For such a small company Evolus (EOLS) sure has made a lot of noise over the past few months. Evolus has a market capitalization of under $500 million, yet it put a scare in Allergan (AGN) – a company with a $58 billion market capitalization – in late May. The market was awaiting a U.S. Food and Drug Administration decision pursuant to PrabotulinumtoxinA (DWP-450), the company’s injectable 900 kDa botulinum toxin type A complex designed to compete in the facial aesthetics market. The results were disappointing as the FDA issued a Complete Response Letter (“CRL”), delaying the drug’s potential launch:
The FDA has issued a Complete Response Letter (“CRL”) to Evolus related to its BLA for DWP-450 for the treatment of glabellar lines, also known as frown lines, in adult patients.
In the CRL, deficiencies cited by the FDA were isolated to items related to Chemistry, Manufacturing, and Controls (“CMC”) processes. No deficiencies were related to clinical or non-clinical matters. Evolus expects to respond with a complete submission to the FDA within 90 days.
Mr. Moatazedi, President and Chief Executive Officer of Evolus, commented, “The successful completion of the FDA inspection of the manufacturing facility and issuance of the EIR represents a key operational milestone and entirely concludes the pre-approval inspection process by the FDA.”
EOLS pulled back about 25% on the news in mid-May. The stock is up over 80% since that juncture. The stock could have more room to run if certain events occur as planned. EOLS wants to take on AGN’s Botox in the U.S. neurotoxin market. Clinical trials for DWP-450 imply it can hold its own. According to Shocking The Street, a premium investment service in conjunction with Seeking Alpha, if EOLS receives FDA approval for DWP-450 then EOLS could rocket higher. Read more: