PDE4

Cerevel Therapeutics Reports Second Quarter 2022 Financial Results and Business Updates

Retrieved on: 
Monday, August 1, 2022
PIN, Brain, GLOBE, Lists of Palestinian rocket attacks on Israel, Anxiety disorder, Research, Schizophrenia, Forward-looking statement, SEC, Panic disorder, KORA, Intention, PDE4, Marketing, Therapy, MDD, COVID-19, Safety, Volunteering, Positive, Conference, Total, Clinical trial, Biotechnology, PAM, Epilepsy, Drug development, Seizure, FDA, Conference call, Patient, Pharmacokinetics, Psychosis, PANSS, Terminology, GABAA, Growth, Lists of diseases, Society, G&A, Pharmaceutical industry, Cryptocurrency, Medical device, Residential care, Copper

ET

Key Points: 
  • ET
    CAMBRIDGE, Mass., Aug. 01, 2022 (GLOBE NEWSWIRE) -- Cerevel Therapeutics , (Nasdaq: CERE), a company dedicated to unraveling the mysteries of the brain to treat neuroscience diseases, today reported financial results for the quarter ended June 30, 2022 and provided key pipeline and business updates.
  • In June 2022, Cerevel initiated its Phase 2 program in schizophrenia:
    Cerevel is conducting two adequately-powered placebo-controlled Phase 2 trials, known as EMPOWER-1 and EMPOWER-2.
  • Cerevel expects to initiate a 52-week open-label safety extension trial, EMPOWER-3, in the third quarter of 2022.
  • ET to discuss its second quarter 2022 financial results and pipeline updates.

FDA Approves Arcutis’ ZORYVE™ (Roflumilast) Cream 0.3% For the Treatment of Plaque Psoriasis in Individuals Age 12 and Older

Retrieved on: 
Friday, July 29, 2022
Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Conditional sentence, IGA, GLOBE, PAP, Sex, Â, Food, Itch, CEO, Icahn School of Medicine at Mount Sinai, New Drug Application, Plaque, PDE4, NDA, Therapy, Safety, NASDAQ, EDT, Webcast, Disease, FDA, Company, National Psoriasis Foundation, Patient, Psoriasis, Week, Kimberley, Mount Sinai, Face, Program, FAAD, Pharmaceutical industry, Dermatology

ZORYVE a once-daily, steroid-free cream in a safe and well tolerated, patient-friendly formulation is uniquely formulated to simplify disease management for people living with plaque psoriasis.

Key Points: 
  • ZORYVE a once-daily, steroid-free cream in a safe and well tolerated, patient-friendly formulation is uniquely formulated to simplify disease management for people living with plaque psoriasis.
  • ZORYVE is the only topical for which data focused on the treatment of intertriginous plaques a common area affected by plaque psoriasis have been specifically generated.
  • As a result, individuals with psoriasis are often prescribed multiple topical medications for different areas, which makes for a complicated treatment regimen.
  • ZORYVE is indicated for topical treatment of plaque psoriasis, including intertriginous areas, in patients 12 years of age and older.

MediciNova Initiates Clinical Evaluation of a New Parenteral Formulation of MN-166 (ibudilast)

Retrieved on: 
Friday, July 22, 2022
IPF, Multiple sclerosis, GLOBE, MPH, Injection, Glioblastoma, U.S. Securities and Exchange Commission, Amyotrophic lateral sclerosis, Trial of the century, Neurodegeneration, Code, Acute respiratory distress syndrome, Intellectual property, Form 8-K, Private Securities Litigation Reform Act, NAFLD, PDE4, Risk, Failure, NASDAQ, DCM, CIPN, MS, ALS, FDA, MD, Security (finance), Tokyo Stock Exchange, Patient, Pharmacokinetics, Annual report, Chemotherapy-induced peripheral neuropathy, Idiopathic pulmonary fibrosis, Non-alcoholic fatty liver disease, Nasdaq, Form 10-K, MIF, Pharmaceutical industry, Doctor of Philosophy

The newly developed MN-166 (ibudilast) formulation will provide an additional option for health care providers to administer MN-166 (ibudilast), in addition to the current oral formulation.

Key Points: 
  • The newly developed MN-166 (ibudilast) formulation will provide an additional option for health care providers to administer MN-166 (ibudilast), in addition to the current oral formulation.
  • With MN-166 expected to be effective to treat a variety of diseases, we believe expanding to a parenteral formulation increases the feasibility of treating more target indications, thus increasing the value of MN-166.
  • Based on two compounds, MN-166 (ibudilast) and MN-001 (tipelukast), with multiple mechanisms of action and strong safety profiles, MediciNova has 11 programs in clinical development.
  • MediciNova has a strong track record of securing investigator-sponsored clinical trials funded through government grants.

Arcutis Biotherapeutics Announces Health Canada Accepts for Review the New Drug Submission for Roflumilast Cream for Adults and Adolescents with Plaque Psoriasis

Retrieved on: 
Monday, July 11, 2022
Safety, Plaque, NDS, CEO, PDE4, Psoriasis, Dermatology, IGA, Nasdaq, Review, GLOBE, Patient, Health Canada, Pharmaceutical industry

We look forward to working closely with Health Canada during the review process.

Key Points: 
  • We look forward to working closely with Health Canada during the review process.
  • Arcutis NDS submission is supported by positive data from Arcutis pivotal Phase 3 program and two long-term open label studies.
  • The safety and efficacy of roflumilast cream remain under investigation and market authorization in Canada has not yet been obtained.
  • A new drug application (NDA) for roflumilast cream for the treatment of plaque psoriasis in adolescents and adults is also under review by the U.S. Food & Drug Administration (FDA).

MediciNova Announces Extension of BARDA Contract to Develop MN-166 (ibudilast) as a Medical Countermeasure Against Chlorine Gas-induced Lung Injury

Retrieved on: 
Thursday, June 30, 2022
FDA, Patient, Code, Amyotrophic lateral sclerosis, MS, Program, Proning, Biomedical Advanced Research and Development Authority, IPF, Nasdaq, MIF, GLOBE, NAFLD, Chlorine, CIPN, Failure, Multiple sclerosis, ALI, United States Department of Health and Human Services, Intellectual property, U.S. Securities and Exchange Commission, ALS, Annual report, PDE4, Redirect, Tokyo Stock Exchange, Development, Glioblastoma, MCM, Chemotherapy-induced peripheral neuropathy, Idiopathic pulmonary fibrosis, Risk, Acute respiratory distress syndrome, Security (finance), Drive, Private Securities Litigation Reform Act, Radiation, Human services, BARDA, NASDAQ, Non-alcoholic fatty liver disease, Form 10-K, DCM, Neurodegeneration, Form 8-K, Pharmaceutical industry, Research

Department of Health and Human Services, to repurpose MN-166 (ibudilast) as a potential medical countermeasure (MCM) against chlorine gas-induced lung damage such as acute respiratory distress syndrome (ARDS) and acute lung injury (ALI).

Key Points: 
  • Department of Health and Human Services, to repurpose MN-166 (ibudilast) as a potential medical countermeasure (MCM) against chlorine gas-induced lung damage such as acute respiratory distress syndrome (ARDS) and acute lung injury (ALI).
  • MN-166 (ibudilast) is a small molecule compound that inhibits phosphodiesterase type-4 (PDE4) and inflammatory cytokines, including macrophage migration inhibitory factor (MIF).
  • Undue reliance should not be placed on these forward-looking statements, which speak only as of the date hereof.
  • MediciNova disclaims any intent or obligation to revise or update these forward-looking statements.

Global Axial Spondyloarthritis Market Analysis and Forecasts, 2022-2032: Focus on Commercialized Therapies, Potential Pipeline Products, Indication, and Country - ResearchAndMarkets.com

Retrieved on: 
Wednesday, June 15, 2022
Biotechnology, General Health, Pharmaceutical, Health, Janus, Eli Lilly and Company, CAGR, Country, Therapy, Pharmacotherapy, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, UCB, Company, TNF, Research, Trade, Growth, JAK, Tofacitinib, Axial spondyloarthritis, Disease, Drug discovery, Merck & Co., Investment, GM-CSF, Ixekizumab, Food, Patient, AbbVie, Awareness, EU4, Drug development, PDE4, Pharmaceutical industry, Spondyloarthropathy, Secukinumab, Pfizer

The "Axial Spondyloarthritis Market - A Global and Country Analysis: Focus on Commercialized Therapies, Potential Pipeline Products, Indication, and Country - Analysis and Forecast, 2022-2032" report has been added to ResearchAndMarkets.com's offering.

Key Points: 
  • The "Axial Spondyloarthritis Market - A Global and Country Analysis: Focus on Commercialized Therapies, Potential Pipeline Products, Indication, and Country - Analysis and Forecast, 2022-2032" report has been added to ResearchAndMarkets.com's offering.
  • The companies operating in the global axial spondyloarthritis market are now focusing more on biologics and personalized therapy to enhance therapeutics and improve patient outcomes.
  • Increasing investments in the research and development of drug manufacturing is one of the major opportunities in the global axial spondyloarthritis market.
  • The ankylosing spondyloarthritis segment dominated the global axial spondyloarthritis market in 2021 due to a greater number of product approvals in seven major countries compared to non-radiographic axial spondyloarthritis.

MediciNova Announces Positive Top-Line Results from Phase 2 Clinical Trial of MN-166 (ibudilast) in Hospitalized COVID-19 Patients at Risk for Acute Respiratory Distress Syndrome

Retrieved on: 
Wednesday, June 8, 2022
Soft tissue injury, Oxygen, IPF, Death, Coronavirus, Pneumonia, Intellectual property, NIAID, DCM, Acute respiratory distress syndrome, CIPN, Form 10-K, Form 8-K, Annual report, Neurodegeneration, NAFLD, Glioblastoma, Tokyo Stock Exchange, Security (finance), U.S. Securities and Exchange Commission, Inflammation, Amyotrophic lateral sclerosis, Female, Failure, Non-alcoholic fatty liver disease, Vaccine, MIF, FDA, Proning, Patient, Infection, MS, Risk, Chemotherapy-induced peripheral neuropathy, GLOBE, ALS, Code, Private Securities Litigation Reform Act, COVID-19, Atmosphere, NASDAQ, Courage, Male, Nasdaq, MD, Clinical trial, Virus, Multiple sclerosis, Oxygen saturation (medicine), MPH, PDE4, Carbon, Idiopathic pulmonary fibrosis, Pharmaceutical industry, Medical imaging, Doctor of Philosophy

The trial achieved statistical significance for one of the co-primary endpoints, the proportion of subjects free of respiratory failure.

Key Points: 
  • The trial achieved statistical significance for one of the co-primary endpoints, the proportion of subjects free of respiratory failure.
  • The clinical trial enrolled 36 subjects and randomized 34 subjects including 17 subjects in the MN-166 (ibudilast) group and 17 subjects in the placebo group.
  • Male and female participants (mean age = 60 years) were equally represented in MN-166 (ibudilast) and placebo treatment groups.
  • In addition, MN-166 (ibudilast) was evaluated in patients that are at risk for developing acute respiratory distress syndrome (ARDS).

Arcutis Announces Positive Topline Results from STRATUM Pivotal Phase 3 Trial of Roflumilast Foam 0.3% in Seborrheic Dermatitis

Retrieved on: 
Monday, June 6, 2022
Scalp, GLOBE, Patient, EDT, PDE4, Dermatitis, Nasdaq

Improvement with roflumilast foam was seen early, with roflumilast separating statistically from vehicle on IGA Success at week two.

Key Points: 
  • Improvement with roflumilast foam was seen early, with roflumilast separating statistically from vehicle on IGA Success at week two.
  • In addition, more than 50% of patients treated with roflumilast foam achieved an IGA score of clear at week eight.
  • Roflumilast foam also demonstrated statistically significant improvements compared to vehicle on key secondary endpoints, including itch, scaling, and redness (erythema).
  • We are excited that investigational roflumilast foam demonstrated strong topline results in our pivotal Phase 3 trial, consistent with previously reported data.

Arcutis Announces First Quarter 2022 Financial Results and Provides Business Update

Retrieved on: 
Thursday, May 5, 2022
Janus, Dermatology, Standard of care, Twitter, Nasdaq, IND, GLOBE, Scalp, Company, NDA, JAK1, U.S. Securities and Exchange Commission, Research, Patient, Atopic dermatitis, PDE4, Review, Clinical trial, FDA, New Drug Application, Skin, Dermatitis, R, Shanda, LinkedIn, Sale, Plaque, Investigational New Drug, SEC, Psoriasis, G&A, ATM, PDUFA, Vitiligo, Security (finance), Pharmaceutical industry, Cosmetics, Medical device

Topline data from each of INTEGUMENT-1 and INTEGUMENT-2, in subjects six years of age or older, are anticipated by the end of 2022.

Key Points: 
  • Topline data from each of INTEGUMENT-1 and INTEGUMENT-2, in subjects six years of age or older, are anticipated by the end of 2022.
  • In April 2022, Arcutis announced the completion of enrollment of the sole pivotal Phase 3 trial (ARRECTOR) for the treatment of scalp and body psoriasis, with topline data anticipated late in the third quarter or early in the fourth quarter of 2022.
  • Research and development (R&D) expenses for the quarter ended March31, 2022 were $40.6 million compared to $21.6 million for the corresponding period in 2021.
  • General and administrative (G&A) expenses for the quarter ended March31, 2022 were $22.0 million compared to $14.5 million for the corresponding period in 2021.

MediciNova to Participate in the B. Riley Neuro & Ophthalmology Conference

Retrieved on: 
Friday, April 22, 2022
Code, ALS, Annual report, Acute respiratory distress syndrome, Substance dependence, Idiopathic pulmonary fibrosis, Nasdaq, Ophthalmology, B. Riley Financial, Non-alcoholic fatty liver disease, DCM, Multiple sclerosis, U.S. Securities and Exchange Commission, Tokyo Stock Exchange, Security (finance), NASDAQ, JD/MBA, MD, MIF, Private Securities Litigation Reform Act, GLOBE, Doctor of Philosophy, Glioblastoma, Chemotherapy-induced peripheral neuropathy, Patient, Form 10-K, Intellectual property, Conference, CIPN, Amyotrophic lateral sclerosis, Failure, Form 8-K, PDE4, Neurodegeneration, NAFLD, IPF, FDA, MS, Risk, Pharmaceutical industry

MN-166 (ibudilast) is a small molecule compound that inhibits phosphodiesterase type-4 (PDE4) and inflammatory cytokines, including macrophage migration inhibitory factor (MIF).

Key Points: 
  • MN-166 (ibudilast) is a small molecule compound that inhibits phosphodiesterase type-4 (PDE4) and inflammatory cytokines, including macrophage migration inhibitory factor (MIF).
  • In addition, MN-166 (ibudilast) is being evaluated in patients that are at risk for developing acute respiratory distress syndrome (ARDS).
  • MediciNova, Inc. is a clinical-stage biopharmaceutical company developing a broad late-stage pipeline of novel small molecule therapies for inflammatory, fibrotic, and neurodegenerative diseases.
  • MediciNova disclaims any intent or obligation to revise or update these forward-looking statements.