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 (SCLX) announced a successful end of Phase II meeting with FDA for SP-103, a triple-strength formulation of ZTlido for chronic neck pain treatment. The FDA provided a clear path to NDA following Phase III trials completion. SP-103, a lidocaine topical system 5.4%, targets the U.S. low back and neck pain market, projected to reach $134.5 billion. According to Syneos Health Consulting research, SP-103's peak sales potential is estimated at $1.2 billion annually by the 6th year post-launch. The company currently has three FDA-approved commercial products: ZTlido, ELYXYB, and Gloperba.
Scilex Holding Company (NASDAQ: SCLX) has set a record date of November 7, 2024, for a preferred stock dividend distribution. The company reports concerns about manipulative and naked short selling of its common stock. Of approximately 197 million outstanding shares: 76 million are restricted until January 2025, 60 million were repurchased, and 60 million constitute the public float. Management believes over 12 million shares are being sold short, with an additional 10 million shares in naked short positions. The company provides guidance to stockholders on recalling loaned shares and demanding delivery of dividend shares from brokerage firms.
Scilex Holding Company (NASDAQ: SCLX) has set November 7, 2024, as the record date for a dividend distribution of 5,000,000 shares of Series 1 Mandatory Exchangeable Preferred Stock. This preferred stock will be exchangeable for up to 10% of Scilex's ownership in Semnur Pharmaceuticals, its wholly-owned subsidiary. The exchange will occur following Semnur's proposed business combination with Denali Capital Acquisition Corp, valued at $2.5 billion pre-transaction. Based on Syneos Health Consulting research, Semnur's SP-102 product candidate is projected to reach peak sales of $3.6 billion annually in the 5th year post-launch. The business combination is expected to close by Q1 2025.
Scilex Holding Company (Nasdaq: SCLX) has announced that its board of directors has authorized management to explore ways to maximize the value of its wholly owned subsidiary, Scilex Pharmaceuticals. This includes potentially conducting a spinoff or public listing of Scilex Pharma securities in markets outside the U.S., such as Hong Kong. The company believes that Scilex Pharma's potential value may exceed Scilex Holding Company's current valuation.
Scilex Pharma has three FDA-approved commercial products in the market:
- ZTlido®: A lidocaine topical system for neuropathic pain relief
- ELYXYB®: An oral solution for acute migraine treatment
- Gloperba®: A liquid oral anti-gout medicine
Additionally, Scilex Pharma is developing SP-103, a next-generation, triple-strength formulation of ZTlido for acute pain treatment, with a projected peak sales potential of $1.2 billion annually.
Semnur Pharmaceuticals, a subsidiary of Scilex Holding Company (NASDAQ: SCLX), plans to file a Registration Statement on Form S-4 with the SEC by October 2024 for its proposed business combination with Denali Capital Acquisition Corp. (NASDAQ: DECA). The deal values Semnur at a pre-transaction equity value of $2.5 billion. The transaction is expected to close by Q4 2024 or Q1 2025.
Semnur is in discussions for potential collaborations or acquisition of SP-102, which could exceed the $2.5 billion valuation post-merger. An independent study projects SP-102 (SEMDEXA™) to reach peak annual sales of $3.6 billion by the 5th year post-launch. Scilex's board has approved a potential dividend of up to 10% of its Semnur ownership to Scilex shareholders, subject to SEC registration.
Scilex Holding Company (Nasdaq: SCLX), a non-opioid pain management company, has released preliminary unaudited financial results for Q3 2024. Key highlights include:
- ZTlido net sales estimated between $11.0 million to $13.0 million, up 9% to 29% from $10.1 million in Q3 2023.
- Total product net sales projected between $12.0 million to $14.0 million, representing a 19% to 39% increase from $10.1 million in the same period last year.
The company notes that these figures are preliminary and subject to change pending full review and audit. Scilex focuses on acquiring, developing, and commercializing non-opioid pain management products for acute and chronic pain treatment.
Scilex Holding Company (Nasdaq: SCLX) has closed a $50 million registered convertible financing. The company issued new tranche B senior secured convertible notes and warrants to purchase up to 7,500,000 shares of common stock. The notes have a 10% original issue discount, 5.5% annual interest rate, and mature in two years. Scilex received $22.5 million in cash and a $22.5 million reduction in its existing debt with Oramed Pharmaceuticals. The notes are convertible at $1.09 per share, and the warrants have an exercise price of $1.09. Net proceeds of approximately $20.5 million will be used for debt repayment, satisfying certain costs, and working capital. The offering was made under a shelf registration statement and placed by StockBlock Securities and Rodman & Renshaw
Oramed Pharmaceuticals (ORMP) announced a restructuring of its debt with Scilex Holding Company (SCLX). Key points:
- Oramed agreed to restructure $22.5 million of Scilex's existing Senior Secured Promissory Note
- In exchange, Oramed receives a $25 million convertible note with 5.5% interest, warrants for 3.75 million Scilex shares, and $12.5 million repayment
- Oramed and other investors will acquire rights to an 8% royalty on net sales of certain Scilex products, including ZTlido
- The restructuring extends part of the payment schedule but offers potential upside through warrants and conversion options
CEO Nadav Kidron stated the restructuring enhances the potential value of Oramed's investment in Scilex while aligning with their strategy to maximize shareholder value.
Scilex Holding Company (Nasdaq: SCLX) has announced a $50 million registered convertible financing to refinance and restructure existing debt, strengthening its financial profile. The offering involves affiliates of Murchinson, 3i LP, and Oramed Pharmaceuticals, Inc., and is expected to close on October 7, 2024. Key points include:
1. Issuance of new tranche B senior secured convertible notes and warrants.
2. Exchange and reduction of $22.5 million principal balance under the existing Oramed Note.
3. Retirement of the revolving facility with eCapital Healthcare Corp.
4. Over the past 12 months, Scilex has addressed and restructured debt with payments exceeding $80 million.
5. The financing aims to position Scilex for sustainable, long-term growth in its plan to become a leading non-opioid pain management company.
Scilex Holding Company (Nasdaq: SCLX) announced that the U.S. Bankruptcy Court for the Southern District of Texas has extended the lock-up period on Scilex Dividend Stock, previously distributed by Sorrento Therapeutics, Inc. (OTC: SRNEQ) to its stockholders, to January 31, 2025. This extension applies only to the Dividend Stock and not to other Scilex securities. The lock-up was previously set to expire on September 30, 2024. As a result, shares of the Dividend Stock, including those held by brokerage firms, cannot be sold, transferred, or disposed of until the new expiration date. Scilex's transfer agent, Continental Stock Transfer & Trust Company, has been notified of this extension.
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