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.
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Scilex Holding Company (Nasdaq: SCLX) achieved significant milestones in 2023 and outlined ambitious goals for 2024. The company reported impressive financial growth, FDA approvals, and strategic expansions.
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Scilex Holding Company (Nasdaq: SCLX) provided preliminary unaudited financial results for gross and net sales for the fiscal year ended December 31, 2023. ZTlido gross sales for 2023 were estimated to be in the range of $145.0 million to $150.0 million, representing a growth of approximately 51% to 56% compared to 2022. ZTlido net sales for 2023 were in the range of $46.0 million to $52.0 million, showing a growth of approximately 21% to 37% compared to 2022. Total product gross sales for 2023 were estimated to be in the range of $150.0 million to $155.0 million, representing a growth of approximately 56% to 61% compared to 2022. Total product net sales for 2023 were in the range of $46.5 million to $52.5 million, showing a growth of approximately 22% to 38% compared to 2022.
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Scilex Holding Company (Nasdaq: SCLX) has filed a New Drug Submission for ELYXYB® with Health Canada for the approval of the first-line treatment for migraine, with or without aura, in Canada. The U.S. oral migraine drug market size is estimated to be $2.3 billion in 2025, and the Canadian migraine therapeutics market is estimated to reach approximately $400 million by 2025. ELYXYB® has the potential to be a fast-acting, safe alternative for acute migraine patients with insufficient response to triptan therapy or contraindications to triptan use, providing pain relief in as little as 15 minutes.
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Scilex Holding Company (SCLX) announced that ZTlido® is the most prescribed non-opioid branded pain treatment, with a 14.2% market share in October 2023, compared to 11.8% in October 2022. Year-to-date gross sales through November 2023 were in the range of $125.0 million to $135.0 million, representing growth of approximately 48% to 60%. Projected full-year gross sales for ZTlido® in 2023 are estimated to be in the range of $140.0 million to $150.0 million, compared to $96.0 million in 2022, representing estimated growth of approximately 46% to 56%.
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Scilex Holding Company (Nasdaq: SCLX) announced the market research study among rheumatologists revealed a high degree of interest in Gloperba® as a liquid colchicine formulation designed for precision dosing. The gout treatment market is projected to reach $2.0 billion in the U.S. by 2028, indicating a significant market opportunity for Gloperba®. Scilex is well-positioned to market and distribute Gloperba® with its experienced commercial and managed care team. The company is currently in discussions with the FDA regarding dosing recommendations for patient populations, reflecting a proactive approach to addressing clinical needs.
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Scilex Holding Company (Nasdaq: SCLX) announced a national leading pharmacy chain to stock ELYXYB®, the first and only ready to use oral solution designed to deliver fast and long-lasting migraine relief with the proven safety of COX-2 selectivity that is FDA-approved for the acute treatment of migraine, with or without aura, in adults. Clinicians expressed their desire for fast and safe alternatives for acute migraine patients, and ELYXYB®'s product profile mapped with a high degree of certainty to these stated unmet needs. In clinical studies, patients treated with ELYXYB® demonstrated pain relief in as little as 15 minutes, and significant pain relief compared to placebo within 45 minutes in approximately 50% of patients.
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Scilex Holding Company (Nasdaq: SCLX) has signed an insurance coverage agreement for ELYXYB® with a national PBM, potentially expanding coverage of ELYXYB® for their Medicare population. ELYXYB® is the first ready-to-use oral solution designed to deliver fast and long-lasting migraine relief with the proven safety of COX-2 selectivity. Clinicians expressed their desire for fast and safe alternatives for acute migraine patients, and ELYXYB®'s product profile meets these unmet needs. Patients treated with ELYXYB® demonstrated pain relief in as little as 15 minutes in clinical studies. The Scilex commercial team continues to demonstrate success in expanding access for ELYXYB®.
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Scilex Holding Company (Nasdaq: SCLX) announced that two states voted to add ZTlido® to their Medicaid Preferred Drug Lists, potentially improving access for approximately 5.0 million lives.
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Scilex Holding Company (Nasdaq: SCLX) announced that the State of Tennessee added ZTlido® to the Medicaid Preferred Drug List, potentially improving access for approximately 1,500,000 adult lives. Jaisim Shah, CEO, highlighted the company's commitment to expanding ZTlido's use and offering non-opioid pain management solutions.
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Scilex Holding Company (Nasdaq: SCLX) announced impressive growth in monthly and year-to-date revenue for November 2023. ZTlido gross sales are estimated to be in the range of $14.0 million to $15.0 million with year-to-date gross sales through November 2023 in the range of $125.0 million to $135.0 million, representing growth of approximately 48% to 60% compared to the same period in 2022. Projected full-year gross sales for ZTlido in 2023 are estimated to be in the range of $140.0 million to $150.0 million, indicating estimated growth of approximately 46% to 56%. Net sales for ZTlido and total product gross and net sales also show significant growth compared to the previous year.
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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)
United States of America
PALO ALTO