Idorsia Ltd

Top 2024 cardiovascular articles highlighted new hypertension treatments, risks of high vitamin B12 and xylitol, and statin therapy benefits for older adults. Statins reduced CVD risk in seniors; xylitol linked to heart risks; semaglutide approved for heart event prevention; Tryvio approved for resistant hypertension; high B12 levels associated with increased mortality.

Actelion Pharmaceuticals Ltd., a Swiss biopharmaceutical company founded in 1997, specializes in drugs for rare diseases, notably pulmonary arterial hypertension (PAH). Acquired by Johnson & Johnson in 2017 for $30 billion, it spun off its R&D unit into Idorsia. Actelion faced legal issues over drug pricing and kickbacks, settling for $360 million. It collaborates with Analytics 4 Life to improve pulmonary hypertension diagnosis.

Insomnia market report forecasts growth from 2020 to 2034, driven by increasing prevalence, awareness, and emerging therapies like Seltorexant and TS-142. Challenges include high treatment costs and patient non-compliance, with unmet needs for long-term solutions with minimal side effects.

Idorsia plans to cut 270 positions globally and potentially sell hypertension treatment Tryvio to recover debt, aiming to conclude restructuring by end of 2024, with full cost reduction by Q2 2025. Shares rose 17.5% post-announcement, and CEO André C Muller targets signing a deal before end of 2024.

Kronos Bio to lay off 83% of workforce, CEO steps down; Idorsia in talks to sell blood pressure drug rights for $35M; PTC Therapeutics shelves failed ALS drug, plans to sell review voucher for $150M; Acadia Pharmaceuticals acquires global rights to Saniona's experimental medicine; Soleno Therapeutics' FDA decision on Prader-Wili syndrome drug delayed to March 2025; Alnylam Pharmaceuticals awaits FDA decision on ATTR-CM drug by March 23.

Seltorexant, a potent, selective orexin-2 receptor antagonist, improved symptoms of major depressive disorder (MDD) and insomnia in a phase III trial. The study drug, when combined with current antidepressant treatment, showed a significant reduction in Montgomery-Åsberg Depression Rating Scale (MADRS) total score compared to placebo. Seltorexant is unique as it targets only OX2 receptors, potentially filling an unmet need for new therapies for MDD and insomnia.

Dopamine agonists, once first-line for restless legs syndrome (RLS), are no longer recommended due to long-term complications like augmentation. New AASM guidelines, led by John Winkelman, MD, PhD, recommend alternatives like alpha-2-delta calcium channel ligands and addressing iron deficiency.

Shionogi & Co. Ltd. has concluded a sales partnership agreement with Nxera Pharma Japan for the insomnia treatment QUVIVIQ®, which selectively binds to orexin receptors to facilitate sleep. Nxera Pharma Japan obtained manufacturing and marketing approval in Japan on September 24, 2024. Shionogi acquired exclusive distribution rights in Japan, paying an upfront fee and royalties to Nxera Pharma Japan, while Mochida Pharmaceutical Plant Co., Ltd. will handle finished product manufacturing.

Viatris Inc., formed by Mylan and Upjohn, navigates pharma challenges with 5% stock rise vs. S&P 500's 2%. Market cap $14.44B, EPS forecasts $2.66/$2.70. NA GX segment growth driven by Breyna, NPL guidance raised to $500-600M. OTC divestiture by mid-2024 aims for leverage target of 3x. Analysts cautious, Barclays 'Underweight'. Medium-term pipeline promising, FDA GA Depot meeting crucial.

Nxera Pharma Japan receives MHLW approval for QUVIVIQ™, a dual orexin receptor antagonist for treating insomnia in adults, based on a Phase 3 trial in Japan that met all primary and secondary endpoints. Plans are underway to make QUVIVIQ available to insomnia patients in Japan.