Welcome to our dedicated page for Scilex Holding Company news (Ticker: SCLX), a resource for investors and traders seeking the latest updates and insights on Scilex Holding Company stock.
Scilex Holding Company (NASDAQ: SCLX) is a forward-thinking, revenue-generating firm headquartered in Palo Alto, California, known for its focus on acquiring, developing, and commercializing non-opioid pain management products. The company's mission centers around addressing acute and chronic pain with innovative treatments that offer alternatives to opioid medications.
Scilex's flagship commercial product is ZTlido (lidocaine topical system) 1.8%, a prescription product approved by the U.S. Food and Drug Administration (FDA) for relieving neuropathic pain associated with postherpetic neuralgia, a form of post-shingles nerve pain. Another key product is ELYXYB, an FDA-approved, ready-to-use oral solution for the acute treatment of migraine, with or without aura, in adults.
The company also markets Gloperba (colchicine USP), the first and only liquid oral formulation of colchicine for the prophylaxis of painful gout flares in adults. The FDA recently approved the commercial manufacturing of Gloperba, and it is set to launch in major wholesalers and pharmacies by June 2024.
In addition to their commercial products, Scilex is advancing three promising product candidates:
- SP-102 (SEMDEXA™): A novel, viscous gel formulation of dexamethasone sodium phosphate for epidural injections to treat lumbosacral radicular pain, including sciatica. It has completed a Phase 3 study and was granted Fast Track status by the FDA in 2017.
- SP-103: A next-generation, triple-strength formulation of ZTlido for the treatment of chronic neck pain, which completed a Phase 2 trial in low back pain and received Fast Track status from the FDA in 2023.
- SP-104: A novel, low-dose delayed-release naltrexone hydrochloride capsule for the treatment of fibromyalgia, with Phase 1 trials completed in mid-2022.
Recently, Scilex resolved ANDA patent issues, paving the way for final FDA approval of an expanded label for Gloperba, which aims to provide specific dosing guidance for patients with renal impairment.
Scilex's focus on unmet needs in pain management, combined with its robust pipeline and strategic partnerships, positions it as a leader in the non-opioid pain management market. The company is dedicated to improving patient outcomes and advancing non-opioid alternatives to meet the growing demand for effective pain relief solutions.
For more information, visit www.scilexholding.com.
Scilex Holding Company (SCLX) has announced an early installment payment of $13.2 million on its senior secured promissory note issued to Oramed Pharmaceuticals (ORMP) in September 2023. Following this early payment, the remaining principal balance will be due in a final payment on March 21, 2025, at which point the Oramed Note will be fully retired.
Scilex, a revenue-generating company, focuses on acquiring, developing, and commercializing treatments for obesity, neurodegenerative and cardiometabolic diseases (through a proposed joint venture with IPMC Company), and non-opioid pain management products.
Scilex Holding Company (SCLX) has completed its previously announced registered direct offering, raising $17.0 million in gross proceeds. The offering included 26,355,347 shares of common stock and 2,401,132 pre-funded warrants, along with common warrants to purchase up to 57,512,958 shares. The common stock and accompanying warrants were sold at $0.59 per share, while pre-funded warrants were priced at $0.5899.
The common warrants, exercisable at $0.6490 per share, will become available six months after issuance, with half expiring in five years and half in two and a half years. The company plans to use the proceeds for working capital, general corporate purposes, including capital expenditures, commercialization, R&D, regulatory affairs, clinical trials, and potential acquisitions or debt repayment.
Scilex Holding Company (SCLX) has announced a $17 million registered direct offering, involving the sale of 26,355,347 common stock shares and 2,401,132 pre-funded warrants. The offering includes common warrants to purchase up to 57,512,958 shares. The combined offering price is $0.59 per share for common stock and $0.5899 for pre-funded warrants.
The pre-funded warrants will have a $0.0001 exercise price and immediate exercisability, while common warrants will have a $0.6490 exercise price, becoming exercisable after six months. The offering is expected to close around December 13, 2024. Additionally, an investor agreed to exercise outstanding warrants for 1,764,706 shares at $0.59, providing approximately $1.0 million in gross proceeds.
Scilex Bio announces progress in its Phase 2 clinical trial for KDS2010 (Tisolagiline), a novel oral tablet targeting Alzheimer's disease. The trial, currently enrolling 114 patients in South Korea, will expand to include U.S. patients in 2025. KDS2010 is a new reversible selective monoamine oxidase B (MAO-B) inhibitor that also influences astrocytic GABA inhibition.
The drug has shown promising results in preclinical studies, significantly reducing astrocytic GABA levels and improving learning and memory in mouse models. Phase 1 trials with 88 subjects demonstrated favorable safety and suitable pharmacokinetics for once-daily dosing. The global Alzheimer's drug market is projected to exceed $15 billion by 2030 in major markets.
Scilex Bio reports progress on its obesity treatment KDS2010, with an ongoing Phase 2 trial currently enrolling approximately 75 overweight or obese patients in South Korea, planning to expand to the U.S. in 2025. The trial is randomized, double-blind, and placebo-controlled. Phase 1 trials, completed with 88 subjects, demonstrated favorable safety, tolerability, and suitable pharmacokinetics for once-daily dosing.
KDS2010 (Tisolagiline) functions as a selective, reversible MAO-B inhibitor, blocking GABA production in reactive astrocytes and eliminating neuronal inhibition in the Lateral Hypothalamic Area. This mechanism stimulates metabolism and energy expenditure without affecting appetite, potentially offering advantages over current obesity treatments like GLP-1 agonists.
Scilex Bio and NeuroBiogen have signed a binding term sheet for worldwide licensing rights of KDS2010, a novel oral tablet targeting the $150 billion weight loss and Alzheimer's disease markets. The agreement grants Scilex Bio exclusive worldwide rights to develop and commercialize KDS2010 for metabolic diseases (including obesity and type 2 diabetes) and neurodegenerative diseases (including Alzheimer's and Parkinson's).
KDS2010, currently in Phase 2 clinical trials for obesity and Alzheimer's disease, is a potent, selective, and reversible MAO-B inhibitor. The collaboration combines NeuroBiogen's research and development expertise with Scilex's commercial and development capabilities in CNS and primary care diseases.
Scilex Holding Company (NASDAQ: SCLX) has entered into a binding term sheet to form a joint venture, Scilex Bio, with IPMC and Bio Open Innovation Consortium. The venture will develop and commercialize KDS2010, a Phase 2 clinical stage oral tablet targeting obesity and neurodegenerative diseases, including Alzheimer's.
KDS2010 has demonstrated promising results in Phase 1 trials with 88 subjects, showing favorable safety and once-daily dosing potential. The drug works by controlling GABA levels in astrocytes and selectively inhibiting MAO-B enzymes. Scilex will own controlling interest upon contributing $50 million of Semnur Pharmaceuticals stock, while IPMC will own 40% for contributing worldwide rights to KDS2010.
The global obesity drug market is projected to reach $131 billion by 2028, while the Alzheimer's drug market is expected to exceed $15 billion by 2030.
Scilex Holding Company (SCLX) has received a notice from Nasdaq's Listing Qualifications Department on November 21, 2024, indicating non-compliance with listing requirements due to failure to file its Q3 2024 Form 10-Q on time. The company has until January 20, 2025 to submit a compliance plan to Nasdaq. If accepted, Nasdaq may grant an extension until May 19, 2025 to regain compliance. Scilex intends to file the Q3 Form 10-Q as soon as possible or submit a detailed plan outlining steps to file the report if unable to meet the January deadline.
Scilex Holding Company (SCLX) announced a data presentation at the 2024 American College of Rheumatology Convergence conference in Washington, D.C. The presentation focuses on GLOPERBA®, their liquid colchicine formulation for gout patients. The data discusses pharmacokinetic model-derived dosing for patients with moderate and severe chronic kidney disease. GLOPERBA® is notable as the first and only liquid colchicine offering precision dosing, including reduced daily doses (0.3 mg/day) for patients with severe renal impairment, following a recent FDA label update.
Semnur Pharmaceuticals, a subsidiary of Scilex Holding Company (SCLX), announced the filing of an S-4 Registration Statement with the SEC regarding its planned merger with Denali Capital Acquisition Corp (DECA). The business combination, valued at $2.5 billion pre-transaction equity, is expected to close by Q1 2025. Scilex has declared a stock dividend of 5,000,000 shares of Series 1 Mandatory Exchangeable Preferred Stock, representing up to 10% of Scilex's ownership in Semnur post-merger. The record date for this dividend is set for November 7, 2024, with investors required to hold Scilex common stock on this date to receive the dividend.
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