Pulmovant, a Roivant subsidiary, completed enrollment in its Phase 2 PHocus study of mosliciguat for pulmonary hypertension associated with interstitial lung disease (PH‑ILD). The study enrolled 120 adult participants across 15 U.S. sites in less than 12 months, a faster timeline than typical for this indication.
The PHocus trial is a randomized, double‑blind, placebo‑controlled, global study with a primary completion date of December 2026 and an overall study completion date of January 2028. Mosliciguat is an inhaled soluble guanylate cyclase (sGC) activator and the first drug of its class to target PH‑ILD; it has also received Orphan Drug Designation in Japan, providing regulatory benefits and underscoring the unmet need in this market.
Completion of enrollment positions Pulmovant to report topline data in the second half of 2026, advancing mosliciguat toward regulatory submission and potential commercialization. The milestone reinforces Roivant’s strategy of accelerating development through nimble subsidiaries and could create a new revenue stream if mosliciguat succeeds.
Roivant Sciences reported a Q4 2025 earnings miss, with earnings per share of –$0.31 versus an estimate of –$0.16 and revenue of $7.57 million versus an estimate of $62.17 million. The miss reflects heavy investment in the pipeline, including mosliciguat, and the enrollment milestone signals progress that may offset near‑term earnings shortfalls.
Pulmovant CEO Drew Fromkin said, “This milestone brings us closer to a differentiated treatment option for patients with PH‑ILD and could open new therapeutic avenues for other pulmonary hypertension indications.”
Roivant’s broader pipeline includes brepocitinib for autoimmune and inflammatory diseases, IMVT‑1402 and batoclimab targeting FcRn, and other programs. The PHocus study adds a first‑in‑class inhaled therapy to this portfolio, strengthening the company’s position in high‑unmet‑needs areas.
PH‑ILD has limited approved therapies and an estimated 200,000 patients in the United States and Europe, representing a significant unmet medical need. If mosliciguat demonstrates safety and efficacy, it could capture a sizable market and provide a compelling value proposition for patients and payers.
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