CHTP positive Adcom vote. PDUFA date issued for IPXL + LGND YMI SGMO CLDX ISTA EXAS QLTI news

Feb 24, 2012 No Comments by

Chelsea Therapeutics International, Ltd. (Nasdaq:CHTP) today announced that the FDA Cardiovascular and Renal Drugs Advisory Committee (CRDAC) voted 7-4 with 1 abstention and 1 non-vote to recommend approval of NORTHERA for the treatment of symptomatic neurogenic orthostatic hypotension (NOH) in patients with primary autonomic failure (Parkinson’s disease, multiple system atrophy and pure autonomic failure), dopamine beta hydroxylase deficiency and non-diabetic autonomic neuropathy. The FDA will make a final decision whether to issue an approval or not on its PDUFA date of March 28, 2012.

Impax Laboratories, Inc. (NASDAQ: IPXL) announced that the FDA has accepted its New Drug Application (NDA) for IPX066 for the treatment of idiopathic Parkinson’s disease (PD). The PDUFA date is October 21, 2012.

Ligand Pharmaceuticals Incorporated (NASDAQ: LGND) gave a further update on its partnered program with the release of its annual filing noting that its partner GSK expects to release safety data for its PROMCATA trial in the treatment of thrombocytopenia in patients with Hepatitis C during 1H 2012 and file a sNDA during 2012. It also announced a PDUFA date of July 27, 2012 for its partner Onyx Pharmaceuticals,  for Captisol-enabled Carfilzomib, for the treatment for multiple myeloma.

With regard to its internal program, it intends to initiate a pivotal Phase 3 trial in 2012 of its CAPTISOL-enabled formulation of melphalan as an injectable, palliative treatment for patients with multiple myeloma to support a US 505(b)(2) filing with the FDA in 2013.

YM BioSciences Inc.  (NYSE Amex: YMI; TSX: YM)  announced that it has commenced an underwritten public offering of its common shares.

Sangamo BioSciences, Inc. (Nasdaq: SGMO) filed a mixed shelf where it may offer and sell from time to time shares of common stock, shares of preferred stock, debt securities or warrants to purchase shares of common stock or shares of preferred stock, to the value of $100m.

Celldex Therapeutics, Inc. (Nasdaq: CLDX) today announced that it is offering shares of its common stock in an underwritten public offering.

ISTA Pharmaceuticals, Inc. (NASDAQ: ISTA) gave a pipeline update today noting that it plans to file a New Drug Application (NDA) in 1H 2012 for PROLENSA in patients with pain and inflammation associated with cataract surgery. It intends to report preliminary results in 1H 2012 from its Phase 2 data of BEPOSONE(TM), for the treatment of symptoms associated with seasonal allergic rhinitis. It also expects to initiate in 2H 2012 a Phase 3 clinical trial for T-PRED(TM), for ocular inflammation and infection. All guidance given was in line with previous press releases.

Exact Sciences Corp. (Nasdaq: EXAS) provided an update today noting that it intends to complete its ongoing DeeP-C clinical trial for Cologuard, its non-invasive colorectal cancer screening test during 2012 as well as making its FDA submission.

QLT Inc. (Nasdaq:QLTI) gave a pipeline update today noting that data from its Phase 2 latanoprost punctal plug delivery system (L-PPDS) trial are due during 2H 2012, with possible Phase 3 development during 2013.


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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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