ASAH

Idorsia announces financial results for the first half 2022 – reaching commercial stage

Retrieved on: 
Tuesday, July 26, 2022
TST, OLE, Health care, Multiple sclerosis, Awareness, Insomnia, MHRA, Medication, Brain, Ageing, Royal commission, Incidence, Polysomnography, CNS, Adult, US, Safety, Pediatrics, Binge eating disorder, Product, Policy, European Commission, Review, Cerebral vasospasm, Neurosurgery, Fabry disease, Patient, Pharmacokinetics, Hypertension, Blood pressure, ASAH, CHF, Medical device, Pharmaceutical industry, EU

Based on the estimated incidence of aSAH in Japan, approximately 10%of aSAH patients were treated with PIVLAZ in June 2022.

Key Points: 
  • Based on the estimated incidence of aSAH in Japan, approximately 10%of aSAH patients were treated with PIVLAZ in June 2022.
  • Daridorexant was approved by the US FDA in January 2022 and by the European Commission in April 2022.
  • Idorsia will also make the detailed results of the Phase 3 study available through scientific presentations and peer-reviewed publications.
  • The study is expected to conclude by the end of 2022, reporting results in the first quarter of 2023.

Acasti Pharma Announces Positive Results for Pharmacokinetic Bridging Study, With Intravenous GTX-104 Meeting All Endpoints

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Wednesday, May 18, 2022
DCI, Death, Telephone, Postherpetic neuralgia, A-T, U.S. Securities and Exchange Commission, AES, SAH, Incidence, Skull, Patient, PHN, NASDAQ, Nimodipine, ASAH, Nerve Damage, SubArachnoid Space, IV, Stroke, Brain, COVID-19, Bleeding, Marketing, Capsule, FDA, Meal, Aneurysm, Plasma, Securities Exchange Act of 1934, Micelle, Subarachnoid hemorrhage, Securities Act of 1933, Neuropathic pain, Disability, Compliance, Rupture, Risk, Drug Quality and Security Act, NDA, Somnolence, Private Securities Litigation Reform Act, Headache, Security (finance), Blood, GI, Vaccine, Online shopping, Medical imaging, Pharmaceutical industry, Ataxia–telangiectasia

LAVAL, Québec, May 18, 2022 (GLOBE NEWSWIRE) -- Acasti Pharma Inc. (“Acasti” or the “Company”) (Nasdaq: ACST and TSX-V: ACST) announced today that the top line results of its pharmacokinetic (PK) bridging study with IV GTX-104, the Company’s lead drug candidate for the treatment of Subarachnoid Hemorrhage (SAH), met all its planned study endpoints. The primary objective of the study was to evaluate the relative bioavailability of IV GTX-104 compared to oral nimodipine in healthy adult male and female subjects, while the secondary objective was to assess its safety and tolerability. The Company plans to submit these results to the US Food and Drug Administration (FDA), along with its proposed study design for the Phase 3 safety study which is on track to start in the second half of 2022. The safety study is expected to be the final step required to seek regulatory approval under the 505(b)(2) regulatory pathway before submitting a New Drug Application to the FDA.

Key Points: 
  • In addition, the diurnal variation associated with IV GTX-104 was approximately half of that seen with the oral nimodipine capsules.
  • Diurnal variation takes into consideration variation in body functions (blood flow, renal function and hepatic metabolism) over the course of a day.
  • Acasti will host a conference call on Wednesday, May 18, 2022 at 1:00 PM Eastern Time to discuss the results of the trial.
  • Acasti is a late-stage specialty pharma company with drug delivery technologies and drug candidates addressing rare and orphan diseases.

PIVLAZ (clazosentan) – Idorsia’s first commercial product – now available for patients in Japan

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Wednesday, April 20, 2022
Patient, Cerebral vasospasm, Perseverance, Â, ETA, National health insurance, Adult, SubArachnoid Space, Research, Incidence, National Health Insurance (Japan), ASAH, Program, Vasospasm, Mortality, Journal, Rupture, Safety, Disease, Neuro, Physician, IDIA, Residential care, Pharmaceutical industry

PIVLAZ is now available to physicians to start treating patients in Japan.

Key Points: 
  • PIVLAZ is now available to physicians to start treating patients in Japan.
  • Idorsia Ltd (SIX: IDIA) and Idorsia Pharmaceuticals Japan today announced that PIVLAZ (clazosentan) is now available to physicians in Japan to start treating aSAH patients.
  • and President of Idorsia Pharmaceuticals Japan, commented:
    I am very proud to be launching Idorsias first product here in Japan, and Im sure it will be the first of many innovative medicines from Idorsia, which will help many patients.
  • When listing PIVLAZ, the National Health Insurance system has recognized this innovative medicine as fulfilling an important medical need for patients facing a life-threatening condition.

Idorsia announces financial results for 2021 – 2022 to be a transformative year – Sustainable profitability expected in 2025

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Tuesday, February 8, 2022
Fabry disease, Cerebral vasospasm, Hypertension, Letter, European Medicines Agency, Binge eating disorder, Essential tremor, AGM, Standard Business Reporting, Annual, ASAH, Lupus, REACT, The Lancet, Research, COVID-19, FDA, Neurocrine Biosciences, Method, Epilepsy, CARE, Drug discovery, Night, Risk, Patient, Review, IDIA, EMA, SIX Swiss Exchange, Janssen Pharmaceuticals, Documentation, Johnson & Johnson, Insomnia, Result, Ponesimod, Income, Science, Board, Annual report, CMO, Heart, Janssen Biotech, Population, CEO, Mission statement, Corporation, Intelligence, Vaccine, Pharmaceutical industry, Animal, Online gambling, Security (finance), Renewable energy, Fine chemical, Management, Risk management, Shareholder, Actelion

Idorsia created 268 new positions worldwide in 2021, bringing the total number of employees (permanent, post-doc, and apprentices) to 1176 (2020: 908).

Key Points: 
  • Idorsia created 268 new positions worldwide in 2021, bringing the total number of employees (permanent, post-doc, and apprentices) to 1176 (2020: 908).
  • My role and that of the Board is to provide direction and oversight, as well as governance of the organization.
  • We are building Idorsia with a long-term focus, and we run the company in a responsible and sustainable way.
  • In 2021, we made great strides toward realizing our vision of creating a sustainable mid-sized biopharmaceutical company based on innovation.

Idorsia presents at the 40th J.P. Morgan Healthcare Conference – Ready for first product launches – QUVIVIQ (daridorexant) approved by the US FDA

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Monday, January 10, 2022
IDIA, Growth, Time in Europe, SIX Swiss Exchange, Cerebral vasospasm, Patient, Conference, Sleep, NDA, ASAH, Winners Don't Use Drugs, Review, Commercial, PMDA, FDA, Insomnia, Pharmaceutical industry, Fine chemical

The presentation will cover the launch preparations for the companys first products, clazosentan in Japan and the newly approved QUVIVIQ (daridorexant) in the US.

Key Points: 
  • The presentation will cover the launch preparations for the companys first products, clazosentan in Japan and the newly approved QUVIVIQ (daridorexant) in the US.
  • He will also present opportunities for future growth with important clinical development results expected in the near-term.
  • At Idorsia, with QUVIVIQ, we are going to help millions of patients and impact a wide-spread societal problem.
  • All eyes will be on the US launch of QUVIVIQ to see how Idorsia intends to disrupt the treatment paradigm in insomnia.

Acasti Pharma Announces Interim Data Meets All Primary Endpoints for Pivotal PK Study for GTX-104

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Thursday, December 2, 2021
American Heart Association, Nimodipine, Group B, DCI, Blood, Death, Company, Compliance, Rupture, TSX, Brain, New Drug Application, Physician, Disability, GLOBE, Incidence, Marketing, NDA, ASAH, Skull, Nerve Damage, Stroke, Securities Exchange Act of 1934, Blood pressure, PK, Private Securities Litigation Reform Act, Vasospasm, Bleeding, Cmax, Group A, Water, ACST, Trial of the century, Review, SAH, IV, Vital signs, Postherpetic neuralgia, Hypotension, Neuropathic pain, FDA, Headache, Association, Standard of care, Securities Act of 1933, Patient, A-T, Safety, Drug Quality and Security Act, Risk, Acquisition, Capsule, Aneurysm, SubArachnoid Space, PHN, SEC, COVID-19, CRU, Micelle, AUC, NASDAQ, Medical imaging, Pharmaceutical industry

As observed in a previous PK study, the inter- and intra-subject variability in the interim analysis was much lower for GTX-104 as compared with oral nimodipine.

Key Points: 
  • As observed in a previous PK study, the inter- and intra-subject variability in the interim analysis was much lower for GTX-104 as compared with oral nimodipine.
  • "This interim data is very encouraging, as it suggests that our current infusion protocol is on track to meet the objectives for this pivotal PK study.
  • In just three months since completing the acquisition, we launched this pivotal PK bridging study for GTX-104 and already have positive interim data with more data to follow in the first half of 2022.
  • The PK bridging study for GTX-104 is being conducted in a total of 50 healthy subjects as a single center, randomized, two-period crossover study.

Acasti Pharma Announces Initiation of Pharmacokinetic Bridging Study for GTX-104, the Company’s Lead Drug Candidate for the Treatment of Subarachnoid Hemorrhage

Retrieved on: 
Monday, September 27, 2021
ACST, Securities Act of 1933, Review, Death, Stroke, Micelle, Bleeding, Safety, Calendar, Blood pressure, Subarachnoid hemorrhage, Compliance, Drug Quality and Security Act, CRU, IV, Central nervous system, SubArachnoid Space, Private Securities Litigation Reform Act, Disability, BA, SAH, Capsule, Incidence, Brain, Orphan, Aneurysm, Water, NASDAQ, U.S. Securities and Exchange Commission, FDA, Nimodipine, Experimental cancer treatment, A-T, Marketing, Acquisition, Company, Vital signs, DCI, GLOBE, PHN, Grace, PK, Risk, TSX, Security (finance), Skull, Postherpetic neuralgia, Patient, Nerve Damage, Rupture, COVID-19, Securities Exchange Act of 1934, Neuropathic pain, Blood, ASAH, Cryptocurrency, Pharmaceutical industry, Medical imaging

This latest study follows an earlier safety and dose-escalation crossover study conducted by Grace, which reported encouraging results.

Key Points: 
  • This latest study follows an earlier safety and dose-escalation crossover study conducted by Grace, which reported encouraging results.
  • Moreover, it could provide a more convenient dosing schedule that would be easier to administer to patients who are unconscious.
  • The PK bridging study is a single center, randomized, two-period crossover study in 50 healthy subjects.
  • Acasti is a late-stage specialty pharma company with drug delivery technologies and drug candidates addressing rare and orphan diseases.

Idorsia announces positive results of the two Japanese registration studies with clazosentan

Retrieved on: 
Monday, November 23, 2020
Neurosurgery, Angiology, Vasospasm, ASAH

Idorsia Ltd (SIX: IDIA) today announced positive top-line results of the Japanese registration program investigating clazosentan in adult Japanese patients post-aSAH.

Key Points: 
  • Idorsia Ltd (SIX: IDIA) today announced positive top-line results of the Japanese registration program investigating clazosentan in adult Japanese patients post-aSAH.
  • Both studies demonstrated that clazosentan reduced the occurrence of cerebral vasospasm-related morbidity and all-cause mortality within 6 weeks post-aSAH with statistical significance (p
  • The studies confirmed the well documented safety profile of clazosentan which has now been administered to over 2000 patients around the globe.
  • In these registration studies in Japanese patients post-aSAH there were no unexpected safety findings.

Aneurysmal Subarachnoid Hemorrhage (aSAH) Market Insight, Epidemiology and Market Forecasts, 2020-2030 - ResearchAndMarkets.com

Retrieved on: 
Tuesday, September 8, 2020
Professional services, Consulting, Medical specialties, Organ systems, Clinical medicine, ASAH, Neurosurgery, RTT, Central nervous system disorders, Intensive care medicine, Neurotrauma, Subarachnoid hemorrhage, Aneurysm, SAH, Medical specialties, Organ systems, Clinical medicine, ASAH, Neurosurgery, RTT, Central nervous system disorders, Intensive care medicine, Neurotrauma, Subarachnoid hemorrhage, Aneurysm, SAH, Medical specialties, Organ systems, Clinical medicine, ASAH, Neurosurgery, RTT, Central nervous system disorders, Intensive care medicine, Neurotrauma, Subarachnoid hemorrhage, Aneurysm, SAH

The "Aneurysmal Subarachnoid Hemorrhage (aSAH)- Market Insight, Epidemiology and Market Forecast -2030" drug pipelines has been added to ResearchAndMarkets.com's offering.

Key Points: 
  • The "Aneurysmal Subarachnoid Hemorrhage (aSAH)- Market Insight, Epidemiology and Market Forecast -2030" drug pipelines has been added to ResearchAndMarkets.com's offering.
  • Aneurysmal Subarachnoid Hemorrhage (aSAH) - Market Insights, Epidemiology and Market Forecast- 2030' report delivers an in-depth understanding of the Aneurysmal Subarachnoid Hemorrhage (aSAH), historical and forecasted epidemiology as well as the Aneurysmal Subarachnoid Hemorrhage (aSAH) market trends in the United States, EU5 (Germany, Spain, Italy, France, and United Kingdom) and Japan.
  • The Aneurysmal Subarachnoid Hemorrhage (aSAH) market report provides current treatment practices, emerging drugs, and market share of the individual therapies, current and forecasted 7MM Aneurysmal Subarachnoid Hemorrhage (aSAH) market size from 2017 to 2030.
  • What was the Aneurysmal Subarachnoid Hemorrhage (aSAH) market share (%) distribution in 2017 and how it would look like in 2030?

Aneurysmal Subarachnoid Hemorrhage (aSAH) Epidemiology and Patient Population 2017-2030

Retrieved on: 
Tuesday, May 5, 2020
Medical specialties, Medicine, Organ systems, Neurotrauma, Neurosurgery, ASAH, Subarachnoid hemorrhage, Aneurysm, SAH, Bleeding

DUBLIN, May 5, 2020 /PRNewswire/ -- The "Aneurysmal Subarachnoid Hemorrhage (aSAH) Epidemiology Forecast to 2030" report has been added to ResearchAndMarkets.com's offering.

Key Points: 
  • DUBLIN, May 5, 2020 /PRNewswire/ -- The "Aneurysmal Subarachnoid Hemorrhage (aSAH) Epidemiology Forecast to 2030" report has been added to ResearchAndMarkets.com's offering.
  • This report delivers an in-depth understanding of the disease, historical and forecasted Aneurysmal Subarachnoid Hemorrhage (aSAH) epidemiology in the United States, EU5 (Germany, Spain, Italy, France, and United Kingdom) and Japan.
  • In the 7MM, the total incident of Subarachnoid Hemorrhage (SAH) was estimated to be 63,072 cases in 2017 whereas the total incident of Aneurysmal Subarachnoid Hemorrhage (aSAH) was estimated to be 53,611.
  • The report covers the descriptive overview of Aneurysmal Subarachnoid Hemorrhage (aSAH), explaining its causes, signs and symptoms, pathophysiology and currently available therapies.