PALO ALTO, Calif., Jan. 21, 2025 (GLOBE NEWSWIRE) -- Scilex Holding Company (Nasdaq: SCLX, Scilex oregon Company), an innovative revenue-generating institution focused connected acquiring, processing and commercializing non-opioid symptom absorption products for the attraction of acute and chronic symptom and, pursuing the enactment of its projected associated task with IPMC Company, neurodegenerative and cardiometabolic disease, contiguous announced that it has received notification from The Nasdaq Stock Market LLC that the Company has regained compliance with Nasdaq Listing Rule 5250(c)(1) arsenic a effect of the filing of its Quarterly Report connected Form 10-Q for the 4th ended September 30, 2024.
For much accusation connected Scilex Holding Company, notation to www.scilexholding.com
For much accusation connected Semnur Pharmaceuticals, Inc., notation to www.semnurpharma.com
For much accusation connected Scilex Holding Company Sustainability Report, notation to www.scilexholding.com/investors/sustainability
For much accusation connected ZTlido ® including Full Prescribing Information, notation to www.ztlido.com.
For much accusation connected ELYXYB ®, including Full Prescribing Information, notation to www.elyxyb.com.
For much accusation connected Gloperba ®, including Full Prescribing Information, notation to www.gloperba.com.
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About Scilex Holding Company
Scilex Holding Company is an innovative revenue-generating institution focused connected acquiring, processing and commercializing non-opioid symptom absorption products for the attraction of acute and chronic symptom and, pursuing the enactment of its projected associated task with IPMC Company, neurodegenerative and cardiometabolic disease. Scilex targets indications with precocious unmet needs and ample marketplace opportunities with non-opioid therapies for the attraction of patients with acute and chronic symptom and is dedicated to advancing and improving diligent outcomes. Scilex's commercialized products include: (i) ZTlido ® (lidocaine topical system) 1.8%, a medicine lidocaine topical merchandise approved by the U.S. Food and Drug Administration (the FDA) for the alleviation of neuropathic symptom associated with postherpetic neuralgia, which is simply a signifier of post-shingles nervus pain; (ii) ELYXYB ®, a imaginable first-line attraction and the lone FDA-approved, ready-to-use oral solution for the acute attraction of migraine, with oregon without aura, successful adults; and (iii) Gloperba ®, the archetypal and lone liquid oral mentation of the anti-gout medicine colchicine indicated for the prophylaxis of achy gout flares successful adults.
In addition, Scilex has 3 merchandise candidates: (i) SP-102 (10 mg, dexamethasone sodium phosphate viscous gel) (SEMDEXA™ oregon SP-102), a novel, viscous gel formulation of a wide utilized corticosteroid for epidural injections to dainty lumbosacral radicular pain, oregon sciatica, for which Scilex has completed a Phase 3 survey and was granted Fast Track presumption from the FDA successful 2017; (ii) SP-103 (lidocaine topical system) 5.4%, (SP-103), a next-generation, triple-strength formulation of ZTlido, for the attraction of acute symptom and for which Scilex has precocious completed a Phase 2 proceedings successful acute debased backmost pain. SP-103 has been granted Fast Track presumption from the FDA successful debased backmost pain; and (iii) SP-104 (4.5 mg, low-dose naltrexone hydrochloride delayed-release capsules) (SP-104), a caller low-dose delayed-release naltrexone hydrochloride being developed for the attraction of fibromyalgia.
Scilex Holding Company is headquartered successful Palo Alto, California.
About Semnur Pharmaceuticals, Inc.
Semnur Pharmaceuticals, Inc. (Semnur) is simply a objective late-stage specialty pharmaceutical institution focused connected the improvement and commercialization of caller non-opioid symptom therapies. Semnur's merchandise candidate, SP-102 (SEMDEXA™), is the archetypal non-opioid caller gel formulation administered epidurally successful improvement for patients with mean to terrible chronic radicular pain/sciatica.
Semnur Pharmaceuticals, Inc. is headquartered successful Palo Alto, California.
Forward-Looking Statements
This property merchandise and immoderate statements made for and during immoderate presumption oregon gathering concerning the matters discussed successful this property merchandise incorporate forward-looking statements related to Scilex and its subsidiaries nether the harmless harbor provisions of Section 21E of the Private Securities Litigation Reform Act of 1995 and are taxable to risks and uncertainties that could origin existent results to disagree materially from those projected. Forward-looking statements see statements regarding Scilex's projected associated task with IPMC Company and the imaginable improvement and commercialization of treatments for obesity, neurodegenerative, cardiometabolic disease.
Risks and uncertainties that could origin Scilex's existent results to disagree materially and adversely from those expressed successful our forward-looking statements, include, but are not constricted to: Scilex's quality to regain compliance with the Nasdaq continued listing standards and to support the listing of the Company's securities thereon, Scilex's quality to consummate a associated task oregon immoderate different transaction with IPMC Company and make and commercialize treatments for obesity, neurodegenerative, cardiometabolic disease; risks associated with the unpredictability of trading markets and whether a marketplace volition beryllium established for Scilex's communal stock; wide economic, governmental and concern conditions; risks related to COVID-19 (and different akin disruptions); the hazard that the imaginable merchandise candidates that Scilex develops whitethorn not advancement done objective improvement oregon person required regulatory approvals wrong expected timelines oregon astatine all; risks relating to uncertainty regarding the regulatory pathway for Scilex's merchandise candidates; the hazard that Scilex volition beryllium incapable to successfully marketplace oregon summation marketplace acceptance of its merchandise candidates; the hazard that Scilex's merchandise candidates whitethorn not beryllium beneficial to patients oregon successfully commercialized; the hazard that Scilex has overestimated the size of the people diligent population, their willingness to effort caller therapies and the willingness of physicians to prescribe these therapies; risks that the result of the trials and studies for SP-102, SP-103 oregon SP-104 whitethorn not beryllium palmy oregon bespeak affirmative outcomes; risks that the anterior results of the objective and investigator-initiated trials of SP-102 (SEMDEXA™), SP-103 oregon SP-104 whitethorn not beryllium replicated; regulatory and intelligence spot risks; and different risks and uncertainties indicated from clip to clip and different risks described successful Scilex's astir caller periodic reports filed with the Securities and Exchange Commission, including Scilex's Annual Report connected Form 10-K for the twelvemonth ended December 31, 2023 and consequent Quarterly Reports connected Form 10-Q that the Company has filed oregon whitethorn record with the SEC, including the hazard factors acceptable distant successful those filings. Investors are cautioned not to spot undue reliance connected these forward-looking statements, which talk lone arsenic of the day of this release, and Scilex undertakes nary work to update immoderate forward-looking connection successful this property merchandise but arsenic whitethorn beryllium required by law.
Contacts:
Investors and Media
Scilex Holding Company
960 San Antonio Road
Palo Alto, CA 94303
Office: (650) 516-4310
Email: investorrelations@scilexholding.com
Website: www.scilexholding.com
SEMDEXA™ (SP-102) is simply a trademark owned by Semnur Pharmaceuticals, Inc., a wholly-owned subsidiary of Scilex Holding Company. A proprietary sanction reappraisal by the FDA is planned.
ZTlido ® is simply a registered trademark owned by Scilex Pharmaceuticals Inc., a wholly-owned subsidiary of Scilex Holding Company.
Gloperba ® is the taxable of an exclusive, transferable licence to Scilex Holding Company to usage the registered trademark.
ELYXYB ® is simply a registered trademark owned by Scilex Holding Company.
All different trademarks are the spot of their respective owners.
© 2025 Scilex Holding Company All Rights Reserved.
Source: Scilex Holding Company