Cereno Scientific: CS1 granted OMPD, complementing FDA ODD - Edison

Cereno Scientific’s lead asset CS1 has been granted the Orphan Medicinal Product Designation (OMPD) from the European Commission as a potential treatment for pulmonary arterial hypertension (PAH). The OMPD provides 10 years of market exclusivity, assuming CS1 receives EU regulatory approval, in addition to fee waivers during the development process. Further, this regulatory designation complements the FDA Orphan Drug Designation (ODD) granted in 2020, bolstering the value proposition of the candidate. We expect this news will be viewed positively as investors await the Phase II CS1 trial’s topline results in PAH, expected in September 2024.

Länk till analysen i sin helhet: https://www.edisoninvestmentresearch.com/research/company/cereno-scientific

Länk till analysen i sin helhet: https://www.edisoninvestmentresearch.com/research/report/cereno-scientific863407/preview