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 (Nasdaq: SCLX), a company focused on non-opioid pain management products, has released its inaugural sustainability report. The report highlights the company's efforts in:
- Environmental stewardship: Commitment to reducing environmental footprint
- Development excellence: Improving patients' lives through innovative non-opioid pain management medicines
- Social responsibility: Ethical business practices, respecting employee rights, and fostering diversity
- Governance: Transparent corporate governance for accountability
CEO Jaisim Shah emphasized Scilex's strategy to advance patient health, foster an inclusive workforce, and reduce environmental impact. The company is committed to expanding access to non-opioid pain management products and investing in scientific excellence. This report demonstrates Scilex's commitment to innovation, responsibility, and growth in areas where they can have the greatest impact.
Scilex Holding Company (SCLX), a non-opioid pain management company, has appointed Dr. Annu Navani to its Board of Directors. Dr. Navani is a highly accomplished leader in interventional and multidisciplinary spine, musculoskeletal, and orthopedic care. She is the former CEO of Comprehensive Spine and Sports Center and current CMO of Boomerang Healthcare. Dr. Navani also serves as an Adjunct Clinical Associate Professor at Stanford University School of Medicine and has extensive experience in pain management and regenerative medicine.
The appointment aims to strengthen Scilex's board with Dr. Navani's expertise in pain management and her track record in both academia and private practice. This addition is expected to support Scilex's growth and advancement of its commercial non-opioid and innovative pipeline of investigational products for acute and chronic pain therapies.
Scilex Holding Company (Nasdaq: SCLX) has entered a Memorandum of Understanding (MOU) with ACEA Therapeutics for collaboration on ZTlido®, a lidocaine topical system for neuropathic pain relief. The agreement grants ACEA exclusive rights to develop and commercialize ZTlido® in Greater China, including mainland China, Taiwan, Hong Kong, and Macau. ACEA will serve as the exclusive distributor in these territories, with a potential minimum purchase commitment once ZTlido® is locally approved.
The collaboration aims to expand Scilex's non-opioid pain management portfolio in the Greater China region. The pain management market in mainland China was valued at US$17.5 billion in 2022, with an annual growth rate of 5.64%. This partnership aligns with Scilex's mission to provide innovative non-opioid medicines to acute and chronic pain patients worldwide.
Semnur Pharmaceuticals, a wholly owned subsidiary of Scilex Holding Company (Nasdaq: SCLX), and Denali Capital Acquisition Corp. (Nasdaq: DECA) have signed a letter of intent for a proposed business combination. This deal values Semnur at up to $2 billion, subject to adjustments, with an expected cash on hand of up to $40 million. The business combination aims to fund the development of SP-102 (SEMDEXA™), a non-opioid corticosteroid gel for treating sciatica. The Phase 3 trial of SP-102 met key endpoints, showing significant pain reduction and safety comparable to placebo. If approved, Semnur will become a publicly traded biopharma company, and Scilex will be the majority shareholder. The transaction is pending final agreement and shareholder approval.
Scilex Holding Company (Nasdaq: SCLX), a company specializing in non-opioid pain management products, will ring the Nasdaq Closing Bell on July 5, 2024, to celebrate the launch of GLOPERBA®, the first oral liquid medicine for the prophylactic treatment of painful gout flares. CEO Jaisim Shah and Executive Chairman Henry Ji will lead the ceremony. The company’s product portfolio includes multiple FDA-approved pain management solutions, with new pipeline programs in advanced stages. This event marks Scilex’s third non-opioid product launch in five years, highlighting its strategic focus on innovative pain management solutions.
Scilex Holding Company, under the ticker SCLX, has released its preliminary unaudited financial results for June 2024 and the second quarter of 2024. ZTlido net sales in June 2024 grew by 70% to 104% year-over-year, with quarterly growth between 28% to 42%. Total product net sales for June 2024 increased 77% to 116% year-over-year, while quarterly growth ranged from 30% to 44%. ZTlido gross sales for June reached $22 million to $26 million.
Cash reserves dropped to $7 million to $10 million from $34.1 million in the previous year. Accounts receivable increased to $38 million to $40 million from $27.6 million. Operating expenses decreased to $23 million to $26 million from $31.2 million, and net loss narrowed to $15 million to $20 million from $26.6 million last year.
This data is preliminary and unaudited, and actual results may vary significantly.
Scilex Holding Company (Nasdaq: SCLX), focused on non-opioid pain management products, announced a new distribution agreement with Endeavor Distribution Endeavor, with over 10 years of logistics experience, will distribute Scilex's products nationally.
This agreement aims to enhance the commercialization of Scilex's three non-opioid products, ZTlido, ELYXYB, and Gloperba, by leveraging Endeavor's expertise in logistics and distribution. CEO Jaisim Shah emphasized that this partnership is part of Scilex's strategy to accelerate growth and successfully launch their products to specialized point-of-care customers.
Scilex Holding Company (Nasdaq: SCLX) has published the results of its Phase 3 trial for SP-102 (SEMDEXA™) in the PAIN journal. Conducted on 401 patients with lumbosacral radicular pain (sciatica), the trial achieved its primary and key secondary endpoints, showcasing significant pain reduction and improved disability scores with a safety profile comparable to a placebo. The results, first presented at the ASIPP conference in May 2022, indicate that SP-102 could become a important treatment for sciatica, which currently lacks FDA-approved therapies. The study, known as the C.L.E.A.R. trial, confirmed the safety of both single and repeat injections of SP-102, with no serious adverse events reported.
Scilex Holding Company (Nasdaq: SCLX) will present a poster on ELYXYB® (celecoxib oral solution) at the 66th Annual Scientific Meeting of the American Headache Society (AHS) in San Diego, CA, from June 13-16, 2024. The poster will highlight results from two Phase 3 clinical trials, showing ELYXYB®'s efficacy in migraine patients with insufficient response to triptans. Specifically, 33.3% of patients treated with ELYXYB® achieved 2-hour pain freedom compared to 14.3% with placebo (p=0.0036), with a 200% greater likelihood of achieving pain freedom (OR=3.0). Dr. Richard B. Lipton, Director of the Montefiore Headache Center, will be the presenting author.
For more details, visit the company's website or view the poster presentation online.
Scilex Holding Company (Nasdaq: SCLX) has entered into a commitment letter with Perigrove and Graf Holdings for a $100 million 5-year term financing with royalty-based payments. The funds will be used primarily to repay an existing $85 million senior secured loan from Oramed Pharmaceuticals, with $15 million allocated for general corporate purposes. The financing includes the issuance of a warrant to purchase up to 32.5 million shares of Scilex's common stock at $1.20 per share. If the Commitment is not funded, the deposit will convert into an unsecured loan with a 5-year maturity and an interest rate based on either a percentage of net sales or 12% per year. This financing aims to eliminate existing debt and improve Scilex's cash position, allowing for reinvestment in their commercial products.
FAQ
What is the current stock price of Scilex Holding Company (SCLX)?
What is the market cap of Scilex Holding Company (SCLX)?
What does Scilex Holding Company specialize in?
What are Scilex's main commercial products?
What is ZTlido used for?
What is ELYXYB?
What recent approval has Gloperba received?
What are Scilex's current product candidates?
What is SP-102?
What is the significance of the FDA Fast Track status for SP-103?
When will Gloperba be available in pharmacies?
Where is Scilex Holding Company headquartered?
