Ipsen has been given an advisory committee date of June 28 for its resubmitted NDA for palovarotene as a potential treatment for fibrodysplasia ossificans progressiva (FOP).
In December of last year, the FDA rejected the drug, asking for more data from its existing studies. But the agency is giving the French pharma another shot, setting a PDUFA date for Aug. 16, 2023, as more information on palovarotene’s clinical trial will be included in the resubmission. This comprises more analyses across the clinical trial program, including the first Phase III study that was carried out in patients.
So far the drug is approved to treat FOP in Canada and the United Arab Emirates.
Ambrx looks to bring in more cash
The San Diego-based biotech Ambrx Biopharma is looking to raise more cash as it plans to sell 5.4 million shares.
