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Pre-Approval Inspection","therapeuticArea":"Dermatology","highestDevelopmentStatus":"Phase III","country":"U.S.A","productType":"Large molecule","productStatus":"Approved","date":"May 2021","url1":"","url2":"","graph1":"Dermatology","graph2":"Phase III"},{"orgOrder":0,"company":"Revance Therapeutics","sponsor":"Goldman Sachs & Co.","pharmaFlowCategory":"D","amount":"$230.0 million","upfrontCash":"Undisclosed","newsHeadline":"Revance Announces Closing of Public Offering and Full Exercise of the Underwriters\u2019 Option to Purchase Additional Shares","therapeuticArea":"Dermatology","highestDevelopmentStatus":"Approved","country":"U.S.A","productType":"Large molecule","productStatus":"Approved","date":"September 2022","url1":"","url2":"","graph1":"Dermatology","graph2":"Approved"},{"orgOrder":0,"company":"Revance Therapeutics","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Revance Provides Regulatory Update on 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Find Clinical Drug Pipeline Developments & Deals for Daxibotulinumtoxin A
The Company intends to use the net proceeds from the offering to advance the commercial growth of its aesthetics portfolio, including DAXXIFY (daxibotulinumtoxinA-Lanm), which is being used for the treatment of moderate to severe glabellar lines.
Daxiffy (daxibotulinumtoxinA-lanm) is an acetylcholine release inhibitor and neuromuscular blocking agent. It is being evaluated in Phase 3 clinical trials for the treatment of cervical dystonia in adults.
Revance will use the proceeds for developing and commercializing innovative aesthetic and therapeutic offerings, including DAXXIFY™ (daxibotulinumtoxinA-lanm) for injection, the RHA® collection of dermal fillers.
DaxibotulinumtoxinA for Injection, is next-generation product aiming to establish a new, premium, long-lasting neuromodulator category. DaxibotulinumtoxinA for Injection is an investigational agent that has not been approved by the FDA and is currently under regulatory review.
DaxibotulinumtoxinA for Injection, including Revance’s first oral presentation of the ASPEN-1 Phase 3 clinical trial data, the positive topline results from the ASPEN Open Label Study, which demonstrated long-term safety and efficacy of repeat treatments.
Partnering with Athyrium on a non-dilutive financing that substantially strengthens the financial position ahead of the potential FDA approval of the lead drug product, DaxibotulinumtoxinA for Injection for glabellar lines.
DaxibotulinumtoxinA for Injection, an investigational agent not approved by FDA and is currently under regulatory review, combines a proprietary stabilizing peptide excipient with a highly purified botulinum toxin that does not contain human or animal-based components.
DaxibotulinumtoxinA combines a proprietary stabilizing peptide excipient with a highly purified botulinum toxin that does not contain human or animal-based components for the treatment of moderate to severe glabellar (frown) lines aesthetic.
Revance has successfully completed a Phase 3 program for DaxibotulinumtoxinA for Injection in glabellar (frown) lines and is pursuing U.S. regulatory approval.
FDA plans to initiate its pre-approval inspection of the company’s manufacturing facility for DaxibotulinumtoxinA for Injection for the treatment of moderate to severe glabellar (frown) lines by the end of June 2021.
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