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BioPharma Dive·3h ago·1 min read
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Roivant reports record-breaking Phase 2 results for PH-ILD drug mosliciguat, starts Phase 3

Sep 8, 2026·read at BioPharma Dive ↗Positive readoutPositive

Roivant announced that its experimental drug mosliciguat met all primary and secondary endpoints in a Phase 2 study in patients with pulmonary hypertension associated with interstitial lung disease (PH-ILD).

The trial showed a 56% reduction in a key hemodynamic measure, which Roivant described as the largest improvement ever seen in a randomized PH trial, and the company has already begun a Phase 3 program.

Analyst David Risinger of Leerink Partners said the data could support a future product worth more than $10 billion in annual sales, and Roivant’s stock jumped about 20% on the news.

In related news, AstraZeneca obtained U.S. approval for its breast-cancer oral therapy Etcamah after earlier facing a negative advisory committee vote.

source

This writeup was produced by pharmadog from original reporting by BioPharma Dive.

Original headline: “Roivant surges on ‘exceptional’ results; Bristol Myers touts first-of-its-kind CAR-T therapy”

read at BioPharma Dive ↗
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companies & drugs in this story

companies
ASTRAZENECA7BRISTOL5BRISTOL MYERS SQUIBB2BRISTOL MYERS SQUIBB CO2Ultragenyx Pharmaceutical Inc.
drugs
Cancer Program4KEYTRUDA4pembrolizumab4PHVS-416PHVS-719arlocabtagene autoleucel
topics
Pulmonology8Hypertension6Oncology5AdCom4Approval3CAR-T3Multiple Myeloma3Breast Cancer2Hematology2Small Molecule2BCMACell TherapyHER2Rare Disease

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