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Scilex Holding Company Announces the Completion of the First Tranche of the Oramed Pharmaceuticals, Inc. Warrant Repurchase
Globenewswire· 2025-10-01 13:00
PALO ALTO, Calif., Oct. 01, 2025 (GLOBE NEWSWIRE) -- Scilex Holding Company (“Scilex” or the “Company”) (Nasdaq: SCLX), 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 neurodegenerative and cardiometabolic disease, today announced that it has repurchased 3,130,000 warrants to purchase shares of Scilex common stock having an exercise price of $0.01 per share (“Warrants”) from Oram ...
Scilex Holding Company Announces Signing of a Securities Purchase Agreement with an Institutional Investor to Exchange $200 Million of Common Stock of Semnur Pharmaceuticals, Inc. Held By Scilex Holding Company for $200 Million in Bitcoin
Globenewswire· 2025-09-23 14:00
PALO ALTO, Calif., Sept. 23, 2025 (GLOBE NEWSWIRE) -- Scilex Holding Company (“Scilex” or the “Company”) (Nasdaq: SCLX), 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 neurodegenerative and cardiometabolic disease, today announced that it has signed a Securities Purchase Agreement (“SPA”) with the institutional investor to exchange $200 million of common stock of its majority ow ...
Semnur Pharmaceuticals, Inc. (“Semnur”), a Majority-Owned Subsidiary of Scilex Holding Company (Nasdaq: SCLX, “Scilex”), and Denali Capital Acquisition Corp. Announce Approval from Denali's Shareholders of the Previously Announced Business Combination
Globenewswire· 2025-09-04 13:00
PALO ALTO, Calif, Sept. 04, 2025 (GLOBE NEWSWIRE) -- Semnur Pharmaceuticals, Inc. (“Semnur”), a majority-owned subsidiary of Scilex Holding Company (“Scilex” or the “Company”) (Nasdaq: SCLX), 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 neurodegenerative and cardiometabolic disease, today announced that the shareholders of Denali Capital Acquisition Corp (“Denali”) approved th ...
Scilex Holding Company (Nasdaq: SCLX) Announces Effectiveness of Registration Statement on Form S-4 for the Proposed Business Combination of Denali Capital Acquisition Corp. and Semnur Pharmaceuticals, Inc., a Majority-Owned Subsidiary of Scilex
Globenewswire· 2025-08-13 10:00
PALO ALTO, Calif., Aug. 13, 2025 (GLOBE NEWSWIRE) -- Scilex Holding Company ("Scilex" or the "Company") (Nasdaq: SCLX) , 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 neurodegenerative and cardiometabolic disease, today announced that the registration statement on Form S-4 (the "Registration Statement"), related to the previously announced proposed business combination (the "Bu ...
Scilex Holding Company Announces Publication on GLOPERBA® Dosing Adjustments in Peer-Review Journal
Globenewswire· 2025-06-05 16:05
Core Insights - Scilex Holding Company announced a publication regarding GLOPERBA dosing adjustments in a peer-reviewed journal, emphasizing its focus on non-opioid pain management products for various conditions [1][5] Company Overview - Scilex Holding Company is dedicated to acquiring, developing, and commercializing non-opioid pain management products aimed at treating acute and chronic pain, neurodegenerative diseases, and cardiometabolic diseases [1][6] - The company’s commercial products include ZTlido, ELYXYB, and GLOPERBA, with GLOPERBA being the first and only liquid oral version of colchicine for gout flare prophylaxis [6][9] Product Details - GLOPERBA allows for precision dosing and is particularly beneficial for over 70% of gout patients who have comorbid conditions requiring dose adjustments [2][4] - The publication highlights the importance of precise dosing for patients with renal impairment, suggesting specific dosages of 0.48 mg for moderate and 0.3 mg for severe renal impairment to maintain therapeutic levels and enhance safety [4][5] Clinical Significance - The publication is expected to provide essential data to guide clinical dosing of colchicine in patients suffering from gout and chronic renal failure, addressing a significant clinical need [5]
Scilex Holding Company Announces FDA Has Approved Our Request for the Orphan Drug Designation for Colchicine for the Treatment of Pericarditis
Globenewswire· 2025-04-16 18:12
Core Insights - Scilex Holding Company has received FDA approval for Orphan drug designation for colchicine to treat pericarditis, enhancing its portfolio in non-opioid pain management products [1][3]. Company Overview - Scilex Holding Company focuses on acquiring, developing, and commercializing non-opioid pain management products for acute and chronic pain, with a commitment to improving patient outcomes [5][10]. - The company is headquartered in Palo Alto, California [9][11]. Product Portfolio - Scilex's commercial products include: - ZTlido (lidocaine topical system) 1.8% for neuropathic pain relief [5][7]. - ELYXYB, an oral solution for acute migraine treatment [5][7]. - Gloperba, the first liquid oral version of colchicine for gout flare prophylaxis [6][7]. - The company has three product candidates in development: - SP-102 (SEMDEXA™), a viscous gel for epidural injections targeting lumbosacral radicular pain, which has completed Phase 3 studies [8]. - SP-103, a next-generation lidocaine topical system for acute pain, recently completing Phase 2 trials [8]. - SP-104, a low-dose naltrexone hydrochloride for fibromyalgia treatment [8]. Regulatory Insights - The Orphan Drug Act allows the FDA to grant orphan designation to drugs intended for rare diseases, which can lead to seven years of market exclusivity upon first approval [3].
Oramed Pharmaceuticals Issues Letter to Shareholders
Prnewswire· 2025-03-04 14:00
Core Insights - Oramed Pharmaceuticals Inc. is advancing its proprietary oral drug delivery technology through a joint venture named OraTech Pharmaceuticals, Inc. with Hefei Tianhui Biotech Co., Ltd. [4][5] - The joint venture aims to initiate a Phase 3 clinical trial in the U.S. for oral insulin, focusing on key patient subpopulations to demonstrate efficacy [6][11] - HTIT has submitted a Marketing Authorization Application for the oral insulin capsule in China, with commercialization preparations underway [7][11] - Oramed plans to distribute OraTech stock to its shareholders via a dividend, coinciding with OraTech's public trading debut on Nasdaq [8][11] - A cash dividend of approximately $0.25 per share is being evaluated to offset potential tax liabilities related to the OraTech stock distribution [9][11] - Oramed's investment in Scilex Holding Company has generated $70 million from a secured loan agreement, with additional payments expected [12][13] - The company maintains a strong financial position, supported by strategic transactions and disciplined capital allocation [13] - Future growth strategies include pursuing acquisitions and partnerships to leverage technology development [14] Joint Venture and Product Development - The OraTech joint venture combines Oramed's drug delivery technology with HTIT's manufacturing capabilities, aiming to set new standards for oral protein delivery [5][6] - OraTech is expected to receive royalties from sales in China, enhancing its revenue potential [7][11] Financial Strategies - Oramed is working on achieving Nasdaq trading status for OraTech and plans to distribute the majority of its ownership in OraTech to shareholders [8][11] - The company is also exploring cash dividends to enhance shareholder value and mitigate tax concerns [9][11] Strategic Investments - Oramed's investment in Scilex includes a royalty stream from multiple products, with expected royalties of $400,000 for Q4 2024 [12][16] - The company holds a 2% royalty on worldwide sales for ELYXYB and GLOPERBA, with additional profit-sharing arrangements [16]