Recce Pharmaceuticals Ltd. is progressing synthetic antibiotic Recce-327 to pivotal phase III trials in Indonesia for the treatment of diabetic foot infections. The trial, which is assessing Recce-327 as a topical gel (R327G), is expected to begin in the first quarter of 2025, Recce CEO James Graham told BioWorld.
Puretech Health plc has announced phase IIb data showing its reformulation of pirfenidone has improved the tolerability and increased the efficacy of the marketed antifibrotic in the treatment of idiopathic pulmonary fibrosis. The tweak on the original molecule involved substituting three hydrogen atoms with three of the heavier counterpart, deuterium, improving stability, whilst retaining the antifibrotic effect.
Mixed results for three of Bicycle Therapeutics plc’s zelenectide pevedotin development programs preceded a strong drop in the company’s stock. Bicycle shares (NASDAQ:BCYC) dropped 31.3% on Dec. 13 to close at $13.81 each, the stock’s lowest price in the past 12 months.
Wall Street wasn’t jumping up and down about Repare Therapeutics Inc.’s early data in gynecological cancers, though the findings look positive and the company has big plans for the combo therapy.
Edap TMS SA recently published data showing that its Focal One high intensity focused ultrasound technology is non-inferior to radical prostatectomy as a first-line treatment for localized prostate cancer. The company is also working towards gaining approval for the technology as a therapy for endometriosis.
Caliway Biopharmaceuticals’ lipolysis candidate, CBL-514, met all the primary and secondary efficacy endpoints in a phase IIb study for subcutaneous fat reduction, paving the way for the company to begin a global pivotal phase III study in 2025.
SK Bioscience Co. Ltd. gained approval from the Human Research Ethics Committee in Australia to start phase I/II trials of GBP-560, its mRNA-based vaccine candidate for mosquito-borne Japanese encephalitis virus, with funding from Coalition for Epidemic Preparedness Innovations.
News that Trevi Therapeutics Inc. got the size just right of the phase IIb Coral trial with Haduvio (oral nalbuphine extended release) led the company’s shares (NASDAQ:TRVI) to close Dec. 12 at $3.60, up $1.11, or 45%, after trading as high as $4.60.
After Keros Therapeutics Inc.’s voluntary halt of dosing in two arms of its phase II study in pulmonary arterial hypertension, the company’s stock crumpled after a year of muscular performance and its recent and massive deal with Takeda Pharmaceutical Co. Ltd.
Kura Oncology, Inc. and Kyowa Kirin Co. Ltd.’s selective oral menin inhibitor ziftomenib showed encouraging data across multiple studies, the most encouraging of which were in combination with other standard of care therapies in patients with NPM1-mutant and KMT2A-rearranged acute myeloid leukemia.
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