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Revance's (RVNC) DaxibotulinumtoxinA BLA Decision Delayed

Zacks Equity Research
·2 min read

Revance Therapeutics, Inc. RVNC announced that the FDA has deferred its decision on the Biologics License Application (BLA) for DaxibotulinumtoxinA for Injection for the time being.

The candidate is an investigational neuromodulator product and the BLA is seeking approval of the same for the treatment of moderate-to-severe glabellar (frown) lines.

The agency informed on Nov 24, 2020, that an inspection of the company’s manufacturing facility is required as part of the BLA approval process. However, it was unable to conduct a required inspection of the company’s Northern California manufacturing facility due to the travel restrictions associated with the COVID-19 pandemic. Hence, the delay in the decision.

Nevertheless, Revance confirmed with the FDA that their communication was not a Complete Response Letter. The FDA did not indicate any other review issues at this time, beyond the on-site inspection.

The BLA was accepted for review in the first quarter of 2020. The submission was based on results from the largest aesthetic neuromodulator clinical program ever conducted for the treatment of glabellar (frown) lines, including the SAKURA 1, 2 and 3 phase III clinical studies.

Revance is also evaluating DaxibotulinumtoxinA for Injection in the full upper face, including glabellar lines, forehead lines and crow’s feet, as well as in two therapeutic indications — cervical dystonia and adult upper limb spasticity.

It has also partnered with Viatris VTRS (formerly Mylan N.V.) to develop a biosimilar to AbbVie’s ABBV Botox.

Revance’s stock has soared 51% in the year so far against the industry’s decline of 0.8%.

 

Earlier, Bristol Myers Squibb BMY too announced that the FDA has informed about a delay in its review of the BLA for lisocabtagene maraleucel (liso-cel) as the agency was unable to conduct an inspection of a third-party manufacturing facility in Texas during the current review cycle due to travel restrictions related to the COVID-19 pandemic.

Revance currently carries a Zacks Rank #3 (Hold). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.

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