Scilex FDA submission for ELYXYB acute pain treatment acknowledged

PALO ALTO, Calif. - Scilex Holding Company (NASDAQ:SCLX), a $77.5 million market cap company known for its focus on non-opioid pain management products, reported that the U.S. Food and Drug Administration (FDA) has acknowledged the receipt of its Supplemental New Drug Application (SNDA) for ELYXYB, intended for the treatment of acute pain. This development marks a potential expansion of Scilex's portfolio in the pain management sector. Despite challenging market conditions that have seen the stock decline over 72% in the past year, the company maintains a healthy gross profit margin of 70%.

ELYXYB, currently approved for use in adults for the acute treatment of migraine, is being considered for broader application in acute pain management. The acknowledgment of the SNDA by the FDA is a procedural step, indicating that the submission has been officially received and will undergo a review process. However, it does not imply any form of approval or assessment of the drug's efficacy or safety for the new indication.

Scilex's commitment to advancing pain management includes a range of products such as ZTlido, a topical system for postherpetic neuralgia pain, and Gloperba, an oral solution for gout flare prophylaxis. Additionally, the company has product candidates in various stages of clinical development aimed at addressing unmet needs in pain treatment. According to InvestingPro data, the company has achieved impressive revenue growth of 22% over the last twelve months, though analysts anticipate continued profitability challenges in the near term. InvestingPro subscribers have access to 7 additional key insights about Scilex's financial health and market position.

The company is also exploring a joint venture with IPMC Company to potentially develop and commercialize treatments for neurodegenerative and cardiometabolic diseases. This collaboration could diversify Scilex's therapeutic offerings beyond pain management.

The press release statement from Scilex Holding Company emphasizes the company's strategic direction and its efforts in non-opioid pain management. It is important to note that the FDA’s acceptance of the SNDA is just one step in the process, and the outcome of the review is not guaranteed.

As Scilex awaits further developments, investors and stakeholders in the pharmaceutical industry will be monitoring the progress of ELYXYB's SNDA, as well as the company's broader non-opioid pain management portfolio. With analyst price targets ranging from $6.25 to $14.00, significantly above current trading levels, InvestingPro analysis suggests the stock may be undervalued. The successful expansion of ELYXYB's indications could potentially meet high unmet needs in the treatment of acute pain, pending FDA review and approval.

In other recent news, Scilex Holding Company has made significant strides in its financial and operational performance. The company recently completed a $17 million direct stock and warrant offering, which included over 26 million shares of common stock and warrants. The funds raised will be allocated for general corporate purposes, including research and development, commercialization, and potential acquisitions or debt repayment.

Scilex has also sought FDA approval for ELYXYB in acute pain management, potentially offering a non-opioid alternative in this field. The company has also reported significant pain relief over six hours with ELYXYB in a double-blind, placebo-controlled study involving 120 adults following dental surgery.

In addition, Scilex has announced a joint venture with IPMC, named Scilex Bio, to develop and commercialize KDS2010, a new treatment for obesity and neurodegenerative diseases currently in Phase 2 clinical trials. This venture will hold global rights for KDS2010, with Scilex contributing $50 million of Semnur Pharmaceuticals, Inc. common stock and IPMC providing the exclusive rights to the compound.

Furthermore, Scilex has reached agreements leading to the sale of a significant portion of its stock to meet debt obligations. The company has also appointed BPM LLP as its new independent registered public accounting firm, ensuring high standards of financial reporting and compliance. Analysts from H.C. Wainwright maintain a Buy rating on Scilex, indicating a positive outlook for the company. These are the recent developments at Scilex Holding Company.

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