CLD-423 Phase 1a Single- and Multiple-Dose Data Demonstrate Favorable Tolerability and Immunogenicity Profiles and Sustained Target Engagement, Supporting Planned Phase 2 Trials in Ulcerative Colitis and Crohn’s Disease in Early 2027 Exclusive Worldwide License for IL-17 x TL1A Bispecific Antibody Program Expands Pipeline of Novel Investigational Therapies for Immune-Mediated Diseases Caldera Therapeutics, Inc. (Caldera), a privately held clinical-stage biotechnology company developing bispecif

— Selective SIK2 inhibitors reduced disease activity in a mouse model of rheumatoid arthritis to levels comparable to approved therapies etanercept and upadacitinib — November 5, 2026 — Nimbus Therapeutics, LLC (“Nimbus Therapeutics” or “Nimbus”), a computational drug discovery company developing breakthrough small molecule medicines through advanced structure-based design and AI-enabled chemistry, today announced that it will present new preclinical data from its highly selective salt-inducibl

$133 million Series B financing co-led by new investors Advent Life Sciences and British Business Bank, with additional new investments from Johnson & Johnson Innovation – JJDC, Inc. (JJDC), Samsara BioCapital, M-Ventures and Lilly, joined by all existing major shareholders Proceeds to fund two first-in-class TCR-CD3 bispecific programmes in cancer and autoimmune disease through to clinical proof-of-concept Dr. Kirsty Crame appointed Chief Development Officer to oversee translational and clinic

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