Compass Pathways plc rolled out favorable top-line findings from the largest randomized, controlled, double-blind psilocybin therapy study ever completed, showing that COMP-360 at 25 mg yielded a highly statistically significant and clinically relevant reduction in symptom severity after three weeks in patients with treatment-resistant depression (TRD)
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Data from Chinook Therapeutics Inc. from an ongoing phase I/II trial with BION-1301 in IgA nephropathy (IgAN) at the American Society of Nephrology Kidney Week, and from Vera Therapeutics Inc. with atacicept, set Wall Street abuzz about chances for the two compounds relative to each other.
Results from two pivotal phase III trials testing Glaxosmithkline plc's daprodustat against anemia due to chronic kidney disease (CKD) found the oral hypoxia-inducible factor prolyl hydroxylase inhibitor helped both non-dialysis and dialysis patients improve or maintain hemoglobin levels without increased cardiovascular risk vs. standard-of-care erythropoietin stimulating agents. Though already approved in Japan as Duvroq, what future the drug might face in the U.S., where the same-class drug roxadustat garnered an FDA complete response letter, remained an open question.
New positive phase III study results for Regeneron Pharmaceuticals Inc.’s COVID-19 monoclonal antibody cocktail show a single dose reduced the risk of contracting the virus by 81.6% during a two- to eight-month follow-up period. The strong data go along with Pfizer Inc.’s recent positive results for its oral antiviral, Paxlovid, hinting that COVID-19 therapeutics could begin cutting into powerful mRNA vaccine margins from Pfizer Inc.-Biontech SE and Moderna Inc.
Calithera Biosciences Inc.’s stock took a severe beating Nov. 5 as shares closed 54.5% downward due to the company’s phase II stumble of telaglenastat in treating non-small-cell lung cancer. It was the therapy’s second clinical failure in the past 12 months.
Shares of Deciphera Pharmaceuticals Inc. (NASDAQ:DCPH) plunged $27.18, or 75.5%, to close at $8.82 on top-line results from the phase III study called Intrigue with Qinlock (ripretinib) in gastrointestinal stromal tumors (GIST) previously treated with kinase inhibitor Gleevec (imatinib, Novartis AG).
Just a day after the world's first approval of Merck & Co. Inc.'s oral antiviral for COVID-19 positioned it to offer a new way to keep Britons at high risk of severe disease out of the hospital, Pfizer Inc. is stopping a phase II/III trial of its oral antiviral, Paxlovid, early for "overwhelming efficacy" in a similar group. Interim results showed that combining the drug, also known as PF-07321332, with ritonavir reduced the risk of hospitalization or death for adults with mild to moderate COVID-19 but at high risk of severe disease by 89% vs. placebo.
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