Camurus's Oclaiz (CAM2029) NDA resubmission accepted in acromegaly
- Sponsor
- Camurus $CAMX
- Drug
- Oclaiz · octreotide
- Indication
- acromegaly
FDA accepted Camurus's NDA resubmission for CAM2029 (Oclaiz, octreotide extended-release subcutaneous) in acromegaly on July 17, 2026, restarting the review clock after the June 10 CRL. Class 2 review with a PDUFA target action date of December 18, 2026.
What this means
Oclaiz (CAM2029) is Camurus's long-acting subcutaneous octreotide — a somatostatin analog for acromegaly, delivered monthly via a prefilled autoinjector pen. FDA accepted Camurus's NDA resubmission on July 17, 2026, restarting review after the June 10 CRL that cited manufacturing (not clinical) findings at a third-party contract manufacturer. Under Class 2 review, the FDA has set a December 18, 2026 target action date. This is the third quality-cause CRL cleared to resubmission this month from the CMO-driven pattern (Elevar, Camurus, Sobi, Unicycive) — remediation on the manufacturing side rather than additional trials.
From the source
Lund, Sweden — 17 July 2026 — Camurus AB (Nasdaq Stockholm: CAMX) today announced that the US Food and Drug Administration (FDA) has accepted for review the resubmission of the New Drug Application (NDA) for CAM2029, octreotide extended-release injection, for the treatment of patients with acromegaly. The application is under Class 2 review, and the FDA has assigned a Prescription Drug User Fee Act (PDUFA) target action date of 18 December 2026.
The resubmission follows the Complete Response Letter (CRL) issued by the FDA on 10 June 2026, which related to observations from a cGMP inspection at a third-party manufacturer. The CRL does not relate to the clinical efficacy or safety of CAM2029, which is supported by the Phase 3 ACROINNOVA clinical program.
"The FDA's acceptance of our resubmission is an important step toward bringing Oclaiz to patients with acromegaly in the United States," said Fredrik Tiberg, President and CEO of Camurus. "We remain confident in the strength of the clinical data and are working closely with our manufacturer to address the observations from the September 2024 inspection."
Reproduced from Camurus Press Releases · view original · public domain or open-licensed government work
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