MDCO and NVS Adcom dates set. AEZS raising more cash. Approvals for BMY AZN GSK + updates for MSTX ALKS

Jan 09, 2014 No Comments by

Aeterna Zentaris Inc. (NASDAQ: AEZS $1.46) announced that it has commenced another underwritten public offering of common shares and warrants, their third offering in just over five months.

GW Pharmaceuticals plc (Nasdaq: GWPH $38.06) announced the pricing of its follow-on offering of American Depositary Shares, or ADSs, on the NASDAQ Global Market. GW will issue 2,441,110 ADSs on the NASDAQ Global Market at a price of $36.00 per ADS raising gross proceeds of $87.9 million.

ARCA biopharma, Inc. (Nasdaq: ABIO) maintained guidance that they expect to initiate their Phase 2b GENETIC-AF trial comparing Gencaro to Toprol-XL for prevention of atrial fibrillation (AF) in patients with heart failure and reduced left ventricular ejection fraction (HFREF), during 1Q 2014.

Alkermes plc (NASDAQ: ALKS $42.81) provided an update noting that data from their Phase 3 trial of the once-monthly formulation of aripiprazole lauroxil, are due in 1H 2014.  In addition, they intend to initiate a Phase 3 trial of ALKS 5461, for the treatment of major depressive disorder (MDD) in patients who have had an inadequate response to standard therapies, in 1Q 2014. They also unveiled aripiprazole lauroxil two-month, a new product candidate addition to its portfolio of atypical antipsychotics for the treatment of schizophrenia.

Mast Therapeutics, Inc. (NYSE MKT: MSTX $0.58) provided an update on their Phase 3 EPIC trial of MST-188 in sickle cell disease. Full enrollment is due to be completed by the end of 2015.

AstraZeneca (NYSE:AZN $58.52) and Bristol-Myers Squibb Company (NYSE:BMY $53.42) announced the FDA has approved Farxiga (dapagliflozin) to improve glycemic control in adults with type 2 diabetes mellitus.

Novartis AG (ADR) (NYSE:NVS $79.71) – The Cardiovascular and Renal Drugs Advisory Committee will meet on February 13, 2014, to discuss the biologics license application of serelaxin injection, as a treatment to improve the symptoms of acute heart failure through reduction of the rate of worsening of heart failure.
The Medicines Company (NASDAQ:MDCO $38.16) – The Cardiovascular and Renal Drugs Advisory Committee will meet on on February 12, 2014,to discuss the New Drug Application of cangrelor injection, for the proposed indication of reduction of thrombotic cardiovascular events including stent thrombosis (events related to blood clots in a stent, a device inserted to keep the artery open) in patients with coronary artery disease undergoing percutaneous coronary intervention (PCI).
GlaxoSmithKline plc [NYSE: GSK $52.73 ] announced that the FDA has approved Mekinist (trametinib) for use in combination with Tafinlar (dabrafenib) for the treatment of patients with unresectable melanoma (melanoma that cannot be removed by surgery) or metastatic melanoma (melanoma which has spread to other parts of the body) with BRAF V600E or V600K mutations. The combination was approved through the FDA’s Accelerated Approval programme and reviewed under a Priority Review designation, following data from their Phase 2 trial. This accelerated approval is contingent on the results of the ongoing Phase 3 trial.
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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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