Nuvectis Reports Positive Data from NXP200 Phase 1b Study Demonstrating Durable Responses, Including Complete Responses, in BRAF V600-mutated Recurrent or Progressive Gliomas

NXP200 received China’s Breakthrough Therapy Designation in September 2026 for recurrent or progressive BRAF V600-mutated high-grade glioma.

Rhea-AI Summary

Nuvectis Pharma (NVCT) reported Phase 1b NXP200 responses in patients with recurrent or progressive BRAF V600-mutated gliomas.

At the May 4, 2026 cutoff, 27 patients were efficacy-evaluable. Objective response rates were 40.0% in 20 high-grade and 42.9% in seven low-grade glioma patients, using RANO 2.0 brain-tumor response criteria. High-grade patients had three complete responses, one preliminary; low-grade patients had one confirmed complete response. Median response duration was 6.97 months in high-grade glioma and had not been reached in low-grade glioma. Median overall survival was 17.15 months and not reached, respectively.

Among 28 safety-evaluable patients, 14.3% had Grade 3 or higher treatment-related adverse events; none caused discontinuation or death. Nuvectis expects to submit a U.S. investigational new drug application for NXP200 by year-end 2026.

16 points · 0 major

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Hollow bars mark forward-looking points. How the balance works

Positive

• Moderate pointHigh-grade glioma response rate was 40.0% (8/20), including three complete responses, one preliminary.
• Moderate pointLow-grade glioma response rate was 42.9% (3/7), including one confirmed complete response.
• Moderate pointExclusive worldwide rights outside Greater China to NXP200 were licensed from Haisco in June 2026.
• Minor pointTumor reduction exceeding 80% occurred in 87.5% (7/8) of high-grade glioma responders.
• Minor pointTumor reduction exceeding 80% occurred in 66.7% (2/3) of low-grade glioma responders.

11 minor points

• Minor pointThree patients previously treated with BRAF inhibitors had two partial responses and one stable disease.
• Minor pointTumor reduction occurred in 81.5% (22/27) of efficacy-evaluable patients.
• Minor pointDisease control rate was 85.2% (23/27), encompassing responses and stable disease.
• Minor pointHigh-grade glioma median response duration was 6.97 months.
• Minor pointLow-grade glioma median response duration had not been reached.
• Minor pointHigh-grade glioma median overall survival was 17.15 months; 12-month survival was 95%.
• Minor pointLow-grade glioma median overall survival had not been reached; 12-month survival was 100%.
• Minor pointNo treatment-related adverse event caused treatment discontinuation or death.
• Minor pointChina Breakthrough Therapy Designation was granted in September 2026 for BRAF V600-mutated recurrent or progressive high-grade glioma.
• Minor pointCDE Starlight Program selection occurred in April 2026 for pediatric BRAF V600-mutated recurrent or progressive glioma.
• Minor point. Forward-looking: it has not happened yet and may not happen.U.S. investigational new drug application submission remains targeted by Nuvectis for year-end 2026.

Negative

• Minor pointGrade 3 or higher treatment-related adverse events occurred in 14.3% of 28 safety-evaluable patients.
• Minor pointOne serious adverse event, increased intracranial pressure, was reported and was unrelated to treatment.

News Explained

Nuvectis presented expanded results from its ongoing Phase 1b NXP200 study; among responders, 7 of 8 high-grade and 2 of 3 low-grade patients had tumor reductions above 80%, while the three patients previously treated with a BRAF inhibitor had two partial responses and one stable disease.

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Key Figures

High-grade glioma objective response rate: 40.0% (8/20) Low-grade glioma objective response rate: 42.9% (3/7) Deep responses in high-grade glioma responders: 87.5% (7/8) +5 more

High-grade glioma objective response rate

40.0% (8/20)

Phase 1b study; includes 3 complete responses

Low-grade glioma objective response rate

42.9% (3/7)

Phase 1b study; includes 1 confirmed complete response

Deep responses in high-grade glioma responders

87.5% (7/8)

Tumor burden reduction greater than 80%

Deep responses in low-grade glioma responders

66.7% (2/3)

Tumor burden reduction greater than 80%

Disease control rate

85.2% (23/27)

Objective response rate plus stable disease

Median duration of response

6.97 months

High-grade glioma cohort

Median overall survival

17.15 months

High-grade glioma cohort

Grade 3 or higher treatment-related adverse events

14.3%

Among 28 safety-evaluable patients

Key Terms

objective response rate, partial response, disease control rate, adverse event

4 terms

objective response rate medical

"The objective response rate (ORR) based on Response Assessment in Neuro-Oncology"

The objective response rate (ORR) is the percentage of patients in a clinical trial whose tumors measurably shrink or disappear according to preset rules. Investors use it as a quick, objective signal of a drug’s ability to produce a clear treatment effect—like counting how many plants visibly respond after applying a new fertilizer—and higher ORR can improve odds of regulatory approval, commercial success, and company valuation.

partial response medical

"two achieved a Partial Response (PR) and one had Stable Disease (SD)"

A partial response is a clinical outcome where a treatment produces a clear, measurable improvement in a disease — for example a substantial shrinkage of a tumor or reduction in symptom measures — but does not eliminate the disease entirely. For investors it signals meaningful efficacy that can support regulatory progress, further trials, or commercial potential, like seeing a product gain market traction even though it hasn’t achieved a complete cure.

disease control rate medical

"the Disease Control Rate (ORR plus SD) was 85.2% (23/27)"

The disease control rate is the share of patients in a clinical trial whose cancer or condition either shrinks or stops getting worse for a specified period after treatment. Think of it like the percentage of people for whom a treatment hits pause or nudges back the problem rather than letting it progress; higher rates suggest the therapy can meaningfully limit disease, which matters to investors assessing a drug’s potential efficacy and commercial value.

adverse event medical

"14.3% experienced a Grade 3 or higher treatment-related adverse event"

An adverse event is any unwanted or harmful medical occurrence experienced by a person during a clinical trial or after using a product, whether or not it is caused by the treatment. Investors watch these reports because they can signal safety problems that delay approvals, trigger additional testing, reduce sales, or harm a company’s reputation — similar to how a series of car breakdowns can cut value and future sales for an automaker.

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• Single-agent NXP200 was administered to 27 patients with recurrent or progressive gliomas (20 with high-grade and 7 with low-grade).
• The objective response rate (ORR) based on Response Assessment in Neuro-Oncology criteria (RANO) 2.0 was 40.0% (8/20) in high-grade glioma, including 3 Complete Responses (CRs), and 42.9% (3/7) in low-grade glioma, including 1 CR.
• Deep responses (>80% tumor burden reduction) were reported in 87.5% (7/8) of responders with high-grade glioma and 66.7% (2/3) of responders with low-grade glioma.
• Of the three patients previously treated with a BRAF inhibitor, two achieved a Partial Response (PR) and one had Stable Disease (SD).
• NXP200 demonstrated a manageable safety profile.

Fort Lee, NJ, Oct. 26, 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, today provided highlights from the oral presentation of positive, expanded data from the Phase 1b study for NXP200, a second-generation, paradox-breaker BRAF inhibitor, in patients with recurrent or progressive BRAF V600-mutated gliomas at the 2026 European Society for Medical Oncology (ESMO) Congress taking place in Madrid, Spain.

Oral Presentation Highlights

• As of the May 4, 2026 cutoff, 27 efficacy-evaluable patients with recurrent or progressive BRAF V600 glioma were treated with NXP200 monotherapy, including 20 patients with high-grade glioma and 7 with low-grade glioma.
• Treatment with NXP200 resulted in an ORR of 40.0% in the high-grade glioma cohort, including 3 CRs (one preliminary CR) and 42.9%, including one confirmed CR, in the low-grade glioma cohort; responses were assessed based on RANO 2.0 criteria.
• Deep responses (>80% tumor burden reduction) were achieved in 87.5% (7/8) of responders with high-grade glioma and 66.7% (2/3) of responders with low-grade glioma. Notably, among the three patients previously treated with a BRAF inhibitor, two achieved a partial response and one had stable disease. 81.5% (22/27) of patients achieved tumor reduction and the Disease Control Rate (ORR plus SD) was 85.2% (23/27).
• In patients with high-grade glioma, the median duration of response was 6.97 months, and the median overall survival was 17.15 months; in patients with low-grade glioma, the median duration of response and overall survival had not been reached. 12-month survival was 95% and 100% in the high-grade and low-grade glioma cohorts, respectively.
• Among 28 safety-evaluable patients, 14.3% experienced a Grade 3 or higher treatment-related adverse event. One serious adverse event (SAE) was reported (intracranial pressure increased), which was not related to treatment. No treatment-related adverse event resulted in treatment discontinuation or death.
• The Phase 1b study is being conducted by Haisco Pharmaceutical Group in China. In June 2026, Nuvectis in-licensed exclusive worldwide, ex-Greater China rights to NXP200 from Haisco.
• In September 2026, NXP200 was granted Breakthrough Therapy Designation for the treatment of patients with BRAF V600-mutated, recurrent or progressive high-grade glioma by China’s Center for Drug Evaluation (CDE). In April 2026, the project was officially selected as a pilot project under the “Pediatric Anti-tumor Drug R&D Encouragement Pilot Scheme (Starlight Program)” for the indication of pediatric BRAF V600-mutated recurrent or progressive glioma by CDE.
• The presentation is available on Nuvectis’ website at www.nuvectis.com.

Ron Bentsur, Chairman and Chief Executive Officer of Nuvectis, commented, “We congratulate our partner Haisco on these robust results with NXP200. The rate and durability of the responses reported with single-agent NXP200 in patients with recurrent or progressive gliomas are very encouraging, given the depth of the observed responses, which include CRs and PRs with >80% tumor burden reduction, together with the ability to induce responses in patients previously treated with a BRAF inhibitor while maintaining a manageable safety profile. We are excited about the emerging clinical profile of NXP200, which demonstrates the potential of NXP200 to become a differentiated, best-in-class, second-generation, paradox-breaker BRAF inhibitor. We look forward to further updates from the ongoing Phase 1b program, including in additional tumor types, and we remain on track to submit a U.S. IND for NXP200 by the end of this year.”

About NXP200

NXP200 is an oral paradox-breaking (second generation) 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 progressive gliomas and other tumor types including non-small cell lung, colorectal and papillary thyroid cancers.

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 NXP100 (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, the emerging clinical profile of NXP200, and the potential of NXP200 based on its preliminary results. Forward looking statements are based on Nuvectis’ current expectations, estimates, and projections and past interpretations of data and information available, including pharmacokinetics, pharmacodynamics, and the preliminary clinical safety and efficacy data generated to date for NXP200. 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

FAQ

AI-generated questions and answers. How Rhea-AI works. Not financial advice.

What response rates did Nuvectis report for NXP200 in its Phase 1b glioma study?

NXP200 produced objective response rates of 40.0% (8/20) in high-grade glioma and 42.9% (3/7) in low-grade glioma. The high-grade cohort included three complete responses, one preliminary, while the low-grade cohort included one confirmed complete response. Results were assessed using RANO 2.0 criteria at the May 4, 2026 cutoff.

What safety results did Nuvectis report for NXP200 in Phase 1b?

Among 28 safety-evaluable patients, 14.3% experienced a Grade 3 or higher treatment-related adverse event. No treatment-related adverse event caused discontinuation or death. One serious adverse event, increased intracranial pressure, was reported and was not related to treatment.

Who is conducting the NXP200 Phase 1b study, and what rights does Nuvectis hold?

Haisco Pharmaceutical Group is conducting the Phase 1b study in China, and Nuvectis holds exclusive worldwide rights outside Greater China. Nuvectis licensed those rights to NXP200 from Haisco in June 2026.

Did NXP200 show responses in glioma patients previously treated with BRAF inhibitors?

Among three patients previously treated with a BRAF inhibitor, two achieved a partial response and one had stable disease with NXP200. These patients were part of the Phase 1b study in recurrent or progressive BRAF V600-mutated gliomas.