New Alert! Nuvectis Pharma (Nasdaq: NVCT) Stock...Consider Following Smart Money

Nuvectis Pharma (NASDAQ: NVCT) Consider Following Smart Money 10XProTrader Member, This is Kevin Vander with "10XProTrader", I'm focused on delivering you another shot at a huge winner, with tremendous upside potential. [Nuvectis Pharma, Inc. (NASDAQ: NVCT) ("Nuvectis" or the "Company"), a clinical-stage biopharmaceutical company focused on the development of innovative precision medicines for the treatment of serious conditions of unmet medical need in oncology.]( are developing two drug candidates, NXP800 and NXP900. [Nuvectis Pharma, Inc. (NASDAQ: NVCT)]( Here))]( [NXP800]( is an oral small molecule that exerts its biologic activity through activation of the kinase GCN2. NXP800 is currently investigated in a clinical trial for the treatment of platinum resistant, ARID1a-mutated ovarian cancer, a development program that was granted Fast Track Designation by the U.S. FDA, and for the treatment of cholangiocarcinoma in an investigator-sponsored clinical trial led by Mayo clinic, an indication that was granted Orphan Drug Designation by the U.S. FDA.]( [NXP900]( is an oral small molecule inhibitor of the SRC Family of Kinases (SFK), including SRC and YES1. NXP900 is currently investigated in a Phase 1 dose escalation clinical trial.]( We liked NVCT, assuming catalysts were on the horizon. And yesterday, one hit. [During our routine check of exciting and emerging biotechs we follow, we saw that NVCT scored an Orphan Drug designation for one of its candidates intending to treat AT-rich interactive domain-containing protein 1a (ARID1a)-deficient ovarian cancer, fallopian tube cancer, and primary peritoneal cancer. That can be a massive value driver. Why? Orphan drug designation is only given to drugs that show potential in treating, preventing, or diagnosing rare diseases or conditions affecting fewer than 200,000 people in the United States. That may seem like a small market- but not when you virtually own it.]( [Here is the link.]( [According to the FDA website... When reviewing a request for orphan drug designation, FDA considers the mechanism of action of the drug to determine what distinct disease or condition the drug is intended to treat, diagnose or prevent.Whether a given medical condition constitutes a distinct disease or condition for the purpose of orphan-drug designation depends on a number of factors, assessed cumulatively, including: Pathogenesis of the disease or condition; course of the disease or condition; prognosis of the disease or condition; and resistance to treatment. These factors are analyzed in the context of the specific drug for which designation is requested.]( [While this news alone supports the bullish thesis, there's plenty more to appreciate. Especially the intrinsic value and inherent potential in its development pipeline that may score additional milestones sooner rather than later. Keep in mind that Nuvectis Pharma is not following the biotech pack. This company is meticulously carving out a niche in the oncology field with a precision medicine approach to treat serious unmet medical conditions, particularly in cancers with specific genetic mutations.](  [A compelling pipeline…]( [They are advancing two drug candidates, NXP800 and NXP900, which reflect that focus and intention.](  - NXP800: GCN2 Kinase Activator NXP800 is a GCN2 kinase activator primarily designed to combat ARID1a-mutated tumors. ARID1a mutations are significant because they affect a critical component of the SWI/SNF complex, which regulates gene expression. In tumors with ARID1a mutations, there is an increased reliance on translation pathways, making them vulnerable to NXP800's mechanism of action. Here's how it works:  ·     Mechanism of Action: NXP800 works by inhibiting cap-dependent translation and triggering the integrated stress response (ISR), leading to cancer cell death. This is particularly effective in ARID1a-mutated tumors, which are more dependent on these processes for survival. ·     Clinical Progress: NXP800 has demonstrated substantial preclinical antitumor activity in ARID1a-mutated ovarian and endometrial carcinoma models. This led to the selection of these cancers as target indications in clinical trials. The drug is currently in a Phase 1b trial targeting platinum-resistant, ARID1a-mutated ovarian cancer, with patients being enrolled in two dosing cohorts (50 mg and 75 mg daily). ·      Preliminary Results: Initial data from the Phase 1b trial revealed promising efficacy, with one patient achieving a partial response (PR) that included a complete response (CR) in non-target lymph node disease. The safety profile is being carefully monitored, particularly regarding hematological toxicities such as thrombocytopenia.  - NXP900: YES1/SRC Inhibitor NXP900 is a highly selective YES1/SRC signaling inhibitor, a pathway involved in various squamous cell cancers. The drug's ability to target this pathway makes it a potent candidate for treating cancers with genetic alterations in the Hippo pathway, which are common in squamous cell carcinomas. Here's how it works:  ·     Mechanism of Action: NXP900 shuts down the SRC pathway by inactivating both the scaffold and catalytic domains of SRC-family kinases, which are critical for tumor growth and survival. This action differentiates NXP900 from other multi-kinase inhibitors that only partially inhibit the SRC pathway. ·     Clinical Development: The drug is currently in a Phase 1a clinical trial, testing its safety and efficacy in patients with advanced solid tumors. Preclinical studies showed that NXP900 has significant single-agent activity in squamous cell cancer models and can overcome resistance to treatments like osimertinib and enzalutamide in non-small cell lung cancer (NSCLC) and metastatic castration-resistant prostate cancer (mCRPC), respectively. ·      Market Potential: NXP900 could address significant unmet medical needs in several cancers, including squamous cell carcinoma of the head and neck, esophagus, cervix, NSCLC, and mesothelioma. These cancers often involve alterations in the Hippo pathway or mutations in the NF2 gene, which NXP900 effectively targets.  Impressive value, low float…  Don't underestimate each's potential. The markets certainly don't. Nuvectis Pharma shares are currently trading at $7.02, generating a market cap of over $130 million. The company's capital structure is also shareholder-friendly, with only 18.95 million shares O/S, according to Yahoo! Finance on Wednesday (8/28/24). More notably, with insiders holding a substantial interest, the float is listed as only 6.64 million, which could induce rally mode, especially on news-generated volume that overwhelms the roughly 90k shares daily trading average.  In other words, a small cap, yes. But penny stock biotech? No way. This company has enormous potential, and the structure to maximize it, with much of it expected to start accruing to prior successes in the near term.  Giving that presumption a boost are strategic deals that bolster its development pipeline, including working with leading institutions like the Institute of Cancer Research in the UK and the University of Edinburgh. Its fast-tracked NXP800 trial is being conducted in collaboration with the GOG Foundation, the Mayo Clinic Health System, and ENGOT. More simply, NVCT is hosting prestigious company that can help accelerate ambitions of making significant contributions to cancer therapy, particularly for patients with few existing treatment options.  For NXP800, an update from this trial is expected in the fall of 2024. Additionally, an investigator-sponsored trial of NXP800 for cholangiocarcinoma is also recruiting patients, with results anticipated by the end of the year. This new Orphan Designation, a welcomed and powerful value driver, wasn't part of our expectations.  If you missed some of my recent big "10x Alerts"  I strongly suggest you get ready for our explosive new breakout alert... Because, you don't want to miss another winner with tremendous upside potential! Pay very close attention to your email inbox, your next alert is just around the corner. Yours for greater gains, Kevin Vander Publisher, 10XProTrader.com Investment Research Sources: - [ - [( - [( - [( - [( - [( - [( - [ - [( - [( - [( - [( - [Designating an Orphan Product: Drugs and Biological Products | FDA]( - [Search Orphan Drug Designations and Approvals (fda.gov)]( You are receiving this e-mail as part of your subscription to 10XProTrader. Please do not reply to this e-mail as this address is not monitored. Our Customer Service team is available Monday - Friday between 9:00 AM and 5:00 PM ET. © 2024 10XProTrader.com. All Rights Reserved. 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