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

Exclusive option rights for up to 37 potential first-to-market biosimilar candidates to significantly expand Fresenius’ portfolio from 29 marketed and pipeline molecules today to up to 66 in the next decade, addressing more than €370 billion in originator sales; the largest development agreement announced in the biosimilars industry to date. Agreement gives Fresenius full strategic flexibility to select and advance biosimilar candidates to develop, against its established selection criteria, whi

November 3rd, 2026 - Oryzon Genomics, S.A. (ISIN Code: ES0167733015, ORY), a clinical-stage biopharmaceutical company and global leader in epigenetics, today announced that VIVALDI, a Phase Ib pilot study sponsored by CETLAM — Grupo Cooperativo de Estudio y Tratamiento de las Leucemias Agudas y Mielodisplásicas, has been authorized in Spain. The study will evaluate iadademstat in combination with azacitidine and venetoclax in patients with newly diagnosed acute myeloid leukemia (ND-AML) belongin

Financing led by Hatteras Venture Partners, with participation from foundational investors Lumira Ventures and adMare BioInnovations and a new syndicate of life sciences investors Proceeds will be used to advance lead Dualase® therapeutic candidate through initial clinical biomarker proof-of-concept in patients with C9ORF72-associated ALS Gene-editing platform designed to precisely remove disease-causing DNA repeat expansions, with potential applications across more than 40 repeat expansion diso

GLORIA Study Team Receives the 2026 German University Medicine Prize for Its Glioblastoma Research with CXCL12 Inhibitor NOX-A12 Researchers from six German university medical centers have received the 2026 German University Medicine Prize for their work in the GLORIA study GLORIA, TME Pharma’s Phase 1/2 study, evaluates NOX-A12 in combination with radiotherapy in newly diagnosed glioblastoma patients who are resistant to chemotherapy. In an expansion cohort, NOX-A12 and radiotherapy were also c

Edison Scientific announced an agreement to deploy the Edison AI Platform and Kosmos, Edison's AI scientist, across Pfizer’s biopharmaceutical research and development pipeline. The collaboration brings together Edison’s industry-leading AI capabilities with Pfizer’s scientific expertise and robust repositories of data across oncology, internal medicine, immunology, and more. Kosmos will access Pfizer’s data to support Pfizer’s scientists, inform critical decisions in R&D, and help accelerate th

Oct. 30, 2026 -- InnoCare Pharma (HKEX: 09969; SSE: 688428), a leading biopharmaceutical company focusing on the treatment of cancer and autoimmune diseases, announced today that the first subject has been dosed in the Phase 1 trial of ICP-B161, a bispecific antibody targeting TL1A and IL-23p19, for the potential treatment of autoimmune diseases, including inflammatory bowel disease (IBD). With its novel molecular design, ICP-B161 delivers an extended half-life, which allows for less frequent d

Company created following Jazz Pharmaceuticals’ acquisition of Actio Biosciences Setara plans to advance clinical-stage small molecule TRPV4 inhibitor for treatment of Charcot-Marie-Tooth disease type 2C (CMT2C) and overactive bladder, along with other early-stage discovery programs Investor syndicate comprised of leading healthcare investors including Deerfield Management, Canaan, Droia Ventures, EcoR1, Euclidean Capital, and Regeneron Ventures, as well as Jazz Pharmaceuticals Setara Bioscienc