Actuate Therapeutics Inc. said its lead candidate, elraglusib, in pancreatic cancer demonstrated a substantial improvement in median overall survival compared to data from the same phase II study released in December 2024, but it wasn’t enough to convince investors.
Aldeyra Therapeutics Inc. is making another run at U.S. FDA clearance for reproxalap in dry eye disease (DED) after nailing the primary endpoint in a phase III randomized, double-masked, vehicle-controlled dry eye chamber trial of 0.25% ophthalmic solution.
Immutep Ltd. announced strong median overall survival of 17.6 months in cohort B of the TACTI-003 (Keynote-PNC-34) phase IIb trial that evaluated eftilagimod alfa in combination with Merck & Co.’s Keytruda (pembrolizumab) as first-line therapy in recurrent/metastatic head and neck squamous cell carcinoma in patients with PD-L1 expression below 1.
PTC Therapeutics Inc. CEO Matthew Klein said the firm “achieved all we set out to [achieve] in phase II” with PTC-518 in Huntington’s disease (HD), but it wasn’t enough to excite Wall Street, as some questioned whether the level of associations between trial findings and efficacy would appease the U.S. FDA. Shares (NASDAQ:PTCT) ended May 5 at $40.65, down $9.30, or 18.6%. Warren, N.J.-based PTC rolled out the most recent data from the Pivot-HD effort in stage 2 and stage 3 HD with PTC-518, an oral, centrally as well as peripherally distributed huntingtin (HTT) pre-mRNA splicing modifier.
Clinical results offered at the recent meeting of the American Urological Association in Las Vegas signal that better treatments may lie ahead for non-muscle invasive bladder cancer.
Shanghai-based D3 Bio (Wuxi) Co. Ltd. showed positive results for its lead candidate, next-generation KRAS G12C inhibitor, D3S-001, also known as elisrasib, in patients with KRAS G12C mutation cancers, including patients previously treated with first-generation KRAS G12C inhibitors. Presented at the American Association for Cancer Research (AACR 2025) meeting on April 29, the data were simultaneously published in Nature Medicine.
Pulsed field ablation dominated discussions and scientific sessions at Heart Rhythm 2025 in San Diego with researchers and manufacturers touting new applications in persistent atrial fibrillation, atrial flutter and addressing specific challenges for existing systems.
Health care technology company Wearoptimo Ltd. developed a next-generation microwearable sensor that accurately detects hydration levels, outperforming the needle-based gold standard.
The intriguing VEGFxPD-1 bispecific antibody space gained oomph with phase III results disclosed April 23 by Akeso Pharmaceuticals Inc. related to Harmoni-6, testing ivonescimab in combination with platinum-based chemotherapy compared with Tevimbra (tislelizumab, Beigene Ltd.), a PD-1 inhibitor also paired with platinum-based chemo in patients with locally advanced or metastatic squamous non-small-cell lung cancer irrespective of PD-L1 expression. Those data were followed by a green light from the U.S. FDA April 24 for marketing the PD-1 monoclonal antibody penpulimab in combination with cisplatin or carboplatin and gemcitabine for the first-line treatment of adult recurrent or metastatic non-keratinizing nasopharyngeal carcinoma.
Orum Therapeutics Inc. on April 26 pulled the plug on a U.S.-based phase I study of ORM-5029, its lead oncology degrader antibody conjugate (DAC) asset, a decision that came months after the company first reported a patient death in November 2024.
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