Curevac GmbH has landed a $52 million equity investment from the Bill & Melinda Gates Foundation plus an additional $24 million equity investment from longstanding investor Dievini Hopp Biotech to support continued development of its messenger RNA-based vaccines and the construction of a new manufacturing facility that will allow it to vastly scale up its capacity to produce commercial quantities of vaccines.
FDA reviewers gave agency advisors the proverbial chin nod in documents briefing them on Kythera Biopharma Inc.'s submental fat reduction drug, ATX-101 (deoxycholic acid), ahead of a March 9 advisory committee meeting, saying company data support a "favorable benefit-risk assessment" of the injectable, an appraisal that boosted Kythera shares (NASDAQ:KYTH) 25.3 percent to $50 on Thursday.
Aura Biosciences Inc. has secured a $21 million series B round intended to carry its synthetic viral nanoparticle-based therapies into a 24-patient phase I/II ahead of planned pivotal testing for a rare ocular cancer.
SAN FRANCISCO – In the wake of last year's hot IPO market, this year's climate is likely to be significantly cooler, giving way to between 25 and 30 U.S. biopharma IPOs, projected venture captialist Brent Ahrens and banker Jennifer Jarrett during a "crystal ball" panel at the CalBio 2015 conference, a gathering of California industry mavens organized by BayBio and Biocom, the state's biggest life sciences trade associations.
Abivax SAS dosed the first patient in a pivotal phase IIb/III trial of ABX203, a therapeutic vaccine it's testing against hepatitis B virus (HBV) e-antigen-negative active chronic HBV.
Orca Pharmaceuticals Ltd. and Astrazeneca plc are joining a growing list of alliances seeking to leverage retinoic acid-related orphan nuclear receptor gamma (RORγ) inhibitors to address a wide range of autoimmune diseases. The exclusive collaboration, adopting Orca's full RORγ pipeline, carries up-front and milestone payments of up to $122.5 million for the Oxford, UK-based company and will likely yield a candidate by year-end ahead of possible 2016 first-in-human studies.
Novartis AG salvaged a win, gaining conditional FDA approval for Farydak (panobinostat), the first histone deacetylase inhibitor (HDAC) approved to treat patients with multiple myeloma (MM), despite an advisory committee's concerns that the drug's benefit could outweigh its risks in certain contexts.
Canada's Valeant Pharmaceuticals International Inc. has moved to acquire gastrointestinal (GI) specialist Salix Pharmaceuticals Ltd. in an all-cash deal valued at about $10.1 billion, or $14.5 billion in enterprise value, a measure including Salix's debt and cash on hand.
Early positive data supporting Celsion Corp.'s plans to further develop its interleukin-12 (IL-12)-producing immunotherapy, GEN-1, for the treatment of advanced platinum-resistant and recurrent ovarian cancer boosted shares (NASDAQ:CLSN) by 12.9 percent to $3.15 at Friday's close, providing early validation for its $14 million cash- and share-based acquisition of Huntsville, Ala.-based Egen Inc.'s nucleic acid-based therapeutic assets.
Neurocrine Biosciences Inc., a San Diego company developing drugs for neurological and endocrine disorders, is banking $250 million in a public offering of about 6.9 million shares priced at $36 each to fund a growing roster of trials, rising R&D costs and plans to market its phase III tardive dyskinesia therapy, NBI-98854, ahead of an anticipated 2016 filing of its new drug application (NDA) for the movement disorder.
