Watchers of the percolating myasthenia gravis space are waiting eagerly for data from Dianthus Therapeutics Inc.’s phase II Magic study testing DNTH-103, an active C1s inhibitor, compared to placebo in patients with anti-AChR-positive generalized disease.
Telix Pharmaceuticals Ltd.’s glioblastoma theranostic, TLX-101, is showing promising overall survival in a phase II trial in recurrent high-grade glioma. The targeted radiation therapy, combined with external beam radiation therapy, demonstrated a median overall survival of 12.4 months from treatment initiation and 32.2 months from initial diagnosis. The results significantly outperform the 9.9-month median survival typically observed with radiation therapy alone in recurrent glioblastoma patients.
Days after Pfizer Inc. pulled the plug on its oral GLP-1 candidate danuglipron, Eli Lilly and Co. aired positive top-line data from the phase III trial called Achieve-1 testing orforglipron vs. placebo in adults with type 2 diabetes and inadequate glycemic control with diet and exercise alone.
Johnson & Johnson’s Medtech division reported the completion of the first cases in the clinical trial for the Ottava robotic surgical system. The cases mark the first clinical experience with the Ottava system, which has been a long time in development.
Remegen Co. Ltd. emerged as a surprise challenger in the generalized myasthenia gravis space, unveiling positive phase III data of its China-approved lupus drug, telitacicept (RCT-18; Tai’ai), in the rare autoimmune neuromuscular disorder at the 2025 American Academy of Neurology conference.
Tryptamine Therapeutics Ltd. is gearing up to enter the clinic with lead compound TRP-8803, an intravenous-infused psilocybin therapy, in patients with binge eating disorder in conjunction with psychotherapy.
Hightide Therapeutics Inc.’s berberine ursodeoxycholate (HTD-1801) met primary and secondary endpoints in the Symphony 1 and Symphony 2 phase III trials in type 2 diabetes in Chinese patients. Based on the data, Shenzhen-based Hightide will submit an NDA to China’s National Medical Products Administration (NMPA) later this year.
Despite missing a phase II study’s primary endpoint in moderate to severe asthma, Sanofi SA sees a way forward to a phase III program in the crowded disease space. Preliminary results showed the annualized exacerbation rate endpoint wasn’t met at the highest dosage of amlitelimab. Those numbers, at week 48, showed nominal significance at the medium dose.
After dropping development in December of its lead program, Spruce Biosciences Inc. has found new life by acquiring a BLA-ready enzyme replacement therapy for the rare genetic neurodegenerative disease Sanfilippo syndrome type B. If approved, the therapy, tralesinidase alfa, could bring Spruce a priority review voucher.
More than a year after Ironwood Pharmaceuticals Inc.’s phase III hitch with apraglutide in short bowel syndrome, the other shoe fell from regulators as did the Boston-based firm’s shares (NASDAQ:IRWD), which ended April 14 at 64 cents, down 29 cents, or 31.5%.
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