Oct 22 (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.