FDA approves ARNA Belviq for obesity. ANTH fails Phase 2b trial. Pipeline updates for XOMA INSM INFI. EMA rejects Folotyn + SNSS news
Arena Pharmaceuticals, Inc. (NASDAQ: ARNA) and Eisai Inc. announced that the FDA has approved BELVIQ for the treatment of obesity.
Anthera Pharmaceuticals, Inc. (Nasdaq: ANTH) announced results from the Phase 2b PEARL-SC clinical study in patients with systemic lupus erythematosus. The pre-specified primary efficacy endpoint, clinical improvement at 24 weeks in the SLE responder index for the pooled blisibimod dose groups, was not met due to a lack of clinical efficacy in the 100mg weekly and 200mg monthly dose groups. However, the company has planned an End of Phase 2 meeting in 3Q 2012, in preparation for a Phase 3 trial.
XOMA Corporation (Nasdaq:XOMA) announced it has initiated a Phase 3 trial of gevokizumab in patients with non-infectious uveitis (NIU) involving the intermediate and/or posterior segment of the eye. It also announced the initiation of a Phase 2 trial in patients with erosive osteoarthritis of the hand and hopes to complete enrollment around the end of 2012.
Insmed Incorporated (Nasdaq CM: INSM) announced that the first patient has been dosed in its Phase 2 trial of ARIKACE (liposomal amikacin for inhalation) in patients with non-tuberculous mycobacterial (NTM) lung disease entitled TARGET-NTM (Treatment with ARIKACE to Realize Greater Efficacy Trial).
Infinity Pharmaceuticals, Inc. (NASDAQ: INFI) announced today that it plans to initiate a Phase 2 trial of IPI-145 in patients with asthma as well as a Phase 2 trial of IPI-145 in patients with rheumatoid arthritis in 2H 2012.
Allos Therapeutics, Inc. (NASDAQ: ALTH) said in a SEC filing that it received a letter from the European Commission stating that the EC had adopted the negative opinion of the European Medicines Agency’s Committee For Medicinal Products for Human Use (“CHMP”) issued in January 2012, and confirmed by the CHMP in April 2012, with respect to its marketing authorisation application for FOLOTYN (pralatrexate injection) for the treatment of patients with peripheral T-cell lymphoma whose disease has progressed after at least one prior systemic therapy. The decision is final and binding, and the Company has no means to appeal.
Sunesis Pharmaceuticals, Inc. (Nasdaq:SNSS) announced that it has received a $1.5m milestone payment from Biogen Idec (Nasdaq:BIIB) for the advancement of pre-clinical work under its multi-kinase inhibitor collaboration agreement.
Omeros Corporation (NASDAQ: OMER) priced its underwritten public offering of 2,926,830 shares of its common stock at a price to the public of $10.25 per share for net proceeds of approximately $28.1m, with an option to issue up to an additional 15 percent of the shares offered, which would result in additional gross proceeds of approximately $4.5m.