VYNE Therapeutics Inc (VYNE) Quote

VYNE new 52 week low

VYNE new 52 week low

Saw this over @ Stocktwits $VYNE - $VYNE We tried to tell you that once the I0,652,543 shares hit the market tomorrow that everyone will sell out as this will be diluted 300% This one is over but With AUVI there is still hope this week for a mega squeeze - https://stocktwits.com/SMALLCAPSTEALS/message/549435540

VYNE Therapeutics Reports Positive Results from Preclinical Models for Oral BD2-Selective BET Inhibitor VYN202
Treatment with VYN202 resulted in significant inhibition of key inflammatory biomarkers and substantial resolution of the signs and symptoms of psoriasis and rheumatoid arthritis
Following completion of recent financing, VYNE expects to initiate a Phase 1a SAD/MAD clinical trial in Q1 2024, followed by Phase 1b trials in moderate-to-severe plaque psoriasis and in moderate-to-severe adult-onset rheumatoid arthritis in the second half of 2024
Preclinical data and clinical programs to be discussed at R&D Day event on November 9, 2023
BRIDGEWATER, N.J., Oct. 30, 2023 (GLOBE NEWSWIRE) -- VYNE Therapeutics Inc. (Nasdaq: VYNE) (“VYNE” or the “Company”), a clinical-stage biopharmaceutical company developing proprietary, innovative and differentiated therapies for the treatment of immuno-inflammatory conditions, today announced new preclinical data showing the positive effect of its oral small molecule BD2-selective BET inhibitor, VYN202, in preclinical models of psoriasis and rheumatoid arthritis.

“We believe VYN202 has the potential to be the most potent and selective BET inhibitor in development and has consistently demonstrated its ability to improve signs and symptoms of disease with marked inhibition of key inflammatory cytokines implicated in the pathology of several chronic autoimmune diseases in preclinical models,” said David Domzalski, President and Chief Executive Officer of VYNE. “These compelling preclinical data in skin inflammation and joint disease models highlight VYN202’s potential for therapeutic utility in both psoriasis and rheumatoid arthritis. We look forward to advancing these programs into the clinic next year and updating investors on our progress.”

Key findings from preclinical in vivo models:

Psoriasis: In a well-established model, a psoriasis phenotype was induced in BALB-C mice. Treatment was then administered intraperitoneally with either VYN202, deucravacitinib (an allosteric TYK2 inhibitor), or placebo. VYN202 and deucravacitinib at equivalent dosing demonstrated comparable onset of action and efficacy. Mice receiving VYN202 3mg/kg had approximately 95% mean reduction in PASI score from baseline by day 7 of treatment, which was consistent with the results in the deucravacitinib 3mg/kg group.Treatment with VYN202 3mg/kg reduced the expression of IL-17A (a major effector cytokine involved in the pathogenesis of psoriasis), by >93% compared to placebo. Treatment with VYN202 at all doses also resulted in a marked reduction of other disease-related cytokines (IL-1ß, IL-6, IL-22, IL-23, and TNF-a) compared to the placebo group.
Rheumatoid Arthritis: In a 21-day collagen-induced arthritis model, signs and symptoms of inflammatory arthritis were induced in Lewis rats. Each treatment group orally received either placebo, GSK620 (an early generation BD2-selective BET inhibitor) at 10 mg/kg, or VYN202 at three different dose strengths (1, 3, or 10 mg/kg). Treatment with VYN202 10mg/kg QD resulted in a 71% reduction in the overall signs and symptoms of rheumatoid arthritis at day 21, compared to mice receiving placebo.Treatment with VYN202 10mg/kg QD resulted in a 79% lower paw volume (a measure of swelling) compared to mice receiving placebo.75% of the animals treated with the highest dose of VYN202 presented with normal joint histopathology at the end of the study, whereas animals treated with placebo experienced marked inflammatory cell infiltrate, granulation tissue, bone erosion and cartilagenous ulceration.Treatment with VYN202 10mg/kg achieved a 98% lower expression of Immunoglobin G1, a biomarker associated with rheumatoid arthritis, compared to treatment with placebo.Treatment with VYN202 at 3 and 10mg/kg demonstrated a statistically-significant superior anti-inflammatory effect compared to GSK620 10mg/kg for all study efficacy endpoints.
Next Steps

R&D Day Event: VYNE will host an R&D Day event on Thursday, November 9, 2023 at 1:30 p.m. ET. VYNE management will discuss these data as well as the final data from VYNE’s Phase 1b trial evaluating VYN201 in vitiligo. The Company will also discuss its development plans for VYN201 and VYN202. Register Here
IND Submission: VYNE expects to submit its IND for VYN202 by year-end 2023 and commence a first-in-human Phase 1a single ascending dose/multiple ascending dose trial in the first quarter of 2024. If successful, VYNE anticipates commencing Phase 1b trials in moderate-to-severe plaque psoriasis and in moderate-to-severe adult-onset rheumatoid arthritis in the second half of 2024.
About VYN202

VYN202 is an oral small molecule BD2-selective BET inhibitor that has been designed to achieve class-leading selectivity (BD2 vs. BD1), maximum potency versus BD2 and optimal oral bioavailability. By maximizing BD2 selectivity, VYNE believes VYN202 has the potential to be a more conveniently-administered non-biologic treatment option for both acute control and chronic management of immuno-inflammatory indications, where the damaging effects of unrestricted inflammatory signaling activity is common. VYN202 is structurally distinct from VYNE’s pan-BET inhibitor (VYN201) and covered by distinct PCT and provisional composition of matter patent applications directed to new chemical entities and their uses.

About BET Inhibitors

BET proteins play a key role in regulating gene transcription via epigenetic interactions (“reading”), and recent research has determined a key role for these proteins in regulating B cell and T cell activation and subsequent inflammatory processes. As epigenetic readers, BET proteins regulate the recruitment of transcriptional factors that are key to the production of several pro-inflammatory cytokines. BET inhibitors have the potential to treat a range of immuno-inflammatory and fibrotic diseases by blocking pro-inflammatory cytokine transcription with additional potential in myeloproliferative neoplastic disorders.

About VYNE Therapeutics Inc.

VYNE’s mission is to improve the lives of patients by developing proprietary, innovative and differentiated therapies for the treatment of immuno-inflammatory conditions. The Company’s unique and proprietary bromodomain & extra-terminal (BET) domain inhibitors, which comprise its InhiBET™ platform, include a locally administered pan-BD BET inhibitor (VYN201) and an orally available BD2-selective BET inhibitor (VYN202) that were licensed from Tay Therapeutics Limited.

For more information about VYNE Therapeutics Inc. or its product candidates, visit www.vynetherapeutics.com. VYNE may use its website to comply with its disclosure obligations under Regulation FD. Therefore, investors should monitor VYNE’s website in addition to following its press releases, filings with the U.S. Securities and Exchange Commission, public conference calls, and webcasts.

Cautionary Statement Regarding Forward-Looking Statements

This release includes forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, including, but not limited to, statements regarding VYNE’s plans and development timelines for VYN202, the potential of VYN202 and VYNE’s InhiBET™ platform, VYNE’s intentions regarding a Phase 1a and Phase 1b trials of VYN202, the granting or conversion of certain patent applications, and other statements regarding the future expectations, plans and prospects of VYNE. All statements in this press release which are not historical facts are forward-looking statements. Any forward-looking statements are based on VYNE’s current knowledge and its present beliefs and expectations regarding possible future events and are subject to risks, uncertainties and assumptions that could cause actual results to differ materially and adversely from those set forth or implied by such forward-looking statements. These risks and uncertainties include, but are not limited to: VYNE’s ability to successfully develop its product candidates; the timing of commencement of future preclinical studies and clinical trials; VYNE’s ability to complete and receive favorable results in, clinical trials for its product candidates; VYNE’s ability to comply with various regulations applicable to its business; VYNE’s ability to create intellectual property and the scope of protection it is able to establish and maintain for intellectual property rights covering its product candidates, including the projected terms of patent protection; risks that any of VYNE’s patents may be held to be narrowed, invalid or unenforceable or one or more of VYNE’s patent applications may not be granted and potential competitors may also seek to design around VYNE’s granted patents or patent applications; estimates of VYNE’s expenses, capital requirements, its needs for additional financing and its ability to obtain additional capital on acceptable terms or at all; VYNE’s expectations regarding licensing, business transactions and strategic operations; VYNE’s future financial performance and liquidity; and volatility in VYNE’s stock price may result in rapid and substantial increases or decreases in the stock price that may or may not be related to VYNE’s operating performance or prospects. For a discussion of other risks and uncertainties, and other important factors, any of which could cause VYNE’s actual results to differ from those contained in the forward-looking statements, see the section titled “Risk Factors” in VYNE’s Annual Report on Form 10-K for the year ended December 31, 2022, Quarterly Report on Form 10-Q for the quarter ended June 30, 2023, and VYNE’s other filings from time to time with the U.S. Securities and Exchange Commission. Although VYNE believes these forward-looking statements are reasonable, they speak only as of the date of this announcement and VYNE undertakes no obligation to update publicly such forward-looking statements to reflect subsequent events or circumstances, except as otherwise required by law. Given these risks and uncertainties, you should not rely upon forward-looking statements as predictions of future events.

Investor Relations:

John Fraunces
LifeSci Advisors, LLC
917-355-2395
jfraunces@lifesciadvisors.com

Tyler Zeronda
VYNE Therapeutics Inc.
908-458-9106
Tyler.Zeronda@vynetx.com

https://www.globenewswire.com/newsroom/ti?nf=ODk2NzkzOSM1ODk2ODQ4IzIwOTM4MDM=
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Source: VYNE Therapeutics Inc.

crazy at one point up 150% today. Volume 30M

float is 14.5m

outstanding share is 3.3M


Maybe this will start a trend moving up.

Damn

1-18 RS today GLTUA

$VYNE climbing again 15% up ask looks thin

it looks like the pump hasn't happened yet.

GLTYA

I learned the hard way about these phase I pop and drops

gotta be in early and take profits

https://marketwirenews.com/news-releases/biotech-catches-major-premarket-bid-6458223093948658.html?i=st

Up 85% > FDA phase I trial. > "Vitiligo is a chronic autoimmune depigmenting disorder of the skin, characterized by the loss of pigment producing cells known as melanocytes. Vitiligo is the most common depigmenting skin condition, with a prevalence estimated at 0.5-2% of the world population.1 There is currently only one FDA-approved product for the treatment of vitiligo.

$VYNE https://finance.yahoo.com/news/vyne-therapeutics-announces-first-vitiligo-210100983.html

wonder if it will gap at opening tomorrow morning

I see crazy

after hours activity up to 100%.

Load up$$$&

Looks good let’s goooo$$$$$

$VYNE: NOw THIRTYyyyyyyyyyyyyyyyyyyyyyyyyyy


BOOoooooooooooooommmmmmmmmmmmmmmm



GO $VYNE

$VYNE: Added 30k at $0.18

Letssssssssss goooooooooooooooooooooooooooooooooo


Ready to MAKE IT HERE now


GO $VYNE

NOTICE IS HEREBY GIVEN that a Special Meeting of Stockholders (the “Special Meeting”) of VYNE Therapeutics Inc., a Delaware corporation (the “Company”), will be held on January 12, 2023, at 10:00 a.m. local time, at 685 Route 202/206, Suite 301A, Bridgewater, NJ 08807, for the following purposes:
1.
To approve and adopt an amendment to the Company’s Amended and Restated Certificate of Incorporation (the “Reverse Stock Split Amendment”) to effect a reverse stock split of the Company’s common stock at a ratio ranging from 1-for-10 shares up to a ratio of 1-for-25 shares, which ratio will be selected by the Company’s Board of Directors and set forth in a public announcement (the “Reverse Stock Split”);
?
2.
To approve the adjournment of the Special Meeting to a later date or dates, if necessary or appropriate, to solicit additional proxies if there are insufficient votes to adopt Proposal 1; and
?
3.
To transact such other business as may properly come before the Special Meeting or any adjournment or postponement thereof.

VYNE up 11% today

I added a some. could this be bottom? hope so up 10% today

Time to buy? what do you think? or this setting up for another drop?

Bottom?

Good news for now No reverse split.


https://www.sec.gov/ix?doc=/Archives/edgar/data/1566044/000110465922088684/tm2222986d1_8k.htm

News out Green premarket

will this ever turn around? ...

DEFA14A out

https://quantisnow.com/insight/3119878

8K out

https://www.sec.gov/cgi-bin/browse-edgar?action=getcompany&CIK=0001566044&owner=include&count=40&hidefilings=0

More News


10:41 am ET


VYNE Therapeutics Concludes Patient Enrolment in Mid-Stage Study Of Skin Inflammation Candidate

VYNE Therapeutics Inc. (NASDAQ: VYNE) has concluded patient enrollment in the Phase 2a study of of its drug candidate FMX114 for the treatment of mild-to-moderate atopic dermatitis (AD).

FMX 114 is evaluated in the Phase 2a four weeks segment study for the treatment in patients suffering from atopic dermatitis compared to vehicle control.

The Phase 2a study was designed to enroll up to 25 subjects, with each subject serving as their own control.

David Domzalski, Chief Executive Officer, commented : “We have been encouraged by the early efficacy results from the Phase 1b segment of the FMX114 trial showing that, based on ADSI scoring, two weeks of FMX114 treatment demonstrated a statistically significant improvement in the signs and symptoms of AD as well as acceptable safety and pharmacokinetics.”

The company expects to report top-line efficacy results in approximately 6 to 8 weeks.

Atopic dermatitis (AD) is a chronic, severe form of eczema that is characterized by the appearance of dry, red, and itchy skin.

VYNE Therapeutics shares are trading higher 4 percent at $0.53.

© 2022 Benzinga.com. Benzinga does not provide investment advice. All rights reserved.

News out.

June 17, 2022

8:00 am ET


*VYNE Therapeutics Completes Enrollment In Phase 2a Trial Of FMX114 For Treatment Of Mild-To-Moderate Atopic Dermatitis
Benzinga

can we go green another day

+13.54% up can we hold and continue to climb?

Close at .50 cents

8K https://fintel.io/doc/sec-vyne-therapeutics-inc-1566044-8k-2022-may-17-19129-2276

BlackRock accumulating again?

.40 low

ATL

up 36%

https://www.globenewswire.com/news-release/2022/04/07/2418427/0/en/VYNE-Therapeutics-Announces-Positive-Phase-1b-Efficacy-Data-for-FMX114-from-Phase-1b-2a-Trial-for-the-Treatment-of-Mild-to-Moderate-Atopic-Dermatitis.html

There's a lot to be optimistic about in the Healthcare sector as 2 analysts just weighed in on VYNE Therapeutics (VYNE – Research Report) and Ocuphire Pharma (OCUP – Research Report) with bullish sentiments. VYNE Therapeutics (VYNE) H.C. Wainwright analyst Joseph Pantginis reiterated a Buy rating on VYNE Therapeutics yesterday and set a price target of $7.00. The company's shares closed last Wednesday at $0.73, close to its 52-week low of $0.46. According to TipRanks.

1 hour chart, ask looks thin can this make a run today?

+22%

some life today. up 10%

Cantor Fitzgerald Reiterates VYNE Therapeutics (VYNE) Overwight, $10 PT, Sees Company's Bromodomain and Extra-Terminal Domain Inhibitors Programs are Under appreciated


https://www.streetinsider.com/Analyst+Comments/Cantor+Fitzgerald+Reiterates+VYNE+Therapeutics+%28VYNE%29+Overwight%2C+%2410+PT%2C+Sees+Companys+Bromodomain+and+Extra-Terminal+Domain+Inhibitors+Programs+are+Underappreciated/19790311.html

H.C. Wainwright Thinks VYNE Therapeutics’ Stock is Going to Recover
TipRanks - 17 Mar



H.C. Wainwright analyst Joseph Pantginis reiterated a Buy rating on VYNE Therapeutics (VYNE – Research Report) today and set a price target of $7.00. The company's shares closed last Thursday at $0...
VYNE



https://www.tipranks.com/news/blurbs/h-c-wainwright-thinks-vyne-therapeutics-stock-is-going-to-recover-2?utm_source=stck.pro&utm_medium=referral

H.C. Wainwright Thinks VYNE Therapeutics’ Stock is Going to Recover
TipRanks - 17 Mar



H.C. Wainwright analyst Joseph Pantginis reiterated a Buy rating on VYNE Therapeutics (VYNE – Research Report) today and set a price target of $7.00. The company's shares closed last Thursday at $0...
VYNE



https://www.tipranks.com/news/blurbs/h-c-wainwright-thinks-vyne-therapeutics-stock-is-going-to-recover-2?utm_source=stck.pro&utm_medium=referral

8K out

Perceptive advisers buying again? Lets see what Joseph Edelman is up to.