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) has announced that the U.S. FDA has acknowledged the submission of their Supplemental New Drug Application (SNDA) for ELYXYB® in the indication of acute pain. Scilex is a revenue-generating company focused on developing and commercializing non-opioid pain management products for both acute and chronic pain. The company is also exploring opportunities in neurodegenerative and cardiometabolic diseases through a proposed joint venture with IPMC Company.
Scilex Holding Company (SCLX) has announced its return to compliance with Nasdaq Listing Rule 5250(c)(1) after filing its Quarterly Report on Form 10-Q for the quarter ended September 30, 2024. The company, which focuses on developing non-opioid pain management products, received official notification from The Nasdaq Stock Market confirming this compliance status.
Scilex is currently expanding its focus through a proposed joint venture with IPMC Company to include treatments for neurodegenerative and cardiometabolic diseases, while maintaining its core business in acute and chronic pain management solutions. The company's product portfolio includes ZTlido®, ELYXYB®, and Gloperba®.
Scilex Holding Company (SCLX) has announced an agreement to extend the maturity date of its Senior Secured Promissory Note issued to Oramed Pharmaceuticals. The note, originally issued on September 21, 2023, will now mature on December 31, 2025, instead of the previous date of March 21, 2025.
The extension agreement includes additional covenants regarding the conduct of the Company's business. Scilex is a revenue-generating company that focuses on non-opioid pain management products for acute and chronic pain treatment. The company is also planning to expand into neurodegenerative and cardiometabolic disease treatments through a proposed joint venture with IPMC Company.
Scilex Holding Company (Nasdaq: SCLX) has announced that its Tranche B senior secured convertible note holders, including Oramed Pharmaceuticals Inc., Murchinson, and 3i LP, plan to participate in funding and acquiring the ex-U.S. commercialization rights for Gloperba® from Romeg Therapeutics,
The note holders will establish a joint venture (JV) to manage the worldwide licensing and distribution of Gloperba®. This development aligns with Scilex's focus on non-opioid pain management products and its proposed joint venture with IPMC Company for neurodegenerative and cardiometabolic disease treatments.
Scilex Holding Company (SCLX) announced filing a Supplemental New Drug Application (SNDA) with the FDA for ELYXYB® in acute pain indication. ELYXYB®, a rapid-onset oral solution of Celecoxib, represents a non-opioid alternative for pain management. The drug's efficacy was demonstrated in a clinical study involving 120 adults post dental surgery, where all three tested doses (62.5, 125, and 250 mg) showed significant superiority over placebo in pain reduction.
The acute pain market in the U.S. was approximately $3 billion in 2021, with about 100 million cases annually. Currently, around 40 million Americans are prescribed opioids for acute pain management. ELYXYB® utilizes self-microemulsifying drug delivery system (SMEDDS) technology, providing improved bioavailability compared to traditional celecoxib capsules.
Scilex Holding Company (NASDAQ: SCLX) has announced the filing of its Quarterly Report on Form 10-Q for the quarter ended September 30, 2024. The company, which focuses on non-opioid pain management products, expects to receive notification from Nasdaq confirming its regained compliance with Listing Rule 5250(c)(1). Scilex is also in the process of forming a proposed joint venture with IPMC Company to expand into neurodegenerative and cardiometabolic disease treatments.
Scilex Holding Company (NASDAQ: SCLX) has amended its license agreement with Romeg Therapeutics for Gloperba®, expanding from US-only to worldwide commercialization rights. Gloperba® is the first and only liquid oral colchicine formulation FDA-approved for preventing painful gout flares in adults.
The medication offers unique advantages through its liquid format, enabling precision dosing particularly beneficial for the over 70% of gout patients with comorbid conditions requiring dose adjustments. The 0.6mg per 5ml dosage provides flexibility for patients who have difficulty swallowing pills and allows for dose reduction in patients with severe renal impairment (0.3 mg/day).
The global gout patient population has significantly increased from 22 million to 53 million over the past 30 years, with a worldwide incidence rate of 0.1-0.3% of the population.
Scilex Holding Company (SCLX) announced the publication of retrospective claims data in Pain Medicine News comparing ZTlido® to lidocaine 5% patch. The study analyzed claims data from the Optum Claims database between May 2018 and September 2023 for patients with neuropathic pain.
Key findings showed that ZTlido® users demonstrated better outcomes in opioid reduction compared to the 5% lidocaine patch:
- 51.9% of ZTlido® patients decreased or discontinued opioid use vs 45.5% for the 5% patch
- 21.3% of ZTlido® patients achieved ≥20% opioid reduction vs 13.4% for the 5% patch (P=0.0008)
- ZTlido® patients showed minimal change in baseline opioid use (+3.1%, P=0.146) while 5% patch users had significant increase (+42.9%, P<0.001)
Scilex Holding Company (NASDAQ: SCLX) has announced a change in the record date for its previously declared dividend of preferred stock. The new record date has been moved from November 7, 2024, to January 28, 2025. The dividend consists of preferred stock exchangeable for up to 10% of Scilex's ownership interest in its wholly owned subsidiary, Semnur Pharmaceuticals. The payment date will be determined by the Board within 60 days following the new record date. This announcement was made after Scilex notified NASDAQ on December 30, 2024.
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.
FAQ
What is the current stock price of Scilex Holding Company (SCLX)?
What is the market cap of Scilex Holding Company (SCLX)?
What does Scilex Holding Company specialize in?
What are Scilex's main commercial products?
What is ZTlido used for?
What is ELYXYB?
What recent approval has Gloperba received?
What are Scilex's current product candidates?
What is SP-102?
What is the significance of the FDA Fast Track status for SP-103?
When will Gloperba be available in pharmacies?
Where is Scilex Holding Company headquartered?
