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NEWPORT BEACH, Calif. - Evolus, Inc. (NASDAQ:EOLS), a $460 million market cap aesthetics company, has submitted the final module of its Premarket Approval (PMA) application to the U.S. Food and Drug Administration for Evolysse™ Sculpt, an injectable hyaluronic acid gel designed to restore mid-face volume. According to InvestingPro data, the company has shown strong revenue growth of 17% over the last twelve months.
The company expects the FDA’s review to follow the standard PMA process, with approval anticipated in the second half of 2026, according to a press release statement.
Evolysse™ Sculpt is positioned to be the flagship product in the company’s collection of injectable hyaluronic acid gels. The product was designed using Cold-X™ technology, which the company states helps preserve the natural structure of the hyaluronic acid molecule.
In support of the PMA application, Evolus conducted a U.S. pivotal study evaluating the safety and effectiveness of the product. The multicenter, double-blinded, controlled trial enrolled 304 patients who were randomized to receive either Evolysse™ Sculpt or Restylane®-Lyft, with patients followed for 24 months from initial treatment.
"Sculpt is our most structured product, manufactured using a novel technology and designed to address mid-face volume loss, a high-value segment in facial aesthetics," said Dr. Rui Avelar, Chief Medical Officer and Head of R&D at Evolus.
If approved, the product would enter what the company describes as the highest value segment of today’s dermal filler market and would be among the few products currently indicated specifically for the mid-face area.
Evolus, which trades on the Nasdaq exchange, focuses on building a portfolio of aesthetic consumer brands, with its flagship product Jeuveau®, a neurotoxin used in aesthetic procedures. Analysts maintain a positive outlook on the stock, with price targets ranging from $17 to $20. For deeper insights into Evolus’s financial health and growth prospects, including additional ProTips and comprehensive analysis, visit InvestingPro, where you’ll find the detailed Pro Research Report covering what really matters for informed investment decisions.
In other recent news, Evolus reported second-quarter 2025 financial results that fell short of expectations. The company announced global net revenue of $69.4 million, which marks a 4% increase year-over-year, but significantly missed the consensus estimate of $82 million. This shortfall was partly attributed to a decline in Jeuveau sales, which dropped approximately 11% year-over-year as customers reduced purchases in late June. Additionally, Evolus posted a larger-than-expected loss, with earnings per share (EPS) of -$0.27, missing the forecasted -$0.10. Following these results, H.C. Wainwright lowered its price target for Evolus to $20 from $27, while BTIG adjusted its target to $18 from $21, both maintaining a Buy rating. These adjustments reflect the analysts’ response to Evolus’s earnings miss and the challenges faced in the market. Despite the revenue increase from the Evolysee launch, the financial performance did not meet analyst projections. These developments underscore the current market headwinds Evolus is navigating.
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