Scilex pany(SCLX)

Search documents
Scilex Holding Company Announces Publication in PAIN Journal Regarding Phase 3 Results of the Pivotal Registration Trial of SP-102 (SEMDEXA™) in Lumbosacral Radicular Pain (Sciatica)
Newsfilter· 2024-06-14 17:41
PALO ALTO, Calif., June 14, 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 publication of results of the pivotal registration trial of SP-102 (SEMDEXA™) in PAIN, the official journal of the International Association for the Study of Pain, which features original research ...
Scilex Holding Company Announces 5-Year Term of $100 Million Financing with Royalty-Based Payments and Potential Strategic Transactions with Perigrove and its Portfolio Companies
Newsfilter· 2024-06-11 23:20
PALO ALTO, Calif., June 11, 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 that it has entered into a commitment letter (the "Commitment Letter") with Perigrove LLC and Graf Holdings (collectively the "Lender") for a $100 million 5-year term financing with royalty-based paymen ...
Scilex Holding Company Announces 5-Year Term of $100 Million Financing with Royalty-Based Payments and Potential Strategic Transactions with Perigrove and its Portfolio Companies
GlobeNewswire News Room· 2024-06-11 23:20
In connection with the transaction, upon receipt of the Commitment funds, the Company will issue to the Lender a warrant to purchase up to an aggregate of 32,500,000 shares of the Company's common stock, with an exercise price of $1.20. In the event the Commitment is not funded in accordance with the Commitment Letter, the Deposit will automatically convert to an unsecured loan and the Company will issue an unsecured promissory note (the "Note") to the Lender to evidence such unsecured loan. The Note will h ...
Scilex Holding Company Announces That Many National Pharmacy Chains and Independent Pharmacies Have Begun Stocking GLOPERBA®
GlobeNewswire News Room· 2024-06-11 13:00
Scilex launched its third commercial product, GLOPERBA® on June 10, 2024. Scilex has officially shipped its recently approved, GLOPERBA® to many national drug/pharmacy chains, as well as independent pharmacies. GLOPERBA® will be the first oral liquid medicine for prophylaxis of gout flares available beginning this week with a WAC Price of $595/bottle. Scilex is also in the process of negotiating similar potential stocking arrangements with additional pharmacy chains in the U.S. Scilex remains committed to e ...
Scilex Holding Company Announces That Many National Pharmacy Chains and Independent Pharmacies Have Begun Stocking GLOPERBA®
Newsfilter· 2024-06-11 13:00
Company Overview - Scilex Holding Company is focused on acquiring, developing, and commercializing non-opioid pain management products for acute and chronic pain treatment [6] - The company is headquartered in Palo Alto, California [8] Product Launch - Scilex launched GLOPERBA® on June 10, 2024, which is an FDA-approved prophylactic treatment for painful gout flares in adults [4][11] - GLOPERBA® is the first oral liquid medicine for the prophylaxis of gout flares, with a wholesale acquisition cost (WAC) price of $595 per bottle [11] Market Opportunity - Gout affects an estimated 9.2 million people in the United States, with increasing cases leading to higher treatment requirements [11] - The gout treatment market is projected to reach $2.0 billion in the U.S. by 2028, indicating a significant unmet need in this area [11] Distribution and Stocking Arrangements - Many national pharmacy chains and independent pharmacies have begun stocking GLOPERBA® [4] - Scilex is negotiating similar stocking arrangements with additional pharmacy chains in the U.S. to ensure broad access and supply [11] Existing Product Portfolio - Scilex's commercial products include ZTlido® for neuropathic pain, ELYXYB® for acute migraine treatment, and GLOPERBA® for gout [6] - The company has three product candidates in development: SP-102 (SEMDEXA™), SP-103, and SP-104, targeting various pain management needs [7]
Scilex Holding Company Announces Stocking of GLOPERBA® is Underway in all of the Wholesalers with which Scilex has Stocking Arrangements Throughout the U.S.
Newsfilter· 2024-06-10 15:49
Product Launch and Stocking - Scilex is launching its third commercial product, GLOPERBA®, which is the first and only liquid oral formulation of the anti-gout medicine colchicine indicated for the prophylaxis of painful gout flares in adults [1][7] - Stocking of GLOPERBA® is underway in all wholesalers with which Scilex has stocking arrangements throughout the U S, and completion is expected by June 12, 2024 [1][7] - Patients will have access to a co-pay savings card for GLOPERBA® [1] Product Pipeline - Scilex has three product candidates: SP-102 (SEMDEXA™), a novel viscous gel formulation of dexamethasone sodium phosphate for epidural injections to treat sciatica, which has completed Phase 3 trials and received FDA Fast Track status in 2017 [2] - SP-103, a next-generation triple-strength formulation of ZTlido for chronic neck pain, has completed Phase 2 trials for low back pain and received FDA Fast Track status [2] - SP-104, a low-dose delayed-release naltrexone hydrochloride capsule for fibromyalgia, completed Phase 1 trials in Q2 2022 [2] Company Overview - Scilex Holding Company is an innovative revenue-generating company focused on acquiring, developing, and commercializing non-opioid pain management products for acute and chronic pain [16] - The company targets indications with high unmet needs and large market opportunities, aiming to improve patient outcomes with non-opioid therapies [16] - Scilex's commercial products include ZTlido® for neuropathic pain, ELYXYB® for migraine treatment, and GLOPERBA® for gout flare prophylaxis [16] Trademarks and Intellectual Property - GLOPERBA® is the subject of an exclusive, transferable license to Scilex Holding Company for the use of the registered trademark [5] - SEMDEXA™ (SP-102) is a trademark owned by Semnur Pharmaceuticals, Inc, a wholly-owned subsidiary of Scilex Holding Company, with a proprietary name review by the FDA planned [10] - ZTlido® and ELYXYB® are registered trademarks owned by Scilex Pharmaceuticals Inc and Scilex Holding Company, respectively [17][18]
Scilex Holding Company Announces Stocking of GLOPERBA® is Underway in all of the Wholesalers with which Scilex has Stocking Arrangements Throughout the U.S.
GlobeNewswire News Room· 2024-06-10 15:49
Core Viewpoint - Scilex Holding Company is launching GLOPERBA®, the first and only liquid oral formulation of colchicine for the prophylaxis of painful gout flares in adults, with stocking expected to be completed by June 12, 2024 [1][4]. Company Overview - Scilex Holding Company is headquartered in Palo Alto, California, and focuses on acquiring, developing, and commercializing non-opioid pain management products for acute and chronic pain [3][4]. - The company targets high unmet needs and large market opportunities with non-opioid therapies [2]. Product Portfolio - Scilex's commercial products include: - ZTlido® (lidocaine topical system) 1.8%, approved for neuropathic pain relief [2]. - ELYXYB®, an FDA-approved oral solution for acute migraine treatment [2]. - GLOPERBA®, launching today, indicated for the prophylaxis of painful gout flares [2][4]. - Scilex has three product candidates in development: - SP-102 (SEMDEXA™), a viscous gel for epidural injections to treat sciatica, with Phase 3 study completed [7]. - SP-103, a next-generation lidocaine topical system for chronic neck pain, recently completed Phase 2 trial [7]. - SP-104, a low-dose naltrexone for fibromyalgia, with Phase 1 trials completed [7].
Scilex Holding Company announces the U.S. FDA has approved the sNDA for commercial manufacturing of Gloperba® which will be launched in the US in the week of June 10th 2024
Newsfilter· 2024-06-06 18:56
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. The gout treatment market is projected to be $2.0 billion in the U.S. by 2028 with a well-defined area of unmet need.2 Over 70% of gout patients have comorbid conditions that may require do ...
Scilex Holding Company announces the U.S. FDA has approved the sNDA for commercial manufacturing of Gloperba® which will be launched in the US in the week of June 10th 2024
GlobeNewswire News Room· 2024-06-06 18:56
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. The gout treatment market is projected to be $2.0 billion in the U.S. by 2028 with a well-defined area of unmet need.2 Over 70% of gout patients have comorbid conditions that may require do ...
Scilex Holding Company Sends Letters to the U.S. Securities and Exchange Commission and Financial Industry Regulatory Authority Regarding Illegal Market Manipulation of the Common Stock of Scilex Holding Company
Newsfilter· 2024-05-30 17:19
Core Viewpoint - Scilex Holding Company is addressing illegal market manipulation of its common stock, specifically targeting manipulative "naked short" selling practices that violate SEC Regulation SHO, which negatively impacts shareholder value and rights [1][2]. Company Overview - Scilex Holding Company is focused on acquiring, developing, and commercializing non-opioid pain management products for acute and chronic pain treatment [4][6]. - The company has several commercial products, including ZTlido® for neuropathic pain, ELYXYB® for acute migraine treatment, and Gloperba® for gout flare prophylaxis, with Gloperba® expected to launch in the first half of 2024 [4][5]. Product Pipeline - Scilex has three product candidates in development: - SP-102 (SEMDEXA™) for lumbosacral radicular pain, which has completed Phase 3 studies and received Fast Track status from the FDA [5]. - SP-103, a next-generation formulation of ZTlido for chronic neck pain, recently completed a Phase 2 trial [5]. - SP-104, a low-dose naltrexone for fibromyalgia, with Phase 1 trials completed in Q2 2022 [5]. Regulatory and Market Context - The company is actively engaging with regulatory bodies, including the U.S. Securities and Exchange Commission and the Financial Industry Regulatory Authority, to combat illegal short selling practices [2][3]. - Scilex aims to improve patient outcomes by targeting high unmet needs in pain management with its non-opioid therapies [4].