How Revance Is Misleading Investors About RT002
Richard Pearson • 11 Comments
Richard Pearson • 11 Comments
Tue, Jun. 14, 12:51 PM
Tue, Jun. 14, 11:00 AM
Tue, Jun. 14, 9:19 AM
Mon, Jun. 13, 5:02 PM
- Thinly traded micro cap Revance Therapeutics (NASDAQ:RVNC) slumps 22% after hours on robust volume in response to its announcement that lead product candidate DaxibotulinumtoxinA Topical Gel (RT001) flunked a Phase 3 study, REALISE 1, in patients with moderate-to-severe lateral canthal lines (crow's feet).
- Based on the disappointing results, the company has decided to terminate the clinical development of RT001 for axillary hyperhidrosis. Instead, it will focus on developing RT002, an injectable formulation of DaxibotulinumtoxinA, currently in Phase 2 development for cervical dystonia and Phase 3 for glabellar (frown) lines.
Dec. 23, 2015, 5:44 PM
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Oct. 29, 2015, 9:13 AM| Oct. 29, 2015, 9:13 AM
Oct. 29, 2015, 8:44 AM
- Results from a Phase 2 clinical trial evaluating Revance Therapeutics' (NASDAQ:RVNC) injectable RT002 against placebo and Allergan's (NYSE:AGN) BOTOX Cosmetic showed RT002's superiority in treating glabellar lines (frown lines). The 268-subject study assessed the safety, efficacy and duration of effect for three doses (20, 40 and 60 units) of RT002, a botulinum toxin A drug candidate.
- At week 4, the primary efficacy measurement of at least a one-point improvement in frown lines based on the IGA-FWS scale for all three doses of RT002 was highly statistically significant compared to placebo (p<0.001). All three doses of RT002 achieved a 100% response rate (minimum of one-point improvement in frown lines) at week 4 versus 95% for BOTOX Cosmetic.
- The 40U dose of RT002 was statistically superior to BOTOX Cosmetic on all three responder definitions for the IGS-FSW duration of effect, with a median duration of 23.6 weeks compared to 18.8 weeks for BOTOX Cosmetic (p=0.020).
- At week 16, more than twice as many participants receiving RT002 40U and 60U maintained none or mild wrinkles per the IGA-FWS scale compared to those receiving BOTOX Cosmetic (p=0.002).
- RTOO2 was safe and well-tolerated across all cohorts.
- The company intends to report final results and meet with the FDA in H2 2016. A Phase 3 is expected to commence shortly thereafter. Revance believes the data will support a six-month duration of effect claim.
- Shares are up 58% premarket on robust volume.
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- Revance (RVNC) continues its volatile ways following its IPO on February 6, when it debuted at $16. The stock is up 2.5% today at $27.61 but that's down sharply from earlier highs and follows a steep fall at the end of last week.
- Revance's lead product is a topical Botulinum Toxin Type A Gel for the treatment of lateral canthal lines (crow's feet). It will complete with Allergan's (AGN) blockbuster injectable treatment Botox.
- Botulinum is in Phase 3 trials in the U.S.
- Anaylsts' price targets range from $37-55.
Revance Therapeutics, Inc. is a clinical stage specialty biopharmaceutical company focused on the development, manufacturing and commercialization of novel botulinum toxin products for multiple aesthetic and therapeutic applications. The company was founded by Jacob M. Waugh and L. Daniel Browne... More
Country: United States
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