Orexo receives FDA review for IZIPRY™ application
The regulatory authority has accepted the resubmitted application with a six-month evaluation period, target date March 29, 2027.
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Pharmaceutical company developing medicines using formulation technologies
orexo.seLast updated
In short: Orexo gained FDA acceptance for IZIPRY, posted Q3 loss and moved to settle DOJ probe
The regulatory authority has accepted the resubmitted application with a six-month evaluation period, target date March 29, 2027.
The company reported a loss of -117.9 mkr and reached a principle agreement with the DOJ. The Zyprexa application was resubmitted to the FDA and OX640 received IND approval.
Proceeds fund OX640 trials, Izipry regulatory processes, and DOJ settlement. Commitments cover 70% of the total amount needed.
The company advances OX640, Izipry, and OX390 trials, initiates financing with DNB Carnegie, and continues DOJ negotiations while restructuring.
Orexo AB (ORX.ST) revealed Loss for its third quarter of -SEK117.9 million The company's earnings came in at -SEK117.9 million, or -SEK3.36 per share. This...
Specialist pharmaceutical company Orexo announces initial results from its first preclinical pharmacokinetic in vivo study of an oral semaglutid tablet. The study showed that a tablet based on Amorphox...
The pharmaceutical company Orexo, which has a market value of 500 million kronor, has decided to carry out a new share issue of approximately 250 million kronor...
Sweden's Orexo today announced the resubmission of the New Drug Application (NDA) for Izipry (naloxone nasal powder) to the US Food and Drug Administration (FDA...
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