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PALO ALTO, Calif. - Scilex Holding Company (NASDAQ:SCLX), a pharmaceutical firm specializing in non-opioid pain management, announced today that the U.S. Food and Drug Administration (FDA) has approved its request for Orphan Drug Designation for colchicine, marketed as Gloperba®, for the treatment of pericarditis. This designation is for drugs intended to treat rare diseases affecting fewer than 200,000 individuals in the U.S. According to InvestingPro data, Scilex has demonstrated strong revenue growth of 21% over the last twelve months, with an impressive gross profit margin of 70.5%.
Gloperba®, a liquid oral formulation of colchicine, is designed for ease of use, particularly for patients who have difficulty swallowing pills. It is currently indicated for the prevention of gout flares in adults and offers adjustable dosing, which may be beneficial for patients with renal or hepatic impairment. While the company’s stock has faced recent market challenges, InvestingPro analysts anticipate sales growth in the current year, with multiple additional bullish indicators available to Pro subscribers.
The Orphan Drug Act provides incentives for the development of drugs for rare diseases, including a seven-year period of exclusive marketing rights upon FDA approval for the designated indication. However, the designation does not change the standard regulatory requirements and review timelines for drug approval.
Scilex, headquartered in Palo Alto, California, focuses on the development and commercialization of non-opioid therapies for acute and chronic pain. Its portfolio includes ZTlido® for postherpetic neuralgia pain, ELYXYB® for acute migraine treatment, and Gloperba® for gout flare prophylaxis. Based on InvestingPro’s Fair Value analysis, the company appears undervalued at current market prices, presenting a potential opportunity for investors interested in the pharmaceutical sector.
The company also has several product candidates in development, such as SP-102 (SEMDEXA™), a gel formulation for sciatica, which has completed Phase 3 studies and received Fast Track status from the FDA.
The FDA’s Orphan Drug Designation for colchicine represents an acknowledgment of the potential for Gloperba® to address the unmet medical need for patients with pericarditis. Notably, InvestingPro analysts predict the company will achieve profitability this year, marking a potential turning point in its financial trajectory. This news is based on a press release statement from Scilex Holding Company and complementary financial analysis from InvestingPro.
In other recent news, Scilex Holding Company announced Health Canada’s approval of ELYXYB, a celecoxib oral solution, for the acute treatment of migraines in adults. This development offers a new treatment option for nearly five million Canadians affected by migraines. Additionally, Scilex declared a 1-for-35 reverse stock split of its common stock to comply with Nasdaq’s minimum bid price requirement. This move will consolidate approximately 243 million outstanding shares into about 6.9 million shares, with no fractional shares issued. Following this announcement, Boral Capital downgraded Scilex’s stock rating from Buy to Hold, adopting a cautious approach as the company undergoes these changes. The reverse stock split will also adjust the exercise and conversion prices of certain securities, including warrants and stock options. Scilex also voluntarily terminated its Sales Agreement with B. Riley Securities Inc., Cantor Fitzgerald & Co., and H.C. Wainwright & Co., LLC, which previously allowed the sale of its common stock. This decision, which resulted in gross proceeds of approximately $2.69 million, was made without penalty.
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