FDA approves Surfaxin. ASTX receives CRL + news from ONTY CYTK ACAD XOMA

Mar 07, 2012 No Comments by

Discovery Laboratories, Inc. (NASDAQ: DSCO) announced that it had received FDA approval for Surfaxin (lucinactant) for the prevention of respiratory distress syndrome (RDS), a breathing disorder that affects premature infants. Surfaxin is the fifth drug approved in the United States to treat RDS in premature infants.

Astex Pharmaceuticals, Inc. (NASDAQ: ASTX) announced its partner Eisai was issued a Complete Response Letter for its supplemental New Drug Application (sNDA) for Dacogen for patients with acute myeloid leukemia (AML) in adults 65 years of age or older who are not considered candidates for induction therapy.

Delcath Systems, Inc. (Nasdaq: DCTH) maintained previous guidance in its 10-K filing that it intends to refile its NDA in 2Q 2012administration of melphalan for use in the treatment of patients with metastatic melanoma in the liver.

Rigel Pharmaceuticals, Inc. (Nasdaq: RIGL) gave a pipeline update noting that its partner AstraZeneca intends to file a new drug application(NDA)  for fostamatinib, currently in a Phase 3 trial in patients with rheumatoid arthritis, during 2H 2013. Rigel expects to initiate a Phase 2 clinical study with R343 for the treatment of allergic asthma in the summer of 2012. It also expects to initiate a Phase 2 trial of R333 in patients with Discoid Lupus Erythematosus in the summer of 2012.

Oncothyreon Inc. (NASDAQ: ONTY) said it was informed by its partner Merck Serono, a division of Merck KGaA of Darmstadt,  that the Independent Data Monitoring Committee (DMC) for the Phase 3 START trial of Stimuvax  in non-small cell lung cancer (NSCLC) met and the DMC recommendation is to continue the study. Final results from the study are expected in 2013.

ACADIA Pharmaceuticals Inc. (Nasdaq: ACAD) released a pipeline update noting that it expects to complete its Phase 3 pimavanserin program for Parkinson’s disease psychosis later in 2012.

Cytokinetics, Incorporated (Nasdaq: CYTK) noted that it expects data from its Phase 2 trial of CK-2017357 in patients with amyotrophic lateral sclerosis (ALS), are expected during 2H 2012.

XOMA Corporation (Nasdaq:XOMA) priced its offering of 29,669,154 shares of its common stock and accompanying warrants to purchase one half of a share of common stock for each share purchased at a price to the public of $1.32. The warrants are exercisable at an exercise price of $1.76 per share, with net proceeds of approximately $36.2m.

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About the author

Currently residing in New Zealand, Mr. A.Burden holds a Master of Commerce 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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