Biogen has announced that salanersen has been given the US FDA Breakthrough Therapy Designation to treat spinal muscular atrophy (SMA).Salanersen is an investigational novel antisense oligonucleotide (ASO) and has the potential to offer high efficacy in SMA with once-yearly dosing. Breakthrough Therapy designation helps to speed up the development and review of drugs intended to treat serious conditions, and where preliminary clinical evidence indicates that the drug may demonstrate substantial

Investigational results from FIND-CKD provide full efficacy and safety data and is the fifth consecutive Phase III clinical trial where KERENDIA met its primary endpoint—adding to a clinical trial program of more than 20,000 patients across multiple patient populations with heart and kidney diseases, now with additional data in a different patient population.1 KERENDIA is currently approved by the FDA for use in adults with chronic kidney disease (CKD) associated with type 2 diabetes (T2D), as

Gilead Sciences (Nasdaq: GILD) and Belgium-based Lakefront Biotherapeutics NV (Euronext & Nasdaq: LKFT) have completed the joint acquisition of Ouro Medicines in a deal valued at up to USD 2.175 billion. The transaction centers on gamgertamig (OM336; CM-336), a clinical-stage BCMAxCD3 bispecific T cell engager under development for auto-immune diseaes, originally licensed from China’s Keymed Biosciences. Gilead is taking commercial rights to the molecule outside Greater China, while Lakefront as

The company is expecting to spend $150 million to develop its Wnt/β-catenin pathway inhibitor zolucatetide for desmoid tumors. Parabilis Medicines is gearing up for an IPO that could eventually bring in as much as $476 million to fund the phase 3 development of its desmoid tumor prospect. The Massachusetts biotech, formerly known as FogPharma, announced plans last month to list on the Nasdaq, and has now put some figures behind that ambition. Parabilis reckons it can offer 25 million shares pr

June 2, 2026 -- Creatv Bio, a Division of Creatv MicroTech, Inc. ("Creatv"), a liquid biopsy company focused on innovative diagnostics for cancer, and Neovia Oncology LLC, a Delaware based pharmaceutical company dedicated to developing novel oncology therapies, announced the signing of a strategic partnership agreement to collaborate on Neovia's upcoming studies treating patients with advanced multiple drug resistant solid tumors who are entering late lines of therapy. The collaboration is expe

June 2, 2026 -- SMi Systems announces today the execution of a non-exclusive evaluation collaboration with Luminex Corporation to assess the feasibility of using Luminex beads with SMi's single-molecule imaging platform and to compare SMi's analytical sensitivity with Luminex's current xMAP readers under defined test conditions. The evaluation is initially focused on research activities to validate the potential for SMi's technology to complement Luminex's industry leading xMAP technology. SMi

Study Results Demonstrated Favorable Safety Profile and Preliminary Signals of Clinical Activity June 2, 2026 -- Evogene Ltd. ("Evogene") (Nasdaq: EVGN) (TASE: EVGN), a pioneering computational chemistry company specializing in generative design of small molecules for the pharmaceutical and agricultural industries, today announced the successful completion of the first-in-human (FIH) Phase 1 clinical study of BMC128, a rationally-designed live bacterial product developed by its subsidiary, Biom

AQUIPTA® (atogepant) is now approved in the European Union for the acute treatment of migraine in adults, with or without aura, and for the prophylaxis of migraine in adults who have at least four migraine days per month. Approval was based on the pivotal Phase 3 ECLIPSE trial, which showed that AQUIPTA resulted in statistically significant pain freedom at two hours versus placebo during the first migraine attack, with sustained pain freedom from 2 to 48 hours and a clinically meaningful and con

China’s NMPA has granted marketing approval to eratrectinib (VC004), a next-generation TRK inhibitor developed by Nanjing-based Jiangsu Vcare PharmaTech Co., Ltd., for adult and adolescent patients with advanced solid tumors harboring NTRK gene fusions. The tumor-agnostic approval is notable for extending coverage to patients who have progressed on first-generation TRK inhibitors — a population for whom treatment options remain limited — and represents the first domestically developed next-gener

Two regimens containing Celcuity's multi-target PAM inhibitor gedatolisib halved the risk of disease progression or death versus Novartis' PI3Kα inhibitor Piqray (alpelisib) in adults with hormone receptor (HR)-positive, HER2-negative, PIK3CA mutated, locally advanced or metastatic breast cancer. The statistically significant and clinically meaningful findings come from the Phase III VIKTORIA-1 trial, which were presented Tuesday at the American Society of Clinical Oncology (ASCO) annual meeting