Shares of Denali Therapeutics (DNLI) dropped significantly in after-hours trading following the news that its Phase 2 study of oditrasertib for multiple sclerosis was discontinued due to failure to meet primary and secondary endpoints. The company is expected to provide further details on the study’s termination during its upcoming earnings call.
Immatics N.V. (IMTX) stock experienced a decline on Thursday following the announcement of a $150 million public offering. However, the company also shared promising Phase 1b data for its IMA203 TCR-T therapy targeting PRAME in melanoma patients, indicating potential for a significant breakthrough in the treatment of this aggressive cancer.
Johnson & Johnson has stopped its Phase 3 SunRISe-2 trial for TAR-200, a potential treatment for muscle-invasive urothelial carcinoma (MIBC), after an independent review board determined it wasn’t outperforming standard chemotherapy. Despite this setback, the company remains confident in the overall potential of the TARIS platform and its future prospects in bladder cancer treatment.
Sage Therapeutics has announced the discontinuation of further clinical development of its drug dalzanemdor for Alzheimer’s disease following disappointing results from the Phase 2 LIGHTWAVE study. The study failed to demonstrate a statistically significant difference in cognitive function between patients treated with dalzanemdor and those receiving placebo. This setback follows earlier failures in trials for dalzanemdor in Parkinson’s disease and the termination of a collaboration agreement with Biogen for another drug candidate, SAGE-324.
PharmAla Biotech Holdings Inc. (MDXXF) has secured a significant agreement to supply its LaNeo MDMA for a clinical trial at Harvard’s McLean Hospital, a renowned institution in neuroscience and psychiatric research. This partnership highlights PharmAla’s commitment to supporting MDMA-based clinical research and expanding its reach across the U.S.
Gritstone Bio’s GRANITE, an individualized neoantigen-targeting immunotherapy, demonstrated potential in treating microsatellite-stable colorectal cancer (MSS-CRC). While the interim Phase 2 data showed positive results, particularly in patients with lower disease burden, the stock price declined due to concerns about the overall impact and future development plans. The company will discuss the progression-free survival data with the FDA and explore potential Phase 2 or 3 trials using ctDNA levels as eligibility criteria.
SciSparc Ltd. (SPRC), a pharmaceutical company specializing in cannabinoid-based treatments, has received FDA approval to proceed with a Phase IIb clinical trial for its Tourette Syndrome (TS) medication, SCI-110. The trial will evaluate the drug’s efficacy, safety, and tolerability in adults, building upon promising results from earlier studies.
Legend Biotech’s Carvykti, a cell therapy for relapsed or lenalidomide-refractory multiple myeloma, demonstrated significant improvement in overall survival compared to standard therapies in a three-year follow-up study. The data presented at the International Myeloma Society Annual Meeting suggests that Carvykti could become a leading treatment option for patients after their first relapse.
Merck & Co’s experimental fixed-dose combination of favezelimab and pembrolizumab failed to improve overall survival in patients with pretreated microsatellite-stable metastatic colorectal cancer (mCRC) in a Phase 3 study. The study, KEYFORM-007, did not meet its primary endpoint, leading to a setback for the company. Despite this, Merck’s Keytruda continues to secure approvals for other cancer types.
Seelos Therapeutics’ stock surged after the company announced a partnership with the US Army to test its intranasal ketamine drug, SLS-002, for PTSD in military personnel and veterans. The trial, funded by the Department of Defense, will evaluate the drug’s effectiveness, safety, and tolerability.
