Gemini Therapeutics Inc.'s $42.5 million series A round will "take us into the clinic with multiple programs," CEO James McLaughlin told BioWorld. The Cambridge, Mass.-based firm is working on genetically defined dry age-related macular degeneration (AMD) and associated rare genetic diseases, with "about 18 months of R&D under our belt," he said.

Whether and to what extent the risk of diabetic retinopathy will figure into deliberations of Wednesday’s FDA panel on Novo Nordisk A/S’ semaglutide stood as one of the main questions as investors scanned briefing documents made public Monday.

CEO Donald McCaffrey told BioWorld that Resverlogix Corp.'s unpaid loan of $68.8 million is "something we don't want, and our shareholders don't want it, and we are very pleased to have that circumstance on the way out."

Acelrx Pharmaceuticals Inc. CEO Vincent Angotti said he was “hesitant to put a timeline on this until we get further clarification from the FDA” regarding what’s required to satisfy the agency’s issues raised in a complete response letter (CRL) related to its NDA for 30-mg sublingual tablet Dsuvia (sufentanil), an opioid therapy that’s intended to reduce moderate to severe acute pain as well as dosing errors that can happen with intravenous administration.

"What we've accomplished from then to now is what we dreamt of," Ardelyx Inc. CEO Mike Raab told BioWorld, referring to stellar phase III data with Na-hydrogen exchanger 3 (NHE3) transporter blocker tenapanor in irritable bowel syndrome (IBS-C), unveiled less than a week before the 10-year anniversary of the firm's founding. "Companies like ours don't get the attention at times from the world out there," he said, because they lack headline-grabbing approaches such as immuno-oncology and often face "a tougher, more extensive path to success."

Anaptysbio Inc.'s phase IIa interim data win with intravenous (I.V.) ANB-020, the antibody targeting interleukin-33 (IL-33) for eczema, touched off speculation about competitors working in the same pathway, as the firm's shares (NASDAQ:ANAB) climbed 101 percent, or $35.41, to close Tuesday at $70.41.

Approval by the FDA of Flexion Therapeutics Inc.'s Zilretta whetted the appetite for more non-opioid drugs, the lack of which has left officials at pain-focused Centrexion Therapeutics Inc. "awestruck," Chief Medical Officer Randall Stevens told BioWorld.

Backed by strong data and boasting a mechanism of action that avoids the opioid route, Zilretta (FX006, triamcinolone acetonide with a poly lactic-co-glycolic acid matrix) – the pain drug for osteoarthritis of the knee from Flexion Therapeutics Inc. – won FDA approval smack on its PDUFA date.

"Nobody has done this before," Visterra Inc. CEO Brian Pereira told BioWorld, talking about the company's approach in immunoglobulin A (IgA) nephropathy, an effort that is part of what fueled his company's just-finished $46.7 million series C financing. Using computational tools and methods from the Massachusetts Institute of Technology, Visterra is "not an antibody discovery company," he said. "We design and engineer novel antibody-based solutions" that include monoclonal antibodies (MAbs), bispecific antibodies and antibody-drug conjugates (ADCs).