Leo Pharma

VYNE Reports First Quarter 2024 Financial Results and Provides Business Update

Retrieved on: 
Giovedì, Maggio 9, 2024
Net, BET, Vitiligo, Safety, Pharmacokinetics, Research, Leo Pharma, Arm, IND, Psoriasis, Bank statement, Therapy, Investigational New Drug, Pharmaceutical industry

“During the first quarter, we made steady progress in advancing our VYN201 program toward a Phase 2b trial,” said David Domzalski, President and CEO of VYNE.

Key Points: 
  • “During the first quarter, we made steady progress in advancing our VYN201 program toward a Phase 2b trial,” said David Domzalski, President and CEO of VYNE.
  • “We are rapidly activating clinical trial sites and expect to dose the first subject in the trial this quarter.
  • Financial Results as of and for the First Quarter Ended March 31, 2024
    Cash position.
  • As of March 31, 2024, VYNE had cash, cash equivalents, restricted cash and marketable securities of $86.0 million.

LEO Pharma Announces Topline Results of Phase 3 Trial in China for Enstilar® (LEO 90100) Demonstrating Superiority in Adult Chinese Subjects With Stable Plaque Psoriasis

Retrieved on: 
Martedì, Maggio 7, 2024
Biotechnology, Pharmaceutical, Health, Clinical Trials, Phase, LEO, Hope, Hospital, Safety, Leo Pharma, Patient, Psoriasis, Plaque, Dermatology, Pharmaceutical industry

LEO Pharma A/S, a global leader in medical dermatology, today announces positive results from the Enstilar® phase 3 trial in China in adult patients living with stable plaque psoriasis.

Key Points: 
  • LEO Pharma A/S, a global leader in medical dermatology, today announces positive results from the Enstilar® phase 3 trial in China in adult patients living with stable plaque psoriasis.
  • Exploratory objectives included evaluating health-related quality of life.1
    The topline results show that Enstilar demonstrated superiority to Daivobet ointment in the primary objective.
  • Following the results, LEO Pharma will proceed with preparations to submit Enstilar for approval with the Chinese authorities.
  • Detailed results from the Enstilar China trial will be submitted for scientific presentation and publication at a later date.

Solid Start to the Year: LEO Pharma Delivers 13% Revenue Growth Driven by Strong Performance in Dermatology

Retrieved on: 
Venerdì, Maggio 3, 2024
Science, Biotechnology, Research, Pharmaceutical, General Health, Health, Clinical Trials, Other Health, American Academy, Dermatitis, Phase, LEO, Risk, Delgocitinib, Annual report, Leo Pharma, Tralokinumab, Growth, DKK, Affiliation, CHE, Patient, Acquisition, Psoriasis, AAD, Skin infection, Multimedia, Marketing, Atopic dermatitis, Ichthyosis, Pharmaceutical industry

In Q1 2024, LEO Pharma delivered a revenue growth of 13% in constant exchange rates (CER).

Key Points: 
  • In Q1 2024, LEO Pharma delivered a revenue growth of 13% in constant exchange rates (CER).
  • Dermatology revenue grew 16% to DKK 2,444 million (Q1 2023: 2,150 million), driven by growth of Adtralza®/Adbry® for atopic dermatitis (AD) and solid growth in the core portfolio.
  • “First quarter marks a solid start to 2024 with a 13% revenue growth and continued progress on our strategic priorities.
  • I am pleased with the strong growth track record for our global dermatology portfolio, primarily driven by performance in North America.

Oruka Therapeutics Expands Leadership Team, Naming Joana Goncalves, MBChB, as Chief Medical Officer

Retrieved on: 
Mercoledì, Aprile 24, 2024
University, CMO, Safety, NDA, Skin, Leo Pharma, Dermatology, Doctor of Philosophy, Freedom, Engineering, Patient, Doctor of Pharmacy, Secukinumab, Psoriasis, Therapy, Celgene, Biotechnology, Chronic kidney disease, Pharmaceutical industry

WALTHAM, Mass., April 24, 2024 (GLOBE NEWSWIRE) -- Oruka Therapeutics, Inc. (“Oruka”), a biotechnology company developing novel biologics designed to set a new standard for the treatment of chronic skin diseases, including plaque psoriasis, today announced the strengthening of its leadership team with the addition of two experienced executives.

Key Points: 
  • Joana Goncalves, MBChB, will serve as Oruka’s Chief Medical Officer, effective April 18, 2024.
  • Dr. Goncalves brings two decades of leadership experience in dermatology clinical development and medical affairs.
  • Oruka also announced that Eugenia Levi, PharmD, will join the company as Vice President of Medical Affairs.
  • Her extensive leadership experience will prove invaluable as we advance our portfolio of potentially best-in-class antibodies and build a high-performing team,” said Lawrence Klein, PhD, Chief Executive Officer of Oruka Therapeutics.

Chiesi USA Appoints Richard Smith as Vice President and Business Unit Leader, U.S. AIR

Retrieved on: 
Lunedì, Aprile 15, 2024
AIR, U.S. AIR, Chronic obstructive pulmonary disease, Health, Leo Pharma, History, Smith, Patient, Asthma, Organization, COPD

Chiesi USA remains steadfast in its preparations for the full-scale U.S. launch of its AIR franchise as part of the company’s commitment to improving respiratory care and health in communities

Key Points: 
  • Chiesi USA remains steadfast in its preparations for the full-scale U.S. launch of its AIR franchise as part of the company’s commitment to improving respiratory care and health in communities
    CARY, N.C., April 15, 2024 (GLOBE NEWSWIRE) -- Chiesi USA, Inc. (key-A-zee), the U.S. affiliate of Chiesi Farmaceutici, an international research-focused healthcare Group (Chiesi Group), today announced it has appointed Richard Smith as vice president and business unit leader of U.S. AIR.
  • Smith will report to Jon Zwinski, CEO and general manager of Chiesi USA.
  • “Richard’s inspirational leadership and track record of enabling actionable programs with multistakeholder engagement reflect Chiesi USA’s mission and values.
  • Before joining Chiesi USA, Smith was vice president and head of the U.S. commercial organization at LEO Pharma, Inc.

Timber Pharmaceuticals, Inc., a LEO Pharma Company, Presents Late-Breaking Preliminary Results of TMB-001 in Moderate-to-Severe Congenital Ichthyosis (CI) at the 2024 AAD Annual Meeting

Retrieved on: 
Domenica, Marzo 10, 2024
Biotechnology, Pharmaceutical, Health, Clinical Trials, LEO, Leo Pharma, Disease, Associate, Patient, Ageing, PKS, Knowledge, Research, American Academy, Acquisition, Tretinoin, Adolescence, Abstract, Yale School of Medicine, Clinical trial, Safety, AAD, Isotretinoin, ISO, FDA, Fissure, ASCEND, IGA, Food, Pharmaceutical industry

“With no specific treatment currently available, CI patients are currently having to deal with their condition with minimal support.

Key Points: 
  • “With no specific treatment currently available, CI patients are currently having to deal with their condition with minimal support.
  • I hope that the data and insights presented today can help provide new knowledge and support for this patient community.”
    In January 2024, LEO Pharma finalized the acquisition of Timber Pharmaceuticals, a clinical-stage biopharmaceutical company focused on the development and commercialization of treatments for rare and orphan dermatologic diseases.
  • Upon completion, the Timber Pharmaceuticals lead investigational product candidate, TMB-001, was added to LEO Pharma’s pipeline.
  • TMB-001 is under investigation and has not been evaluated by any health authority.

LEO Pharma Unveils Late-Breaking Data for Landmark DELTA 3 Open-Label Extension Trial at the 2024 AAD Annual Meeting

Retrieved on: 
Sabato, Marzo 9, 2024
Health, Clinical Trials, Research, Pharmaceutical, Science, Biotechnology, Janus, Medicine, AAD, Safety, JAK, COVID-19, Abstract, Patient, CHE, Congress, Disease, LEO, Leo Pharma, American Academy, Pharmaceutical industry

For DELTA 3, subjects who completed the 16-week treatment period in one of the parent trials DELTA 1 and DELTA 2 were treated with twice daily delgocitinib cream as needed to control their chronic hand eczema for 36 weeks.

Key Points: 
  • For DELTA 3, subjects who completed the 16-week treatment period in one of the parent trials DELTA 1 and DELTA 2 were treated with twice daily delgocitinib cream as needed to control their chronic hand eczema for 36 weeks.
  • “Having the opportunity to present the DELTA 3 findings for the first time at AAD is a chance to prove our complete dedication to addressing the immense burden of this disease.
  • By continuing to share our key data at major dermatology congresses, we hope to drive forward the clinical development of delgocitinib cream as a potential new treatment option.”
    Key secondary endpoints demonstrated an efficacy profile consistent with DELTA 1 and 2 parent trials.
  • Alongside the presentation, new data sets at AAD were shared as e-posters from the preceding DELTA 1 and 2 trials regarding safety, efficacy and systemic exposure.2,3,4

LEO Pharma Presents New Long-Term Adbry® (tralokinumab-ldrm) Data in Adults with Moderate-to-Severe Atopic Dermatitis at the 2024 AAD Annual Meeting

Retrieved on: 
Venerdì, Marzo 8, 2024
Science, Other Science, Biotechnology, Research, Pharmaceutical, Health, FDA, Clinical Trials, EVP, Atopic dermatitis, ICI, EASI, AAD, Safety, Abstract, Patient, Congress, LEO, Ageing, Leo Pharma, American Academy, Pharmaceutical industry

LEO Pharma A/S, a global leader in medical dermatology, today unveiled new data analyzing the long-term therapeutic response of treatment with Adbry® (tralokinumab-ldrm) in adults (18 years and above) with moderate-to-severe atopic dermatitis (AD).

Key Points: 
  • LEO Pharma A/S, a global leader in medical dermatology, today unveiled new data analyzing the long-term therapeutic response of treatment with Adbry® (tralokinumab-ldrm) in adults (18 years and above) with moderate-to-severe atopic dermatitis (AD).
  • The findings are being shared via an e-poster at the 82nd American Academy of Dermatology (AAD) Congress in San Diego, California.1
    The results are part of a wide-ranging data program from LEO Pharma at AAD, with eight abstracts accepted in total for the meeting, showcasing an ongoing commitment to advancing the standard of research in medical dermatology.
  • “The data presented for Adbry at AAD further builds upon an established, wide-ranging collection of clinical evidence that aims to improve the support for those living with moderate-to-severe AD,” said Brian Hilberdink, EVP and President, Region North America, LEO Pharma.
  • “This new analysis demonstrates the benefits of the long-term use of Adbry for adults who live with this chronic condition.”

LEO Pharma to Maintain Leadership Role at AAD in 2024 with New Late-Breaking Data Spanning Multiple Therapeutic Areas

Retrieved on: 
Mercoledì, Marzo 6, 2024
Health, Clinical Trials, Research, Pharmaceutical, Science, Biotechnology, Adolescence, EVP, American Academy of Dermatology, Ichthyosis, Atopic dermatitis, Pain, Dermatology, Calendar, Annual general meeting, AAD, Safety, Pharmacokinetics, Abstract, CHE, Congress, LEO, ASCEND, Leo Pharma, American Academy, Pharmaceutical industry

LEO Pharma A/S, a global leader in medical dermatology, will present a breadth of new data on moderate-to-severe chronic hand eczema (CHE), congenital ichthyosis (CI) and atopic dermatitis (AD) at the upcoming 82nd American Academy of Dermatology (AAD) Annual Meeting.

Key Points: 
  • LEO Pharma A/S, a global leader in medical dermatology, will present a breadth of new data on moderate-to-severe chronic hand eczema (CHE), congenital ichthyosis (CI) and atopic dermatitis (AD) at the upcoming 82nd American Academy of Dermatology (AAD) Annual Meeting.
  • The event is being held from March 8th to 12th in San Diego, California.
  • “Our growing body of clinical evidence reinforces our passion and commitment to advancing the standard of care in medical dermatology,” said Kreesten Meldgaard Madsen, LEO Pharma’s Chief Development Officer.
  • I am proud that we can follow up on our 2023 AAD program with this level of critical data,” said Brian Hilberdink, EVP and President, Region North America, LEO Pharma.

Annual Report 2023: LEO Pharma Delivers 10% Revenue Growth and Returns to Positive EBITDA

Retrieved on: 
Giovedì, Febbraio 29, 2024
Health, Clinical Trials, Research, Pharmaceutical, Science, Biotechnology, Acquisition, EMA, Dermatology, DKK, Investment, CER, Growth, Research and development, Business development, Skin, Delgocitinib, Net, Risk, Development, LEO, Movement, Leo Pharma, Pharmaceutical industry

LEO Pharma delivers a solid operational performance uplift with double-digit revenue growth and an EBITDA uplift of DKK 2.1 billion, corresponding to a 20%-points margin improvement.

Key Points: 
  • LEO Pharma delivers a solid operational performance uplift with double-digit revenue growth and an EBITDA uplift of DKK 2.1 billion, corresponding to a 20%-points margin improvement.
  • LEO Pharma exceeded our profitability guidance and hit the upper range of our revenue growth guidance provided in March 2023.
  • LEO Pharma delivered 11.4 billion in revenue, corresponding to 7% revenue growth in 2023.
  • LEO Pharma exceeded our profitability guidance and hit the upper range of our revenue growth guidance provided in March 2023.