The question of whether ordinary equity offerings are better than the sale of convertible notes as a financing method found differing answers from thriving Ironwood Pharmaceuticals Inc. and troubled intravenous-iron specialist Amag Pharmaceuticals Inc., both of which raised $175 million.
Fueled by $45 million in Series A money, gene therapy player Voyager Therapeutics Inc. is expected to make public today the details of its adeno-associated virus (AAV) approach in central nervous system (CNS) disorders.
The ability to seamlessly switch patients from an intravenous (I.V.) to an oral version of the same, broad-spectrum antibiotic could give Melinta Therapeutics Inc. a leg up in the field, and the company raised $70 million to help find out whether phase III-stage fluoroquinolone delafloxacin will make the grade.
The “not-testosterone” mantra long chanted by Repros Therapeutics Inc. with regard to its Androxal (enclomiphene), for secondary hypogonadism finally took hold, and the FDA agreed that the company will not need new safety tests before submitting the new drug application (NDA) before the end of this year.
Topical Botox developer Revance Therapeutics Inc. priced its initial public offering (IPO) at the top of the projected range, sold more shares than expected and came out of the gate strong, with the stock (NASDAQ:RVNC) closing Thursday at $26.85, up $10.85, or 67.8 percent.
Merck & Co. Inc.’s minor slip in its latest earnings wrap-up was offset by news of three separately done deals to combine the company’s prized immunotherapy MK-3475 in various phase I/II trials with cancer drugs from Amgen Inc., Incyte Corp. and Pfizer Inc. – arrangements intended to help Merck gain ground against the likes of Bristol-Myers Squibb Co. (BMS) in the anti-PD-1 space by getting access to unpartnered cancer assets by way of research pacts.
Furiex Pharmaceuticals Inc.’s Phase III win with lead compound eluxadoline in diarrhea-predominant irritable bowel syndrome (IBS-D) turned investors’ eyes to next moves, including a potential partner for the locally acting mu opioid receptor agonist and delta opioid receptor antagonist or a possible buyout, given the success earlier of its approved diabetes therapy Nesina (alogliptin benzoate).
The FDA’s Center for Drug Evaluation and Research (CDER) is ramping up efforts to make certain that clinical trials include wide enough breadths of patient populations, and don’t unnecessarily keep out subjects with multiple chronic conditions (MCCs) who could turn up important data that would otherwise be missed.
Vanda Pharmaceuticals Inc.’s sales force for Hetlioz (tasimelteon) is “intact and in launch mode,” said CEO Mihael Polymeropoulos, after Friday’s approval of the selective melatonin receptor agonist for non-24-hour wake-sleep disorder (non-24).
Metastatic, castration-resistant prostate cancer as a therapeutic space is heating up still more with the disclosure by Medivation Inc. and partner Astellas Pharma Inc. of powerful data with Xtandi (enzalutamide) from the Phase III study known as PREVAIL.
