It’s not often that disclosure of a complete response letter (CRL) causes a company’s share price to rise, but that was case for Aquestive Therapeutics Inc., which saw its stock (NASDAQ:AQST) rise 39% to close Feb. 2 at $4.10 on news the U.S. FDA has declined – for now – to approve the NDA for Anaphylm (dibutepinephrine), delaying the commercial entry of what could be the first oral alternative to Epipen.
Researchers at the Institut Pasteur have developed a vaccine that spurred the production of autoantibodies to immunoglobulin E antibodies, protecting vaccinated mice from anaphylaxis.
Researchers at the Institut Pasteur have developed a vaccine that spurred the production of autoantibodies to immunoglobulin E (IgE) antibodies, protecting vaccinated mice from anaphylaxis. In their paper, which they published in Science Translational Medicine on Dec. 3, 2025, the authors noted that the polyclonal antibodies generated by their vaccine lasted “for up to 12 months postvaccination with a similar avidity as the approved anti-IgE mAb omalizumab [Xolair, Roche AG].”
Anaphylaxis rates caused Larimar Therapeutics Inc.’s stock (NASDAQ:LRMR) to take a hit on the latest data from an open-label study with nomlabofusp in the neuromuscular disease Friedreich’s ataxia (FA), but the company is targeting a BLA submission to seek accelerated approval in the second quarter of next year.
In the first patenting from Lent Innovations LLC, the company’s founder, Anne Lent – an allergist and immunologist – describes their invention of an epinephrine auto-injector tailored to the specific needs of children to reduce the risk of use errors and incorrect injection technique.
Five months after getting a complete response letter from the U.S. FDA, Regeneron Pharmaceuticals Inc. has landed conditional European marketing approval for odronextamab, a bispecific antibody for treating lymphoma. Now named Ordspono, the approval is for treating adult patients with relapsed or refractory follicular lymphoma or diffuse large B-cell lymphoma, after two or more lines of therapy. The European Commission also approved Merck & Co. Inc.’s Winrevair (sotatercept) for pulmonary arterial hypertension and ARS Pharmaceuticals Inc.'s Eurneffy (inhaled epinephrine) for anaphylaxis.
Insignis Therapeutics Inc.’s sublingual anaphylaxis treatment IN-001 has received Fast Track designation from the FDA. The Fast Track program is designed to expedite the product review and facilitate the development of drugs that treat serious conditions and address unmet medical needs.
Executives of ARS Pharmaceuticals Inc. are anticipating a quick switch for severe allergy patients following the U.S. FDA approval of Neffy (epinephrine nasal spray 2 mg), marking the first needle-free treatment option.
In what represents its first patenting, Anjo.ai Inc seeks protection of systems for remote monitoring, early detection and notification for life-threatening allergic anaphylactic reactions using wearable sensors and artificial intelligence. The system can recognize an allergic reaction even before the visible symptoms appear.
Aquestive Therapeutics Inc.’s oral epinephrine prodrug to treat life-threatening allergic reactions, Anaphylm, produced a faster time to maximum concentration than currently available autoinjectors in healthy adults, early pivotal phase III data show, meeting both pharmacokinetic (PK) primary and secondary endpoints.
