Chronic obstructive pulmonary disease

Apogee Therapeutics Provides Pipeline Progress and Reports Fourth Quarter and Full Year 2023 Financial Results

Retrieved on: 
Tuesday, March 5, 2024
SQ, PD, Injection, I&I, Research, OX40L, Inflammation, Atopic dermatitis, Growth, Asthma, TARC, Chronic obstructive pulmonary disease, IPO, Interim, Safety, Therapy, Pharmacokinetics, Patient, Clinical trial, Half-life, G&A, Pharmaceutical industry

SAN FRANCISCO and WALTHAM, Mass., March 05, 2024 (GLOBE NEWSWIRE) -- Apogee Therapeutics, Inc. (Nasdaq: APGE), a clinical-stage biotechnology company advancing differentiated biologics for the treatment of atopic dermatitis (AD), chronic obstructive pulmonary disease (COPD), asthma and other inflammatory and immunology (I&I) indications, today reported pipeline highlights and fourth quarter and full year 2023 financial results.

Key Points: 
  • “2023 was a momentous year for Apogee with the completion of a successful IPO, initiation of our first clinical program of APG777 in healthy volunteers and the nomination of our second pipeline candidate, APG808,” said Michael Henderson, M.D., Chief Executive Officer of Apogee.
  • Cash Position: Cash, cash equivalents and marketable securities were $395.5 million as of December 31, 2023, compared to $151.9 million as of December 31, 2022.
  • Based on current operating plans, Apogee expects its existing cash, cash equivalents and marketable securities will enable the company to fund its operating expenses into 4Q 2026.
  • Net loss increased primarily as a result of higher R&D and G&A operating expenses as described above, partially offset by higher interest income.

Apogee Announces Positive Interim Results from Phase 1 Healthy Volunteer Trial for APG777, its Novel Half-Life Extended Anti-IL-13 Antibody for the Treatment for Atopic Dermatitis and Other Inflammatory Diseases, Exceeding its Trial Objectives Ahead of Sc

Retrieved on: 
Tuesday, March 5, 2024
Paragon, Well, SAD, PD, Injection, I&I, Waldman, Headache, Inflammation, Quality of life, Management, Atopic dermatitis, Asthma, TARC, AUC, Volunteering, Cmax, Chronic obstructive pulmonary disease, Outline of health sciences, Safety, Biomarker, Therapy, CQD, Chronic pain, Immunology, IGA, Webcast, Sleep, Patient, MPH, Half-life, Serum, Pharmaceutical industry

Based on these data, the company plans to initiate a randomized, placebo-controlled, Phase 2 clinical trial in patients with moderate-to-severe AD in the first half of 2024 ahead of schedule.

Key Points: 
  • Based on these data, the company plans to initiate a randomized, placebo-controlled, Phase 2 clinical trial in patients with moderate-to-severe AD in the first half of 2024 ahead of schedule.
  • At Apogee, we refuse to stop at good enough and are dedicated to advancing innovative solutions for patients.
  • The Phase 1 trial is a first-in-human, randomized, double-blind, placebo-controlled study designed to evaluate safety and PK of APG777 in healthy volunteers.
  • A live webcast of the call will be available on the Investor Relations page of Apogee’s website at https://investors.apogeetherapeutics.com/news-events/events .

Apogee to Host Conference Call and Webcast to Report Interim Results from Phase 1 Healthy Volunteer Trial for APG777, its Novel Half-Life Extended Anti-IL-13 Antibody for the Treatment for Atopic Dermatitis and Other Inflammatory Diseases on March 5, 2024

Retrieved on: 
Monday, March 4, 2024
Chronic obstructive pulmonary disease, Atopic dermatitis, SAN, Asthma, I&I, Therapy, Webcast

(Nasdaq: APGE), a clinical-stage biotechnology company advancing differentiated biologics for the treatment of atopic dermatitis, chronic obstructive pulmonary disease, asthma and other inflammatory and immunology (I&I) indications, today announced it will report interim results from the Phase 1 APG777 healthy volunteer trial on Tuesday, March 5, 2024.

Key Points: 
  • (Nasdaq: APGE), a clinical-stage biotechnology company advancing differentiated biologics for the treatment of atopic dermatitis, chronic obstructive pulmonary disease, asthma and other inflammatory and immunology (I&I) indications, today announced it will report interim results from the Phase 1 APG777 healthy volunteer trial on Tuesday, March 5, 2024.
  • Following the announcement, the Company will host a conference call and webcast at 7:00am ET to discuss the results.
  • To access the live and archived webcast, please visit the Investor Relations page of Apogee’s website at https://investors.apogeetherapeutics.com/news-events/events .
  • The archived webcast will be available for a limited time on the Company’s website.

Verona Pharma Reports Fourth Quarter and Full Year 2023 Financial Results and Provides Corporate Update

Retrieved on: 
Thursday, February 29, 2024
Conference call, AstraZeneca, Research, New Drug Application, FDA, Quality of life, Marketing, EST, Growth, PDUFA, Travel, Conference, Chronic obstructive pulmonary disease, GMT, Hub, Safety, Information technology, Patient, Pharming, Clinical trial, Novartis, Disease, VRNA, IND, NDA, Head, Bromide, COPD, Pharmaceutical industry

LONDON and RALEIGH, N.C., Feb. 29, 2024 (GLOBE NEWSWIRE) -- Verona Pharma plc (Nasdaq: VRNA) ("Verona Pharma" or the "Company"), a clinical-stage biopharmaceutical company focused on respiratory diseases, announces its financial results for the fourth quarter and full year ended December 31, 2023, and provides a corporate update.

Key Points: 
  • The debt facility provides non-dilutive capital and further financial flexibility to support Verona Pharma’s continued growth, including the commercialization of ensifentrine.
  • Net loss: Net loss was $14.1 million for the fourth quarter ended December 31, 2023 (Q4 2022: net loss $10.5 million).
  • Verona Pharma will host an investment community webcast and conference call at 9:00 a.m. EST / 2:00 p.m. GMT on Thursday, February 29, 2024, to discuss the fourth quarter and full year 2023 financial results and the corporate update.
  • An electronic copy of the fourth quarter and full year 2023 results press release will also be made available today on the Company’s website.

Dupixent® (dupilumab) sBLA Accepted for FDA Priority Review for Treatment of COPD with Type 2 Inflammation

Retrieved on: 
Friday, February 23, 2024
Regeneron Pharmaceuticals, Headache, Diarrhea, FDA, Food, Smoker, Back pain, Chronic obstructive pulmonary disease, Common, Safety, COVID-19, Patient, Priority, Disease, Diagnosis, Priority review, COPD, Pharmaceutical industry

TARRYTOWN, N.Y. and PARIS, Feb. 23, 2024 (GLOBE NEWSWIRE) -- Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) and Sanofi today announced that the U.S. Food and Drug Administration (FDA) has accepted for Priority Review the supplemental Biologics License Application (sBLA) for Dupixent® (dupilumab) in a sixth potential indication as an add-on maintenance treatment in certain adult patients with uncontrolled chronic obstructive pulmonary disease (COPD). The target action date for the FDA decision is June 27, 2024. Regulatory submissions are under review in China and Europe.

Key Points: 
  • The target action date for the FDA decision is June 27, 2024.
  • Regulatory submissions are under review in China and Europe.
  • In both trials, Dupixent rapidly and significantly improved lung function compared to placebo, with improvements sustained at 52 weeks.
  • Priority Review is granted to regulatory applications seeking approval for therapies that have the potential to provide significant improvements in the treatment, diagnosis or prevention of serious conditions.

Press Release: Dupixent® sBLA accepted for FDA Priority Review for treatment of COPD with type 2 inflammation

Retrieved on: 
Friday, February 23, 2024
Eosinophil, Headache, Diarrhea, FDA, Food, Back pain, Chronic obstructive pulmonary disease, Common, European, Safety, COVID-19, Patient, Priority, Diagnosis, Smoker, COPD, Priority review

The U.S. Food and Drug Administration (FDA) has accepted for Priority Review the supplemental Biologics License Application (sBLA) for Dupixent® (dupilumab) in a sixth potential indication as an add-on maintenance treatment in certain adult patients with uncontrolled chronic obstructive pulmonary disease (COPD).

Key Points: 
  • The U.S. Food and Drug Administration (FDA) has accepted for Priority Review the supplemental Biologics License Application (sBLA) for Dupixent® (dupilumab) in a sixth potential indication as an add-on maintenance treatment in certain adult patients with uncontrolled chronic obstructive pulmonary disease (COPD).
  • The target action date for the FDA decision is June 27, 2024.
  • In both trials, Dupixent also rapidly and significantly improved lung function compared to placebo, with improvements sustained at 52 weeks.
  • Priority Review is granted to regulatory applications seeking approval for therapies that have the potential to provide significant improvements in the treatment, diagnosis or prevention of serious conditions.

RS BioTherapeutics Creates Therapeutic Expert Council to Provide Guidance on Development of First-in-Class Agent Focused on Chronic Obstructive Pulmonary Disease and Idiopathic Pulmonary Fibrosis

Retrieved on: 
Wednesday, February 21, 2024
TEC, IPF, University, Idiopathic disease, Division, Assistant, Critical care, Idiopathic pulmonary fibrosis, Chronic obstructive pulmonary disease, Clinical research, Outline of health sciences, Consultant, Respiratory Medicine, Death, SUNY, Observation, Harvard Medical School, COPD, Pharmaceutical industry

CUMBERLAND, Md., Feb. 21, 2024 (GLOBE NEWSWIRE) -- RS BioTherapeutics, whose mission is to develop life-changing medicines for the millions of people suffering from diseases characterized by pulmonary inflammation, is pleased to announce the formation of its Therapeutic Expert Council (TEC).

Key Points: 
  • CUMBERLAND, Md., Feb. 21, 2024 (GLOBE NEWSWIRE) -- RS BioTherapeutics, whose mission is to develop life-changing medicines for the millions of people suffering from diseases characterized by pulmonary inflammation, is pleased to announce the formation of its Therapeutic Expert Council (TEC).
  • The TEC will help guide the development of RS BioTherapeutics’ first-in-class, steroid-free agent, RSBT-001, in development for Chronic Obstructive Pulmonary Disease (COPD), the third leading cause of death in the world; and Idiopathic Pulmonary Fibrosis (IPF), a rare disease with no cure that claims 40,000 lives each year in the U.S.
  • All have exceptional credentials and are uniquely qualified to help support the development of our first investigational compound, RSBT-001.
  • I’m excited to collaborate with them and look forward to engaging their diverse perspectives spanning the fields of COPD, IPF, and other diseases characterized by pulmonary inflammation.”

UTMHealthcare Partners with Somml Health to Enhance Chronic Disease Care with Launch of NuLink Health

Retrieved on: 
Wednesday, March 6, 2024
Health Technology, Diabetes, Telemedicine, Virtual Medicine, Technology, Practice Management, Apps, Applications, Managed Care, Mental Health, Infectious Diseases, Hospitals, Cardiology, Software, Nursing, Health, Mobile, Wireless, Heart, Hospital, Caregiver, RPM, Conditional sentence, Communication, Chronic obstructive pulmonary disease, Hypertension, Patient, Wide Open West, Pharmaceutical industry

UTMHealthcare , a leading mobile health technology company, today announced the launch of NuLink Health in collaboration with virtual care platform Somml Health .

Key Points: 
  • UTMHealthcare , a leading mobile health technology company, today announced the launch of NuLink Health in collaboration with virtual care platform Somml Health .
  • NuLink Health partners with providers to improve the care of at-risk patients between office visits, creating operational and cost efficiencies for medical practices.
  • NuLink Health leverages UTMHealthcare’s remote patient monitoring (RPM) solution and Somml Health’s virtual care platform to provide optimal care for patients with complex chronic conditions, with the goal of lowering hospital readmissions for these patients.
  • “NuLink transmits live, accurate and secure patient data to help busy medical practices manage the care of chronic disease patients,” said Seth Lachterman, a partner and co-founder of UTMHealthcare and its parent company, YouThisMe.

Pulmonx Announces Treatment of the First Patient with the AeriSeal® System in CONVERT II Pivotal Trial

Retrieved on: 
Monday, February 26, 2024
Health, Medical Devices, Health Technology, Clinical Trials, Research, Science, Biotechnology, Foam, PMA, Teaching hospital, FDA, Quality of life, News, Food, IDE, American International Group, Chronic obstructive pulmonary disease, Safety, Lung, Endobronchial valve, Patient, Periodic breathing, Corporation, COPD, Fissure, Medical device

Successful treatment with the AeriSeal System is followed by treatment with commercially available Zephyr® Valves.

Key Points: 
  • Successful treatment with the AeriSeal System is followed by treatment with commercially available Zephyr® Valves.
  • Pulmonx received a staged IDE approval by the Food and Drug Administration (FDA) to commence the CONVERT II Pivotal Trial for the AeriSeal System in late 2023.
  • Severe COPD/emphysema patients with collateral ventilation confirmed with Pulmonx’s proprietary Chartis® Pulmonary Assessment System (Chartis) undergo the AeriSeal System treatment.
  • “We hope the CONVERT II Trial will move us closer to the goal of helping patients with collateral ventilation to also receive benefit from our Zephyr Valves.”

MANDARA Phase III data published in New England Journal of Medicine show remission is an achievable goal in eosinophilic granulomatosis with polyangiitis (EGPA) with FASENRA

Retrieved on: 
Friday, February 23, 2024
Health, Clinical Trials, Research, Pharmaceutical, Science, Biotechnology, Metabolism, AstraZeneca, Hypereosinophilic syndrome, Chronic pain, Growth, Skin, Fatigue, Immunology, Polyp (medicine), Efficacy, COPD, Biopharmaceutical, Social media, Placebo, Safety, Treatment, Chronic obstructive pulmonary disease, ClinicalTrials.gov, Abstract (summary), Respiratory Medicine, OCS, Bell, Rash, Biomarker, Heart, HES, Sinusitis, Inflammation, Weight loss, Asthma, Gastrointestinal tract, Death, OLE, Disease, Pharmaceutical industry

AstraZeneca is an established leader in respiratory care with a 50-year heritage and a growing portfolio of medicines in immune-mediated diseases.

Key Points: 
  • AstraZeneca is an established leader in respiratory care with a 50-year heritage and a growing portfolio of medicines in immune-mediated diseases.
  • Fasenra met the primary endpoint in the MANDARA Phase III trial in eosinophilic granulomatosis with polyangiitis (EGPA).
  • Burden of illness and costs associated with eosinophilic granulomatosis with polyangiitis: evidence from a managed care database in the United States.
  • A Phase 3 Study to Evaluate the Efficacy and Safety of Benralizumab in Patients With Hypereosinophilic Syndrome (HES) (NATRON).