The “deep dive” April 8 by Ovid Therapeutics Inc. into potassium-chloride co-transporter 2 (KCC2) research included company officials and independent experts in the space, where a handful of drug developers are known to be working. New York-based Ovid owns a portfolio of potential first-in-class direct activators of KCC2, and the firm detailed pharmacodynamic results along with the translational and clinical development strategy.
Seaport Therapeutics Inc. joined Nasdaq May 1, raising gross proceeds of $254.9 million, as its parent, Boston-based Puretech Health plc moved to exit the market, opting for a sole listing on the London Stock Exchange (LSE) in order to reduce its cost base and cut bureaucracy.
There is broad agreement that psychiatric diagnoses in their current form are not reflective of any underlying biology, and that this is one of the things hampering psychiatric drug development. “We are still fully reliant on descriptive diagnoses that yield heterogeneous patient cohorts,” Steve Hyman told the audience at the European Congress of Neuropsychopharmacology (ECNP) Roadmap Meeting on Precision Psychiatry in Amsterdam in January.
Vanda Pharmaceuticals Inc. gained U.S. FDA approval for Bysanti (milsaperidone), cleared for use in acute bipolar I disorder and schizophrenia and ensuring continuation of the firm’s atypical antipsychotic franchise, with Fanapt (iloperidone) set to start losing patent protection in 2027. It also offered a rare straightforward regulatory win for Vanda, which has tussled with the FDA in recent years.
Reviva Pharmaceuticals Holdings Inc. may be headed back to the clinic for another phase III study of brilaroxazine in treating schizophrenia. With a successful series of early and mid-stage studies behind the treatment, the U.S. FDA recommended a second study for the serotonin-dopamine and neuroinflammatory signaling modulator after a pre-NDA meeting in order to net more efficacy results and expand the safety dataset.
Maplight Therapeutics Inc.’s pricing of a $258.9 million financing this week revived the debate over whether targeting the M1 as well as the M4 muscarinic receptor – as Bristol Myers Squibb Co. does with U.S. FDA-approved Cobenfy (xanomeline and trospium chloride) for schizophrenia – is a better strategy than going after M4 alone.
