United Therapeutics (UTHR) Misses Q4 EPS by 69c, Revenues Miss
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Pre-Open Stock Movers 02/24: (NGM) (NNVC) (A[T) Higher; (EPZM) (AMD) (AAPL) Lower (more...)
February 24, 2020 9:24 AM ESTToday's Pre-Open Stock Movers
NGM Biopharmaceuticals, Inc. (NASDAQ: NGM) 56.8% HIGHER; announced positive preliminary topline results from the 24-week double-blind, randomized, placebo-controlled cohort (Cohort 4) of an adaptive Phase 2 study evaluating the efficacy, safety and tolerability of 1 mg aldafermin in patients with biopsy-confirmed non-alcoholic steatohepatitis (NASH) with stage 2 or 3 liver fibrosis (F2-F3). Aldafermin (formerly NGM282), NGMs lead wholly-owned drug candidate, is an engineered variant of the human hormone FGF19 being developed as a once-daily treatment for patients with NASH. Cohort 4 was powered to demonstrate the effect of aldafermin... More
United Therapeutics (UTHR), DEKA Report Additional FDA Clearance Related to Unity Subcutaneous Delivery System for Remodulin
February 24, 2020 6:18 AM ESTUnited Therapeutics Corporation (NASDAQ: UTHR) and DEKA Research & Development Corp. today announced receipt of an additional 510(k) clearance by the U.S. Food and Drug Administration (FDA) related to the Unity Subcutaneous Delivery System for Remodulin® (treprostinil) Injection, also referred to as the Remunity pump, enabling United Therapeutics to launch the system using drug reservoirs that have been prefilled by specialty pharmacies.
The Remunity system, which was jointly developed by United Therapeutics and DEKA, is indicated for continuous subcutaneous delivery of Remodulin to treat pulmonary arterial... More
United Therapeutics (UTHR) Reports INCREASE Study of Tyvaso Meets Primary and All Secondary Endpoints
February 24, 2020 6:02 AM ESTUnited Therapeutics Corporation (NASDAQ: UTHR) today announced that preliminary analysis indicates that the INCREASE clinical study of Tyvaso® (treprostinil) Inhalation Solution in patients suffering from World Health Organization (WHO) Group 3 pulmonary hypertension associated with interstitial lung disease (PH-ILD) has met its primary efficacy endpoint of demonstrating improvement in six-minute walk distance (6MWD).
Tyvaso increased six-minute walk distance by 21 meters versus placebo (p=0.0043, Hodges-Lehmann estimate) after 16 weeks of treatment. Benefits of Tyvaso were observed across several key subgroups, including etiology of PH-ILD, disease severity, age, gender, baseline hemodynamics, and... More
