Curatis receives FDA green light for corticorelin development plan

LIESTAL, Switzerland - Curatis Holding AG (SIX:CURN), a $97.7 million market cap biotechnology company with impressive revenue growth of 19.3% over the last twelve months, announced Thursday it has received official minutes from its September 9 meeting with the FDA, confirming the company can proceed as planned with the clinical development of corticorelin. According to InvestingPro analysis, the company currently appears undervalued based on its Fair Value metrics.

The drug is being developed as a treatment to reduce or eliminate steroid use in patients suffering from peritumoral brain edema (PTBE) associated with metastatic brain tumors. PTBE occurs when fluid accumulates around brain tumors, causing symptoms such as headaches, vomiting, and neurological dysfunction.

According to the company, the FDA meeting covered chemistry, manufacturing, control, nonclinical and clinical aspects of the development plan. Curatis may now proceed with a regulatory submission supporting a pivotal Phase 3 study, which will utilize an adaptive trial design with a dose optimization lead-in and confirmatory segment.

"This validation of our clinical plans for corticorelin in patients with brain metastases secondary to solid tumors marks a milestone, enabling us to pursue partnering opportunities with global leaders in oncology and specialty care," said Dr. Roland Rutschmann, CEO of Curatis.

The company stated that current standard treatment for PTBE involves corticosteroids, which can cause serious side effects including muscle wasting, impaired glucose metabolism, osteoporosis, and hypertension. Corticosteroids may also counteract certain cancer therapies.

In previous clinical studies, corticorelin demonstrated potential to substantially reduce or completely replace steroid use, potentially improving patient quality of life by mitigating these side effects.

Curatis noted that more than 150,000 patients in the U.S. alone suffer from PTBE, which commonly occurs with metastases from lung cancer, breast cancer, melanoma, and colorectal cancer.

The information was disclosed in a company press release. Corticorelin remains an investigational drug not yet approved for therapeutic use in the United States or elsewhere.

In other recent news, Currency Exchange International announced an amendment to its share buyback program. The company has increased the maximum number of common shares that may be repurchased from 316,646 to 377,000 shares. This amended program represents 8.09% of the public float as of November 18, 2024, and 10% of the public float as of August 20, 2025. The buyback initiative, which started on December 2, 2024, is set to continue until December 1, 2025, unless concluded earlier. The Toronto Stock Exchange has accepted this amendment, signaling a step forward in the company’s capital management strategy. Investors may view this move as a sign of confidence in the company’s financial health. Such buyback programs are often aimed at enhancing shareholder value by reducing the number of outstanding shares. This development marks a significant update in the company’s recent activities.

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