|Over a month ago|
Menlo, Cutia enter license agreement for AMZEEQ, minocycline products » 08:1904/2304/23/20
Menlo Therapeutics Inc.…
Menlo Therapeutics Inc. (MNLO) announced that its wholly-owned subsidiary, Foamix Pharmaceuticals Ltd. (FOMX), has entered into a licensing agreement with specialty pharmaceutical company Cutia Therapeutics Limited, an affiliate of Cutia Therapeutics for AMZEEQ topical foam, 4% as well as its other topical minocycline product candidates, once approved, on an exclusive basis in Greater China. Under the terms of the agreement, Cutia will have an exclusive license to obtain regulatory approval of and commercialize AMZEEQ and, if approved in the U.S., FMX103 and FCD105 in the Greater China territory. Foamix will supply the finished licensed products to Cutia for clinical and commercial use. Foamix will receive an upfront cash payment of $10 million and will be eligible to receive an additional $1 million payment upon the receipt of marketing approval in China of the first licensed product. Foamix will also receive royalties on net sales of any licensed products. In October 2019, Foamix received U.S. Food and Drug Administration approval for AMZEEQ, a minocycline topical foam, 4%, for the treatment of non-nodular inflammatory moderate-to-severe acne vulgaris in adults and pediatric patients 9 years of age and older. In addition to AMZEEQ, the Company is working to develop and commercialize in the U.S. a topical minocycline foam, 1.5% for the potential treatment of inflammatory lesions (papules and pustules) of rosacea in adults, which is currently being reviewed by the FDA with a PDUFA action date of June 2, 2020, and FCD105, a topical foam combination of minocycline and adapalene therapy for the potential treatment of acne vulgaris, which is currently in Phase 2 clinical development with top line results expected in the second quarter of 2020.
|Over a quarter ago|
Menlo Therapeutics says LEO Pharma remedies Finacea Foam supply chain issues » 08:0804/0204/02/20
The company said,…
The company said, "Menlo (MNLO) further announces that LEO Pharma has remedied the supply chain issues related to Finacea Foam (FOMX) that Foamix previously disclosed in April 2019. Pursuant to the license agreement between Foamix and LEO Pharma, Foamix is entitled to the payment of royalties based on the net sales of Finacea Foam. This week, LEO Pharma informed Menlo that it has remedied its supply issues and expects to resupply batches of Finacea Foam for commercial sales in the U.S. in the coming weeks. Following the resupply, we anticipate that our royalty payments for Finacea Foam will increase."
Menlo Therapeutics announces settlement to conclude Finacea Foam litigation » 08:0704/0204/02/20
MNLO, FOMX, TEVA, PRGO
Menlo Therapeutics (MNLO)…
Menlo Therapeutics (MNLO) announced that its wholly-owned subsidiary, Foamix Pharmaceuticals Ltd. (FOMX) has entered into a settlement and license agreement to resolve the remaining pending patent litigation involving Finacea Foam. Details of the settlement agreement are confidential, and the settlement agreement is subject to the review of the Federal Trade Commission and the U.S. Department of Justice. Foamix is the owner of patents that have been licensed to LEO Pharma A/S to market Finacea Foam, a topical prescription medicine used to treat the inflammatory papules and pustules of mild to moderate rosacea. This settlement concludes the litigation relating to Finacea Foam and comes after the settlements in October 2019 with an affiliate of Teva Pharmaceutical Industries (TEVA) and in April 2019 with affiliates of Perrigo Company (PRGO).
Menlo Therapeutics to hold a conference call » 08:2503/1203/12/20
Conference call to…
Menlo Therapeutics expects data from Foamix Phase 2 trial for FCD105 in 2Q20 07:5003/1203/12/20
Menlo Therapeutics reports Foamix FY19 EPS ($1.66) vs. ($1.70) last year » 07:4903/1203/12/20
Reports 2019 revenue…
Reports 2019 revenue $443,000 vs. $3.6M last year.
Menlo Therapeutics to hold a conference call » 04:5503/1203/12/20
Conference call to…
One new option listing and two option delistings on March 10th » 08:3003/1003/10/20
MNLO, FOMX, ZAYO
New option listings for…
New option listings for March 10th include Menlo Therapeutics Inc (MNLO). Option delistings effective March 10th include Foamix Pharmaceuticals Ltd (FOMX) and Zayo Group Holdings Inc (ZAYO).
Menlo Therapeutics to hold a conference call » 17:0403/0903/09/20
Conference call to…
Menlo Therapeutics, Foamix announce completion of merger » 08:1703/0903/09/20
Menlo Therapeutics Inc.…
Menlo Therapeutics Inc. (MNLO) announced the completion of its merger with Foamix Pharmaceuticals Ltd. (FOMX) following the satisfaction of all closing conditions required by the merger agreement. Upon completion of the merger, pursuant to the terms of the merger agreement, Foamix became a wholly owned subsidiary of Menlo. Under the terms of the merger, Foamix shareholders received 0.5924 of a share of Menlo common stock for each Foamix share owned, as well as a non-transferrable contingent stock right. These contingent stock rights potentially allow Foamix shareholders to receive additional shares of Menlo common stock based on the results of Menlo's Phase 3 trials of serlopitant for the treatment of pruritus associated with prurigo nodularis, as more fully described in the companies' joint proxy statement/prospectus on Form S-4. Foamix ordinary shares ceased trading as of the close of trading on March 6, 2020. On March 9, 2020, newly issued Menlo shares will commence trading under the ticker "MNLO" on Nasdaq. Since announcing the transaction on November 11, 2019, the Company achieved a major milestone with the launch of its first product, AMZEEQ 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.. In the coming weeks, the Company anticipates announcing the results of its Phase 3 clinical trials of serlopitant for the treatment of pruritus associated with prurigo nodularis. Additionally, the Company expects to announce the results of its Phase 2 clinical trial for FCD105 for the treatment of acne in the second quarter of 2020. The Company has also taken meaningful steps towards facilitating a successful integration and capitalizing on expected cost synergies. Effective upon the closing of the merger, Foamix's management team will manage the Company, led by David Domzalski as CEO. As part of the transaction, Foamix has designated five of its pre-closing directors, David Domzalski, Sharon Barbari, Rex Bright, Anthony Bruno and Stanley Hirsch to serve as members of the Menlo Board of Directors. Menlo has designated two of its pre-closing directors, Steve Basta, Menlo's Chief Executive Officer prior to the consummation of the merger, and Elisabeth Sandoval, to be directors of the Company following the merger.