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MDXG: the stock has moved nicely in the past few weeks, and the company just reported positive earnings. Thank you for bringing it up last year.
Jason
ECYT: I'm only referring to the percentages listed in that pert of the PR
If there is a 30% reduction in risk of death in the group, then
the reduction in the risk of death OR worsening of disease cannot be less than 30% since the group that benefited is larger.
The third line is just the second line with some reordering of the words, so the percentage should be the same in both
Jason
Do these people read what they write, or are numbers fungible
30% reduction in the risk of death
27% reduction in risk of worsening of disease or death
Risk of disease worsening or death (PFS) was reduced by 25%
MON: What looks like a bullish option transaction today
2000 Jan 2015 125.00 puts sold for 18.10 (current bid/ask 18.30 / 18.55)
3500 Jan 2015 125.00 calls bought for 2.62 (current bid/ask 2.48 / 2.62)
Wellington Management also sold out recently
http://services.corporate-ir.net/SEC.Enhanced/SecCapsule.aspx?c=219651&fid=9093957
Item 1.
(a) Name of Issuer
AVEO Pharmaceuticals, Inc.
Item 2.
(a) Name of Person Filing
Wellington Management Company, LLP (''Wellington Management'')
(d) Title of Class of Securities
Common Stock
Item 3. If This Statement is Filed Pursuant to Rule 13d-1(b), or 13d-2(b) or (c), Check Whether the Person Filing is a:
(e) [X] An investment adviser in accordance with Rule 240.13d-1(b)(1)(ii)(E);
Item 4. Ownership.
Provide the following information regarding the aggregate number and percentage of the class of securities of the issuer identified in Item 1.
(a) Amount Beneficially Owned:
Wellington Management, in its capacity as investment adviser, may be deemed to beneficially own 0 shares of the Issuer which are held of record by clients of Wellington Management.
(b) Percent of Class:
0.00%
(c) Number of shares as to which such person has:
(i) sole power to vote or to direct the vote 0
(ii) shared power to vote or to direct the vote 0
(iii) sole power to dispose or to direct the disposition of 0
(iv) shared power to dispose or to direct the disposition of 0
Item 5. Ownership of Five Percent or Less of Class.
If this statement is being filed to report the fact that as of the date hereof the reporting person has ceased to be the beneficial owner of more than five percent of the class of securities, check the following: [X]
GVHD
DYAX
This report has HAE-market related information that may be of interest:
http://bir-llc.com/wp-content/uploads/2012/04/BER-VPHM-Cinryze-Report-11-9-2011.pdf
Trillium is supposedly merging with another Canadian biotech, which will give it a listing on a Canadian exchange:
http://ca.finance.yahoo.com/news/stem-cell-therapeutics-announces-agreement-120000754.html
FN
A Mac uses the Option key in conjunction with other keys to produce characters such as ç or v.
I created a spreadsheet with the corresponding Option-set by typing <Option><key> for all the keys and then <Option><Shift><key> for all of them.
Some are used in three key combinations, e.g., <Option>`a = à or 1<Option><Shift>14 = 1/4.
Other useful combinations
<Option>e<aeiou> = á, …
<Option>u<aeiou> = ä, …
<Option>i<aeiou> = â, …
<Option>˜<aon> = ã, …
Windows must have an equivalent key.
Jason
[Edit] some of the combinations do not display on the forum. The 'v' in the first sentence was originally a 'check-mark', and the '1/4' in the second paragraph had the three characters mashed together like a single character.
CLSN: I owned it in 2000, and I think it was working on the same technology and forever showing great promise. Has not changed much.
Here are two paragraphs with interesting transcriptions by Seeking Alpha's speech processor
Agios Pharmaceuticals, Inc. and The University of Pennsylvania Announce New Collaboration
Collaboration Announced in Conjunction with Resolution of Legal Proceeding
Cambridge, Massachusetts and Philadelphia, Pennsylvania – August 31, 2012 – Agios Pharmaceuticals, Inc. ("Agios") and The University of Pennsylvania ("Penn") today announced that, in connection with the resolution of litigation announced earlier today, Agios and Penn have entered into a licensing agreement involving new intellectual property focused on the development of diagnostic products to detect the metabolism of certain cancers. The collaboration could result in significant benefits to cancer patients, as well as financial benefits to Agios, Penn and the Abramson Family Cancer Research Institute.
"We are pleased to be collaborating with Penn and value the contributions of their scientists to this exciting field," stated David Schenkein, M.D., Chief Executive Officer of Agios. "We are excited to now focus on the most important task of all – transforming the lives of cancer patients."
"We are pleased to be moving forward in a collaborative manner around newly identified intellectual property," commented Chi Van Dang, M.D., Ph.D., Professor of Medicine and Director of the Abramson Cancer Center at Penn. "We look forward to working with Agios on this project and potentially other unrelated projects in the future."
Media Inquiries:
Dan Budwick
Pure Communications
973-271-6085
The company was formerly known as Cominco Fertilizer Ltd. and changed its name to Agrium Inc. in 1995. Agrium Inc. was founded in 1931.
X marks the spot. Thank you!
The button to stop following a board has disappeared or is no longer located in the bar above the message list for a board I am following. Is this a known problem that will be fixed soon?
Since the premise is false, the statement is logically true.
Hi all. I have a question for the board on the utility of Bavituximab. Since the exposure of phosphatidylserine on a cell's surface flags it as apoptotic to the immune system and needing removal, what additional benefit does Bavituximab add to the removal of the cell?
Jason
This statement from the PPHM PR is not a good sign. Emphasis added.
http://services.corporate-ir.net/SEC.Enhanced/SecCapsule.aspx?c=219651&fid=7910385
$250,000,000
PROSPECTUS
LOGO
Common Stock
Preferred Stock
Debt Securities
Warrants
Units
We may issue securities from time to time in one or more offerings. This prospectus describes the general terms of these securities and the general manner in which these securities will be offered. We will provide the specific terms of these securities in supplements to this prospectus. The prospectus supplements will also describe the specific manner in which these securities will be offered and may also supplement, update or amend information contained in this prospectus. You should read this prospectus and any applicable prospectus supplement before you invest.
We may offer these securities in amounts, at prices and on terms determined at the time of offering. The securities may be sold directly to you, through agents, or through underwriters and dealers. If agents, underwriters or dealers are used to sell the securities, we will name them and describe their compensation in a prospectus supplement.
Our common stock trades on the NASDAQ Global Market under the symbol “AVEO.”
Investing in these securities involves certain risks. See “Risk Factors” on page 5 of this prospectus and any other risk factors included in any accompanying prospectus supplement and in the documents incorporated by reference in this prospectus for a discussion of the factors you should carefully consider before deciding to purchase these securities.
Neither the Securities and Exchange Commission nor any state securities commission has approved or disapproved of these securities or passed upon the adequacy or accuracy of this prospectus. Any representation to the contrary is a criminal offense.
The date of this prospectus is , 2012.
AVEO Announces Patient Enrollment in Phase 2 Clinical Trial of Tivozanib in Combination with mFOLFOX6 in Patients with Advanced Colorectal Cancer
The Trial, BATON-CRC, is Second in Series of Tivozanib Biomarker Trials
CAMBRIDGE, MASS.--(BUSINESS WIRE)--Dec. 22, 2011-- AVEO Pharmaceuticals, Inc. (NASDAQ: AVEO) today announced the initiation of patient enrollment in an open-label, multicenter, randomized Phase 2 clinical trial, called BATON-CRC, evaluating tivozanib in combination with modified FOLFOX6 (mFOLFOX6) compared to bevacizumab in combination with mFOLFOX6 as first-line therapy in patients with advanced metastatic colorectal cancer (CRC). BATON-CRC is the second trial to be initiated as part of the BATON (Biomarker Assessment of Tivozanib in ONcology) program, a series of clinical trials planned to assess tivozanib biomarkers in solid tumors. BATON-RCC, a Phase 2 exploratory biomarker study in patients with advanced renal cell carcinoma, was initiated by AVEO in early 2011.
“There have been a number of advances in the treatment of metastatic colorectal cancer, particularly over the past decade, which have extended patients’ survival; however, there remains an urgent need for new agents to further improve outcomes for patients,” said Al Benson, M.D., F.A.C.P., professor of medicine in the Division of Hematology/Oncology at Northwestern University Feinberg School of Medicine, and BATON-CRC primary investigator. “It is critical that we develop strategies that will enhance our understanding of patient populations that will best respond to specific therapeutic regimens, and I believe that BATON-CRC is a step forward on this front. I am excited to be involved in this trial and to learn more about how this treatment regimen with tivozanib may benefit patients living with colorectal cancer.”
BATON-CRC, which is being led by AVEO’s collaborator Astellas Pharma Inc. (Tokyo:4503, “Astellas”), will enroll approximately 252 patients with no prior VEGF-targeted therapy at approximately 80 centers in the U.S., Canada, Australia and Europe. Patients will be randomized to one of the two treatments arms in a 2:1 ratio (168 patients in the tivozanib arm and 84 patients in the bevacizumab arm). One component of BATON-CRC is the assessment of biomarker relationships that may be predictive of response, including lactate dehydrogenase (LDH). LDH is a protein that normally appears throughout the body in small amounts and can be elevated in patients with certain cancers, including colorectal cancer. Measuring LDH levels can be helpful in monitoring cancer treatment and determining patients’ response to therapy. For additional information, please visit clinicaltrials.gov.
“BATON-CRC is further example of AVEO’s commitment to patient care and advancing the science behind biomarkers,” said William Slichenmyer, M.D., Sc.M., chief medical officer at AVEO. “The identification and development of relevant biomarkers through our Human Response Platform is a core component of our oncology drug development efforts. We plan to use biomarker data from BATON-CRC and BATON-RCC to inform our clinical development strategy in an effort to bring tivozanib to the patients who will benefit most.”
A Phase 1b clinical trial evaluating tivozanib in combination with mFOLFOX6 in patients with advanced gastrointestinal (GI) cancers, including colorectal cancer, was completed by AVEO last year. Results showed partial responses in more than a third (35 percent) of patients evaluated (n=17) and disease control in 82 percent of patients; and, the combination was considered tolerable at the full tivozanib dose (1.5 mg/day) and standard mFOLFOX6 dose.
The following is from a scan of the President/CEO's letter that was included in the material mailed to shareholders for the November 7 annual meeting.
September 15, 2011
Dear Shareholders:
The last year was both challenging and exciting. In August 2011, we announced that the U.S. Food and Drug Administration, or the FDA, had accepted for review the resubmission of the new drug application (NDA) we submitted for the taliglucerase alfa, our proprietary plant cell expressed form of human Glucocerebrosidase (GCD), which is being developed for the treatment of Gaucher disease. The FDA has granted a February 1, 2012 action date under the Prescription Drug User Fee Act (PDUFA), the date by which the FDA is expected to respond to the NDA. This announcement represents a promising milestone for our company.
As you know, we first submitted an NDA for taliglucerase alfa in April 2010, and in February 2011, we received a Complete Response Letter, or CRL. from the FDA with respect to the NDA. A CRL is issued by the FDA when its review of a file is complete and questions remain that preclude the NDA in its then current form. While we were of course disappointed by this development, we were encouraged by the nature of the questions in the CRL. Notably, the FDA clid not request additional clinical studies. Rather, the CRL also requested data regarding our taliglucerase alfa switchover trial and our long-term extension trial, data that was not available when we first submitted the NDA. The FDA also presented questions in the CRL that were intended to clarify issues relating to chemistry, manufacturing and controls (CMC). Final top line results from the adult patients participating in the switchover trial were released in July 2011 and the requested data was included in our resubmission. The resubmission also included requested clinical data from our long-term extension trial.
We are pleased with the results of the switchover trial. Twenty six adult patients were enrolled in the switchover trial in which they were switched from Cerezyme to an equivalent dose of taliglucerase alfa, Cerezyme was the standard of care when we initiated the switchover trial. The data supports the efficacy and safety data package and shows that patients can be switched from Cerezyme to taliglucerase alfa. The long-term extension trial studied patients that completed our phase III clinical trial of taliglucerase alfa and were subsequently treated with taliglucerase alfa for a total of at least 24 months. These patients continued to show a mean improvement in efficacy and the drug was well tolerated. We intend to release complete results from the switchover trial and the long-term extension trial at various medical conferences over the next year.
An encouraging side note to our experience with the CRL response is the experience we have had with Pfizer Inc., our commercial partner for taliglucerase alfa. We have found Pfizer to be a true partner and a valuable regulatory and analytical resource as we worked together to prepare our response to the FDA.
As we wait for the FDA to respond to the resubmitted NDA, we are excited about our company's future. We believe that we have adequately addressed the requests outlined by the FDA in the CRL, and we plan to work closely with the FDA as it moves forward with its review of the NDA. The anticipated FDA marketing approval of taliglucerase alfa will not only present us with our first commercial product, we believe that it will serve as a proof of concept of our ground-breaking plant cell based protein expression technology, and will mark a new era in therapeutic protein biotechnology.
While we have focused significant efforts on the FDA approval of taliglucerase alfa, we have also been focused on other important regulatory approvals. We have applied for marketing approval of taliglucerase alfa in Israel and Pfizer, with our assistance, has submitted applications for marketing approval of taliglucerase alfa in the European Union, Brazil and Australia. Since the applications were submitted, our manufacturing facility in Carmiel, Israel has been found acceptable in audits by the FDA and the comparable authorities of Israel and Brazil.
Although not yet approved for commercial use, hundreds of patients have been treated to date with taliglucerase alfa under several regulatory settings which has allowed us to collect a robust global clinical database regarding taliglucerase alfa. In addition to our clinical trials, we have provided taliglucerase alfa for patients in the United States, the European Union, Israel, South Africa, Brazil and other countries through compassionate use and similar programs. We do not generate revenues in connection with most of those programs. However, Pfizer has sold taliglucerase alfa to the Brazilian government for gross proceeds of approximately $30 million in connection with a short-term supply agreement and is selling the drug to the French government under a Temporary Authorization for Use (ATU).
Our efforts have not been limited to taliglucerase alfa. In December 2010, we conducted a pre-lnvestigational New Drug (IND) meeting with the FDA regarding PRX-102, our product candidate under development for the treatment of Fabry disease. We expect to file an IND with the FDA before the end of this year and to commence a phase I/lI clinical trial of PRX-102, our modified alpha Galactosidase enzyme shortly thereafter. Subjects in the first trial will be patients of Fabry disease. We are continuing development efforts for PRX-105, our plant cell expressed pegylated recombinant acetylcholinesterase product candidate for biodefense indications, and are in discussions with defense authorities and other government bodies around the world. We have completed a phase I clinical trial of PRX-105. In addition, we are promoting the use of this product candidate for other important clinical indications. We expect to hold meetings with regulatory authorities in the near future in connection with PRX-106, or pr-antiTNF, our plant cell expressed fusion protein that we are developing for the treatment of certain immune diseases, such as rheumatoid arthritis, We are continuing our development of an orally-administered glucocerebrosidase enzyme for the treatment of Gaucher disease. In addition to these candidates, we have additional undisclosed proteins that are currently the subject of animal studies.
In March 2011, we raised approximately $22 million in a public offering of our common stock underwritten by Citigroup Global Markets and Barclays Capital. We believe that these resources, together with revenues from taliglucerase alfa sold in Brazil and France, have provided, and will continue to provide, the capital necessary to fund our on-going and planned clinical trials, and to as enhance our research and development activities and manufacturing capacity.
Last year, the chairman of our Board of Directors, Mr. Eli Hurvitz, unfbrtunately had to resign from his position. On behalf of our company, I would like to thank Eli for his leadership and to wish success to Mr. Zeev Bronfeld who stepped up to the position of interim chairman.
We believe we have addressed many of the challenges of the last year and we are looking forward to continuing our efforts in the upcoming year. We thank our shareholders, employees and partners for their continued support.
Dr. David Aviezer
President and Chief Executive Officer
Seattle Genetics Announces Initiation of a Phase II Clinical Trial of ADCETRIS™ in CD30-Positive Non-Hodgkin Lymphoma
Press Release Source: Seattle Genetics, Inc. On Tuesday August 23, 2011, 9:00 am EDT
BOTHELL, Wash.--(BUSINESS WIRE)-- Seattle Genetics, Inc. (NASDAQ:SGEN - News) today announced that it has initiated a phase II clinical trial of ADCETRIS™ (brentuximab vedotin) for patients with relapsed or refractory CD30-positive non-Hodgkin lymphomas, including diffuse large B-cell lymphoma, peripheral T-cell lymphoma and other less common lymphoma subtypes. The trial is designed to assess the antitumor activity, duration of response and safety profile of ADCETRIS in these patients. ADCETRIS is an antibody-drug conjugate (ADC) directed to CD30. On August 19, 2011, the U.S. Food and Drug Administration granted accelerated approval of ADCETRIS for two indications.
“This clinical trial is part of our comprehensive development plan to broadly evaluate the potential of ADCETRIS in CD30-positive malignancies, building on the data we have generated in certain patients with Hodgkin lymphoma and systemic ALCL,” said Thomas C. Reynolds, M.D., Ph.D., Chief Medical Officer of Seattle Genetics. “We believe the targeting ability of ADCETRIS to CD30 provides significant opportunities in selected lymphoma subtypes. This study and our other planned trials will further define the potential role of ADCETRIS in these patients.”
The primary endpoint of the phase II trial is to determine the antitumor activity of ADCETRIS as measured by objective response rate. In addition, the trial will characterize the relationship of CD30 expression with antitumor activity. Eligible patients must have relapsed or refractory CD30-positive non-Hodgkin lymphoma, other than cutaneous or systemic anaplastic large cell lymphoma (ALCL). The study is expected to enroll up to approximately 55 patients at multiple centers in the United States.
Trius Therapeutics Obtains Special Protocol Assessment With FDA for Second Phase 3 Study of Torezolid Phosphate
Study Will Examine Efficacy and Safety of IV and Oral Dosing of Torezolid Phosphate in Patients With ABSSSI
Press Release Source: Trius Therapeutics, Inc. On Friday August 5, 2011, 6:00 am EDT
SAN DIEGO, Aug. 5, 2011 (GLOBE NEWSWIRE) -- Trius Therapeutics, Inc. (Nasdaq: TSRX - News) announced today that it has reached agreement with the United States Food and Drug Administration (FDA), under the Special Protocol Assessment (SPA) process, on the design of its second planned Phase 3 study for the intravenous and oral dosage forms of torezolid phosphate for treatment of acute bacterial skin and skin structure infections (ABSSSI). This double-blind pivotal study will compare the efficacy and safety of once-daily administration of 200 milligrams of torezolid phosphate for six days of treatment to twice-daily administration of 600 milligrams of linezolid (Zyvox) for 10 days of treatment. All patients will be initiated on the intravenous dosage (IV) form for a minimum of one day's treatment and will be transitioned to the oral dosage form at the discretion of the clinical investigator. As with the first on-going Phase 3 study testing the oral dosage form, the primary efficacy endpoint of the IV to oral transition study will be the cessation of infected lesion spread and absence of fever at 48 to 72 hours following initiation of treatment. Secondary endpoints will include, among other things, sustained clinical response at the end of therapy visit, and the investigator's assessment of clinical response at all visits and clinical success at the post treatment evaluation visit. Provided non-inferiority is met, an assessment of superiority of torezolid phosphate to linezolid with respect to the primary efficacy endpoint will also be made. Trius expects to start this second pivotal study in the fourth quarter of this year.
Some comments from Forbes
3) Cameco (CCJ)
The uranium miner suffered a huge gap down when the tsunami wiped out that Japanese nuclear power plant. That gap doesn’t look like it´ll get filled anytime soon. That 50-day moving average on the daily chart crossed below the 200-day in early May and continued downward. Price is now rallying back, weakly, to the downtrending 50-dma. The weekly chart paints the same bearish pattern. And the point-and-figure projection is much, much lower — not the most encouraging group of x´s and o´s in boxes. A move above 33 would tend to negate this analysis.
http://blogs.forbes.com/johnnavin/2011/05/26/585/?partner=yahootix
This is a repost to fix the back-chain of these posts
Clinical / Regulatory / Litigation Calendar
[Please keep these entries up to date! See
the updating procedure at the end of this post.]
NOTE: ANYONE MAY UPDATE THIS FILE
Edits: ADLR (pain parternship dumped by PFE), AIS (Anturol NDA filed Dec 2010 and MTX trial started Feb 2011), ISIS (several- taking my lashes from Dew...but who can keep up with all ISIS moving parts?) MYRX (Azixa first-line p2b GBM trial bgean 12/2010
ABT – Bioresorbable DES: EU launch 2H12 (following reimbursement negotiations—product already approved); US launch possible in 2013 (pending clinical results).
ACHN – ACH-1625 PI: start phase-2a trial Sep 2010; report 12w data end 2011.
ACHN – ACH-2684 PI: file IND 1H11; phase-1b data end 2011.
ACHN – ACH-2928 NS5A: file IND 1H11; phase-1b data end 2011.
ACHN – Start all-oral ACH-1625 + ACH-2928 program 2012.
AGN – LapBand label expansion: FDA approval likely in early 2011 (positive FDA advisory panel 12/3/10).
AGN – Botox for OAB: sBLA PDUFA date Aug 2011 (standard review); data presentation at urology conference in 2011.
AGN – Latisse for androgenetic alopecia: phase-1 data early 2012.
AIS - Anturol PDUFA ~ Oct 2011
AIS - First TEVA undisclosed pen injector ANDA file late 2011
AMGN – Xgeva: BLA submission for prevention of bone mets in CRPC 1H11 (top-line phase-3 data reported 12/13/10); BLA submission for bone health in non-metastatic cancer 2012-2013, pending results of phase-3 trial in breast cancer.
AMLN – Bydureon (exenatide LAR) second-pass PDUFA date 10/22/10. (Original CRL issued by FDA 3/15/10.)
ANDS – ANA598 phase-2a SVR12/SVR data for patients re-randomized to 24 weeks of SoC 1H11; phase-2b data see http://investorshub.advfn.com/boards/read_msg.aspx?message_id=58413513 .
Bayer – Xarelto: see JNJ.
Bayer – VEGF-Trap-Eye: see REGN.
BMY – Apixaban vs aspirin in AF/stroke prevention: NDA rolling submission based on AVERROES study to be completed in 1Q11.
BMY – Apixaban in AF/stroke prevention: data from phase-3 ARISTOTLE study 2Q11; NDA submission (based on ARISTITLE AND AVERROES) 2H11.
BMY – Apixaban for VTE prevention appears to be on the back burner (or dead). In Dec 2009, BMY/PFE said a European MAA would occur in 1H10 (http://investorshub.advfn.com/boards/read_msg.aspx?message_id=44219816 ), but nary a peep about VTE prevention since then.
BMY – Belatacept: FDA decision on BMY’s response to May 2010 CRL is on hold until BLA fixes manufacturing problems in Puerto Rico.
BMY – Ipilimumab in second-line metastatic melanoma: PDUFA date 3/26/11. (ODAC panel originally scheduled for 2/9/11 was canceled.) European MAA submitted and accepted by EMA for review.
BMY – Ipilimumab in first-line metastatic melanoma: data from phase-3 ‘024’ trial testing DTIC±Ipi expected 1Q11.
BMY – Ipilimumab in melanoma brain mets: OS data from phase-2 ‘042’ trial 2011 (RR data reported at 2010 ASCO).
BMY – Ipilimumab in NSCLC/SCLC: OS data from phase-2 ‘041’ trial 2011 (PFS data for NSCLC reported at 2010 ASCO). Decision has been made to advance to phase-3 in NSCLC.
BPAX – LibiGel: 2,500 pt enrollment 10/18/10, no safety concerns again at latest DSMB review, but low CV event vs forcast means insufficient non-inferiority statisitical power, continue enrolling and will assess after each subsequent CV event. Avg pt exposure was 10.7 months at this date, need to extend to 12 months. Would hit maximum 4000 pts enrolled early 2011.
CHTP - Droxidopa in ADHD PII : Due Q1 11
CHTP - Droxidopa in NOH in Parkinsons pts only PIII Study 306 : Due Q2 11.
CHTP - CH-4051 Interim PII in RA : Due Q3 11
CHTP - Droxidopa in Fibromyalgia : Due Q4 11
CORT – Corlux: last patient will be dosed next week, efficacy results 4Q10, timeline slip for NDA submission to 1Q11: http://investorshub.advfn.com/boards/read_msg.aspx?message_id=51692765
CORT - CORT 108297 Phase I initiated in February, original guidance was for 2Q10 completion. http://investorshub.advfn.com/boards/read_msg.aspx?message_id=46958126
ELN – Bapineuzumab: see JNJ.
GILD – Elvitegravir vs Isentress phase-3: report 96-week 1H12. (Duration for primary endpoint was changed from 48w to 96w on 1/10/11.).
GILD – ‘Btripla’ TMC278+Truvada combo pill: NDA submitted to FDA 11/23/10; FDA decision on priority review Jan 2011. Btripla MAA submitted to EU 9/3/10. (See JNJ for further TMC278 info.)
GSK – ‘761 (IDX899) for HIV: start phase-2b vs Sustiva in first-line HIV early 2011. (The SONNET phase-2b trial in second-line HIV started Nov 2010.)
GSK – Benlysta: see HGSI.
HGSI – Benlysta in SLE: PDUFA date 3/10/11 (extended by three months on 12/3/10).
IDIX – IDX899: see GSK.
IDIX – IDX184/IDX320: possible lifting of FDA clinical hold 1H11.
IDIX – NS5A inhibitor: select lead compound 1H11 (was supposed to be 2010).
INHX – INX-189 HCV polymerase inhibitor: start phase-1b 3-day monotherapy trial early 4Q10; data early 2011.
ISIS - GSK1 [undisclosed target] start p1 late 2010 or early 2011 (still waiting)
ISIS - Mipomersin NDA mid-2011 HoFH only, EU filing 1h2011, HoFH and severe HeFH
ISIS - CRP start p2 trials in multiple myeloma, RA, autologous BM transplant 4q10-early 2011 (still waiting)
ISIS - PTP1b start 26wk p2b study ???? [odds decent that this becomes next candidate ditched for more potent backup
ISIS - GCGR, GCCR start p1 late 2010 or early 2011 (still waiting)
ISIS - SGLT2 p1 data 2010 and p2 2011 (still waiting)
ISIS - LLY218108 Survivin cancer data late 2010, potential p3 2011
ISIS - SOD1 registrational p2 in ALS niche begin 2011
ITMN – Pirfenidone: No specific timeline for response to FDA’s CRL of 5/4/10 requesting a new trial. (Pirfenidone approved by EU’s CHMP 12/17/10.)
JNJ – Xarelto: Various submissions in EU and US were made 1/5/11:
http://investorshub.advfn.com/boards/read_msg.aspx?message_id=58426102 .
JNJ – TMC278 for HIV: PDUFA date May 2011 (assuming a standard review—NDA submitted 7/26/10). MAA submission 3Q10. (See GILD re TMC278+Truvada combo pill.) JNJ – Remicade/Simponi arbitration with MRK Dec 2010, decision expected early 2011.
JNJ – Nevo drug-eluting stent: EU submission late 2010; FDA submission 2012.
JNJ – PurTox botulinum toxin: submit BLA 2011 after completing two phase-3 trials. (First phase-3 trial reported positive data 10/1/08.)
JNJ – Bapineuzumab: ‘301’/‘302’ (N. American) phase-3 trials conducted by JNJ: data in 2H12; int’l phase-3 trials conducted by PFE: data in 2014 (confirmed on PFE’s 1Q10 CC).
JNJ – Telaprevir: see VRTX.
LGND - Promacta p3 HCV data 2h11
LGND - p38 inhibitor BMS add'l p2 trial 2011
LGND - Aprela menopause NDA 2011
LGND - SCH527123 (MRK) CXCR2 antagonist p2 COPD is enrolled, data early 2012
LGND - Dinaciclib (MRK) CDK inhibitor, multiple cancer p2 ongoing, report late 2010 thru 2012
LGND - LGD-4033 SARM inhibitor- p1b completing, data 2q11 and partner soon thereafter
LLY – Bydureon: see AMLN.
MDVN – Dimebon: see PFE.
Merck KGaA – Cladribine NDA in RRMS: PDUFA date 12/5/10. (Rejected in Europe 9/24/10.)
MNTA – See http://investorshub.advfn.com/boards/read_msg.aspx?message_id=58661242 .
MRK – Boceprevir: PDUFA date May 2011 (NDA has priority review).
MRK – Remicade/Simponi arbitration: see JNJ.
MYRX - complete p1 for -3100 HSP90 inhibitor by ye10
MYRX - oral anti-interferon and cancer metabolism inhibitor candidates INDs by 6/30/11
NVAX – H1N1 VLP vaccine 1,000 patient “stage A” trial in Mexico data complete and submitted to Mexican authorities. 3500 patient “stage B” completed enrollment in early March: http://finance.yahoo.com/news/NOVAVAX-Announces-Positive-prnews-4040674703.html?x=0&.v=1
NVAX – BARDA funding decision awaits site inspection… update in conference call, site inspection complete.
http://finance.yahoo.com/news/NOVAVAX-Notified-by-prnews-1260458837.html?x=0&.v=1
NVAX – seasonal trivalent head to head phaseIIb vs. Fluzone. see:
http://finance.yahoo.com/news/Novavaxs-Seasonal-Influenza-prnews-3904001081.html/print?x=0
OREX – Contrave PDUFA date 1/31/11. (FDA advisory panel endorsed approval by 13-7 vote on 12/7/10.)
PFE – Apixaban: see BMY.
PFE – Bapineuzumab: see JNJ.
PFE – Dimebon: AD program terminated 5/10/10 except the CONCERT study testing Aricept±Dimebon in mild-to-moderate AD. HORIZON study in HD continues.
REGN - Rilonacept in flare prevention upon initiation of allopurinol - results expected in 2010; Rilonacept in flare treatment - results expected in 2010.
REGN - Aflibercept in 3 different ph iii's (total enrollment expected is ~4000). VELOUR (2nd line colorectal + chemo cocktail), VITAL (2nd line NSCLC with docetaxel), VENICE (1st line HRPC with docetaxel + pred)
REGN – VEGF-Trap-Eye: NDA submission 1H11 (top-line data reported 11/22/10).
Roche – RG7128 + SoC: Phase-2b (separate from PROPEL study) testing regimens with 24w of RG7128+SoC in geno-1/4 started enrollment Feb 2010. Phase-2b in geno-2/3, originally planned to start 2H10, will supposedly start in 1H11 ( see http://investorshub.advfn.com/boards/read_msg.aspx?message_id=58513484 ).
Roche – INFORM-SVR trial of Danoprevir (RG7127) + RG7128 with SVR endpoint will supposedly start in 1Q11. [I’m skeptical that it will start at all—Dew.]
Roche – Danoprevir + SoC: Phase-2b was supposed to start in 2010. [I think the program is probably dead—Dew.]
SPPI - Belinostat (CUP w/ chemo) complete p2 ye10 and release data 3q11
SPPI - Belinostat (PTCL monotherapy) NDA 2011 [but very little comment on enrollment, etc]
SPPI - Belinostat initiate p2 NSCLC trial 4q10
SPPI - submit sNDA to remove Zevalin bioscan requirement 4q10
SPPI - Fusilev CRL response filed 10/29/10, pending acceptance by FDA
TEVA – Copaxone and Lovenox litigation: see MNTA.
TEVA –“Low-volume” Copaxone: FDA issued CRL 12/23/10; no further info available. [I question whether this program has any future—Dew.]
TEVA – Thrice-weekly formulation of Copaxone: phase-3 GALA study results expected Nov 2012.
TEVA – Laquinimod for MS: results of phase-3 BRAVO study expected 3Q11.
VRTX – Telaprevir PDUFA date 5/23/11.
VRTX – Telaprevir + VX-222: report phase-2 interim safety, efficacy, and PK data 1Q11. (Note: this trail no longer has any arms testing Telaprevir + VX-222 without either SoC or ribavairin.)
VRTX – VX-509 JAK3 inhibitor: phase-2 interim data 2H10 (trial started Jan 2010).
VRUS – RG7128: see Roche.
VRUS – PSI-7977, PSI-938, and PSI-661: see bottom of http://investorshub.advfn.com/boards/read_msg.aspx?message_id=58513484 .
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