Currently enrolling randomized, double-blind, placebo-controlled, dose-finding, Phase 2 clinical trial to evaluate the safety and efficacy of KDS2010 in patients with Alzheimer’s disease with mild cognitive impairment and mild dementia is currently recruiting in South Korea in 114 patients and U.S. cohort will be added in 2025.KDS2010 (Tisolagiline) is a new reversible selective monoamine oxidase B (MAO-B) inhibitor being studied for its potential in treating neurodegenerative diseases like Alzheimer's dise ...

PALO ALTO, Calif., Nov. 22, 2024 (GLOBE NEWSWIRE) -- Scilex Holding Company (Nasdaq: SCLX, “Scilex” or the “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, today reported that it received a notice (the “Notice”) on November 21, 2024 from the Listing Qualifications Department of The Nasdaq Stock Market LLC (“Nasdaq”) advising the Company that it was not in compliance with ...

Scilex management is determined to enhance its stockholders’ value and protect their stockholder rights, and is taking steps to combat manipulative and naked short selling practices in Scilex common stock.Scilex notified NASDAQ on October 28, 2024 that it has set a record date of November 7, 2024 for the dividend of Scilex preferred stock to Scilex’s stockholders and certain other securityholders of Scilex. Such record date may be changed by Scilex’s board of directors for any reason at any time prior to th ...

Core Points - Scilex Holding Company has set a record date of November 7, 2024, for a dividend of preferred stock to its stockholders and certain other securityholders [2][4] - The dividend consists of 5,000,000 shares of Series 1 Mandatory Exchangeable Preferred Stock, which will be exchangeable for up to 10% of Scilex's ownership interest in Semnur Pharmaceuticals, Inc. following a business combination [3][4] - The business combination between Semnur and Denali Capital Acquisition Corp. is expected to close by the first quarter of 2025, with a pre-transaction equity value of Semnur estimated at $2.5 billion [1][2] - SP-102 (SEMDEXA™), a product candidate held by Semnur, is projected to have peak sales potential of $3.6 billion annually in the fifth year post-launch [1][9] Company Overview - Scilex is focused on acquiring, developing, and commercializing non-opioid pain management products for acute and chronic pain [6][8] - The company’s commercial products include ZTlido®, ELYXYB®, and Gloperba®, which target high unmet needs in pain management [6][7] - Scilex has three product candidates in development: SP-102, SP-103, and SP-104, with various stages of clinical trials and FDA designations [7][9] Business Combination Details - The business combination will involve a registration statement filed with the SEC by the end of October 2024 [1][2] - The Series 1 Preferred Stock will automatically exchange for a pro-rata portion based on Scilex's ownership in Semnur or a maximum of $200 million, depending on the closing price of Semnur's common stock [3][4] - The dividend payment is contingent upon the Board's decisions and the effectiveness of the filing with the Secretary of State of Delaware [2][4]

Sales Growth Estimates - ZTlido net sales for Q3 2024 estimated between $11.0 million to $13.0 million, representing growth of approximately 9% to 29% compared to the same period last year[3] - Total product net sales for Q3 2024 estimated between $12.0 million to $14.0 million, representing growth of approximately 19% to 39% compared to the same period last year[3] Financial Reporting - Preliminary unaudited financial results for Q3 2024 were issued in a press release on October 8, 2024[4]

ZTlido net sales for the quarter ended September 30, 2024 were in the range of $11.0 million to $13.0 million, compared to $10.1 million for the same period last year, representing growth in the range of approximately 9% to 29%. Total product net sales for the quarter ended September 30, 2024 were in the range of $12.0 million to $14.0 million, compared to $10.1 million for the same period last year, representing growth in the range of approximately 19% to 39%. PALO ALTO, Calif., Oct. 08, 2024 (GLOBE NEWSWI ...

PALO ALTO, Calif., Oct. 08, 2024 (GLOBE NEWSWIRE) -- Scilex Holding Company (Nasdaq: SCLX, "Scilex" or the "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, today announced the closing of its previously announced registered direct offering of new tranche B senior secured convertible notes (the "Notes") in the aggregate principal amount of $50 million and warrants to purcha ...

Affiliates of Murchinson, 3i LP, and existing senior debt holder, Oramed Pharmaceuticals, Inc. ("Oramed"), are expected to participate in the $50 million convertible note offering, which is expected to close on or about October 7, 2024. The offering involves a refinancing and restructuring of existing debt and is expected to position Scilex for sustainable, long-term growth, as part of its multi-year plan to transform into a potential global and leading non-opioid pain management company. Scilex will receiv ...

PALO ALTO, Calif., Aug. 30, 2024 (GLOBE NEWSWIRE) -- Scilex Holding Company (Nasdaq: SCLX, "Scilex" or the "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, today announced oral, poster presentations, and symposia on ZTlido (lidocaine topical system) at the 2024 Annual PAINWeek conference in Las Vegas, NV on September 3-5, 2024. Key highlights of the ZTlido (lidocaine topi ...

FDA Final Approval to Precision Dosing for GLOPERBA® Label. We believe GLOPERBA® is the first and only liquid oral version of the anti-gout medicine colchicine indicated for the prophylaxis of painful gout flares in adults. Gout is a painful arthritic disorder affecting an estimated 9.2 million people in the United States1. As gout cases increase every year, treatment requirements increase. According to data gathered by Evaluate Pharma, the gout treatment market is projected to reach $2.0 billion in the U.S ...