Biotech Stocks Facing FDA Decision In February


Evolus Inc. (EOLS), a medical aesthetics company, expects the FDA decision on its lead product candidate Jeuveau to be announced on February 2, 2019.

Jeuveau, formerly known as DWP-450, is proposed for the treatment of glabellar lines, also known as frown lines, in adult patients.

This is the second time that Jeuveau is at the FDA altar seeking approval. Last May, the FDA had rejected the product, citing deficiencies in items related to Chemistry, Manufacturing, and Controls ("CMC") processes.

The Company resubmitted the Biologics License Application for Jeuveau to the FDA last August.

If approved, Jeuveau is expected to be launched in the United States in spring 2019.

DWP-450 was approved in Canada last August and is expected to be launched there in the first half of 2019. The product is also under review in the European Union, and an opinion from the Committee for Medicinal Products for Human Use (CHMP) is expected by the first quarter of 2019. If the CHMP provides a favorable opinion, a final decision by the European Medicines Agency can be expected in the first half of 2019.

Jeuveau/DWP-450 is an injectable formulation of a 900 kilodalton, or kDa, Botulinum toxin Type A complex, produced by Clostridium botulinum.

Currently, Allergan plc's (AGN) Botox is the neurotoxin market leader and the only known approved 900 kDa botulinum toxin type A complex in the United States. Botox cosmetics brought in net revenue of $649.2 million for Allergan in the nine months ended September 30, 2018, up 11% compared to year-ago period.

EOLS closed Tuesday’s (Jan.29, 2019) trading at $15.09, up 0.67%.