In the Phase 1b/2 trial, zoci, a potential first-in-class DLL3-targeting antibody drug conjugate, demonstrated clinically meaningful responses in patients with previously treated advanced extrapulmonary neuroendocrine carcinomas (epNECs), with a confirmed objective response rate (ORR) of 40.0% and a median duration of response (mDOR) of 5.6 months Results indicate responses to zoci monotherapy treatment among multiple epNEC subtypes, including gastroenteropancreatic NEC (GEP-NEC) and other epNEC

Johnson & Johnson won a label expansion for the subcutaneous formulation of its EGFR/MET inhibitor on Thursday. The FDA granted accelerated approval to Rybrevant Faspro (amivantamab and hyaluronidase-lpuj) as a second-line treatment for adults with recurrent or metastatic head and neck squamous cell carcinoma (HNSCC), broadening its reach beyond non–small-lung cancer. The regulatory nod, granted following a priority review, is the first for a dual-targeted therapy in the specific HNSCC setting.

Egetis Therapeutics’ lead asset, EMCITATE®, isthe first and only approved treatment in U.S. and Europe for peripheral thyrotoxicosis associated with MCT8 deficiency, a rare genetic disorder, impacting approximately 1 in 70K males Supported by ANI’s proven track record in Rare Disease, EMCITATE® has potential to reach over $300 million in peak sales in its approved indication, with U.S. and EU Orphan Drug Exclusivity and patent protection into 2045 Combines ANI’s resources, Rare Disease expertise

Financing led by Viking Global Investors alongside a syndicate of venture philanthropy investors with deep expertise in epidermolysis bullosa Proceeds to support scale-up manufacturing, IND-enabling development of NvA-021, and advance the program through an initial clinical proof-of-concept study Nov. 05, 2026 -- Nova Anchora, a biotechnology company developing a corrective topical protein therapy for dystrophic epidermolysis bullosa (DEB), today announced a $23 million equity financing led by

— Eligible for development incentives including 7 years of US market exclusivity upon regulatory approval — — Marks the second US FDA Orphan Drug Designation for sovleplenib, following its recent designation for primary ITP — Nov. 04, 2026 -- HUTCHMED (China) Limited (“HUTCHMED”) (Nasdaq/AIM:​HCM; HKEX:​13) today announces that the US Food and Drug Administration (“FDA”) has granted Orphan Drug Designation to sovleplenib for the treatment of autoimmune hemolytic anemia (“AIHA”). Sovleplenib is

The completed Phase 1a study data in healthy volunteers showed early signs of pharmacodynamic activity supporting further clinical evaluation of RES-010 The Phase 1b study in healthy overweight and moderately obese participants is ongoing with data expected in H1 2027 November 05, 2026 – Resalis Therapeutics today announced topline data from the first-in-human study of its lead candidate, RES-010, a novel antisense oligonucleotide targeting microRNA-22 (miR-22). RES-010 is designed to address t

AbbVie has added another angle to its relationship with Nxera, with the Big Pharma paying $100 million upfront for a phase 1 inflammatory bowel disease (IBD) candidate. In exchange for the worldwide rights to develop the oral EP4 receptor agonist, dubbed NXE0033744, in IBD, AbbVie is also liable to pay up to $1.37 billion in development and commercial milestones, as well as tiered royalties should the candidate make it to market. AbbVie is already a major player in the IBD space, courtesy of the

Impressive early anti-tumour activity and a therapy-leading safety pro in heavily pretreated patients across multiple B-cell lymphoma subtypes Objective response rate of 53% in 17 efficacy evaluable patients, including responses in patients previously treated with CD19-directed CAR-T cell therapy Iksuda Therapeutics (Iksuda), the developer of class leading, antibody drug conjugates (ADCs), today announces the presentation of preliminary data from the dose escalation portion of its Phase 1 study

Both doses of CBT-001 demonstrated statistically significant improvements in conjunctival hyperemia at Month 3 versus vehicle (p<0.001), with improvement observed as early as Week 2 and maintained through Month 12 Both doses also demonstrated statistically significant prevention of progression of pterygium lesion length at Month 12 versus vehicle (p<0.001) Superficial punctate keratitis was reported in 20% of patients receiving CBT-001 0.1%, compared with 8% receiving vehicle; the majority

Series A financing co-led by Sofinnova Partners and RA Capital alongside founding investor Oxford Science Enterprises with support from Cancer Research Horizons and the University of Oxford, bringing together a world-class transatlantic syndicate Proceeds will fund the Phase 1/2a studies needed to progress ATX-011, a first-in-class therapy for essential thrombocythaemia (ET) and advance additional MPN programmes toward IND submission ATX-011 binds a novel target with potential for broad therapeu