The FDA has requested additional phase 3 trials for MDMA-assisted psychotherapy for PTSD, putting a hold on potential landmark approval. Despite this setback, Lykos Therapeutics remains committed to navigating the FDA’s requirements, while other psychedelic therapies continue to progress in clinical trials.
Incannex Healthcare, a biotech company specializing in psychedelic and cannabinoid medicine, has secured a significant $60 million financing agreement with Arena Investors. This deal will fuel the advancement of Incannex’s clinical trials for their proprietary therapeutics, targeting chronic conditions like obstructive sleep apnea, generalized anxiety disorder, and rheumatoid arthritis.
Terns Pharmaceuticals’ stock surged after its experimental obesity drug, TERN-601, demonstrated promising weight loss results in a Phase I study. The drug showed dose-dependent weight reduction and a favorable safety profile, prompting the company to initiate a Phase II trial in 2025.
Terns Pharmaceuticals announced positive topline data from its Phase 1 trial of TERN-601, a potential new treatment for obesity. The drug demonstrated significant weight loss and was well-tolerated in healthy adults, paving the way for Phase 2 clinical development in 2025.
Summit Therapeutics’ ivonescimab demonstrated a significant improvement in progression-free survival compared to Keytruda in a Phase 3 trial for non-small cell lung cancer. The drug also showed positive results in a Phase 2 trial for resectable lung cancer, highlighting its potential as a promising treatment option.
Eli Lilly and Company announced positive results from two Phase 3 clinical trials evaluating the efficacy and safety of their once-weekly insulin efsitora alfa (efsitora) in adults with type 2 diabetes. Both trials demonstrated non-inferior A1C reduction compared to existing insulin therapies, indicating efsitora’s potential as a new treatment option for managing blood sugar levels.
Irish psychedelic biotech firm GH Research PLC (GHRS) reported its second-quarter financial results, highlighting a net loss of $10.4 million but significant progress in clinical trials for its DMT-related drug candidates. The company is investigating two mebufotenin-based products for treatment-resistant depression.
Psyence Biomedical’s stock (PBM) plummeted 28.6% on Wednesday after the company announced an exclusive licensing agreement with PsyLabs for pharmaceutical-grade psilocybin. The agreement aims to facilitate clinical trials and potential commercialization of psychedelic treatments for conditions like alcohol use disorder and Adjustment Disorder in cancer patients.
The Nasdaq Composite fell by approximately 2% on Tuesday, with Vaxcyte, Inc. (PCVX) leading the gainers after positive Phase 1/2 trial results for its pneumococcal conjugate vaccine candidate. Other notable stock movers included Sable Offshore, Shoals Technologies, Polestar Automotive, Big Tree Cloud, Applied Optoelectronics, Unity Software, BridgeBio Pharma, Montana Technologies, Intchains Group, Keros Therapeutics, XPeng, Vera Therapeutics, Novavax, Bilibili, and The J. M. Smucker Company.
Gain Therapeutics, Inc. (GANX) has announced positive results from its Phase 1 study for GT-02287, a potential treatment for Parkinson’s disease. The study found the drug to be safe and well-tolerated in healthy volunteers, with evidence of target engagement in the brain. The company is now planning to start a Phase 2 trial in Parkinson’s patients by the end of 2024.
