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Fly Intel: Pre-market Movers » 08:5806/0506/05/20
ACTG, OXFD, KNDI, AVGO, DOMO, WORK, GPS, YEXT, MNLO, GME
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Menlo Therapeutics 27.1M share Spot Secondary priced at $1.85 » 07:1206/0506/05/20
Cowen and Piper Sandler…
Cowen and Piper Sandler acted as joint book running managers for the offering.
Fly Intel: After-Hours Movers » 19:0506/0406/04/20
DOMO, MTN, DOCU, RH, AVGO, IMUX, VECO, WORK, GPS, YEXT, COO, PD, CAL, MDB, ZUMZ, MNLO, GME
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Menlo Therapeutics files to sell common stock, no amount given » 16:0106/0406/04/20
Cowen and Piper Sandler…
Cowen and Piper Sandler & Co. are acting as joint book-runners for the proposed offering. LifeSci Capital LLC is acting as lead manager
Menlo Therapeutics announces results from Phase 2 trial of FCD105 » 08:0206/0206/02/20
Menlo Therapeutics announced positive results from a Phase 2 clinical trial evaluating the preliminary safety and efficacy of FCD105, the first ever topical minocycline-based combination product, for the treatment of moderate-to-severe acne vulgaris. Study FX2016-40 enrolled 447 patients in the United States who were randomized to either FCD105 foam, 3% minocycline foam, 0.3% adapalene foam, or vehicle foam. The Company has begun preparations to conduct an End of Phase 2 meeting with the FDA before the end of this year. FCD105 showed a highly statistically significant improvement compared to vehicle for the endpoints of Investigator's Global Assessment treatment success and absolute change from baseline in mean inflammatory counts at Week 12. The proportion of patients achieving IGA treatment success in the FCD105 treatment group was 35.9% compared to 15.7% of patients in the vehicle treatment group. Absolute reduction in inflammatory lesion counts at Week 12 was -19.4 for the FCD105 treatment group compared to -15.58 for the vehicle treatment group. The trial was not originally powered to demonstrate a statistical difference between FCD105 and either 3% minocycline foam or 0.3% adapalene foam treatments; however, the majority of these comparisons did show a statistically significant improvement of FCD105 at Week 12. Numerical improvement was observed for FCD105 on all efficacy endpoints for these comparisons at Week 12. Absolute reduction in non-inflammatory lesion counts at Week 12 was also assessed with a mean lesion count reduction of -24.94 for the FCD105 treatment group compared to -22.87 for the vehicle treatment group. Although numerical improvement was shown, this was not statistically significant, which has been attributed to outlier results affecting both FCD105 and vehicle treatment groups. Conversely, absolute reduction in non-inflammatory lesion counts at Week 12 for FCD105 did show a statistically significant improvement compared to each of 3% minocycline foam and 0.3% adapalene foam. The most commonly reported treatment-emergent adverse event in the trial was upper respiratory tract infection with dry skin being the most commonly reported cutaneous adverse event. The majority of adverse events were assessed as mild in severity. There were no serious adverse events. FCD105 was comparably tolerated to vehicle in all local skin tolerability assessments with 93% or greater of severity scores being assessed as "none" or "mild" for burning/stinging, itching, dryness, scaling, erythema and hyperpigmentation.
Menlo Therapeutics price target raised to $6 from $3.50 at Northland » 08:2306/0106/01/20
Northland analyst Tim…
Northland analyst Tim Chiang raised the firm's price target on Menlo Therapeutics to $6 from $3.50 and keeps an Outperform rating on the shares. The analyst believes Amzeeq and Zilxi will lead to "meaningful revenue growth" for the company. The recent approval of ZIlxi (adds a complementary product to Menlo's dermatology arsenal, Chiang tells investors in a research note.
Menlo Therapeutics price target raised to $3.50 from $2.50 at H.C. Wainwright » 06:3206/0106/01/20
H.C. Wainwright analyst…
H.C. Wainwright analyst Oren Livnat raised the firm's price target on Menlo Therapeutics to $3.50 from $2.50 and keeps a Buy rating on the shares. The analyst increased estimates for the company with Amzeeq volume already up 50% over the last four weeks as shutdowns start to lift. Amzeeq is bouncing back from COVID-19 faster than the analyst expected.
Menlo set up for 'successful' Q4 launch of Zilxi, says Cantor Fitzgerald » 12:2605/2905/29/20
After Menlo Therapeutics…
After Menlo Therapeutics announced that Zilxi has received FDA approval for the treatment of inflammatory lesions of rosacea, Cantor Fitzgerald analyst Louise Chen said she views the approval positively and believes it sets up the company for a potential "successful" launch of its second FDA approved product in the fourth quarter of this year. Chen, who continues to believe that the peak sales potential for Menlo's products and pipeline are being "underappreciated," keeps an Overweight rating and $15 price target on the shares.
Menlo Therapeutics receives FDA approval of ZILXI topical foam » 11:4305/2905/29/20
Menlo Therapeutics announced that the U.S. Food and Drug Administration has approved ZILXI topical foam, 1.5%, for the treatment of inflammatory lesions of rosacea in adults. ZILXI, developed as FMX103 by Menlo's wholly-owned subsidiary Foamix Pharmaceuticals, is the first minocycline product of any kind to be approved by the FDA for use in rosacea. Rosacea is a diverse skin condition that most commonly presents with symptoms such as deep facial redness, spider veins and acne-like inflammatory lesions. Minocycline is one of several broad-spectrum antibiotics known as tetracyclines with anti-inflammatory properties; their use in some patients is limited due to systemic side effects when taken orally. In ZILXI, Menlo has once more leveraged its proprietary Molecule Stabilizing Technology platform to effectively deliver minocycline in a foam-based vehicle. The FDA approval of ZILXI is primarily supported by data from two clinical trials in 1,522 patients 18 years of age and older. In each 12-week multicenter, randomized, double-blind, vehicle-controlled trial, subjects with inflammatory lesions of rosacea were treated once daily with ZILXI or vehicle. No other topical or systemic medication affecting the course of inflammatory lesions of rosacea was permitted for use during these trials. The co-primary efficacy endpoints were the absolute change from baseline in inflammatory lesion counts at Week 12 and the proportion of subjects with treatment success at Week 12 defined as an IGA score of 0 or 1, and at least a two-grade improvement from baseline at Week 12. ZILXI met both co-primary endpoints in each clinical trial, demonstrating statistically significant improvements in inflammatory lesion count and Investigator Global Assessment treatment success. No treatment-related serious adverse events were reported. The most common adverse reaction reported by greater than or equal to1% of subjects treated with ZILXI and more frequently than in subjects treated with vehicle was diarrhea, respectively. Menlo anticipates having ZILXI available for prescribing by 4th quarter of this year.
Menlo Therapeutics announces covered status for AMZEEQ topical foam » 08:2605/2705/27/20
Menlo Therapeutics announced that its novel AMZEEQ topical foam, 4%, for the treatment of inflammatory lesions of non-nodular moderate to severe acne vulgaris in adults and pediatric patients 9 years of age and older, has been added to the prescription drug formulary of one of the largest payors in the U.S. AMZEEQ was approved by the U.S. Food and Drug Administration in October 2019. Minocycline, a broad-spectrum antibiotic known for its efficacy in treating moderate to severe acne, has not previously been available as a topical treatment due to its instability in traditional topical formulations. In AMZEEQ, Foamix has leveraged its proprietary Molecule Stabilizing Technology platform to deliver minocycline in a foam-based vehicle that maintains the stability of the active ingredient while delivering it directly on the skin.