Third Point pushes for Amgen breakup
Activist investor Third Point on Tuesday outlined a plan for increasing the valuation of Amgen Inc. (NASDAQ:AMGN) by more than 80% in the next two years. The firm wants Amgen to split into two companies, one each for "cash-generative Mature Products and R&D-intensive Growth Products," although it didn't provide specifics.
FDA panel backs Kalydeco for R117H CF patients
FDA's Pulmonary-Allergy Drugs Advisory Committee voted 13-2 that data support approval of Kalydeco ivacaftor from Vertex Pharmaceuticals Inc. (NASDAQ:VRTX) to treat cystic fibrosis patients six and older with an R117H mutation in the CF transmembrane conductance regulator (CFTR) gene. The panel also voted 9-6 that efficacy data provide substantial evidence of a clinically meaningful benefit, and 14-1 that safety data for the overall Kalydeco CF program are sufficient for approval. The PDUFA date is Dec. 30.
Enanta falls on revised AbbVie deal
Enanta Pharmaceuticals Inc. (NASDAQ:ENTA) fell $4.76 (10%) to $41.83 on Tuesday after the company said it decided not to exercise its option to co-develop HCV candidate ABT-493 with AbbVie Inc. (NYSE:ABBV) in the U.S. Enanta and Abbott Laboratories (NYSE:ABT) discovered the next-generation HCV NS3/4A protease inhibitor under a 2006 deal.
NICE backs GSK's Tafinlar for melanoma
NICE issued final guidance recommending Tafinlar dabrafenib from GlaxoSmithKline plc (LSE:GSK; NYSE:GSK) to treat unresectable metastatic melanoma with a BRAF V600 mutation, its approved indication.
FDA approves expanded Xiaflex label
FDA approved an sBLA from Auxilium Pharmaceuticals Inc. (NASDAQ:AUXL) for Xiaflex collagenase clostridium to treat up to two Dupuytren's contracture joints in the same hand during a single treatment visit. The injectable form of collagenase previously was approved for one collagen cord.
Omeros suspends Phase II Huntington's trial
Omeros Corp. (NASDAQ:OMER) was off $1.70 (12%) to $12.12 on Tuesday after suspending a Phase II trial of OMS824 to treat Huntington's disease (HD).
Illumina, Actelion boost guidance
Illumina Inc. (NASDAQ:ILMN) gained $2.1 billion in market cap on Tuesday in the wake of its earnings release after market on Monday. The shares added $15.08 to $179.55 after the sequencing company said revenue jumped 35% year over year to $480.6 million and raised its revenue guidance for the year. The company now anticipates revenue to grow about 30% over 2013, up from prior guidance of 25-26% growth.
Unum launches with $12M series A
Oncology play Unum Therapeutics (Cambridge, Mass.) raised $12 million in a series A round led by Atlas Venture and Fidelity Biosciences. Sanofi-Genzyme BioVentures also participated.
Viamet replaces IPO with $60M D round
One day after withdrawing a proposed IPO, Viamet Pharmaceuticals Inc. (Durham, N.C.) closed a $60 million series D round led by new investor Brandon Point Industries Ltd. working with Woodford Investment Management.
Tobira amends IPO
Tobira Therapeutics Inc. (San Francisco, Calif.) amended the terms for its proposed IPO on NASDAQ underwritten by Oppenheimer & Co., removing the price range, the number of shares and several of the underwriters. The company on Aug. 7 said it would postpone the offering, but did not give a reason (see BioCentury Extra, Aug. 7).
POLITICS & POLICY
FDA backs further study of kidney biomarkers
FDA issued its first Letter of Support for two kidney biomarkers identified by the Predictive Safety Testing Consortium (PSTC) of the Critical Path Institute (C-Path).