Brief: Orexo Announces FDA Acceptance Of Investigational New Drug Application
14/09/2026 07:03
BRIEF-Orexo Announces FDA Acceptance Of Investigational New Drug Application Sept 14 (Reuters) - Orexo AB ORX.ST:
OREXO AB: OREXO ANNOUNCES FDA ACCEPTANCE OF INVESTIGATIONAL NEW DRUG (IND) APPLICATION FOR OX640 FOR THE TREATMENT OF ANAPHYLAXIS
FIRST PIVOTAL STUDY PLANNED FOR Q4 2026, WITH REGULATORY SUBMISSION TARGETED FOR 2028
CONTINUING ITS ONGOING ACTIVITIES TO IDENTIFY A PARTNER FOR FURTHER DEVELOPMENT AND COMMERCIALIZATION OF OX640
OX640 NDA IS EXPECTED TO BE READY IN 2028 FOR REGULATORY SUBMISSION
Source text: ID:nMFN36BPRx
Further company coverage: ORX.ST
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