Aptinyx Inc. CEO Norbert Riedel said the design is unclear of the pivotal trial due next year with the N-methyl-D-aspartate (NMDA) receptor modulator NYX-783 in post-traumatic stress disorder (PTSD), as fine points must be hashed out with the FDA.
Cambridge, U.K.-based Bicycle Therapeutics plc’s phase I dosing about a month ago of its first patient with nectin-4-targeting BT-8009 put the company on the road to hoped-for success by pursuing the same mechanism of action as Padcev (enfortumab vedotin-ejfv), the antibody-drug conjugate (ADC) from Astellas Pharma Inc. and Seagen Inc.
The large-scale failure of a handful of drugs repurposed for COVID-19 hasn’t slowed efforts to find existing – and new – therapies as well as vaccines that can fight the pandemic, with research updates continuing to roll out.
CEO Christopher Missling said New York-based Anavex Life Sciences Corp. is still deciding on the dose for the pivotal study with Anavex2-73 (blarcamesine) in Parkinson’s disease dementia (PDD), and called the phase II findings “just the first data run,” about which the firm “wanted to immediately inform shareholders.”
Cyclerion Therapeutics Inc.’s phase II blowup with sickle cell disease (SCD) candidate olinciguat ended its development, and attention turned to the Cambridge, Mass.-based firm’s earlier-stage effort with IW-6463, a drug in the same class for central nervous system (CNS) disorders.
Gossamer Bio Inc.’s finding of a subset of especially good responders in the phase IIb study called Leda may have taken some of the edge off two failures with GB-001, an oral DP2 antagonist undergoing tests in asthma and chronic rhinosinusitis. But the Street still wasn’t happy, and shares (NASDAQ:GOSS) of the San Diego-based firm closed Oct. 13 at $10.09, down $3.50, or 26%.
New York-based Avenue Therapeutics Inc. took receipt from the FDA of a surprise complete response letter (CRL) – characterized by Wainwright analyst Joseph Pantginis as “bizarre” – with regard to the NDA for intravenous (I.V.) tramadol in acute pain.
Opioid-related hazards with Alkermes plc’s combo drug ALKS-3831 – specifically, with the samidorphan element – and the significance of weight-gain reduction brought about by the tablet, which also includes olanzapine, became key topics in the joint meeting of the FDA’s Psychopharmacologic Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee.
Dublin-based Jazz Pharmaceuticals plc’s phase III top-line win with Xywav (calcium, magnesium, potassium, and sodium oxybates) oral solution in adults with idiopathic hypersomnia (IH) provides the company with a needed foothold there as generics threaten its other sleep disorder drug, Xyrem (sodium oxybate).
