PALO ALTO, Calif. - Scilex Holding Company (NASDAQ:SCLX), a firm specializing in non-opioid pain management solutions, has announced the expiration of the 45-day review period by the U.S. Federal Trade Commission and Department of Justice regarding its Settlement Agreement with Takeda Pharmaceuticals.
The U.S. District Court for the District of Delaware issued a Consent Judgment on May 3, 2024, endorsing the agreement, which resolves a patent infringement lawsuit related to Scilex's gout treatment, Gloperba.
The legal action stemmed from Scilex's attempt to expand the label of its FDA-approved liquid colchicine product, Gloperba, designed for gout prevention. As part of the settlement, Scilex and its subsidiary Scilex Pharmaceuticals Inc. have entered into a License Agreement with Takeda, granting a non-exclusive license to Takeda's patents. The specifics of these agreements remain confidential.
Following the resolution, Scilex Pharma has submitted the Consent Judgment to the FDA, seeking final approval for the proposed label expansion of Gloperba. The company believes it has met all requirements for the FDA's final nod. The label expansion aims to address dosing flexibility and provide specific guidance for patients with renal impairment, which could enhance patient adherence to treatment guidelines.
Market research among rheumatologists indicates a strong interest in Gloperba's liquid formulation, particularly for its precision dosing capabilities. This interest aligns with the American College of Rheumatology's guidelines, which advocate for dose adjustments in patients with various degrees of renal or hepatic impairment.
Scilex's product portfolio also includes ZTlido, a lidocaine topical system for post-shingles pain, and ELYXYB, an oral solution for acute migraine treatment. The company has several other products in development, including SP-102, a corticosteroid gel for sciatica pain relief, SP-103, a topical system for chronic neck pain, and SP-104, a delayed-release capsule for fibromyalgia treatment.
This announcement is based on a press release statement and reflects Scilex's current plans for Gloperba's market launch, expected in the first half of 2024. The company's forward-looking statements are subject to risks and uncertainties that could affect actual results, including regulatory approvals and market conditions.
InvestingPro Insights
In the wake of Scilex Holding Company's recent legal settlement and ongoing efforts to expand its product portfolio, current financial metrics and market performance provide a broader context for evaluating the company's prospects. Scilex operates with a significant debt burden and is quickly burning through cash, which may raise concerns about its financial stability.
Specifically, the company's market capitalization stands at 97.49 million USD, indicating a relatively small size in the pharmaceutical market. Moreover, the negative Price/Earnings (P/E) ratio of -0.62 for the last twelve months as of Q4 2023 suggests that investors are not anticipating earnings growth in the near term, and the company is not profitable at this juncture.
Despite these challenges, analysts anticipate sales growth in the current year, with a reported revenue growth of 22.9% for the last twelve months as of Q4 2023. This could signal potential for Scilex's products, including Gloperba, to gain traction in the market. Additionally, the Relative Strength Index (RSI) suggests the stock is in oversold territory, which could attract investors looking for undervalued opportunities.
InvestingPro Tips highlight that the stock has taken a significant hit over the last week, month, and year, with price total returns of -12.25%, -39.48%, and -85.12%, respectively. The company's short-term obligations also exceed its liquid assets, which may present liquidity challenges. As such, potential investors should consider these factors alongside the company's product developments when making investment decisions.
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