— 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 — HONG KONG and FLORHAM PARK, N.J., Nov. 04, 2026 (GLOBE NEWSWIRE) -- 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 o

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 Torino, Italy, 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 desi

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

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