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Scilex Holding Co - SCLX STOCK NEWS

Welcome to our dedicated page for Scilex Holding Co news (Ticker: SCLX), a resource for investors and traders seeking the latest updates and insights on Scilex Holding Co stock.

Company Overview

Scilex Holding Company is a specialized biopharmaceutical enterprise focused on acquiring, developing, and commercializing innovative non-opioid therapies for the management of acute and chronic pain. With a robust portfolio that includes FDA-approved products and promising candidates in early and mid-stage clinical trials, the company addresses significant unmet needs in pain management as well as the treatment of neurodegenerative and cardiometabolic diseases. Keywords such as non-opioid pain management, FDA-approved therapeutic solutions, and innovative clinical pipeline are integral to its strategy, positioning Scilex as a critical player in its niche market.

Core Products and Clinical Pipeline

Scilex Holding Company has established its market presence with several key commercial products. The prescription lidocaine topical system, known as ZTlido, is designed for the relief of neuropathic pain associated with postherpetic neuralgia. This product exemplifies Scilex’s commitment to non-opioid solutions that help minimize reliance on addictive analgesics.

In addition to ZTlido, the company has launched ELYXYB, an oral solution that offers an alternative approach for the management of acute migraine-related pain. Another notable product is Gloperba, which provides a first-in-class liquid oral formulation of colchicine aimed at prophylaxis of painful gout flares, catering to patient populations with specific dosing requirements and sensitivity issues.

Complementing its commercial success, Scilex is actively advancing a promising clinical pipeline. Product candidates such as SP-102 (a viscous gel formulation of a corticosteroid for epidural injections), SP-103 (a triple-strength version of its topical system for acute pain), and SP-104 (a low-dose, delayed release formulation intended for fibromyalgia) reflect the company’s ongoing efforts to innovate and refine its therapeutic offerings.

Market Position and Operational Strategy

Positioned within a highly competitive and regulation-driven industry, Scilex Holding Company leverages its expertise in clinical development, regulatory strategy, and commercialization. The company’s business model is centered on generating revenue through the rapid commercialization of approved products while simultaneously investing in the advancement of its pipeline candidates. Its rigorous approach to clinical research and development, including obtaining Fast Track status for select candidates, evidences a commitment to both quality and efficiency in meeting unmet patient needs.

Scilex maintains a strategic focus on therapeutic areas where conventional opioid-based treatments have significant limitations. By addressing safety concerns, dosage flexibility, and patient compliance, the company differentiates its non-opioid solutions in a crowded market. The integration of innovative formulations and targeted delivery systems ensures that each therapy not only meets regulatory requirements but also delivers clinical benefits with minimized side effects.

Regulatory and Clinical Development Excellence

Demonstrating strong adherence to E-E-A-T principles, Scilex underscores its operational integrity by ensuring all products in its portfolio conform to stringent regulatory standards. Its products have achieved significant milestones, including FDA approvals for key therapeutic indications, and its pipeline candidates have attracted regulatory incentives such as Fast Track designations. Such milestones reinforce the company’s reputation for rigorous clinical research and a deep commitment to advancing patient outcomes through science-based innovation.

Competitive Landscape and Strategic Differentiators

Scilex’s approach to product innovation sets it apart from competitors by targeting indications that historically have been underserved by traditional opioid-based treatments. The company’s strategic acquisition and development of therapies that combine advanced drug delivery techniques with established therapeutic frameworks enable it to capture large market opportunities in its targeted segments. Moreover, its proactive clinical development strategy and engagement with regulatory bodies further enhance its credibility as a revenue-generating, innovative pharmaceutical company.

Commitment to Patient Outcomes

At its core, Scilex Holding Company is dedicated to improving patient lives by providing alternative treatment options for pain management and related conditions. The company’s diverse portfolio and ongoing development efforts aim to reduce dependency on opioids, offering solutions that are tailored to improve patient convenience, safety, and overall treatment effectiveness.

This comprehensive approach—from market-focused commercialization of FDA-approved products to an expansive, innovative clinical pipeline—highlights Scilex’s integrative strategy in addressing contemporary challenges in pain management and beyond.

Rhea-AI Summary
Scilex Holding Company (Nasdaq: SCLX) strengthens its intellectual property position with the issuance of a new patent for its lead commercial product, ZTlido®. The U.S. Patent and Trademark Office has issued Patent No. 11,786,455, further securing the company's coverage for the non-opioid pain management product. This patent covers a non-aqueous lidocaine patch and a method of relieving pain through its application, enhancing the company's IP portfolio. The new patents will be listed in the U.S. FDA's Orange Book, providing additional protection for ZTlido® until its expiration in 2031.
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Scilex Holding Company (Nasdaq: SCLX) announced the issuance of a new patent, No. 11,793,766, by the U.S. Patent and Trademark Office for its lead commercial product, ZTlido®. The patent strengthens the company's intellectual property position and coverage for non-opioid pain management products. Titled 'Non-aqueous Patch for the Relief of Pain,' the patent covers a method of relieving pain through the application of a lidocaine-containing patch, showcasing the company's commitment to innovation and addressing unmet needs in pain management.
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Scilex Holding Company announces results of skin penetration studies for SP-103, ZTlido, and Pennsaid. The studies show higher diffusive transport of lidocaine compared to diclofenac, with SP-103 resulting in significantly higher lidocaine concentration in muscle tissue than ZTlido. The results indicate that SP-103 is highly effective in delivering lidocaine into muscle tissue for the treatment of musculoskeletal pain disorders.
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Scilex Holding Company announces positive Type C meeting with the FDA regarding the clinical development of SP-102, a non-opioid pain management product. The company plans to file a New Drug Application utilizing the 505(b)(2) regulatory pathway. An open-label multi-center trial is expected to begin in the first half of 2024 with enrollment of approximately 700 patients. SP-102 would be the first corticosteroid with an indication for epidural administration in the U.S.
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Scilex Holding Company announced record monthly revenue in October 2023 for ZTlido, with gross sales estimated to be in the range of $14.5 million to $15.5 million and net sales estimated to be in the range of $4.0 million to $5.0 million. Year-to-date gross sales for ZTlido through October 2023 are estimated to be in the range of $110.0 million to $120.0 million, representing a growth of 47% to 60% compared to the same period in 2022. Year-to-date net sales for ZTlido through October 2023 are estimated to be in the range of $35.0 million to $40.0 million, representing a growth of 15% to 32% compared to the same period in 2022.
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Scilex Holding Company has filed an emergency motion for the production of books and records from certain brokers, dealers, banks, and other nominees. The motion was filed in the U.S. Bankruptcy Court for the Southern District of Texas. Scilex previously provided proposals to Short Sellers and lenders of short positions, offering them the opportunity to cover their positions and avoid further expenses. The Short Seller Proposal ended on October 27, 2023, while the Lender Proposal is still in effect until October 31, 2023.
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Scilex Holding Company retains legal firms to investigate potential market manipulation of its restricted shares of common stock
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Scilex Holding Company provides notice to lenders of short positions in restricted shares of Scilex common stock. The Scilex Dividend Stock was subject to restrictions on transfer through March 31, 2024. Short sellers who engaged in illegal naked short selling did not opt into a settlement. Scilex now offers a proposal to lenders of short positions to cover their positions and receive a release from Scilex for any claims related to naked short selling. The Lender Proposal commences on October 9, 2023, and ends on October 31, 2023.
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Scilex Holding Company provides notice to record holders and beneficial owners of restricted shares of Scilex common stock. Sorrento Therapeutics authorized a dividend of 76,000,000 shares of Scilex common stock to equity holders. Short selling of Scilex common stock may constitute a violation of SEC Regulation SHO. Settlements reached with short sellers resulted in approximately 800,000 short positions closed or covered. Short sellers who engaged in illegal naked short selling have the opportunity to cover their short positions and avoid fees and expenses. Proposal allows short sellers to purchase shares in the open market to close out or cover their short positions. Deadline to participate in the proposal is October 27, 2023.
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Scilex Holding Company has submitted a request to withdraw its Registration Statement on Form S-1, which had not been declared effective by the SEC. No securities had been sold pursuant to the Registration Statement.
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FAQ

What is the current stock price of Scilex Holding Co (SCLX)?

The current stock price of Scilex Holding Co (SCLX) is $6.02 as of April 17, 2025.

What is the market cap of Scilex Holding Co (SCLX)?

The market cap of Scilex Holding Co (SCLX) is approximately 986.9K.

What is the primary focus of Scilex Holding Company?

Scilex Holding Company is focused on acquiring, developing, and commercializing non-opioid pain management products as well as therapies targeting neurodegenerative and cardiometabolic diseases.

What are the key commercial products in Scilex's portfolio?

The company’s commercial products include ZTlido, a lidocaine topical system for neuropathic pain; ELYXYB, an oral solution for acute migraine; and Gloperba, a unique liquid oral formulation of colchicine for prophylaxis of painful gout flares.

How does Scilex generate revenue?

Revenue is generated primarily through the commercialization of its FDA-approved therapies, coupled with investments in its advanced clinical pipeline aimed at addressing significant unmet medical needs.

What distinguishes Scilex’s approach to pain management?

Scilex differentiates itself by developing non-opioid solutions that focus on advanced drug formulations, improved safety profiles, and better patient adherence compared to traditional opioid-based therapies.

What are some of the clinical development milestones achieved by Scilex?

Scilex has achieved regulatory milestones such as FDA approval for its flagship products and secured Fast Track designations for several pipeline candidates, reflecting its expertise in clinical research and development.

Can you describe the pipeline candidates currently under development?

Pipeline candidates include SP-102, a corticosteroid gel for epidural use; SP-103, a next-generation, triple-strength formulation for acute pain; and SP-104, a low-dose, delayed-release capsule targeting fibromyalgia.

How does Scilex address the challenges of competitive markets?

The company leverages innovative formulations and targeted clinical strategies to meet high unmet needs, ensuring that its products not only comply with regulatory standards but also offer distinct therapeutic advantages.

What role does regulatory approval play in Scilex's operations?

Regulatory approval is central to the company’s operational strategy, as it validates the safety and efficacy of its products. The rigorous adherence to regulatory standards underpins Scilex's reputation for scientific excellence.
Scilex Holding Co

Nasdaq:SCLX

SCLX Rankings

SCLX Stock Data

986.90k
5.15M
25.93%
20.34%
3.43%
Drug Manufacturers - General
Biological Products, (no Disgnostic Substances)
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