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
NXP800 and NXP900. 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.
NXP800 FDA Regulatory 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:
- 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
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:
- 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
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