Nuvectis Announces NXP200 Granted Breakthrough Therapy Designation in China for BRAF V600-Mutant, Recurrent or Progressive, High-Grade Glioma
Nuvectis holds NXP200 rights outside Greater China and plans a U.S. investigational new drug submission.
Rhea-AI Summary
Nuvectis Pharma (NVCT) announced NXP200 received Breakthrough Therapy Designation in China for BRAF V600-mutant recurrent or progressive high-grade glioma. China’s Center for Drug Evaluation granted the designation to the investigational oral, brain-penetrant BRAF inhibitor, also known as HSK42360.
Nuvectis in-licensed exclusive worldwide rights to NXP200 outside Greater China from Haisco Pharmaceutical Group in June 2026. The company reports single-agent clinical activity in primary central nervous system tumors and other cancers, including in patients previously treated with BRAF inhibitors. Nuvectis plans a U.S. investigational new drug submission in the fourth quarter of 2026.
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News Market Reaction – NVCT
On Sep 24, the day this news came out, NVCT closed 2.99% above the previous close. Relative volume reached 2.4x the daily average during tracking.
Data tracked by StockTitan Argus for the Sep 24 session.
Key Figures
- U.S. IND submission target
- Q4 2026
- NXP200
Key Terms
breakthrough therapy designation regulatory
braf inhibitor medical
brain-penetrant medical
ind submission regulatory
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Fort Lee, NJ, Sept. 24, 2026 (GLOBE NEWSWIRE) -- Nuvectis Pharma, Inc. (NASDAQ: NVCT) ("Nuvectis" or the "Company"), a clinical-stage biopharmaceutical company focused on the development of innovative therapies for the treatment of complement-related conditions and oncology, announced today that NXP200 (HSK42360), an oral, brain-penetrant, paradox-breaker BRAF inhibitor, has been granted Breakthrough Therapy Designation (BTD) for the treatment of patients with BRAF V600-mutant, recurrent or progressive high-grade glioma by China’s Center for Drug Evaluation (CDE).
NXP200 is a paradox-breaking BRAF inhibitor designed to block the BRAF pathway without triggering paradoxical activation that is seen with first-generation BRAF inhibitors. To date, NXP200 has demonstrated single-agent clinical activity, including in heavily pre-treated patients as well as in patients previously treated with BRAF inhibitors, against primary central nervous system (CNS) tumors and other tumor types including non-small cell lung, colorectal and papillary thyroid cancers.
In June 2026, Nuvectis in-licensed exclusive worldwide, ex-Greater China rights to NXP200 from Haisco Pharmaceutical Group.
Ron Bentsur, Chairman and Chief Executive Officer of Nuvectis, commented, “We congratulate our partner Haisco for achieving this significant regulatory milestone, which is further testament to its tremendous strategic and operational capabilities. The CDE’s granting of Breakthrough Therapy Designation underscores the compelling clinical activity observed to date with NXP200 in patients with recurrent or progressive BRAF V600-mutant high-grade glioma. In parallel, we continue to advance NXP200 toward a U.S. IND submission in the fourth quarter of 2026.”
About Nuvectis Pharma, Inc.
Nuvectis Pharma, Inc. is a clinical stage biopharmaceutical company focused on the development of innovative therapies for the treatment of immune complement-related conditions and oncology. The Company’s pipeline includes ciprocopan (NXP100), a complement Factor B inhibitor in development for the treatment of complement-mediated diseases, and the oncology drug candidates NXP200 and NXP900, in development for the treatment of advanced cancers.
The company’s lead drug candidate is ciprocopan, a once-a-day Factor B inhibitor, with best-in-class potential, recently approved in China for the treatment of PNH patients previously untreated with complement inhibitors.
NXP200 is an oral, brain-penetrant, paradox-breaker BRAF inhibitor for the treatment of BRAF V600X-mutated and Class II/III non-V600-mutated solid tumor malignancies, with best-in-class potential.
NXP900 is an oral small molecule inhibitor of the SRC family kinases, including SRC and YES1.
Forward Looking Statements
This press release contains “forward-looking statements” within the meaning of the U.S. federal securities laws, which 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. These forward-looking statements include, but are not limited to, statements regarding future events, including statements about the approvability and market potential of our pipeline products. Forward looking statements are based on Nuvectis’ current expectations, estimates, and projections and past interpretations of data and information available, including preclinical and clinical safety, pharmacokinetics, pharmacodynamics, and efficacy data generated to date for NXP200 and the clinical and regulatory implications of a Breakthrough Therapy Designation for NXP200 in China. The outcomes 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. 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 may also be subject to market and other conditions and described more fully in the section titled "Risk Factors" in Nuvectis’ second quarter 2026 Form 10-Q and Nuvectis’ other public filings with the U.S. 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 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 Nuvectis’ 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
rbentsur@nuvectis.com
Media Relations Contact
Kevin Gardner
LifeSci Advisors
kgardner@lifesciadvisors.com
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