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VYNE Therapeutics (VYNE)

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Last Post: 5/17/2022 11:30:51 AM - Followers: 19 - Board type: Free - Posts Today: 0

Company Website
Menlo's Nasdaq Page

Menlo's Edgar Filings



$MNLO; LICENSING ;;;;; 04-23-2020

-- Menlo Therapeutics Inc. (MNLO) (“Menlo” or the “Company”),
a specialty pharmaceutical company focused on developing and commercializing proprietary therapies to
address unmet needs in dermatology, today announced that its wholly-owned subsidiary,

Foamix Pharmaceuticals Ltd. (“Foamix”), has entered into a licensing agreement with specialty pharmaceutical company Cutia Therapeutics
(HK) Limited, an affiliate of Cutia Therapeutics
(“Cutia”) for AMZEEQ™ (minocycline) 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.

“We believe that this agreement with Cutia speaks to the importance
of our topical minocycline technology and the strong demand for
AMZEEQ worldwide,” said David Domzalski, CEO of Menlo.

“We intend to partner with other companies outside the U.S. to
extend our commercial reach in order to bring AMZEEQ and our
topical minocycline product candidates to the hundreds of millions
of patients suffering from acne and rosacea.”

“We recognized the value of Foamix’s unique foam technology for dermatology and looked to license its minocycline products as
anchor assets as we aim to build China’s leading dermatology platform,” said Lele Zhang, CEO of Cutia.

Cutia is a portfolio company of 6 Dimensions Capital, a leading global investment firm with a focus on life sciences and
healthcare with over 10B RMB ($1.5B USD) currently under management.

In October 2019,
Foamix received U.S. Food and Drug Administration (FDA) 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% (FMX103) 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.

With over 200 granted patents worldwide Menlo is a leader in innovative topical technologies and
has out-licensed novel delivery platforms to pharmaceutical companies for the development of
proprietary topical products containing various active pharmaceutical ingredients.



Stock analysts at Piper Sandler decreased their Q2 2020 earnings estimates for
Menlo Therapeutics in a research report issued to clients and investors on

Monday, May 11th. Piper Sandler analyst D. Amsellem now forecasts
the company will post earnings of ($0.18) per share for the quarter,

down from their previous estimate of ($0.11).

Piper Sandler also issued estimates for Menlo Therapeutics’ Q3 2020 earnings at ($0.18) EPS,

Q4 2020 earnings at ($0.14) EPS,
FY2020 earnings at ($0.79) EPS,
Q1 2021 earnings at ($0.12) EPS,
Q2 2021 earnings at ($0.08) EPS,
Q3 2021 earnings at ($0.08) EPS,
Q4 2021 earnings at ($0.05) EPS,
FY2021 earnings at ($0.33) EPS and
FY2022 earnings at $0.03 EPS.







Menlo Announces Settlement to Conclude Finacea Foam Litigation and Announces that Partner,
LEO Pharma A/S, Remedies Finacea Foam Supply Issues

BRIDGEWATER, N.J., April 02, 2020 (GLOBE NEWSWIRE) -- Menlo Therapeutics Inc. (MNLO) (“Menlo” or the “Company”),
a biopharmaceutical company focused on developing and commercializing proprietary therapies to address unmet needs in dermatology,
today announced that its wholly-owned subsidiary, Foamix Pharmaceuticals Ltd. (“Foamix”) 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 (“LEO Pharma”) 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 Ltd. and in April 2019 with affiliates of Perrigo Company plc.

Expected Resupply of Finacea Foam

Menlo further announces that LEO Pharma has remedied the supply chain issues related to Finacea Foam 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. 

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VYNE News: Analysts Offer Insights on Healthcare Companies: VYNE Therapeutics (VYNE) and Nano-X Imaging (NNOX) 05/24/2022 12:15:16 AM
VYNE News: H.C. Wainwright Thinks VYNE Therapeutics’ Stock is Going to Recover 05/18/2022 02:18:46 AM
VYNE News: Current Report Filing (8-k) 05/17/2022 06:05:18 AM
VYNE News: Prospectus Filed Pursuant to Rule 424(b)(5) (424b5) 05/12/2022 01:01:42 PM
VYNE News: Current Report Filing (8-k) 05/12/2022 12:17:10 PM
#776   8K https://fintel.io/doc/sec-vyne-therapeutics-inc-1566044-8k-2022-may-17-1912 Tzr250rg 05/17/22 11:30:51 AM
#775   BlackRock accumulating again?https://investorshub.advfn.com/uimage/uploads/ Tzr250rg 05/13/22 01:26:02 PM
#774   .40 low Tzr250rg 04/25/22 01:05:16 PM
#773   ATL Tzr250rg 04/20/22 10:28:19 AM
#772   up 36% Tzr250rg 04/07/22 08:07:33 AM
#771   https://www.globenewswire.com/news-release/2022/04/07/2418427/0/en/VYNE-Therapeu Tzr250rg 04/07/22 08:06:01 AM
#770   There's a lot to be optimistic about in adamski 04/01/22 02:40:22 AM
#769   https://investorshub.advfn.com/uimage/uploads/2022/3/23/TPQGGVAUVTAM.png[/i Tzr250rg 03/23/22 09:27:58 AM
#768   +22% Tzr250rg 03/18/22 01:30:28 PM
#767   some life today. up 10% Tzr250rg 03/18/22 09:52:43 AM
#766   Cantor Fitzgerald Reiterates VYNE Therapeutics (VYNE) Overwight, $10 Tzr250rg 03/17/22 01:27:13 PM
#765   H.C. Wainwright Thinks VYNE Therapeutics’ Stock is Going Tzr250rg 03/17/22 01:26:00 PM
#764   H.C. Wainwright Thinks VYNE Therapeutics’ Stock is Going Tzr250rg 03/17/22 01:25:58 PM
#763   8K out Tzr250rg 03/17/22 01:06:05 PM
#762   Perceptive advisers buying again? Lets see what Joseph Tzr250rg 02/15/22 09:23:36 AM
#761   hope you correct! Tzr250rg 01/18/22 12:29:54 PM
#760   massive news OH NO- NOT AGAIN 01/14/22 03:17:10 PM
#759   massive news OH NO- NOT AGAIN 01/14/22 03:17:09 PM
#758   back to a $1 OH NO- NOT AGAIN 01/14/22 02:53:59 PM
#757   1/2 billllllllllion OH NO- NOT AGAIN 01/14/22 02:45:52 PM
#756   the day traders on discord have noticed it. realfast95 01/13/22 09:24:20 AM
#755   Even though the deal came in Q1/22 they realfast95 01/13/22 09:17:07 AM
#754   Its amazing to see all this volume. Why HolesInMyPockitz 01/13/22 09:14:35 AM
#753   Underwhelming. Never underestimate this CEO from realfast95 01/13/22 09:12:13 AM
#752   Sea of red selling all morning premarket.. must OH NO- NOT AGAIN 01/13/22 09:07:06 AM
#751   Fantastic news and added more. Need to do HolesInMyPockitz 01/13/22 07:44:33 AM
#750   VYNE Therapeutics Divests Topical Minocycline Assets; Transaction Includes realfast95 01/13/22 07:16:59 AM
#749   VYNE investor presentation Jan 2022 adamski 01/05/22 09:21:14 AM
#748   I came in today with 10,000 shares. The Amrsto1000 12/10/21 08:11:56 PM
#747   yup Tzr250rg 12/10/21 02:56:52 PM
#746   Blackrock owns 2% of the OS banks buy bottoms MatrixMoney 12/10/21 09:17:51 AM
#745   Multiple SEC form 4's. Employees loading VYNE fast crudeoil24 12/10/21 07:24:30 AM
#744   VYNE > Vyne Therapeutics Inc. is a specialty crudeoil24 12/10/21 07:21:03 AM
#743   running in pre-market 3.9m shares traded so far realfast95 12/10/21 06:09:35 AM
#742   Premarket hit at $2.34. What the...... hedge_fun 12/10/21 05:50:56 AM
#741   Still waiting for the Sale of the ointment realfast95 12/09/21 04:54:51 PM
#740   Nice climb this week ... hopefully it continues. GLTU Tzr250rg 12/09/21 11:51:48 AM
#739   VYNE Therapeutics assumed with a Buy at H.C. realfast95 12/06/21 02:11:25 PM
#738   30mil in volume Something is up. not sure Tzr250rg 12/06/21 01:19:56 PM
#737   Looks like some funds are buying this. ;) EuroFund 12/06/21 12:25:30 PM
#736   up +32% Tzr250rg 12/06/21 10:34:04 AM
#735   up 24% Tzr250rg 12/06/21 10:18:13 AM
#734   https://investorshub.advfn.com/uimage/uploads/2021/11/10/FPCZSAQCCVGBGKGYZKG.png Tzr250rg 11/10/21 02:51:40 PM
#733   Premarket 1.45 Tzr250rg 11/09/21 08:55:08 AM
#732   premarket 1.66 Tzr250rg 11/04/21 08:57:46 AM
#731   HOD 1.48 Tzr250rg 11/03/21 11:40:36 AM
#730   HOD 1.42 Tzr250rg 11/02/21 02:58:47 PM
#729   HOD 1.41 Tzr250rg 11/01/21 10:51:51 AM
#728   HOD 1.39 Tzr250rg 10/29/21 12:06:40 PM
#727   https://vynetherapeutics.com/press-releases/vyne-therapeutics-to-report-third-qu Tzr250rg 10/28/21 09:17:24 AM
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