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.

— 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

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

SynKIR™-110 demonstrated faster tumor control with approximately 10-fold lower IFNγ and 30-fold lower TNFα and IL-2 production compared to CD28-based single-chain CAR T in preclinical models Preclinical in vivo data showed reduced exhaustion of tumor-infiltrating SynKIR™-110 T cells and no accumulation in healthy lung tissue compared to conventional single-chain CAR T designs In vitro data showed reductions in T cell exhaustion, off-target proliferation, and toxicity with SynKIR™-110 Nov. 3, 20

The FDA recognizes through this designation both the clinical evidence supporting daridorexant and the significant unmet medical need in pediatric insomnia, where no FDA-approved pharmacological treatments are currently available. The positive large Phase 2 study demonstrated a statistically significant dose-dependent improvement in total sleep time in the overall pediatric population, with pronounced efficacy in patients with neurodevelopmental disorders This designation enables intensive FDA g

— FDA clearance allows Pasithea to advance PAS-004 for NF1-associated cNF, a condition affecting over 95% of people with NF1 and for which there are currently no FDA-approved systemic therapies — Nov. 03, 2026 -- Pasithea Therapeutics Corp. (Nasdaq: KTTA) (“Pasithea” or the “Company”), a clinical-stage biotechnology company developing PAS-004, a next-generation oral macrocyclic MEK inhibitor for the treatment of chronic diseases, including neurofibromatosis type 1 (NF1)-associated neurofibromas

Enlivex Announces Favorable 12-Month Topline Data from Phase I/IIa Allocetra Trial, Demonstrating Durable Treatment Response In patients aged 64+: 79.2% of patients achieved a clinically meaningful response (reduced pain and improved knee function) in the Allocetra™ group vs. 47.6% in the placebo group at 12 months (p=0.027)1 Allocetra™ treatment benefit at 12 months was consistent with the response rates observed at 3 and 6 months, demonstrating a durable effect from a single treatment cycle Th