CEO Shawn Singh of Vistagen Therapeutics Inc. called the favorable vote for ketamine derivative esketamine by a joint meeting of FDA advisory panels "the writing of a bright new chapter in the history of neuropsychiatry," telling BioWorld that the "next transformative step" will involve developing more convenient, at-home options. Esketamine is given under medical supervision.
Trouble surfaced early in the joint FDA panel meeting to deliberate the drug-device combo esketamine 28-mg single-use nasal spray from Johnson & Johnson unit Janssen Pharmaceuticals Inc. when an agency official said U.S. gatekeepers didn't necessarily agree about the efficacy offered to support the ketamine-derived therapy for treatment-resistant depression (TRD).
The recent deal between Meiragtx Holdings plc and New Brunswick, N.J.-based Johnson & Johnson (J&J) arm Janssen Pharmaceuticals Inc. drew more eyeballs to companies targeting inherited retinal diseases (IRDs), which can only mean good things for the likes of Nightstar Therapeutics plc.
Although Wall Street hammered shares of Solid Biosciences Inc. (NASDAQ:SLDB) down to $15.15, or 67.8 percent, to close them Thursday at $7.19, company officials told investors of a thesis based on preclinical work that could lead to better results with SGT-001 microdystrophin gene transfer for Duchenne muscular dystrophy (DMD)
Analysts during a conference call with Macrogenics Inc. characterized themselves as "dead wrong" and called the company's phase III victory "especially sweet" with margetuximab (marge) that was "written off by so many" in HER2-positive metastatic breast cancer. The news sent shares (NASDAQ:MGNX) up 130.4 percent, or $14.49, to close Wednesday at $25.60.
Luciano Rossetti, head of global R&D for Merck KGaA's biopharma branch EMD Serono, told BioWorld that "a very elegant molecule, fascinating from a protein-engineering point of view in addition to the biology" lies at the heart of the potential €3.7 billion (US$4.2 billion) deal with Glaxosmithkline plc (GSK).
Sunovion Pharmaceuticals Inc. stayed mostly mum on details regarding the FDA's complete response letter (CRL) related to the NDA for apomorphine sublingual film (APL-130277) to treat "off" episodes in Parkinson's disease (PD).
Details are yet to come about Evolus Inc.'s "user-centric" focus regarding Jeuveau (prabotulinumtoxinA-xvfs) for injection, as the product goes up against Botox (onabotulinumtoxinA, Allergan plc) as well as Dysport (abobotulinumtoxinA, Galderma Laboratories LP) in treating severe glabellar (frown) lines associated with corrugator and/or procerus muscle activity in adults. There's also Xeomin (botulinum toxin type A, Merz Pharma GmbH & Co. KGaA).
Epizyme Inc. recently charmed investors by disclosing its brisker path forward with EZH2 inhibitor tazemetostat in follicular lymphoma (FL), and drew more attention to the subtype of non-Hodgkin lymphoma (NHL).
