Revance Therapeutics, Inc. - RVNC STOCK NEWS

Revance Therapeutics (RVNC) reported Q3 2021 revenue of $19.7 million, a substantial increase from $3.8 million in Q3 2020, primarily driven by the RHA® Collection of dermal fillers, which generated $18.3 million this quarter. The net loss decreased to $74.4 million from $81.3 million year-over-year. The company plans to request a Type A meeting with the FDA to address deficiencies in its BLA for DaxibotulinumtoxinA for Injection for glabellar lines. Additionally, positive results from the ASPEN-OLS Phase 3 study for cervical dystonia were announced, showing the product's long-term safety and effectiveness.

Revance Therapeutics, Inc. (NASDAQ: RVNC) will announce its third quarter 2021 financial results on November 9, 2021, after market close. A conference call and live webcast will occur at 1:30 p.m. PT / 4:30 p.m. ET to discuss the results and offer a business and pipeline update. Revance focuses on innovative aesthetic and therapeutic products, including the next-generation neuromodulator DaxibotulinumtoxinA for Injection, aiming for U.S. regulatory approval. The company also partners with Viatris to develop a biosimilar to BOTOX®.

Revance Therapeutics (NASDAQ: RVNC) announced a Complete Response Letter (CRL) from the FDA regarding its Biologics License Application (BLA) for DaxibotulinumtoxinA for Injection, intended for treating moderate to severe glabellar lines. Received on October 15, the CRL indicates deficiencies found during the FDA's inspection of Revance's manufacturing facility. Revance plans to request a Type A meeting with the FDA to address these issues. CEO Mark Foley expressed disappointment at this unexpected response but reiterated the company's commitment to launching their neuromodulator product.

Revance Therapeutics (NASDAQ: RVNC) announces that its Biologics License Application (BLA) for DaxibotulinumtoxinA for Injection remains under FDA review. The company anticipates FDA approval for treating glabellar lines in 2021. While the issuance of a Form 483 is common post-inspection, Revance confidently submitted a response in July 2021. The innovative neuromodulator product DaxibotulinumtoxinA features a proprietary stabilizing peptide excipient, enhancing its market potential.

Revance Therapeutics (NASDAQ: RVNC) has announced the launch of OPUL™, an innovative Relational Commerce Platform tailored for aesthetic practices in the U.S. This cloud-based system integrates payment solutions, data analytics, and enhanced customer service to boost consumer loyalty. Key features include comprehensive practice analytics, customizable checkout options, and transparent payment processing. Revance aims to replace traditional discount-based models, focusing instead on nurturing long-term relationships with clients, addressing the evolving needs of the aesthetic market.

Revance Therapeutics (RVNC) has announced the presentation of Phase 3 trial data for DaxibotulinumtoxinA for Injection at the International Parkinson and Movement Disorder Society (MDS) Virtual Congress from September 17-22, 2021. The ASPEN-1 trial results show a meaningful reduction in cervical dystonia symptoms, highlighting DaxibotulinumtoxinA's long duration of effect and safety. The company plans to file a Supplemental Biologics License Application to advance treatment options for this debilitating condition.

Revance Therapeutics announced the presentation of new data on the effectiveness and safety of its RHA® Collection of dermal fillers for treating moderate-to-severe nasolabial folds in patients with darker skin color. This post-hoc analysis will be showcased at the 2021 Virtual Skin of Color Update meeting from September 10-12, 2021. The findings reinforce Revance's dedication to safety and efficacy in aesthetic treatments, particularly for underrepresented patient populations, underlining its innovation in the aesthetic portfolio.

Revance Therapeutics (Nasdaq: RVNC) announced its participation in the Wells Fargo Securities Healthcare Conference, a fully virtual event on September 9-10. CEO Mark Foley will present on September 9 at 11:40 a.m. CT / 12:40 p.m. ET. Interested parties can access the live audio webcast from the Investor Relations section of their website, with a replay available for 30 days post-event.

Revance focuses on innovative aesthetic and therapeutic products, including the neuromodulator DaxibotulinumtoxinA, which is awaiting U.S. regulatory approval.

Revance Therapeutics announced positive results from a post-hoc analysis of the SAKURA Phase 3 clinical program for DaxibotulinumtoxinA for Injection, focusing on static glabellar lines. The study revealed significant and sustained improvement in static lines with repeated treatments among 568 subjects. Key findings include a 70% reduction in static lines 4 weeks after the third treatment cycle and a 54.4% complete elimination rate after the first treatment. Results were published in Dermatologic Surgery, indicating potential for dermal remodeling due to prolonged muscle inactivity.