla., Feb. 24, 2017 (GLOBE NEWSWIRE) --
Idera Pharmaceuticals, Inc. (NASDAQ:IDRA), a clinical-stage biopharmaceutical company developing toll-like receptor and RNA therapeutics for patients with cancer and rare diseases, today is reporting additional data from the dose-escalation phase of its ongoing Phase 1/2 clinical trial of intratumoral IMO-2125, an agonist of TLR9 in combination with ipilimumab or pembrolizumab for treatment of patients with metastatic melanoma with disease that is refractory to PD-1 inhibitors.
In the poster presentation at the 2017 ASCO-SITC Clinical Immuno-Oncology Symposium, entitled, "Intratumoral (i.t.) IMO-2125, a TLR9 agonist is active in combination with ipilimumab (ipi) in PD-(L)1 refractory melanoma (RM)," Marc Uemura, M.D. from the University of Texas, MD Anderson Cancer Center, presented an update on the clinical and translational findings from the ongoing trial.
A copy of the poster presentation is currently available on Idera's corporate website at http://www.iderapharma.com/our-approach/key-publications/.
"We are very pleased to have achieved successful completion of all our objectives in the Phase 1 portion of this trial which established safety across all doses tested, and demonstrated preliminary evidence of clinical activity, including durable responses of over one year in two of the evaluable patients so far," stated Mark Cornfeld, M.D., Idera's Medical Lead, Oncology. "Additionally from a scientific standpoint, we've established proof of mechanism through our translational effort which has gone well beyond the norm compared to what is typically done in oncology drug development."
Continued Cornfeld, "At this point we have very clear justification to further the development of IMO-2125 and we'll soon be moving to the phase 2 portion of the trial, which will expand to multiple centers. Additionally we are undertaking a parallel development pathway for IMO-2125 in combination with pembrolizumab and while that is not the focus of this presentation today, we are making good progress with safety and dose evaluation in that arm."
The company is also announcing the acceptance of two abstracts at the upcoming American Association for Cancer Research (AACR) 2017 Annual Meeting being held April 1-5, in Washington DC. Idera has gained acceptance of two presentations related to IMO-2125.
On Wednesday, April 5, 2017, Dr. Cara Haymaker of MD Anderson Cancer Center will present an update on the translational data outcomes in a poster presentation entitled, "Translational evidence of reactivated innate and adaptive immunity with intratumoral IMO-2125 in combination with systemic checkpoint inhibitors from a Phase 1/2 study in patients with anti-PD-1 refractory metastatic melanoma."
Additionally, on the same day, Daqing Wang, Ph.D., Principal Scientist, Idera Pharmaceuticals will present new IMO-2125 pre-clinical data in a poster entitled, "Local treatment with novel TLR9 agonist IMO-2125 demonstrates anti-tumor activity in preclinical models of pancreatic cancer."
About IMO-2125
Toll-like receptors (TLRs) play a central role in the innate immune system, the body's first line of defense against invading pathogens, as well as damaged or dysfunctional cells including cancer cells. The innate immune system is also involved in activating the adaptive immune system, which marshals highly specific immune responses to target pathogens or tissue. Cancer cells may exploit regulatory checkpoint pathways to avoid being recognized by the immune system, thereby shielding the tumor from immune attack. Checkpoint inhibitors such as agents targeting CTLA4 or programmed cell death protein 1 (PD1) are designed to enable the immune system to recognize tumor cells. In this setting, intratumoral TLR9 agonist administration may increase the tumor-infiltrating lymphocytes (TILs), and thereby potentiate anti-cancer activity of checkpoint inhibitors in the injected tumor as well as systemically.
Idera's TLR9 agonist, IMO-2125 has been created using the company's proprietary chemistry-based discovery platform. IMO-2125 has been shown in various scientific presentations and publications to activate dendritic cells and induce interferon. Idera selected IMO-2125 to advance into clinical development in combination with checkpoint inhibitors based on this immunological profile. In previously completed clinical trials, subcutaneous administration of IMO-2125 was generally well tolerated in about 80 patients with hepatitis C. Idera has conducted further preclinical research evaluating the potential of IMO-2125 to enhance the anti-tumor activity of other checkpoint inhibitors in cancer immunotherapy with data being presented at several medical conferences during the past twelve months. The posters from these presentations can be found at http://www.iderapharma.com/our-approach/key-publications.
About Metastatic Melanoma
Melanoma is a type of skin cancer that begins in a type of skin cell called melanocytes. As is the case in many forms of cancer, melanoma becomes more difficult to treat once the disease has spread beyond the skin to other parts of the body such as by through the lymphatic system (metastatic disease). Melanoma accounts for only one percent of skin cancer cases, but causes a large majority of skin cancer deaths. The American Cancer Society estimates that in 2016, there will be 76,380 new cases of melanoma in the U.S., and about 10,130 will die of this disease.
About Idera Pharmaceuticals
Idera Pharmaceuticals is a clinical-stage biopharmaceutical company developing novel nucleic acid-based therapies for the treatment of certain cancers and rare diseases. Idera's proprietary technology involves designing synthetic oligonucleotide-based drug candidates to modulate the activity of specific TLRs. In addition to its TLR programs, Idera has used its proprietary knowledge to create a third generation antisense technology platform which inhibits the production of disease-associated proteins by targeting RNA. To learn more about Idera, visit www.iderapharma.com.
Forward Looking Statements
This press release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. All statements, other than statements of historical fact, included or incorporated in this press release, including statements regarding the Company's strategy, future operations, collaborations, intellectual property, cash resources, financial position, future revenues, projected costs, prospects, plans, and objectives of management, are forward-looking statements. The words "believes," "anticipates," "estimates," "plans," "expects," "intends," "may," "could," "should," "potential," "likely," "projects," "continue," "will," and "would" and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. Idera cannot guarantee that it will actually achieve the plans, intentions or expectations disclosed in its forward-looking statements and you should not place undue reliance on the Company's forward-looking statements. There are a number of important factors that could cause Idera's actual results to differ materially from those indicated or implied by its forward-looking statements. Factors that may cause such a difference include: whether interim results from a clinical trial, such as preliminary results reported in this release, will be predictive of the final results of the trial, whether results obtained in preclinical studies and clinical trials such as the preclinical data described in this release will be indicative of the results that will be generated in future clinical trials, including in clinical trials in different disease indications; whether products based on Idera's technology will advance into or through the clinical trial process on a timely basis or at all and receive approval from the United States Food and Drug Administration or equivalent foreign regulatory agencies; whether, if the Company's products receive approval, they will be successfully distributed and marketed; and such other important factors as are set forth under the caption "Risk Factors" in the Company's Annual Report and on Form 10-Q for the period ended September 30, 2016. Although Idera may elect to do so at some point in the future, the Company does not assume any obligation to update any forward-looking statements and it disclaims any intention or obligation to update or revise any forward-looking statement, whether as a result of new information, future events or otherwise.
Investor and Media Contact
Robert Doody
Vice President, Investor Relations and Corporate Communications
Office: 617-679-5515
Mobile: 484-639-7235
rdoody@iderapharma.com
Source: Idera Pharmaceuticals, Inc.
This article appears in: News Headlines
Referenced Stocks: IDRA
Read more: http://www.nasdaq.com/press-release/idera-pharmaceuticals-presents-update-from-ongoing-phase-1-dose-escalation-clinical-trial-of-20170224-00771#ixzz4ZcbaEICf
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IDRA
Real strong finish at close with ~50,000 shares bought at the HOD of $1.73. Two great recent days while the sector has been down on each.
Tomorrow.
IDRA
Bristol-Myers Looms as Pharma's Next Megadeal as Activists Join
by Cynthia Koons
February 23, 2017, 5:00 AM EST
Jana adds board members to drugmaker, Icahn said to have stake
‘I think everybody is looking at Bristol,’ Allergan CEO says
Bristol-Myers Squibb Co. was once one of the drug industry’s highest-flying companies. Now the pharmaceutical giant has gone from predator to prey, as its sagging stock price has invited in activist investors who are already forcing changes.
On Tuesday, it announced an agreement with Jana Partners LLC to add three board members, and later in the day activist investor Carl Icahn was reported to have taken a stake and sees the drugmaker as potentially ripe for a takeover. Potential buyers could include Pfizer Inc., Gilead Sciences Inc. and Novartis AG, all of which have an interest in cancer and have money to spend.
“I think everybody is looking at Bristol,” Allergan Plc CEO Brent Saunders said in an interview at Bloomberg headquarters in New York on Wednesday. Saunders said it would be a “very, very high hurdle” for a company like Allergan to do such a deal, but for any CEO, “you’re going to at least take five minutes to think about it.”
Bristol-Myers was itself once one of the drug industry’s major acquirers, snapping up pipeline assets in what it referred to as its “string of pearls” strategy. Those deals landed it the drug Opdivo, which used the immune system to attack cancers and got remarkable results in once-fatal diseases like advanced melanoma. More recently, though, it’s lost ground to rivals like Merck & Co., which has a similar drug, Keytruda, that has taken the lead in some oncology markets.
Tempting Target
Bristol-Myers is still a tempting target. “If you believe in the immuno-oncology franchise, then it’s obviously an attractive asset because there’s not many ways to get into this space,” said David Heupel, a senior health-care analyst at Thrivent Financial.
A takeover of Bristol-Myers would be one of the industry’s largest ever. It commands a market valuation of about $92.6 billion, compared with almost $130 billion in July. That’s big, but not too big for some of the drug giants.
While Pfizer has a partnership with Germany’s Merck KGaA in immune-system-based cancer drugs, it’s well behind Bristol-Myers and Merck. Novartis, another player in oncology, could raise the cash to do a deal through asset sales and debt. Gilead has amassed billions of dollars from sales of its hepatitis C drugs and is looking for its next move.
Spokesmen for Pfizer, Bristol-Myers and Gilead all declined to comment.
A Pfizer deal for Bristol-Myers would make sense “if they feel like they needed to make a move and become a very relevant player in immuno-oncology,” said Thrivent’s Heupel. His fund owns shares of both.
Potential Buyers
Novartis, meanwhile, may have money to spend. The Swiss drugmaker said last month it’s weighing options including a spinoff or IPO for its Alcon eye-care unit, which could generate as much as $20 billion, according to Bloomberg Intelligence. It also has a stake in Roche AG that could be worth another $13 billion, and could raise the rest via debt and by offering stock in a deal.
Gilead needs to make up for its fading blockbuster hepatitis C franchise, which brought in $14.8 billion last year but is capturing fewer patients. Chief Executive Officer John Milligan has said he’s anxious to do deals in areas including cancer. In January, Gilead hired Novartis’ former head of global oncology development, Alessandro Riva, to oversee its efforts in oncology and hematology.
The company has a “nascent oncology platform, but what I don’t yet see is a drug that we can rally around,” Milligan said in a May interview.
Carl Icahn
Icahn’s stake in Bristol-Myers was reported by the Wall Street Journal on Tuesday, and he sees the drugmaker as a potential acquisition target, the Journal said, citing people familiar with the matter. The investor has a history of taking positions in companies and then working to force a sale. Worth about $20 billion, according to the Bloomberg Billionaires Index, Icahn primarily invests his own fortune. He endorsed Saunders becoming CEO of Forest Laboratories Inc., one of his first CEO jobs, after taking a position in Forest.
“Carl is a very smart, thoughtful investor. I have to believe that he looks at Bristol-Myers and the industry and he’s saying, ‘Great company, great pipeline and an industry that should potentially consolidate.’ So that’s a formula that Carl tends to like,” Saunders said. Spokesmen for Icahn didn’t respond to requests for comment.
Another factor that could accelerate pharma merger and acquisition activity is U.S. tax reform. U.S. drugmakers have tens of billions of dollars in profits held overseas in lower-tax jurisdictions, and there has been discussion about a tax holiday to let the money come back at a lower rate. While tax reform won’t drive the company’s strategy, Pfizer CEO Ian Read said on a call last month with analysts, it could help.
“Some deals that previously would not have been affordable may now be affordable,” Read said.
_____________________________________________
https://www.bloomberg.com/news/articles/2017-02-23/bristol-myers-looms-as-pharma-s-next-megadeal-as-activists-join
BMY
Bingo, a use for the voucher:
Epclusa designated as orphan treatment for pediatric chronic HCV
http://www.accessdata.fda.gov/scripts/opdlisting/oopd/detailedIndex.cfm?cfgridkey=554816
GILD
Schedule 13D is an SEC filing that must be submitted to the US Securities and Exchange Commission within 10 days, by anyone who acquires beneficial ownership of more than 5% of any class of publicly traded securities in a public company. A filer must promptly update its Schedule 13D filing to reflect any material change in the facts disclosed, including, among other things, the acquisition or disposition of 1% or more of the class of securities that are the subject of the filing.
So Icahn could purchase close to $4.5B and we would see no 13D.
BMY
I had to add the 200 to my chart to see what you were saying since I don't use it and now see, and agree. The 200 is in play. Still strong and still a good chart. Saw the drop coming and should have sold if I had conviction. I find the trouble trading IDRA is the volatility which lolls you into thinking it will pop back up, but it didn't yesterday.
I pay more attention to movement of Wm%R, CII, and RSI which usually move in unison into over-bought and sold with the WmR% leading. The RSI and the Wm%R are no longer over-bought. SAR intact and MACD fine. Probably a needed pullback.
You ever use BarChart cheatsheet to confirm the chart?
https://www.barchart.com/stocks/quotes/IDRA/cheat-sheet
IDRA
The abstract:
http://abstracts.asco.org/194/AbstView_194_178724.html
"Updated safety, antitumor activity, PK, and biomarker data will be presented at the meeting. Clinical trial information: NCT02644967"
IDRA
Nothing new, but context:
_____________________________________________________
Buyout buzz swells for the giant Bristol-Myers after Carl Icahn makes an entrance, stage left
by john carroll
February 21, 2017 04:53 PM EST
Updated: 04:57 PM
Carl Icahn, the aging activist who’s prodded a series of high-profile biopharma companies into the arms of eager buyers, has taken a stake in the highly stressed Bristol-Myers Squibb, building speculation that the troubled giant could be in line for a buyout – as improbable as that may sound to many.
Bristol-Myers started the day by announcing that it added three new directors and struck a $2 billion stock buyback deal in a pact with Jana Partners, another activist which has been spurring Bristol-Myers to take action to get out of the rut it’s found itself in.
Once the darling of the checkpoint community, Merck last year leapfrogged Bristol-Myers on non-small cell lung cancer with a series of clinical advances that still astonishes some longtime observers of the field. Just days ago you could begin to hear the scuttlebutt about takeout rumors, as the company’s stock languished in the wake of its setbacks.
Today, though, Bristol-Myers stock $BMY continued a surge in after-market trading after the Wall Street Journal posted the news of Icahn’s arrival.
Once a widely respected/feared player in biopharma, Icahn and his team pushed Biogen to overhaul its executive suite, bringing in George Scangos as the company made Tecfidera its flagship therapy after initially calling for a sale of the company. He helped steer ImClone to a $6.5 billion deal with Eli Lilly while pushing Amylin back into Bristol-Myers arms in 2012.
Now 81, Icahn still packs plenty of clout when it comes to generating fresh speculation about a deal. Bristol-Myers, though, has a market cap of $91 billion, making it a megamarket target that only a handful of companies could pull off. That won’t stop the speculation, though, as the big biopharma moves to the center of the M&A scene now that Icahn has entered, stage left.
___________________________________________
https://endpts.com/buyout-buzz-swells-for-the-giant-bristol-myers-after-carl-icahn-makes-an-entrance-stage-left/
BMY
From what I read GILD now has 2 vouchers. See no info on Twitter as to how the new one will be used, only speculation that they can buy a hot Phase III company and accelerate the pace. Suppose like having a get out of jail free card which given their cash might be nice insurance.
I suppose at the least they can sell it for more than they paid because seemingly they got it at a bargain price.
GILD
WSJ reports Icahn has taken a stake -- sees BMY as possible takeover target and likes pipeline.
BMY
I believe it is a pediatric voucher which be definition is limited to age 18.
GILD
Another take:
_________________________________________________
Gilead snaps up Sarepta's priority review voucher for $125M
Ned Pagliarulo
@NedPagliarulo
PUBLISHED
Feb. 21, 2017
Dive Brief:
Hoping to speed up future regulatory review for its drug candidates, Gilead has agreed to buy a priority review voucher from Sarepta Therapeutics for $125 million, according to a regulatory document filed by Sarepta.
Sarepta had obtained the voucher — a transferrable credit designed to speed review by the Food and Drug Administration by four months — for winning approval of its disease-modifying treatment for Duchenne muscular dystrophy (DMD) last year.
The price paid by Gilead, while still steep, is well below the $200 million plus fetched in previous sales of priority review vouchers. AbbVie, for example, paid United Therapeutics a princely $350 million for one in 2015.
Dive Insight:
This isn't the first time Gilead has raided the bank to pick up one of the coveted priority review vouchers. The large biotech paid a similar $125 million to acquire one from Knight Therapeutics in March 2014 and a regulatory filing from last summer disclosed the purchase of another for an undisclosed price.
Backing out other known costs from Gilead's estimates in that regulatory document, it is likely Gilead paid somewhere in the $200 million or below range for that second voucher, according to EP Vantage's Jacob Plieth.
Pharmaceutical companies are willing to pay up for the vouchers because use of one can shave off four months from the FDA's usual regulatory review period of 10 months. That additional time on market can be vital for securing market share ahead of competitors.
Sanofi and Regeneron, for example, used a priority review voucher they obtained from BioMarin to speed up review of their PCSK9 inhibitor Praluent (alirocumab), which was approved a month ahead of Amgen's rival Repatha.
Sanofi used another voucher, bought from Retrophin for $245 million in 2015, in an effort to get its insulin/GLP-1 combination treatment approved before a rival product from Novo Nordisk. The FDA, however, asked Sanofi for more information on the combo, delaying approval. Both Sanofi's and Novo's products were approved last November.
Sarepta had received its voucher from the FDA under a program designed to speed development of neglected or rare pediatric diseases. Developers of drugs for designated conditions receive a priority review voucher upon approval and can then sell or use that voucher. Another parallel program provides the same incentive to developers of drugs for rare tropical diseases.
Sale of the voucher, albeit for a lower price than some had expected, will bolster Sarepta's cash position and help fund clinical development of Sarepta's pipeline and manufacturing scale-up, company CFO Sandy Mahatme said on a recent earnings call.
For Gilead, the voucher could be used to speed review for one of its several late-stage candidates. The $125 million is a relative bargain as well, compared to both the recent prices paid by Sanofi and AbbVie as well as to Gilead's large cash hoard.
________________________________________
http://www.biopharmadive.com/news/sarepta-priority-review-voucher-gilead-sale-125/436572/
GILD
I believe they were referring to this:
_______________________________________________
What Other Types of Vouchers Exist?
To date, only one other type of voucher exists: The Rare Pediatric Disease Priority Review Voucher.
The rare pediatric voucher was created in 2012 under the Food and Drug Administration Safety and Innovation Act (FDASIA), and specifically targets the need for additional therapies for rare pediatric subsets of other diseases.
Section 908 of FDASIA defines a "rare pediatric disease" as one which "primarily affects individuals aged from birth to 18 years, including age groups often called neonates, infants, children and adolescents," and is a rare disease according to federal statute (200,000 persons in the US or fewer).
The rare pediatric voucher system is closely modeled off the tropical disease voucher system, with several exceptions. Perhaps the most notable difference at the time of the pediatric voucher's initial passing was its relative ease of use. Unlike the tropical voucher, which required FDA to be notified 365 days prior to its use, the rare pediatric voucher could be used just 90 days prior to its use.
Another key difference: The rare pediatric voucher could be transferred (i.e. sold) an unlimited number of times, unlike the tropical disease voucher which could only be sold once.
However, as of December 2014, both of these differences have been erased under the Adding Ebola to the FDA Priority Review Voucher Program Act, which eliminated the disparity between the two vouchers. Tropical vouchers may now be redeemed in just 90 days, and may be resold an unlimited number of times.
FDA has also indicated that the vouchers will require the same user fee.
- See more at: http://www.raps.org/Regulatory-Focus/News/2015/07/02/21722/Regulatory-Explainer-Everything-You-Need-to-Know-About-FDA%E2%80%99s-Priority-Review-Vouchers/#sthash.xkebF4yD.dpuf
Lot of info there. It is new to me. Seems like GILD got a good deal. Bullish blog about GILD's advantage on SA.
GILD
Sarepta sells FDA review voucher for $125M, but analyst questions price
Feb 21, 2017, 9:49am EST
Max Stendahl
Biotech Reporter
Boston Business Journal
Sarepta Therapeutics on Tuesday sold a voucher that can speed up FDA reviews to Gilead Sciences for $125 million, but one analyst said the Cambridge biotech may have undervalued the asset.
Sarepta (Nasdaq: SRPT) received the rare pediatric disease priority review voucher when the FDA approved its Duchenne muscular dystrophy drug, Exondys51, in September. Companies can use the vouchers to shorten the review period for a subsequent drug, or sell them to other firms.
The headquarters of Sarepta Therapeutics at 215 First St. in Cambridge.
Enlarge
The headquarters of Sarepta Therapeutics at 215 First St. in Cambridge.
Gilead (Nasdaq: GILD) may now use the voucher to potentially speed up approval of any drug that treats a serious or life-threatening disease that affects people up to age 18.
In a research note, Leerink Partners analyst Joseph Schwartz said that the price tag was lower than his expectation of $200 million. In recent years, such vouchers have fetched anywhere from $67.5 million to $350 million.
"While this non-dilutive amount will surely add additional runway to Sarepta's cash position, we cannot help but wonder if this transaction reflects a 1) broader decline in PRV interest among bidders, or 2) an undervalued asset sale," he wrote.
Exondys51 targets a specific gene mutation shared by about 13 percent of patients with DMD, a disorder that causes progressive muscle weakness. It works by skipping over one specific gene mutation that prevents the creation of dystrophin, a protein needed for muscle maintenance. The FDA’s approval sparked controversy given the limited nature of the company’s trial data.
“Our mission at Sarepta Therapeutics is to treat more boys with Duchenne muscular dystrophy,” Sarepta CEO Ed Kaye said in a statement Tuesday. “The sale of the PRV provides an important source of non-dilutive capital to support the rapid advancement of our follow on exon skipping candidates and next generation RNA targeted antisense platform.”
Shares of Sarepta were 2 percent higher on Tuesday to $28.78 as of 9:45 a.m.
Sarepta announced in January that Exondys51 had generated $5.4 million in sales in the fourth quarter of 2016, beating analysts’ expectations. The company is developing other exon-skipping treatments for DMD, as well as drugs that take a gene therapy approach to the disorder.
______________________________________
http://www.bizjournals.com/boston/news/2017/02/21/sarepta-sells-fda-review-voucher-for-125m-but.html?ana=yahoo
GILD
I'm referring to over-bought as evidenced by technical indicators which chartists use. First entered over-bought about 2 weeks ago, depending on the indicator used and the setting. Left over-sold last several days of January. You need to subscribe to StockCharts to see all the indicators on this chart:
IDRA
The F-R rule has nothing to do with the FDA decision, only the Phase III results. For a discussion, including the one exception to the rule:
______________________________________________________
Does The Feuerstein-Ratain Rule Predict Failure For The Aldoxorubicin Phase 3 Study?
Jun. 28, 2016 4:43 PM ET|2 comments |Includes:CytRx Corporation (CYTR)
CytRx (NASDAQ:CYTR) is not a large or small cap developmental stage biotech company--they're a micro cap biotech company with a candidate that has progressed to phase 3 (P3) development. Generally I feel an aversion towards investing in such companies, especially when they are close to reporting topline P3 data for an oncology product. The reason being that the market has been pretty efficient at rewarding companies with P3 oncology trials advanced on spurious grounds with low market caps ("MC") over the last 16 years. Actually, CYTR is the first such exception I've made.
A rule known as the Feuerstein-Ratain (F-R) rule exemplifies just this sort of efficient market hypothesis. However, though highly predictive thus far (CPXX the most prominent exception), the sample being used to validate the F-R rule is admittedly "small."
...we calculated the market capitalization (ie, the total shares outstanding times the price per share) for each company at 120 days before each of the public announcements using data derived from Supplementary Tables 1 and 2 in Rothenstein et al. and publically available information. This analysis demonstrated a remarkable difference between companies that had positive and negative announcements.
Specifically, the median market capitalization was approximately 80-fold greater for the companies with positive trials vs companies with negative trials ($17.8 billion vs $220 million, P < .001, two-sided Mann-Whitney test). There were no positive trials among the 21 micro-cap companies (ie, companies with less than $300 million market capitalization), whereas 21 of 27 studies reported by the larger companies analyzed (greater than $1 billion capitalization) were positive.
The F-R rule plainly states that no--or at this point amended to "very few"--phase 3 studies will be successful if sponsored or co-sponsored by a micro cap company (< $300mm MC). 48 studies were cited in the above retrospective analysis, which included 21 sponsored by micro caps. F-R updated their rule in early 2014, uncovering a further 15 such failures.
Adam stated:
When Dr. Mark Ratain and I came up with the concept for the F-R Rule in 2011, we were limited to analyzing a data set of 59 phase III oncology clinical trials conducted between 2000 and 2009.
For the update, I asked the research staff at BioMedTracker to help me bridge the gap between the initial analysis and the present by compiling a new list of phase III oncology studies conducted from 2009 through February 2014. BioMedTracker delivered to me a list of 72 oncology phase III trials. [These were the findings]:
Companies with a MC > $1B:
-37 pivotal P3 trials
-20 were positive (54%)
-17 were negative (46%)
Small cap companies (MC $300mm - $999mm):
-11 pivotal P3 trials
-6 were positive (55%)
-5 were negative (45%)
Micro cap companies (MC < $300mm)
-15 pivotal P3 trials
-0 were positive
-15 were negative
(9 not included in analysis because either privately held or could not determine MC).
He concluded:
We're beyond calling the F-R Rule a fluke finding at this point. Combined, the two data sets encompass 112 oncology phase III clinical trials from 2000 to February 2014. Of these 112 trials, 36 were conducted by companies with market caps of $300 million or less, measured four months prior to results being announced. NONE of these 36 trials reported a positive outcome.
There is a real and noticeable phenomenon here. However, any time we find a correlation there is also the potential to wrongfully assume causation.
Journalists are constantly being reminded that "correlation doesn't imply causation;" yet, conflating the two remains one of the most common errors in news reporting on scientific and health-related studies. In theory, these are easy to distinguish-an action or occurrence can cause another (such as smoking causes lung cancer), or it can correlate with another (such as smoking is correlated with high alcohol consumption). If one action causes another, then they are most certainly correlated. But just because two things occur together does not mean that one caused the other, even if it seems to make sense.
Have Adam and Dr. Ratain identified a correlation? Yes, it seems they have. But have they identified the cause? Does a sub-$300mm MC, four months before topline data are reported, cause a phase 3 study to fail? No, of course not--that should be obvious. So what is the true cause of failure? Adam sought to provide a reasonable explanation as follows:
The internal discipline at larger companies that kill off weaker cancer drug candidates before they reach phase III studies are totally absent in micro and small-cap companies.
All drugs are "stars" at small companies. R&D budgets are tighter, which steers these companies towards running smaller phase II studies -- most non-randomized and uncontrolled -- which too often deliver clinical data skewed positive. The positive signals seen in phase II studies cannot be replicated in larger, better-designed phase III studies.
The management teams of small cancer drug companies are incentivized to ignore signals their drugs may not work and just push ahead with new trials.
Larger companies certainly don't have perfect cancer drug track records, but they do have fatter pipelines, which forces early-stage drugs to compete for R&D dollars. The bar for moving a drug into phase III studies is higher at larger companies, which is why their success rates are higher.
The market also incentivizes larger companies to be more disciplined with R&D expenses. Wasted R&D steals from earnings -- something investors do not like.
And so in essence what he is suggesting is the market, being a collective of minds with experience and insight, tend to come to accurate conclusions about the potential success or failure of a company or drug candidate. This is reflected (in large part) in the MC.
But when has the market ever been wrong? The answer is: many a time. It doesn't take that long to come up with any number of examples. APPL, BRK.A, GILD, CPXX are all stocks that were undervalued, or severely undervalued at one point or other even when information to decide otherwise had already been disseminated. The market is much better at accurately valuing what it can see clearly than it is at predicting anything. In fact, the market seems at times completely incompetent at predicting. Those times that stand out in my mind in which it has tried were often failures--such as the tech bubble. The market, like us, because it is us, is either hopeful or pessimistic prior to everything being "out on the table," and often expresses exaggerations of either predisposition.
Is there an alternative explanation for why we are seeing this supposed correlation (< $300mm MC = 0% oncology P3 success)? It is my opinion that Adam mostly has it right. The market has predicted it very accurately here. Almost shockingly so. Although I think he overextends when he also claims it cannot be a fluke, now that the sample has grown to a massive n=36... (I jest). Instead, we are likely seeing an inflammation of probability. In other words, variance.
There have been hundreds of P3 oncology studies sponsored by big pharma during the time those 36 micro cap sponsored P3 studies reported topline (13 years). The meta-analyses are skewed in this respect. The number of big pharma P3 studies are vastly under-represented in the sample. It would be very easy to find 50 or 100 such BP failures during those years. Were there stretches of time in which BP recorded 10, 15, 20 failures in a row? Certainly. Especially (and this is key) if futility halts were included in the list of fails.
Most larger companies have futility stopping boundaries included in their study designs. This of course saves them money and time put to better use in developing therapies that have a greater chance of success. Micro caps often forgo the futility analysis, or make the stopping boundaries that may trigger a halt for futility abnormally high (or make them "non-binding"), because, as Adam points out, they have their whole companies essentially riding on the result. It's unpalatable for them to potentially halt a study for futility before its completion, even if the chance of success after an interim review is extremely small.
So when BP reports topline data, most of these studies have already passed one or multiple futility looks. You actually don't even hear about many of the ones that didn't pass, as it is not a material event for them. The F-R rule is making an unequal comparison by not factoring in this variable. It's a classic example of ascertainment bias. But even if it did avoid such bias, the sample is too small to derive a reliable conclusion from (from a statistical point of view).
The F-R rule is an artifact of consequence. What we are seeing with the rule is an observation made in a window of time. It would likely take 1,000 or more studies to begin to have a grasp on the probability inherent to this exercise, and only if all other variables could be controlled (say with flipping an unbiased coin). In other words, with all other things being equal.
Of course, by the time 1,000 micro cap sponsored studies were conducted, everything in the "environment" will have changed; there is no way to control the variability that may impact data in this exercise. The extraneous circumstances surrounding micro cap bios running P3 studies from 2000-2014 will never be repeated--at least not in exactly the same way. Therefore the high predicting power of the F-R rule at present is limited, and may even be imaginary. Perhaps the "true" probability is closer to 65% - 80%. As with flipping a coin, anything can happen in a short window of time (12 heads vs 2 tails) that will not accurately reflect the true probability of outcome. I say "short" relative to the time it would take to have a statistically meaningful sample.
So the question naturally arises, how reliable is an observation noted from a small sample in a "short" window of time in a vastly dynamic environment? I would posit that the reliability of such an observation continually repeating, and to what degree, is largely unknown.
Not that the F-R rule was the intention of the original analyses anyway, which I'll get into in a moment. But considering CPXX recently broke the rule at a very small MC (approx $64mm -120 to -1 days before topline--they were acquired a few months later for $1.5B, representing an incredible and utter "misread" by the market, which also only awarded CPXX with a $350mm MC after topline was reported), and also CTIC not long before that--it is possible that the true predicting power of the F-R rule is much less than the 95% accuracy it currently touts. In fact, if we took only the last 4 micro cap sponsored P3 studies that reported topline data, and compare that success rate with big pharma's last 4, the micro caps would be doing better. I'm making a faulty conclusion, of course, based on a very small sample--but then probably so does the F-R rule.
The rule began as a retrospective analysis of a meta-analysis, one that sought to find trends in stock prices before positive data or regulatory approval. It was a follow-on study, inspired by this one:
We examined stock prices of biotechnology products before and after announcement of Phase III clinical trial and Food and Drug Administration (FDA) Advisory Panel results for indirect evidence of insider trading.
Biotechnology stock prices were recorded for 98 products undergoing Phase III clinical trials and 49 products undergoing FDA Advisory Panel review between 1990 and 1998. Prices were recorded for 120 consecutive trading days before and after public announcement of these two events. We compared the average change in stock price of successful products ('winners') with unsuccessful products ('losers') before the public announcement of results for both critical events.
The difference between average stock price change from 120 to 3 days before public announcement of results of Phase III clinical trial winners (+27%) and losers (-4%) was highly significant (P = 0.0007). A similar but non-significant difference was observed between the average stock price of winning (+27%) and losing products (+13%) before FDA Advisory Panel review announcements (P = 0.25).
I would be very curious to learn how many < $300mm MC companies were "winners" in the above analysis (pre-2000), if any, that were omitted in F-R's analysis (post-2000). It's an interesting question: how has this rule performed historically, adjusted for inflation?
The above meta-analysis shows a clear trend from 120 days to 3 days before topline data were divulged, wherein the stock price of companies that reported successful outcomes trended up in the 4 months leading to data, while those with unsuccessful outcomes trended down. This led the authors to suspect leaked data from one source or another (CRO perhaps, or someone with access to confidential patient data at a site that had enrolled a significant number of patients, MOB, etc.).
The follow-on meta anlaysis examined these findings further, and also found an up-trend in stock price from companies that reported positive or negative data from 120 days in, though not significant (p=0.09). They also found a stronger and statistically significant uptrend from 60 days in (p=0.03).
Adam and Dr. Ratain made a retrospective discovery from the second of the two above analyses. A significant discovery, in my opinion, though the meta analyses were not designed to determine such a thing. Have there really only been 36 phase 3 oncology studies from micro cap companies that reported topline data between 2000-2014? No where do the authors make the claim that the list is exhaustive. Also, no claims are made on micro cap bio companies prior to 2000. And it appears based on the first of the above two meta-analyses that there may have been a few of them among the "winners."
So although helpful as a guide it appears the F-R rule is lacking on several fundamental points. For one, the sample is small (n=36) and confined to a "short" window of time (2000-2014). Hence, and due to variance, the true probability of this rule has not yet been determined. Currently it is trending very high (just 2 out of some 40 P3 studies sponsored by micro caps were successful--95% predictive), but would take a while to derive reliable predictive power from. Over the last 4 topline readouts it has only been 50% predictive (with micro caps doing better than BP).
As an example of variance, let's say you rolled a die 36 times and never saw a "1." It would be very rare (1/500), but it is possible--and given enough time, actually must happen. If that were to occur on a given round of 36 rolls, you might come to conclude, "The '1' very, very rarely ever comes--maybe it never does." And let's say you also noted that the "6" came up 15/36 times (41%), and further concluded the "6" comes up more often than any other number. Of course all of that would be wrong--you were only experiencing variance. The true predictive power for rolling a "1" or a "6" on a six-sided die are equal at about 16.7%. After rolling the die 1,000--or better yet, 10,000 times, you would see a much more balanced distribution of outcome, with each number coming up closer and closer to 16.7% of the time.
What I see as the main issue with the F-R rule is that there is no underlying law of nature to force the probability to abide by, with calculated variance. An "odds-on" scenario that '95% of P3 oncology studies sponsored by a micro cap will fail' (currently, until it goes down even lower), cannot strictly apply for fundamental reasons. This is not a vacuum in which probability can be determined simply by dividing 1 by the number of potential outcomes. It just isn't that simple. The 'magic' number "$300mm" will actually not tell you anything.
There are some things we do know: a) the market will be wrong at predicting outcomes, at least a significant % of the time; b) the F-R rule has been broken 2 out of 40 known times, and interestingly 2 out of the last 4; d) the true predictive power of the F-R rule is unknown due to variance, variability of external stimuli, and small sample size; e) in the case of the F-R rule, correlation does not imply causation; f) the F-R rule does not consider futility halts from larger market cap sponsors that go unreported, committing ascertainment bias; and lastly, e) a more complete analysis should be conducted going back to 1980 (adjusted for inflation), with verification that every single oncology P3 study sponsored by a micro cap was covered, with none left out of the analysis. Although even this much larger data set would be lacking--past performance does not guarantee future outcome.
The F-R rule is certainly not something that can be ignored, however, and should be weighed against any long-thesis--but it is no law, and it's 95% predictive power (currently) could be, and probably is, overblown. It is still very much a hypothesis, or at best a general maxim or 'trend' that should be allowing of exceptions. And in my opinion it places too much confidence in the market's ability to predict, something that has been spurious in the past.
Stocks: CYTR
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http://seekingalpha.com/instablog/18578282-steven-giardino/4894923-feuerstein-ratain-rule-predict-failure-aldoxorubicin-phase-3-study
By the way CYTR failed.
AEZS odds are not good.
(I have no shares)
AEZS
JANA influence:
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Bristol-Myers Squibb Appoints Three New Independent Directors
By Business Wire, February 21, 2017, 06:59:00 AM EDT
Announces $2 BillionAccelerated Share Repurchase Program
NEW YORK--(BUSINESS WIRE)-- Bristol-Myers Squibb Company (NYSE:BMY) announced today that it has appointed Robert J. Bertolini, Matthew W. Emmens and Theodore R. Samuels to its Board of Directors, effective immediately. In connection with these appointments, the Board will temporarily expand to 14 directors until the 2017 Annual Meeting, to be held on May 2, 2017. Only 11 directors will stand for election at the meeting. Bristol-Myers Squibb also announced that it has entered into an accelerated share repurchase ("ASR") program to repurchase, in aggregate, $2 billion of Bristol-Myers Squibb's common stock.
Giovanni Caforio, M.D., chief executive officer of Bristol-Myers Squibb, said, "Bristol-Myers Squibb continues to take decisive action to best position the company for growth driven by our leading portfolio of Immuno-Oncology medicines, including Opdivo, and by an exciting diversified portfolio of medicines such as Eliquis and Orencia. We are committed to advancing the promising opportunities represented by our portfolio and pipeline in oncology as well as continuing our efforts to diversify through promising pipeline agents in heart failure, immunoscience and fibrosis. Our new directors add important experience and skills managing large businesses and operations, broaden our overall expertise in the pharmaceutical sector and more broadly in capital markets, and complement extremely well the existing skills on our Board. We look forward to working with them to advance our business strategy.
"In addition, the decision to implement an accelerated share repurchase program demonstrates our focus on enhancing shareholder returns as we continue to capitalize on our long-term opportunities," Caforio continued.
"I am pleased to welcome Bob, Matt and Ted to the Board, and know that their unique skill sets and experience will be invaluable to the company going forward," said Lamberto Andreotti, chairman of the Board. "As I announced in December, I will be retiring as chairman, effective May 2, 2017. I am happy to be leaving with such a strong Board in place and am confident Bristol-Myers Squibb has a bright future."
Bristol-Myers Squibb noted that, since JANA Partners LLC ("JANA") became a Bristol-Myers Squibb shareholder in the fourth quarter of 2016, members of the Board and management have engaged in discussions with representatives of JANA to better understand their views. Today's Board appointments follow discussions between the two parties regarding the Board.
"These three new independent directors will add valuable industry knowledge and fresh perspectives to the Board, and shareholders stand to reap a substantial benefit from the company's sizable investment in its undervalued shares," said Barry Rosenstein, founder and managing partner of JANA. "These are two very positive developments for all Bristol-Myers Squibb shareholders."
Togo D. West, Jr., the board's lead independent director, said, "Bristol Myers-Squibb benefits from a strong Board that comprises leaders who have diverse expertise relevant to the company's strategy and mission. We welcome Bob, Matt and Ted to the Board and look forward to their contributions."
"Bristol-Myers Squibb is widely regarded as an innovator and a leader with a strong portfolio of assets that will help drive value for shareholders," said Samuels. "I look forward to working with my colleagues on the Board to continue advancing the company's important mission."
"I am honored to join the Bristol-Myers Squibb Board and to work alongside some of the great minds in science and medicine," said Emmens. "With a diverse portfolio and a strong pipeline, I am confident that Bristol-Myers Squibb will continue to find solutions for patients with high unmet medical needs."
"I am pleased to be joining the Board during a period of innovation and scientific discovery," said Bertolini. "I look forward to joining my fellow directors and the management team in helping Bristol-Myers Squibb with the compelling opportunities ahead."
Accelerated Share Repurchase
Bristol-Myers Squibb has entered into an ASR program with each of Morgan Stanley & Co. LLC and Goldman, Sachs & Co. to repurchase, in aggregate, $2 billion of Bristol-Myers Squibb's common stock. The company expects to fund the repurchase with a combination of debt and cash. Approximately 80 percent of the shares to be repurchased under the transaction will be received by Bristol-Myers Squibb on February 28, 2017. The total number of shares ultimately repurchased under the program will be determined upon final settlement and will be based on a discount to the volume-weighted average price of Bristol-Myers Squibb's common stock during the ASR period. The program is part of Bristol-Myers Squibb's existing share repurchase authorization. Bristol-Myers Squibb anticipates that all repurchases under the ASR will be completed by the end of the second quarter of 2017. Bristol-Myers Squibb notes that it is commencing a 10b5-1 plan to facilitate continuous stock repurchase activity by the company.
Robert J. Bertolini
Bob Bertolini, who currently serves on the boards of Charles River Laboratories and Actelion Pharmaceuticals Ltd., is the former president and CFO of Bausch & Lomb. Previously, Bertolini served as executive vice president and CFO at Schering-Plough Corporation and as a Partner and Pharmaceutical Industry Practice Leader at PricewaterhouseCoopers LLC. He brings extensive financial and accounting expertise and significant strategic and operational leadership experience in the biopharmaceutical industry to the Board of Bristol-Myers Squibb.
Matthew W. Emmens
Matt Emmens is the former chairman, president and CEO of Vertex Pharmaceuticals. Prior to Vertex, Emmens served as chairman and CEO of Shire Pharmaceuticals and as president and CEO of Astra Merck, the joint venture between Merck and Astra AB. He brings to the Board of Bristol-Myers Squibb more than 40 years of experience in the biopharmaceutical industry, with significant management, business development and operations expertise.
Theodore R. Samuels
Ted Samuels, who currently serves on the boards of Perrigo Company plc and Stamps.com, has more than 35 years of financial industry experience. As the former president of Capital Guardian Trust Company and a former global equity portfolio manager at Capital Group, Samuels has extensive business and operational experience, particularly with respect to economics, capital markets and investment decision making.
Morgan Stanley is serving as financial advisor to Bristol-Myers Squibb and Kirkland & Ellis LLP is serving as legal counsel. Covington & Burling LLP is serving as legal counsel to Bristol-Myers Squibb in connection with the ASR.
About Bristol-Myers Squibb
Bristol-Myers Squibb is a global biopharmaceutical company whose mission is to discover, develop and deliver innovative medicines that help patients prevail over serious diseases. For more information about Bristol-Myers Squibb, visit us at BMS.com or follow us on LinkedIn, Twitter, YouTube and Facebook.
Statement on Cautionary Factors
These materials contain certain forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 regarding, among other things, statements relating to goals, plans and projections regarding the company's financial position, results of operations, market position, product development and business strategy. These statements may be identified by the fact that they use words such as "anticipate," "estimates," "should," "expect," "guidance," "project," "intend," "plan," "believe" and other words and terms of similar meaning in connection with any discussion of future operating or financial performance. Such forward-looking statements are based on current expectations and involve inherent risks and uncertainties, including factors that could delay, divert or change any of them, and could cause actual outcomes and results to differ materially from current expectations.
These factors include, among other things, effects of the continuing implementation of governmental laws and regulations related to Medicare, Medicaid, Medicaid managed care organizations and entities under the Public Health Service 340B program, pharmaceutical rebates and reimbursement, market factors, competitive product development and approvals, pricing controls and pressures (including changes in rules and practices of managed care groups and institutional and governmental purchasers), economic conditions such as interest rate and currency exchange rate fluctuations, judicial decisions, claims and concerns that may arise regarding the safety and efficacy of in-line products and product candidates, changes to wholesaler inventory levels, variability in data provided by third parties, changes in, and interpretation of, governmental regulations and legislation affecting domestic or foreign operations, including tax obligations, changes to business or tax planning strategies, difficulties and delays in product development, manufacturing or sales including any potential future recalls, patent positions, the ultimate outcome of any litigation matter, and our level of indebtedness. These factors also include the company's ability to execute successfully its strategic plans, including its business development strategy, the expiration of patents or data protection on certain products, including assumptions about the company's ability to retain patent exclusivity of certain products, and the impact and result of governmental investigations. There can be no guarantees with respect to pipeline products that future clinical studies will support the data described in this release, that the compounds will receive necessary regulatory approvals, or that they will prove to be commercially successful; nor are there guarantees that regulatory approvals will be sought, or sought within currently expected timeframes, or that contractual milestones will be achieved. For further details and a discussion of these and other risks and uncertainties, see the company's periodic reports, including the annual report on Form 10-K, quarterly reports on Form 10-Q and current reports on Form 8-K, filed with or furnished to the SEC. The company undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events or otherwise.
View source version on businesswire.com: http://www.businesswire.com/news/home/20170221005787/en/
Source: Bristol-Myers Squibb Company
Read more: http://www.nasdaq.com/press-release/bristolmyers-squibb-appoints-three-new-independent-directors-20170221-00351#ixzz4ZKEMOrCd
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BMY
Abstracts:
Embargo Policy
The embargo on all abstracts part of the 2017 ASCO-SITC Clinical Immuno-Oncology Symposium will lift at 5:00 PM ET on Tuesday, February 21, 2017. An embargoed presscast (virtual press briefing held via teleconference and webinar) will be held at 12:00 noon ET on February 21 for credentialed media.
https://www.asco.org/about-asco/press-center/media-resources-meetings/asco-sitc-clinical-immuno-oncology-symposium-media
IDRA
Solid volume:
Today's High /Low $ 1.76 / $ 1.655
Share Volume 479,829
50 Day Avg. Daily Volume 832,151
Read more: http://www.nasdaq.com/symbol/idra#ixzz4YxoinuVE
IDRA
Out of GIII @ $26.50 for small gain. Probably will run today, but have kept seeing early gains slowly diminishing to EOD.
GIII
Strange after-hours trade yesterday:
17:05:54 $ 59.785 High 37
And pre-market trade today:
08:00:03 $ 53.58 Low 60
BMY
Good information, thanks. I'm guessing they are available at market close on the 21st. You know?
Volume and pps have picked up anticipating positive data.
IDRA
Gilead Receives Approval In Canada For ODEFSEY(TM) For The Treatment Of HIV-1 Infection
CNW Group - 14 minutes ago
- ODEFSEY is the Second Single Tablet Regimen Containing the DescovyTM Backbone and the Third Product in Gilead's New TAF Portfolio to Receive Approval in Canada -
Gilead Sciences Canada, Inc. (Gilead Canada) today announced that Health Canada has granted a Notice of Compliance (NOC) for ODEFSEYTM (emtricitabine 200 mg/rilpivirine 25 mg/tenofovir alafenamide 25 mg) tablets as a complete regimen for the treatment of adults with HIV-1 infection. ODEFSEY is the most recent product approved from Gilead Canada's range of tenofovir alafenamide (TAF)-based regimens that include GENVOYA® and DESCOVYTM.
ODEFSEY is indicated in Canada as a complete regimen for the treatment of adults infected with HIV-1 with no known mutations associated with resistance to the non-nucleoside reverse transcriptase inhibitor (NNRTI) class, tenofovir or emtricitabine, and who have HIV-1 RNA levels less than or equal to 100,000 copies per mL.
TAF is a novel targeted prodrug of tenofovir that has demonstrated high antiviral efficacy similar to and at a dose less than one-tenth that of Gilead's VIREAD® (tenofovir disoproxil fumarate, TDF). TAF has also demonstrated improvement in surrogate laboratory markers of renal and bone safety as compared to TDF in clinical trials in combination with other antiretroviral agents. Data show that because TAF loads cells, including HIV-infected cells, more efficiently than TDF, it can be given at a much lower dose resulting in >90 per cent lower concentrations of tenofovir in plasma.
"People living with HIV today are increasingly likely to be receiving treatment for other conditions, such as heart, kidney and liver disease, because they are living longer than ever before, exposing them for longer periods of time to the virus and to the antiviral medications used to treat it," said Dr. Stephen Shafran, Professor of Medicine, Division of Infectious Diseases, University of Alberta. "Therefore, we need new treatments that are not only efficacious, but well tolerated and simple to dose.
"In clinical studies, TAF has shown improvements in multiple bone and renal laboratory parameters compared to TDF (tenofovir disoproxil fumarate)," added Dr. Shafran. "ODEFSEY offers a new treatment option to support patients who are new to antiretroviral treatment, or who may be needing a replacement for an older antiretroviral regimen in those who are virologically suppressed. Today, the goal of treatment is beyond achieving an undetectable status, as we are now able to address longer-term side effects to help patients live an improved quality of life."
"The approval of ODEFSEY underscores Gilead's ongoing commitment to researching and developing new treatment options to help address the evolving needs of a range of HIV patients, which for many patients has now become a chronic condition," said Kennet Brysting, General Manager, Gilead Canada. "As such, novel simple and well tolerated treatments, such as TAF-based regimens, are becoming the cornerstone of HIV therapy."
ODEFSEY does not cure, nor prevent, HIV infection or AIDS.
Important Safety Information
The ODEFSEY Product Monograph has serious warnings regarding the risks of lactic acidosis, severe hepatomegaly with steatosis, and post treatment exacerbation of hepatitis B. For important safety information for ODEFSEY, including contraindications and additional warnings and precautions, please see the Canadian Product Monograph.
About Gilead Sciences
Gilead Sciences, Inc. (Gilead) is a biopharmaceutical company that discovers, develops and commercializes innovative therapeutics in areas of unmet medical need. The company's mission is to advance the care of patients suffering from life-threatening diseases. Gilead has operations in more than 30 countries worldwide, with headquarters in Foster City, California. Gilead Sciences Canada, Inc., is the Canadian affiliate of Gilead Sciences, Inc. and was established in Mississauga, Ontario, in 2005.
Forward-Looking Statement
This press release includes forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 that are subject to risks, uncertainties and other factors, including the risk that physicians may not see the benefits of prescribing ODEFSEYTM. These risks, uncertainties and other factors could cause actual results to differ materially from those referred to in the forward-looking statements. The reader is cautioned not to rely on these forward-looking statements. These and other risks are described in detail in Gilead's Quarterly Report on Form 10-Q for the quarter ended September 30, 2016, as filed with the U.S. Securities and Exchange Commission. All forward-looking statements are based on information currently available to Gilead, and Gilead assumes no obligation to update any such forward-looking statements.
Canadian Product Monograph for ODEFSEYTM is available at www.gilead.ca
COMPLERA®, DESCOVYTM, GENVOYA®, ODEFSEYTM are trademarks of Gilead Sciences, Inc., or its related companies.
EDURANT® is a registered trademark of Janssen Sciences Ireland UC.
For more information on Gilead Sciences, please visit the company's website at www.gilead.com, follow Gilead on Twitter (@GileadSciences) or call Gilead Public Affairs at 1-800-GILEAD-5 or1-650-574-3000
SOURCE Gilead Sciences, Inc.
To view this news release in HTML formatting, please use the following URL: http://www.newswire.ca/en/releases/archive/February2017/16/c3178.html
SOURCE: Gilead Sciences, Inc.
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GILD