Revance Therapeutics, Inc. (RVNC) has experienced a decline of 33.07% in the aftermarket because the company provided a Regulatory Update on DaxibotulinumtoxinA. However, the last trading session concluded at $22.71 with an increase of 0.66%.
Regulatory Update on DaxibotulinumtoxinA for Injection for the Treatment of Moderate to Severe Glabellar (Frown) Lines
On 15th October 2021, RVNC announced that FDA has granted a Complete Response Letter for DaxibotulinumtoxinA for Injection, for the treatment of mild to moderate glabellar (frown) lines. The FDA has concluded that it is unable to accept the BLA in its current form. Hence it has been stated that there are issues relating to the FDA’s onsite inspection at Revance’s manufacturing plant.
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RVNC intends to request an FDA Type A meeting as soon as feasible to address the issues presented. FDA’s unexpected reaction has disappointed RVNC and therefore the company is requesting further information from the agency. However, the firm is dedicated to bringing its next-generation neuromodulator to market for both aesthetic and therapeutic purposes.
HAGENS BERMAN, NATIONAL TRIAL ATTORNEYS: RVNC Investigation
RVNC announced on 15th October that it intends to compete in the Botulinum Toxin (BOTOX) industry, which is currently controlled by Allegan. The business claims that its primary product candidate, DAXI is the first long-lasting botulinum toxin. Moreover, it is pursuing FDA clearance for its usage in brow frown lines. RVNC’s claims on the FDA’s pre-approval inspection of the company’s DAXI manufacturing plant in Northern California, as well as the timeliness and likelihood of FDA approval, are the subject of the inquiry. However, RVNC management felt pleased that the FDA was carrying out the scheduled examination and that their commercialization preparations were moving well.
Launch of OPUL
On 11th October 2021, RVNC announced the introduction of OPULTM, the first-of-its-kind Relational Commerce Platform for aesthetic practices in the United States. It combines seamless, easy, and smart payment options, practice data analytics, and better customer care. This will help encourage higher client loyalty and retention. It helps to improve patient experiences and business outcomes by cultivating strong client loyalty and connections. Moreover, OPUL is the first technology platform in the aesthetics industry to revolutionize the physician and customer experience. This launch shows RVNC’s dedication to creating new benchmarks through our products and services.
RVNC announced Data from Phase 3 ASPEN-1 Clinical Trial
RVNC announced data from Phase 3 ASPEN-1 Clinical Trial Evaluating Efficacy, Duration of Effect, and Safety of DaxibotulinumtoxinA on 16th September 2021. The sustained period of effect will encourage the safety profile of DaxibotulinumtoxinA by injection for the treatment of cervical dystonia. However, the company is excited to submit a Supplemental Biologics License Application. This might assist patients with this severe illness to get long-term symptom alleviation.