(Reuters) – The U.S. Food and Drug Administration has declined to approve Camurus’ drug for the treatment of a rare hormonal disorder due to deficiencies at a third-party manufacturing facility, the Swedish drugmaker said late Monday.
WHY IT’S IMPORTANT
The FDA’s decision could delay the approval and subsequent launch of the drug, CAM2029, meant to treat patients with acromegaly, which is diagnosed in three to 14 of every 100,000 people.
KEY QUOTE
The decision is “disappointing, however, we are confident in the data supporting our NDA and the potential of CAM2029 to address unmet medical needs of patients with acromegaly,” Camurus CEO Fredrik Tiberg said.
MARKET REACTION
Camurus’ shares plummeted by 10% in Stockholm trade following the decision.
WHAT’S NEXT
The manufacturing issues could delay the approval of Oclaiz for six months to one year, pushing its launch to the fourth quarter of 2025, according to Jefferies analysts.
(Reporting by Sruthi Narasimha Chari and Christy Santhosh in Bengaluru; editing by Alan Barona)
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