RESPIRATORIUS Aktie

 

Respiratorius AB (publ) today announced that the company has received the official meeting minutes from the pre-IND (Investigational New Drug) meeting recently held with the US Food and Drug Administration (FDA). The purpose of the meeting was to discuss strategic considerations ahead of the forthcoming clinical development of the company's drug candidate VAL001. The candidate is intended for the treatment of previously untreated diffuse large B-cell lymphoma (DLBCL).   The minutes provide a clear summary of the key topics discussed, including study design and the conduct of the...

Das Instrument HF00 SE0023314315 RESPIRATORIUS AB EQUITY wird cum Kapitalmassnahme gehandelt am 15.08.2025 und ex Kapitalmassnahme am 18.08.2025 The instrument HF00 SE0023314315 RESPIRATORIUS AB EQUITY is traded cum capital adjustment on 15.08.2025 and ex capital adjustment on 18.08.2025...

Respiratorius AB (publ) announces that the company has held an advisory pre-IND (Investigational New Drug) meeting with the US Food and Drug Administration (FDA). The purpose of the meeting was to discuss strategic considerations ahead of the upcoming clinical development of the drug candidate VAL001, intended for the treatment of previously untreated diffuse large B-cell lymphoma (DLBCL). Prior to the meeting, Respiratorius submitted comprehensive background material to the FDA, including data from previous studies as well as specific questions regarding the planning and design of a future...

Respiratorius AB (publ) today announces that the company has been granted a pre-IND meeting with the U.S. Food and Drug Administration (FDA) ahead of a planned Investigational New Drug (IND) application for its drug candidate VAL001. The purpose of the meeting is to obtain regulatory guidance for the next steps in the clinical development of VAL001 in the strategically important U.S. market. The granted meeting request reflects interest from multiple stakeholders and forms a key part of the company's ongoing efforts to strengthen the positioning of the candidate. In collaboration with an...

Respiratorius AB (publ) today announces that the European Patent Office (EPO) has issued a formal Notice of Allowance for its patent application covering the novel oral formulation of sodium valproate that supports VAL001. This milestone marks Respiratorius' first granted formulation patent, protecting a unique method for administering valproate as a pre‑treatment in oncology. The patent carries a priority date of April 21, 2016, and once formally granted, will confer market exclusivity for at least 20 years from that date. Corresponding patents have already been approved in Japan, Canada...

Respiratorius AB (publ) today announces that its scientific manuscript titled “Combined immediate-release and extended release formulation of sodium valproate provides stable plasma levels for inhibition of histone deacetylation” has been accepted for publication in the peer-reviewed journal Clinical Pharmacology in Drug Development. The study demonstrates that a novel formulation of sodium valproate – incorporating both immediate-release and sustained-release components – achieves stable plasma concentrations that are crucial for effective inhibition of histone deacetylases (HDAC). These...