FDA Grants Fast Track Designation to Nuvectis Pharma's NXP800 for the Treatment of Platinum-Resistant, ARID1A-Mutated Ovarian Carcinoma
Nuvectis Pharma (NASDAQ: NVCT) announced on December 1, 2022, that the FDA granted Fast Track Designation to its drug candidate NXP800, aimed at treating platinum-resistant, ARID1A-mutated ovarian carcinoma. This designation highlights the drug's potential to meet urgent medical needs in oncology. CEO Ron Bentsur expressed confidence in NXP800's ability to improve patient outcomes. Nuvectis is also developing NXP900, a SRC/YES1 kinase inhibitor, currently in preclinical studies. Fast Track allows for expedited drug development and review for serious conditions.
- FDA granted Fast Track Designation to NXP800, indicating potential for expedited development.
- NXP800 targets a significant medical need in platinum-resistant, ARID1A-mutated ovarian carcinoma.
- None.
Fort Lee, NJ, Dec. 01, 2022 (GLOBE NEWSWIRE) -- Nuvectis Pharma, Inc (NASDAQ: NVCT) (“Nuvectis” or the “Company”), a biopharmaceutical company focused on the development of innovative precision medicines for the treatment of serious conditions of unmet medical need in oncology, today announced that the U.S. Food and Drug Administration (the “FDA”) has granted Fast Track Designation to NXP800 for the treatment of platinum-resistant, ARID1A-mutated ovarian carcinoma.
“We are very pleased with the FDA’s decision to grant Fast Track Designation to NXP800 for the treatment of platinum-resistant, ARID1A-mutated ovarian carcinoma, which underscores the potential of NXP800 to address this serious condition of unmet medical need,” said Ron Bentsur, Chairman and Chief Executive Officer of Nuvectis. Mr. Bentsur added, “We remain focused on our mission of developing novel treatments for severe oncological conditions, and we believe that with our pipeline of targeted-therapy drug candidates and experienced development team we are well positioned to achieve our goals."
About Fast Track Designation
Fast Track is a process designed to facilitate the development, and expedite the review of drugs to treat serious conditions and fill an unmet medical need. The purpose is to get important new drugs to the patient earlier. Clinical programs conducted under Fast Track Designation may be eligible to apply for Accelerated Approval and Priority Review if relevant criteria are met.
About Nuvectis Pharma, Inc.
Nuvectis Pharma, Inc. is a biopharmaceutical company focused on the development of innovative precision medicines for serious conditions of unmet medical need in oncology. The Company is currently developing two drug candidates: NXP800, a clinical-stage HSF1 pathway inhibitor currently in a Phase 1a dose-escalation study in patients with advanced solid tumors, and NXP900, a novel SRC/YES1 kinase inhibitor currently in preclinical development with IND-enabling studies ongoing.
Forward Looking Statements
This press release contains "forward-looking statements" within the meaning of the federal securities laws, which statements are subject to substantial risks and uncertainties. All statements, other than statements of historical fact, contained in this press release are forward-looking statements. Forward-looking statements contained in this press release may be identified by the use of words such as "anticipate," "believe," "contemplate," "could," "estimate," "expect," "intend," "seek," "may," "might," "plan," "potential," "predict," "project," "target," "aim," "should," "will," "would," or the negative of these words or other similar expressions, although not all forward-looking statements contain these words. Forward-looking statements are based on Nuvectis Pharma, Inc.’s current expectations, estimates, and projections about future events and trends that we believe may affect our business, financial condition, results of operations, prospects, business strategy, and financial needs. These forward-looking statements include, but are not limited to, statements regarding any potential benefits of the Fast Track Designation for NXP800 and NXP800's potential to improve clinical outcomes in platinum-resistant, ARID1A-mutated Ovarian Carcinoma or any other form of cancer. The outcome of the events described in these forward-looking statements are subject to inherent uncertainties, risks, assumptions, market and other conditions, and other factors that are difficult to predict and include expectations regarding the the preclinical and clinical expectations for NXP800 and NXP900, including the results and completion of the Phase 1a dose-escalation study of NXP800 and the expected commencement of the Phase 1b study for NXP800, as well as the results and completion of the NXP900 IND-enabling studies and the expected submission and potential acceptance of an IND, or an equivalent application, for NXP900. Further, certain forward-looking statements are based on assumptions as to future events that may not prove to be accurate. These and other risks and uncertainties are subject to market and other conditions and described more fully in the section titled "Risk Factors" in the 2021 Form 10-K filed with the Securities and Exchange Commission (“SEC”). However, these risks are not exhaustive and new risks and uncertainties emerge from time to time and it is not possible for us to predict all risks and uncertainties that could have an impact on the forward-looking statements contained in this press release or other filings with the SEC. Any forward-looking statements contained in in this press release speak only as of the date of this press release. We expressly disclaim any obligation or undertaking to release publicly any updates or revisions to any forward-looking statements contained herein to reflect any change in our expectations or any changes in events, conditions or circumstances on which any such statement is based, except as may be required by law, and we claim the protection of the safe harbor for forward-looking statements contained in the Private Securities Litigation Reform Act of 1995.
Company Contact:
Ron Bentsur
Chairman, Chief Executive Officer and President
Media Relations Contact:
Christopher M. Calabrese
LifeSci Advisors
Tel: 917-680-5608
ccalabrese@lifesciadvisors.com
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