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.
Black Diamond Therapeutics announced encouraging Phase 2 data for their drug BDTX-1535 in patients with EGFR-mutant lung cancer who have become resistant to standard treatment. The drug showed a significant response rate and durable results, offering hope for a new treatment option.
Biohaven Ltd. (BHVN) announced positive results from a pivotal study demonstrating the efficacy of troriluzole in slowing the progression of Spinocerebellar Ataxia (SCA). The drug showed statistically significant improvements in f-SARA scores after three years, leading to a potential FDA approval and commercialization in 2025.
AstraZeneca’s datopotamab deruxtecan (Dato-DXd) failed to meet its primary endpoint of overall survival in a Phase 3 breast cancer trial, but the drug continues to show potential in treating lung cancer. The drug did achieve its primary endpoint in the breast cancer trial for progression-free survival and also demonstrated improvement in patient-reported outcomes.
Kangpu Biopharmaceuticals, a clinical-stage company, has successfully concluded a bridging clinical study of KPG-818 in China. This study evaluated the safety, tolerability, and pharmacokinetics of KPG-818 in healthy volunteers, paving the way for future clinical trials in patients.
