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Incyte Announces Data from Phase 2b Study Evaluating Povorcitinib (INCB54707) in Patients with Extensive Nonsegmental Vitiligo

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Saturday, March 18, 2023

Biotechnology, Pharmaceutical, Health, Clinical Trials, JAK1, American Academy, LSM, Patient, AAD, Week, Safety, American Academy of Dermatology, Pharmaceutical industry

Incyte (Nasdaq:INCY) today announced new data from a Phase 2b clinical trial evaluating the safety and efficacy of povorcitinib (INCB54707), an investigational oral JAK1 inhibitor, in adult patients with extensive nonsegmental vitiligo.

Key Points:

Incyte (Nasdaq:INCY) today announced new data from a Phase 2b clinical trial evaluating the safety and efficacy of povorcitinib (INCB54707), an investigational oral JAK1 inhibitor, in adult patients with extensive nonsegmental vitiligo.
Results from the study demonstrate that treatment with oral povorcitinib was associated with substantial total body repigmentation in patients with extensive nonsegmental vitiligo, as measured by total Vitiligo Area Scoring Index (T-VASI) scores.
“Vitiligo is a chronic, immune-mediated disease which, until recently, had limited treatment options available to patients.
“As vitiligo can impact patients in different ways, I am encouraged by the continued focus on expanding medical treatment options, and I believe these data highlight the potential of this investigational oral treatment for patients with extensive nonsegmental vitiligo.”

Incyte Announces Long-Term Extension Data from Phase 3 TRuE-V Program Demonstrating Long-Term Safety and Durability of Response of Opzelura® (Ruxolitinib) Cream in Vitiligo

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Saturday, March 18, 2023

Biotechnology, Pharmaceutical, Health, Clinical Trials, Inflammation, Week, The New England Journal of Medicine, Autoimmunity, American Academy, Depigmentation, Patient, AAD, BID, American Academy of Dermatology, Vitiligo, LTE, Skin, Safety, Pharmaceutical industry

The 104-week long-term extension (LTE) data build on the positive 52-week TRuE-V1 and TRuE-V2 results previously announced and published in The New England Journal of Medicine.

Key Points:

The 104-week long-term extension (LTE) data build on the positive 52-week TRuE-V1 and TRuE-V2 results previously announced and published in The New England Journal of Medicine.
“The results presented today at AAD are significant because they provide important long-term efficacy and safety data for nonsegmental vitiligo patients treated with Opzelura,” said Jim Lee, M.D., Ph.D., Group Vice President, Inflammation & Autoimmunity, Incyte.
Approximately 29% of patients randomized to the withdrawal arm (i.e., applying vehicle cream) relapsed (
“Vitiligo is a chronic condition and these results demonstrate the long-term potential of this medical treatment for people with vitiligo who are interested in repigmentation.”

Takeda Announces Positive Results in Phase 2b Study of Investigational TAK-279, an Oral, Once-Daily TYK2 Inhibitor, in People with Moderate-to-Severe Plaque Psoriasis

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Saturday, March 18, 2023

Takeda ( TSE:4502/NYSE:TAK ) today announced positive results from a Phase 2b clinical trial of TAK-279 (NDI-034858), a highly selective, oral allosteric tyrosine kinase 2 (TYK2) inhibitor, in patients with moderate-to-severe plaque psoriasis.

Key Points:

Takeda ( TSE:4502/NYSE:TAK ) today announced positive results from a Phase 2b clinical trial of TAK-279 (NDI-034858), a highly selective, oral allosteric tyrosine kinase 2 (TYK2) inhibitor, in patients with moderate-to-severe plaque psoriasis.
Changes in laboratory parameters were consistent with known effects of allosteric TYK2 inhibition.1
“These compelling TAK-279 data strengthen its potential for people with moderate-to-severe plaque psoriasis.
Results from the Phase 2b study have no impact on the full year consolidated reported forecast for the fiscal year ending March 31, 2023 (Fiscal Year 2022).
*In the TAK-279 2mg arm, the PASI 90 response rate was 8% with a nominal p-value = 0.037 compared to placebo.1

POLISHED.COM INVESTIGATION INITIATED by Former Louisiana Attorney General: Kahn Swick & Foti, LLC Investigates the Officers and Directors of Polished.com, Inc. - POL

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Saturday, March 18, 2023

Retail, Online Retail, Legal, Professional Services, Failure, KSF, NYSE, Private investigator, Main Directorate of Information of the Polish Army

Former Attorney General of Louisiana, Charles C. Foti, Jr., Esq., a partner at the law firm of Kahn Swick & Foti, LLC (“KSF”), announces that KSF has commenced an investigation into Polished.com, Inc. f/k/a Goedeker Inc. (the “Company”) (NYSE: POL).

Key Points:

Former Attorney General of Louisiana, Charles C. Foti, Jr., Esq., a partner at the law firm of Kahn Swick & Foti, LLC (“KSF”), announces that KSF has commenced an investigation into Polished.com, Inc. f/k/a Goedeker Inc. (the “Company”) (NYSE: POL).
Then, in October 2022, the Company disclosed that its Chief Executive Officer and President, Chief Operating Officer, and Chief Financial Officer and Secretary, had resigned from the Company effective immediately.
KSF’s investigation is focusing on whether Polished’s officers and/or directors breached their fiduciary duties to its shareholders or otherwise violated state or federal laws.
About Kahn Swick & Foti, LLC
KSF, whose partners include former Louisiana Attorney General Charles C. Foti, Jr., is one of the nation’s premier boutique securities litigation law firms.

Y-MABS THERAPEUTICS 72 HOUR DEADLINE ALERT: Former Louisiana Attorney General and Kahn Swick & Foti, LLC Remind Investors With Losses in Excess of $100,000 of Deadline in Class Action Lawsuit Against Y-mAbs Therapeutics, Inc. - YMAB

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Saturday, March 18, 2023

Class Action Lawsuit, Professional Services, Legal, Advisory Committee, Food and Drug Administration, District court, Aerospace, KSF, Special warfare combatant-craft crewmen, Court, FDA, Therapy, News, Food

This action is pending in the United States District Court for the Southern District of New York.

Key Points:

This action is pending in the United States District Court for the Southern District of New York.
Y-mAbs and certain of its executives are charged with failing to disclose material information during the Class Period, violating federal securities laws.
On this news, shares of Y-mAbs declined by $5.32 per share, or approximately 59.57%, from $8.93 to close at $3.61 on October 31, 2022.
About Kahn Swick & Foti, LLC
KSF, whose partners include former Louisiana Attorney General Charles C. Foti, Jr., is one of the nation’s premier boutique securities litigation law firms.

Aquavit Files Two IND's For Its Botulinum Toxin With FDA

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Friday, March 17, 2023

AB toxin, Neurotoxin, Roa, Hyperhidrosis, Toxicity, Botulinum toxin, Physician, AAD, Knowledge, FDA, IND, Clostridium botulinum, Pharmaceutical industry, Canning, Dermatology, Aquavit

NEW YORK, March 17, 2023 /PRNewswire/ -- Aquavit Holdings, the exclusive licensee of Huons Global's Botulinum Toxin in the USA and Canada, will officially unveil the Aquatox™ program at the Annual American Academy of Dermatology - 2023, the world's largest dermatology conference scheduled from March 17-21, 2023, in New Orleans, LA.

Key Points:

According to The Aesthetic Society and the Global Market Insights, botulinum toxin has been the #1 non-surgical aesthetic procedure since 1999 and is still growing rapidly with only 4 companies with approved botulinum toxin in the US.
With a projected CAGR of 7-9%, the global botulinum toxin market in 2026 is expected to be $8.9B.
For several years, Aquavit has been investing in its proprietary delivery technologies and related intellectual property for botulinum toxin.
We plan to introduce the most innovative botulinum toxin products, uplift and modernize the treatment paradigm" said Sobin Chang, CEO of Aquavit.

Samsung Bioepis Presents Phase 1 Study Results of SB17 (Ustekinumab), A Proposed Biosimilar to Stelara, at 2023 AAD Annual Meeting

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Friday, March 17, 2023

SB5, PK, EU, Etanercept, Cis, SB2, Adalimumab, Pharmacokinetics, American Academy, Trial of the century, Infliximab, AAD, American Academy of Dermatology, Biosimilar, Ustekinumab, Interval (mathematics), Safety, Generic drug, Cmax

These results will be presented at the 2023 American Academy of Dermatology (AAD) Annual Meeting held in New Orleans, Louisiana, from March 17 to 21, 2023.

Key Points:

These results will be presented at the 2023 American Academy of Dermatology (AAD) Annual Meeting held in New Orleans, Louisiana, from March 17 to 21, 2023.
In this Phase 1, randomized, double-blind, single-dose comparative pharmacokinetic study, a total of 201 subjects were randomized 1:1:1 to receive a single dose 45 mg of either SB17, EU-sourced reference ustekinumab, or US-sourced reference ustekinumab via subcutaneous injection.
The primary objective of this study was to demonstrate PK similarity by assessing area under the concentration-time curve from time zero to infinity (AUCinf) and maximum serum concentration (Cmax).
The secondary objectives were to investigate and compare the safety, tolerability, and immunogenicity between three treatment groups.

MOMENTIVE INVESTOR ALERT by the Former Attorney General of Louisiana: Kahn Swick & Foti, LLC Investigates Adequacy of Price and Process in Proposed Sale of Momentive Global Inc. - MNTV

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Friday, March 17, 2023

Class Action Lawsuit, Professional Services, Legal, Symphony Technology Group, MNTV, KSF, Sale, Momentive

and the law firm of Kahn Swick & Foti, LLC (“KSF”) are investigating the proposed sale of Momentive Global Inc. (NasdaqGS: MNTV) to a consortium led by Symphony Technology Group.

Key Points:

and the law firm of Kahn Swick & Foti, LLC (“KSF”) are investigating the proposed sale of Momentive Global Inc. (NasdaqGS: MNTV) to a consortium led by Symphony Technology Group.
Under the terms of the proposed transaction, shareholders of Momentive will receive $9.46 in cash for each share of Momentive that they own.
KSF is seeking to determine whether this consideration and the process that led to it are adequate, or whether the consideration undervalues the Company.
To learn more about KSF, whose partners include the Former Louisiana Attorney General, visit www.ksfcounsel.com .

CVENT HOLDING INVESTOR ALERT by the Former Attorney General of Louisiana: Kahn Swick & Foti, LLC Investigates Adequacy of Price and Process in Proposed Sale of Cvent Holding Corp. - CVT

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Friday, March 17, 2023

Class Action Lawsuit, Professional Services, Legal, Blackstone, Cvent, CVT, KSF, Sale

and the law firm of Kahn Swick & Foti, LLC (“KSF”) are investigating the proposed sale of Cvent Holding Corp. (NasdaqGM: CVT) to an affiliate of Blackstone.

Key Points:

and the law firm of Kahn Swick & Foti, LLC (“KSF”) are investigating the proposed sale of Cvent Holding Corp. (NasdaqGM: CVT) to an affiliate of Blackstone.
Under the terms of the proposed transaction, shareholders of Cvent will receive $8.50 in cash for each share of Cvent that they own.
KSF is seeking to determine whether this consideration and the process that led to it are adequate, or whether the consideration undervalues the Company.
To learn more about KSF, whose partners include the Former Louisiana Attorney General, visit www.ksfcounsel.com .

UNIVAR SOLUTIONS INVESTOR ALERT by the Former Attorney General of Louisiana: Kahn Swick & Foti, LLC Investigates Adequacy of Price and Process in Proposed Sale of Univar Solutions Inc. - UNVR

Retrieved on:

Friday, March 17, 2023

Chemicals, Plastics, Legal, Professional Services, Manufacturing, Sale, KSF, NYSE, Apollo Global Management, APO, Univar Solutions

and the law firm of Kahn Swick & Foti, LLC (“KSF”) are investigating the proposed sale of Univar Solutions Inc. (NYSE: UNVR) to Apollo Global Management, Inc. (NYSE: APO).

Key Points:

and the law firm of Kahn Swick & Foti, LLC (“KSF”) are investigating the proposed sale of Univar Solutions Inc. (NYSE: UNVR) to Apollo Global Management, Inc. (NYSE: APO).
Under the terms of the proposed transaction, shareholders of Univar will receive $36.15 in cash for each share of Univar that they own.
KSF is seeking to determine whether this consideration and the process that led to it are adequate, or whether the consideration undervalues the Company.
To learn more about KSF, whose partners include the Former Louisiana Attorney General, visit www.ksfcounsel.com .