Bristol Myers Squibb Co. (BMS) dodged a black-box warning on the label of just-approved Sotyktu (deucravacitinib), but hurdles lie ahead for the first-in-class, oral, allosteric tyrosine kinase 2 inhibitor. Designed to treat adults with moderate to severe plaque psoriasis who are candidates for systemic therapy or phototherapy, Sotyktu is priced as $75,000 per year, and will become available during September, BMS said.
The bad news in March 2022 from Takeda Pharmaceutical Co. Ltd. regarding Natpara, its recombinant human parathyroid hormone for hypoparathyroidism (HPT), served to generate more interest in the already bubbling space, where a handful of players large and small own prospects at various clinical stages.
The U.S. FDA’s approval of Revance Therapeutics Inc.’s Daxxify (daxibotulinumtoxinA-lanm) for the temporary improvement of moderate to severe glabellar lines, or frown lines, in adults, positioned the drug to compete with Abbvie Inc.’s blockbuster, Botox (onabotulinumtoxinA), which tallied $678 million in global net revenues for the second quarter of 2022.
Wall Street trimmed shares of Veru Inc. (NASDAQ:VERU) by upwards of 20% in the wake of an editorial published Aug. 23 in The New England Journal of Medicine publication NEJM Evidence. The opinion piece, by two critical-care pulmonologists, added verve to the debate about the efficacy of drugs for people hospitalized with COVID-19.
Questioners probed the fine points during Iveric Bio Inc.’s conference call, but news proved unmistakably good with Zimura (avacincaptad pegol) in geographic atrophy (GA), and shares of the firm (NASDAQ:ISEE) closed Sept. 6 at $15.70, up $6.26, or 66%, on positive top-line data from Gather 2, the firm’s second phase III study.
A recent paper in the Journal of Neuroscience detailing preclinical research from the University of Texas shone new light on triggering receptor expressed on myeloid cells 2 (Trem2), an increasingly popular target in drug discovery that a handful of companies are pursuing.
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.
