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Nice day for HGEN. Looks like it took off in the last hour of trading today, but the only news I see is that they'll be presenting at an investor conference tomorrow, with an update on the Phase 3 Covid enrollment.
TA/charts are not especially useful with bio stocks, but PRVB looks like it's trying to move up through key resistance (Jan and June highs), so a good sign. I haven't gotten up to speed on the stock yet, so can't comment on the fundamentals, but the chart looks promising.
KZIA looks like it might consolidate further, into the 8-9 range, based on the chart anyway. Support is the Aug/Sept high (low 8s) and the rising 50 MA (7.78). Fwiw, I'll probably be starting a position in that 8-9 area, subject to my $1000 limit of course :o)
I'm curious why you continue to have your neck out so far with these bio stocks? Once an investor has really big success, as you have, there is usually a transition to a more conservative style.
Blade, >> did very well <<
That sounds like an understatement :o) I'm curious why you continue to have your neck out so far with these bio stocks? Once an investor has really big success, as you have, there is usually a transition to a more conservative style.
Being conservative is on the boring side however. I try to spice things up with some sector ETFs, while keeping fairly strict position limits. You seem to have relatively huge positions, so I hope you aren't 'hooked on the excitement', which can be a slippery slope, as I can attest from past misadventures.
>> HGEN <<
I had HGEN on my radar screen over the summer (loosely), but decided against Covid plays in general, and then HGEN did a reverse split ~Sept and I lost interest. But as you said, they do have a non-Covid pipeline and a good cash position. There was an I-Hub poster involved in bio research who liked the stock, which is how I heard about it.
Looks like Covid has been an expensive distraction for a lot of bio companies, but some also used it as a way to lift their stock price and raise money. The reverse split (which scared me off) also served to clean up HGEN's share structure, which is now down to 51 mil outstanding, per Yahoo, which restores their ability to raise more money. More often a reverse split is a signal to get out of a stock, but there are always exceptions.
Blade, >> CCXI only 10,000 shares left <<
Yikes, that's a huge position, and you had 10 times that before? With money like that, I'd be sitting on my yacht instead of researching stocks :o)
>> HGEN <<
I had HGEN on my radar screen over the summer (loosely), but decided against Covid plays in general, and then HGEN did a reverse split ~Sept and I lost interest. But as you said, they do have a non-Covid pipeline and a good cash position. There was an I-Hub poster involved in bio research who liked the stock, which is how I heard about it.
Looks like Covid has been an expensive distraction for a lot of bio companies, but some also used it as a way to lift their stock price and raise money. The reverse split (which scared me off) also served to clean up HGEN's share structure, which is now down to 51 mil outstanding, per Yahoo, which restores their ability to raise more money. More often a reverse split is a signal to get out of a stock, but there are always exceptions.
Yes, gfp, that's my list except for HGEN, a COVID-19 treatment play. I don't think the vaccines will make HGEN worthless.
I may re-enter TRIL at some point. But I want to see more data. Same with MEIP.
I'm looking at NCNA and AUTL as possibilities.
I've sold over 90% of my CCXI. I have only 10,000 shares left.
Bladerunner
>>> Oncternal Therapeutics, Inc. (ONCT), a clinical-stage biopharmaceutical company, develops oncology therapies for the treatment of cancers with critical unmet medical need. The company's product pipeline include cirmtuzumab, a monoclonal antibody designed to inhibit the receptor-tyrosine kinase-like orphan receptor 1 (ROR1) that is in Phase I/II clinical trial in combination with ibrutinib for the treatment of patients with mantle cell lymphoma and chronic lymphocytic leukemia; and is in Phase Ib clinical trial in combination with paclitaxel for the treatment of women with human epidermal growth factor receptor 2-negative metastatic or breast cancer. It also develops TK-216, a small-molecule that is designed to inhibit E26 transformation specific family of oncoproteins, which is in Phase I clinical trial to treat patients with Ewing sarcoma and in combination with vincristine chemotherapy. In addition, the company develops a chimeric antigen receptor-T product candidate that targets ROR1, which is in preclinical development for treating hematologic cancers and solid tumors. Oncternal Therapeutics, Inc. is headquartered in San Diego, California.
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Blade, >> ONCT << Thanks :o)
So far I have KZIA, CRVS, ONCT, CRDF, MYOV, PRVB, CCXI on my list. Any others you are liking? Thanks.
I've been reluctant to get back into bio investing, even a little, but I figure it might be ok as long as there are strict position limits of $1000 per stock. I've become a big believer in a more disciplined approach to investing, asset allocation, etc, and so far it's been working great, when combined with the criteria of only owning stocks/sectors for the longer term, so no short term trading. Even though they are speculative, your bio picks fit in with that criteria, and you have a talent for finding promising well funded small/micro caps :o)
CRVS, one of my favorites.
Bladerunner
gfp,
Check out ONCT, a nano-cap, oncology-focused biotech.
Bladerunner
>>> Corvus Pharmaceuticals, Inc. (CRVS), a clinical stage biopharmaceutical company, focuses on the development and commercialization of immuno-oncology therapies. Its lead product candidate is Ciforadenant (CPI-444), an oral, small molecule antagonist of the A2A receptor that is in Phase Ib/2 clinical trial for adenosine, an immune checkpoint. The company is also developing CPI-006, an anti-CD73 monoclonal antibody, which is in Phase I/Ib clinical trial that inhibits the production of adenosine and stimulate various immune cells, as well as Phase I clinical trial of CPI-006 for COVID-19; an antagonist of the adenosine A2B receptor; and CPI-818, a small molecule covalent inhibitor of interleukin-2-inducible T-cell kinase, that is Phase I/Ib clinical trial. Corvus Pharmaceuticals, Inc. also entered into a strategic collaboration with Angel Pharmaceuticals for the development its pipeline of targeted investigational medicines. The company was founded in 2014 and is based in Burlingame, California.
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>>> FDA authorizes the first coronavirus vaccine, a rare moment of hope in the deadly pandemic
Wash Post
by Laurie McGinley, Carolyn Y. Johnson
https://www.msn.com/en-us/news/us/fda-authorizes-the-first-coronavirus-vaccine-a-rare-moment-of-hope-in-the-deadly-pandemic/ar-BB1bR9AC?li=BBnb7Kz
Pfizer-BioNTech coronavirus vaccine approved, beginning scramble to innoculate…
FDA authorizes the first coronavirus vaccine, a rare moment of hope in the deadly pandemic
The Food and Drug Administration on Friday gave emergency use authorization to the nation’s first coronavirus vaccine, launching what scientists hope will be a critical counteroffensive against a pathogen that has killed more than 290,000 Americans, shredded the nation’s social and political fabric and devastated the economy.
The historic authorization of the vaccine from Pfizer and BioNTech for people age 16 and older, just 336 days after the genetic blueprint of a novel coronavirus was shared online by Chinese scientists, sets in motion a highly choreographed and complex distribution process aimed at speeding vaccines throughout the United States to curb the pandemic.
The FDA action came after White House Chief of Staff Mark Meadows on Friday told FDA commissioner Stephen Hahn to be prepared to submit his resignation if the agency did not clear the vaccine by day’s end, according to people familiar with the situation who spoke on the condition of anonymity because they were not authorized to discuss what happened.
Meadows’s threat followed months of efforts by FDA scientists to try to ward off President Trump’s importuning on the vaccine and keep the review process apolitical and transparent in hopes of boosting public confidence in the shots. The FDA already had planned to clear the vaccine Saturday morning, and accelerating the authorization to Friday night was not expected to change the delivery timeline of the first shots.
The nation set a record for covid-19 deaths Thursday for the second day in a row, surpassing 3,300. The death tally for Friday was 2,950, only slightly lower, bringing the U.S. death toll to nearly 295,000.
Federal officials have said distribution of the first 2.9 million doses of the highly effective vaccine would begin within 24 hours of an authorization. Meanwhile, an advisory committee for the Centers for Disease Control and Prevention, which has recommended that health-care workers and nursing home residents be the first recipients, was expected to bless the vaccine on Saturday, paving the way for inoculations to begin early next week.
The vaccine achievement creates a paradigm for vaccine development, proving that fast and flexible technologies paired with a single-minded focus by pharmaceutical companies and government can accomplish in 11 months what typically takes years. And it marks a rare triumph for the Trump administration, which in many other areas — such as ensuring adequate testing supplies and providing consistent guidance on whether to wear masks — has failed to produce a coherent and sustained response to the crisis.
“It’s an all-capital-letters, followed by several exclamation points,” accomplishment, said Howard Markel, a medical historian at the University of Michigan who predicted that the scientists who were responsible will be lionized for ending the pandemic.
Daniel Carpenter, a political scientist at Harvard University, said it was unprecedented to go from the discovery of a disease to the development of a vaccine in 11 months. The shortest timeline previously was for the mumps vaccine, which took four years. Most vaccines are produced for ailments that have been around for a long time, after years of research often marked by failures and disappointments. In the case of AIDS, there still is no vaccine, nearly four decades after HIV was identified.
Pfizer and its Germany-based partner, BioNTech, harnessed a fast, flexible genetic technology that had been in development for decades but never deployed in an approved medical product. It was used to build a vaccine that surpassed all expectations by being 95 percent effective at preventing disease in a clinical trial with tens of thousands of participants. The vaccine has already been approved in Britain, Canada, Saudia Arabia and Bahrain.
Meanwhile, the FDA, working closely with the companies, conducted an accelerated review that compressed into three weeks the typical months-long scrutiny of safety, effectiveness and data on manufacturing quality.
Operation Warp Speed, the administration’s effort to accelerate the development and distribution of coronavirus vaccines and treatments, has spent billions of dollars on a portfolio of vaccines, with Pfizer-BioNTech’s being the first to cross the finish line. Unlike the other companies, Pfizer and BioNTech did not take government money for research and development, but they did receive a $1.95 billion contract for 100 million doses, about 25 million of which will be delivered this year.
“To get there has required a host of innovations. … Any one of those would have been cause for considerable amazement,” said Francis S. Collins, director of the National Institutes of Health. “But when you put them together, it’s a path so revolutionary it would be hard to imagine somebody contemplating it five years ago.”
But while the vaccine enterprise has been impressive, its credibility has been repeatedly threatened by Trump, who for months pressured the FDA to authorize a vaccine before Election Day and, when that did not happen, bitterly accused the agency and Pfizer of deliberately orchestrating delays to harm his reelection prospects. On Friday, he continued his criticism on Twitter, calling the agency “a big, old, slow turtle,” adding, “Get the dam vaccines out NOW.”
The White House maneuvers seemed designed to ensure Trump gets credit just as the vaccine crosses the finish line. But experts said his behavior risked undermining public confidence — not because it would force a vaccine through prematurely but because it could create the appearance that politics, not science, drove the decision.
“There was no plausible way the FDA would not authorize this vaccine … but this makes it appear [their decision] is politically motivated,” said Dorit Reiss, a professor of law who writes about vaccine policy at the University of California Hastings College of the Law. “Making it appear there was political pressure will undermine trust.”
Hahn, in a statement Friday, dismissed reports that his job was threatened. “This is an untrue representation of the phone call with the Chief of Staff,” he said. “The FDA was encouraged to continue working expeditiously on Pfizer-BioNTech’s EUA request. FDA is committed to issuing this authorization quickly, as we noted in our statement this morning.”
The White House said in an email that “we don’t comment on private conversations, but the Chief regularly requests updates on progress toward a vaccine.”
The political machinations are in sharp contrast to the impressive scientific achievement of producing a vaccine in record time. The Pfizer-BioNTech product, and the one right on its heels, from biotechnology company Moderna, use a snippet of genetic material encapsulated in a fat bubble to instruct cells to build the spiky proteins that dot the coronavirus. These shots will be the first time the genetic technology has been used in people outside clinical trials.
The government’s big bet on the promising method, which allowed for much faster vaccine development, was controversial but is paying off: Moderna’s shot is expected to be authorized shortly after a review by the FDA’s outside advisers scheduled for Thursday. The biotech companies behind the vaccines, Moderna and BioNTech, have never made a commercial product but ballooned into pharmaceutical heavyweights, with Moderna valued at $60 billion and BioNTech at $30 billion.
“I feel focused, and I feel also that this is a huge task,” said Ugur Sahin, chief executive of BioNTech.
While a potential lifesaver for those who receive it, the new coronavirus vaccine is not likely to have a dramatic impact on the immediate course of the pandemic. The supply of vaccines will initially fall far short of the 300 million doses some officials had hoped for last spring, when Operation Warp Speed was created.
In addition, formidable challenges lay ahead involving the massive scale-up of manufacturing and a complicated distribution plan overseen by cash-strapped states. On scientific questions, experts still do not know how long the vaccine’s protection lasts.
While the CDC’s Advisory Committee on Immunization Practices has recommended that health-care workers and nursing home residents be first in line for the vaccine, states ultimately will have the final say on which groups get priority. Much of the general population — including younger people who do not have underlying health conditions or jobs that put them at risk — are unlikely to be offered the vaccine before late spring or early summer. And if a significant proportion of Americans spurn the shot, efforts to banish the coronavirus or turn it into a low-level threat could be made much more difficult.
Still, the unquestionably good news on the Pfizer shot arrives as other vaccines also have moved forward: AstraZeneca and the University of Oxford published results in a peer-reviewed journal, China’s Sinopharm announced positive results, and Russia has reported promising data on a vaccine. But even multiple successful vaccines may not prove enough to reach all the world’s people.
“The entire world is seeing the light at the end of the tunnel, but for most of the world, they are still in a very, very long tunnel, and that’s the problem,” said Richard Hatchett, chief executive of the Coalition for Epidemic Preparedness Innovations, a nonprofit group that funds vaccine development. “The reason we’ve developed the vaccine is to end the pandemic, and you don’t end the pandemic until you … protect the most vulnerable people, who are globally distributed.”
The FDA’s action came the day after an agency advisory committee found that the benefits of the Pfizer vaccine exceeded the known risks and recommended that an emergency use authorization be granted for people 16 and older. The agency directed Pfizer to keep a close eye on possible allergic reactions after British health authorities reported two recipients had severe allergic responses after being vaccinated Tuesday.
The vaccine is not recommended for anyone with a known history of a severe allergic reaction to any ingredient, and the patient information sheet warns there is “a remote chance” of an allergic reaction.
FDA emergency authorizations are temporary approvals used to accelerate the availability of medical products during a public health emergency. They require less data than regular approvals and can be issued based on a lower standard. In the case of a vaccine, however, the FDA has said it would use rigorous criteria because millions of healthy people are expected to receive it.
The first 2.9 million shots are expected to be shipped to more than 600 sites — mostly large health-care systems — from Pfizer’s freezer farm in Kalamazoo, Mich., in special coolers packed with 50 pounds of dry ice. The vaccines must be kept at sub-Antarctic temperatures, by refreshing the coolers or by storing doses in an ultra-low-temperature freezer.
The government is holding back another 2.9 million doses for the second shot, to be administered 21 days later, and reserving 500,000 doses in case some are lost or spoiled. Officials say it will take time for nursing homes to coordinate with the pharmacy chains responsible for administering shots at those sites. CVS Health plans to administer the first shots of the Pfizer-BioNTech vaccine in nursing homes Dec. 21, according to spokesman T.J. Crawford.
Government officials project that Moderna and Pfizer will be able to deliver 40 million doses of vaccine this year, enough for 20 million people to receive the full regimen. The pace of vaccination is projected to increase in the first months of next year as manufacturing capacity increases and as other vaccines potentially come online. Data on the effectiveness of a one-shot vaccine from Johnson & Johnson is expected in early January.
But long-term questions about the supply remain. The United States has secured only 300 million shots — enough for 150 million people — from Pfizer-BioNTech and Moderna and needs hundreds of millions of additional doses to cover the populace. The country has secured additional doses from other vaccine makers, but it is still uncertain whether those vaccines will be successful.
FDA scientists, in their review of the Pfizer data, confirmed the vaccine was safe and highly effective at preventing illness after two shots spaced three weeks apart. They identified a promising signal that the vaccine appeared to provide a level of protection even after a single shot, meaning that vaccinations could begin to have an impact sooner than many had expected.
In its effort to clear the first coronavirus vaccine, the FDA has faced daunting technical and political challenges.
For months, the agency has tried to balance pressures to expedite the vaccine with the need to keep standards high, to reassure the public that a vaccine produced in record time would be safe and effective.
Adding to the sensitivity was the agency’s effort to bolster its own credibility. Its image was tarnished when earlier in the year it authorized hydroxychloroquine, a malaria medicine that Trump repeatedly touted as a covid-19 treatment, then revoked that authorization when subsequent data showed it could be harmful.
In August, Hahn overstated the benefits of another treatment, convalescent plasma, during a briefing with Trump. Stung by criticism from the scientific community, Hahn apologized and began speaking out about the importance of agency career scientists’ making independent decisions.
Peter Marks, director of the agency’s Center for Biologics Evaluation and Research, which oversees vaccines, said during a recent American Medical Association webinar that the FDA helped expedite the clinical trial process by eliminating “dead spaces” that typically occur between phases of investigation by vaccine makers.
To ensure that companies understood the FDA’s expectations, the agency took the unusual step of issuing guidelines in June that specified any vaccine should be at least 50 percent effective compared with a placebo, or saltwater shot. A few months later, after it became clear the agency would employ an emergency use authorization to clear the vaccine, the FDA spelled out detailed standards and called for the manufacturers to produce two months of safety data on half of the trial participants.
That safety requirement meant any vaccine would be delayed until after Election Day, infuriating Trump, who tweeted angrily about the FDA and Pfizer. White House ire intensified when Britain authorized the vaccine first, on Dec. 2.
On the AMA webinar, Marks acknowledged that the agency had paid a price for its careful scrutiny. “Unfortunately, there is a cost to being this careful. Another regulatory agency made the vaccine available before we did,” he said. “That’s because we are really taking care to make sure when people get this vaccine, we will have really vetted it for safety.”
Harvard’s Carpenter said being careful will pay off in the long run with greater acceptance of the vaccine, boosting public health. “You need to think about the confidence effects,” he said.
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KZIA up almost 20% on this news.
ASX RELEASE
9 December 2020
TOP-LINE FINAL DATA FROM CANTRIXIL PHASE I STUDY CONFIRMS PRIOR
POSITIVE EFFICACY AND SAFETY SIGNALS
Sydney, 9 December 2020 – Kazia Therapeutics Limited (ASX: KZA; NASDAQ: KZIA), an
Australian oncology-focused biotechnology company, is pleased to share top-line final data
from its phase I study of Cantrixil (TRX-E-002-1) in patients with persistent or recurrent
ovarian cancer (NCT02903771).
Key Points
• 25 patients with advanced metastatic ovarian cancer received at least one dose of
Cantrixil at six sites in the United States and Australia, comprising 11 patients in Part
A (dose escalation) and 14 patients in Part B (dose expansion)
• Trial achieved its primary objective, determining the maximum tolerated dose (MTD)
of Cantrixil to be 5 mg/kg
• Overall, 16 patients were evaluable for efficacy. One patient demonstrated a
complete response (CR) and two patients experienced a partial response (PR),
according to industry-standard RECIST criteria, making an overall response rate
(ORR) of 19%
• The patient who experienced a complete response remains in remission some three
years after her last dose of Cantrixil
• The drug was generally well-tolerated, with primarily gastrointestinal toxicities
observed (abdominal pain, vomiting, and nausea)
Australian lead investigator, Associate Professor Jim Coward, commented, “this was a
heavily pre-treated population, comprising patients with very advanced disease. Existing
treatment options for such patients are limited, and there remains an urgent need for new
therapies. My colleagues and I are excited by the potential for Cantrixil to provide benefit
here, and we look forward to seeing the drug move forward in its development.”
Kazia expects the full data to be presented at a suitable academic conference and published
in a peer-reviewed journal in 1H CY2021. In accordance with common practice, the full data
will remain embargoed until they are formally published, in order not to prejudice the
appropriate dissemination of the data, and only top-line data are discussed here.
Bladerunner
Anyone here follow CRVS? Opinions?
Data at ASH looks good to my untrained and uneducated eye.
https://finance.yahoo.com/news/corvus-presents-data-investigational-itk-150000009.html
Management teams looks impressive.
This seems to me to be very undervalued. I loaded up today at $4.05.
Bladerunner
>>> 3 Value Stocks Warren Buffett Owns That You Should Consider Buying Too
The Oracle of Omaha knows a good bargain when he sees one.
Motley Fool
Keith Speights
Dec 6, 2020
https://www.fool.com/investing/2020/12/06/3-value-stocks-warren-buffett-owns-that-you-should/
As a young man, Warren Buffett learned from Benjamin Graham, a man who would come to be known as "the father of value investing." Graham wrote the classic book on value investing, The Intelligent Investor. Buffett has called it "the best book about investing ever written."
Thanks in large part to the influence of Benjamin Graham, Buffett became a value investor himself. Through the years, he became more open to buying stocks that didn't totally adhere to Graham's principles. However, Buffett still likes a bargain when he can find one for Berkshire Hathaway's (NYSE:BRK-A) (NYSE:BRK-B) portfolio.
Are there some value stocks in Berkshire's holdings right now? Absolutely. Here are three value stocks Buffett owns that you should consider buying too.
1. AbbVie
Berkshire recently loaded up on big pharma stocks, including the purchase of nearly 21.3 million shares of AbbVie (NYSE:ABBV). Buffett probably liked the idea of buying a cash cow that trades well below nine times expected earnings.
AbbVie's bargain-bin valuation stems primarily from the looming headwinds for its top-selling drug, Humira. The autoimmune disease drug already has lost market share in Europe because of biosimilar competition. Humira faces biosimilar rivals in the U.S. beginning in 2023.
However, AbbVie has known for a long time that the day would come when it couldn't rely on Humira's huge sales. The company has built a solid lineup of other winners, notably including blood cancer drugs Imbruvica and Venclexta. It has also developed worthy successors to Humira with Rinvoq and Skyrizi now on the market and gaining major momentum.
The upcoming challenges for Humira will likely constrain AbbVie's growth prospects for a while. Buffett is a patient investor, though, and usually doesn't mind waiting when he knows he invested at an attractive price. In this case, he'll be paid handsomely to wait: AbbVie's dividend yields nearly 5%.
2. Bristol Myers Squibb
Bristol Myers Squibb (NYSE:BMY) is another big pharma stock recently added to Berkshire's portfolio. And like AbbVie, BMS is a bargain. Its shares currently trade at a little over eight times expected earnings.
With its acquisition of Celgene last year, BMS picked up Revlimid, a megablockbuster blood cancer drug. The bad news is that Revlimid will begin to face limited-volume generic competition in 2022. The good news is that the Celgene deal gave BMS plenty of other rising stars, including another blood cancer drug, Pomalyst, and multiple sclerosis drug Zeposia.
BMS already had some big winners of its own. Sales continue to climb for blood thinner Eliquis, autoimmune disease drug Orencia, and cancer immunotherapy Yervoy. The company has gained new indications for its other top cancer immunotherapy, Opdivo, that should fuel additional growth.
These products along with a robust pipeline should enable BMS to generate average annual earnings growth of more than 20% over the next few years. BMS also pays a dividend that yields a little under 3%. This stock looks like a great pick for Buffett and for ordinary investors.
3. Pfizer
Continuing with the pharma theme, Berkshire also scooped up shares of Pfizer (NYSE:PFE) in the third quarter of 2020. Although Pfizer isn't as cheap as AbbVie and Bristol Myers Squibb, its shares trade at only 12 times expected earnings. That's a lot lower than the S&P 500's forward price-to-earnings multiple of 22.
Pfizer's discount valuation is directly connected with its abysmal revenue and earnings growth in recent years. Sales for a basket of the company's older drugs have plunged as they lost patent exclusivity. However, that's in the past.
It's a whole new ballgame for Pfizer now. The company recently completed the merger of its Upjohn unit (home to those older drugs with declining sales) with Mylan to form a new company, Viatris. This paves the way for Pfizer to return to much stronger growth. And that growth could be accelerated thanks to Pfizer's promising COVID-19 vaccine.
Pfizer's dividend will be a little lower going forward after the Upjohn-Mylan transaction. However, the yield will still be attractive. There's a good chance that Pfizer will deliver market-beating total returns over the next decade. Buffett probably won't regret buying the big pharma stock. Investors who aren't famous billionaires probably won't, either.
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Viatris - >>> After nearly 60 years, Mylan makes way for Viatris
By: Paul J. Gough – Reporter
Pittsburgh Business Times
November 17, 2020
https://www.wpxi.com/news/business/after-nearly-60-years-mylan-makes-way-viatris/BV3OB6HECNDG3PWOWZSM6WUKTA/
PITTSBURGH — After nearly 60 years as a West Virginia and Pennsylvania pharmaceutical company, Mylan NV has transformed into Viatris (Nasdaq: VTRS), the global drug manufacturer formed with the merger of Mylan and the Upjohn division of Pfizer Inc.
The merger, announced in late July 2019, took effect Monday. The new company will trade on Nasdaq with the ticker symbol VTRS, and Mylan (Nasdaq: MYL) will no longer trade. Viatris' management team is based in Pittsburgh, and the company is incorporated in Delaware.
Viatris is headquartered in the United States and will retain its Canonsburg facility as one of its three global centers, with the other two in Shanghai and Hyderabad, India. It also has a big manufacturing plant and research and development center in Morgantown, West Virginia. There are 45,000 employees in the combined company, but it said in a statement Monday that it was beginning a restructuring program that would save $1 billion.
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>>> Kazia Presents Further Paxalisib Data At Sno, Confirming Earlier Positive Safety And Efficacy Signals In Glioblastoma
Yahoo Finance
November 17, 2020
https://finance.yahoo.com/news/kazia-presents-further-paxalisib-data-233900624.html
SYDNEY, Nov. 18, 2020 /PRNewswire/ -- Kazia Therapeutics Limited (ASX: KZA; NASDAQ: KZIA), an Australian oncology-focused biotechnology company, is pleased to share a summary of new paxalisib data presented at the Society for Neuro-Oncology (SNO) Annual Meeting, which is being held virtually from 19-21 November 2020.
Key Points
New interim analysis of paxalisib phase II study in glioblastoma (NCT03522298) is highly consistent with prior data
Median progression-free survival (PFS) of 8.4 months reported on this analysis (versus 5.3 months for temozolomide, the existing standard of care)
Median overall survival (OS) of 17.5 months reported (versus 12.7 months for temozolomide)
First substantial presentation of safety data at a 60mg dose shows profile very similar to prior experience, with the most common toxicities including rash, stomatitis (mouth ulcers), and hyperglycemia (high blood sugar), consistent with other PI3K and mTOR inhibitors
Phase I study in DIPG (NCT03696355) shows paediatric maximum tolerated dose (MTD) of 27 mg/m2, with safety profile and pharmacokinetics similar to adult data
Kazia CEO, Dr James Garner, commented, "this is very reassuring data from the glioblastoma study, confirming our earlier results with the data now much more mature. In studies such as this, volatility is the enemy of dependability. From the very first efficacy data we reported from this study, in November 2019, through the ASCO and AACR presentations in June 2020, to today's latest analysis, the PFS and OS figures have remained extremely stable as the study has progressed. This gives us a great deal of confidence that what we are seeing is representative and reliable."
He added, "we expect this study to conclude in the first half of calendar 2021, but it has already provided useful information to guide the development of paxalisib. We have moved into the operational phase of the GBM AGILE pivotal study, and we expect that study to now be the primary focus of our work in glioblastoma from this point forward."
The poster presentation is available for download via the Kazia website at:-
https://www.kaziatherapeutics.com/researchpipeline/paxalisib
Summary of Paxalisib Data in Comparison to Temozolomide (existing standard of care)
Temozolomide[1]
(FDA-approved treatment)
Paxalisib
(interim phase II data)
Progression-Free Survival (PFS)
5.3 months
8.4 months
Overall Survival (OS)
12.7 months
17.5 months
Professor Patrick Wen, the first author on the poster, commented "as this study has matured, we have seen encouraging results that are very stable over successive analyses, and very consistent with prior clinical experience in this drug. Paxalisib is now moving into the GBM AGILE study in glioblastoma, and we expect this to provide definitive data regarding the drug's potential use in this disease and, if successful, a basis for regulatory approval. There remains a profound need for new treatments in glioblastoma, and paxalisib has proven to be an exciting potential candidate."
Initial Data from St Jude Study of Paxalisib in DIPG and Diffuse Midline Gliomas
Dr Christopher Tinkle, lead investigator for the SJPI3K study of paxalisib in DIPG and diffuse midline glioma (NCT03696355), gave an invited oral presentation on interim results from that study.
The SJPI3K study is a first-in-paediatric study, designed to establish the safety and pharmacokinetics of paxalisib in children, and to explore potential early signals of efficacy in this patient population.
The study recruited 27 patients, ranging from 3 to 16 years of age. Four patients discontinued participation prior to receiving a first dose of paxalisib, generally due to disease progression. At the time of analysis, five patients remain on paxalisib treatment, and several patients remain in post-treatment follow-up.
The paediatric maximum tolerated dose (MTD) was determined to be 27 mg/m2. The dose-limiting toxicities (DLTs) included hyperglycaemia, oral mucositis, and rash, which are entirely consistent with the adult experience.
The pharmacokinetics of the drug, a term which describes the concentration of the drug in plasma over time, was very consistent with the adult experience. The study found no meaningful difference between administration of intact capsules and administration via opening of capsules and sprinkling of contents onto a food carrier.
The study has not at this stage shown a clear survival benefit for paxalisib in comparison to historical controls. In terms of PFS, the proportion of patients alive and progression-free at six months (PFS6) was 96%, which compares favourably to an historical control of 58%[2]. However, the authors note that PFS can be a complex endpoint to interpret in DIPG trials due to the confounding effect of incidental radiological changes associated with radiation therapy.
Dr Tinkle commented, "my colleagues and I are very pleased with the outcome of this study. We have determined an appropriate dose for future paediatric work, established an acceptable tolerability profile in children, and demonstrated pharmacokinetic equivalence between intact capsule and open and sprinkled administration, which are critical steps in the development of any new drug for paediatric cancer."
He added, "DIPG is an extremely treatment-resistant disease, and no drug has ever shown convincing efficacy as a monotherapy. Our view has always been that the treatment of this disease will consist in combination therapy, and we have shown that paxalisib is eminently suitable to now be evaluated alongside other agents. We look forward to discussing follow-on work that will explore these opportunities and further investigate paxalisib's potential."
Dr Garner commented, "we are grateful to have had the opportunity to collaborate with one of the world's leading paediatric oncology hospitals in this study. The results provide an excellent foundation for the further development of paxalisib in DIPG, and we will be excited to discuss the next phase of work with our collaborators in coming months."
Next Steps
The paxalisib phase II study remains ongoing, with final data expected in 1H CY2021. The paxalisib arm of the GBM AGILE study has moved into an operational phase, and first patient in is expected early in 1Q CY2021.
The St Jude study in DIPG remains ongoing, with final data expected during 1H CY2021.
Investor Conference Call
Kazia is pleased to invite investors to attend a conference call to discuss the results further.
The call will be held on Thursday 19 November 2020 at 12:00pm, Sydney time (AEDT), which is 5pm on Wednesday 18 November 2020 in San Francisco (PST) and 8pm on Wednesday 18 November 2020 in New York (EST).
Participants will need to pre-register for the call via the following link:
https://s1.c-conf.com/diamondpass/10011029-8iqiBr.html
Click the 'Register Now' button and follow the prompts to complete pre-registration. You will then receive a calendar invite with dial in numbers, a passcode and a PIN to dial into the conference call.
[1] ME Hegi, A-C Desirens, T Gorlia, et al. N Engl J Med (2005); 352:997-1003
[2] T Cooney, A Lane, U Bartels, et al. Neuro-Oncology (2017); 19(9):1279-1280
SOURCE Kazia Therapeutics Ltd
<<<
KZIA up another 60% today. It was halted for a bit this morning.
Bladerunner
re: KZIA
YES
Bladerunner
Blade, In addition to the presentation this week, doesn't KZIA have some Phase 2 data coming soon?
>>> The lead program at the company is for GBM, which is in an open-label Phase II study that plans to read out in late 2020 or early 2021. The drug will also be included in the Phase III GBM AGILE study being performed by the Global Coalition for Adaptive Research (GCAR) <<<
https://kza.irmau.com/irm/PDF/4b39cb93-1de2-4542-92b9-07098509c6fa/EdisonResearchKaziaTherapeuticsBringingavetteddrugclasstothebrain
Perhaps the Phase 2 results are starting to leak out, especially since it's open label and not blinded, but just a guess.
The stock is cheap from a market cap perspective, still under $100 mil, so it could have quite a run ahead if the drug works and is safe. It sounds like safety has been the big problem with P13K inhibitors in the past, but apparently the side effects have been OK so far with KZIA's drug.
In addition to the main GBM indication, using the drug as a combo tx to prevent brain metastasis when treating other cancers could be a big potential market.
Bottom line, the stock is looking great :o)
KZIA up 50% more in AH. Not sure why.
Bladerunner
KZIA continues its spectacular run. Presentation at SNO in a few days. I bought more this morning.
Bladerunner
Johnson & Johnson - >>> A Dividend King that won't let you down
https://www.fool.com/investing/2020/10/24/5-great-stocks-you-can-buy-and-hold-forever/
Johnson & Johnson (NYSE:JNJ) shares have done marvelously for long-term investors over the years.
Its clout in the consumer and healthcare sectors, a solid portfolio, brand power, impressive research and development, and an incredible dividend track record are just some of the things that have powered this company's returns upward. While the consumer side of the business -- which includes household names like Band-Aid, Neutrogena, and Listerine -- is a consistent cash-flow generator, Johnson & Johnson consistently scouts for growth in healthcare. That's exemplified by its latest acquisition -- autoimmune disease-drug specialist Momenta Pharmaceuticals, for which it paid $6.5 billion in cash. In 2019, Johnson & Johnson generated half its revenues from pharmaceuticals and one-third from medical devices.
Can Johnson & Johnson still build wealth for new investors? Sure it can, if you hang on to the stock. The company continues to prioritize R&D spending and has a humongous biotech pipeline. While these stories play out, you can collect rising dividend payouts year after year: Johnson & Johnson is a Dividend King, having boosted its payouts annually for 58 straight years. Shareholders can reinvest those dividends, then just sit back and watch their money grow.
<<<
Thanks,gfp.
I may have a new one next week for you.
Bladerunner
Blade, Wow, nice going with KZIA and MYOV. I guess KZIA is climbing in anticipation of that presentation next week. The chart looks like it may be just getting warmed up, and the market cap is still under $100 mil. The chart looks like mid teens or 20 could be coming.
I see that UROV merger. Looks like a raft of shareholder lawsuits being announced, they didn't waste any time. Funny how a quick double is viewed as a lawsuit opportunity these days lol.
KZIA finishes at its high of the day ($10.05). Up 30% on top of yesterday.
16X the average daily volume.
Bladerunner
KZIA up another 15% on 10X the average daily volume. KZIA will present next week at SNO (Society of NeuroOncology).
Bladerunner
MYOV up almost 7% in AH trading on the coattails of the UROV acquisition. Sumitomo owns a high percentage of MYOV shares.
Bladerunner
KZIA up over 10% on 5X the average daily volume. (And it's only 2:00)
Bladerunner
MYOV reports 2nd quarter, fiscal 2020, results.
Myovant Sciences Announces Corporate Updates and Financial Results for Second Quarter Fiscal Year 2020
Myovant Sciences to Host Second Fiscal Quarter 2020 Earnings Conference Call at 8:30 a.m. Eastern Time on November 12, 2020
Myovant Sciences Presents Additional Data on Relugolix Combination Therapy from Studies in Endometriosis and Uterine Fibroids
Myovant Sciences Announces Corporate Updates and Financial Results for Second Quarter Fiscal Year 2020
By GlobeNewswire, November 12, 2020, 07:00:00 AM EDT
FDA Priority Review of New Drug Application (NDA) for relugolix monotherapy tablet for advanced prostate cancer on track for decision by December 20, 2020 target action date
NDA for relugolix combination tablet for uterine fibroids accepted for FDA review with a decision expected by June 1, 2021 target action date
Positive one-year efficacy and safety data from Phase 3 LIBERTY program for relugolix combination therapy in women with uterine fibroids, including bone mineral density data, presented at the American Society for Reproductive Medicine (ASRM) 2020 Virtual Congress
Positive efficacy and safety data from Phase 3 SPIRIT program for relugolix combination therapy in women with endometriosis-associated pain presented at the ASRM 2020 Virtual Congress
BASEL, Switzerland, Nov. 12, 2020 (GLOBE NEWSWIRE) -- Myovant Sciences (NYSE: MYOV), a healthcare company focused on redefining care for women and for men, today announced corporate updates and financial results for the second quarter fiscal year 2020.
"I am very pleased with the significant progress we made during the second fiscal quarter in advancing both relugolix monotherapy tablet and relugolix combination tablet toward potential regulatory approvals, while preparing for commercialization in advanced prostate cancer, uterine fibroids, and endometriosis," said Lynn Seely, M.D., chief executive officer of Myovant Sciences, Inc. "We have assembled a strong and highly-experienced team, spanning medical affairs, market access, commercial operations, marketing, and sales, which will enable us to rapidly and efficiently deliver relugolix monotherapy tablet to urologists, medical oncologists, and their patients, if approved, for our first commercial launch."
Second Quarter Fiscal Year 2020 and Recent Corporate Updates
Relugolix Clinical Programs
Prostate Cancer:
Relugolix monotherapy tablet is under Priority Review by the U.S. Food and Drug Administration (FDA) and is on track for a decision by its December 20, 2020 target action date. The NDA is supported by the positive Phase 3 HERO study results, including a 97% responder rate and six positive key secondary endpoints. Relugolix also demonstrated a lower incidence of major adverse cardiovascular events compared to leuprolide acetate, the current standard of care. The Phase 3 HERO study results were published in the New England Journal of Medicine on June 4, 2020.
On September 29, 2020, Myovant announced results of an additional secondary endpoint of castration resistance-free survival assessed in the subgroup of men with metastatic prostate cancer from the Phase 3 HERO study of relugolix monotherapy in advanced prostate cancer. Relugolix monotherapy had a similar rate of castration resistance-free survival compared to leuprolide acetate (74% vs. 75%, respectively), and did not achieve statistical superiority (p = 0.84).
On October 19, 2020, Myovant presented an economic analysis of the Phase 3 HERO data at the Academy of Managed Care Pharmacy (AMCP) Nexus 2020 Virtual Meeting, demonstrating that treatment with oral relugolix may prevent one major adverse cardiovascular event for every 31 patients treated versus patients receiving leuprolide injections.
Uterine Fibroids:
In August 2020, the FDA accepted Myovant's NDA for once-daily, oral relugolix combination tablet for the treatment of women with heavy menstrual bleeding associated with uterine fibroids, setting a target action date of June 1, 2021.
On September 14, 2020, Myovant announced one-year data on bone mineral density (BMD) from the Phase 3 LIBERTY program. The BMD results from the LIBERTY program demonstrated maintenance of BMD through one year and were consistent with those observed in a separate prospective observational study of untreated, age-matched women with uterine fibroids. These findings were presented at the American Society for Bone and Mineral Research (ASBMR) 2020 Annual Meeting Virtual Event, held on September 11-15, 2020.
On October 21, 2020, Myovant announced the presentation of data at the American Society for Reproductive Medicine (ASRM) 2020 Virtual Congress, including long-term extension data in women with symptomatic uterine fibroids. Results indicated that women experienced, on average, a 90% reduction in menstrual blood loss from baseline at one year. Additionally, 87.7% of women achieved the responder criteria for reduction in menstrual blood loss at one year, and lumbar spine and total hip BMD were maintained over one year. A poster presentation also described a validated exposure-response model simulating long-term effects of relugolix combination therapy on BMD at the lumbar spine that projected maintenance of BMD for at least three years. Other data from the LIBERTY program - including improvement in quality of life, reduction in menstrual blood loss in the first treatment cycle, and reduction in uterine fibroid-associated pain - were also presented.
Additional data from the Phase 1 ovulation inhibition study from 67 healthy women treated with relugolix combination therapy, resulting in 100% ovulation inhibition and 100% return to ovulation or menses after discontinuation of treatment, were also presented at the ASRM 2020 Virtual Congress.
Endometriosis:
Data from the replicate Phase 3 SPIRIT 1 and SPIRIT 2 studies were presented at the ASRM 2020 Virtual Congress on October 20, 2020 in an oral presentation named the Prize Paper by the Endometriosis Special Interest Group. Relugolix combination therapy resulted in clinically meaningful reductions in dysmenorrhea and non-menstrual pelvic pain, compared with placebo over 24 weeks of therapy (p < 0.0001) in each study. Changes in BMD over 24 weeks were minimal in the relugolix combination therapy groups.
COVID-19 Pandemic Environment
Myovant's priorities during the COVID-19 pandemic are protecting the health and safety of its employees and patients while continuing its mission to redefine care for women and for men. To date, the impact of the COVID-19 pandemic on Myovant's ability to advance its clinical studies, regulatory activities, and preparation for the potential commercialization of its product candidates has been limited, and all of Myovant's publicly announced milestones remain on track. However, if the COVID-19 pandemic persists, and depending on the further evolution of the pandemic and its effects on Myovant's activities, Myovant may experience more significant impacts on its business operations.
Expected Upcoming Milestones
Relugolix monotherapy tablet for advanced prostate cancer FDA target action date of December 20, 2020.
Data from the LIBERTY randomized withdrawal study expected in the first quarter of calendar year 2021.
One-year efficacy and safety data from the SPIRIT extension study expected in the first quarter of calendar year 2021.
Relugolix combination tablet for uterine fibroids FDA target action date of June 1, 2021.
Marketing Authorization Application (MAA) submission to European Medicines Agency (EMA) for relugolix monotherapy tablet for advanced prostate cancer in the first half of calendar year 2021.
NDA submission for relugolix combination tablet for the treatment of women with endometriosis-associated pain expected in the first half of calendar year 2021.
European Commission decision on the uterine fibroids MAA expected in 2021. If approved, this launch will be executed by Gedeon Richter, Myovant's commercialization partner for relugolix combination tablet for the uterine fibroids and endometriosis indications in Europe and certain other international markets.
MAA submission to EMA for relugolix combination tablet for the treatment of women with endometriosis-associated pain expected in 2021. Gedeon Richter will be the MAA sponsor.
Second Quarter Fiscal Year 2020 Financial Summary
Research and development (R&D) expenses in the three months ended September 30, 2020, were $40.5 million compared to $50.8 million for the comparable prior year period. The decrease in R&D expenses reflects a decrease in clinical study costs as a result of the completion and continued wind down of Myovant's Phase 3 LIBERTY, HERO, and SPIRIT studies. This decrease was partially offset primarily by increased expenses by the medical affairs organization in preparation for Myovant's anticipated commercial launches, if approved, of relugolix monotherapy tablet for men with advanced prostate cancer and relugolix combination tablet for the women's health indications, as well as an increase in personnel expenses.
General and administrative (G&A) expenses in the three months ended September 30, 2020, were $31.3 million compared to $16.6 million for the comparable prior year period. The increase was primarily due to increases in expenses related to commercial readiness activities, personnel-related expenses, and other general overhead expenses to support Myovant's organizational growth and anticipated commercial launches, if approved, of relugolix monotherapy tablet for men with advanced prostate cancer and relugolix combination tablet for the women's health indications.
Interest expense was $2.1 million in the three months ended September 30, 2020, compared to $3.8 million in the comparable prior year period. The decrease in interest expense was driven by lower interest rates associated with the Sumitomo Dainippon Pharma Loan Agreement as compared to Myovant's previously outstanding debt obligations, which were repaid in December 2019.
Interest income in the three months ended September 30, 2020, was less than $0.1 million compared to $0.9 million for the comparable prior year period. The decrease was primarily due to decreases in interest rates and lower balances in cash equivalents and marketable securities.
Other (income) expense, net in the three months ended September 30, 2020, was income of $6.7 million compared to expenses of $0.1 million for the comparable prior year period. This was primarily the result of a foreign currency exchange gain on Myovant's outstanding balance under the Sumitomo Dainippon Pharma Loan Agreement during the three months ended September 30, 2020 for which there was no such gain in the comparable prior year period.
Net loss for the three months ended September 30, 2020, was $67.1 million compared to $70.6 million for the comparable prior year period. On a per common share basis, net loss was $0.75 and $0.79 for the three months ended September 30, 2020, and 2019, respectively.
Capital resources: Cash, cash equivalents, marketable securities, and committed amounts available under the Sumitomo Dainippon Pharma Loan Agreement totaled $257.6 million as of September 30, 2020, and consisted of $111.3 million of cash, cash equivalents, and marketable securities and $146.3 million of available borrowing capacity under the Sumitomo Dainippon Pharma Loan Agreement.
On August 5, 2020, Myovant obtained a debt commitment letter (amended on September 29, 2020) from Sumitomo Dainippon Pharma, pursuant to which, subject to the terms and conditions set forth therein, Sumitomo Dainippon Pharma has committed to provide Myovant with an additional $200.0 million, low-interest, five-year term loan, which, subject to negotiation of a definitive agreement, will bring its total financing support for Myovant to $600.0 million. Including the additional debt commitment, cash and committed funding as of September 30, 2020 totaled approximately $460.0 million.
Conference Call
As previously announced, Myovant will hold a webcast and conference call at 8:30 a.m. Eastern Time (5:30 a.m. Pacific Time) today, November 12, 2020, to discuss corporate updates and financial results for its second fiscal quarter 2020, ended September 30, 2020. Investors and the general public may access a live webcast of the call by visiting the investor relations page of Myovant's website at investors.myovant.com. Institutional investors and analysts may also participate in the conference call by dialing 1-800-532-3746 in the U.S. or +1-470-495-9166 from outside the U.S.
The webcast will be archived on Myovant's Investor Relations website following the call.
About Relugolix
Relugolix is a once-daily, oral gonadotropin-releasing hormone (GnRH) receptor antagonist that reduces testicular testosterone, a hormone known to stimulate the growth of prostate cancer, and ovarian estradiol, a hormone known to stimulate the growth of uterine fibroids and endometriosis. Relugolix monotherapy tablet (120 mg) is under regulatory review in the U.S. for men with advanced prostate cancer. Relugolix combination tablet (relugolix 40 mg, estradiol 1.0 mg, and norethindrone acetate 0.5 mg) is under regulatory review in Europe and the U.S. for women with uterine fibroids and is under development for women with endometriosis.
About Myovant Sciences
Myovant Sciences aspires to redefine care for women and for men through purpose-driven science, empowering medicines, and transformative advocacy. Our lead product candidate, relugolix, is a once-daily, oral GnRH receptor antagonist. Relugolix monotherapy tablet (120 mg) is under regulatory review in the U.S. for men with advanced prostate cancer. Relugolix combination tablet (relugolix 40 mg, estradiol 1.0 mg, and norethindrone acetate 0.5 mg) is under regulatory review in Europe and the U.S. for women with uterine fibroids and is under development for women with endometriosis. We are also developing MVT-602, an oligopeptide kisspeptin-1 receptor agonist, which has completed a Phase 2a study for female infertility as part of assisted reproduction. Sumitovant Biopharma, Ltd., a wholly owned subsidiary of Sumitomo Dainippon Pharma Co., Ltd., is our majority shareholder. For more information, please visit our website at www.myovant.com. Follow @Myovant on Twitter and LinkedIn.
About Sumitomo Dainippon Pharma Co., Ltd.
Sumitomo Dainippon Pharma is among the top-ten listed pharmaceutical companies in Japan, operating globally in major pharmaceutical markets, including Japan, the U.S., China and the European Union. Sumitomo Dainippon Pharma is based on the merger in 2005 between Dainippon Pharmaceutical Co., Ltd., and Sumitomo Pharmaceuticals Co., Ltd. Today, Sumitomo Dainippon Pharma has more than 6,000 employees worldwide. Additional information about Sumitomo Dainippon Pharma is available through its corporate website at https://www.ds-pharma.com.
About Sumitovant Biopharma Ltd.
Sumitovant is a global biopharmaceutical company with offices in New York City and London. Sumitovant is a wholly owned subsidiary of Sumitomo Dainippon Pharma. Sumitovant is the majority shareholder of Myovant and Urovant, and wholly owns Enzyvant, Spirovant and Altavant. Sumitovant's promising pipeline is comprised of early- through late-stage investigational medicines across a range of disease areas targeting high unmet need. For further information about Sumitovant, please visit https://www.sumitovant.com.
Bladerunner
gfp,
I still think Cortex had a good drug. Just got caught up in the politics of the FDA's CNS Division, Laughren and Katz and all that crap.
I made the same mistake as you on IMGN and SGEN.
Bladerunner
Blade, Thanks. Guess I'll have to update my list :o) It's amazing how you can follow that many stocks. Even following a few bios is a challenge.
I more or less gave up on the sector a few years ago, but still follow them loosely. Of the bios I followed closest, one is now sub-penny (COR-RSPI), another went bankrupt but was re-acquired (PYMX-CTIX-IPIX), and I see good old IMGN is back down to where it was trading 20 years ago lol. Instead of IMGN we should have went with the other 'armed MAB' company, Seattle Genetics (Seagen) which now has a $30 bil market cap.
Great to see that you prevailed in the end, with some monster picks that made you rich :o)
Blade, Thanks. I hope you don't mind me using your stock picks as the basis for a small/micro cap biotech 'ETF' that I'm creating for my own investing. So far the list includes -
ADRO, CRDF, CHMA, CCXI, KZIA, KURA, MGTA, MGNX, MEIP, NERV, OTIC, PIRS, PRVB, SYBX, XENE
Blade, Thanks. I hope you don't mind me using your stock picks as the basis for a small/micro cap biotech 'ETF' that I'm creating for my own investing. So far the list includes -
ADRO, CRDF, CHMA, CCXI, KZIA, KURA, MGTA, MGNX, MEIP, NERV, OTIC, PIRS, PRVB, SYBX, XENE
Now that buying stocks is commission-free, the approach I'm using with 1/2 of the stock allocation is to put relatively small amounts into a lot of promising stocks/sectors (the other 1/2 goes into broad market index ETFs).
Let me know if you have some additional bio stocks of interest. You are definitely one of the better stock pickers around :o)
Btw, any thoughts on the Aduro-Chinook merger? Do you plan to continue holding? Thanks.
re: CRDF
Anything under $17 is a good buy, IMO.
Bladerunner
>>> Cardiff Oncology, Inc. (CRDF), a clinical-stage biotechnology company, develops drugs for the treatment of cancer. Its lead drug candidate is onvansertib, a Polo-like Kinase 1 selective adenosine triphosphate competitive inhibitor that is in Phase Ib/II clinical trial in acute myeloid leukemia (AML); has completed a Phase I clinical trial in advanced solid tumors; and Phase Ib/II clinical trial for metastatic colorectal cancer in combination with FOLFIRI and Avastin. The company's onvansertib is also in Phase II clinical trial in combination with Zytiga for metastatic castration-resistant prostate cancer. In addition, it develops therapeutics, such as belinostat (Beleodaq); quizartinib (AC220), a development stage FLT3 inhibitor; and bortezomib (Velcade) for the treatment of leukemias, lymphomas, and solid tumor cancers. The company primarily serves pharmaceutical companies. Cardiff Oncology, Inc. has a research collaboration with Nektar Therapeutics for the treatment of colorectal cancer. The company was formerly known as Trovagene, Inc. and changed its name to Cardiff Oncology, Inc. in May 2020. Cardiff Oncology, Inc. was founded in 1999 and is headquartered in San Diego, California.
<<<
>>> Pfizer's COVID-19 vaccine proves 90% effective in first results from Phase 3 clinical trial
Market Watch
by Darrell Etherington
November 9, 2020
https://finance.yahoo.com/news/pfizers-covid-19-vaccine-proves-121216032.html
The COVID-19 vaccine being developed by Pfizer and its partner BioNTech has shown to be effective blocking vaccine in 90 percent of participants in its Phase 3 clinical trial, the companies announced on Monday. That's based on data analyzed by an external, independent committee assigned to check the results of the trial, and reflects only early results from the trial, and not the final verified result, but it's still extremely promising news for progress towards a viable and more broadly available vaccine.
Pfizer and BioNTech's vaccine candidate is an mRNA-based vaccine, which is a newer technology that many companies pursued for COVID-19 in part because it offers some advantages in pace of development and potential efficacy. These results from the test were based on an equable case total of 94 confirmed COVID-19 cases among study participants – passing the minimum threshold agreed to by the companies and the FDA of 62 confirmed cases for a proper, scientifically rigorous assessment.
The Phase 3 trial conducted by the companies included 43,358 participants, and Pfizer reports "no serious safety concerns have been observed" thus far in addition to the positive prevention rate. Based on this early data, individuals who receive the vaccine are protected at 28 days after first dose, and the vaccine uses a two-dose process.
There is still additional safety testing and continued studies to conduct, with the companies estimating that two full months of safety data (which is what the FDA requires for Emergency Use Authorization) will be available in the third week of this month. Participants will also be monitored for two full years after they receive their second and final dose in order to test for long-term effects. Pfizer still thinks that it can produce up to 50 million doses of its vaccine by the end of this year, and as many as 1.3 billion doses through 2021.
Full data from this trial still need to undergo peer-review by other researchers and scientific publications, but this is definitely the most promising and clearly positive news yet from the vaccine development front, and could mean that large-scale distribution of a vaccine begins even before the end of 2020 if all goes well.
<<<
>>> Date Is Set for Merger Between Mylan and Pfizer's Upjohn Unit
The Federal Trade Commission has signed off on the deal.
Motley Fool
by Brian Orelli
Oct 30, 2020
https://www.fool.com/investing/2020/10/30/pfizer-and-mylan-set-merger-date/
The merger of Pfizer's (NYSE:PFE) generic drug business, Upjohn, with Mylan (NASDAQ:MYL) will be going through shortly, now that the companies have agreed to a consent order with the U.S. Federal Trade Commission. The companies didn't give any details about what they had agreed to do in order to comply with that consent order.
On Nov. 13, Pfizer will spin off Upjohn, and its shareholders will receive stock in the new company. Upjohn will then immediately merge with Mylan. That deal is expected to close three days later, and the combined company will be renamed Viatris.
Pfizer's shareholders won't have to do anything -- other than remain shareholders -- to get shares of the new company. The exact number of shares of Viatris that they'll get for each Pfizer share will be determined by the number of outstanding shares of Pfizer and Mylan at closing. The ratio used will result in Pfizer's shareholders owning 57% of Viatris, while Mylan's shareholders will own 43%.
The premise of the merger is that Upjohn's global reach will accelerate the sales growth of Mylan's drugs. In addition to generic drugs, Upjohn will also bring along brand-name pharmaceuticals that have generic competition, such as Lipitor, Celebrex, and Viagra.
The combined company will have a portfolio of more than 1,400 drugs that it will sell in more than 165 countries and territories. When the deal was announced last year, the companies were expecting annual revenue for Viatris would be in the $19 billion to $20 billion range with cash flow expected to exceed $4 billion.
<<<
Gamida Cell Announces Positive Topline Data on Secondary Endpoints from Phase 3 Clinical Study of Omidubicel in Patients with Hematologic Malignancies
Business Wire Business Wire•October 6, 2020
— Study met secondary endpoints related to platelet engraftment, infections and hospitalizations, key clinical measures in bone marrow transplant —
— Omidubicel represents potential transformative treatment option for patients in need of a bone marrow transplant —
— Company anticipates initiating BLA submission in fourth quarter of 2020 —
https://finance.yahoo.com/news/gamida-cell-announces-positive-topline-103100746.html
KZIA offers 31,541 million shares at $.80/share Australian.
https://www.asx.com.au/asxpdf/20201001/pdf/44n7yvk78nfkxb.pdf
Bladerunner
re: PRVB
Provention Bio Files Clinical Module for Teplizumab for the Delay or Prevention of Clinical Type 1 Diabetes in At-Risk Individuals
Wed, September 30, 2020, 1:05 PM PDT
- Expect to complete filing of the rolling Biologics License Application (BLA) submission for teplizumab in Q4 2020 -
RED BANK, N.J., Sept. 30, 2020 /PRNewswire/ -- Provention Bio, Inc. (Nasdaq: PRVB), a biopharmaceutical company dedicated to intercepting and preventing immune-mediated disease, today announced the submission of the clinical module of the Company's Biologic License Application (BLA) to the U.S. Food and Drug Administration (FDA) for teplizumab (PRV-031), an investigational anti-CD3 monoclonal antibody for the delay or prevention of clinical Type 1 Diabetes (T1D) in at-risk individuals.
A rolling submission allows for completed modules of the BLA to be submitted to the FDA on an ongoing basis. Provention initiated the rolling submission with the filing of the non-clinical module in April 2020. The Company expects to submit the final modules including the chemistry, manufacturing and controls (CMC) module in Q4 2020. Once the complete BLA has been submitted, the FDA will have 60 days to review the submission to determine if it is complete. If deemed complete, the application will be considered acceptable for review and the FDA will set a PDUFA goal date.
"The filing of the BLA clinical module for teplizumab is a critical step in our efforts to deliver teplizumab to pre-symptomatic patients to delay or prevent insulin-dependent T1D," said Dr. Eleanor (Leni) Ramos, MD, CMO, Provention Bio. "I especially want to thank Dr. Sharon Rowland, our SVP and Head of Regulatory Affairs and the BLA clinical team who have worked tirelessly for many months to achieve this goal. We look forward to working closely with the FDA as we advance the regulatory process and we remain on track to complete the full BLA submission in Q4 2020. In addition, we continue to scale our organization in preparation for a potential commercial launch, and we are well-positioned to execute our strategy to bring this disease-modifying treatment to the T1D community as soon as possible."
About Teplizumab (PRV-031):
Teplizumab is an anti-CD3 monoclonal antibody (mAb) being developed for the interception, delay, or prevention of type 1 diabetes (T1D). More than 800 patients have received teplizumab in multiple clinical studies involving more than 1,000 subjects. In previous studies of newly diagnosed patients, teplizumab has consistently demonstrated the ability to preserve beta-cell function, a measure of endogenous insulin production, and correspondingly reduce the need for exogenous insulin use. Teplizumab has been granted Breakthrough Therapy Designation by the U.S. Food and Drug Administration (FDA) and PRIME designation by the European Medicines Administration. Provention Bio has initiated a rolling submission of the Biologic License Application for teplizumab for the delay or prevention of insulin-dependent T1D for use in presymptomatic patients and expects to complete the submission in Q4 2020. Provention is currently evaluating teplizumab in patients with newly diagnosed insulin-dependent T1D (the Phase 3 PROTECT Study).
About Provention Bio, Inc.:
Provention Bio, Inc. (Nasdaq: PRVB) is a biopharmaceutical company leveraging a transformational drug development strategy focused on the prevention or interception of immune-mediated disease. Provention's mission is to source, transform and develop therapeutic candidates targeting the high morbidity, mortality and escalating costs of autoimmune diseases. Provention's diversified portfolio includes teplizumab, a clinical-stage candidate that has been shown in a clinical study to delay the onset of insulin-dependent type 1 diabetes (T1D) in at-risk patients during the presymptomatic phase of the disease as compared to placebo. The Company's portfolio includes additional clinical product development candidates that have demonstrated in pre-clinical or clinical studies proof-of-mechanism and/or proof-of-concept in other autoimmune diseases, including celiac disease and lupus.
Bladerunner
BrainStorm Announces Scientific Presentation at the Annual NEALS Meeting
Presentation outlines design of pivotal Phase 3 trial evaluating NurOwn® as a treatment for ALS
Trial remains on track for topline data in 4Q-2020
NEW YORK, Sept. 30, 2020 /PRNewswire/ -- BrainStorm Cell Therapeutics Inc. (NASDAQ: BCLI), a leading developer of adult stem cell therapies for neurodegenerative diseases, announced the presentation of a poster titled, "Advancing NurOwn® for ALS: Phase 3 Clinical Trial Design" at the Annual Northeast ALS (NEALS) Meeting, being held virtually. The poster, which will be presented virtually today by Stacy Lindborg, Ph.D., Executive Vice President and Head of Global Clinical Research at Brainstorm, details the design of the Company's placebo-controlled, randomized, double-blind, Phase 3 trial evaluating NurOwn® (MSC-NTF cells) as a treatment for ALS patients.
"This pivotal study has been rigorously designed and powered to detect clinically meaningful effects of NurOwn® in rapidly progressing ALS patients," said Dr. Lindborg. "Compelling Phase 2 data showed that a single NurOwn® administration slowed disease progression in this patient population, and the current Phase 3 trial aims to confirm this effect in a larger study cohort and show that its duration can be extended through repeated administrations. To test this hypothesis, we are comparing the rate of patient level decline in ALS disease as measured by the ALS Functional Rating Scale between the pre-treatment period to the rate of decline observed after the initiation of treatment. Such an analysis allows us to compare the magnitude of change in disease progression resulting from NurOwn® and placebo treatments while accounting for important variable factors known to influence disease progression. We look forward to sharing the results of this analysis later this year."
https://www.stocktitan.net/news/BCLI/brain-storm-announces-scientific-presentation-at-the-annual-neals-7sairklics1t.html
BiondVax has spent years developing and testing its potential universal flu vaccine M-001, and now it’s nearly ready to report efficacy results. After starting a massive phase 3 study in eastern Europe back in 2018, the drugmaker expects to report efficacy between late September and the end of October.
For the study, the company tested its vaccine candidate in more than 12,000 adults age 50 and older in seven countries over the span of two flu seasons.
If the results come in positive, BiondVax plans to seek marketing approval in Europe and the U.S., CEO Ron Babecoff said an in interview. The vaccine doesn’t induce the immune system to create antibodies, but instead induces cellular immunity, the CEO explained. It’s made up of nine common peptides that are a “common denominator” of flu strains, Babecoff said.
https://www.fiercepharma.com/special-report/biondvax-m-001
ASX RELEASE
22 September 2020
KAZIA ENTERS CLINICAL COLLABORATION WITH
DANA-FARBER CANCER INSTITUTE FOR PRIMARY CNS LYMPHOMA
Sydney, 22 September 2020 – Kazia Therapeutics Limited (ASX: KZA; NASDAQ: KZIA), an
Australian oncology-focused biotechnology company, is pleased to announce that it has
entered into a collaboration with Dana-Farber Cancer Institute (DFCI) in the United States,
to investigate the use of Kazia’s investigational new drug, paxalisib (formerly GDC-0084), in
primary central nervous system (CNS) lymphoma, a potential new indication for the drug.
Key Points
• Lymphoma is a cancer of white blood cells. It occurs in the lymphatic system and can
spread almost anywhere in the body; primary CNS lymphoma (PCNSL) occurs
exclusively in the brain and central nervous system
• The PI3K inhibitor class is well validated in lymphoma outside the brain; three of the
four FDA-approved PI3K inhibitors are treatments for forms of lymphoma, but they
are assumed ineffective for PCNSL since they cannot cross the blood-brain barrier
• DFCI will initiate an open-label phase II clinical trial of paxalisib in PCNSL
• The study is expected to recruit up to 25 patients, taking up to 2 years to complete
• Kazia will provide support including study drug and a financial grant
• This study will be the sixth ongoing clinical trial of paxalisib in brain cancer
Dana-Farber Cancer Institute (DFCI) is a world-leading cancer treatment and research
centre, based in Boston, Massachusetts. It is a principal teaching affiliate of Harvard Medical
School and has been designated a Comprehensive Cancer Center by the US National Cancer
Institute. DFCI participates in as many as 600 clinical trials at any given time and has been an
important contributor to the development of many important new cancer therapies.
Kazia CEO, Dr James Garner, commented, “this is an exciting new opportunity for the
paxalisib program. We are delighted to support the team at Dana-Farber to explore the
potential for paxalisib to benefit patients with PCNSL. Dana-Farber is one of the world’s
leading centres of excellence in this disease, so we are immensely fortunate to be working
with them. We are pleased also to see a new and important target added to the broader
paxalisib clinical program, and we look forward to seeing the project commence.”
Bladerunner
Lexaria and Altria (tobacco Giant) complete development program finished first part.
>>> AstraZeneca's Coronavirus Vaccine Setback 'Mixed Blessing' For Moderna: Analyst
Benzinga
Shanthi Rexaline
September 9, 2020
https://finance.yahoo.com/news/astrazenecas-coronavirus-vaccine-setback-mixed-195902687.html
Moderna Inc (NASDAQ: MRNA) shares, which shed over 13% Tuesday on an analyst downgrade, are reversing course — with a competitor's clinical woes as the catalyst.
The Moderna Analyst: SVB Leerink analyst Mani Foroohar has a Neutral rating on Moderna with a $41 price target.
The Moderna Takeaways: AstraZeneca plc's (NYSE: AZN) clinical hold reflects reasonable caution given the high safety bar for a vaccine that is being developed for potential administration to many millions of healthy individuals, Foroohar said in a Wednesday note.
Yet the read-through is limited for mRNA or protein subunuit vaccine candidates given the key differences in delivery vectors and underlying technology, the analyst said.
The common cause for concern for all vaccine developers may be the extent to which this event leads to broader vaccine hesitance among the general population or greater regulatory scrutiny across mechanisms of action, he said.
Moderna shares will likely trade up in reaction to reduced competition to become second-to-market after the Pfizer Inc. (NYSE: PFE)/BioNTech SE – ADR (NASDAQ: BNTX) combine, Foroohar said.
Given that clinical holds in such large diverse populations are not uncommon, the delay could prove temporary, the analyst said.
If so, Moderna will be in for increased competition from AstraZeneca and Pfizer/BioNTech, he said.
"For now, vigilance and careful review of clinical trial data is the order of the day across all SARS-CoV-2 vaccine programs."
Moderna confirmed that it expects no impact from the AstraZeneca/Oxford adverse event on the COVE study, Foroohar said.
The analyst said he expects that Pfizer/BioNTech and Moderna will be the first two vaccines available under emergency use authorization.
MRNA Price Action: Moderna shares were trading 5.02% higher to $57.07 ahead of the close Wednesday.
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Gamida Cell Presents Analysis of Observational Data Demonstrating the Impact of Donor Age in Hematopoietic Stem Cell Transplant Outcomes at the Virtual Cord Blood Connect Meeting
Business Wire Business Wire•September 10, 2020
— Study shows younger donor age is associated with improved outcomes following bone marrow transplant —
Gamida Cell Ltd. (Nasdaq: GMDA), an advanced cell therapy company committed to cures for blood cancers and serious blood diseases, today announced data from an observational study demonstrating that younger donor age is associated with more rapid time to neutrophil engraftment and increased overall survival in patients who received hematopoietic stem cell transplant (HSCT, or bone marrow transplant) for the treatment of hematological malignancies. These data are being presented at the Cord Blood Connect Meeting, which is taking place virtually today and on September 17.
The study is the result of a research agreement between Gamida Cell and the CIBMTR® (Center for International Blood and Marrow Transplant Research®) designed to collect and analyze health outcomes data in patients with hematologic malignancies who receive a hematopoietic stem cell transplant or cellular therapy infusion, including bone marrow transplant graft from various donor sources. The study evaluated clinical outcomes for 660 patients in the CIBMTR registry who underwent a bone marrow transplant with a matched unrelated, mismatched unrelated or haploidentical graft source contemporaneous to the Phase 3 study of omidubicel, Gamida Cell’s investigational advanced cell therapy in development as a treatment option for patients in need of a bone marrow transplant. Key clinical outcomes, including time to neutrophil engraftment and overall survival, were improved for patients with donors under the age of 30.
"As new graft options evolve for bone marrow transplant, and we as a field learn more about the long-term patient outcomes of these graft options, the selection algorithms that are used to match patients with donors must also evolve to take into account the most current clinical data," said Ronit Simantov, M.D., chief medical officer at Gamida Cell. "These data indicate that donor age is a factor in clinical outcomes and that donor age should be considered when matching patients with a graft source."
In May, Gamida Cell reported that its Phase 3 study of omidubicel achieved its primary endpoint, demonstrating a highly statistically significant reduction (p < 0.001) in time to neutrophil engraftment, a key milestone in recovery from a bone marrow transplant. Omidubicel is the first bone marrow transplant product to receive Breakthrough Therapy Designation from the U.S. Food and Drug Administration (FDA). Gamida Cell expects to begin submitting the biologics license application for omidubicel to the FDA on a rolling basis in the fourth quarter of 2020.
"This analysis reinforces the importance of considering donor age when selecting a bone marrow graft source for patients, as donors aged 30 or younger resulted in improved overall survival," said Julian Adams, Ph.D., chief executive officer at Gamida Cell. "As we look toward our anticipated regulatory submission of omidubicel to the FDA and potential approval, given that omidubicel is derived from cord blood, we believe these findings could potentially have future implications for considering omidubicel for any patient who does not have an available related or unrelated donor of suitable age."
https://finance.yahoo.com/news/gamida-cell-presents-analysis-observational-130100500.html
2 Coronavirus Treatment Stocks to Buy Right Now
Eli Lilly and Kamada are two of the most intriguing companies working on this part of the COVID-19 problem.
George Budwell
(TMFGBudwell)
Sep 9, 2020 at 10:00AM
Kamada: A convalescent plasma therapy play
Kamada is a plasma-centered biopharmaceutical company with two FDA-approved products on the market: Glassia, a treatment for the inherited lung/liver disorder known as alpha-1 antitrypsin deficiency; and Kamrab, a preventative treatment for rabies.
Although neither of its commercial-stage products is a major cash cow, relatively speaking, Kamada has been posting respectable levels of revenue growth, positive free cash flow, and a steadily improving cash position over the past few quarters.
The biotech's main draw for investors, though, arguably isn't its current product line-up, but rather its experimental convalescent plasma therapy for COVID-19. On Aug. 23, President Trump announced that the FDA had issued an emergency use authorization for this intriguing treatment to be administered to hospitalized COVID-19 treatments.
Since then, the scientific community has raised concerns about the effectiveness of convalescent plasma therapy, given the lack of placebo-controlled clinical trials for them. But this skepticism probably won't dim the commercial potential for Kamada's therapy -- at least not in the short term.
The big picture is that this biotech has one of the most advanced plasma-based COVID-19 treatments in development, a fact which might translate into a healthy boost in its sales in the not-so-distant future.
https://finance.yahoo.com/m/ed13f1d6-ee74-33f0-a242-a5492609dfc4/2-coronavirus-treatment.html?source=eptyholnk0000202&utm_source=yahoo-host&utm_medium=feed&utm_campaign=article&yptr=yahoo
>>> Johnson & Johnson adds to debt frenzy, borrows $7.5 billion to buy Momenta
MarketWatch
Aug. 20, 2020
By Joy Wiltermuth
https://www.marketwatch.com/story/johnson-johnson-adds-to-debt-frenzy-borrows-7-5-billion-to-buy-momenta-11597969957?siteid=bigcharts&dist=bigcharts
Johnson & Johnson leveraged its top AAA credit ratings on Thursday to borrow $7.5 billion worth of cheap funding for its buyout of Momenta Pharmaceuticals, Inc.
J&J, which makes drugs, consumer goods and medical devices, stands as the only other major U.S. corporation, aside from Microsoft Corp MSFT, -1.40%, still carrying top AAA credit ratings, which NPR’s Planet Money explains are akin to the highest possible score in consumer credit.
In theory, that means J&J should have access to cheaper funding than companies with lower credit ratings that are considered a higher default or downgrade risk, although the pandemic-fueled boom in corporate borrowing has blurred the lines of what might be considered “low” or “high” yields.
Demand for J&J’s six-part corporate bond deal helped the 130-year-old-plus conglomerate lock in some of the lowest-cost funding available in years.
Final pricing details pegged the yield on the shortest five-year slug of bonds at 0.57% and at 2.49% for the longest 40-year class of debt.
With the Federal Reserve’s pandemic support, U.S. investment-grade companies have gone on a record $1.4 trillion bond-borrowing spree this year at record-low yields, issuing about 74% more debt than the same period of last year, according to BofA data.
BofA Global created this chart to show investment-grade bonds hitting a fresh 24-year low this summer on a yield basis. Bond prices move in the opposite direction of yields.
The new financing mostly will be used by J&J to purchase Momenta MNTA, -0.02% in a cash, tender offer valued at $6.7 billion, which was announced Wednesday and sent shares of Cambridge, Mass.-based biotechnology company 69% higher to close at $52.12 per share.
Under terms of the agreement, J&J will pay $52.50 for each outstanding Momenta share. The deal is expected to close in the second half of 2020.
The remainder of the debt financing was pegged for general corporate purposes.
Moody’s Investors Service gave the debt financing a AAA rating, but with a negative outlook. While the credit-rating firm expects J&J’s pharmaceutical business to generate “mid-to-high single-digit growth” over the next few years, that contrasts with lower growth forecasts for its other business areas, which also face risks tied to “unresolved litigation involving opioids and talc,” that could constrain free cash flow “over multiple years.”
Johnson & Johnson, Moderna Inc. MRNA, -3.45%, Pfizer Inc. PFE, -0.11% and AstraZeneca PLC AZN, -1.07%, have been racing to get trials under way to help accelerate the development of a COVID-19 vaccine, with J&J planning to start a 60,000 person worldwide trial by late next month to test if it can protect people against the virus.
Vaccine hopes have been one catalyst helping to lift major U.S. stock indexes back to, or beyond, their prior all-time highs before the pandemic, with the S&P 500 index SPX, -0.81% this week marking its quickest recovery in history.
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MGTA in the news
Magenta Therapeutics Named Co-Recipient of Grant from the National Institutes of Health to Explore Use of Novel Targeted Conditioning Agents with Gene Editing Approaches to Cure HIV
Business Wire Business Wire•September 2, 2020
Magenta Therapeutics Named Co-Recipient of Grant from the National Institutes of Health to Explore Use of Novel Targeted Conditioning Agents with Gene Editing Approaches to Cure HIV
– NIH grant funds an interdisciplinary effort among researchers from University of Southern California; University of Washington and Fred Hutchinson Cancer Research Center; Harvard University and Massachusetts General Hospital; the Ragon Institute; and Magenta Therapeutics –
– Magenta will utilize its tool CD45 and CD117 antibody-drug conjugate (ADC) conditioning agents, as well as its stem cell biology platform to identify the optimal strategy for curative immune system transplant in patients with HIV –
Magenta Therapeutics (Nasdaq: MGTA), a clinical-stage biotechnology company developing novel medicines to bring the curative power of immune reset to more patients, today announced it is part of a multi-project, broad-based research effort awarded a five-year, $14.6 million U19 grant from the National Institutes of Health (NIH) to explore gene- and cell-based approaches to advance research into curing HIV.
This cross-institutional research program brings together leaders in the fields of gene editing, HIV and stem cell transplant. The team, which includes researchers from the University of Southern California, the University of Washington, the Fred Hutchinson Cancer Research Center, Harvard University, Massachusetts General Hospital; the Ragon Institute and Magenta Therapeutics, will explore novel hematopoietic stem and progenitor cell (HSPC) engineering and transplantation approaches aimed at achieving complete remission of HIV-1 infection.
"We are excited to collaborate with our colleagues in this important multi-institution research team to help advance gene editing approaches with our novel targeted antibody drug conjugate (ADC) conditioning platform to one day be able to cure patients living with HIV," said John Davis Jr., M.D., M.P.H., M.S., Head of Research & Development and Chief Medical Officer, Magenta. "These studies leverage our proprietary stem cell biology pipeline and ADC platform to provide important insights into which conditioning strategy is best suited to aim for HIV."
Magenta will utilize its conditioning technology to optimize cell dose in animal models and determine whether targeted conditioning and gene-modified HSPC transplant enables disease control.
About Magenta Therapeutics
Magenta Therapeutics is a clinical-stage biotechnology company developing medicines to bring the curative power of immune system reset through stem cell transplant to more patients with autoimmune diseases, genetic diseases and blood cancers. Magenta is combining leadership in stem cell biology and biotherapeutics development with clinical and regulatory expertise, a unique business model and broad networks in the stem cell transplant world to revolutionize immune reset for more patients.
Magenta is based in Cambridge, Mass. For more information, please visit www.magentatx.com.
Follow Magenta on Twitter: @magentatx.
Bladerunner
Name | Symbol | % Assets |
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Newmont Corp | NEM | 12.36% |
Barrick Gold Corp | ABX.TO | 11.02% |
Franco-Nevada Corp | FNV.TO | 7.17% |
Newcrest Mining Ltd | NCM.AX | 5.15% |
Agnico Eagle Mines Ltd | AEM.TO | 4.96% |
Wheaton Precious Metals Corp | WPM.TO | 4.95% |
Anglogold Ashanti Ltd ADR | AU.JO | 4.14% |
Kirkland Lake Gold Ltd | KL.TO | 4.07% |
Royal Gold Inc | RGLD | 3.70% |
Kinross Gold Corp | K.TO | 3.11% |
Name | Symbol | % Assets |
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Kinross Gold Corp | K.TO | 6.00% |
Northern Star Resources Ltd | NST.AX | 6.00% |
Sibanye-Stillwater ADR | SBGL.JO | 5.99% |
Pan American Silver Corp | PAAS.TO | 5.49% |
Gold Fields Ltd ADR | GFI.JO | 4.60% |
Yamana Gold Inc | YRI.TO | 4.40% |
Evolution Mining Ltd | EVN.AX | 4.00% |
B2Gold Corp | BTO.TO | 3.73% |
Buenaventura Mining Co Inc ADR | BVN | 2.99% |
Saracen Mineral Holdings Ltd | SAR.AX | 2.95% |
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