DVAX files BLA. RGEN Adcom meeting cancelled, CRL expected + ONXX ITMN CYTR CYTK THRX POZN news

Apr 27, 2012 No Comments by

Dynavax Technologies Corporation (NASDAQ: DVAX) announced that it has filed a U.S. Biologics License Application (BLA) to the FDA for HEPLISAV, for hepatitis B virus in adults 18 through 70 years of age. The company intends to file a European Marketing Authorization Application (MAA) for HEPLISAV in 3Q 2012.

Repligen Corporation (NASDAQ:RGEN) announced the FDA notified the company that the FDA Advisory Committee meeting previously scheduled for May 31 to review RG1068 for pancreatic imaging has been cancelled by the FDA. It expects to receive a Complete Response letter on the previously announced June 21 PDUFA date requesting additional clinical trial data to support the New Drug Application (NDA).

Onyx Pharmaceuticals, Inc. (Nasdaq: ONXX) announced that the FDA Oncologic Drugs Advisory Committee (ODAC) will review its new drug application (NDA) for carfilzomib for the treatment of patients with relapsed and refractory multiple myeloma who have received at least two prior therapies on June 20, 2012. The PDUFA date is July 27, 2012.

InterMune, Inc. (Nasdaq: ITMN) today gave an update on its Phase 3 pirfenidone study, ASCEND, for the treatment of mild-to-moderate idiopathic pulmonary fibrosis (IPF). It expects results from the study will be available in 1H 2014.

CytRx Corporation (Nasdaq:CYTR) announced the initiation of a Phase 2 clinical trial of INNO-206 in patients with advanced pancreatic ductual adenocarcinomas (PDA) who have progressed after receiving two prior therapies.

POZEN Inc. (NASDAQ: POZN) said in a filing yesterday that in a pre-NDA meeting for PA32540, the FDA suggested that the company  also seek approval for a lower dose formulation of the product containing 81 mg of enteric coated aspirin as part of its NDA for PA32540. Absent the availability of such a lower dose formulation in the market if PA32540 is approved, the FDA indicated that it may limit the indication for PA32540 to use in post coronary artery bypass graft surgery (CABG) with a treatment duration not to exceed one year. The NDA filing may now be delayed by approximately 6 months from the original planned submission date in 3Q 2012.

Cytokinetics, Incorporated (Nasdaq: CYTK) gave a pipeline update noting that it now expects data from its Phase IIa Evidence of Effect clinical trial of CK-2017357 in patients with generalized myasthenia gravis (CY 4023), to be released in 2H 2012. During 2Q 2012 it expects a decision regarding the potential progression to the second cohort of the ATOMIC-AHF clinical trial for Omecamtiv Mecarbil, following a review of data from the first cohort by an independent data monitoring committee.

Theravance, Inc. (Nasdaq:THRX) gave a pipeline update noting that its partner, GSK, remains on track to submit NDA and MAA filings for RELOVAIR in patients with patients with chronic obstructive pulmonary disease (COPD) in mid-2012. It expects to file a MAA for patients with asthma in Europe from mid-2012. Data from its Phase 3a LAMA/LABA program is expected in 2012. Topline results from its Phase 2b trial of TD−1211 in patients with opioid-induced constipation (OIC) are expected to be reported in mid-2012. The company also noted that enrollment is ongoing in its Phase 2 proof-of-concept study of TD-9855 in patients with Attention-Deficit/Hyperactivity Disorder (ADHD).

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About the author

Currently residing in New Zealand and employed in the education industry, Mr. A. Burden holds a M.Com in International Business from the University of Sydney and used these skills together with his passion for investing to establish BioPharmCatalyst in June 2010 as a tool for investing decisions in the US pharmaceutical market. He spends much of his free time mountain biking, playing squash and hiking.
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