Scilex Holding Co Stock Price, News & Analysis

Scilex Holding Company (Nasdaq: SCLX), a company focused on non-opioid pain management products, announced the acceptance of a presentation at the 2024 American College of Rheumatology Convergence conference. The presentation, titled 'Prophylaxis of Gout Flares in Patients with Renal Impairment: Dosing Adjustments with Colchicine Oral Solution Informed by a Pharmacokinetic Model', will be held on November 16, 2024.

The presentation will focus on GLOPERBA®, the first liquid formulation of colchicine, which offers precision dosing for at-risk gout patients. Scilex recently received FDA approval for an updated GLOPERBA® label, allowing for dosage adjustments in various clinical situations, including a reduced daily dose for patients with severe renal impairment.

Semnur Pharmaceuticals, a subsidiary of Scilex Holding Company (SCLX), has signed a merger agreement with Denali Capital Acquisition Corp (DECA) for a proposed business combination. The deal values Semnur at $2.5 billion pre-transaction. This merger aims to create a publicly traded biopharma company, focusing on Semnur's non-opioid product SP-102 (SEMDEXA™), a Phase 3 novel gel for treating sciatica.

Key points:

• SP-102 has FDA Fast Track status and projected annual sales of $1.5-$2.0 billion by the 5th year of launch
• The merger is expected to close by Q1 2025
• Scilex will remain the majority shareholder of the combined company
• The combined company will be renamed Semnur Pharmaceuticals, Inc. and listed on Nasdaq as 'SMNR'

Scilex Holding Company (Nasdaq: SCLX), a non-opioid pain management company, will present research on ZTlido (lidocaine topical system) at the 2024 Annual PAINWeek conference in Las Vegas, NV, September 3-5, 2024. Key highlights include:

1. A non-CME presentation by Dr. Charles Argoff on September 4, discussing pain relief options when gabapentinoids are insufficient.

2. Two presentations by Dr. Srinivas Nalamachu on September 5, comparing Lidocaine Topical System 1.8% to Lidocaine 5% Patch, focusing on decreased opioid utilization and cost effectiveness.

These presentations aim to showcase ZTlido's potential in addressing unmet needs in pain management, particularly for patients with neuropathic pain conditions like PHN.

Scilex Holding Company (Nasdaq: SCLX) announced FDA approval for label updates to GLOPERBA®, the first and only liquid oral version of colchicine for gout flare prophylaxis in adults. This approval allows for precision dosing, particularly beneficial for the 70% of gout patients with chronic kidney disease or gastrointestinal sensitivity who may require lower doses than the standard 0.6 mg tablet.

GLOPERBA® enables dosage reduction to 0.3 mg/day for patients with severe renal impairment. The gout treatment market is projected to reach $2.0 billion in the U.S. by 2028. A recent market study showed high interest among rheumatologists in GLOPERBA® for at-risk patient populations needing lower precision dosing to mitigate colchicine toxicity risk.

Scilex Holding Company (NASDAQ: SCLX) announced that the U.S. Patent and Trademark Office will issue a new patent for ELYXYB®, their acute migraine treatment drug, in late 2024. This patent strengthens Scilex's intellectual property position for ELYXYB®, a liquid, micro-encapsulation formulation of celecoxib.

ELYXYB® is the only FDA-approved, ready-to-use oral solution for acute migraine treatment in adults. It offers a non-opioid alternative to habit-forming opioids and acetaminophen. In clinical studies, ELYXYB® demonstrated pain relief in as little as 15 minutes, with significant relief compared to placebo within 45 minutes in about 50% of patients.

The U.S. oral migraine drug market was estimated at $1.8 billion in 2022, while the total acute pain market in the U.S. was approximately $3 billion in 2021. Scilex launched ELYXYB® in the U.S. in April 2023, positioning it as a fast-acting treatment with potentially lower gastrointestinal side effects compared to other NSAIDs.

Scilex Holding Company (Nasdaq: SCLX) has entered into a Master Distributor Agreement with Devart Middle East Food Supplements and CH Trading Group to expand the distribution of ZTlido® in Morocco, Tunisia, Libya, Jordan, Iraq, and South Africa. ZTlido® is a lidocaine topical system approved for relief of neuropathic pain associated with post-herpetic neuralgia (PHN).

Key points:

• ZTlido® is the #1 prescribed, non-opioid, branded pain medication by pain specialists in the US
• Over 1 million US patients treated since launch
• 89% patient satisfaction rate in a 2023 survey
• Designed for improved adhesion and continuous 12-hour pain relief

This agreement expands Scilex's reach in Middle East and North/South Africa markets, potentially including other products from their non-opioid pain portfolio.

Scilex Holding Company (Nasdaq: SCLX) has released preliminary unaudited financial results for July 31, 2024, showing significant growth in sales. ZTlido net sales for the month were estimated between $4.0 million to $5.0 million, representing a 48% to 85% increase compared to the same period last year. Total product net sales ranged from $4.3 million to $5.3 million, indicating a 54% to 89% growth year-over-year. These figures demonstrate Scilex's continuous sales growth, particularly in its ZTlido product line, as the company enters the third quarter of 2024. However, it's important to note that these are preliminary estimates and may be subject to change upon final review and audit.

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.