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Camurus announces FDA acceptance of NDA resubmission for Oclaiz™ for the treatment of acromegaly

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SANDOSTATIN®
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PDUFA target action date set to 10 June 2026 LUND, Sweden, Jan. 9, 2026 /PRNewswire/ -- Camurus (NAS...

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AI Summary

FDA accepted Camurus' NDA resubmission for Oclaiz™. PDUFA target action date is June 10, 2026. Oclaiz™ is a monthly self-administered treatment for acromegaly. Previous application faced a Complete Response Letter due to manufacturing issues. Oclaiz™ shows promising clinical results in managing acromegaly.

Sentiment Rationale

Successful approval of Oclaiz™ could significantly boost revenue, similar to historical approvals of novel treatments in rare diseases.

Trading Thesis

While June 2026 will be a critical milestone, actual sales and market capture will influence long-term investor sentiment.

Market-Moving

  • Oclaiz™ has potential to capture significant acromegaly market share if approved.
  • FDA's acceptance indicates confidence in Camurus' clinical data.
  • Positive market reception upon successful EU launch may drive interest.
  • Market sentiment could be bullish leading to the PDUFA date.
  • Upcoming clinical data releases may further impact stock price.

Key Facts

  • FDA accepted Camurus' NDA resubmission for Oclaiz™.
  • PDUFA target action date is June 10, 2026.
  • Oclaiz™ is a monthly self-administered treatment for acromegaly.
  • Previous application faced a Complete Response Letter due to manufacturing issues.
  • Oclaiz™ shows promising clinical results in managing acromegaly.

Companies Mentioned

  • SANDOSTATIN® (SANDOSTATIN®)

Corporate Developments

The upcoming PDUFA date and existing clinical data make this highly relevant to CAMX's future performance.

Camurus Receives FDA Acceptance for Oclaiz™ NDA Resubmission

Camurus (NASDAQ: CAMX) has announced today that the U.S. Food and Drug Administration (FDA) has accepted for review the company’s resubmission of the New Drug Application (NDA) for Oclaiz™ (CAM2029). This innovative octreotide extended-release injection is aimed at treating patients with acromegaly. The FDA has set a Prescription Drug User Fee Act (PDUFA) action date of June 10, 2026.

Commitment to Patients

Fredrik Tiberg, President & CEO of Camurus, stated, “We look forward to the continued collaboration with the FDA to make Oclaiz available to patients with acromegaly in the US as soon as possible.” The company's commitment is evident in their development of Oclaiz, a subcutaneous long-acting octreotide depot designed for optimized disease control and convenient self-administration.

Details on Oclaiz™ (CAM2029)

Oclaiz is prepared for monthly subcutaneous self-administration using a pre-filled autoinjector pen, employing Camurus’ proprietary FluidCrystal® technology. The NDA resubmission is backed by data derived from seven clinical studies, including two Phase 3 trials from the ACROINNOVA program. The updated NDA was submitted on December 10, 2025, in response to a Complete Response Letter issued by the FDA that pertained to observations from a cGMP inspection at a third-party manufacturer.

Acromegaly: A Rare and Serious Condition

Acromegaly is a rare endocrine disorder typically caused by a pituitary tumor that produces excess growth hormone. This leads to increased levels of insulin growth factor-1 (IGF-1), resulting in abnormal growth and various clinical symptoms. The prevalence of acromegaly is estimated to be about 60 cases per million, making effective treatment crucial for improving patients' quality of life.

Clinical Insights and Benefits

The Oclaiz (CAM2029) clinical program has shown significant promise, with studies indicating a five-fold increase in bioavailability compared to currently approved long-acting intramuscular octreotide. Notably, the ACROINNOVA 1 study revealed a higher proportion of patients achieving normalized IGF-1 levels with CAM2029 compared to placebo. Furthermore, the ACROINNOVA 2 study confirmed sustained improvements in IGF-1 levels and reduced disease symptoms over a treatment period of 52 weeks.

  • Common side effects included gastrointestinal disorders, nervous system disorders, and injection site reactions.
  • Oclaiz is also being developed for two additional indications: gastroenteropancreatic neuroendocrine tumors (GEP-NET) and polycystic liver disease (PLD).

About Camurus

Camurus is a globally recognized biopharmaceutical company focused on innovative, long-acting medicines for chronic conditions. Leveraging the FluidCrystal® technology, Camurus is dedicated to developing best-in-class therapies for various diseases. The company operates in Europe, the U.S., and Australia, with its headquarters located in Lund, Sweden. Camurus is publicly traded on Nasdaq Stockholm under the ticker symbol CAMX. For more information, visit www.camurus.com.

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