Aicuris Anti-Infective Cures AG is preparing to file for U.S. FDA approval after reporting positive phase III results for lead antiviral pritelivir in the healing of refractory herpes simplex virus lesions in immunocompromised patients.

Success by nearly all measures with Praxis Precision Medicines Inc.’s essential tremor phase III candidate, ulixacaltamide, drove the company’s stock up significantly and provided solid data for an NDA filing planned for early 2026.

Astellas Pharma Inc. reported Oct. 14 that its CLDN18.2-targeting monoclonal antibody, zolbetuximab (Vyloy), did not meet the primary endpoint of overall survival in the phase II Gleam trial of patients with advanced pancreatic cancer.

The importance of scalability, combination therapies, immunotherapies and speed in developing cancer drugs are paramount in creating a revolution in treating patients who often don’t have much hope, according to a panel of developers who spoke at the BioFuture conference in New York.

Tvardi Therapeutics Inc. stock lost 83.9% of its value as investors took in poor preliminary results of the phase II study of its lead candidate for idiopathic pulmonary fibrosis (IPF). The company’s shares (NASDAQ:TVRD) closed at $6.69 each on Oct. 13.

A paper last month in the Journal of Clinical Oncology reported on the pooled analysis of data showing that the use of neoadjuvant immune checkpoint inhibitors work better than the frequently used FLOT regimen (fluorouracil, leucovorin, oxaliplatin and docetaxel) in certain gastroesophageal adenocarcinoma (GEA) cancers. But there’s plenty more coming down the pike, even as scientific knowledge about the disease advances.

Eight years after Novartis AG gained U.S. FDA approval of the first CAR T therapy, Kymriah (tisagenlecleucel), for B-cell acute lymphoblastic leukemia, developers are advancing prospects that could significantly impact another disease space outside of cancer – autoimmunity. The efforts are getting a swirl of attention, with Bristol Myers Squibb Co. (BMS) announcing Oct. 10 that it would offer $1.5 billion in cash to buy three-year-old privately held Orbital Therapeutics Inc., including its lead, next-generation CAR T-cell therapy OTX-201, which is designed to reprogram cells in vivo for autoimmune diseases.

Among severe insulin-deficient diabetes patients, 12 weeks of 100-mg, once-daily dosing of Biomea Fusion Inc.’s icovamenib lowered hemoglobin A1c by 1.8% from placebo at the 52-week timepoint, an increased benefit over and above what was seen at 26 weeks.

A top-line readout of the 26-week phase IIa Cbeyond trial showed nimacimab, Skye Bioscience Inc.’s peripherally restricted CB1 inhibitor antibody for weight loss, fell short of statistical significance as a monotherapy vs. placebo on the primary endpoint of weight loss, sending the company’s shares down 60%. Skye executives, however, offered a more optimistic outlook for the findings, which they said provide clear direction for moving forward.

Takeda Pharmaceutical Co. Ltd. is exiting all work in cell therapies and will seek an external partner to advance the company’s research and clinic-ready cell therapy programs, the company said, noting that it is not currently running any clinical trials using cell therapy technology.