This section highlights FDA-related milestones and regulatory updates for drugs developed by Nuvectis Pharma (NVCT).
Over the past two years, Nuvectis Pharma has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as
NXP900 and NXP800. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend.
Select a button below to view the list of FDA events for that drug.
NXP900 FDA Regulatory Timeline and Events
NXP900 is a drug developed by Nuvectis Pharma for the following indication: Novel inhibitor of the SRC family of kinases.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- NXP900
- Announced Date:
- March 31, 2026
- Indication:
- Novel inhibitor of the SRC family of kinases
Announcement
Nuvectis Pharma, Inc. announced upcoming presentations for NXP900 at the upcoming 2026 American Association for Cancer Research Meeting (2026 AACR), taking place from April 17th to April 22nd in San Diego, CA.
AI Summary
Nuvectis Pharma, Inc. announced it will present information about its candidate NXP900 at the 2026 American Association for Cancer Research (AACR) Annual Meeting. The conference runs April 17–22, 2026, in San Diego, CA. The company said attendees can expect updates on NXP900 during sessions at the meeting.
The presentations are meant to share scientific and development updates on NXP900, highlighting data and research that could advance understanding of the candidate. Nuvectis aims to communicate progress to researchers, clinicians, and investors attending AACR and to place its work in the broader context of ongoing cancer science.
For more details on Nuvectis and to find specific presentation times or materials, visit the company website at https://nuvectis.com/.
Read Announcement- Drug:
- NXP900
- Announced Date:
- December 17, 2025
- Indication:
- Novel inhibitor of the SRC family of kinases
Announcement
Nuvectis Pharma, Inc. announced the initiation of the Phase 1b study of NXP900 in combination with osimertinib in patients with EGFRmut+ NSCLC.
AI Summary
Nuvectis Pharma announced the start of a Phase 1b study testing NXP900 together with osimertinib (Tagrisso) in patients with EGFR-mutant non–small cell lung cancer (EGFRmut+ NSCLC). NXP900 is an oral small molecule that blocks the SRC and YES1 kinases. This combination is being studied to see if it can help patients who have developed or may develop resistance to EGFR-targeted therapy.
Scientists have shown that activation of the SRC/YES1 pathway can cause resistance to EGFR inhibitors like osimertinib. Osimertinib is a widely used third‑generation EGFR inhibitor. By adding NXP900, the company aims to shut down that resistance pathway and improve outcomes with an all-oral regimen.
The trial enrolls patients with unresectable, metastatic, or locally advanced EGFRmut+ NSCLC who previously responded to osimertinib. Patients with known osimertinib-resistance EGFR mutations or other non‑EGFR oncogenic drivers are excluded. Nuvectis completed Phase 1a testing of NXP900 and expects multiple data readouts in 2026.
Read Announcement- Drug:
- NXP900
- Announced Date:
- November 25, 2025
- Indication:
- Novel inhibitor of the SRC family of kinases
Announcement
Nuvectis Pharma, Inc announced that the Company will host a virtual Key Opinion Leader Meeting on Tuesday, December 2, 2025 at 8:00 AM ET to discuss the NXP900 Phase 1b Program in Advanced Solid Tumors, including the combination with osimertinib in non-small cell lung cancer..
AI Summary
Nuvectis Pharma will hold a virtual Key Opinion Leader meeting on Tuesday, December 2, 2025 at 8:00 AM ET to discuss the NXP900 Phase 1b program in advanced solid tumors, including the planned combination with osimertinib in non‑small cell lung cancer. Speakers Alexander Spira, MD, PhD, and Professor Asier Uncita‑Broceta will join company management to review key preclinical and clinical data, outline the strategy for both monotherapy and combination arms, and answer live questions from attendees.
NXP900 is an oral, selective type 1.5 SRC/YES1 kinase inhibitor designed to block both catalytic and scaffolding functions of the SRC pathway without causing paradoxical activation. The drug completed a Phase 1a dose‑escalation study and is in a Phase 1b single‑agent dose expansion. Drug‑drug interaction data support starting the Phase 1b combination arm, anticipated by year‑end 2025. A replay will be available on the Nuvectis investors website and registration is through the company site.
Read Announcement- Drug:
- NXP900
- Announced Date:
- October 27, 2025
- Indication:
- Novel inhibitor of the SRC family of kinases
Announcement
Nuvectis Pharma, Inc. today provided highlights for NXP900 poster presentations that took place last week at the 2025 AACR-NCI-EORTC International Conference on Molecular Targets and Cancer Therapeutics in Boston, MA.
AI Summary
Nuvectis Pharma summarized results from NXP900 poster sessions at the 2025 AACR-NCI-EORTC conference in Boston. CEO Ron Bentsur said Phase 1a dose escalation and drug-drug interaction studies are key steps toward making NXP900 a best-in-class SRC/YES1 inhibitor. In 33 advanced cancer patients who received 20–300 mg daily, safety was acceptable, with mostly mild diarrhea, fatigue and nausea. At doses ≥150 mg/day, the drug produced strong and lasting pharmacodynamic responses.
A healthy volunteer study showed NXP900 did not induce major CYP450 enzymes, supporting future combination therapies. Preclinical findings revealed NXP900 blocks YAP1 nuclear localization, inhibits tumor growth in FAT1-mutant xenograft models, and support a biomarker-driven patient selection strategy in the ongoing Phase 1b program. With Phase 1b monotherapy underway, Nuvectis plans to begin combination studies soon and share data updates as the program advances.
Read Announcement- Drug:
- NXP900
- Announced Date:
- October 16, 2025
- Indication:
- Novel inhibitor of the SRC family of kinases
Announcement
Nuvectis Pharma, Inc announced upcoming poster presentations for NXP900 at the 2025 AACR-NCI-EORTC International Conference on Molecular Targets and Cancer Therapeutics taking place October 22-26, 2025 in Boston, MA.
AI Summary
Nuvectis Pharma, Inc. announced that it will present data on its lead candidate, NXP900, at the 2025 AACR-NCI-EORTC International Conference on Molecular Targets and Cancer Therapeutics. The meeting takes place October 22–26, 2025, in Boston, MA.
On October 23, 2025, from 12:30–4:00 pm ET (Poster Session A), Gerald Falchook, MD (Sarah Cannon Research Institute, Denver) will present “Clinical safety, pharmacokinetics, pharmacodynamics, and cytochrome P450 interactions for the SRC/YES1 kinase inhibitor NXP900” (Poster LB-A019).
At the same session and time, Asier Unciti-Broceta (University of Edinburgh) will present “NXP900, a novel YES1/SRC kinase inhibitor currently in clinical development, potently inhibits tumor growth in FAT1 mutated xenograft models” (Poster A099).
NXP900 is an oral small-molecule inhibitor of the SRC family kinases, including SRC and YES1. It has completed a Phase 1a dose escalation study and is advancing through Phase 1b trials.
Read Announcement- Drug:
- NXP900
- Announced Date:
- August 11, 2025
- Indication:
- Novel inhibitor of the SRC family of kinases
Announcement
Nuvectis Pharma, Inc. announced the initiation of the Phase 1b program for NXP900.
AI Summary
Nuvectis Pharma, Inc. announced the initiation of its Phase 1b clinical program for NXP900, an oral small molecule that inhibits SRC family kinases. This study follows a successful Phase 1a dose‐escalation and drug–drug interaction trial. The program has two parts: a single‐agent arm testing NXP900 in patients with advanced solid tumors carrying YES1 amplification, FAT1 or NF2 mutations, or other Hippo pathway alterations; and a combination arm, set to begin later this year, evaluating NXP900 alongside EGFR and ALK inhibitors in non‐small cell lung cancer (NSCLC) patients who have developed resistance to those therapies.
The single‐agent segment is already underway, targeting tumors selected for relevant genetic changes and scientific rationale. By assessing NXP900 both alone and with established lung cancer drugs, Nuvectis aims to explore its therapeutic potential across multiple tumor types.
To review the Phase 1b design and discuss the market opportunity for NXP900, Nuvectis will hold a conference call on Tuesday, August 12 at 8:30 AM ET.
Read Announcement- Drug:
- NXP900
- Announced Date:
- April 29, 2025
- Indication:
- Novel inhibitor of the SRC family of kinases
Announcement
Nuvectis Pharma, Inc. today provided poster presentation highlights for NXP900 from the 2025 American Association for Cancer Research Meeting (2025 AACR).
AI Summary
Nuvectis Pharma, Inc. shared new poster presentation highlights for its experimental drug NXP900 at the 2025 American Association for Cancer Research Meeting (AACR). The posters detailed data from the Phase 1a dose-escalation study, where advanced cancer patients received NXP900 at doses ranging from 20 to 250 mg/day. Results showed that the drug produced robust pharmacodynamic responses with increasing exposure and an encouraging safety profile, as no dose-limiting toxicity was observed even at the highest doses. The findings support further clinical evaluation of NXP900 both as a single agent in biomarker-selected cancers and in combination with established therapies to tackle treatment resistance in non-small cell lung cancer. These insights pave the way for the Phase 1b program aimed at targeting specific gene amplifications and pathway alterations in cancer patients.
Read Announcement- Drug:
- NXP900
- Announced Date:
- March 26, 2025
- Indication:
- Novel inhibitor of the SRC family of kinases
Announcement
Nuvectis Pharma, Inc announced upcoming presentations for NXP900 at the upcoming 2025 American Association for Cancer Research Meeting (2025 AACR), taking place from April 25th to April 30th in Chicago, IL.
AI Summary
Nuvectis Pharma, Inc. announced that it will present new data on its investigational drug NXP900 at the 2025 American Association for Cancer Research (AACR) Meeting in Chicago, IL, from April 25th to April 30th, 2025. The company is set to share findings from its Phase I clinical trial of NXP900, a first-in-class SRC family kinase inhibitor, in patients with advanced solid tumors. Among the presentations are studies on overcoming osimertinib resistance in non-small cell lung cancer (NSCLC) and exploring NXP900’s synergy with ALK inhibitors in ALK-resistant NSCLC models. Additional sessions will cover how NXP900 affects YAP1 signaling in NSCLC and its impact on endocrine therapy-resistant luminal A breast cancer cells. These presentations highlight Nuvectis Pharma’s commitment to advancing precision oncology with innovative targeted therapies.
Read Announcement- Drug:
- NXP900
- Announced Date:
- March 5, 2025
- Indication:
- Novel inhibitor of the SRC family of kinases
Announcement
Nuvectis Pharma announced that new independent research conducted at the Lerner Research Institute, Cleveland Clinic (at Case Western Reserve University) has demonstrated the superior efficacy of NXP900 when combined with osimertinib (Tagrisso®) in EGFR-mutated non-small cell lung cancer (NSCLC) models.
AI Summary
Nuvectis Pharma announced new independent research from the Lerner Research Institute at the Cleveland Clinic (affiliated with Case Western Reserve University). This study showed that combining NXP900 with osimertinib (Tagrisso®) significantly improves treatment outcomes in EGFR-mutated non-small cell lung cancer (NSCLC) models. The research found that the combination therapy not only slowed cancer cell growth but also increased cancer cell death more effectively than osimertinib alone. The study, published in the journal Molecular Cancer Research, supports earlier findings that NXP900 helps overcome resistance mechanisms that reduce the effectiveness of standard EGFR inhibitors. These promising results offer hope for improving treatment options for patients with EGFR-mutated lung cancer, a field where osimertinib is already a key part of the treatment but faces issues with resistance.
Read Announcement- Drug:
- NXP900
- Announced Date:
- March 4, 2025
- Indication:
- Novel inhibitor of the SRC family of kinases
Announcement
Nuvectis Pharma, Inc. announced a new publication from the laboratory of Prof. Ruth Keri, (Cleveland Clinic, Cleveland, OH, USA) demonstrating that the combination of NXP900 and osimertinib (the active ingredient in Tagrisso®) was superior to single agent osimertinib in vivo in a model of Epidermal Growth Factor Receptor(EGFR) mutated non-small cell lung cancer (NSCLC), and led to decreased cell proliferation and increased apoptosis in vitro.
AI Summary
Nuvectis Pharma, Inc. announced a new publication from the laboratory of Prof. Ruth Keri at the Cleveland Clinic, which highlights promising results for non-small cell lung cancer (NSCLC) treatment. The study found that combining NXP900 with osimertinib—the key ingredient in Tagrisso®—was more effective than using osimertinib alone in an in vivo model of EGFR-mutated NSCLC. In addition, the combination led to decreased cell proliferation and increased apoptosis in vitro. These findings support the mechanistic rationale for pairing NXP900 with EGFR inhibitors to treat cancers with EGFR mutations and reinforce earlier data showing that NXP900 can reverse resistance to osimertinib in resistant cell lines. The research, published in Molecular Cancer Research, builds a strong case for further clinical exploration of this drug combination as a potential treatment option for patients with EGFR-mutated lung cancer.
Read Announcement
NXP800 FDA Regulatory Timeline and Events
NXP800 is a drug developed by Nuvectis Pharma for the following indication: To treat platinum resistant, ARID1a-mutated ovarian carcinoma.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- NXP800
- Announced Date:
- July 31, 2025
- Indication:
- To treat platinum resistant, ARID1a-mutated ovarian carcinoma.
Announcement
Nuvectis Pharma, Inc. today provided the final clinical data update from the Phase 1b study of NXP800 in recurrent, platinum resistant, ARID1a-mutated ovarian cancer and reported on the progress towards the initiation of the Phase 1b program for NXP900.
AI Summary
Nuvectis Pharma reported final data from its Phase 1b study of NXP800 in 13 patients with recurrent, platinum-resistant, ARID1a-mutated ovarian cancer treated at 75 mg/day. Two patients achieved partial responses and three had stable disease. Early thrombocytopenia was managed successfully by switching to an intermittent dosing schedule. While the company will not pursue further development of NXP800 in ovarian cancer, it plans to explore opportunities for this agent in other cancer types, such as endometrial and prostate cancers, where patient characteristics might allow for greater benefit.
Separately, Nuvectis completed a clinical drug-drug interaction study of NXP900 in healthy volunteers and a Phase 1a dose-escalation trial in patients with advanced solid tumors. No dose-limiting toxicities were reached, and pharmacodynamic data showed strong target inhibition at doses ≥150 mg/day. The company expects to launch the Phase 1b program for NXP900 in the coming weeks, evaluating its safety and efficacy both as a single agent and in combination with other anti-cancer therapies.
Read Announcement- Drug:
- NXP800
- Announced Date:
- February 25, 2025
- Indication:
- To treat platinum resistant, ARID1a-mutated ovarian carcinoma.
Announcement
Nuvectis Pharma, Inc. today reported its financial results for the year ended December 31, 2024 and provided an update on recent business progress.
AI Summary
Nuvectis Pharma, Inc. reported its full-year 2024 financial results alongside updates on its recent business progress. The Company posted a net loss of $19 million for the year, with a decrease in both research and development as well as general and administrative expenses compared to 2023. Despite the net loss, Nuvectis highlighted promising progress with its two clinical-stage drug candidates, NXP800 and NXP900. The NXP800 Phase 1b trial, involving patients with platinum-resistant, ARID1a-mutated ovarian cancer, is ongoing with updated results anticipated in the second quarter of 2025. Concurrently, the NXP900 Phase 1a dose escalation study continues to enroll patients, and preparations for its subsequent Phase 1b program are underway, with a planned start in mid-2025.
A successful follow-on offering in February 2025 raised additional funds, extending the Company’s cash runway into 2027, positioning it well for future clinical milestones.
Read Announcement- Drug:
- NXP800
- Announced Date:
- August 29, 2024
- Indication:
- To treat platinum resistant, ARID1a-mutated ovarian carcinoma.
Announcement
Nuvectis Pharma, Inc. announced that NXP800 was granted Orphan Drug Designation by the United States Food and Drug Administration ("FDA") for the treatment of AT-rich interactive domain-containing protein 1a (ARID1a) ARID1a-deficient ovarian, fallopian tube, and primary peritoneal cancers.
AI Summary
Nuvectis Pharma, Inc. announced a major milestone with the U.S. FDA granting Orphan Drug Designation for its lead candidate, NXP800. This designation is specifically for the treatment of ARID1a-deficient ovarian, fallopian tube, and primary peritoneal cancers. The FDA grants this status to drugs that show promise in treating rare conditions affecting fewer than 200,000 individuals in the U.S.
With this designation, NXP800 may benefit from several incentives, including tax credits for clinical trial costs, fee exemptions, and the possibility of up to seven years of market exclusivity after approval. This important recognition supports Nuvectis' mission to develop innovative treatments for patients facing limited options due to genetic mutations in their cancer, marking a promising step forward in addressing challenging oncology needs.
Read Announcement
