ActoGeniX NV closed a Series B equity financing round, raising €10.7 million (US$14 million) to move its ActoBiotics program to the investigational new drug application (IND) stage in a second indication of inflammatory bowel disease (IBD).
Sarepta Therapeutics Inc. disclosed Monday afternoon following the market's close that the FDA has asked for additional information from its existing eteplirsen dataset before making a determination about a new drug application (NDA) filing for the drug under Subpart H accelerated approval.
Portola Pharmaceuticals Inc. became the 12th biotech in 2013 and the third in the second quarter seeking to move into the U.S. public markets, filing an S-1 with the SEC for an initial public offering (IPO). The company did not disclose the number of shares or price range.
Privately held Armetheon Inc. was launched in October 2011 with a mission to create novel antibiotics for drug-resistant bacteria. However, that program quickly took a back seat when the founders discovered a new use for a compound, tecarfarin, advanced by another biotech where several of them had played leading roles.
Pity the poor drug developer that thinks using the combination drug/device regulatory pathway through the FDA's Office of Combination Products (OCP) could be a shortcut to approval, bypassing the sometimes unpredictable regulatory oversight of the Center for Drug Evaluation and Research (CDER) or the Center for Biologics Evaluation and Research (CBER).
Privately held Ambrx Inc. gained another partner for one of its signature technologies, attracting Tokyo-based Astellas Pharma Inc. to an oncology-focused discovery and development collaboration in antibody drug conjugates (ADCs).
Shape Pharmaceuticals Inc. is not aiming to reshape the industry. The Cambridge, Mass.-based biotech has the more modest goal of advancing its single asset, topical histone deacetylase (HDAC) inhibitor SHP-141, in cutaneous T-cell lymphoma (CTCL) and, potentially, other inflammatory skin conditions.
A 300-page S-1 filing with the SEC on Wednesday revealed that Geron Corp.'s human embryonic stem cell (ESC) assets, left dangling when the company abandoned the field in late 2011, will be reborn at Asterias Biotherapeutics Inc., a newly formed subsidiary of regenerative medicine specialist BioTime Inc.
