What did the PHocus study evaluate and what were the primary results?

PHocus is a randomized, double-blind, placebo-controlled Phase 2 trial of inhaled mosliciguat in adults with PH-ILD, enrolling 135 patients across 87 sites in 20 countries. The primary endpoint was a placebo-adjusted reduction in pulmonary vascular resistance of -56.3% at Week 16 (-51.3% for mosliciguat vs. +6.6% for placebo; p<0.0001).

What were the secondary endpoint results?

At Week 16, mosliciguat showed a placebo-adjusted improvement in six-minute walk distance of +35.2 meters (+20.3 meters for mosliciguat vs. -14.9 meters for placebo; p=0.0027) and a placebo-adjusted reduction in NT-proBNP of -357.7 pg/mL, corresponding to a -53.2% reduction from baseline (p=0.0002).

What is the status of the Phase 3 PHrontier study?

The company announced that the Phase 3 PHrontier study has been initiated and enrollment is underway. The study is a randomized (1:1), double-blind, placebo-controlled global trial designed to enroll approximately 375 patients with PH-ILD.

What was the safety profile observed in the trial?

The company stated that mosliciguat was well tolerated with a favorable safety profile and adverse events consistent with the underlying PH-ILD condition. Cough, a common tolerability concern with inhaled prostacyclins, occurred in 12.1% of mosliciguat patients compared with 18.2% of placebo patients.

Is this disclosure filed or furnished, and what liability applies?

The information under Item 7.01, including Exhibit 99.1, is furnished rather than filed. It is not deemed filed for purposes of Section 18 of the Securities Exchange Act of 1934 and is not subject to the liabilities of Sections 11 and 12(a)(2) of the Securities Act of 1933, and it is not incorporated by reference into other SEC filings.

ROIV 8-K: Regulation FD

Q: What were the secondary endpoint results?

At Week 16, mosliciguat showed a placebo-adjusted improvement in six-minute walk distance of +35.2 meters (+20.3 meters for mosliciguat vs. -14.9 meters for placebo; p=0.0027) and a placebo-adjusted reduction in NT-proBNP of -357.7 pg/mL, corresponding to a -53.2% reduction from baseline (p=0.0002).

Q: What is the status of the Phase 3 PHrontier study?

The company announced that the Phase 3 PHrontier study has been initiated and enrollment is underway. The study is a randomized (1:1), double-blind, placebo-controlled global trial designed to enroll approximately 375 patients with PH-ILD.

Q: What was the safety profile observed in the trial?

The company stated that mosliciguat was well tolerated with a favorable safety profile and adverse events consistent with the underlying PH-ILD condition. Cough, a common tolerability concern with inhaled prostacyclins, occurred in 12.1% of mosliciguat patients compared with 18.2% of placebo patients.

Q: Is this disclosure filed or furnished, and what liability applies?

The information under Item 7.01, including Exhibit 99.1, is furnished rather than filed. It is not deemed filed for purposes of Section 18 of the Securities Exchange Act of 1934 and is not subject to the liabilities of Sections 11 and 12(a)(2) of the Securities Act of 1933, and it is not incorporated by reference into other SEC filings.

01—Abstract

Summary

Summary of the 8-K filed September 8, 2026. Cited figures are marked; the original filing is the authoritative source.

Roivant Sciences Ltd. (ROIV) furnished a Form 8-K under Item 7.01 (Regulation FD Disclosure) announcing positive results from the Phase 2 PHocus clinical trial of mosliciguat, an inhaled sGC activator being developed for pulmonary hypertension associated with interstitial lung disease (PH-ILD).

The trial was conducted by its subsidiary, Pulmovant, Inc., and the results were presented at the European Respiratory Society International Congress 2026. The study met its primary endpoint, with a placebo-adjusted reduction in pulmonary vascular resistance (PVR) of -56.3%^a at Week 16 (p<0.0001), and met its secondary endpoints of a placebo-adjusted improvement in six-minute walk distance (+35.2 meters, p=0.0027) and a placebo-adjusted reduction in NT-proBNP of -357.7 pg/mL (p=0.0002) at Week 16. In a pre-specified exploratory analysis, placebo-adjusted improvements at Week 24 reached +52.7 meters in 6MWD and -487.1 pg/mL (-75.9%) in NT-proBNP, both with nominal p<0.0001.

The company reported that mosliciguat was well tolerated, with cough reported in 12.1%^b of mosliciguat patients versus 18.2% of placebo patients. The company also announced that the Phase 3 PHrontier study, designed to enroll approximately 375 patients, has been initiated and enrollment is underway.

The filing is a furnished (not filed) disclosure, and the press release contains forward-looking statement language. Investors should note that the results are from a Phase 2 trial with a relatively small sample of 135 patients across 87 sites in 20 countries, and that the Phase 3 study is ongoing.

02—Key points

Key Highlights

PHocus Phase 2 trial met its primary endpoint: placebo-adjusted reduction in PVR of -56.3% (-51.3% mosliciguat vs. +6.6% placebo) at Week 16, p<0.0001.
Secondary endpoints met at Week 16: placebo-adjusted 6MWD improvement of +35.2 meters (p=0.0027) and placebo-adjusted NT-proBNP reduction of -357.7 pg/mL (-53.2% from baseline, p=0.0002).
Pre-specified exploratory Week 24 results showed placebo-adjusted 6MWD improvement of +52.7 meters and NT-proBNP reduction of -487.1 pg/mL (-75.9%), both with nominal p<0.0001.
Cough incidence was 12.1% with mosliciguat versus 18.2% with placebo; the company described mosliciguat as well tolerated with a favorable safety profile.
Phase 3 PHrontier study of mosliciguat in PH-ILD has been initiated, with enrollment underway; the study is designed to enroll approximately 375 patients on a 1:1 randomized basis.
Results were presented at the European Respiratory Society (ERS) International Congress 2026 by Professor Marc Humbert, and the company hosted an investor conference call at 8:00 a.m. ET on September 8, 2026.
The information is furnished under Item 7.01 and Exhibit 99.1 (press release dated September 8, 2026) and is not deemed filed for Section 18 purposes.

03—Questions

Frequently Asked Questions

What did the PHocus study evaluate and what were the primary results?
PHocus is a randomized, double-blind, placebo-controlled Phase 2 trial of inhaled mosliciguat in adults with PH-ILD, enrolling 135 patients across 87 sites in 20 countries. The primary endpoint was a placebo-adjusted reduction in pulmonary vascular resistance of -56.3% at Week 16 (-51.3% for mosliciguat vs. +6.6% for placebo; p<0.0001).
What were the secondary endpoint results?
At Week 16, mosliciguat showed a placebo-adjusted improvement in six-minute walk distance of +35.2 meters (+20.3 meters for mosliciguat vs. -14.9 meters for placebo; p=0.0027) and a placebo-adjusted reduction in NT-proBNP of -357.7 pg/mL, corresponding to a -53.2% reduction from baseline (p=0.0002).
What is the status of the Phase 3 PHrontier study?
The company announced that the Phase 3 PHrontier study has been initiated and enrollment is underway. The study is a randomized (1:1), double-blind, placebo-controlled global trial designed to enroll approximately 375 patients with PH-ILD.
What was the safety profile observed in the trial?
The company stated that mosliciguat was well tolerated with a favorable safety profile and adverse events consistent with the underlying PH-ILD condition. Cough, a common tolerability concern with inhaled prostacyclins, occurred in 12.1% of mosliciguat patients compared with 18.2% of placebo patients.
Is this disclosure filed or furnished, and what liability applies?
The information under Item 7.01, including Exhibit 99.1, is furnished rather than filed. It is not deemed filed for purposes of Section 18 of the Securities Exchange Act of 1934 and is not subject to the liabilities of Sections 11 and 12(a)(2) of the Securities Act of 1933, and it is not incorporated by reference into other SEC filings.

04—Continue

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