Camurus' NDA resubmission for CAM2029 in acromegaly accepted for review by the US FDA
Camurus announces that the FDA has accepted for review its NDA resubmission for CAM2029 in acromegaly.
Camurus
Camurus is a Swedish specialty pharmaceutical company developing and commercializing innovative medicines based on its proprietary FluidCrystal technology platform for long-acting injectable drug delivery. The company focuses on rare diseases, oncology, and CNS disorders.
Company Info
Sector:Pharmaceutical / Specialty Drug Delivery
Headquarters:Lund, Sweden
Founded:1991
Website:www.camurus.com/
Upcoming Milestones & Key Dates
Q3 2026
Regulatory
FDA decision on Oclaiz acromegaly resubmission (PDUFA)
Late 2026
Clinical Trial
Phase 3 readout of treprostinil in PAH
Clinical Development Pipeline
Oclaiz (CAM2029, octreotide SC depot)
Target: Somatostatin analog (long-acting subcutaneous)CAM2038 (buprenorphine FluidCrystal)
Target: Long-acting injectable buprenorphineCAM2029 (treprostinil SC depot)
Target: Long-acting subcutaneous treprostinilRecent News
Camurus' Second CRL for Acromegaly Drug; Teva Details Workforce Cuts
Camurus received a second Complete Response Letter from FDA for its acromegaly candidate, while Teva provided fresh details on its multi-year workforce reduction plan covering both its generics and specialty operations.