Sinusitis

Optinose Announces $55 Million Registered Direct Offering

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木曜日, 5月 9, 2024
Sale, FDA, Prospectus, Sinusitis, ENT, Nose, OPTN, Patient, MPH, Ear, Polyp (medicine), Security (finance)

YARDLEY, Pa., May 09, 2024 (GLOBE NEWSWIRE) -- Optinose (NASDAQ:OPTN), a pharmaceutical company focused on patients treated by ear, nose and throat (ENT) and allergy specialists, today announced that it has entered into agreements for the sale of approximately $55 million of its common stock and pre-funded common stock warrants to a group of existing and new institutional investors in a registered direct offering.

Key Points: 
  • The gross proceeds from the offering are expected to be approximately $55 million, before deducting estimated offering expenses.
  • The registered direct offering is expected to close on or about May 10, 2024, subject to the satisfaction of customary closing conditions.
  • We expect the post-offering cash and cash equivalents of approximately $100 million to fund operations and debt service obligations through 2025.
  • A preliminary prospectus supplement relating to the offering was filed with the SEC on May 9, 2024 and is available on the SEC’s website at www.sec.gov.

Lyra Therapeutics Reports Topline Results from Phase 3 ENLIGHTEN 1 Trial for LYR-210 in Chronic Rhinosinusitis

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月曜日, 5月 6, 2024
Sinusitis, CRS, LYRA, Network congestion, Data, Workforce, ITT, Therapy, Nosebleed

WATERTOWN, Mass., May 06, 2024 (GLOBE NEWSWIRE) -- Lyra Therapeutics, Inc. (Nasdaq: LYRA) (“Lyra” or the “Company”), today announced topline results from the Company’s Phase 3 ENLIGHTEN 1 trial evaluating LYR-210 for the treatment of chronic rhinosinusitis (CRS). ENLIGHTEN 1 did not meet its primary endpoint of demonstrating statistically significant improvement compared to sham control in the composite score of the three cardinal symptoms (3CS) of CRS (nasal obstruction, nasal discharge, facial pain/pressure) at 24 weeks. ENLIGHTEN 1 is one of two Phase 3 clinical trials evaluating LYR-210, a bioabsorbable sinonasal implant (7500µg mometasone furoate), as a six-month treatment for chronic rhinosinusitis (CRS).

Key Points: 
  • WATERTOWN, Mass., May 06, 2024 (GLOBE NEWSWIRE) -- Lyra Therapeutics, Inc. (Nasdaq: LYRA) (“Lyra” or the “Company”), today announced topline results from the Company’s Phase 3 ENLIGHTEN 1 trial evaluating LYR-210 for the treatment of chronic rhinosinusitis (CRS).
  • ENLIGHTEN 1 is one of two Phase 3 clinical trials evaluating LYR-210, a bioabsorbable sinonasal implant (7500µg mometasone furoate), as a six-month treatment for chronic rhinosinusitis (CRS).
  • “We are surprised and disappointed by the ENLIGHTEN 1 topline results,” said Maria Palasis, Ph.D., President and Chief Executive Officer, Lyra Therapeutics.
  • The ENLIGHTEN 1 trial is ongoing and data from the 52-week extension phase are expected in Q4 2024.

Optinose Provides Corporate Update on XHANCE Launch and Outlook and Announces Preliminary First Quarter 2024 XHANCE Net Revenue of $14.9 million

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木曜日, 4月 25, 2024
FDA, Sinusitis, CS, ENT, Nose, Webcast, OPTN, Patient, MPH, Physician, Fluticasone, Ear, Telephone, Polyp (medicine), GAAP, Growth, Pharmaceutical industry

The Company will host an investor call at 10:00 a.m. Eastern Time today to discuss its commercial strategy and financial outlook.

Key Points: 
  • The Company will host an investor call at 10:00 a.m. Eastern Time today to discuss its commercial strategy and financial outlook.
  • In addition, the Company announced preliminary XHANCE net product revenue of $14.9 million for the three months ended March 31, 2024, representing growth of approximately 26% over the first quarter of 2023.
  • “The recent FDA approval of XHANCE as the first and only approved drug treatment for chronic sinusitis (CS) is a landmark achievement,” said Ramy Mahmoud, MD, MPH, CEO of Optinose.
  • In addition, a replay of the webcast will be available on the Company website for 60 days following the event.

AstraZeneca unveils latest research across key respiratory and immune-mediated diseases at ATS 2024 showcasing strength of its broad pipeline and portfolio

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水曜日, 5月 1, 2024
Biotechnology, Health, Pharmaceutical, Clinical Trials, Oncology, Mortality, FDA, Risk, ICS, Death, Weight loss, Growth, Gastrointestinal tract, Rash, TSLP, Formoterol, Biopharmaceutical, AstraZeneca, LABA, Inflammation, Salbutamol, Skin, Tezepelumab, Approval, EGPA, AMG, Allergy, Polyp (medicine), Bronchitis, Chronic obstructive pulmonary disease, Patient, Eosinophilic, Sinusitis, Rheumatology, Heart, Atmosphere, Fatigue, Immunology, Budesonide, Lung, Chronic pain, Asthma, COPD, Gastroenterology, Emphysema, Disease, Science, Conditional sentence, Dermatology, Pharmaceutical industry

In addition, we are also collaborating with AstraZeneca on AMG104/AZD8630, an inhaled anti-TSLP compound currently in development for asthma.

Key Points: 
  • In addition, we are also collaborating with AstraZeneca on AMG104/AZD8630, an inhaled anti-TSLP compound currently in development for asthma.
  • Respiratory & Immunology, part of BioPharmaceuticals, is one of AstraZeneca’s main disease areas and is a key growth driver for the Company.
  • With common pathways and underlying disease drivers across respiratory and immunology, AstraZeneca is following the science from chronic lung diseases to immunology-driven disease areas.
  • AstraZeneca’s ambition in Respiratory & Immunology is to achieve disease modification and durable remission for millions of patients worldwide.

FASENRA approved for treatment of children aged 6 to 11 with severe asthma

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木曜日, 4月 11, 2024
Health, FDA, General Health, Research, Science, Pharmaceutical, Biotechnology, Efficacy, Safety, Gastroenterology, HES, Chronic obstructive pulmonary disease, Sinusitis, Social media, Polyp (medicine), Pharmacokinetics, Rheumatology, Conference call, Asthma, TATE, AstraZeneca, FY, Hypereosinophilic syndrome, Death, ClinicalTrials.gov, Dermatology, Conference, COPD, Webcast, Growth, Disease, Vasculitis, Respiratory Medicine, EGPA, Immunology, Metabolism, Diagnosis, Biomarker, PD, Biopharmaceutical, Ageing, Pharmaceutical industry

TATE was an open-label, Phase III trial evaluating the safety of FASENRA in children aged 6 to 11 years with severe eosinophilic asthma.

Key Points: 
  • TATE was an open-label, Phase III trial evaluating the safety of FASENRA in children aged 6 to 11 years with severe eosinophilic asthma.
  • The Company aims to transform the treatment of asthma and COPD by focusing on earlier biology-led treatment, eliminating preventable asthma attacks, and removing COPD as a top-three leading cause of death.
  • Benralizumab in children with severe eosinophilic asthma: pharmacokinetics and long-term safety (TATE study).
  • Severe uncontrolled asthma in children: practical approach on diagnosis and management.

Esperion Presents Important New Data from CLEAR Outcomes at ACC.24 Highlighting Value of NEXLETOL® (bempedoic acid) Tablets in Diverse Populations Including Women, Hispanics/Latinx and Patients with Obesity

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日曜日, 4月 7, 2024
Uric acid, Urinary tract infection, Anaphylaxis, Myocardial infarction, Common, Bronchitis, Patient, Atherosclerosis, FAHA, Cleveland Clinic, Bempedoic acid, Ezetimibe, Therapy, Anemia, Pain, MACE, Sinusitis, ACC, FOMA, FNLA, FACC, Obesity, Cardiovascular disease, Esperion Therapeutics, Abdominal pain, Risk, Gout, Spasm, Woman, American College, Body mass index, ESPR, Back pain, Outcome, ATP, Safety, Fatigue, Arthralgia, ANN, Angioedema, Kidney, Journal, Constipation, University, Adverse event, Pregnancy, CLEAR, Rash, MPH, Rupture, FDA, Molina Healthcare, JACC, Hypersensitivity, Health, Circulatory system, Tablet, CVD, Incidence, Diarrhea, Fetus, Gallstone, Diet, Excipient, Upper respiratory tract infection, Dietary supplement

ANN ARBOR, Mich., April 07, 2024 (GLOBE NEWSWIRE) -- Esperion (Nasdaq: ESPR) today announced the presentation of results from three pre-specified subgroups from CLEAR Outcomes at the 2024 American College of Cardiology’s Annual Scientific Sessions (ACC.24): women, Hispanic/Latinx, and patients with obesity. These results align with the American College of Cardiology’s robust diversity, equity and inclusion programs to drive cultural change across the profession and ensure that the cardiovascular care team is as diverse as the patients they care for and that all patients are represented in cardiovascular research. The data also reinforce the mission of the ACC: transforming cardiovascular care for all.

Key Points: 
  • “Bempedoic acid is the only FDA approved non-statin LDL lowering therapy to demonstrate reductions in MACE in both primary prevention and secondary prevention patient populations.
  • The Hispanic population is the largest ethnic minority in the U.S., yet is a population historically underrepresented in clinical trials.
  • At Esperion, we discover, develop, and commercialize innovative medicines to help improve outcomes for patients with or at risk for cardiovascular and cardiometabolic diseases.
  • CLEAR Outcomes is part of the CLEAR clinical research program for NEXLETOL® (bempedoic acid) Tablet and NEXLIZET® (bempedoic acid and ezetimibe) Tablet.

OM1 and Medtronic Partner on Propel Study to Assess Long-term Outcomes for Patients With Chronic Rhinosinusitis

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火曜日, 4月 9, 2024
Data Management, Technology, Other Health, Health, General Health, Pharmaceutical, Health Technology, Research, Artificial Intelligence, Surgery, Science, University Challenge 2013–14, Partnership, Physician, Inflammation, Patient, American Academy, Standard of care, CRS, AI, Medtronic, PROPEL, ENT, Sinusitis, ESS, Adhesion, Pharmaceutical industry

The study focused on healthcare resource use (HCRU) and long-term outcomes in patients with chronic rhinosinusitis (CRS) who underwent endoscopic sinus surgery (ESS).

Key Points: 
  • The study focused on healthcare resource use (HCRU) and long-term outcomes in patients with chronic rhinosinusitis (CRS) who underwent endoscopic sinus surgery (ESS).
  • The study found that PROPEL devices are associated with lower HCRU and revision surgery during a 24-month follow-up period after ESS.
  • Thus, the use of PROPEL devices may lead to payer savings from reduced healthcare resource utilization.
  • “The results of this study demonstrate a rare win-win-win within healthcare,” said Amy Van Sach, president of Medtronic ENT.

U.S. FDA Approves Broad New Labels for NEXLETOL® and NEXLIZET® to Prevent Heart Attacks and Cardiovascular Procedures in Both Primary and Secondary Prevention Patients, Regardless of Statin Use

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金曜日, 3月 22, 2024
Glucose, Urinary tract infection, Anaphylaxis, Myocardial infarction, Common, Bronchitis, Patient, European Medicines Agency, Ezetimibe, Therapy, Anemia, Pain, Sinusitis, Esperion Therapeutics, Bempedoic acid, Abdominal pain, Risk, Gout, Committee, Spasm, ESPR, Back pain, ATP, Safety, Membrane protein, Fatigue, CHMP, Arthralgia, Angioedema, Cardiovascular disease, Kidney, Constipation, Death, Adverse event, Pregnancy, CLEAR, Rash, Esperies, Rupture, FDA, Molina Healthcare, Hypersensitivity, Health, Conference, Tablet, CVD, Incidence, Diarrhea, Fetus, Gallstone, Diet, Excipient, Upper respiratory tract infection, Uric acid, Pharmaceutical industry

In addition, the enhanced labels support the use of NEXLETOL and NEXLIZET either alone or in combination with statins.

Key Points: 
  • In addition, the enhanced labels support the use of NEXLETOL and NEXLIZET either alone or in combination with statins.
  • They also include new indications for primary hyperlipidemia, alone or in combination with a statin, and are the only LDL-C lowering non-statin drugs indicated for primary prevention patients.
  • NEXLETOL and NEXLIZET are also the first oral non-statin LDL-C lowering drugs to be approved by the FDA to reduce the risk of CV events in both primary and secondary prevention patients.
  • CLEAR Outcomes is part of the CLEAR clinical research program for NEXLETOL® (bempedoic acid) Tablet and NEXLIZET® (bempedoic acid and ezetimibe) Tablet.

CHMP Issues Positive Opinions For Both Bempedoic Acid And The Bempedoic Acid / Ezetimibe Fixed-Dose Combination Tablet As Treatments For Hypercholesterolemia And Significantly Reducing Cardiovascular Events

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金曜日, 3月 22, 2024
Urinary tract infection, Anaphylaxis, Bronchitis, European Commission, Tendon rupture, Patient, European Medicines Agency, Bempedoic acid, Ezetimibe, Therapy, Citrate synthase, Anemia, Pain, Sinusitis, Abdominal pain, Risk, Gout, Ageing, Committee, ACL, Spasm, EMA, Back pain, ATP, Safety, Fatigue, CHMP, Arthralgia, Angioedema, Tablet, Constipation, Agent handling, Death, Pregnancy, CLEAR, Rash, Kidney, Moyamoya disease, Rupture, Apolipoprotein, Hypercholesterolemia, Hypersensitivity, Health, CVD, Incidence, Diarrhea, Fetus, Esperion Therapeutics, Diet, Upper respiratory tract infection, FDC, Uric acid

ANN ARBOR, Mich. and MUNICH, Germany, March 22, 2024 (GLOBE NEWSWIRE) -- Daiichi Sankyo Europe GmbH (hereafter, ‘Daiichi Sankyo’) and Esperion Therapeutics, Inc. jointly announced today, that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted positive opinions for the label update of both bempedoic acid (marketed as NILEMDO®▼) and the bempedoic acid / ezetimibe fixed dose combination (FDC) (marketed as NUSTENDI®▼ ), recommending their approval as treatments to reduce low-density lipoprotein cholesterol (LDL-C) and cardiovascular risk.2 The existing label of bempedoic acid (NILEMDO®▼) provides authorisation for adults with primary hypercholesterolaemia (heterozygous familial and non-familial) or mixed dyslipidaemia, as an adjunct to diet:2

Key Points: 
  • “We are thrilled with the positive CHMP opinion, which reflects the significant cardiovascular risk reduction benefit that the bempedoic acid global franchise brings to patients worldwide,” said Sheldon Koenig, President and CEO, Esperion.
  • The CHMP is a scientific committee of the EMA that reviews medical product applications on their scientific and clinical merit.
  • Hyperuricemia: Bempedoic acid, a component of NEXLIZET and NEXLETOL, may increase blood uric acid levels which may lead to gout.
  • CLEAR Outcomes is part of the CLEAR clinical research program for NEXLETOL® (bempedoic acid) Tablet and NEXLIZET® (bempedoic acid and ezetimibe) Tablet.

Lyra Therapeutics Reports Fourth Quarter and Full Year 2023 Financial Results and Provides Corporate Update

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木曜日, 3月 21, 2024
Research, LYRA, Common, Bronchitis, Disease, MF, New Drug Application, COVID-19, Patient, Smell, Network congestion, CRS, United, Nasal cavity, Pharmacotherapy, Investment, Clinical trial, Therapy, Safety, Sinusitis, ESS, FDA, Food, Pharmaceutical industry

WATERTOWN, Mass., March 21, 2024 (GLOBE NEWSWIRE) -- Lyra Therapeutics, Inc. (Nasdaq: LYRA) (“Lyra” or the “Company”), a clinical-stage biotechnology company developing long-acting, anti-inflammatory nasal inserts for the treatment of chronic rhinosinusitis (CRS), today reported its financial results for the fourth quarter and full year ended December 31, 2023 and provided a corporate update.  

Key Points: 
  • WATERTOWN, Mass., March 21, 2024 (GLOBE NEWSWIRE) -- Lyra Therapeutics, Inc. (Nasdaq: LYRA) (“Lyra” or the “Company”), a clinical-stage biotechnology company developing long-acting, anti-inflammatory nasal inserts for the treatment of chronic rhinosinusitis (CRS), today reported its financial results for the fourth quarter and full year ended December 31, 2023 and provided a corporate update.
  • LYR-220, a larger insert, is designed for CRS patients whose nasal cavity is enlarged due to previous ESS.
  • Cash, cash equivalents and short-term investments were $102.8 million as of December 31, 2023, compared to $102.6 million as of September 30, 2023.
  • The Company recorded an impairment charge of $1.6 million related to long-lived assets for the year ended December 31, 2023.