Sample Alerts - inThought Research

Ardelyx launches Ibsrela for IBS-C

HIGH IMPACT - Ardelyx has launched Ibsrela (tenapanor) for the treatment of IBS-C in adults. Ardelyx has also created a patient support program ArdelyxAssist. Ibsrela messaging highlights its different mechanisms of action, 3 way in which…

Analysis

FDA panel votes that current data do not support AMX0035 in ALS

HIGH IMPACT - The FDA's Peripheral and Central Nervous System Drugs Advisory Committee (PCNSDAC) reviewed Amylyx's NDA for AMX0035 in ALS and voted that the current data do not support the efficacy for AMX0035 to treat ALS. Amylyx's FDA…

Analysis

Servier seeks EU approval for Tibsovo in unfit IDH1-mutated AML

MODERATE IMPACT - Servier has resubmitted an MAA to the EMA for its IDH1 inhibitor Tibsovo (ivosidenib) for use with azacitidine as a first-line treatment for patients with IDH1-mutated AML who are not eligible for intensive chemotherapy, and…

Analysis

Voyager enters license agreement with Novartis for TRACER AAV capsids

HIGH IMPACT - At its 4Q/full-year 2021 earnings release, Voyager announced a license agreement with Novartis for the TRACER AAV capsids. Under the agreement, Novartis may exercise options to license novel AAV capsids generated from Voyager’s…

Analysis

Madrigal reports positive results from phase 3 MAESTRO-NAFLD study of resmetirom

HIGH IMPACT - Madrigal reported positive topline data from the double-blind portion of the its phase 3 MAESTRO-NAFLD study of resmetirom in NASH. Patients in the study were identified based on non-invasive imaging and biomarkers, and were treated…

Analysis

Roche Presents GENERATION-HD1 Trial Data And Post-Hoc Subgroup Analysis

HIGH IMPACT - During Roche’s HDSA presentation, the company discussed GENERATION-HD1 trial data and post-hoc analysis in subgroups of patients. The call was led by Peter McColgan (Roche) and Lauren Boak (Roche). The speaker mentioned that…

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