The goal of this clinical trial is to test the effects of DaxibotulinumtoxinA-Lanm (Daxxify) in patients with benign essential blepharospasms (BEB) and hemifacial spasms (HFS). The main questions to answer:
1. Is there clinically significant difference (measured by Jankovic Rating Scale (JRS) score from base to peak efficacy) for patients with BEB and HFS treated with Daxxify?
2. What percentage of patients achieve a clinical response?
Participants historically treated with Botox for either BEB or HFS will be crossed over to Daxxify treatment in order to serve as their own control and examine the efficacy of Daxxify.

Start Date01 Jan 2025

Sponsor / Collaborator

Montefiore Medical Center

[+1]

NCT06411002

/ RecruitingPhase 2

A Phase 2a Study to Evaluate the Effects of DaxibotulinumtoxinA for Injection on the Treatment of Dynamic Forehead Lines and Glabellar Lines

This is a Phase 2a open-label, single-arm study to evaluate the effects of DaxibotulinumtoxinA-lanm (DAXI) for Injection on the treatment of dynamic forehead lines (FHL) and glabellar lines (GL).
Approximately 40 subjects (18 years of age and above) with moderate to severe GL and FHL (all assessed at maximum contraction) will be screened for eligibility with the goal of enrolling and treating 30 subjects to receive DAXI for injection after providing informed consent.
The primary objective of this study is to determine the efficacy and safety of the combined treatment of two upper facial regions with DAXI for injection.

Start Date08 Apr 2024

Sponsor / Collaborator

Revance Therapeutics, Inc.

NCT06225492

/ RecruitingPhase 4IIT

Use of DaxibotulinimtoxinA Injection for Platysma Bands of the Neck

This study seeks to evaluate the effectiveness and duration of action of DaxibotulinumtoxinA for neck rejuvenation through treatment of platysmal bands. This study will consist of one treatment visit with subjects being randomized to receiving 15 or 20 units of DaxibotulinumtoxinA per platysmal band. Subjects will return for 5 follow-up visits at 8, 12, 16, 20, and 24 weeks for evaluation.

Start Date01 Jan 2024

Sponsor / Collaborator

Main Line Center for Laser Surgery

100 Clinical Results associated with Daxibotulinumtoixn A-LANM

100 Translational Medicine associated with Daxibotulinumtoixn A-LANM

100 Patents (Medical) associated with Daxibotulinumtoixn A-LANM

Literatures (Medical) associated with Daxibotulinumtoixn A-LANM

01 Dec 2024·Journal of Plastic Reconstructive and Aesthetic Surgery

DaxibotulinumtoxinA for injection to treat moderate or severe glabellar lines: A randomized, multicenter, Phase III, double-blind, placebo-controlled trial in China

Article

Author: Ge, Lei ; Wang, Hui ; Sun, Jiaming ; Li, Li ; Guo, Qing ; Li, Qingfeng ; Wang, Xingli ; Wang, Baoxi ; Liu, Quanzhong ; Fan, Xiaojing ; Su, Juan ; Zhao, Hongyi ; Xie, Yun

BACKGROUND:

DaxibotulinumtoxinA for injection (DAXI), a novel botulinum toxin type A formulation, is FDA-approved for glabellar lines treatment. Its clinical efficacy has been demonstrated in two Phase III trials (SAKURA 1 and SAKURA 2).

OBJECTIVE:

To evaluate DAXI efficacy and safety in Chinese adults with moderate/severe glabellar lines.

METHODS:

In this Phase III, randomized (2:1), double-blind trial, Chinese adults with moderate/severe glabellar lines received 40 U DAXI or placebo into the corrugator muscles bilaterally and the procerus. Glabellar line severity was evaluated by investigators (Investigator Global Assessment-Frown Wrinkle Severity [IGA-FWS] scale) and participants (Patient Frown Wrinkle Severity [PFWS] scale) for ≥24 to 36 weeks. The primary endpoint was the proportion of 2-point composite responders achieving ≥2-point reduction in IGA-FWS and PFWS scores at week 4 post-treatment.

RESULTS:

Overall, 307 participants received treatment (DAXI, 205; placebo, 102). A significantly greater proportion of participants in the DAXI arm vs the placebo arm achieved a 2-point composite response at week 4: 125 (61.0%) vs 1 (1.0%); difference, 60.0% [95% CI 49.40-66.46]; 2-sided p < 0.0001). At week 4, 94.1% of the DAXI-treated participants achieved an IGA-FWS score 0/1 (none/mild) and 86.3% achieved PFWS 0/1; median time to loss of none/mild on IGA-FWS and PFWS was 23.9 weeks. The benefits of DAXI over placebo through week 24 occurred regardless of the baseline IGA-FWS score, prior botulinum toxin type A (BoNTA) exposure, sex or age. DAXI was well tolerated with no new safety signals.

CONCLUSION:

DAXI provided durable efficacy and acceptable safety for treating moderate/severe glabellar lines in Chinese participants.

01 Sep 2024·DERMATOLOGIC SURGERY

Clinical Benefits of DaxibotulinumtoxinA for Injection: Beyond Glabellar Line Effacement?

Review

Author: Shamban, Ava ; Green, Jeremy B. ; Gross, Todd M. ; Mariwalla, Kavita ; Brown, Jessica ; Gallagher, Conor J.

BACKGROUND:

Botulinum toxin type A (BoNTA) is standard of care for glabellar lines ameliorization. DaxibotulinumtoxinA for Injection (DAXI) is a new BoNTA with a unique formulation representing the latest advancement in BoNTA technology. There is an unmet need for patients to understand the full potential of BoNTA treatment and new technologies.

OBJECTIVE:

To update clinical data supporting the use of DAXI for glabellar lines within the context of clinical experience.

MATERIALS AND METHODS:

A narrative review of the literature and summary of clinical experience with DAXI.

RESULTS:

The DAXI clinical trial program reflects clinical experience post-FDA approval, with DAXI demonstrating rapid onset, high patient response rates, and extended treatment duration versus conventional BoNTAs. Clinical observations suggest that DAXI has limited diffusion from the injection site, enabling more localized control of muscle activity and greater improvements in wrinkle severity. DAXI enables practitioners to exert greater finesse in their injections and in predicting changes to eyebrow shape and position and achieve improvement in skin quality.

CONCLUSION:

Advances in BoNTA technology can provide patients with greater options for treatment outcomes. The potential for enhanced localized effects with DAXI may contribute to more precise and targeted effects on muscle activity and additional aesthetic benefits to patients.

27 Feb 2024·Neurology

Efficacy and Safety of DaxibotulinumtoxinA for Injection in Cervical Dystonia

Article

Author: Cooper, Christine ; Yegiaian, Sharon ; Mcallister, Peter ; Truong, Daniel ; Kumar, Rajeev ; Hedera, Peter ; Sycha, Thomas ; Harrower, Timothy ; Heitzman, Daragh ; Bouhour, Francoise ; Paus, Sebastian ; Isaacson, Stuart ; Szabela, Dariusz ; Moore, Peter ; Dashtipour, Khashayar ; Haslinger, Bernhard ; Ehler, Edvard ; Hermanowicz, Neal ; Koziorowski, Dariusz ; Manzanares, Lydia Lopez ; Kollewe, Katja ; Barbano, Richard ; Mora, Javier Pagonabarraga ; Feigenbaum, Danielle ; Singer, Carlos ; Gitt, Jeffrey ; Bettle, Norman ; Ondo, William ; Tse, Winona ; Lohmann, Ebba ; Gross, Todd M. ; Evidente, Virgilio ; Kobylecki, Christopher ; LeDoux, Mark ; Kupsch, Andreas ; Goudreau, John ; Tate, Jessica ; Frei, Karen ; Ellenbogen, Aaron ; Bösch, Sylvia ; Kompoliti, Aikaterini ; Pillai, Rekha ; Trejo, Jose Maria ; Vasquez, Alberto ; Deik, Andres ; Slawek, Jaroslaw ; Comella, Cynthia L. ; Massey, Janice ; Rubio, Roman G. ; Vitarella, Domenico ; Moro, Elena ; Woznicova, Ivana ; Criswell, Susan ; Jankovic, Joseph ; Boyd, James ; Kreisler, Alexandre ; Hernandez-Vara, Jorge ; Patel, Atul T. ; Thakur, Nicklesh ; Tutaj, Andrzej ; LeWitt, Peter ; Schwartz, Harvey ; Hauser, Robert A. ; Castelnovo, Giovanni ; Chand, Pratap ; Banach, Marta D. ; Habibi, Behzad ; Jech, Robert ; Isaacs, David ; Jinnah, Hyder ; Peckham, Elizabeth ; Rudzinska, Monika ; Vysata, Oldrich ; Malaty, Irene ; Torres, Diego ; Albrecht, Philipp ; Fox, Susan

BACKGROUND AND OBJECTIVES:

ASPEN-1 was a phase 3, randomized, double-blind, placebo-controlled study to evaluate the efficacy, duration of response, and safety of 2 doses of DaxibotulinumtoxinA for Injection (DAXI), a novel botulinum toxin type A formulation in participants with cervical dystonia (CD).

METHODS:

Adults (aged 18-80 years) with moderate-to-severe CD (Toronto Western Spasmodic Torticollis Rating Scale [TWSTRS] total score ≥20) were enrolled at 60 sites across 9 countries in Europe and North America. Participants were randomized (3:3:1) to single-dose intramuscular DAXI 125U, 250U, or placebo and followed for up to 36 weeks after injection. The primary end point was change from baseline in TWSTRS total score averaged across weeks 4 and 6. Key secondary end points included duration of effect, Clinical and Patient Global Impression of Change (CGIC, PGIC), TWSTRS subscale scores, and safety. Multiplicity-adjusted intent-to-treat hypothesis tests with multiple imputation were performed using ANCOVA and Cochran-Mantel-Haenszel analyses.

RESULTS:

Of 444 individuals screened, 301 were randomized to DAXI 125U (n = 125) or 250U (n = 130) or placebo (n = 46). DAXI 125U and 250U significantly improved the mean TWSTRS total score vs placebo (least squares mean [standard error] difference vs placebo: DAXI 125U, -8.5 [1.93], p < 0.0001; DAXI 250U, -6.6 [1.92], p = 0.0006). The median duration of effect (time from treatment until loss of ≥80% of the peak improvement in average TWSTRS total score achieved at weeks 4 and 6) was 24.0 (95% confidence interval 20.3-29.1) weeks with DAXI 125U and 20.3 (16.7-24.0) weeks with DAXI 250U. Significant improvements were also observed with DAXI in CGIC and PGIC responder rates and TWSTRS subscales. Treatment-related treatment-emergent adverse events (TEAEs) were reported by 29.6% of participants with DAXI 125U, 23.8% with DAXI 250U, and 17.4% with placebo, with injection site pain being the most common overall. The most frequently reported treatment-related TEAEs of interest in DAXI 125U, DAXI 250U, and placebo, respectively, were muscular weakness (4.8%, 2.3%, 0%), musculoskeletal pain (2.4%, 3.1%, 0%), and dysphagia (1.6%, 3.8%, 0%).

DISCUSSION:

This study demonstrated that DAXI, at doses of 125U and 250U, is an effective, safe, long-acting, and well-tolerated treatment for CD.

TRIAL REGISTRATION INFORMATION:

ClinicalTrials.gov identifier (NCT03608397, submitted July 11, 2018) and EU Clinical Trials Register (ClinicalTrialsRegister.eu EudraCT identifier 2018-000446-19, submitted September 13, 2018). First participant enrolled on June 11, 2018. Trial registration was performed in accordance with the Food and Drug Administration Amendments Act (FDAAA 801), which stipulates that the responsible party register an applicable clinical trial not later than 21 calendar days after enrolling the first human participant (42 CFR 11.24).

CLASSIFICATION OF EVIDENCE:

This study provides Class I evidence that in adults with moderate-to-severe idiopathic cervical dystonia, DAXI reduces dystonia more effectively than placebo.

News (Medical) associated with Daxibotulinumtoixn A-LANM

05 Feb 2025

·endpts.com

Revance and Crown are almost ready to close their deal after earlier bidding war

The fight over who gets control of Revance Therapeutics and its Botox competitor, Daxxify, is coming to a close. On Wednesday, Revance said it’s moving forward with its sale to Crown Laboratories. The two companies had been in talks for months when, in January, Revance’s commercial partner Teoxane submitted a competing bid . Crown had initially offered $6.66 per share in August to acquire Revance. Shortly after, Teoxane initiated a contract dispute with Revance that delayed the deal and was a factor in Crown’s decision to slash its offer to $3.10 a share. Teoxane, which develops dermal fillers, then proposed to buy Revance for $3.60 per share. Teoxane argued that its offer was a “superior, attractive and actionable alternative” to Crown’s deal. But Crown CEO Jeff Bedard said in a letter to Revance’s board of directors that Teoxane’s actions “have been clearly designed to disrupt a transaction involving Revance and Crown, to the significant detriment of Revance and its stockholders.” Revance said it would talk to Teoxane about its offer. But when Crown raised its bid to $3.65 per share late last month, Revance said the Crown proposal was “the only fully financed offer currently available.” The companies expect to close the deal on Thursday, they announced in a joint press release. Daxxify has been approved since 2022 as a treatment for moderate-to-severe glabellar lines, otherwise known as frown lines. It’s also approved to treat cervical dystonia, a condition in which the neck muscles contract uncontrollably. However, Crown has expressed a particular interest in the aesthetics side of Revance’s business.

Drug ApprovalAcquisition

05 Feb 2025

·www.prnewswire.com

Crown Laboratories and Revance Therapeutics Announce Expiration of Tender Offer

JOHNSON CITY, Tenn. and NASHVILLE, Tenn., Feb. 5, 2025 /PRNewswire/ -- Crown Laboratories, Inc. ("Crown") and Revance Therapeutics, Inc. (NASDAQ: RVNC) ("Revance"), today announced that the tender offer to purchase all of the issued and outstanding shares of common stock, par value $0.001 per share ("Shares") of Revance at a purchase price of $3.65 per Share, net to the stockholder in cash without interest and less any required tax withholding (the "Offer"), expired as scheduled at one minute past 11:59 p.m., Eastern Time, on February 4, 2025 and was not extended (such date and time, the "Expiration Time"). Continue Reading Revance Therapeutics, Inc. Computershare Trust Company, N.A., the depositary and paying agent for the Offer, has advised Crown that, as of the Expiration Time, 86,197,893 Shares were validly tendered and not validly withdrawn in the Offer, representing 82.0% of the issued and outstanding Shares as of the Expiration Time. Accordingly, all conditions to the Offer have been satisfied. Crown and its affiliate, Reba Merger Sub, Inc. ("Merger Sub"), will promptly accept for payment, and will promptly pay for, all Shares validly tendered and not validly withdrawn in the Offer. The parties expect to consummate the acquisition on February 6, 2025, in accordance with, and subject to the terms of, the definitive agreement for the proposed acquisition. Advisors Centerview Partners LLC is serving as exclusive financial advisor for Revance; Skadden, Arps, Slate, Meagher & Flom LLP is serving as legal advisor for Revance. Leerink Partners and PJT Partners are serving as financial advisors to Crown; Kirkland & Ellis LLP and Lowenstein Sandler LLP are serving as legal advisors to Crown. About Crown Crown, a privately held, fully integrated global skincare company, is committed to developing and providing a diverse portfolio of aesthetic, premium and therapeutic skincare products that improve the quality of life for its consumers throughout their skincare journey. An innovative company focused on skin science for life, Crown's unyielding pursuit of delivering therapeutic excellence and enhanced patient outcomes is why it has become a leader in Dermatology and Aesthetics. Crown has been listed on the Inc. 5000 Fastest Growing Privately Held Companies List for 11 years and has expanded its distribution to over 50 countries. For more information, visit . The "Crown" logo, PanOxyl and Blue Lizard are registered trademarks of Crown Laboratories, Inc. SkinPen and StriVectin are registered trademarks of Bellus Medical, LLC and StriVectin Operating Company, Inc., respectively. About Revance Revance is a biotechnology company setting the new standard in healthcare with innovative aesthetic and therapeutic offerings that enhance patient outcomes and physician experiences. Revance's portfolio includes DAXXIFY (DaxibotulinumtoxinA-lanm) for injection and the RHA Collection of dermal fillers. RHA® technology is proprietary to and manufactured in Switzerland by Teoxane SA. Revance has partnered with Teoxane SA to supply HA fillers for U.S. distribution. Revance has also partnered with Viatris Inc. to develop a biosimilar to onabotulinumtoxinA for injection and Shanghai Fosun Pharmaceutical to commercialize DAXXIFY in China. Revance's global headquarters and experience center are located in Nashville, Tennessee. Learn more at Revance.com, RevanceAesthetics.com, DAXXIFY.com, HCP.DAXXIFYCervicalDystonia.com, or connect with us on LinkedIn. "Revance," the Revance logo, and DAXXIFY are registered trademarks of Revance Therapeutics, Inc. Resilient Hyaluronic Acid® and RHA are trademarks of TEOXANE SA. Additional Information and Where to Find It This communication is for informational purposes only and is neither an offer to purchase nor a solicitation of an offer to sell any securities, nor is it a substitute for the tender offer materials that Crown and Merger Sub, filed with the U.S. Securities and Exchange Commission (the "SEC"). The solicitation and offer to buy outstanding Shares of Revance was only made pursuant to the tender offer materials that Crown and Merger Sub filed with the SEC. The tender offer materials are available for free on the SEC's website at . Forward-Looking Statements Certain statements contained in this press release are "forward-looking statements." The use of words such as "anticipates," "hopes," "may," "should," "intends," "projects," "estimates," "expects," "plans" and "believes," among others, generally identify forward-looking statements. All statements, other than statements of historical fact, are forward-looking statements. These forward-looking statements include, among others, statements relating to Revance's and Crown's future financial performance, business prospects and strategy, expectations with respect to the anticipated merger, including the timing thereof and Revance's and Crown's ability to successfully complete such transactions and realize the anticipated benefits. Actual results could differ materially from those contained in these forward-looking statements for a variety of reasons, including, among others, the risks and uncertainties inherent in the anticipated merger, including, among other things, the ability to satisfy the conditions to the closing of the anticipated merger, the expected timing of the anticipated merger, the possibility that the anticipated merger will not be completed, difficulties or unanticipated expenses in connection with integrating the parties' operations, products and employees and the possibility that anticipated synergies and other anticipated benefits of the transaction will not be realized in the amounts expected, within the expected timeframe or at all, the effect of the anticipated merger on Revance's and Crown's business relationships (including, without limitations, partners and customers), the occurrence of any event, change or other circumstances that could give rise to the termination of the merger agreement, the expected tax treatment of the transaction, and the impact of the transaction on the businesses of Revance and Crown, and other circumstances beyond Revance's and Crown's control. You should not place undue reliance on these forward-looking statements. Certain of these and other risks and uncertainties are discussed in Revance's and Crown's filings with the SEC, including the Schedule TO (including the offer to purchase, a related letter of transmittal and related documents) Crown and its acquisition subsidiary have filed with the SEC, and the Solicitation/Recommendation Statement on Schedule 14D-9 Revance has filed with the SEC, and Revance's most recent Form 10-K and Form 10-Q filings with the SEC. Except as required by law, neither Revance nor Crown undertakes any duty to update forward-looking statements to reflect events after the date of this press release. Contacts Media: Alecia Pulman ICR [email protected] Investors: Laurence Watts NewStreet [email protected] SOURCE Crown Laboratories, Inc. WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

Acquisition

31 Jan 2025

·www.prnewswire.com

Revance Stockholders Urged to Tender Their Shares in Support of Crown Transaction by the February 4th Deadline

Crown offer of $3.65 per share is the only offer available to Revance stockholders Crown offer unanimously approved by the Revance Board of Directors Teoxane withdraws its previous proposal, says it will tender its 6.2% stake in Revance into Crown tender Tender offer expires at one minute past 11:59 p.m., Eastern Time, on February 4, 2025 JOHNSON CITY, Tenn. and NASHVILLE, Tenn., Jan. 31, 2025 /PRNewswire/ -- Crown Laboratories, Inc. ("Crown") and Revance Therapeutics, Inc. (NASDAQ: RVNC) ("Revance"), today reminded Revance stockholders of the recommendation to tender their shares in support of Crown's cash tender offer (the "tender offer") to acquire all of the issued and outstanding shares of common stock, par value $0.001 per share ("Shares") of Revance, at a price of $3.65 per Share in cash, without interest and less any applicable tax withholding, before the expiry of the tender offer at one minute past 11:59 p.m., Eastern Time, on February 4, 2025. Continue Reading Revance Therapeutics, Inc. Mark J. Foley, Chief Executive Officer of Revance said: "The Crown tender offer of $3.65 per share has been unanimously approved by the Revance Board of Directors. After a robust process, our Board concluded that Crown's offer represents the best outcome for our stockholders. Now that Teoxane has withdrawn their previous proposal and has indicated that they will tender their shares in support of the Crown transaction, the Crown offer is the only acquisition offer available to shareholders. To complete the transaction, stockholders must tender their shares before the expiration of the tender offer at one minute past 11:59 p.m., Eastern Time, on February 4th." Crown's offer is the ONLY OFFER available to Revance stockholders The Crown tender offer of $3.65 per Share in cash, without interest and less any applicable tax withholding, which has been unanimously recommended by Revance's Board of Directors, is the only offer available to Revance stockholders. Teoxane INTENDS TO TENDER its shares in Crown's tender offer On January 30th, Teoxane SA announced that it has withdrawn its non-binding proposal to acquire Revance and intends to tender all of its Shares, representing a 6.2% stake, in the tender offer. Revance stockholders must tender by FEBRUARY 4 DEADLINE for transaction to close Crown's tender offer will expire at one minute past 11:59 p.m. Eastern Time, on February 4, 2025. The outside termination date under the Amended and Restated Merger Agreement, dated December 7, 2024 (the "A&R Merger Agreement") remains February 7, 2025. Crown reiterates that it does not intend to extend the outside termination date of the A&R Merger Agreement. Subject to customary closing conditions, including the tender of more than 50% of the Shares into the tender offer, the transaction is expected to close by February 6, 2025. Tender Offer Details Computershare Trust Company, N.A., the depositary and paying agent for the tender offer, has advised Crown that, as of 4:00 p.m., Eastern Time, on January 30, 2025, approximately 10,946,712 Shares have been validly tendered and not properly withdrawn in the tender offer, representing approximately 10.4313% of the issued and outstanding Shares, as of such date and time. Holders that have previously tendered their Shares do not need to re-tender their Shares or take any other action. The tender offer continues to be subject to the remaining conditions set forth in the Offer to Purchase that Crown and its acquisition subsidiary filed with the Securities and Exchange Commission ("SEC"), as amended or supplemented from time to time. Complete terms and conditions of the tender offer can be found in the Offer to Purchase, the Letter of Transmittal, and certain other materials contained in the tender offer statement on Schedule TO originally filed with the SEC on December 12, 2024 by Crown and its acquisition subsidiary, as amended and as may be further amended from time to time, and are available at . The terms of the tender offer remain the same as set forth in the Offer to Purchase, the Letter of Transmittal, in each case, as amended. Advisors Centerview Partners LLC is serving as exclusive financial advisor for Revance; Skadden, Arps, Slate, Meagher & Flom LLP is serving as legal advisor for Revance. Leerink Partners and PJT Partners are serving as financial advisors to Crown; Kirkland & Ellis LLP and Lowenstein Sandler LLP are serving as legal advisors to Crown. About Crown Crown, a privately held, fully integrated global skincare company, is committed to developing and providing a diverse portfolio of aesthetic, premium and therapeutic skincare products that improve the quality of life for its consumers throughout their skincare journey. An innovative company focused on skin science for life, Crown's unyielding pursuit of delivering therapeutic excellence and enhanced patient outcomes is why it has become a leader in Dermatology and Aesthetics. Crown has been listed on the Inc. 5000 Fastest Growing Privately Held Companies List for 11 years and has expanded its distribution to over 50 countries. For more information, visit . The "Crown" logo, PanOxyl and Blue Lizard are registered trademarks of Crown Laboratories, Inc. SkinPen and StriVectin are registered trademarks of Bellus Medical, LLC and StriVectin Operating Company, Inc., respectively. About Revance Revance is a biotechnology company setting the new standard in healthcare with innovative aesthetic and therapeutic offerings that enhance patient outcomes and physician experiences. Revance's portfolio includes DAXXIFY (DaxibotulinumtoxinA-lanm) for injection and the RHA Collection of dermal fillers. RHA® technology is proprietary to and manufactured in Switzerland by Teoxane SA. Revance has partnered with Teoxane SA to supply HA fillers for U.S. distribution. Revance has also partnered with Viatris Inc. to develop a biosimilar to onabotulinumtoxinA for injection and Shanghai Fosun Pharmaceutical to commercialize DAXXIFY in China. Revance's global headquarters and experience center are located in Nashville, Tennessee. Learn more at Revance.com, RevanceAesthetics.com, DAXXIFY.com, HCP.DAXXIFYCervicalDystonia.com, or connect with us on LinkedIn. "Revance," the Revance logo, and DAXXIFY are registered trademarks of Revance Therapeutics, Inc. Resilient Hyaluronic Acid® and RHA are trademarks of TEOXANE SA. Additional Information and Where to Find It In connection with its proposed acquisition of Revance, Crown caused its acquisition subsidiary to commence a tender offer to acquire all outstanding Shares of Revance. This communication is for informational purposes only and is not an offer to buy nor a solicitation of an offer to sell any securities of Revance, nor is it a substitute for the tender offer materials that Crown and its acquisition subsidiary filed with the SEC upon commencement of the tender offer. A solicitation and offer to buy all outstanding Shares of Revance is only being made pursuant to the tender offer statement on Schedule TO, including an offer to purchase, a letter of transmittal and other related materials that Crown and its acquisition subsidiary have filed with the SEC. In addition, Revance has filed with the SEC a Solicitation/Recommendation Statement on Schedule 14D-9 with respect to the tender offer. THE TENDER OFFER MATERIALS (INCLUDING AN OFFER TO PURCHASE, A RELATED LETTER OF TRANSMITTAL AND CERTAIN OTHER TENDER OFFER DOCUMENTS) AND THE SOLICITATION/RECOMMENDATION STATEMENT CONTAIN IMPORTANT INFORMATION ABOUT THE PROPOSED TRANSACTION AND THE PARTIES THERETO. INVESTORS AND STOCKHOLDERS OF REVANCE ARE URGED TO READ THESE DOCUMENTS CAREFULLY (AS EACH MAY BE AMENDED OR SUPPLEMENTED FROM TIME TO TIME) BECAUSE THEY CONTAIN IMPORTANT INFORMATION THAT INVESTORS AND STOCKHOLDERS OF REVANCE SHOULD CONSIDER BEFORE MAKING ANY DECISION REGARDING TENDERING THEIR SHARES OF COMMON STOCK IN THE TENDER OFFER. Investors may obtain a free copy of these materials (including the tender offer statement, Offer to Purchase and a related Letter of Transmittal, as well as the Solicitation/Recommendation Statement) and other documents filed by Crown and Revance with the SEC at the website maintained by the SEC at . Investors may also obtain, at no charge, any such documents filed with or furnished to the SEC by Revance under the "News" section of Revance's website at . The information contained in, or that can be accessed through, Revance's or Crown's website is not a part of, or incorporated by reference herein. Forward-Looking Statements Certain statements contained in this press release are "forward-looking statements." The use of words such as "anticipates," "hopes," "may," "should," "intends," "projects," "estimates," "expects," "plans" and "believes," among others, generally identify forward-looking statements. All statements, other than statements of historical fact, are forward-looking statements. These forward-looking statements include, among others, statements relating to Revance's and Crown's future financial performance, business prospects and strategy, expectations with respect to the tender offer and the anticipated merger, including the timing thereof and Revance's and Crown's ability to successfully complete such transactions and realize the anticipated benefits. Actual results could differ materially from those contained in these forward-looking statements for a variety of reasons, including, among others, the risks and uncertainties inherent in the tender offer and the anticipated merger, including, among other things, regarding how many of Revance's stockholders will tender their Shares in the tender offer, the possibility that competing offers will be made, the ability to obtain requisite regulatory approvals, the ability to satisfy the conditions to the closing of the tender offer and the anticipated merger, the expected timing of the tender offer and the anticipated merger, the possibility that the anticipated merger will not be completed, difficulties or unanticipated expenses in connection with integrating the parties' operations, products and employees and the possibility that anticipated synergies and other anticipated benefits of the transaction will not be realized in the amounts expected, within the expected timeframe or at all, the effect of the tender offer and the anticipated merger on Revance's and Crown's business relationships (including, without limitations, partners and customers), the occurrence of any event, change or other circumstances that could give rise to the termination of the merger agreement, the expected tax treatment of the transaction, and the impact of the transaction on the businesses of Revance and Crown, and other circumstances beyond Revance's and Crown's control. You should not place undue reliance on these forward-looking statements. Certain of these and other risks and uncertainties are discussed in Revance's and Crown's filings with the SEC, including the Schedule TO (including the offer to purchase, a related letter of transmittal and related documents) Crown and its acquisition subsidiary have filed with the SEC, and the Solicitation/Recommendation Statement on Schedule 14D-9 the Company has filed with the SEC, and Revance's most recent Form 10-K and Form 10-Q filings with the SEC. Except as required by law, neither Revance nor Crown undertakes any duty to update forward-looking statements to reflect events after the date of this press release. Contacts Media: Alecia Pulman/Brittany Fraser ICR [email protected] Investors: Laurence Watts NewStreet [email protected] SOURCE Crown Laboratories, Inc. WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

Acquisition

100 Deals associated with Daxibotulinumtoixn A-LANM

R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Dystonic Disorders	CN	Shanghai Fosun Pharmaceutical Industrial Development Co., Ltd.	22 Nov 2024
cervical dystonia	US	Revance Therapeutics, Inc.	11 Aug 2023
Glabellar frown lines	US	Revance Therapeutics, Inc.	07 Sep 2022

Developing

10 top R&D records.

to view more data

Indication	Highest Phase	Country/Location	Organization	Date
Torticollis	NDA/BLA	US	Revance Therapeutics, Inc.	20 Oct 2022
Isolated cervical dystonia	Phase 3	US	Revance Therapeutics, Inc.	05 Sep 2018
Isolated cervical dystonia	Phase 3	AT	Revance Therapeutics, Inc.	05 Sep 2018
Isolated cervical dystonia	Phase 3	CA	Revance Therapeutics, Inc.	05 Sep 2018
Isolated cervical dystonia	Phase 3	CZ	Revance Therapeutics, Inc.	05 Sep 2018
Isolated cervical dystonia	Phase 3	FR	Revance Therapeutics, Inc.	05 Sep 2018
Isolated cervical dystonia	Phase 3	DE	Revance Therapeutics, Inc.	05 Sep 2018
Isolated cervical dystonia	Phase 3	PL	Revance Therapeutics, Inc.	05 Sep 2018
Isolated cervical dystonia	Phase 3	ES	Revance Therapeutics, Inc.	05 Sep 2018
Isolated cervical dystonia	Phase 3	GB	Revance Therapeutics, Inc.	05 Sep 2018

Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


AAN2024	Not Applicable	cervical dystonia	-	DaxibotulinumtoxinA for injection (DAXI) 250U	oqsvhazczr(pcfgqncdqt) = mkfwhiqapf oovzgzxrmr (rrfgmqesuw )	-	09 Apr 2024
AAN2024	Not Applicable	cervical dystonia	-	DaxibotulinumtoxinA	exhnunxhvu(yludciqcrl) = hllcgxbdod sdnhalkchj (efglhyzuvs ) View more	-	09 Apr 2024
NCT02973269 (CTgov)	Phase 2	Fasciitis, Plantar	7	daxibotulinumtoxin type A (DAXI 240 U)	hyhkwblgof(rqgnhhojpe) = yyciuhcyuh owinflzayh (innocyeymw, khtymbgwfy - skrsbithir) View more	-	03 Apr 2024
				Placebo (Placebo)	hyhkwblgof(rqgnhhojpe) = gauqzwjzga owinflzayh (innocyeymw, omamehwzba - nzbjfrjfgv) View more
NCT03608397 \| EUCTR2018-000446-19-AT (ASPEN-1, Pubmed \| Neurology) Manual	Phase 3	cervical dystonia	301	DAXI125U	lnhhogvrxx(wmvtlbyesf) = sukiysipcr tdndorwrxb (pzabxilsbf, 1.30) View more	Positive	31 Jan 2024
				DAXI250U	lnhhogvrxx(wmvtlbyesf) = nkeggbbsnh tdndorwrxb (pzabxilsbf, 1.25) View more
NCT03825315 (CTgov)	Phase 2	Fasciitis, Plantar	155	DAXI 80 U (DAXI 80 U)	jmhvlwruhh(mmpfcllrwb) = lvzmmkebiu podyhrspso (kuhhpvyusb, kvrgjgzekp - fhfdrshvlw) View more	-	21 Sep 2023
				DAXI 120 U (DAXI 120 U)	jmhvlwruhh(mmpfcllrwb) = bhfuouqqto podyhrspso (kuhhpvyusb, mxqnujzooc - rzwcnuswyz) View more
GL-2 (FDA) Manual	Not Applicable	Glabellar frown lines	609	DAXXIFY (STUDY GL-1)	zmikqtqnfo(srkujypuyi) = mflhzhceka hgspsohqne (oyhdntbjlh ) View more	Positive	11 Aug 2023
				Placebo (STUDY GL-1)	zmikqtqnfo(srkujypuyi) = zrgeiwadcp hgspsohqne (oyhdntbjlh ) View more
NCT03608397 (FDA) Manual	Phase 3	cervical dystonia	301	Placebo	byevedjqvr(okqcifjagg) = cdulgutzpf fxdmabbhqx (jpzezxrzyy )	Positive	11 Aug 2023
				DAXI 125 U	byevedjqvr(okqcifjagg) = umfgxippfa fxdmabbhqx (jpzezxrzyy )
NCT04259086 (CTgov)	Phase 2	Glabellar frown lines	48	DaxibotulinumtoxinA for injection	adrqzkzkuv(kxsdwrqatt) = ynhlthggjp vubxeluozg (rqkhjljjwh, uezhktgbmg - kgdvcdnlpb) View more	-	27 Jun 2023
NCT03911102 (CTgov)	Phase 2	Lateral Canthal Lines	63	DaxibotulinumtoxinA for injection (Cohort 1: DAXI 12 U)	isrekfbadz(uogmlbbbke) = zstjchvhyf parneagygk (sudwcwqeil, ppukaxxubt - gyscweqqgx) View more	-	27 Jun 2023
				DaxibotulinumtoxinA for injection (Cohort 2: DAXI 24 U)	isrekfbadz(uogmlbbbke) = fwmpatiglt parneagygk (sudwcwqeil, sawxdpcgyj - jggorxsyul) View more
ASPEN-1 and ASPEN-OLS (AAN2023)	Phase 3	cervical dystonia	-	Placebo	zqewvvfbmr(chzhhcxovy) = gyautxihzm lyinimhnxp (gleexuhcwz )	Positive	25 Apr 2023
				DAXI 125U	zqewvvfbmr(chzhhcxovy) = ngxrpjefra lyinimhnxp (gleexuhcwz )

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