Vitiligo

VYNE Therapeutics Reports Year-End 2022 Financial Results and Provides Business Update

Retrieved on: 
Thursday, March 9, 2023
School of Life Sciences (University of Dundee), University, BD2, IND, Letter, BD1, Therapy, Patient, FDA, Vitiligo, AD, Disease, Patent, Inflammation, Atopic dermatitis, BET, Pharmaceutical industry

BRIDGEWATER, N.J., March 09, 2023 (GLOBE NEWSWIRE) -- VYNE Therapeutics Inc. (Nasdaq: VYNE) (“VYNE” or the “Company”), a clinical-stage biopharmaceutical company focused on developing proprietary, innovative and differentiated therapies for the treatment of immuno-inflammatory conditions, today announced financial results for the fourth quarter and year ended December 31, 2022 and provided a business update.

Key Points: 
  • “With only one FDA-approved therapy currently available for this large patient population, vitiligo remains a significant unmet medical need.
  • Based on these preliminary results, the Company has selected three doses for testing in the Phase 1b portion of the trial.
  • The patent, exclusively licensed to Tay Therapeutics Ltd. ("Tay") and sublicensed to VYNE, will expire in April 2040.
  • In February 2023, VYNE and its license partner, Tay, extended the exclusive option agreement for VYN202 to April 30, 2023.

ASLAN Pharmaceuticals to Host Virtual Research and Development Day on Novel DHODH Inhibitor Farudodstat for Alopecia Areata

Retrieved on: 
Wednesday, March 8, 2023
Janus, MD, SAN, Atopic dermatitis, AA, Hair loss, Skin, KOL, IP, Granuloma annulare, ASLN, Yale University, Scalp, JAK, Vitiligo, Yale School of Medicine, Patient, Associate, Autoimmune disease, Hair, DHODH, Immune privilege, Lichen planus, Alopecia areata, Sarcoidosis, Pharmaceutical industry, Dermatology

Farudodstat has been shown to inhibit IFN-γ secretion, reduce immune cell proliferation, and potentially protect hair follicles from IP collapse in a human AA disease model.

Key Points: 
  • Farudodstat has been shown to inhibit IFN-γ secretion, reduce immune cell proliferation, and potentially protect hair follicles from IP collapse in a human AA disease model.
  • ASLAN plans to initiate a proof-of-concept study of farudodstat in AA in the second quarter of 2023.
  • A replay of the event and presentation materials will be available on the Investor Relations section of ASLAN’s website .
  • He has pioneered the use of Janus kinase (JAK) inhibitors in dermatology, in particular for alopecia areata, vitiligo, atopic dermatitis, granuloma annulare, sarcoidosis, erosive lichen planus, and other disorders.

Multiple Abstracts from Incyte’s Growing Dermatology Portfolio Featured at American Academy of Dermatology (AAD) Annual Meeting

Retrieved on: 
Monday, March 6, 2023
Biotechnology, Other Health, Health, Pharmaceutical, Clinical Trials, Cream, Shift, Janus, American Academy, Chronic, Journal, Dermatology, Conference call, Patient, Interest, Hidradenitis suppurativa, American Academy of Dermatology, AAD, Janus kinase inhibitor, Inflammation, JAK1, Use, Adolescence, Atopic dermatitis, Randomness, Post hoc analysis, Autoimmunity, Maintenance, JAAD, Conference, Abstract, HS, Safety, Cryptocurrency, Pharmaceutical industry, Communications satellite, Disease, Vitiligo, Incyte

Incyte (Nasdaq:INCY) today announced that multiple abstracts featuring data from its dermatology portfolio will be presented at the upcoming 2023 American Academy of Dermatology (AAD) Annual Meeting, held March 17-21, 2023, in New Orleans.

Key Points: 
  • Incyte (Nasdaq:INCY) today announced that multiple abstracts featuring data from its dermatology portfolio will be presented at the upcoming 2023 American Academy of Dermatology (AAD) Annual Meeting, held March 17-21, 2023, in New Orleans.
  • “The research being featured at this year’s AAD Annual Meeting highlights the potential of Incyte therapies to meet the needs of patients living with vitiligo and other serious skin conditions,” said Jim Lee, M.D., Ph.D., Group Vice President, Inflammation & Autoimmunity, Incyte.
  • Saturday, March 18, 9:30 a.m. CT)
    Efficacy and Safety of Povorcitinib in Vitiligo: Results from a Phase 2, Placebo-Controlled, Dose Ranging Study (Session: S042 – Late-Breaking Research: Session 2.
  • They will also be published online via the Journal of the American Academy of Dermatology (JAAD) supplement in Fall 2023.

STRATA Skin Sciences Announces the Launch of New, Patient-Focused XTRAC® Website

Retrieved on: 
Thursday, March 2, 2023
SSKN, Dermatitis, Strata Skin Sciences, Marketing, Atopic dermatitis, Laser, Patient, Vitiligo, Psoriasis, Pharmaceutical industry

HORSHAM, Pa., March 02, 2023 (GLOBE NEWSWIRE) -- STRATA Skin Sciences, Inc. (NASDAQ: SSKN), a medical technology company dedicated to developing, commercializing and marketing innovative products for the treatment of dermatologic conditions, today announced the launch of the new XTRAC® website, www.xtracclear.com .

Key Points: 
  • HORSHAM, Pa., March 02, 2023 (GLOBE NEWSWIRE) -- STRATA Skin Sciences, Inc. (NASDAQ: SSKN), a medical technology company dedicated to developing, commercializing and marketing innovative products for the treatment of dermatologic conditions, today announced the launch of the new XTRAC® website, www.xtracclear.com .
  • The new website educates patients on XTRAC excimer laser therapy for the treatment of psoriasis, vitiligo, and atopic dermatitis (eczema).
  • Additional features of the site include:
    “We are proud to announce the launch of our new XTRAC website,” stated Bob Moccia, Chief Executive Officer of STRATA Skin Sciences.
  • “Our goal in designing this new resource is to increase product awareness, make it easy for patients to seek out treatment at their convenience, and ultimately allow more patients with these conditions to benefit from XTRAC therapy.”

Arcutis Announces Fourth Quarter and Full Year 2022 Financial Results and Provides Business Update

Retrieved on: 
Tuesday, February 28, 2023
Janus, Skin, Hair, SG, Psoriasis, ESG, Research, Vitiligo, Acquisition, JAK1, Webcast, FDA, Patient, R, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Biophysical environment, Scalp, NDA, Growth, Inflammation, PDE4, Prescription, New Drug Application, Shanda, Pharmacy, Alopecia areata, Food, Ageing, Dermatitis, Atopic dermatitis, Video game, Health insurance, Pharmaceutical industry, Cosmetics, Cryptocurrency

In the fourth quarter of 2022, Arcutis announced positive topline results from INTEGUMENT-1 and INTEGUMENT-2, the two pivotal Phase 3 trials evaluating roflumilast cream 0.15% for the treatment of atopic dermatitis in individuals 6 years of age or older.

Key Points: 
  • In the fourth quarter of 2022, Arcutis announced positive topline results from INTEGUMENT-1 and INTEGUMENT-2, the two pivotal Phase 3 trials evaluating roflumilast cream 0.15% for the treatment of atopic dermatitis in individuals 6 years of age or older.
  • In September 2022, Arcutis announced positive topline results from the ARRECTOR pivotal Phase 3 trial for the treatment of scalp and body psoriasis.
  • Net cash used in operating activities was $71.1 during the fourth quarter and $257.7 million during the full year 2022.
  • Arcutis management will host a conference call and webcast today at 4:30pm ET to discuss the financial results for the quarter and provide a business update.

AVITA Medical Reports Fourth Quarter and Full Year 2022 Financial Results and Provides 2023 Financial Guidance

Retrieved on: 
Thursday, February 23, 2023
EBITDA, Telephone, Anticipation, ASX, Vitiligo, FDA, Avita Medical, Burns, Regenerative medicine, Burn, BARDA, AVH, Pharmaceutical industry, Video game, Cryptocurrency

“We delivered strong fourth quarter and 2022 results, ending the year in a solid financial position,” said Jim Corbett, AVITA Medical Chief Executive Officer.

Key Points: 
  • “We delivered strong fourth quarter and 2022 results, ending the year in a solid financial position,” said Jim Corbett, AVITA Medical Chief Executive Officer.
  • “We expect FDA approvals in June 2023 for our soft tissue repair and vitiligo indications, which we believe will be transformative for our company.
  • Total operating expenses for the quarter increased by 2% to $15.0 million, compared to $14.8 million in the same period in 2021.
  • The Company will host a conference call to discuss the fourth quarter financial results, full-year 2022 financial results, business highlights, and 2023 revenue guidance on Thursday, February 23, 2023, at 1:30 p.m. Pacific Time (being Friday, February 24, 2023, at 8:30 a.m. Australian Eastern Daylight Time).

Incyte Announces Positive CHMP Opinion for Ruxolitinib Cream (Opzelura™) for the Treatment of Non-segmental Vitiligo in Adults and Adolescents

Retrieved on: 
Friday, February 24, 2023
Biotechnology, Pharmaceutical, Health, CHMP, Headache, Safety, Dermatology, Civil service commission, The New England Journal of Medicine, News, Week, European, Committee, Urinary tract infection, European Medicines Agency, Vitiligo, Patient, Committee for Medicinal Products for Human Use, EMA, Acne, Common, Committee on Herbal Medicinal Products, European Commission, Professor, Incidence, Pharmaceutical industry, EU

Incyte (Nasdaq:INCY) today announced that the European Medicines Agency (EMA) Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion recommending the approval of ruxolitinib cream (Opzelura™) for the treatment of non-segmental vitiligo with facial involvement in adults and adolescents from 12 years of age.

Key Points: 
  • Incyte (Nasdaq:INCY) today announced that the European Medicines Agency (EMA) Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion recommending the approval of ruxolitinib cream (Opzelura™) for the treatment of non-segmental vitiligo with facial involvement in adults and adolescents from 12 years of age.
  • “The positive CHMP opinion brings us one step closer to bringing ruxolitinib cream, the first ever treatment for repigmentation in non-segmental vitiligo, to patients and healthcare professionals in the European Union (EU),” said Steven Stein, M.D., Chief Medical Officer, Chief Medical Officer, Incyte.
  • The CHMP’s opinion is now being reviewed by the European Commission, which has the authority to grant centralized marketing authorizations for medicinal products in the EU.
  • When approved, this will be the first approved vitiligo therapy available in the EU indicated for the treatment of non-segmental vitiligo with facial involvement in adults and adolescents from 12 years of age.

VYNE Therapeutics Announces Positive Results from Phase 1a Single and Multiple Ascending Dose Trial for Investigational Novel BET Inhibitor VYN201

Retrieved on: 
Wednesday, February 15, 2023
Biomarker, Vitiligo, Volunteering, Therapy, Safety, Photography, BET, Patient, Pharmacokinetics, Clinical trial, Vaccine, Pharmaceutical industry

BRIDGEWATER, N.J., Feb. 15, 2023 (GLOBE NEWSWIRE) -- VYNE Therapeutics Inc. (Nasdaq: VYNE) (“VYNE” or the “Company”), a biopharmaceutical company developing proprietary, innovative, and differentiated therapies for the treatment of immuno-inflammatory conditions, today announced positive results from the Phase 1a portion of its Phase 1a/b clinical trial evaluating its novel BET inhibitor, VYN201, for vitiligo.

Key Points: 
  • In the Phase 1a portion of the study, single ascending and multiple ascending doses of VYN201 were applied topically once daily to 30 healthy volunteers in five dose cohorts for two weeks with a one-week safety follow-up visit to evaluate the safety, tolerability and pharmacokinetics of VYN201.
  • The safety and tolerability results are summarized below:
    There were no serious adverse events and no dose adjustments were required.
  • VYNE has selected 0.5%, 1.0% and 2.0% ointment strengths for evaluation in the ongoing Phase 1b study evaluating VYN201 in non-segmental vitiligo patients.
  • The primary objective of the Phase 1b portion of the study will be to evaluate the safety and pharmacokinetics of VYN201.

Target RWE Launches 35 New Disease State Registries in Complex Indications with High Unmet Medical Needs and Rapidly Evolving Therapies

Retrieved on: 
Wednesday, January 11, 2023
Degenerative disease, Alopecia areata, Hidradenitis suppurativa, Disease, Vitiligo, Atopic dermatitis, Entrepreneurship, Immunology, Publication, Lupus, Natural history, Public health, Chief Medical Advisor to the President, Psoriatic arthritis, Icahn School of Medicine at Mount Sinai, Cushing's disease, Safety, Ankylosing spondylitis, RWD, Psoriasis, Plasma, RWE, Diabetes, Patient, Research, Serum, Target, Mount Sinai, Acquisition, Non-alcoholic fatty liver disease, Doctor of Philosophy, NASH, Rheumatoid arthritis, Registry, Pharmaceutical industry, Dermatology, Kidney, Gastroenterology, Obesity

DURHAM, N.C., Jan. 11, 2023 /PRNewswire/ -- Target RWE, the leader and largest provider of real-world evidence (RWE) in non-cancer conditions, announced today the launch of 35 new observational disease state registries, including, TARGET-AUTOIMMUNE, TARGET-NEURO and TARGET-METABOLIC. Additional disease state registries launched today include Kidney (TARGET-KIDNEY) and Gastroenterology (TARGET-GASTRO), and an expansion of its existing Liver community.

Key Points: 
  • Additional disease state registries launched today include Kidney (TARGET-KIDNEY) and Gastroenterology (TARGET-GASTRO), and an expansion of its existing Liver community.
  • The TARGET-NEURO and TARGET-METABOLIC registries capture real-world patient data in high unmet need disease states such as Alzheimer's Disease/ Related Dementias, Obesity, Cushing's Disease, Diabetes and Nonalcoholic Steatohepatitis (NASH).
  • Meaningful real-world research considers all of these complexities," said Michael W. Fried, M.D., FAASLD, Co-Founder and Chief Medical Officer, Target RWE.
  • Follow Target RWE on LinkedIn and Twitter to keep up with the latest on our new communities and other company news.

VYNE Therapeutics Announces First Vitiligo Patient Dosed in Phase 1a/b Clinical Trial of Novel BET Inhibitor VYN201

Retrieved on: 
Monday, January 9, 2023
Clinical trial, BET, Vitiligo, Pharmacokinetics, Photography, Safety, Patient, Biomarker, Therapy, Pharmaceutical industry

BRIDGEWATER, N.J., Jan. 09, 2023 (GLOBE NEWSWIRE) -- VYNE Therapeutics Inc. (Nasdaq: VYNE) (“VYNE” or the “Company”), a biopharmaceutical company developing proprietary, innovative, and differentiated therapies for the treatment of immuno-inflammatory conditions, today announced that the first vitiligo patient has been dosed in a Phase 1a/b clinical trial of VYN201. VYN201 is a locally administered, small molecule, pan-bromodomain and extra-terminal domain (BET) inhibitor that is being developed for the treatment of immuno-inflammatory diseases. The clinical trial is a first-in-human study designed to generate safety and pharmacokinetic data in healthy volunteers (Phase 1a) as well as provide early clinical proof-of-concept data in vitiligo patients (Phase 1b).

Key Points: 
  • BRIDGEWATER, N.J., Jan. 09, 2023 (GLOBE NEWSWIRE) -- VYNE Therapeutics Inc. (Nasdaq: VYNE) (“VYNE” or the “Company”), a biopharmaceutical company developing proprietary, innovative, and differentiated therapies for the treatment of immuno-inflammatory conditions, today announced that the first vitiligo patient has been dosed in a Phase 1a/b clinical trial of VYN201.
  • VYN201 is a locally administered, small molecule, pan-bromodomain and extra-terminal domain (BET) inhibitor that is being developed for the treatment of immuno-inflammatory diseases.
  • The clinical trial is a first-in-human study designed to generate safety and pharmacokinetic data in healthy volunteers (Phase 1a) as well as provide early clinical proof-of-concept data in vitiligo patients (Phase 1b).
  • “Dosing the first vitiligo patient in our Phase 1a/b clinical trial represents a significant clinical milestone for VYNE and our novel InhiBET™ BET inhibitor platform,” said David Domzalski, President and Chief Executive Officer of VYNE.