With a wholly owned drug for Parkinson’s disease (PD) at the phase III stage, Adamas Pharmaceuticals Inc. said Forest Laboratories Inc. – its partner for a combo Alzheimer’s disease (AD) therapy – submitted a new drug application (NDA) to the FDA for the once-daily capsule MDX-8704 to treat AD-related dementia.
Bolstering its phase III push with the JAK2/FLT3 inhibitor pacritinib in the heating-up myelofibrosis (MF) space, Cell Therapeutics Inc. (CTI) began Persist-2, a study in patients with the disease and platelet counts less than or equal to 100,000 per microliter.
A $50 million up-front payment from new partner Celgene Corp. gives Abide Therapeutics Inc. time to “focus entirely on the science, without worrying for a while about raising extra capital,” and the company likely has enough runway to reach “substantial milestones that would validate what we’re trying to do,” CEO Alan Ezekowitz told BioWorld Today.
Pulling down about $142 million from a public offering of 8 million shares priced at $17.75 each, Neurocrine Biosciences Inc. is moving ahead with phase III plans for the vesicular monoamine transporter 2 (VMAT2) inhibitor for tardive dyskinesia candidate NBI-98854.
Intermune Inc. plans to resubmit its new drug application (NDA) for Esbriet (pirfenidone) for idiopathic pulmonary fibrosis (IPF) in the third quarter of this year, based on home run phase III data from a trial called ASCEND that sent the company’s shares into the upper altitudes. Given a six-month review, Esbriet could hit the U.S. market as early as the second quarter of 2015.
Thesan Pharmaceuticals Inc. followed up last fall’s $16 million series A financing with $49 million in series B money to support research in acne and atopic dermatitis.
Calling the top-line phase Ia/IIb data with the company’s antisense drug for spinal muscular atrophy (SMA) in children “achingly important” and the benefit in a subset “shocking,” Isis Pharmaceuticals Inc. CEO Stanley Crooke said intrathecal ISIS-SMNRx has proven safe so far, too.
Not surprising but hardly well taken by investors was the second setback with Onconova Therapeutics Inc.’s intravenous (I.V.) rigosertib for higher-risk myelodysplastic syndromes (MDS), which failed to meet its primary endpoint of overall survival (OS) in the phase III trial known as ONTIME.
With a launch expected in the second half of this year, Chelsea Therapeutics International Ltd. is firming up other plans for Northera (droxidopa), just approved by the FDA for neurogenic orthostatic hypotension (NOH), or a sudden drop in blood pressure when the patient stands up.
With phase IIb experiments under way in nondialysis chronic kidney disease patients with anemia, Akebia Therapeutics Inc. filed for an initial public offering (IPO) that would raise as much as $75 million, as plans also firm up for a phase II study in dialysis patients, slated to begin in the first half of this year.
