Shares of Proteon Therapeutics Inc. hit a wall after the company disclosed that the phase III PATENCY-1 trial of its recombinant human elastase, vonapanitase, missed its primary endpoint of improved primary unassisted patency compared to placebo.
Next up for Achaogen Inc. is a new drug application (NDA) filing with the FDA, expected in the second half of 2017, after the phase III EPIC (Evaluating plazomicin in cUTI) registration trial of lead candidate, plazomicin, met the agency's objective of non-inferiority compared to meropenem in patients with complicated urinary tract infections (cUTI) and acute pyelonephritis (AP).
Shares of Synergy Pharmaceuticals Inc. popped early to a one-year high of $6.28 Friday after the company reported top-line data from the first of two pivotal phase III trials of plecanatide in adults with irritable bowel syndrome with constipation (IBS-C).
Horizon Pharma plc reported an all-around failure of its phase III trial, STEADFAST (Safety, Tolerability and Efficacy of Actimmune Dose Escalation in Friedreich’s Ataxia study), which missed its primary and secondary endpoints in evaluating Actimmune (interferon gamma-1b) to treat Friedreich’s ataxia (FA).
One month after shares of Anthera Pharmaceuticals Inc. (NASDAQ:ANTH) took a 30 percent haircut following a phase III miss by blisibimod in the lead indication of systemic lupus erythematosus (SLE), investors did an about-face on maturing data from the phase BRIGHT-SC proof-of-concept study of the same agent in individuals with IgA nephropathy (IgAN), also known as Berger's disease.
Smack in the middle of the American Society of Hematology (ASH) annual meeting in San Diego, presenter Spark Therapeutics Inc. disclosed a licensing deal that harnesses the synthetic vaccine particles (SVP) platform technology developed by Selecta Biosciences Inc. for co-administration with Spark's gene therapy program in up to five targets, beginning with factor VIII (FVIII) in hemophilia A.
After a bruising U.S. presidential campaign and, let’s just say, less than conventional preparation for the nation’s 45th president, we could all use a bit of holiday cheer. In a neighborly gesture, Peter Winter, Ottawa-based editor of BioWorld Insight, suggested U.S. citizens might treat themselves to a gift of Canadian real estate. “The timing couldn’t be better,” Winter quipped. “Low interest rates and a favorable exchange rate between the U.S. dollar and the Canadian dollar make buying a home in Canada very affordable. What better way to give yourself peace of mind for the next four years?” If that idea...
The management team at Nivalis Therapeutics Inc. didn’t exactly pull the plug on lead candidate cavosonstat (N91115) after it flunked its first phase II experiment in adult patients with cystic fibrosis (CF) who had two copies of the F508del-CFTR mutation and were being treated with Orkambi (lumacaftor/ivacaftor, Vertex Pharmaceuticals Inc.). But investors were less forgiving.
Last year's approvals of hemophilia A therapies Nuwiq (simoctocog alfa) from Octapharma AG, of Lachen, Switzerland, and long-acting Adynovate (antihemophilic factor [recombinant], pegylated) from Baxalta Inc. (now part of Shire plc) capped a two-year rush of products to treat bleeding disorders following a long dry spell in the space. As the American Society of Hematology (ASH) annual meeting prepares to kick off this week in San Diego, analysts are handicapping the next generation of treatments, designed to extend therapeutic benefits from days to weeks, and watching for clues on the trajectory of potentially curative gene therapies.
Less than two weeks before the start of the American Society of Hematology (ASH) annual meeting in San Diego, Novartis AG nabbed under-the-radar biotech Selexys Pharmaceuticals Corp. for up to $665 million in up-front, acquisition and milestone payments.
