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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.

News

Scilex Holding Company announces successful FDA audit of enhanced ZTlido® manufacturing facility in Japan

Rhea-AI Summary
Scilex Holding Company (Nasdaq: SCLX) successfully completes FDA inspection of enhanced manufacturing facility for ZTlido®, ensuring increased capacity to meet growing demand. Two new patents covering ZTlido® in the U.S. provide proprietary protection through January 2031.
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Scilex Holding Company announces pharmacy initiative to stock ELYXYB® in over 500 stores for a leading pharmacy chain in the U.S.

Rhea-AI Summary
Scilex Holding Company (SCLX) has announced an agreement with a leading U.S. pharmacy chain to stock ELYXYB® in over 500 stores, with potential similar arrangements with other major pharmacy chains. Clinicians expressed a desire for fast and safe alternatives for acute migraine patients, which ELYXYB® addresses. Clinical studies show patients treated with ELYXYB® experienced pain relief in as little as 15 minutes, with significant pain relief compared to placebo within 45 minutes in approximately 50% of patients.
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Scilex Holding Company announces completion of commercial manufacturing of Gloperba® with the brand marketed and distributed under Scilex Pharmaceuticals, Inc. and is expecting to Launch in the U.S. in the first quarter of 2024

Rhea-AI Summary
Scilex Holding Company (SCLX) has completed commercial manufacturing of Gloperba®, the first and only liquid oral version of the anti-gout medicine colchicine, and is expecting to launch it in the U.S. in the first quarter of 2024. With the gout treatment market projected to be $2.0 billion in the U.S. by 2028, Gloperba® has the potential to address the well-defined area of unmet need in the market.
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Scilex Holding Company Announces Market Research Results with Neurologists, Headache Specialists, and Primary Care Physicians Demonstrating Potential High Unmet Needs In Treating Acute Migraine Targeted By ELYXYB® with Potential Advantages Compared to Calcitonin Gene-Related Peptide (CGRP) Products and Triptan Therapy

Rhea-AI Summary
Scilex Holding Company (SCLX) announced that Elyxyb meets the high unmet needs of clinicians treating patients with acute migraine, with and without aura, in adults. Elyxyb demonstrated pain relief in as little as 15 minutes and significant pain relief compared to placebo within 45 minutes in nearly 50% of patients. Approximately 34% of patients were pain-free at two hours. The product is preferred by physicians to address migraine attacks and is safe and well-tolerated in large Phase III clinical studies.
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Scilex Holding Company Announces Production Increase, Product Availability, and The Brand Marketed and Distributed Under Scilex Pharmaceuticals, Inc. for ELYXYB®

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Scilex Holding Company (SCLX) has increased the manufacturing of ELYXYB® to meet rising demand and stocking needs. ELYXYB® is the first ready-to-use oral solution designed to deliver fast and long-lasting migraine relief with proven safety and FDA approval. The U.S. migraine drug market size is estimated to be $4.1 billion in 2022.
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Scilex Holding Company Announces Issuance of a Second New Patent in the U.S. for Its Lead Commercial Product ZTlido® (lidocaine topical system) for a Method of Relieving Pain Through the Application of a Non-Aqueous Lidocaine-Containing Patch

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 Announces Issuance of New Patent in the U.S. for Its Lead Commercial Product ZTlido® (lidocaine topical system) for a Method of Relieving Pain Through the Application of a Lidocaine-Containing Patch

Rhea-AI Summary
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 New Data From Deeper Skin Penetration Studies to Support SP-103 (lidocaine topical system) 5.4%, a Triple Strength Formulation of ZTlido®, in Treatment of Musculoskeletal Pain Disorders

Rhea-AI Summary
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 and Reaches Agreement on Path Forward to File an NDA for SP-102 (SEMDEXATM) in Lumbosacral Radicular Pain (Sciatica)

Rhea-AI Summary
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 Generates Record Monthly Revenue In October 2023 And Provides Certain Preliminary Unaudited Financial Results For Gross And Net Sales For The One Month Ended October 2023, And Year-To-Date Through October 31, 2023, Based On Currently Available Information

Rhea-AI Summary
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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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.

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Scilex Holding Company

Nasdaq:SCLX

SCLX Rankings

#4653 Ranked by Market Cap
N/A Ranked by Dividends

SCLX Stock Data

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