UPDATE 1-FDA declines to approve Evolus Inc's rival treatment to Botox [Reuters]
Evolus, Inc. (EOLS)
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Source: Reuters
UPDATE 1-FDA declines to approve Evolus Inc's rival treatment to Botox | Reuters Reuters Staff 2 Min Read (Adds details, background, shares) May 16 (Reuters) - U.S. health regulators on Wednesday declined to approve Evolus Inc’s rival product to Allergan Plc’s Botox, citing certain deficiencies related to its potential treatment for frown lines. Evolus’ shares were down 22 percent at $11.50 in premarket trading. DWP-450 is the company’s potential treatment of glabellar lines, also known as frown lines, in adult patients. The deficiencies cited by the U.S. Food and Drug Administration were isolated to items related to chemistry, manufacturing, and controls processes, the company said. The FDA’s decision was widely anticipated, after it had issued a “form 483”, which outlined violations at the company’s facilities following inspections in 2017. FDA rejection of the application was likely, and an expected approval for the treatment could come by late summer, Cantor Fitzgerald analyst Lou
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News
- Evolus to Report First Quarter Financial Results on May 7, 2024Business Wire
- Evolus Announces Publication of Safety and Duration Data from Phase 2 Study for "Extra-Strength" 40U Formulation of Jeuveau® [Yahoo! Finance]Yahoo! Finance
- Evolus Announces Publication of Safety and Duration Data from Phase 2 Study for “Extra-Strength” 40U Formulation of Jeuveau®Business Wire
- Counterfeit Botox has been found in several states. Here's what consumers should know. [CNN]CNN
- Counterfeit Botox has been found in several states. Here's what consumers should know. [CNN]CNN
EOLS
Earnings
- 3/7/24 - Miss
EOLS
Sec Filings
- 4/3/24 - Form 8-K
- 3/29/24 - Form 4
- 3/21/24 - Form 4
- EOLS's page on the SEC website