Celecoxib

PALO ALTO, Calif., Jan. 22, 2025 (GLOBE NEWSWIRE) -- Scilex Holding Company (Nasdaq: SCLX, “Scilex” or “Company”), an innovative revenue-generating company focused on acquiring, developing and commercializing non-opioid pain management products for the treatment of acute and chronic pain and, following the formation of its proposed joint venture with IPMC Company, in neurodegenerative and cardiometabolic disease, today announced that the U.S. FDA has acknowledged the submission of our Supplemental New Drug Application (SNDA) for ELYXYB® in acute pain indication. For more information on Scilex Holding Company, refer to www.scilexholding.com. For more information on Semnur Pharmaceuticals, Inc., refer to www.semnurpharma.com. For more information on Scilex Holding Company Sustainability Report, refer to www.scilexholding.com/investors/sustainability. For more information on ZTlido® including Full Prescribing Information, refer to www.ztlido.com. For more information on ELYXYB®, including Full Prescribing Information, refer to www.elyxyb.com. For more information on Gloperba®, including Full Prescribing Information, refer to www.gloperba.com. https://www.facebook.com/scilex.pharm https://www.linkedin.com/company/scilex-holding-company/ info@scilexholding.com About Scilex Holding Company Scilex Holding Company is an innovative revenue-generating company focused on acquiring, developing and commercializing non-opioid pain management products for the treatment of acute and chronic pain and, following the formation of its proposed joint venture with IPMC Company, in neurodegenerative and cardiometabolic disease. Scilex targets indications with high unmet needs and large market opportunities with non-opioid therapies for the treatment of patients with acute and chronic pain and is dedicated to advancing and improving patient outcomes. Scilex’s commercial products include: (i) ZTlido® (lidocaine topical system) 1.8%, a prescription lidocaine topical product approved by the U.S. Food and Drug Administration (the “FDA”) for the relief of neuropathic pain associated with postherpetic neuralgia, which is a form of post-shingles nerve pain; (ii) ELYXYB®, a potential first-line treatment and the only FDA-approved, ready-to-use oral solution for the acute treatment of migraine, with or without aura, in adults; and (iii) Gloperba®, the first and only liquid oral version of the anti-gout medicine colchicine indicated for the prophylaxis of painful gout flares in adults. In addition, Scilex has three product candidates: (i) SP-102 (10 mg, dexamethasone sodium phosphate viscous gel) (“SEMDEXA™” or “SP-102”), a novel, viscous gel formulation of a widely used corticosteroid for epidural injections to treat lumbosacral radicular pain, or sciatica, for which Scilex has completed a Phase 3 study and was granted Fast Track status from the FDA in 2017; (ii) SP-103 (lidocaine topical system) 5.4%, (“SP-103”), a next-generation, triple-strength formulation of ZTlido, for the treatment of acute pain and for which Scilex has recently completed a Phase 2 trial in acute low back pain. SP-103 has been granted Fast Track status from the FDA in low back pain; and (iii) SP-104 (4.5 mg, low-dose naltrexone hydrochloride delayed-release capsules) (“SP-104”), a novel low-dose delayed-release naltrexone hydrochloride being developed for the treatment of fibromyalgia. Scilex Holding Company is headquartered in Palo Alto, California. About Semnur Pharmaceuticals, Inc. Semnur Pharmaceuticals, Inc. (“Semnur”) is a clinical late-stage specialty pharmaceutical company focused on the development and commercialization of novel non-opioid pain therapies. Semnur’s product candidate, SP-102 (SEMDEXA™), is the first non-opioid novel gel formulation administered epidurally in development for patients with moderate to severe chronic radicular pain/sciatica. Semnur Pharmaceuticals, Inc. is headquartered in Palo Alto, California Forward-Looking Statements This press release and any statements made for and during any presentation or meeting concerning the matters discussed in this press release contain forward-looking statements related to Scilex and its subsidiaries under the safe harbor provisions of Section 21E of the Private Securities Litigation Reform Act of 1995 and are subject to risks and uncertainties that could cause actual results to differ materially from those projected. Forward-looking statements include statements regarding Elyxyb’s potential as an acute pain therapy, whether the FDA approves the sNDA for ELYXYB, ELYXYB’s potential to further expand Scilex’s non-opioid portfolio and its potential to address high unmet needs in treating acute pain, Scilex’s proposed joint venture with IPMC Company and the potential development and commercialization of treatments for obesity, neurodegenerative, cardiometabolic disease. Risks and uncertainties that could cause Scilex’s actual results to differ materially and adversely from those expressed in our forward-looking statements, include, but are not limited to: the risk that the sNDA for ELYXYB may not be approved by the U.S. FDA, Scilex’s ability to consummate a joint venture or any other transaction with IPMC Company and develop and commercialize treatments for obesity, neurodegenerative, cardiometabolic disease; risks associated with the unpredictability of trading markets and whether a market will be established for Scilex’s common stock; general economic, political and business conditions; risks related to COVID-19 (and other similar disruptions); the risk that the potential product candidates that Scilex develops may not progress through clinical development or receive required regulatory approvals within expected timelines or at all; risks relating to uncertainty regarding the regulatory pathway for Scilex’s product candidates; the risk that Scilex will be unable to successfully market or gain market acceptance of its product candidates; the risk that Scilex’s product candidates may not be beneficial to patients or successfully commercialized; the risk that Scilex has overestimated the size of the target patient population, their willingness to try new therapies and the willingness of physicians to prescribe these therapies; risks that the outcome of the trials and studies for SP-102, SP-103 or SP-104 may not be successful or reflect positive outcomes; risks that the prior results of the clinical and investigator-initiated trials of SP-102 (SEMDEXA™), SP-103 or SP-104 may not be replicated; regulatory and intellectual property risks; and other risks and uncertainties indicated from time to time and other risks described in Scilex’s most recent periodic reports filed with the Securities and Exchange Commission, including Scilex’s Annual Report on Form 10-K for the year ended December 31, 2023 and subsequent Quarterly Reports on Form 10-Q that the Company has filed or may file with the SEC, including the risk factors set forth in those filings. Investors are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date of this release, and Scilex undertakes no obligation to update any forward-looking statement in this press release except as may be required by law. Contacts: Investors and MediaScilex Holding Company 960 San Antonio RoadPalo Alto, CA 94303Office: (650) 516-4310 Email: investorrelations@scilexholding.com Website: www.scilexholding.com SEMDEXA™ (SP-102) is a trademark owned by Semnur Pharmaceuticals, Inc., a wholly-owned subsidiary of Scilex Holding Company. A proprietary name review by the FDA is planned. ZTlido® is a registered trademark owned by Scilex Pharmaceuticals Inc., a wholly-owned subsidiary of Scilex Holding Company. Gloperba® is the subject of an exclusive, transferable license to use the registered trademark by Scilex Holding Company. ELYXYB® is a registered trademark owned by Scilex Holding Company. All other trademarks are the property of their respective owners. © 2025 Scilex Holding Company All Rights Reserved.

AUSTIN, Texas--( BUSINESS WIRE )-- Natera, Inc. (NASDAQ: NTRA), a global leader in cell-free DNA and genetic testing, today announced that the first set of abstracts have been released from several studies that will be shared at the American Society of Clinical Oncology’s Gastrointestinal Cancers Symposium (ASCO GI) taking place Jan. 23 – 25, 2025 in San Francisco, CA. BESPOKE CRC Study New data will be presented in an oral presentation on Jan. 25 from BESPOKE CRC, a multicenter, prospective, observational study in colorectal cancer (CRC). The study underscores Signatera’s capability as a prognostic and a predictive biomarker in a cohort of over 1,000 patients wherein post-surgical Signatera-positivity was predictive of inferior outcomes in stage II patients [disease-free survival (DFS) (HR=10.4; p<0.0001), and stage III patients (HR=10.1; p<0.0001)]. 24-month DFS estimates for stages II-III combined were 91.7% for Signatera-negative and 41.4% for Signatera-positive. Signatera-positive patients benefitted from adjuvant treatment while Signatera-negative patients did not, and clearance of ctDNA during and after treatment led to superior DFS outcomes. Additional data from the study will be shared during the symposium illustrating the impact of MRD detection on clinical decision-making. The data show that even in the early days of MRD commercialization, a significant number of oncologists escalated or de-escalated post-surgical chemotherapy plans based on Signatera results, and the vast majority of oncologists found that Signatera results strengthened the treatment plan under consideration. In addition, surveillance with Signatera enabled a high rate of curative-intent surgery among recurrent patients. Readouts in Tissue-Free MRD and Early Cancer Detection Initial results from a clinical performance study on Natera’s novel tissue-free MRD detection test will be presented, where high sensitivity and specificity were observed in patients evaluable for clinical outcomes. The study demonstrated that the tissue-free MRD assay was prognostic, with MRD-positive patients showing inferior recurrence-free survival. The data also showed that the test was predictive, as MRD-positive patients benefited from adjuvant therapy whereas MRD-negative patients did not. In addition, the data showed strong concordance between the tissue-free MRD test and the gold standard Signatera test, with a positive percent agreement of 86% (95% CI:77-93%) and a negative percent agreement of 98% (95% CI: 95-100%). Natera will also present case-control data in early cancer detection, including data from screen-detected colorectal cancer cases from the CIRCULATE study and controls from the PROCEED-CRC study, respectively. The data reports an overall sensitivity of 95% (95% CI: 92-99%) and a specificity of 91% (95% CI: 88-94%). Among patients with stage I disease, sensitivity was 92% overall. Stage-adjusted sensitivity was 91% in screen-detected individuals. “ This data at ASCO GI demonstrates the ongoing strength of Signatera complemented by our exciting innovation pipeline,” said Adham Jurdi, MD, senior medical director in oncology at Natera. “ The results from BESPOKE CRC highlight the potential value of Signatera-based MRD detection for treatment-decision making, with strong findings in clinical utility. Our readouts in early cancer detection and tissue-free MRD offer great promise for expanding Natera’s portfolio to help millions of additional patients with cancer.” Full list of Signatera presentations and activities during ASCO GI Oral Presentations Jan. 25, 1:00 PM PT | Abstract # 15 | Stage II-III Colorectal Cancer (Oral Presentation) Presenter: Purvi K. Shah, MD, MBBS, Virginia Cancer Institute Circulating Tumor DNA for Detection of Molecular Residual Disease (MRD) in Patients (pts) with Stage II/III Colorectal Cancer (CRC): Final Analysis of the BESPOKE CRC sub cohort Jan. 25, 1:00 PM PT | Abstract # LBA14 | Colon Cancer (Oral Presentation) Presenter: Jonathan A. Nowak, MD, PhD, Brigham and Women's Hospital Prognostic and predictive role of circulating tumor DNA (ctDNA) in stage III colon cancer treated with celecoxib: Findings from CALGB (Alliance)/SWOG 80702 P osters Jan. 23, 11:30 AM PT | Abstract # TPS512 | Gastroesophageal adenocarcinoma (Poster) Presenter: Elizabeth Catherine Smyth, MD, Oxford University Hospitals NHS Foundation Trust A single arm phase II trial of trastuzumab deruxtecan in patients with gastroesophageal adenocarcinoma cancer who are ctDNA and HER2 posiative: DECIPHER Jan. 23, 11:30 AM PT | Abstract # 836 | Gastrointestinal cancers (Poster) Presenter: Sakti Chakrabarti, MD, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center Short interval circulating tumor DNA (ctDNA) kinetics as a predictor of tumor response in patients with gastrointestinal (GI) cancer receiving immune checkpoint inhibitor (ICI)-based treatment Jan. 25, 7:00 AM PT | Abstract # 266 | Tissue-free MRD testing (Poster) Presenter: John Paul Y.C. Shen, MD, University of Texas MD Anderson Cancer Center Development of a methylation-based, tissue-agnostic test for the detection of molecular residual disease by circulating tumor DNA Jan. 25, 7:00 AM PT | Abstract # 232 | Early cancer detection: colorectal cancer (Poster) Presenter: Yoshiaki Nakamura, MD, PhD, Department of Gastroenterology and Gastrointestinal Oncology, National Cancer Center Hospital East Performance of a blood-based screening test for the early detection of colorectal cancer Jan. 25, 7:00 AM PT | Abstract # TPS306 | Early cancer detection: Trial in Progress (Poster) Presenter: Sarah Sawyer, PhD, Clinical Trial Operations, Natera, Inc. Austin, TX, USA Trial in progress for a colorectal cancer detection blood test Jan. 25, 7:00 AM PT | Abstract # LBA 22 | Colorectal cancer (Poster) Presenter: Hideaki Bando, MD, National Cancer Center Hospital Japan A Randomized, Double-Blind, Phase III Study Comparing Trifluridine/Tipiracil (FTD/TPI) Versus Placebo in Patients with Molecular Residual Disease Following Curative Resection of Colorectal Cancer (CRC): The ALTAIR Study Jan. 25, 7:00 AM PT | Abstract # 220 | Metastatic colorectal cancer (Poster) Presenter: D.E. van Steijn, MSc, Netherlands Cancer Institute Longitudinal ctDNA measurements for treatment response monitoring in patients with metastatic colorectal cancer undergoing systemic therapy: The ORCA trial Jan. 25, 7:00 AM PT | Abstract # 284 | Locally advanced rectal cancer (Poster) Presenter: Jun Watanabe, MD, PhD, Department of Colorectal Surgery, Kansai Medical University Circulating tumor DNA for predicting complete response to total neoadjuvant therapy in locally advanced rectal cancer: ENSEMBLE-2 Jan 25, 7:00 AM PT | Abstract # 263 | Rectal adenocarcinoma (Poster) Presenter: Seth Felder, MD, H. Lee Moffitt Cancer Center Correlation of mid-chemoradiation ctDNA results and clinical complete response to total neoadjuvant therapy (TNT) for locally advanced rectal adenocarcinoma Jan 25, 7:00 AM PT | Abstract # 48 | Colorectal cancer (Poster) Presenter: Elisabeth Arrondo, BSc, Translational Research Support Office, National Cancer Center Hospital East Molecular characteristics and prognostic impact of GNAS mutation in colorectal cancer: An international collaborative study between United States and Japan About Signatera Signatera is a personalized, tumor-informed, molecular residual disease test for patients previously diagnosed with cancer. Custom-built for each individual, Signatera uses circulating tumor DNA to detect and quantify cancer left in the body, identify recurrence earlier than standard-of-care tools, and help optimize treatment decisions. The test is available for clinical and research use and is covered by Medicare for patients with colorectal cancer, breast cancer, ovarian cancer, and muscle-invasive bladder cancer, as well as for immunotherapy monitoring of any solid tumor. Signatera has been clinically validated across multiple cancer types and indications, with published evidence in over 100 peer-reviewed papers. About Natera Natera™ is a global leader in cell-free DNA and genetic testing, dedicated to oncology, women’s health, and organ health. We aim to make personalized genetic testing and diagnostics part of the standard of care to protect health and inform earlier, more targeted interventions that help lead to longer, healthier lives. Natera’s tests are validated by more than 250 peer-reviewed publications that demonstrate high accuracy. Natera operates ISO 13485-certified and CAP-accredited laboratories certified under the Clinical Laboratory Improvement Amendments (CLIA) in Austin, Texas, and San Carlos, California. For more information, visit www.natera.com . Forward-Looking Statements All statements other than statements of historical facts contained in this press release are forward-looking statements and are not a representation that Natera’s plans, estimates, or expectations will be achieved. These forward-looking statements represent Natera’s expectations as of the date of this press release, and Natera disclaims any obligation to update the forward-looking statements. These forward-looking statements are subject to known and unknown risks and uncertainties that may cause actual results to differ materially, including with respect to whether the results of clinical or other studies will support the use of our product offerings, the impact of results of such studies, our expectations of the reliability, accuracy, and performance of our tests, or of the benefits of our tests and product offerings to patients, providers, and payers. Additional risks and uncertainties are discussed in greater detail in "Risk Factors" in Natera’s recent filings on Forms 10-K and 10-Q, and in other filings Natera makes with the SEC from time to time. These documents are available at www.natera.com/investors and www.sec.gov .