ARS PHARMACEUTICALS

Insilico Medicine announced results from a clinical trial of ISM001-055, designed using generative AI to treat idiopathic pulmonary fibrosis, showing improvements in lung function and quality of life. Enveda began clinical trials of ENV-294, an oral inflammatory agent for atopic dermatitis, derived from natural compounds identified using AI. Various healthcare updates include FDA approvals, licensing agreements, and collaborations in drug discovery and treatment development.

ARS Pharmaceuticals reports progress on U.S. commercial launch of neffy® (epinephrine nasal spray) 2 mg for Type I allergic reactions, including anaphylaxis, in adults and children ≥30 kg. The company highlights strong demand, early payer discussions, and a $145 million upfront payment from ALK-Abelló for commercializing neffy in Europe, Canada, and other regions. ARS Pharma plans to initiate a Phase 2b study of its intranasal epinephrine technology in patients with chronic spontaneous urticaria in 2025.

ARS Pharmaceuticals' Form 10-Q report details financial performance: $2.1 million in revenue, $(21.7) million in operating loss, and $(19.1) million in net loss. neffy, a needle-free epinephrine product, was launched in the U.S. in September 2024, with regulatory approvals in the EU and plans for additional filings globally. The company faces challenges including market acceptance, regulatory approvals, and financial performance fluctuations.

ALK enters strategic license agreement with ARS Pharma for exclusive global rights to neffy® adrenaline nasal spray, excluding USA, Australia, New Zealand, Japan, and China. The deal supports ALK's Allergy+ strategy and long-term financial goals, with potential for new indications like acute urticaria. ALK to pay USD 145 million upfront plus future milestones and royalties.

ALK enters strategic license agreement with ARS Pharma for neffy® adrenaline nasal spray, excluding USA, Australia, New Zealand, Japan, and China. The deal supports ALK's Allergy+ strategy and long-term financial ambitions, with ALK paying USD 145 million upfront and additional milestones and royalties. neffy®, approved in EU and US in 2024, is the first needle-free emergency treatment for anaphylaxis, with potential new indications in acute urticaria. ALK plans to focus on European and Canadian markets initially, with a portfolio approach to meet diverse patient needs.

PPAHS welcomes five new members to its Board of Advisors, expanding expertise in pharmacovigilance, public health, strategic planning, healthcare startup investment, and insurance payer sectors.

20+ companies, including Regeneron and Sanofi, are advancing 25+ urticaria drugs through clinical trials, addressing unmet needs in treatment.

Small molecule therapies remain crucial; FDA approves BMS's Cobenfy for schizophrenia, Gilead licenses lenacapavir for HIV, ARS's neffy for anaphylaxis, AstraZeneca's Tagrisso for lung cancer, Bayer's darolutamide for prostate cancer, Novartis' Kisqali for breast cancer, and Pfizer withdraws voxelotor for sickle cell disease due to safety concerns.

EURneffy, a needle-free adrenaline nasal spray, was approved in the EU and US as a first-of-its-kind treatment for anaphylaxis, overcoming barriers like fear of injections and accidental needle-related side effects. It offers comparable efficacy to traditional injectables, with simpler use and better temperature sensitivity, potentially increasing patient compliance.

Epinephrine nasal spray Neffy, developed by ARS Pharmaceuticals, aims to reduce fear of needle injections for treating severe allergic reactions. FDA-approved for patients 66 lbs or heavier, it offers painless, instantaneous relief with potential side effects like throat irritation. ARS is working on lower doses for children and infants.