Amicus Therapeutics Inc., of Cranbury, N.J., reported net revenue of $7.2 million, primarily from commercial sales of its Fabry disease therapy Galafold (migalastat), which launched in May 2016. Net loss for the quarter was $48.1 million, or 34 cents per share, compared to a net loss of $51.1 million, or 40 cents per share, for the second quarter 2016. The company ended the quarter with about $227.2 million in cash and cash equivalents. Its shares (NASDAQ:FOLD) gained 67 cents to close at $13.90.

Zynerba Pharmaceuticals Inc. shares (NASDAQ:ZYNE) plunged more than 55 percent Monday to $6.67 on news that its lead candidate, the cannabidiol (CBD) gel ZYN-002, missed the primary endpoint of a phase II trial, failing to help adult epilepsy patients with focal seizures achieve a statistically significant reduction in seizures during the 12-week treatment period of the trial, called Star 1.

Talk turned to the finer points of phase IIb data from the trial called ROYAL-1 – in particular, success with regard to high-sensitivity C-reactive protein (hsCRP) – after Wall Street put a dent in Gemphire Therapeutics Inc., despite the fact that gemcabene achieved its primary endpoint of cholesterol lowering in the study.

Mallinckrodt plc said it plans to acquire Infacare Pharmaceutical Corp., the developer of a late-stage severe jaundice treatment, for $80 million up front plus up to $345 million in potential milestone payments. If approved, the FDA fast-tracked candidate, stannsoporfin, could potentially be used to reduce or prevent the need for phototherapy, risky exchange transfusions and the incidence of pricey hospital readmissions.

Two-year-old IFM Therapeutics Inc. became the latest biopharma unicorn, as Bristol-Myers Squibb Co. (BMS) picked up the Boston-based company for $300 million up front and another $1.01 billion in potential development, regulatory and sales milestones for each of the first products from the deal's two oncology programs. IFM is eligible for more contingent milestone payments for additional products that emerge from the programs.

Enanta Pharmaceuticals Inc. CEO Jay Luly told BioWorld that, with the FDA's approval for Abbvie Inc.'s hepatitis C virus (HCV) drug Mavyret (glecaprevir/pibrentasvir), his firm is one milestone away from hitting every goal set by the deal.

LONDON – The Pew Charitable Trusts is stepping in to fill a gap in the international fight against antimicrobial resistance (AMR), with the formation of a virtual laboratory that will bring together disparate datasets and leading experts in an open platform for use by industry, academics and nonprofits.

Activating mutations in the BRAF kinase, such as those targeted by melanoma drug Zelboraf (vemurafenib, Roche Holding AG), are a well-known cause of cancer.

Omeros Corp., of Seattle, said the FDA granted orphan designation to OMS-721, its lead human monoclonal antibody targeting mannan-binding lectin-associated serine protease-2, in immunoglobulin A (IgA) nephropathy.

Infinity Pharmaceuticals Inc., of Cambridge, Mass., said it completed the monotherapy dose-escalation portion of its four-part phase I trial testing IPI-549 in patients with advanced solid tumors.