ARNA positive Adcom vote. APPA NDA due mid-2012. PATH to resubmit NDA 3Q + TZYM OMER BIOD CTIC MNOV ANAC PBTH updates

May 10, 2012 No Comments by

Arena Pharmaceuticals, Inc. (NASDAQ: ARNA) and Eisai Inc. announced today that the FDA Endocrinologic and Metabolic Drugs Advisory Committee voted 18 to 4, with one abstention, to recommend approval of lorcaserin in patients with obesity. The current PDUFA date is June 27, 2012. However, this may be extended by three months if further data is provided by the company.

A.P. Pharma, Inc.(OTCBB:APPA.OB) said it hopes to resubmit its NDA for APF530 for preventing chemotherapy-induced nausea and vomiting, in mid-2012.

NuPathe Inc. (NASDAQ: PATH) said it hopes to resubmit its NDA for its migraine patch in 1H 2012 with an anticipated six-month review.

Tranzyme Pharma (Nasdaq:TZYM)  announced that top-line data from its Phase 2b trial, evaluating TZP-102 for diabetic gastroparesis, are expected by the end of 2012.

Omeros Corporation (NASDAQ: OMER) maintained guidance that data are expected from its second OMS302 Phase 3 trial in patients undergoing cataract surgery or refractive lens exchange, in 2H 2012.

Biodel Inc. (Nasdaq: BIOD) said it plans to file a New Drug Application (NDA) by 1Q 2014 for its glucagon rescue formulation. It also said that it had been granted a transfer to the NASDAQ Capital Market, giving it a further six months to push its bid price above $1.

MediciNova, Inc.  (Nasdaq:MNOV) said today that it plans to release data of its Phase 2 trial of MN-221 for treatment of acute exacerbations of asthma for patients who do not respond to standard pharmacotherapy, in 2Q 2012.

Cell Therapeutics, Inc. (Nasdaq and MTA: CTIC) today announced that it has received conditional marketing authorization from the European Commission for Pixuvri (pixantrone) as monotherapy for the treatment of adult patients with multiply relapsed or refractory aggressive non-Hodgkin B-cell lymphomas (NHL).

Anacor Pharmaceuticals (NASDAQ:ANAC) gave a pipeline update noting that it expects to announce top-line data from the first Phase 3 trial of tavaborole in onychomycosis in January 2013 and from the second Phase 3 trial later in that same quarter. It expects to file its NDA in 1H 2013. It also expects to initiate the following Phase 2 trials of AN2728 in atopic dermatitis in the next 12 months:

  • 1. Phase 2 safety / PK and efficacy study in adolescents
  • 2. Phase 2 safety / PK and efficacy study in children (ages 2 to 11)
  • 3. Phase 2 dose-ranging bilateral study in adolescents

Phase 2 safety / PK and efficacy data of AN2728 in adolescents are expected in 2H 2012. Phase 2 safety / PK and efficacy data in children and Phase 2 dose-ranging data are both due in 1H 2013. It also expects to initiate a Phase 3 trial in atopic dermatitis in mid-2013.

PROLOR Biotech, Inc. (NYSE Amex: PBTH; TASE: PBTH) announced that it intends to offer shares in a public offering.




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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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