How Revance Is Misleading Investors About RT002
Richard Pearson • 11 Comments
Richard Pearson • 11 Comments
Thu, Jul. 14, 5:09 PM
- Thinly traded micro cap Revance Therapeutics (NASDAQ:RVNC) slumps 6% after hours on higher-than-average volume in apparent response to its announcement that it completed its Type B/pre-IND/pre-Phase 3 meeting with the FDA regarding the advancement of RT002 (daxibotulinumtoxinA for injection) for the treatment of glabellar (frown) lines. Clinical trials should commence in H2.
- The Phase 3 program will include two placebo-controlled pivotal studies in the U.S. and Canada. The primary endpoint will be a composite of the proportion of patients who achieve a score of 0 or 1 (none or mild) and a two-point improvement from baseline in glabellar line severity at maximum contraction at week 4. The program will also include a long-term open-label safety study. The prospective timeline appears to have disappointed investors.
- In a Phase 2 trial, RT002 beat Allergan's (NYSE:AGN) BOTOX Cosmetic.
- Previously: Revance's RT002 beats BOTOX in mid-stage study; shares up 58% premarket (Oct. 29, 2015)
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
Oct. 29, 2015, 12:53 PM
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.
May 14, 2015, 12:45 PM
Jan. 8, 2015, 5:35 PM
Nov. 13, 2014, 12:48 PM
Nov. 13, 2014, 9:10 AM
Aug. 7, 2014, 12:47 PM
Jun. 9, 2014, 12:45 PM
Apr. 22, 2014, 9:14 AM
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