• (PLX AI) – Camurus shares dropped 17% after the FDA again issued a CRL for Brixadi, citing deficiencies in Camurus’s US partner Braeburn’s third-party manufacturer.
  • • Camurus is seeking further information from Braeburn and will consider all options to ensure that Brixadi becomes available to US patients as soon as possible, the company said
  • • This is exactly what happened last year, and we are surprised that Camurus’s partner has not done more to avoid a repeat, DNB analysts said
  • • This is clearly negative for the share price: DNB
  • • Last year with the other CRL due to manufacturing issues it took another year to get a final answer from the FDA and we believe this is what we should expect this time too, DNB said

Quelle: PLX AI