Replimune Group Inc. has found consistent treatment efficacy in its pivotal phase II Ignyte melanoma study. The interim data strongly bolstered the stock (NASDAQ:REPL), which ended Dec. 7 with a 22% increase to $23.09. The new results for the combination treatment show what Replimune called clinically meaningful durable activity across the range of anti-PD1 failed cutaneous melanoma presentations, including in patients with moderate to high tumor burden, with 85% of responses ongoing.
In a massive deal that is one of the year’s biggest, Akeso Inc. signed a collaboration and license deal with Summit Therapeutics Inc. to out-license its bispecific antibody, ivonescimab (AK-112), for development and commercialization in the U.S., Canada, Europe and Japan.
Following the tone set in an October U.S. FDA Oncologic Drugs Advisory Committee meeting, the agency has issued a complete response letter (CRL) to Y-mabs Therapeutics Inc.’s BLA for Omblastys (131I-omburtamab) to treat central nervous system/leptomeningeal metastasis arising from neuroblastoma.
Twelve months after a single shot of Valneva SE’s chikungunya vaccine, positive antibody persistence was found, threatening a deadly disease that has long resisted treatment. The new data are derived from a study of 363 healthy adult participants that followed them from month 6 after vaccination to month 12. Nearly all, 99%, kept their neutralizing antibody titers for 12 months beyond the seroresponse threshold of 150, which hit the primary endpoint and the antibody level agreed with regulators as endpoint under the accelerated approval pathway.
Anavex Life Sciences Corp. posted positive top-line data from its phase IIb/III study of ANAVEX 2-73-AD-004 (blarcamesine) in treating mild cognitive impairment due to Alzheimer’s disease (AD) and mild AD. The oral small-molecule activator of the sigma-1 receptor (SIGMAR1) met the study’s primary endpoints and key secondary endpoint with statistically significant results.
The U.S. FDA has approved its first fecal microbiota treatment. Rebyota (fecal microbiota, live-jslm), from privately held Ferring Pharmaceuticals Inc., is now approved to prevent recurring Clostridioides difficile infection (CDI) in adults. The Nov. 30 approval came about two months after the FDA’s Vaccines and Related Biological Products Advisory Committee voted 13-4 to support the microbiome therapy’s effectiveness in reducing recurrent CDI in adults after antibiotic treatment for recurrent CDI.
The shadow of two reported patients’ deaths hovers over Eisai Co Ltd. and Biogen Inc.’s Alzheimer’s disease treatment, lecanemab, as the companies prepare to present phase III study data on the drug later today at the 15th Clinical Trials on Alzheimer's Disease conference.
Axsome Therapeutics Inc.’s AXS-05 (dextromethorphan + bupropion) has notched another success by hitting its phase III primary endpoint in treating a notoriously difficult Alzheimer’s disease (AD) indication when compared to placebo. Newly released data from the Accord study showed AXS-05, an oral, NMDA receptor antagonist with multimodal activity, statistically significantly delayed time to relapse of AD agitation vs. placebo (p=0.014), which was the primary endpoint.
As GSK plc pulls Blenrep (belantamab mafodotin) from the U.S. market, the biotech giant will watch a lot of revenue go with it. Only two weeks ago a phase III confirmatory study data for the already-approved multiple myeloma drug fell short of meeting requirements for the U.S. FDA’s accelerated approval regulations, so the agency asked GSK to take the drug off the market.
Researcher, serial entrepreneur and investor Gregory Verdine has helped Fogpharma Inc. bring in a $178 million series D financing. The company plans to use the proceeds to develop its lead candidate, FOG-001, a direct beta-catenin inhibitor, which is expected to enter clinical development in an oncology indication.
