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The Insulin-Only Bionic Pancreas Pivotal Trial Showed Consistent Mean HbA1c Reductions Across a Variety of Subgroups at ADA’s 82nd Scientific Sessions
June 09, 2022 14:00 ET | Beta Bionics, Inc.
Caution: The iLet® Bionic Pancreas is an investigational device limited by Federal (or United States) law to investigational use. Not available for sale. The randomized Insulin-Only Bionic Pancreas...
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Arcutis Announces Positive Topline Results from STRATUM Pivotal Phase 3 Trial of Roflumilast Foam 0.3% in Seborrheic Dermatitis
June 06, 2022 07:30 ET | Arcutis Biotherapeutics, Inc.
Study met its primary endpoint with 80.1% of individuals treated with roflumilast foam achieving Investigator Global Assessment (IGA) Success compared to 59.2% of patients treated with vehicle...
Recardio and FDA Reach Agreement on Pivotal Phase 3 Trial Design
June 01, 2022 09:00 ET | Recardio Inc.
SAN FRANCISCO, June 01, 2022 (GLOBE NEWSWIRE) -- Recardio's Phase 2 trial results demonstrated the excellent safety profile of its lead drug Dutogliptin along with data suggesting potential positive...
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The iLet® Bionic Pancreas Significantly Reduced HbA1c and Improved Time in Range vs Standard of Care for a Diverse Range of People with Type 1 Diabetes
April 30, 2022 04:00 ET | Beta Bionics, Inc.
The trial achieved key primary and secondary endpoints, demonstrating improved outcomes over standard of care for people living with type 1 diabetes.The study population — 440 adults and children 6...
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uniQure Announces Positive 52-Week Clinical Data from HOPE-B Pivotal Trial of Etranacogene Dezaparvovec Gene Therapy in Patients with Hemophilia B and Provides Regulatory Update
June 22, 2021 11:31 ET | uniQure Inc.
~ Sustained increases in Factor IX (FIX) levels with mean FIX activity of 41.5 percent of normal in full study population one year following a single administration of etranacogene dezaparvovec ~ ~...
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SetPoint Medical Receives IDE Approval for U.S. Pivotal Trial to Study its Bioelectronic Platform in Rheumatoid Arthritis Patients
May 06, 2020 09:00 ET | SetPoint Medical
VALENCIA, Calif., May 06, 2020 (GLOBE NEWSWIRE) -- SetPoint Medical, a clinical-stage bioelectronic medicine company developing therapy for chronic autoimmune diseases, today announced that it has...
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uniQure Provides Update on Dose-Confirmation Study of AMT-061 in Patients with Hemophilia B
September 24, 2018 07:00 ET | uniQure Inc.
~ Third patient treated in Phase IIb study ~ ~ Topline data expected to be available before the end of 2018 ~ LEXINGTON, Mass and AMSTERDAM, the Netherlands, Sept. 24, 2018 (GLOBE NEWSWIRE) --...
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MyoKardia Doses First Patient in Pivotal Phase 3 EXPLORER-HCM Trial of Mavacamten in Symptomatic Obstructive Hypertrophic Cardiomyopathy
June 26, 2018 08:30 ET | MyoKardia, Inc.
SOUTH SAN FRANCISCO, Calif., June 26, 2018 (GLOBE NEWSWIRE) -- MyoKardia, Inc. (Nasdaq:MYOK), a clinical-stage biopharmaceutical company pioneering a precision medicine approach for the treatment of...
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Adamas Announces First Patient Enrolled in Phase 3 Trial of ADS-5102 in Multiple Sclerosis Patients with Walking Impairment
April 03, 2018 09:00 ET | Adamas Pharmaceuticals, Inc.
EMERYVILLE, Calif., April 03, 2018 (GLOBE NEWSWIRE) -- Adamas Pharmaceuticals, Inc. (Nasdaq:ADMS) today announced that the first patient has been enrolled in its pivotal Phase 3 clinical trial of...