Roivant Sciences launches Pulmovant to advance mosliciguat
Roivant Sciences Ltd. has launched Pulmovant, a dedicated subsidiary focused on moving mosliciguat forward as a potential treatment for pulmonary hypertension. The new unit follows Roivant’s move to secure exclusive worldwide rights to the medicine from Bayer AG.
Deal terms and financial backdrop
Under the agreement with Bayer, Roivant made an upfront cash payment of about $14 million. The deal also outlines up to $280 million in potential development and regulatory milestone payments, plus sales-based royalties that are structured as tiered high-single-digit returns. In short: a modest entry check today, with most economics tied to progress and future sales.
Mosliciguat at a glance
Mosliciguat is an inhaled, once-daily sGC activator designed for targeted delivery to the lungs using a dry powder inhaler. The dosing approach is simple by design. It contrasts with many existing pulmonary hypertension therapies that often require several doses a day and more complicated routines.
What the ATMOS trial set out to learn
Pulmovant has begun sharing data from the proof-of-concept Phase 1b ATMOS study, presented at the European Respiratory Society Congress. The trial assessed efficacy, safety, tolerability, and pharmacokinetics in adults aged 18 to 80 with pulmonary hypertension. In total, 38 participants received mosliciguat in this early-stage study.
Key results and what they might mean
The Phase 1b ATMOS results showed meaningful reductions in pulmonary vascular resistance (PVR). In the per-protocol analysis, average peak reductions reached -25.9%, -38.1%, and -36.3% with 1.0 mg, 2.0 mg, and 4.0 mg doses, respectively. Roivant’s CEO, Matt Gline, underscored confidence in the program, pointing to the strength of the PVR findings and their standing among pulmonary hypertension clinical trial results.
Why the dosing approach matters
Unlike other inhaled options for pulmonary hypertension, mosliciguat is taken once per day. For patients who struggle to keep up with complex dosing schedules, a single daily inhalation could lower the burden of treatment and make adherence more manageable.
What’s next in clinical development
Pulmovant plans to start a global Phase 2 program called PHocus. The study is designed for patients with pulmonary hypertension associated with interstitial lung disease (PH-ILD), a subgroup within Group 3 pulmonary hypertension. The company expects to enroll approximately 120 patients, with the trial set to begin shortly.
Stock snapshot
In recent trading, ROIV shares fell 1.88% to close at $12.27. Investors will be watching how Pulmovant’s progress—and mosliciguat’s next readouts—feed back into the story from here.
Frequently Asked Questions
What is Pulmovant?
Pulmovant is a new subsidiary of Roivant Sciences created to develop and, if approved, commercialize mosliciguat for pulmonary hypertension. It was formed following Roivant’s agreement to obtain exclusive worldwide rights to the drug candidate from Bayer AG.
How is mosliciguat designed to be used?
Mosliciguat is an inhaled, once-daily sGC activator delivered via a dry powder inhaler for targeted lung delivery. Its once-daily schedule is intended to simplify treatment compared with therapies that require multiple doses per day.
What are the key financial terms of the Roivant–Bayer deal?
Roivant paid approximately $14 million upfront for global rights. The agreement also includes up to $280 million in potential development and regulatory milestone payments, plus tiered high-single-digit sales royalties.
What did the Phase 1b ATMOS study show?
The ATMOS study, presented at the European Respiratory Society Congress, enrolled adults aged 18 to 80 with pulmonary hypertension, with 38 participants receiving mosliciguat. In the per-protocol analysis, average peak PVR reductions were -25.9%, -38.1%, and -36.3% at the 1.0 mg, 2.0 mg, and 4.0 mg doses, respectively.
What’s the next step for mosliciguat?
Pulmovant plans to launch PHocus, a global Phase 2 clinical program in patients with pulmonary hypertension associated with interstitial lung disease (PH-ILD), a subgroup of Group 3 pulmonary hypertension. The study aims to enroll around 120 patients and is expected to begin soon.
