Revance Therapeutics, Inc. - RVNC STOCK NEWS

Revance Therapeutics (NASDAQ: RVNC) announced a $300 million note purchase agreement with Athyrium Capital Management, enhancing its financial position ahead of the FDA approval for DaxibotulinumtoxinA for Injection. The agreement includes $200 million in committed borrowings and an additional $100 million option. The first tranche of $100 million has been issued, extending the company's cash runway into 2024, contingent on FDA approval. The total notes have a fixed interest rate of 8.5% and mature in 2026 or 2028 under specific conditions.

Revance Therapeutics has resubmitted its Biologics License Application (BLA) for DaxibotulinumtoxinA for Injection to the FDA, targeting treatment for moderate to severe glabellar lines. This resubmission addresses the Complete Response Letter issued in October 2021, following a Type A meeting in December 2021. The process includes the qualification of a new working cell bank to meet FDA requirements.

Revance aims to secure approval after completing multiple drug substance lots and is pursuing broader applications for DaxibotulinumtoxinA in conditions like cervical dystonia and upper limb spasticity.

Revance Therapeutics (Nasdaq: RVNC) will participate in the Cowen 42nd Annual Health Care Conference, a virtual event from March 7-9. CEO Mark Foley and CFO Tobin Schilke will present on March 9 at 12:50 p.m. CT / 2:50 p.m. ET. A live audio webcast of the presentation will be available on the company's Investor Relations page and will remain accessible for 30 days post-event. Revance is known for its innovative products, including the long-acting neuromodulator DaxibotulinumtoxinA, currently seeking U.S. regulatory approval.

Revance Therapeutics (RVNC) reported significant revenue growth in Q4 2021, achieving $26.0 million, up from $11.1 million in Q4 2020, driven by strong sales of the RHA® Collection of dermal fillers. Full-year revenue reached $77.8 million. The company completed critical drug substance manufacturing for the FDA's BLA resubmission of DaxibotulinumtoxinA for Injection. Cash reserves totaled $225.1 million. However, the net loss for 2021 was substantial at $281.3 million. The company anticipates 2022 operating expenses between $375 million to $400 million, maintaining an optimistic outlook for growth and product approvals.

Revance Therapeutics will release its Q4 and full year 2021 financial results on February 28, 2022 after market close. A conference call and live webcast will occur at 4:30 p.m. ET to discuss results and provide a business update. Revance is focused on innovative aesthetic and therapeutic products with a strong pipeline, including DaxibotulinumtoxinA, currently seeking U.S. regulatory approval for glabellar lines and cervical dystonia. They also hold exclusive U.S. rights to the RHA® Collection of dermal fillers.

Revance Therapeutics (NASDAQ: RVNC) announced that it received Type A meeting minutes from the FDA concerning the Complete Response Letter (CRL) for DaxibotulinumtoxinA for Injection. A requalification of the new working cell bank (WCB) is required, which involves producing three drug substance lots and one drug product lot. The FDA mandates a reinspection of Revance’s facility once the resubmission is accepted, which could take up to 6 months. The CEO expressed confidence in a clear path for BLA resubmission.

Revance Therapeutics (RVNC) reported preliminary Q4 2021 RHA® Collection revenue between $23.0 million and $24.0 million, bringing full-year revenue to approximately $70.0 million to $71.0 million. Cash, cash equivalents, and short-term investments stood at about $225 million as of December 31. The company expects its operating expenses for the year to be at the lower end or below earlier guidance of $375 million to $390 million. Revance held a Type A meeting with the FDA regarding DaxibotulinumtoxinA for Injection.

Revance Therapeutics (NASDAQ: RVNC) presented new data on DaxibotulinumtoxinA for Injection at the ASDS Virtual Annual Meeting from November 19-21, 2021. Highlights include findings from the SAKURA Phase 3 trials, which assessed immunogenicity and treatment for glabellar lines. An innovative injection technique for midface volumization using hyaluronic acid fillers was also discussed. The presentations underscore Revance's commitment to setting new standards in facial aesthetics and its robust growth pipeline.

Revance Therapeutics (NASDAQ: RVNC) announces CEO Mark Foley and CFO Tobin Schilke will participate in a fireside chat at the Piper Sandler 33rd Annual Virtual Healthcare Conference. This event will stream online starting November 22 in the investor relations section of Revance’s website. The conference runs from November 30 to December 2, 2021. Revance focuses on innovative aesthetic and therapeutic solutions, including DaxibotulinumtoxinA for Injection, which is seeking U.S. regulatory approval after completing Phase 3 trials.