RVNC Revance Therapeutics Inc.

26.23
+1.09  (+4%)
Previous Close 25.13
Open 25.52
52 Week Low 9.88
52 Week High 27.97
Market Cap $1,500,306,051
Shares 57,209,001
Float 49,759,836
Enterprise Value $1,126,214,195
Volume 264,776
Av. Daily Volume 565,052
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Upcoming Catalysts

Drug Stage Catalyst Date
DAXI (RT002)
Moderate to severe glabellar (frown) lines
PDUFA
PDUFA
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DAXI (RT002) - ASPEN
Cervical dystonia
Phase 3
Phase 3
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DAXI (RT002)
Plantar fasciitis
Phase 2a
Phase 2a
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DAXI (RT002)
Full Upper Face
Phase 2
Phase 2
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DAXI (RT002) - JUNIPER
Upper limb spasticity
Phase 2
Phase 2
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Drug Pipeline

Drug Stage Notes
DAXI (RT002)
Forehead lines
Phase 2
Phase 2
Phase 2 data noted 100% of subjects achieved a score of none or mild wrinkle or line severity at Week 4 in at least one treatment group - June 30, 2020.
DAXI (RT002)
Lateral Canthal (Crow’s Feet) Lines
Phase 2
Phase 2
Phase 2 top-line data released June 30, 2020. 88% of subjects achieved a score of none or mild wrinkle or line severity at Week 4 in at least one treatment group.

Latest News

  1. - Enrollment closed with at least 76 subjects; study protocol modified in light of ongoing COVID-19 pandemic -

    - Revance now expects to report topline results from JUNIPER trial in early 2021 -

    Revance Therapeutics, Inc. (NASDAQ:RVNC), a biotechnology company focused on innovative aesthetic and therapeutic offerings, including its next-generation neuromodulator product, DaxibotulinumtoxinA for Injection, today announced a decision to complete enrollment in its JUNIPER Phase 2 trial of DaxibotulinumtoxinA for Injection for the treatment of upper limb spasticity in adults after stroke or traumatic brain injury. Due to ongoing COVID-19 concerns related to subject enrollment and scheduling in-person study visits, the company has chosen to end…

    - Enrollment closed with at least 76 subjects; study protocol modified in light of ongoing COVID-19 pandemic -

    - Revance now expects to report topline results from JUNIPER trial in early 2021 -

    Revance Therapeutics, Inc. (NASDAQ:RVNC), a biotechnology company focused on innovative aesthetic and therapeutic offerings, including its next-generation neuromodulator product, DaxibotulinumtoxinA for Injection, today announced a decision to complete enrollment in its JUNIPER Phase 2 trial of DaxibotulinumtoxinA for Injection for the treatment of upper limb spasticity in adults after stroke or traumatic brain injury. Due to ongoing COVID-19 concerns related to subject enrollment and scheduling in-person study visits, the company has chosen to end screening and complete the study with 76 subjects enrolled, along with a few subjects currently being evaluated for participation in the study. The 73 subjects dosed before enrollment was paused in March due to COVID-19 will be followed for up to 36 weeks; subjects enrolled after this will be followed to Week 12. Revance now expects to announce topline data from the JUNIPER Phase 2 trial in early 2021.

    "In announcing the close of enrollment for our JUNIPER Phase 2 trial, we are taking a pragmatic approach and making a proactive decision in light of the ongoing COVID-19 pandemic," said Roman Rubio, M.D., Senior Vice President of Clinical Development at Revance. "Fortunately, we have enrolled approximately two-thirds of the initial target subjects, which will produce phase 2 trial data that provides adequate information to advance our clinical program in upper limb spasticity."

    Added Mark Foley, President and Chief Executive Officer, "While the vast majority of our clinical development programs for DaxibotulinumtoxinA for Injection have been unaffected by the coronavirus pandemic, the one exception has been our JUNIPER trial, as previously communicated. We announced a pause in enrollment due to challenges in ongoing recruitment and subject monitoring due to social distancing. As COVID-related concerns have continued, we reassessed our assumptions and timeline, concluding that truncating the Phase 2 trial now could potentially allow us to move into the pivotal Phase 3 upper limb spasticity trials earlier than originally planned, while also avoiding patient enrollment during this challenging time."

    Today's announcement means Revance's therapeutic programs for DaxibotulinumtoxinA for Injection will generate three topline clinical results near term: A Phase 3 pivotal trial in cervical dystonia; a Phase 2 trial in plantar fasciitis; and a Phase 2 trial in upper limb spasticity. Concluded Foley, "We believe this enrollment decision is optimal for Revance's upper limb spasticity program, as well as for the patients we hope to treat, and we look forward to announcing the readouts in three therapeutic indications in the coming months."

    About JUNIPER Phase 2 Study

    The company's JUNIPER study is a Phase 2, randomized, double-blind, placebo-controlled, parallel group, dose-ranging, multi-center trial to evaluate the efficacy and safety of DaxibotulinumtoxinA for Injection for the treatment of upper limb spasticity in adults following stroke or traumatic brain injury. The study is being conducted at 28 sites in the United States and has enrolled male and female patients between the age of 18 to 75 years old. Patients have been randomized into one of four treatment groups: low dose, medium doses, high dose and a placebo. The study was designed to run for up to 36 weeks, with two primary outcome measures: change from baseline in muscle group most severely affected by spasticity score at Week 6; and change from Baseline Physician Global Impression of Change score at Week 6. Five secondary outcome measures are also included in the study to assess muscle tone improvement and duration of effect.

    Additional information about the JUNIPER Phase 2 study can be found at www.clinicaltrials.gov using the identifier NCT03821402.

    About Revance Therapeutics, Inc.

    Revance Therapeutics, Inc. is a biotechnology company focused on innovative aesthetic and therapeutic offerings, including its next-generation neuromodulator product, DaxibotulinumtoxinA for Injection. DaxibotulinumtoxinA for Injection combines a proprietary stabilizing peptide excipient with a highly purified botulinum toxin that does not contain human or animal-based components. Revance has successfully completed a Phase 3 program for DaxibotulinumtoxinA for Injection in glabellar (frown) lines and is pursuing U.S. regulatory approval in 2020. Revance is also evaluating DaxibotulinumtoxinA for Injection in the full upper face, including glabellar lines, forehead lines and crow's feet, as well as in three therapeutic indications - cervical dystonia, adult upper limb spasticity and plantar fasciitis. Beyond DaxibotulinumtoxinA for Injection, Revance has exclusive rights to commercialize TEOXANE SA's Resilient Hyaluronic Acid® (RHA®) Collection of dermal fillers in the U.S., the first and only range of FDA-approved fillers for correction of dynamic facial wrinkles and folds. Revance also has an agreement with Mylan N.V. to develop a biosimilar to BOTOX®, which would compete in the existing short-acting neuromodulator marketplace. Revance is dedicated to making a difference by transforming patient experiences. For more information or to join our team visit us at www.revance.com.

    "Revance Therapeutics" and the Revance logo are registered trademarks of Revance Therapeutics, Inc.

    Resilient Hyaluronic Acid® and RHA® are trademarks of TEOXANE SA.

    BOTOX® is a registered trademark of Allergan, Inc.

    Forward-Looking Statement

    This press release contains forward-looking statements, including statements related to Revance Therapeutics' 2020 financial outlook, expected cash runway and other financial performance, the process and timing of, and ability to complete, current and anticipated future clinical development of our investigational drug product candidates, the initiation, design, timing and results of our clinical studies, including the SAKURA 3 study of DaxibotulinumtoxinA for Injection, Phase 3 program for treatment of cervical dystonia, Phase 2 and other clinical programs for the management of plantar fasciitis and for the treatment of adult upper limb spasticity, and related results and reporting of such results; results of our non-clinical programs; statements about our business strategy, timeline and other goals and market for our anticipated products, plans and prospects; including our pre-commercialization plans and timing of our potential submission of a BLA filing for DaxibotulinumtoxinA for Injection to treat glabellar (frown) lines and potential regulatory approach and product launch; statements about our ability to obtain, and the timing relating to, regulatory approval with respect to our drug product candidates; statements regarding additional milestone payments through our partnerships, and potential benefits of our drug product candidates and our excipient peptide and other technologies.

    Forward-looking statements are subject to risks and uncertainties that could cause actual results to differ materially from our expectations. These risks and uncertainties include, but are not limited to: the outcome, cost, and timing of our product development activities and clinical trials; the uncertain clinical development process, including the risk that clinical trials may not have an effective design or generate positive results; our ability to obtain and maintain regulatory approval of our drug product candidates; our ability to obtain funding for our operations; our plans to research, develop, and commercialize our drug product candidates; our ability to achieve market acceptance of our drug product candidates; unanticipated costs or delays in research, development, and commercialization efforts; the applicability of clinical study results to actual outcomes; the size and growth potential of the markets for our drug product candidates; our ability to successfully commercialize our drug product candidates and the timing of commercialization activities; the rate and degree of market acceptance of our drug product candidates; our ability to develop sales and marketing capabilities; the accuracy of our estimates regarding expenses, future revenues, capital requirements and needs for financing; our ability to continue obtaining and maintaining intellectual property protection for our drug product candidates; and other risks. Detailed information regarding factors that may cause actual results to differ materially from the results expressed or implied by statements in this press release may be found in Revance's periodic filings with the Securities and Exchange Commission (the "SEC"), including factors described in the section entitled "Risk Factors" of our annual report on Form 10-K filed May 8, 2020. These forward-looking statements speak only as of the date hereof. Revance disclaims any obligation to update these forward-looking statements.

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  2. - At least one dose in each study demonstrated a measurable treatment effect in 100% of subjects at 4 weeks, with median duration of 27 weeks in forehead lines and 24 weeks in crow's feet -

    - DaxibotulinumtoxinA for Injection was well tolerated across all doses in both indications -

    Revance Therapeutics, Inc. (NASDAQ:RVNC), a biotechnology company focused on innovative aesthetic and therapeutic offerings, including its next-generation neuromodulator product, DaxibotulinumtoxinA for Injection, today announced results for two Phase 2a open-label, dose escalation studies of its investigational drug candidate DaxibotulinumtoxinA for Injection in the treatment of dynamic forehead lines (FHL) following glabellar (frown) line injections and lateral…

    - At least one dose in each study demonstrated a measurable treatment effect in 100% of subjects at 4 weeks, with median duration of 27 weeks in forehead lines and 24 weeks in crow's feet -

    - DaxibotulinumtoxinA for Injection was well tolerated across all doses in both indications -

    Revance Therapeutics, Inc. (NASDAQ:RVNC), a biotechnology company focused on innovative aesthetic and therapeutic offerings, including its next-generation neuromodulator product, DaxibotulinumtoxinA for Injection, today announced results for two Phase 2a open-label, dose escalation studies of its investigational drug candidate DaxibotulinumtoxinA for Injection in the treatment of dynamic forehead lines (FHL) following glabellar (frown) line injections and lateral canthal lines (LCL), commonly known as crow's feet. The company announced that both studies demonstrated positive efficacy results and that DaxibotulinumtoxinA for Injection was well tolerated. Additionally, the studies evaluated a range of doses and while not powered to provide clinical significance, they provide directional guidance on the impact of dose on efficacy and duration of effect.

    In the forehead lines study, a total of 61 subjects were enrolled into one of four dose groups with each receiving 40 units of DaxibotulinumtoxinA for Injection in the glabellar complex, followed two weeks later by injections of either 12, 16, 24, or 30 units in the forehead for a total study duration of up to 38 weeks. In the crow's feet study, a total of 63 patients were enrolled into one of four dose groups to receive either 12, 24, 36 or 48 units of DaxibotulinumtoxinA for Injection, then followed for up to 36 weeks.

    TREATMENT EFFECT

    The primary endpoint for efficacy was the proportion of subjects achieving a score of none or mild in wrinkle or line severity at Week 4 either at maximum eyebrow elevation for forehead lines or at maximum smile for crow's feet. The scores were based on the investigator assessment. In the forehead lines study, 100% of subjects achieved a score of none or mild at Week 4 in at least one treatment group. In the crow's feet study, 88% of subjects achieved a score of none or mild at Week 4 in at least one treatment group.

    In addition, the proportion of subjects with a measurable treatment effect, as assessed by the investigator, was analyzed. A dose-dependent change in percent of subjects with at least a one-point change from baseline was observed. In both studies, 100% of subjects achieved a score of at least a one-point change from baseline at Week 4 in at least one treatment group.

    One of the exploratory endpoints in these studies was duration of effect, defined as the median time to return to baseline wrinkle severity based on both investigator and patient assessment. At least one dose in each study demonstrated a median duration of effect of 27 weeks in the forehead lines study and 24 weeks in the crow's feet study.

    SAFETY

    In these two Phase 2a studies, DaxibotulinumtoxinA for Injection was well-tolerated at all dose levels. Adverse events were mild, localized and transient as expected and there were no treatment-related serious adverse events, as is common with other approved neuromodulators in the treatment of upper facial lines. The most common treatment-emergent adverse events after forehead line treatment were edema (10%), erythema (6.7%) and headache (5%). There was a single occurrence of mild eyelid ptosis that was fully resolved by Day 9. The most common treatment-emergent adverse events after crow's feet treatment were nasopharyngitis (11.1%), bruising (7.9%) and headache (7.9%). There were no events of ptosis.

    ADJACENT STUDIES

    Interim Week 4 data from these two Phase 2a studies were used in the final design of Revance's current upper facial lines Phase 2 study (glabellar lines, forehead lines and lateral canthal lines), to optimize dosing and injection patterns. Revance is scheduled to report results from that study in the fourth quarter of 2020. The SAKURA Phase 3 program assessing DaxibotulinumtoxinA for Injection as a potential treatment for moderate to severe glabellar lines yielded positive results, and the subsequent submission for regulatory approval has been given a Prescription Drug User Fee Act (PDUFA) VI program date of November 25, 2020, by the U.S. Food and Drug Administration (FDA).

    "We are very encouraged by the results of these two studies, designed to evaluate safety and efficacy, as well as identify safe and effective doses, for DaxibotulinumtoxinA for Injection in the treatment of forehead lines and crow's feet," said Roman Rubio, M.D., Senior Vice President of Clinical Development at Revance. "The finding that at least one dose in each study produced a response rate of 24-weeks duration provides a compelling initial demonstration that DaxibotulinumtoxinA for Injection holds promise for the treatment of forehead lines and crow's feet."

    Added Mark Foley, President and Chief Executive Officer, "Exploring DaxibotulinumtoxinA for Injection in other areas of the upper face beyond glabellar lines provides an expanded body of knowledge on the performance of our long-acting, next-generation neuromodulator. Our aim is to provide physicians and patients with a true advancement in the treatment of not only facial wrinkles, but also a number of debilitating muscle movement and pain disorders, which are being addressed through ongoing therapeutic clinical trials."

    Phase 2a Clinical Program in Forehead Lines

    The company's Phase 2a clinical program was a multicenter, open-label, dose escalation study to evaluate treatment of moderate or severe dynamic forehead lines (FHL) (frontalis) in conjunction with treatment of the glabellar complex. The study was conducted at four sites in the United States and Canada and enrolled 61 male and female patients with moderate to severe FHL, from the ages of 18 to 65 years old. Patients were enrolled sequentially into 1 of 4 treatment cohorts to receive DaxibotulinumtoxinA for Injection at 1 of 4 dose levels, ranging from 12 to 30 units. At the Day 1 study visit, patients received a single 40-unit dose of DaxibotulinumtoxinA for Injection for the treatment of glabellar lines. At the Week 2 study visit, patients received the assigned dose of DaxibotulinumtoxinA for Injection for the treatment of forehead lines. The total study duration was 38 weeks, plus up to 2 weeks for screening. Patients were then followed for a minimum of 24 weeks.

    Phase 2a Clinical Program in Lateral Canthal Lines

    The company's Phase 2a clinical program was a multicenter, open-label, dose escalation study that evaluated treatment of moderate or severe lateral canthal lines (LCL) or crow's feet. The study was conducted at three sites in the United States and enrolled 63 male and female patients with moderate to severe lateral canthal lines, from the ages of 18 to 65 years old. Patients were enrolled into the first two treatment cohorts simultaneously, then sequentially into cohorts 3 and 4, to receive DaxibotulinumtoxinA for Injection at doses ranging from 12 to 48 units. The total study duration was up to 36 weeks, plus up to 2 weeks for screening. Patients were then followed for a minimum of 24 weeks.

    Additional information about each Phase 2a study can be found at www.clinicaltrials.gov.

    About Revance Therapeutics, Inc.

    Revance Therapeutics, Inc. is a biotechnology company focused on innovative aesthetic and therapeutic offerings, including its next-generation neuromodulator product, DaxibotulinumtoxinA for Injection. DaxibotulinumtoxinA for Injection combines a proprietary stabilizing peptide excipient with a highly purified botulinum toxin that does not contain human or animal-based components. Revance has successfully completed a Phase 3 program for DaxibotulinumtoxinA for Injection in glabellar (frown) lines and is pursuing U.S. regulatory approval in 2020. Revance is also evaluating DaxibotulinumtoxinA for Injection in the full upper face, including glabellar lines, forehead lines and crow's feet, as well as in three therapeutic indications - cervical dystonia, adult upper limb spasticity and plantar fasciitis. Beyond DaxibotulinumtoxinA for Injection, Revance has exclusive rights to commercialize TEOXANE SA's Resilient Hyaluronic Acid® (RHA®) Collection of dermal fillers in the U.S., the first and only range of FDA-approved fillers for correction of dynamic facial wrinkles and folds. Revance also has an agreement with Mylan N.V. to develop a biosimilar to BOTOX®, which would compete in the existing short-acting neuromodulator marketplace. Revance is dedicated to making a difference by transforming patient experiences. For more information or to join our team visit us at www.revance.com.

    "Revance Therapeutics" and the Revance logo are registered trademarks of Revance Therapeutics, Inc.

    Resilient Hyaluronic Acid® and RHA® are trademarks of TEOXANE SA.

    BOTOX® is a registered trademark of Allergan, Inc.

    Forward-Looking Statement

    This press release contains forward-looking statements, including statements related to Revance Therapeutics' 2020 financial outlook, expected cash runway and other financial performance, the process and timing of, and ability to complete, current and anticipated future clinical development of our investigational drug product candidates, the initiation, design, timing and results of our clinical studies, including the SAKURA 3 study of DaxibotulinumtoxinA for Injection, Phase 3 program for treatment of cervical dystonia, Phase 2 and other clinical programs for the management of plantar fasciitis and for the treatment of adult upper limb spasticity, and related results and reporting of such results; results of our non-clinical programs; statements about our business strategy, timeline and other goals and market for our anticipated products, plans and prospects; including our pre-commercialization plans and timing of our potential submission of a BLA filing for DaxibotulinumtoxinA for Injection to treat glabellar (frown) lines and potential regulatory approach and product launch; statements about our ability to obtain, and the timing relating to, regulatory approval with respect to our drug product candidates; statements regarding additional milestone payments through our partnerships, and potential benefits of our drug product candidates and our excipient peptide and other technologies.

    Forward-looking statements are subject to risks and uncertainties that could cause actual results to differ materially from our expectations. These risks and uncertainties include, but are not limited to: the outcome, cost, and timing of our product development activities and clinical trials; the uncertain clinical development process, including the risk that clinical trials may not have an effective design or generate positive results; our ability to obtain and maintain regulatory approval of our drug product candidates; our ability to obtain funding for our operations; our plans to research, develop, and commercialize our drug product candidates; our ability to achieve market acceptance of our drug product candidates; unanticipated costs or delays in research, development, and commercialization efforts; the applicability of clinical study results to actual outcomes; the size and growth potential of the markets for our drug product candidates; our ability to successfully commercialize our drug product candidates and the timing of commercialization activities; the rate and degree of market acceptance of our drug product candidates; our ability to develop sales and marketing capabilities; the accuracy of our estimates regarding expenses, future revenues, capital requirements and needs for financing; our ability to continue obtaining and maintaining intellectual property protection for our drug product candidates; and other risks. Detailed information regarding factors that may cause actual results to differ materially from the results expressed or implied by statements in this press release may be found in Revance's periodic filings with the Securities and Exchange Commission (the "SEC"), including factors described in the section entitled "Risk Factors" of our annual report on Form 10-K filed May 8, 2020. These forward-looking statements speak only as of the date hereof. Revance disclaims any obligation to update these forward-looking statements.

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  3. Revance Therapeutics, Inc. (NASDAQ:RVNC), a biotechnology company focused on innovative aesthetic and therapeutic offerings, including its next-generation neuromodulator product, DaxibotulinumtoxinA for Injection, today announced that the company will participate in the 40th Annual William Blair Growth Stock Conference, a fully virtual management access conference, taking place June 9-11.

    President and Chief Executive Officer, Mark Foley, is scheduled to participate in a fireside chat on Thursday, June 11, at 10:00 a.m. PT / 12:00 p.m. CT / 1:00 p.m. ET.

    Interested parties can access the live audio webcast for this conference from the Investor Relations section of the company's website at www.revance.com. The webcast replay will be available…

    Revance Therapeutics, Inc. (NASDAQ:RVNC), a biotechnology company focused on innovative aesthetic and therapeutic offerings, including its next-generation neuromodulator product, DaxibotulinumtoxinA for Injection, today announced that the company will participate in the 40th Annual William Blair Growth Stock Conference, a fully virtual management access conference, taking place June 9-11.

    President and Chief Executive Officer, Mark Foley, is scheduled to participate in a fireside chat on Thursday, June 11, at 10:00 a.m. PT / 12:00 p.m. CT / 1:00 p.m. ET.

    Interested parties can access the live audio webcast for this conference from the Investor Relations section of the company's website at www.revance.com. The webcast replay will be available after the conclusion of the live presentation for approximately 30 days.

    About Revance Therapeutics, Inc.

    Revance Therapeutics, Inc. is a biotechnology company focused on innovative aesthetic and therapeutic offerings, including its next-generation neuromodulator product, DaxibotulinumtoxinA for Injection. DaxibotulinumtoxinA for Injection combines a proprietary stabilizing peptide excipient with a highly purified botulinum toxin that does not contain human or animal-based components. Revance has successfully completed a Phase 3 program for DaxibotulinumtoxinA for Injection in glabellar (frown) lines and is pursuing U.S. regulatory approval in 2020. Revance is also evaluating DaxibotulinumtoxinA for Injection in the full upper face, including glabellar lines, forehead lines and crow's feet, as well as in three therapeutic indications - cervical dystonia, adult upper limb spasticity and plantar fasciitis. Beyond DaxibotulinumtoxinA for Injection, Revance has exclusive rights to commercialize TEOXANE SA's Resilient Hyaluronic Acid® (RHA®) Collection of dermal fillers in the U.S., the first and only range of FDA-approved fillers for correction of dynamic facial wrinkles and folds. Revance also has an agreement with Mylan N.V. to develop a biosimilar to BOTOX®, which would compete in the existing short-acting neuromodulator marketplace. Revance is dedicated to making a difference by transforming patient experiences. For more information or to join our team visit us at www.revance.com.

    "Revance Therapeutics" and the Revance logo are registered trademarks of Revance Therapeutics, Inc.

    Resilient Hyaluronic Acid® and RHA® are trademarks of TEOXANE SA.

    BOTOX® is a registered trademark of Allergan, Inc.

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  4. Revance Therapeutics, Inc. (NASDAQ:RVNC), a biotechnology company focused on innovative aesthetic and therapeutic offerings, including its next-generation neuromodulator product, DaxibotulinumtoxinA for Injection, today announced that the company will present at the Goldman Sachs 41st Annual Global Healthcare Conference Webcast, a fully virtual management access conference, taking place June 9-11.

    President and Chief Executive Officer, Mark Foley, is scheduled to present on Tuesday, June 9, at 12:50 p.m. PT / 3:50 p.m. ET.

    Interested parties can access the live audio webcast for this conference from the Investor Relations section of the company's website at www.revance.com. The webcast replay will be available after the conclusion of the…

    Revance Therapeutics, Inc. (NASDAQ:RVNC), a biotechnology company focused on innovative aesthetic and therapeutic offerings, including its next-generation neuromodulator product, DaxibotulinumtoxinA for Injection, today announced that the company will present at the Goldman Sachs 41st Annual Global Healthcare Conference Webcast, a fully virtual management access conference, taking place June 9-11.

    President and Chief Executive Officer, Mark Foley, is scheduled to present on Tuesday, June 9, at 12:50 p.m. PT / 3:50 p.m. ET.

    Interested parties can access the live audio webcast for this conference from the Investor Relations section of the company's website at www.revance.com. The webcast replay will be available after the conclusion of the live presentation for approximately 30 days.

    About Revance Therapeutics, Inc.

    Revance Therapeutics, Inc. is a biotechnology company focused on innovative aesthetic and therapeutic offerings, including its next-generation neuromodulator product, DaxibotulinumtoxinA for Injection. DaxibotulinumtoxinA for Injection combines a proprietary stabilizing peptide excipient with a highly purified botulinum toxin that does not contain human or animal-based components. Revance has successfully completed a Phase 3 program for DaxibotulinumtoxinA for Injection in glabellar (frown) lines and is pursuing U.S. regulatory approval in 2020. Revance is also evaluating DaxibotulinumtoxinA for Injection in the full upper face, including glabellar lines, forehead lines and crow's feet, as well as in three therapeutic indications - cervical dystonia, adult upper limb spasticity and plantar fasciitis. Beyond DaxibotulinumtoxinA for Injection, Revance has exclusive rights to commercialize TEOXANE SA's Resilient Hyaluronic Acid® (RHA®) Collection of dermal fillers in the U.S., the first and only range of FDA-approved fillers for correction of dynamic facial wrinkles and folds. Revance also has an agreement with Mylan N.V. to develop a biosimilar to BOTOX®, which would compete in the existing short-acting neuromodulator marketplace. Revance is dedicated to making a difference by transforming patient experiences. For more information or to join our team visit us at www.revance.com.

    "Revance Therapeutics" and the Revance logo are registered trademarks of Revance Therapeutics, Inc.

    Resilient Hyaluronic Acid® and RHA® are trademarks of TEOXANE SA.

    BOTOX® is a registered trademark of Allergan, Inc.

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  5. - First neurotoxin formulation to be developed as a potential biosimilar product to BOTOX®, potentially giving Mylan access to 14 indications upon approval -

    - $30 million milestone payable to Revance from Mylan -

    Revance Therapeutics, Inc. (NASDAQ:RVNC) and Mylan N.V. (NASDAQ:MYL) today announced Mylan's decision to move forward with a development plan, under a 351(k) pathway, for a proposed biosimilar to BOTOX® and BOTOX® Cosmetic (onabotulinumtoxinA), the market-leading neuromodulator.

    Feedback obtained from the U.S. Food and Drug Administration (FDA) during a Biosimilar Initial Advisory Meeting (BIAM) held in February 2019 indicated that the 351(k) regulatory pathway for an onabotulinumtoxinA product is viable. Based on this meeting…

    - First neurotoxin formulation to be developed as a potential biosimilar product to BOTOX®, potentially giving Mylan access to 14 indications upon approval -

    - $30 million milestone payable to Revance from Mylan -

    Revance Therapeutics, Inc. (NASDAQ:RVNC) and Mylan N.V. (NASDAQ:MYL) today announced Mylan's decision to move forward with a development plan, under a 351(k) pathway, for a proposed biosimilar to BOTOX® and BOTOX® Cosmetic (onabotulinumtoxinA), the market-leading neuromodulator.

    Feedback obtained from the U.S. Food and Drug Administration (FDA) during a Biosimilar Initial Advisory Meeting (BIAM) held in February 2019 indicated that the 351(k) regulatory pathway for an onabotulinumtoxinA product is viable. Based on this meeting, along with the results from additional characterization and analysis completed by Revance, the two companies are now moving forward with the development program.

    "We are excited to move forward with Revance on a clear and achievable development pathway for what will potentially be the first biosimilar to BOTOX®, and to leverage our worldwide reach and commercial expertise to maximize this exciting opportunity globally while expanding access to this important product for patients," said Mylan President Rajiv Malik. "This collaboration adds another high-profile, large-market, complex biologic, across both aesthetic and therapeutic categories, to our industry-leading biosimilars pipeline."

    Added Mark Foley, President and Chief Executive Officer of Revance Therapeutics, "We are pleased with Mylan's decision to opt-in to the biosimilar to BOTOX development program, as it reflects our mutual confidence in the path forward. Assuming regulatory approval, it would allow us to financially participate in the short-acting neuromodulator market, while focusing our commercial efforts on creating the new, long-acting neuromodulator category."

    Mylan and Revance signed a collaboration and license agreement in February 2018 for the development and regulatory approval of a biosimilar to BOTOX®, to be followed with commercialization by Mylan in the U.S., Europe and applicable markets throughout the rest of the world. The agreement included an upfront payment of $25 million to Revance. In August 2019, the companies amended the agreement to include an additional one-time payment of $5 million to extend the period in which Mylan could choose to continue its collaboration and license agreement to develop Revance's biosimilar to BOTOX®.

    With Mylan's decision to move forward with the development program announced today, a payment of $30 million is now payable to Revance by Mylan. Furthermore, the collaboration and license agreement also provides for an additional $70 million in milestone payments, contingent upon the achievement of further clinical and regulatory milestones. Additionally, per the agreement, Revance is eligible to receive sales target milestone payments and royalties in all relevant markets.

    About Mylan

    Mylan is a global pharmaceutical company committed to setting new standards in healthcare. Working together around the world to provide 7 billion people access to high quality medicine, we innovate to satisfy unmet needs; make reliability and service excellence a habit; do what's right, not what's easy; and impact the future through passionate global leadership. We offer a portfolio of more than 7,500 marketed products around the world, including antiretroviral therapies on which more than 40% of people being treated for HIV/AIDS globally depend. We market our products in more than 165 countries and territories. We are one of the world's largest producers of active pharmaceutical ingredients. Every member of our approximately 35,000-strong workforce is dedicated to creating better health for a better world, one person at a time. Learn more at Mylan.com. We routinely post information that may be important to investors on our website at investor.mylan.com.

    Forward-Looking Statement: Mylan

    This press release includes statements that constitute "forward-looking statements," including with regard to the timing of regulatory approvals and commercialization of products; the outcome of clinical trials; the first neurotoxin formulation to be developed as a potential biosimilar product to BOTOX® potentially giving Mylan access to 14 indications upon approval; a decision to move forward with a development plan, under a 351(k) pathway, for a proposed biosimilar to BOTOX® and BOTOX® Cosmetic (onabotulinumtoxinA); that Mylan is excited to move forward with Revance on a clear and achievable development pathway, for what will potentially be the first biosimilar to BOTOX®, and to leverage our worldwide reach and commercial expertise to maximize this exciting opportunity globally while expanding access to this important product for patients; and potential future milestone and royalty payments. Because forward-looking statements inherently involve risks and uncertainties, actual future results may differ materially from those expressed or implied by such statements. Factors that could cause or contribute to such differences include, but are not limited to the potential widespread and highly uncertain impact of public health outbreaks, epidemics and pandemics, such as the COVID-19 pandemic; any changes in, interruptions to, or difficulties with Mylan's or its partners' ability to develop, manufacture, and commercialize products; the effect of any changes in Mylan's or its partners' customer and supplier relationships and customer purchasing patterns; other changes in third-party relationships; the impact of competition; changes in the economic and financial conditions of the businesses of Mylan or its partners; the scope, timing, and outcome of any ongoing legal proceedings and the impact of any such proceedings on Mylan's or its partners' business; any regulatory, legal, or other impediments to Mylan's or its partners' ability to bring products to market; actions and decisions of healthcare and pharmaceutical regulators, and changes in healthcare and pharmaceutical laws and regulations, in the United States and abroad; Mylan's and its partners' ability to protect intellectual property and preserve intellectual property rights; risks associated with international operations; other uncertainties and matters beyond the control of management; and the other risks detailed in Mylan's filings with the Securities and Exchange Commission. Mylan undertakes no obligation to update these statements for revisions or changes after the date of this release.

    About Revance Therapeutics, Inc.

    Revance Therapeutics, Inc. is a biotechnology company focused on innovative aesthetic and therapeutic offerings, including its next-generation neuromodulator product, DaxibotulinumtoxinA for Injection. DaxibotulinumtoxinA for Injection combines a proprietary stabilizing peptide excipient with a highly purified botulinum toxin that does not contain human or animal-based components. Revance has successfully completed a Phase 3 program for DaxibotulinumtoxinA for Injection in glabellar (frown) lines and is pursuing U.S. regulatory approval in 2020. Revance is also evaluating DaxibotulinumtoxinA for Injection in the full upper face, including glabellar lines, forehead lines and crow's feet, as well as in three therapeutic indications - cervical dystonia, adult upper limb spasticity and plantar fasciitis. Beyond DaxibotulinumtoxinA for Injection, Revance gained exclusive rights to commercialize TEOXANE SA's Resilient Hyaluronic Acid® (RHA®) line of fillers in the U.S., the first and only range of FDA-approved dermal fillers for correction of dynamic facial wrinkles and folds. Revance has also begun development of a biosimilar to BOTOX®, which would compete in the existing short-acting neuromodulator marketplace. Revance is dedicated to making a difference by transforming patient experiences. For more information or to join our team visit us at www.revance.com.

    "Revance Therapeutics" and the Revance logo are registered trademarks of Revance Therapeutics, Inc.

    Resilient Hyaluronic Acid® and RHA® are trademarks of TEOXANE SA.

    BOTOX® is a registered trademark of Allergan, Inc.

    Forward-Looking Statement: Revance Therapeutics

    This press release contains forward-looking statements, including statements related to Revance Therapeutics' 2020 financial outlook, expected cash runway and other financial performance, the process and timing of, and ability to complete, current and anticipated future clinical development of our investigational drug product candidates, the initiation, design, timing and results of our clinical studies, including the SAKURA 3 study of DaxibotulinumtoxinA for Injection, Phase 3 program for treatment of cervical dystonia, Phase 2 and other clinical programs for the management of plantar fasciitis and for the treatment of adult upper limb spasticity, and related results and reporting of such results; development of a biosimilar to BOTOX®; results of our non-clinical programs; statements about our business strategy, timeline and other goals and market for our anticipated products, plans and prospects; including our pre-commercialization plans and timing of our potential submission of a BLA filing for DaxibotulinumtoxinA for Injection to treat glabellar (frown) lines and potential regulatory approach and product launch; statements about our ability to obtain, and the timing relating to, regulatory approval with respect to our drug product candidates; statements regarding additional milestone payments through our partnerships, and potential benefits of our drug product candidates and our excipient peptide and other technologies. Forward-looking statements are subject to risks and uncertainties that could cause actual results to differ materially from our expectations. These risks and uncertainties include, but are not limited to: the outcome, cost, and timing of our product development activities and clinical trials; the uncertain clinical development process, including the risk that clinical trials may not have an effective design or generate positive results; our ability to obtain and maintain regulatory approval of our drug product candidates; our ability to obtain funding for our operations; our plans to research, develop, and commercialize our drug product candidates; our ability to achieve market acceptance of our drug product candidates; unanticipated costs or delays in research, development, and commercialization efforts; the applicability of clinical study results to actual outcomes; the size and growth potential of the markets for our drug product candidates; our ability to successfully commercialize our drug product candidates and the timing of commercialization activities; the rate and degree of market acceptance of our drug product candidates; our ability to develop sales and marketing capabilities; the accuracy of our estimates regarding expenses, future revenues, capital requirements and needs for financing; our ability to continue obtaining and maintaining intellectual property protection for our drug product candidates; and other risks. Detailed information regarding factors that may cause actual results to differ materially from the results expressed or implied by statements in this press release may be found in Revance's periodic filings with the Securities and Exchange Commission (the "SEC"), including factors described in the section entitled "Risk Factors" of our quarterly report on Form 10-Q filed May 8, 2020. These forward-looking statements speak only as of the date hereof. Revance disclaims any obligation to update these forward-looking statements.

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