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VYNE Therapeutics (VYNE)

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Last Post: 5/7/2021 7:21:20 PM - Followers: 28 - Board type: Free - Posts Today: 0

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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: Statement of Changes in Beneficial Ownership (4) 05/07/2021 05:32:17 PM
VYNE News: Securities Registration Statement (simplified Form) (s-3) 05/06/2021 05:03:23 PM
VYNE News: Quarterly Report (10-q) 05/06/2021 08:47:13 AM
VYNE News: Current Report Filing (8-k) 05/06/2021 07:11:30 AM
VYNE News: VYNE Therapeutics EPS beats by $0.03, misses on revenue 05/06/2021 07:06:53 AM
News News Alert: Statement of Changes in Beneficial Ownership (4) 05/07/2021 05:32:17 PM
#704   Can it get worse? yes realfast95 05/07/21 07:21:20 PM
#703   $VYNE HC Wainwright & Co. analyst Oren Livnat realfast95 05/07/21 06:58:21 AM
#702   as if kicking us with so-so earnings wasn't realfast95 05/07/21 06:54:09 AM
#701   Ive been a long holder of this, even DB1787 05/06/21 09:02:41 AM
#700   missed both revenue and earnings realfast95 05/06/21 07:15:47 AM
#699   VYNE Therapeutics Reports First Quarter 2021 Financial Results realfast95 05/06/21 07:13:15 AM
#698   $VYNE BRIDGEWATER, N.J., April 28, 2021 (GLOBE NEWSWIRE) realfast95 04/28/21 08:03:32 AM
#697   That's wrong information. realfast95 04/15/21 09:31:55 AM
#696   some positive news Tzr250rg 04/15/21 09:00:52 AM
#695   ugly realfast95 04/09/21 06:13:01 PM
#694   blood in the streets, scavengers are not even biting realfast95 04/09/21 03:18:08 PM
#693   FD Disclosure. realfast95 03/30/21 06:54:30 PM
#692   new slide added realfast95 03/30/21 06:48:39 PM
#691   $vyne $7.8 ^ 0.4 (5.41%) Taurus69 03/21/21 09:12:23 PM
#690   Good day realfast95 03/17/21 07:30:11 PM
#689   Yeah. Weird daleb2130 03/16/21 06:15:48 PM
#688   I don't know if that will make any realfast95 03/16/21 06:14:14 PM
#687   Ahhh. So do you think the patent news daleb2130 03/16/21 05:52:05 PM
#686   the after hours rise, is from the SEC realfast95 03/16/21 05:43:33 PM
#685   Is that why it's up .36 cents after hours? daleb2130 03/16/21 05:35:33 PM
#684   LEPORE bought, bingo realfast95 03/16/21 04:53:38 PM
#683   Patent news coming realfast95 03/16/21 04:44:29 PM
#682   Amzeeq mentioned in this article. Author also disclosed realfast95 03/15/21 01:30:38 PM
#681   industry article realfast95 03/15/21 07:31:13 AM
#680   hit 200 day moving average this morning realfast95 03/10/21 05:37:56 PM
#679   I see $22 on my Robinhood site. 7 daleb2130 03/09/21 04:56:27 PM
#678   $VYNE Barclays Maintains Buy Rating On VYNE Therapeutics, realfast95 03/09/21 01:09:58 PM
#677   Q4 Earnings transcript realfast95 03/07/21 01:33:49 PM
#676   perhaps a moderator can update the info on garrettf 03/06/21 11:12:23 AM
#675   $VYNE HC Wainwright Maintains Buy Rating On Vyne realfast95 03/05/21 11:38:57 AM
#674   BRIDGEWATER, N.J., March 04, 2021 (GLOBE NEWSWIRE) -- realfast95 03/05/21 07:10:30 AM
#673   replay http://public.viavid.com/index.php?id=143225 pricing - mid-year 200 to 250, and no realfast95 03/04/21 10:32:10 AM
#672   looks like alot of panic selling Tzr250rg 03/04/21 10:12:41 AM
#671   all up gaps closed realfast95 03/04/21 09:57:54 AM
#670   VYNE Therapeutics Q4 EPS $(0.55) Misses $(0.53) Estimate, realfast95 03/04/21 07:33:44 AM
#669   VYNE Therapeutics to Present at the Cowen 41st realfast95 03/01/21 04:44:24 PM
#668   VYNE Therapeutics Announces Development Program for FMX114 Combination realfast95 03/01/21 08:08:59 AM
#667   As of now, it appears they will miss realfast95 02/27/21 06:58:37 PM
#666   free options realfast95 02/24/21 05:50:46 PM
#665   one gap filled realfast95 02/23/21 10:05:40 AM
#664   Pivot Point 3rd Support Point 7.74 realfast95 02/23/21 08:04:22 AM
#663   BRIDGEWATER, N.J., Feb. 23, 2021 (GLOBE NEWSWIRE) -- realfast95 02/23/21 08:01:15 AM
#662   $vyne $8.65 ^ 0.11 (1.29%) Taurus69 02/21/21 07:42:49 PM
#661   VYNE Therapeutics In (VYNE) mick 02/21/21 02:47:14 PM
#660   Supposedly, VYNE is to embark on a few realfast95 02/19/21 06:49:21 AM
#659   VYNE is a great company. This video, however, artfulife 02/18/21 09:19:19 PM
#658   The day I saw Billionaire Joseph Edelman's daleb2130 02/18/21 10:53:25 AM
#657   got fill at 8.90 realfast95 02/18/21 08:40:43 AM
#656   great video Tzr250rg 02/18/21 08:06:47 AM
#655   Up from here. I expect news after the daleb2130 02/17/21 10:33:54 PM
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