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• Patients taking Mosliciguat walked 35.2 meters farther than those receiving placebo in a 6-Minute Walk Distance test.
• Roivant has started enrolling patients in its Phase 3 PHrontier trial.
• PH-ILD affects up to 200,000 people across the U.S. and Europe, according to the company.

Roivant (ROIV) shares surged 22% in pre-market trading on Tuesday, on track to hit a record high, after its experimental lung disease drug Mosliciguat met the primary goal in a key Phase 2 study.

If the levels hold after the opening bell, ROIV shares would clock their biggest single-day gains in more than seven months.

Roivant’s Mosliciguat Delivers Major Phase 2 Win 

The Phase 2 PHocus trial tested Mosliciguat in patients with pulmonary hypertension associated with interstitial lung disease (PH-ILD), a serious condition in which lung damage contributes to high blood pressure.

The 135-patient study met its primary endpoint, with the drug reducing pulmonary vascular resistance (PVR) by 56.3% compared with placebo after 16 weeks. PVR measures how difficult it is for blood to flow through the lungs, so a reduction means the heart faces less resistance when pumping blood.

Patients taking Mosliciguat also walked 35.2 meters farther than those receiving placebo in a 6-Minute Walk Distance (6MWD) test. The drug also reduced NT-proBNP, a marker of heart stress, by 53.2% compared with the placebo.

Phase 3 Trial Kicks Off

Roivant has already started enrolling patients in its Phase 3 PHrontier trial. PH-ILD affects up to 200,000 people across the U.S. and Europe, according to the company.

“PH-ILD is a disease as bad as some forms of cancer, with a median survival of just 1.5-2 years despite best-available standard of care,” said Mayukh Sukhatme, President and Chief Investment Officer at Roivant.

“This data set puts Mosliciguat in a league of its own on PVR reduction, 6MWD improvement, NT-proBNP % reduction, cough rate, and ease of use.”

Retail Sees Shorting Opportunity

Retail sentiment surrounding ROIV on Stocktwits flipped to ‘bullish’ from ‘bearish’ over the past 24 hours.

One user highlighted a reason to potentially short the stock.

The stock has gained nearly 96% so far this year.

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