AVII data due Monday. RPTP ISIS NDA filings. TELK reverse split + ONTY XOMA EXEL RIGL CYCC CUR DEPO STEM IMGN news

Mar 31, 2012 No Comments by

AVI BioPharma, Inc. (NASDAQ: AVII) announced it will hold a conference call at 8:00 a.m. EDT (5:00 a.m. PDT) on Monday, April 2, 2012 to discuss top-line results from its Phase 2b study evaluating eteplirsen for the treatment of Duchenne Muscular Dystrophy (DMD).

Raptor Pharmaceutical Corp.  (Nasdaq:RPTP) submitted its New Drug Application (NDA) seeking approval for Cysteamine Bitartrate Delayed-release Capsules (RP103), in patients with nephropathic cystinosis.The company has requested a 6-month Priority Review.

Genzyme (EURONEXT: SAN and NYSE: SNY), and Isis Pharmaceuticals Inc. (NASDAQ: ISIS)  submitted their New Drug Application (NDA) seeking approval for KYNAMRO (mipomersen sodium, in patients with homozygous familial hypercholesterolemia (HoFH).

Telik, Inc. (NASDAQ: TELK)  announced a 1-for-30 reverse split of its common stock.  Telik’s common stock will begin trading on a post-split basis on the NASDAQ Capital Market on April 2, 2012.  The reverse split is expected to enable the company to meet the $1.00 minimum bid price required for continued listing on the NASDAQ Capital Market.

Oncothyreon Inc. (NASDAQ: ONTY) priced its public offering of 11.75m shares at a price to the public of $4.00 per share for net proceeds of $43.6 million, with an option to issue additional shares valued up to $7.1 m.

XOMA Corporation (Nasdaq:XOMA) shareholders will vote on May 24, 2012 to increase the number of authorized shares by an additional 46m to 138,666,666 shares.

Exelixis Inc.(NASDAQ:EXEL) shareholders will vote on May 23, 2012 to increase the number of authorized shares from 200m to 400m shares.

Rigel Pharmaceuticals, Inc. (Nasdaq: RIGL) shareholders will vote on May 22, 2012 to increase the number of authorized shares from 100m to 200m shares.

Cyclacel Pharmaceuticals, Inc. (Nasdaq:CYCC) gave a pipeline update noting it expects to report the following in 2012;

  • Report updated Phase 2 sapacitabine data in 2nd line MDS following previous treatment with hypomethylating agents;
  • Report updated Phase 2 sapacitabine data in AML preceded by MDS following previous treatment with hypomethylating agent(s) for the preceding MDS;
  • Report updated Phase 2 sapacitabine data in NSCLC;

Neuralstem, Inc. (NYSE Amex: CUR) said that it hopes to in 2012 complete its Phase 1 amyotrophic lateral sclerosis (ALS trial) and file with the FDA to progress to a Phase 2 trial.

Depomed, Inc. (NASDAQ: DEPO) received a Paragraph IV Certification Notice in accordance with 21 U.S.C.§355(j)(2)(B) from Impax Laboratories, Inc. (NASDAQ: IPXL) advising the them of the filing by Impax of an Abbreviated New Drug Application (aNDA) with the FDA for a generic version of Gralise (gabapentin) 300mg and 600mg tablets.

StemCells, Inc.(Nasdaq:STEM) announced today that it will host a conference call and webcast to discuss results from its Phase I clinical trial in Pelizaeus-Merzbacher Disease (PMD) on Monday, April 2, at 11:00 a.m. Eastern Time (8:00 a.m. Pacific Time).

 ImmunoGen, Inc. (Nasdaq: IMGN) announced that Roche has announced that it met the progression-free survival endpoint from its trastuzumab emtansine (T-DM1) EMILIA Phase 3 trial, for the treatment of HER2-positive metastatic breast cancer (mBC) in patients who have previously received treatment with trastuzumab (Herceptin) and a taxane.

 

 

 

 

 

 

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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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