Cartesian Therapeutics Inc. followed up December’s phase IIb data with more good news regarding Descartes-08, offering 12-month efficacy and safety results that whetted Wall Street’s appetite for the phase III Aurora effort ahead. Milos Miljkovic, chief medical officer, told BioWorld that minimum symptom expression – among the areas where Descartes-08 shone, providing relief for “months and months after the last dose of treatment” – is especially important to patients.
Lexeo Therapeutics Inc. produced more positive interim data from early stage studies of its gene therapy to treat Friedreich’s ataxia cardiomyopathy. The results have prompted the company to continue their ongoing dialogue with U.S. FDA regulators to finalize a registrational study protocol and launch that study by early 2026 with data the following year.
Rhythm Pharmaceuticals Inc.’s sales with Imcivree (setmelanotide) in weight management could exceed $1 billion by 2028 if hypothalamic obesity (HO) is added to the label of the drug, Oppenheimer analyst Leland Gershell said in a report. Boston-based Rhythm rolled out positive top-line data from the pivotal phase III study called Transcend with the melanocortin-4 receptor agonist in HO. The global trial met its primary endpoint with a statistically significant and highly clinically meaningful reduction in body mass index in adult and pediatric HO patients vs. placebo.
Radiopharmaceuticals, including 16α-18F-fluoro-17β-estradiol (18F-FES) PET/CT, are emerging as powerful tools with new diagnostic and therapeutic potential in breast cancer diagnosis and treatment, Han Sang-won, professor from the department of nuclear medicine at Asan Medical Center, recently told BioWorld.
Beigene Ltd. said it is shutting down development of its anti-TIGIT antibody, ociperlimab (BGB-A1217), after the humanized IgG1-variant monoclonal antibody failed a phase III trial in lung cancer. The move is one of many in a string of anti-TIGIT immunotherapy failures.
“Men in general have been playing golf for a longer time – in those old boy networks we still haven’t tapped into.” It may seem far-fetched, but that is put forward as a reason for underinvestment in women’s health companies. The argument goes that women heading women’s health startups find it hard to raise money because their networks are weaker, making it harder to tap into investment networks.
The latest obesity contender, Antag Therapeutics A/S, has dosed the first participants in a phase I trial of a glucose-dependent insulinotrophic polypeptide (GIP) agonist it said will address key gaps in the current treatment options, not least the gastrointestinal side effects seen with GLP-1 agonists.
Greenwich Lifesciences Inc. followed a February update with another on the phase III Flamingo-01 trial, providing open-label immune response data for GLSI-100, a HER2/neu peptide vaccine immunotherapy to prevent breast cancer recurrences in patients who have completed standard therapy. Specifically, GLSI-100 combines GP2, the HER2/neu-derived peptide, with granulocyte-macrophage colony-stimulating factor.
Top-line data from the second and third parts of Edgewise Therapeutics Inc.’s four-part phase II Cirrus-HCM study in hypertrophic cardiomyopathy (HCM) has produced more positive data. There was however less enthusiasm for the results than there had been in September for the first batch of data.
Otsuka Pharmaceutical Development & Commercialization Inc. filed its BLA with the U.S. FDA for sibeprenlimab to treat immunoglobulin A nephropathy (IgAN). The company’s first BLA, sibeprenlimab is a monoclonal antibody (MAb) that selectively inhibits the activity of APRIL (A PRoliferation-Inducing Ligand) in adults with IgAN.
RSS
