Speculation about potentially wider meaning among developers of psychedelic drugs was reignited after the complete response letter (CRL) from the U.S. FDA to Lykos Therapeutics Inc. for midomafetaminecapsules, which the company wants to use in combination with psychological intervention to treat post-traumatic stress disorder (PTSD). CEO Amy Emerson called the FDA move “deeply disappointing,” adding that San Jose, Calif.-based Lykos plans to request a meeting with the FDA to ask for reconsideration.
Halda Therapeutics Inc. announced it has secured an additional $126 million in funding in a series B extension, bringing its total funding to date to $202 million. The company expects its lead molecule HLD-0915 to enter a phase I trial in the first half of 2025 for the treatment of patients with metastatic castration-resistant prostate cancer (mCRPC).
Concerns of lower-than-expected efficacy, which prompted AN2 Therapeutics Inc. to pause enrollment in the phase III portion of the phase II/III trial earlier this year, turned out to be well-founded, as top-line data proved disappointing for epetraborole in treatment-refractory Mycobacterium avium complex (MAC) lung disease. As a result, the company is dropping the program and restructuring.
Aldeyra Therapeutics Inc. has bounced back from a complete response letter in November to produce positive phase III data for reproxalap in treating dry eye disease. The company is one of many developing treatments using diverse mechanisms of action.
Researchers from Alzecure Pharma AB presented preclinical data for ACD-137, a negative allosteric modulator (NAM) of tropomyosin receptor kinase A (TrkA), being developed for the treatment of pain.
Researchers from Contineum Therapeutics Inc. have presented preclinical data for the novel brain penetrant lysophosphatidic acid receptor 1 (LPAR1) antagonist, PIPE-791, being evaluated in models of neuropathic pain.
Novo Nordisk A/S presented a mixed bag of R&D results for its cardiometabolic assets in the first half of 2024 as it axed three drug candidates but advanced one to a late-stage study. In the search for greener pastures beyond a crowding obesity market, Novo announced Aug. 7 that it advanced ziltivekimab into a phase III study to assess the subcutaneous therapy’s cardiovascular outcomes in acute myocardial infarction patients.
Researchers from Indiana University have presented data from a study that aimed to assess the potential of suppressing GABA metabolism through inhibition of its degradation enzyme, GABA aminotransferase (GABA-AT), as novel analgesic strategy. The effect of next-generation GABA-AT inhibitor OV-329 was assessed in C57BL/6J mice that were intraperitoneally injected with paclitaxel to generate neuropathic nociception. Treatment with OV-329 attenuated the development and maintenance of paclitaxel-induced mechanical hypersensitivity.
Researchers at Leiden University have synthesized semisynthetic guanidino lipoglycopeptides with in vitro and in vivo activity gram-positive bacteria, including methicillin-resistant and vancomycin-resistant Staphylococcusaureus.
In December 2020, Servier Pharmaceuticals LLC bought Agios Pharmaceuticals Inc.’s approved acute myeloid leukemia drug, Tibsovo (ivosidenib), and the rest of its oncology business in a deal valued at up to $2 billion. Now, the U.S. FDA has approved one of those assets, with the brand name Voranigo (vorasidenib), for treating gliomas.
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