(Nasdaq: NVCT) Orphan Drug Designation Granted by the FDA for NXP800 for the Treatment of deficient Ovarian Cancers

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 FDR Member, BREAKING NEWS OUT THIS MORNING!   [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](  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.”  An age-old adage has led us to this company. Just three words: FOLLOW THE MONEY. It's been a proven strategy not only for passive investors but also for savvy ones who like to move quickly based on credible data and others' due diligence. There's nothing wrong with trusting others' work or actions. Face it, if investors simply followed Warren Buffet's strategy of buying quality, following insiders closely, and having patience over an investment lifetime, this world would have many more billionaires.  Unfortunately, while many meet two of those criteria, most lack the most important one—patience. That's okay, Primetimers. While we embrace the practice of allowing investments to mature, there is also a time to trade the momentum, especially when presented with an investment opportunity where potentially enormous value may be imminently unleashed. Nuvectis Pharma, Inc. (NASDAQ: NVCT) may be presenting precisely that proposition.   Insiders are scooping up shares…  On this one, we appreciate the potential in both trading camps- long-term and short-term. And we're no strangers to NVCT. This one has been on our radar after news hit about impressive levels of insider buying. Like many, we view that as one of the most positive signs a company is on the precipice of delivering value. We like it more when these insiders start to chase that investment.  Face it, no one invests to lose money; they invest for profit. And insiders are no different. The one big difference separating the insiders from common shareholders is that their window of opportunity is often limited, causing them to purchase shares before data is public or immediately after. The latter isn't ideal, especially if the company's stock races higher on their update.  That's precisely why we paid attention to NVCT insider purchases made over the past few quarters. The largest single purchase of NVCT stock was made by Co-Founder Ron Bentsur, who purchased about $51,000 worth of shares at $10.29 per share. Here's the interesting part of that decision: He purchased those shares when the stock was trading at just $6.97. By paying considerably more, it's fair to conclude he was optimistic about NVCT's future. He wasn't the only one.  Also, over the past twelve months, other Nuvectis Pharma insiders have been committed to buying, not selling. They acquired shares at an average price of roughly $9.18, still higher and indeed an optimistic vote of confidence no matter the then-current price. While they may not have traded on non-public trial data, they likely did on expectations. Check those transactions here.  Milestones reached, others in the crosshairs…  Members, 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.  That could be the case here. Remember, these designations aren't free passes. Orphan Drug designations are earned, with the FDA using them to incentivize developing orphan drugs by providing them with financial benefits, tax credits, exemption from the roughly $3 million new drug fee, and, most importantly, market exclusivity for seven years to protect their competitive and marketing advantage.  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. 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.  Members, you won't wait long for updates, either. 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. Don't rule out announcements before those targets. This new Orphan Designation, a welcomed and powerful value driver, wasn't part of our expectations.  We have been focused on insider buying and the progression of its two leading drug candidates, which we were due for an update. Moreover, we recognize that with $18.1 million in cash and equivalents on June 30th, the cash runway should extend well into 2025. That means that the expected good news can remain accretive. More importantly, if partnerships become a consideration, Nuvectis can bargain from a position of strength.  An easy strategy to follow…  Members, all of that leads us back to the original thesis- FOLLOW THE MONEY. With insiders purchasing at above-market prices, a pipeline that is getting value recognition from the FDA, an ample cash war chest to fund its operations, and collaborations with leading institutions, Nuvectis Pharma makes that an easy strategy to follow.  Better still, for those looking to exploit the short-term potential and those with the patience to watch a pipeline mature to meet long-term expectations, Nuvectis Pharma presents an equally compelling proposition. In other words, this company may present the ultimate win-win proposition regarding individual investment time horizons. To Your Trading Success, Michael Reece Editor, Financial Driven Research Sources: - [ - [( - [( - [( - [( - [( - [( - [ - [( - [( - [( - [( © 2024 Financial Driven Research, All Rights Reserved. Financial Driven Research (“FDR” or “Company”) is a financial publisher that does not offer any personal financial advice or advocate the purchase or sale of any security or inves∙tment for any specific individual. FDR full disclosure is to be read and fully understood before using FDR website or joining FDR email or sms list. By viewing FDR website and/or reading FDR email or sms list you are agreeing to FDR full disclosure This publication may contain information regarding inves∙tment ideas and third-party ratings regarding specific securities. We hold n∙o inves∙tment licenses and are thus neither licensed nor qualified to provide inves∙tment adv∙ice. 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