In Phase III with its quest for a topical Botox, Revance Therapeutics Inc. filed for an initial public offering (IPO) to raise as much as $86.25 million, cash that would help efforts with RT001, a physician-applied topical formulation of botulinum toxin type A, most advanced for lateral canthal lines (crow’s feet), but undergoing tests in other indications as well.
Cardium Therapeutics Inc.’s first data from the first stage of its Phase III trial with its gene therapy Generx (alferminogene tadenovec, Ad5FGF-4) in patients with myocardial ischemia due to arteriosclerosis were favorable enough that the firm is accelerating the study, with interim data in the first half of next year.
Though not a huge surprise, the complete response letter (CRL) from the FDA for Lemtrada (alemtuzumab) sent a rumble through the multiple sclerosis (MS) therapy space, and shook investors in Genzyme Corp., which has been told by the agency that approval of the CD52-targeting antibody requires more trials.
With vaccines in the works for herpes simplex virus 2 (HSV-2) and pneumonia, Genocea Biosciences Inc. added to a banner year for initial public offerings (IPOs) in biotech, filing to go public and raise $75 million by way of selling an unspecified number of shares at an also-undisclosed price range.
Caught off guard by the FDA’s approval – and ahead of schedule, to boot – of Orenitram (treprostinil) extended-release tablets for pulmonary arterial hypertension (PAH), United Therapeutics Corp. plans to launch the product within the next six months.
Intrexon Corp.’s $26 million takeover of Medistem Inc. brings aboard endometrial regenerative cells (ERCs), derived from menstrual blood, for use with integrated synthetic biology platforms developed by Intrexon, opening potential for cell-based therapeutic candidates across a range of conditions.
The ongoing effort by Bristol-Myers Squibb Co. (BMS) to become a specialty biopharma firm led to its $2.7 billion split from the joint venture for Type II diabetes with Astrazeneca plc, leaving investors in both firms to sort through details.
Ribavirin (RBV) could drop out of hepatitis C virus (HCV) therapy for genotype 1 (GT1) patients, as a result of Gilead Sciences Inc.’s triumph in the Phase III program known as ION, which tested the once-daily, fixed-dose combination of its approved nucleotide analog polymerase inhibitor Sovaldi (sofosbuvir) and the NS5A inhibitor ledipasvir, with and without RBV.
Targacept Inc.’s Phase II blowup of TC-5619 in schizophrenia, months after its fizzle in attention deficit hyperactivity disorder (ADHD), nixed the development program and turned investor eyes to a separate therapy for overactive bladder (OAB), also in Phase II, due to report data in the middle of next year.
Shopping among European collaborators for its drug-device pain combo known as Zalviso, Acelrx Pharmaceuticals Inc. “had a number of different suitors approach us,” with “a lot of very large-scale players interested,” said CEO Richard King.