In the steadily heating-up psychedelics space, Wall Street is closely watching a number of players, among them Compass Pathways plc, which has slated an R&D update for Oct. 12. The check-in could provide guidance for investors on how the FDA regards COMP-360, the firm’s oral psilocybin for treatment-resistant depression (TRD). It could also help observers guess about the fate of pipeline prospects in the hands of others, including GH Research plc, advancing a would-be TRD fix derived from dried venom secreted by the Bufo alvarius toad.
How to get reasonable efficacy in cancer without toxicity – problematic especially in older patients – is a dilemma made ever more poignant by the advent of CAR T therapies and bispecific antibodies, which have been showing overall response rates of about 70%, but with side effects that can severely limit their use. Invariant natural killer T cells may provide an answer, and New York-based Mink Therapeutics Inc. aims to find out.
As the PDUFA date looms for Bristol Myers Squibb Co. with its candidate, deucravacitinib, for psoriasis, others – notably Dice Therapeutics Inc. – strive for new solutions to the skin disease, which has remained problematic for many patients despite approvals of multiple drugs in various classes.
Likely to garner attention at the upcoming European Society of Medical Oncology meeting are the MAGE-A4 and PRAME antigens which, although well-known and validated, have proved evasive for drug developers – a situation that may soon change.
Kyowa Kirin Co. Ltd.’s decision, disclosed July 26, to quit development of the adenosine A2a receptor antagonist KW-6356 for Parkinson’s disease (PD) didn’t do much to flatten interest in the target, still under investigation by other firms in cancer.
The phase III miss disclosed Aug. 11 by Kubota Pharmaceutical Holdings Co. Ltd. subsidiary Kubota Vision Inc. in Stargardt disease put more eyes on the rare, inherited, juvenile-onset form of macular degeneration, for which nothing is approved.
The U.S. FDA’s effort to push companies toward more and better randomized, controlled trials ahead of accelerated approvals – apparently driven by the lack of confirmatory studies done afterward – is “an important and meaningful move by the agency,” said Day One Pharmaceuticals Inc. CEO Jeremy Bender. “The industry’s history in that space has been a little mixed.” Bender’s remarks came Aug. 9 as part of a wide-ranging panel discussion hosted by analyst Robert Driscoll during the Wedbush Pacgrow Healthcare Conference.
Prometheus Biosciences Inc.’s stock-boosting news July 26 put more investor eyes on inflammatory bowel disease (IBD), where the company during its R&D Day revealed the target of PRA-052, the clinical candidate that emerged from the program known as PR-600. PRA-052 takes aim at the CD30 ligand, which acts as a co-stimulatory molecule to drive T-cell proliferation and differentiation.
Shares of Poseida Therapeutics Inc. (NASDAQ:PSTX) closed Aug. 3 at $4.51, up $2.08, or 85%, as a result of the collaboration and licensing deal with Roche Holding AG that brings $110 million up front as well as the same amount in near-term milestone payments described by CEO Mark Gergen as “highly achievable,” and the arrangement could be worth as much as $6 billion if goals farther down the road are met.
Doctors will “unequivocally view as a major advance” Cincor Pharma Inc.’s oral baxdrostat for patients with treatment-resistant hypertension, said Deepak Bhatt, director of interventional cardiovascular programs at Brigham and Women’s Hospital and professor at Harvard Medical School. “There are a lot of these folks out there, and physicians don’t know what to do with them right now,” he said, noting that many end up in emergency rooms.
