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- The FDA has approved Orzeyful (oveporexton), the first drug designed to mimic orexin, the brain peptide missing in people with narcolepsy type 1. - In two phase 3 trials, oveporexton roughly doubled sleep latency versus placebo and cut weekly cataplexy rates by up to 88.8%. - Adverse events occurred in 86 to 89 percent of oveporexton-treated participants, most commonly increased urinary frequency and transient insomnia. - Alkermes and Eli Lilly are pursuing similar orexin-targeting programs, with Lilly agreeing to pay up to $7.8bn for Centessa Pharmaceuticals.
- UK biotech sector raised £552 million in total equity financing during Q1 2026, marking an 18% increase from the previous quarter's £466 million. - Venture capital investment rose 17% to £516 million with deal activity surging 67% year-on-year to 25 transactions, indicating broader distribution of funding across companies. - Major M&A deals including Eli Lilly's £4.6 billion acquisition of Centessa Pharmaceuticals and Amgen's £626 million purchase of Dark Blue Therapeutics reinforced international interest in UK biotech assets. - The UK captured 57% of all European biotech venture capital in Q1 2026, though public market activity remained stagnant with no British companies going public during the quarter.
- Eli Lilly announced a definitive agreement to acquire UK-based Centessa Pharmaceuticals for up to $7.8 billion, marking the company's strategic expansion into sleep medicine and neurological disorders. - Centessa's lead candidate cleminorexton has demonstrated potential best-in-class profile in Phase 2a studies across narcolepsy type 1, narcolepsy type 2, and idiopathic hypersomnia through its orexin receptor 2 agonist mechanism. - The acquisition includes $38 per share in cash plus contingent value rights worth up to $9 per share, with payments tied to FDA approvals for narcolepsy and idiopathic hypersomnia treatments. - The deal represents Lilly's continued diversification beyond its metabolic portfolio, following recent acquisitions of Orna Therapeutics for $2.4 billion and Ventyx Biosciences for over $1 billion.
- Centessa Pharmaceuticals appointed Mario Alberto Accardi as CEO effective January 1, 2026, to lead the company's strategic focus on orexin receptor 2 (OX2R) agonists for neuroscience indications. - Lead candidate ORX750 demonstrated promising Phase 2a results in narcolepsy and idiopathic hypersomnia, with registrational trials expected to begin in Q1 2026. - New preclinical data shows OX2R activation reduced behavioral despair and enhanced wakefulness in animal models of major depressive disorder, supporting expansion into neuropsychiatric indications. - The company is advancing next-generation asset ORX142 into clinical trials and positioning orexin agonism as a broader CNS platform for multiple neuroscience disorders.
- Global Acquired Hemophilia A pipeline comprises over 10 companies developing innovative therapies across various clinical stages, according to DelveInsight's 2025 report. - Recent clinical advances include promising results for rituximab as a potential first-line therapy and Pfizer's positive Phase 3 AFFINE trial results for giroctocogene fitelparvovec gene therapy. - Key pharmaceutical players including Novo Nordisk, Sanofi, Pfizer, and Belief Biomed are advancing treatments ranging from gene therapies to monoclonal antibodies targeting this rare autoimmune bleeding disorder.
- Centessa Pharmaceuticals appointed Stephen Kanes as Chief Medical Officer, leveraging his 30+ years of experience in neuroscience and drug development. - Dr. Kanes will focus on advancing Centessa's orexin receptor 2 (OX2R) agonist program, including ORX750, currently in Phase 2 trials for sleep-wake disorders. - Centessa's ORX750 has shown promise in Phase 1 trials, restoring wakefulness in sleep-deprived individuals, with Phase 2a studies underway for narcolepsy and idiopathic hypersomnia. - Kanes previously led the development of ZULRESSO® for postpartum depression at Sage Therapeutics, bringing valuable expertise to Centessa's neurology and psychiatry pipeline.
- Centessa Pharmaceuticals has commenced a Phase 2 clinical trial of ORX750 for narcolepsy type 1 (NT1), narcolepsy type 2 (NT2), and idiopathic hypersomnia. - ORX750, an orally administered orexin receptor 2 (OX2R) agonist, was designed using Nxera Pharma's technology to target orexin neuron loss. - The trial initiation triggers a US$3.5 million milestone payment to Nxera Pharma, to be recognized as revenue in Q4 FY2024. - Nxera Pharma holds a significant equity stake in Centessa and is eligible for further milestone payments and royalties upon successful development of ORX750.
• Several companies are actively developing novel therapies for Hemophilia A and B, with many in various phases of clinical trials, showing promise for improving treatment options. • TiumBio Co., Ltd. has submitted a Clinical Trial Application to initiate a Phase 1b investigation of TU7710, a new recombinant activated factor VII for hemophilia patients with inhibitors. • The FDA approved ALTUVIIIO (efanesoctocog alfa) in February 2023, a factor VIII replacement therapy for adults and children with Hemophilia A, for routine prophylaxis and on-demand treatment. • BioMarin received FDA approval for Roctavian in June 2023, a single-dose gene therapy for severe Hemophilia A, marking a significant advancement in treatment.
- Centessa Pharmaceuticals' ORX750, an orexin receptor 2 (OX2R) agonist, demonstrated significant improvements in wakefulness in sleep-deprived healthy volunteers. - The 2.5 mg dose of ORX750 restored normal wakefulness, achieving a mean sleep latency of 32 minutes compared to 17 minutes with placebo. - ORX750 exhibited a favorable safety profile, with mild and transient adverse events and no significant on-target effects observed. - Based on these positive Phase 1 results, Centessa plans to initiate Phase 2 trials in patients with narcolepsy types 1 and 2, and idiopathic hypersomnia in late 2024.
