Sovargen Co. Ltd. inked a $550 million license deal with Angelini Pharma SpA, granting Angelini development and commercialization rights to SVG-105, a novel antisense oligonucleotide drug candidate in preclinical development as a potential treatment for intractable epilepsy.
Hanmi Pharmaceutical Co. Ltd. and Health Hope Pharma Ltd. may be getting a second wind for encequidar and the Orascovery platform, with Gilead Sciences Inc. picking up exclusive global rights to develop and commercialize encequidar in the field of virology for $2.5 million up front.
Enanta Pharmaceuticals Inc.’s phase IIb study of zelicapavir missed its primary endpoint in treating respiratory syncytial virus (RSV) but mined enough positive results to get the company to talk about advancing the once-daily oral treatment into further, larger studies.
Eli Lilly and Co.’s oral selective estrogen receptor degrader (SERD) imlunestrant has been approved by the U.S. FDA for treating late-stage breast cancer patients. Branded Inluriyo, the second-line treatment is for treating adults with estrogen receptor-positive, human epidermal growth factor receptor-2-negative estrogen receptor 1-mutant advanced or metastatic breast cancer.
Crinetics Pharmaceuticals Inc.’s green light under priority review from the U.S. FDA for Palsonify (paltusotine) in first-line acromegaly sets up a not-uncommon David vs. Goliath-type scenario in the indication caused by excessive growth hormone made by the pituitary gland.
Genfleet Therapeutics (Shanghai) Inc. debuted on the Hong Kong Stock Exchange on its second attempt at an IPO, raising HK$1.819 billion (US$234 million). Genfleet’s shares (HKEX:2595) rose to HK$44.00 at the opening bell on Sept. 19 and closed at HK$42.10, about 106% higher than the listing price.
After a long regulatory road that included a complete response letter in May, Stealth Biotherapeutics Inc. finally got its Barth syndrome drug across the finish line, with the U.S. FDA granting accelerated approval to Forzinity (elamipretide HCl) to improve muscle strength in those with the ultra-rare pediatric mitochondrial cardioskeletal disease.
Genfleet Therapeutics (Shanghai) Inc. debuted on the Hong Kong Stock Exchange on its second attempt at an IPO, raising HK$1.819 billion (US$234 million). Genfleet’s shares (HKEX:2595) rose to HK$44.00 at the opening bell on Sept. 19 and closed at HK$42.10, about 106% higher than the listing price.
With positive phase III results in hand, Roivant Sciences Ltd. and Priovant Therapeutics Inc. anticipate an NDA filing in the first half of 2026, seeking approval for brepocitinib, a dual inhibitor of tyrosine kinase 2 and JAK1, in dermatomyositis, a rare autoimmune disease with limited treatment options.
Three-year-old Areteia Therapeutics Inc. hit the primary endpoint in its Exhale-4 phase III study of dexpramipexole for eosinophilic asthma, bringing the oral small molecule one step closer to the U.S. market, where it could challenge currently approved injectable anti-IL-5/5R biologics.
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