PDE4

Arcutis and Sato Announce Strategic Collaboration and Licensing Agreement for Topical Roflumilast in Japan

Retrieved on: 
Wednesday, February 28, 2024

“We are delighted to partner with Sato, who share our mission to provide meaningful innovation to individuals suffering from immune-mediated skin diseases.

Key Points: 
  • “We are delighted to partner with Sato, who share our mission to provide meaningful innovation to individuals suffering from immune-mediated skin diseases.
  • Topical roflumilast has been shown to effectively clear skin and reduce itch, with a safe and well-tolerated profile.
  • With this collaboration, we believe we can make an impact for individuals suffering from immune-mediated skin diseases in Japan,” said Seiichi Sato, president and chief executive officer, Sato.
  • Sato will be responsible for development, manufacturing, and commercialization of roflumilast cream and roflumilast foam and other topical roflumilast presentations in Japan.

Arcutis Announces Fourth Quarter and Full Year 2023 Financial Results and Provides Business Update

Retrieved on: 
Tuesday, February 27, 2024

The Company saw significant GTN improvement in the fourth quarter compared to the GTN in the third quarter, and anticipates further GTN improvement in 2024.

Key Points: 
  • The Company saw significant GTN improvement in the fourth quarter compared to the GTN in the third quarter, and anticipates further GTN improvement in 2024.
  • Total revenues for the quarter ended December 31, 2023 were $13.5 million compared to $3.0 million for the corresponding period in 2022.
  • Net cash used in operating activities was $56.2 during the fourth quarter and $247.1 million during the full year 2023.
  • Arcutis management will host a conference call and webcast today at 8:30 am ET to discuss the financial results for the quarter and year and provide a business update.

Phosphodiesterase-4 (PDE4) Inhibitor Market to Witness Significant Growth by 2034 Driven by In-depth Industry Analysis and Forecast - ResearchAndMarkets.com

Retrieved on: 
Tuesday, March 5, 2024

The "Phosphodiesterase-4 (PDE4) Inhibitor Market Size, Target Population, Competitive Landscape & Market Forecast - 2034" report has been added to ResearchAndMarkets.com's offering.

Key Points: 
  • The "Phosphodiesterase-4 (PDE4) Inhibitor Market Size, Target Population, Competitive Landscape & Market Forecast - 2034" report has been added to ResearchAndMarkets.com's offering.
  • Research into the Phosphodiesterase-4 (PDE4) Inhibitor market reveals critical insights into its expected evolution through the year 2034.
  • A market outlook sheds light on how these developments could influence market dynamics, juxtaposing current therapies with their next-generation counterparts.
  • The comprehensive report arms industry professionals with the requisite intelligence to anticipate the trajectory of the PDE4 Inhibitor market.

Palisade Bio Announces Positive Preclinical Data of Lead Program PALI-2108 at the 2024 Crohn’s & Colitis Congress

Retrieved on: 
Monday, January 29, 2024

Carlsbad, CA, Jan. 29, 2024 (GLOBE NEWSWIRE) -- Palisade Bio, Inc. (Nasdaq: PALI) (“Palisade” or the “Company”), a biopharmaceutical company focused on developing novel therapeutics for serious chronic gastrointestinal (GI) diseases, today announced the presentation of positive preclinical data of its lead asset, PALI-2108 at the Crohn’s & Colitis Congress, which was held on January 25-27, 2024 in Las Vegas, NV.

Key Points: 
  • The preclinical data was presented in a poster titled, Local Bioactivation and Efficacy of PALI-2108: A Promising PDE4 Inhibitor Prodrug for Ulcerative Colitis Treatment.
  • PALI-2108 is the Company’s orally administered, locally acting colon-specific phosphodiesterase-4B (PDE4B) inhibitor prodrug in development for patients affected by moderate-to-severely active ulcerative colitis (UC).
  • The poster is available on the Scientific Publications page of the Company’s website .
  • This feature ensures localized bioactivation, leading to colon-specific distribution with limited systemic exposure, as confirmed by a tissue distribution study.

Clarivate Identifies Thirteen Potential Blockbuster Drugs and Gamechangers in Annual Drugs to Watch Report

Retrieved on: 
Monday, January 8, 2024

LONDON, Jan. 8, 2024 /PRNewswire/ -- Clarivate Plc (NYSE:CLVT), a global leader in connecting people and organizations to intelligence they can trust to transform their world, today announced the release of its annual Drugs to Watch™ report. The report provides in-depth predictive analysis of drugs with the potential for standout commercial and/or clinical success. The report, a key industry resource in the evolving healthcare landscape, has identified over 85 Drugs to Watch over the 11-year course of its publication.

Key Points: 
  • The report provides in-depth predictive analysis of drugs with the potential for standout commercial and/or clinical success.
  • The report, a key industry resource in the evolving healthcare landscape, has identified over 85 Drugs to Watch over the 11-year course of its publication.
  • Leveraging deep industry expertise and comprehensive therapeutic area differentiated data, this year's Drugs to Watch report identifies innovative medicines based on recent scientific breakthroughs poised to have extraordinary impacts on patient outcomes."
  • Included in Drugs to Watch 2023, a delayed U.S. launch meant that it remains a drug to watch for 2024.

Clarivate Identifies Thirteen Potential Blockbuster Drugs and Gamechangers in Annual Drugs to Watch Report

Retrieved on: 
Monday, January 8, 2024

LONDON, Jan. 8, 2024 /PRNewswire/ -- Clarivate Plc (NYSE:CLVT), a global leader in connecting people and organizations to intelligence they can trust to transform their world, today announced the release of its annual Drugs to Watch™ report. The report provides in-depth predictive analysis of drugs with the potential for standout commercial and/or clinical success. The report, a key industry resource in the evolving healthcare landscape, has identified over 85 Drugs to Watch over the 11-year course of its publication.

Key Points: 
  • The report provides in-depth predictive analysis of drugs with the potential for standout commercial and/or clinical success.
  • The report, a key industry resource in the evolving healthcare landscape, has identified over 85 Drugs to Watch over the 11-year course of its publication.
  • Leveraging deep industry expertise and comprehensive therapeutic area differentiated data, this year's Drugs to Watch report identifies innovative medicines based on recent scientific breakthroughs poised to have extraordinary impacts on patient outcomes."
  • Included in Drugs to Watch 2023, a delayed U.S. launch meant that it remains a drug to watch for 2024.

Human medicines European public assessment report (EPAR): Daxas, roflumilast, Date of authorisation: 05/07/2010, Revision: 20, Status: Authorised

Retrieved on: 
Tuesday, January 2, 2024

Human medicines European public assessment report (EPAR): Daxas, roflumilast, Date of authorisation: 05/07/2010, Revision: 20, Status: Authorised

Key Points: 


Human medicines European public assessment report (EPAR): Daxas, roflumilast, Date of authorisation: 05/07/2010, Revision: 20, Status: Authorised

FDA Accepts Arcutis’ Supplemental New Drug Application for Roflumilast Cream 0.15% for the Treatment of Atopic Dermatitis in Adults and Children Down to Age 6

Retrieved on: 
Wednesday, November 29, 2023

The FDA assigned the application a Prescription Drug User Fee Act (PDUFA) target action date of July 07, 2024.

Key Points: 
  • The FDA assigned the application a Prescription Drug User Fee Act (PDUFA) target action date of July 07, 2024.
  • “Atopic dermatitis is a chronic and recurring inflammatory skin condition that requires therapy that is effective, tolerable, and suitable for long-term use by both adults and children.
  • INTEGUMENT-1 and INTEGUMENT-2 (The INterventional Trial EvaluatinG roflUMilast cream for the treatmENt of aTopic dermatitis) were two identical Phase 3, parallel group, double blind, vehicle-controlled trials evaluating the safety and efficacy of roflumilast cream 0.15% in AD.
  • The most common adverse reactions included headache (2.9%), nausea (1.9%), application site pain (1.5%), diarrhea (1.5%), and vomiting (1.5%).

Palisade Bio Reports Third Quarter 2023 Financial Results and Provides Business Outlook

Retrieved on: 
Friday, November 10, 2023

Carlsbad, CA, Nov. 10, 2023 (GLOBE NEWSWIRE) -- Palisade Bio, Inc. (Nasdaq: PALI) (“Palisade”, “Palisade Bio” or the “Company”), a biopharmaceutical company focused on developing novel therapeutics for serious chronic gastrointestinal (GI) diseases, today reported its financial results for the third quarter 2023 and provided a business outlook.

Key Points: 
  • Carlsbad, CA, Nov. 10, 2023 (GLOBE NEWSWIRE) -- Palisade Bio, Inc. (Nasdaq: PALI) (“Palisade”, “Palisade Bio” or the “Company”), a biopharmaceutical company focused on developing novel therapeutics for serious chronic gastrointestinal (GI) diseases, today reported its financial results for the third quarter 2023 and provided a business outlook.
  • “The past quarter was marked by a transformative transaction for Palisade.
  • We believe that novel therapeutics which demonstrate safety and efficacy have the potential to gain significant market share.
  • Palisade has the only PDE4 inhibitor prodrug under development for the treatment of ulcerative colitis, our lead indication,” commented J.D.

Arcutis Announces Third Quarter 2023 Financial Results and Provides Business Update

Retrieved on: 
Friday, November 3, 2023

The Company anticipates further GTN improvement in the fourth quarter of 2023.

Key Points: 
  • The Company anticipates further GTN improvement in the fourth quarter of 2023.
  • In October 2023, Arcutis received FDA approval for ZORYVE for an expanded indication for the treatment of plaque psoriasis in children down to 6 years of age.
  • In September 2022, Arcutis announced positive topline results from the ARRECTOR Pivotal Phase 3 trial for the treatment of scalp and body psoriasis.
  • Arcutis management will host a conference call and webcast today at 8:30am ET to discuss the financial results for the quarter and provide a business update.