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 (Nasdaq: SCLX) announced that the stocking of GLOPERBA®, its third commercial product, is underway in all wholesalers with which it has stocking arrangements throughout the U.S. The process is expected to complete by June 12, 2024. GLOPERBA® is the first and only liquid oral formulation of colchicine for the prophylaxis of gout flares in adults. Scilex has increased the production of GLOPERBA® and supports patients with a co-pay savings card. For more details, visit www.gloperba.com.
Scilex Holding announced FDA approval for the commercial manufacturing of Gloperba®, the first and only liquid colchicine for gout prophylaxis. Launching in the U.S. on June 10, 2024, Gloperba® targets a growing market of 9.2 million gout sufferers. The U.S. gout treatment market may reach $2 billion by 2028. Gloperba® offers flexible dosing, potentially benefiting over 70% of gout patients with comorbid conditions and 17% experiencing severe gastrointestinal side effects from other colchicine forms. Scilex's experienced team and established distribution network will support the launch.
Scilex Holding Company (Nasdaq: SCLX) has sent letters to the U.S. Securities and Exchange Commission (SEC) and the Financial Industry Regulatory Authority (FINRA) regarding illegal market manipulation of its common stock. The company alleges that manipulative practices such as 'naked short selling' are being used to devalue its stock, violating SEC Regulation SHO. Scilex Management is committed to combating these illegal activities to protect shareholder value and rights. Copies of the letters can be accessed via the provided links.
Scilex Holding Company (Nasdaq: SCLX) announced it will be added to the MSCI Global Micro Cap Index effective May 31, 2024. This inclusion is expected to enhance visibility for Scilex’s non-opioid pain management therapeutics within global financial markets. MSCI, a leading provider of research and data for investment decision support, acknowledged Scilex’s progress over the past year. The company focuses on developing and commercializing products for acute and chronic pain management and has seen strong investor interest in its innovative clinical-stage portfolio.
Scilex Holding Company (Nasdaq: SCLX) has sent a letter to the U.S. House of Representatives regarding illegal market manipulation of its common stock. The company highlights concerns over 'naked short' selling or maintaining 'naked short' positions, which may violate SEC Regulation SHO. These practices are believed to reduce shareholder value and infringe upon shareholders' rights. Scilex is committed to combating this manipulative and illegal short selling to protect its stock and shareholder interests. Further details can be accessed on Scilex's official website.
Scilex Holding Company (Nasdaq: SCLX) announced final court approval of a settlement agreement with Takeda Pharmaceuticals, resolving a patent infringement lawsuit related to Scilex's intention to expand the label for its liquid colchicine product, Gloperba®. The U.S. District Court for the District of Delaware approved the settlement, allowing Scilex a non-exclusive license to certain Takeda patents. Following this, Scilex requested the FDA convert its tentative approval of the expanded Gloperba® label to final approval.
The expanded label aims to address unmet medical needs, offering specific dosing guidance for patients with renal impairment. Market research shows high interest among rheumatologists for Gloperba®'s precision dosing capabilities. The expanded label would provide dosing flexibility and personalized adjustment options for patients, aligning with American College of Rheumatology guidelines.
Scilex Holding Company is taking steps to combat manipulative and naked short selling practices in its common stock. The company provided information to its stockholders regarding short selling activities. Scilex believes there are approximately 10 million shares being sold short and more than 10 million Dividend Shares sold as 'naked short' positions. It is determined to protect shareholder value and rights by addressing these practices.
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