Nuvectis Pharma (Nasdaq: NVCT) Nuvectis Pharma Announces Orphan Drug Designation Granted by the FDA

Nuvectis Pharma (NASDAQ: NVCT) Breaking News! Nuvectis Pharma Announces Orphan Drug Designation Granted by the FDA for NXP800 for the Treatment of ARID1a-deficient Ovarian, Fallopian Tube, and Primary Peritoneal Cancers 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))]( [Breadking News!]( [Nuvectis Pharma Announces Orphan Drug Designation Granted by the FDA for NXP800 for the Treatment of ARID1a-deficient Ovarian, Fallopian Tube, and Primary Peritoneal Cancers]( Nuvectis Pharma, Inc. FORT LEE, N.J., Aug. 29, 2024 (GLOBE NEWSWIRE) -- 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, today 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. Ron Bentsur, Chairman and Chief Executive Officer of Nuvectis, commented, “We are very pleased to have received this designation from the FDA for NXP800. The prevalence of ovarian cancer, which is comprised of ovarian, fallopian tube and primary peritoneal cancers, exceeds the 200,000 patient threshold below which drugs may be eligible to receive Orphan Drug Designation in the United States and in ovarian cancer it has been uncommon to receive this designation for the treatment of a subset of the disease. We therefore believe that this Orphan Drug Designation granted by the FDA for NXP800 for the treatment of a subset of ovarian cancer, specifically for patients with an ARID1a deficiency, provides further validation for NXP800's mechanism of action and the target patient population in our ongoing Phase 1b clinical trial in patients with platinum resistant, ARID1a-mutated ovarian cancer. We expect to provide a data update from this study this coming fall.” About Orphan Drug Designation Orphan Drug Designation is granted by the FDA to drugs or biologics intended to treat a rare disease or condition, defined as one that affects fewer than 200,000 people in the United States. Orphan Drug Designation provides certain financial incentives to support clinical development, and the potential for up to seven years of marketing exclusivity for the product for the designated orphan indication in the United States if the product is approved for its designated indication. About Nuvectis Pharma, Inc. Nuvectis Pharma, Inc. is a biopharmaceutical company focused on the development of innovative precision medicines for the treatment of serious conditions of unmet medical need in oncology. The Company is currently developing two clinical-stage drug candidates, NXP800 and NXP900. NXP800 is an oral small molecule GCN2 activator currently in a Phase 1b clinical trial for the treatment for platinum resistant, ARID1a-mutated ovarian carcinoma and in an Investigator-sponsored clinical trial for the treatment of cholangiocarcinoma. The U.S. Food and Drug Administration granted Fast Track Designation to the NXP800 development program in platinum resistant, ARID1a-mutated ovarian carcinoma, and Orphan Drug Designation for the treatment of cholangiocarcinoma and ARID1a-deficient ovarian, fallopian tube, and primary peritoneal cancers. NXP900 is an oral small molecule inhibitor of the SRC Family of Kinases (SFK), including SRC and YES1. NXP900 has a unique mechanism of action in that it inhibits both the catalytic and scaffolding functions of the SRC kinase thereby providing complete shutdown of the signaling pathway. NXP900 is currently in a Phase 1a dose escalation study. Forward Looking Statements Certain statements in this presentation constitute “forward-looking statements” within the meaning of the federal securities laws, which statements 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. Forward-looking statements are based on Nuvectis Pharma, Inc.'s current expectations, estimates, and projections about future events and trends that we believe may affect our business, financial condition, results of operations, prospects, business strategy, and financial needs. The outcome 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 and include statements regarding the potential benefits of the Orphan Drug Designation granted to NXP800, the preclinical and the Phase 1a data generated to date for NXP800 and the clinical expectations for the NXP800 Phase 1b study, including statements regarding NXP800's mechanism of action and its potential ability to become a therapeutic option for the treatment of platinum-resistant, ARID1a-mutated ovarian carcinoma, cholangiocarcinoma, and potentially other cancer indications, and the timing for this study. 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 are subject to market and other conditions and described more fully in the section titled “Risk Factors” in our 2Q 2024 Form 10-Q and our other public filings with the 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 our 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. ---------------------------------------- [Link to the News]( _______________________ [Link to the FDA site]( [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.]( [Nuvectis Pharma, Inc. (NASDAQ: NVCT)Â]( 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.](  [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. Nothing in this email should be considered personalized financial advice. Although our employees may answer your general customer service questions, they are not licensed under securities laws to address your particular inves∙tment situation. N∙o communication by our employees to you should be deemed as personalized financial advice. 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