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Scilex Holding Company - SCLX STOCK NEWS

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.

Rhea-AI Summary
Scilex Holding Company reported strong preliminary unaudited financial results for ZTlido® in the first quarter of 2024, with gross sales between $34.0 million to $38.0 million and net sales between $12.0 million to $13.0 million, showing significant growth compared to the same period in 2023. The company also announced plans to reduce R&D and administrative expenses in 2024 while focusing on expanding commercial activities and product production.
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Scilex Holding Company launches co-pay programs for ZTlido® and ELYXYB® for commercially insured patients, with out-of-pocket costs capped at $25 monthly. Multi-State Medicaid Pharmaceutical Purchasing Group adds ELYXYB® to its purchasing pool. Scilex aims to improve patient affordability and access to non-opioid pain management products.
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Scilex Holding Company (SCLX) announced the extension of the lock-up period for the shares of common stock previously distributed by Sorrento Therapeutics, Inc. The Court approved the extension to September 30, 2024, or until certain claims are resolved. This extension prohibits the sale, transfer, or disposal of the Dividend Stock.
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Scilex Holding Company (SCLX) announces capped out-of-pocket costs for its pain management products for commercially insured patients, with some eligible patients paying as low as $0. The company is focused on providing affordable non-opioid solutions, resolving issues with co-pay savings card processing, and launching a new product in 2024.
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Scilex Holding Company (SCLX) seeks FDA approval to modify Gloperba® label for dosing flexibility, targeting gout patients with renal impairment. The market potential is significant with increasing gout cases and unmet needs.
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Scilex Holding Company (SCLX) settles patent infringement lawsuit with Takeda Pharmaceuticals, granting non-exclusive license to certain patents. The terms of the agreements are confidential and subject to approval by relevant authorities.
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Scilex Holding Company (SCLX) announced paying off $1.3 million in convertible debentures and $15 million in a promissory note, signaling financial strength and readiness for growth. The company aims to develop non-opioid pain management products, expand commercialization efforts, and address the opioid crisis.
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Scilex Holding Company (Nasdaq: SCLX) announces progress in obtaining approval for ELYXYB®, a first-line treatment for migraine, in Canada. The market potential is significant, with a focus on fast and safe alternatives for acute migraine patients.
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Scilex Holding Company (SCLX) obtains Halal Certification for ZTlido, opening access to Islamic markets globally. The certification enhances the company's global expansion strategy, focusing on the Middle East and North Africa region.
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Scilex Holding Company announces approval of settlement agreement with Virpax Pharmaceuticals by U.S. Bankruptcy Court, involving payments and royalty agreements.
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FAQ

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

The current stock price of Scilex Holding Company (SCLX) is $0.4475 as of December 20, 2024.

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

The market cap of Scilex Holding Company (SCLX) is approximately 72.0M.

What does Scilex Holding Company specialize in?

Scilex specializes in acquiring, developing, and commercializing non-opioid pain management products for acute and chronic pain.

What are Scilex's main commercial products?

Scilex's main products include ZTlido (lidocaine topical system), ELYXYB (oral solution for migraines), and Gloperba (liquid colchicine for gout).

What is ZTlido used for?

ZTlido is a prescription lidocaine topical product used to relieve neuropathic pain associated with postherpetic neuralgia.

What is ELYXYB?

ELYXYB is an FDA-approved, ready-to-use oral solution for the acute treatment of migraine, with or without aura, in adults.

What recent approval has Gloperba received?

The FDA recently approved the commercial manufacturing of Gloperba, and it is set to launch in June 2024.

What are Scilex's current product candidates?

Scilex's product candidates include SP-102 (SEMDEXA), SP-103 (triple-strength ZTlido), and SP-104 (low-dose naltrexone hydrochloride).

What is SP-102?

SP-102, or SEMDEXA, is a viscous gel formulation of dexamethasone sodium phosphate for epidural injections to treat lumbosacral radicular pain, such as sciatica.

What is the significance of the FDA Fast Track status for SP-103?

The FDA Fast Track status for SP-103, a triple-strength lidocaine topical product, expedites its development and review process for treating chronic neck pain.

When will Gloperba be available in pharmacies?

Gloperba is expected to be available in major wholesalers and pharmacies starting June 10, 2024.

Where is Scilex Holding Company headquartered?

Scilex Holding Company is headquartered in Palo Alto, California.

Scilex Holding Company

Nasdaq:SCLX

SCLX Rankings

SCLX Stock Data

72.01M
128.90M
32.79%
18.16%
4.03%
Drug Manufacturers - General
Biological Products, (no Disgnostic Substances)
Link
United States of America
PALO ALTO