Camurus Faces Fresh FDA Setback, Hormone Disorder Drug Approval Pushed to 2027
Camurus' Oclaiz Approval Delayed: Regulatory and Market Impacts
By Sruthi Narasimha Chari and Christy Santhosh
Regulatory Setback and Market Reaction
June 11 (Reuters) - Wall Street has pushed to next year expectations for a U.S. approval for Camurus' drug to treat a rare hormonal condition after the health regulator's second refusal on Wednesday.
Shares of the Swedish drugmaker declined 5% in Stockholm trade on Thursday.
The U.S. Food and Drug Administration declined to approve the drug, Oclaiz, citing unresolved issues at a third-party manufacturing site, marking another setback after similar deficiencies blocked approval in 2024.
Camurus' Response and Remediation Efforts
Camurus said it is working towards resubmitting its application soon, adding that its contract manufacturer has taken corrective actions, updated the FDA on remediation progress and declared inspection readiness of the facility.
Analyst Perspectives on Approval Timeline
But Jefferies analyst Shan Hama said an early resubmission with the current manufacturer looks unlikely. Camurus could refile in the fourth quarter of the year with a second validated manufacturer, with potential approval in the first half of 2027, Hama said.
Redeye analyst Richard Ramanius said Thursday's share fall does not reflect any change in the company's fundamentals and added that third-party manufacturing issues are common among European companies that use local production and seek U.S. approval.
About Oclaiz and Acromegaly
Oclaiz: Indications and Formulation
Oclaiz, approved in the EU and UK under the brand name Oczyesa, is used as maintenance treatment for adults with acromegaly, a rare condition typically caused by a pituitary gland tumor that leads to excess growth hormone production and abnormal enlargement of bones, organs and other tissues.
Extended-Release Therapy Benefits
It is formulated as an extended-release therapy, intended for sustained drug exposure over a month, making it more convenient for patients requiring regular dosing.
Acromegaly: Prevalence and Risks
Acromegaly affects roughly 3 to 14 people per 100,000 globally. Patients with uncontrolled acromegaly have increased risk of death.
(Reporting by Sruthi Narasimha Chari and Christy Santhosh in Bengaluru; Editing by Sahal Muhammed)
