Pulmovant

Pulmovant

Clinical-stage biotech developing inhaled sGC activator

Overview

Pulmovant focuses on developing mosliciguat, an inhaled soluble guanylate cyclase (sGC) activator, as a therapy for pulmonary diseases, especially pulmonary hypertension associated with interstitial lung disease (PH-ILD). It advances mosliciguat through clinical trials with a dry powder inhaler designed for targeted delivery to the lungs to cause pulmonary vasodilation while aiming to limit systemic exposure. The company differentiates itself by pursuing a first-in-class inhaled sGC activator, leveraging Roivant’s biotech ecosystem, and seeking regulatory advantages such as orphan drug designation in Japan, to address a patient group of about 200,000 in the U.S. and Europe who have few treatment options. Pulmovant is moving mosliciguat through Phase 2 programs (PHocus and PHactor) with topline Phase 2 results anticipated in late 2026, and aims to progress toward regulatory approval and broader access for PH-ILD patients.

About Pulmovant

Simplify's Rating
Why Pulmovant is rated
B-
Rated B on Competitive Edge
Rated B on Growth Potential
Rated C on Differentiation

Industries

Biotechnology

Healthcare

Company Size

11-50

Company Stage

N/A

Total Funding

N/A

Headquarters

Waltham, Massachusetts

Founded

N/A

Get referred to Pulmovant

See people who can refer or advise you

Simplify Jobs

Simplify's Take

What believers are saying

  • PHocus enrolled 135 patients by February 6, 2026, and delivered topline on September 8, 2026.
  • PHrontier launched September 8, 2026, signaling Roivant confidence after positive Phase 2 data.
  • Japan granted orphan drug designation in September 2025, supporting future regulatory and pricing leverage.

What critics are saying

  • Pulmovant owns one clinical asset; PHrontier failure would collapse the company.
  • Tyvaso already dominates PH-ILD and limits Pulmovant's commercial runway.
  • Mosliciguat still needs Phase 3 success before approval; timelines slip into 2028.

What makes Pulmovant unique

  • September 8, 2026 PHocus showed 56.3% placebo-adjusted PVR reduction, unusually strong for PH-ILD.
  • Mosliciguat is once-daily inhaled sGC activation, targeting lungs while limiting systemic vasodilation.
  • Roivant owns 97% of Pulmovant, giving capital, trial infrastructure, and commercial control.

Help us improve and share your feedback! Did you find this helpful?

Benefits

Remote Work Options

Company News

GlobeNewswire
Sep 6th, 2026
Pulmovant to present topline results from the Phase 2 PHocus study of mosliciguat in patients with Pulmonary Hypertension associated with Interstitial Lung Disease (PH-ILD) at the ERS Congress 2026...

Pulmovant to present topline results from the Phase 2 PHocus study of mosliciguat in patients with Pulmonary Hypertension associated with Interstitial Lung Disease (PH-ILD) at the ERS Congress 2026 on Tuesday, September 8, 2026. September 06, 2026 01:00 ET | Source: Pulmovant, Inc. WALTHAM, Mass., Sept. 06, 2026 (GLOBE NEWSWIRE) - Pulmovant, a clinical-stage biotechnology company committed to transforming the lives of patients with pulmonary diseases, and a Roivant (Nasdaq: ROIV) company, today announced that results from the Phase 2 PHocus study of mosliciguat in patients with pulmonary hypertension associated with interstitial lung disease (PH-ILD) will be presented at the European Respiratory Society (ERS) International Congress 2026 at 12:15 CEST (6:15 a.m. ET) on Tuesday, September 8, 2026, by Marc Humbert, MD, PhD, Professor of Respiratory Medicine at Université Paris-Saclay and Director of the French National Reference Center for Pulmonary Hypertension. Mosliciguat is a potential first-in-class, once-daily, inhaled sGC activator with a differentiated mechanism of action designed to deliver targeted pulmonary vasodilation with limited systemic side effects for the treatment of PH-ILD. The Phase 2 PHocus clinical study (NCT06635850) is a randomized, double-blind, placebo-controlled, global trial that enrolled 135 adult participants with PH-ILD to assess the safety and efficacy of mosliciguat. Mosliciguat is also being evaluated in the Phase 2 PHactor clinical study (NCT07333183), an open-label trial evaluating the tolerability and safety of inhaled mosliciguat in combination with inhaled treprostinil in participants with PH-ILD. About Pulmonary Hypertension and Interstitial Lung Disease Pulmonary hypertension (PH) is a progressive and debilitating condition characterized by high blood pressure in the blood vessels of the lungs. This elevated pressure forces the heart to work harder to pump blood through the lungs, leading to symptoms such as shortness of breath, fatigue, chest pain, and dizziness. The World Health Organization (WHO) has classified PH into five groups based on their underlying causes, symptoms, and treatment approaches. Group 3 PH is a subtype of PH that arises from lung diseases, such as interstitial lung disease (ILD). ILD describes a large group of diseases that cause progressive damage to the lungs, making it difficult for patients to breathe. Up to 200,000 patients across the U.S. and Europe are living with PH-ILD, a subset of Group 3 PH, and have limited or no approved treatment options. For more information, please visit https://www.pulmovant.com/our-science. About Mosliciguat Mosliciguat is a potential first-in-class, once-daily, inhaled sGC activator with a differentiated mechanism of action, which may have broad application across the spectrum of pulmonary hypertension (PH). Mosliciguat targets sGC, a key enzyme in the nitric oxide (NO)/cyclic guanosine monophosphate (cGMP) signaling pathway that catalyzes cGMP production. Elevated cGMP levels are known to promote vasodilation, contribute to anti-fibrotic effects, reduce inflammation and apoptosis and reverse vascular remodeling. Unlike sGC stimulators, which require reduced heme and NO to exert their effect, mosliciguat is an sGC activator that is believed to work independently of heme and NO. In the Phase 1b ATMOS study of mosliciguat, a single dose of inhaled mosliciguat in PH patients was well tolerated and led to clinically meaningful, mean peak reduction in pulmonary vascular resistance (PVR) of up to 38%, one of the highest reductions seen in pulmonary hypertension trials to date. For information on the Phase 2 PHocus study of mosliciguat, please visit https://phocusstudy.com. About Pulmovant Pulmovant is a clinical-stage biotechnology company committed to transforming the lives of patients with pulmonary diseases and is a Roivant (Nasdaq: ROIV) company. Pulmovant' s first investigational candidate, mosliciguat, is designed to provide a novel, once-daily, inhaled treatment option for patients with pulmonary hypertension associated with Interstitial Lung Disease (PH-ILD). Mosliciguat is a potential first-in-class soluble guanylate cyclase activator with a differentiated mechanism of action currently being evaluated in the Phase 2 PHocus global clinical trial in PH-ILD. For more information, please visit https://www.pulmovant.com. About Roivant Roivant (Nasdaq: ROIV) is a commercial-stage biopharmaceutical company that aims to improve the lives of patients by accelerating the development and commercialization of medicines that matter. Roivant's pipeline includes LISRAYA(TM)(brepocitinib), a potent small molecule inhibitor of JAK1 and TYK2 FDA-approved for the treatment of dermatomyositis in adult patients and also in late-stage development for the treatment of non-infectious uveitis, cutaneous sarcoidosis and lichen planopilaris; IMVT-1402, a fully human monoclonal antibody targeting FcRn in development across several IgG-mediated autoimmune indications; and mosliciguat, an inhaled sGC activator in development for pulmonary hypertension associated with interstitial lung disease. We advance our pipeline by creating nimble subsidiaries or "Vants" to develop and commercialize our medicines and technologies. For more information, visit www.roivant.com. Forward-Looking Statements This press release contains forward-looking statements. Statements in this press release may include statements that are not historical facts and are considered forward-looking within the meaning of Section 27A of the Securities Act of 1933, as amended (the "Securities Act"), and Section 21E of the Securities Exchange Act of 1934, as amended (the "Exchange Act"), which are usually identified by the use of words such as "anticipate," "believe," "continue," "could," "estimate," "expect," "intends," "may," "might," "plan," "possible," "potential," "predict," "project," "should," "would" and variations of such words or similar expressions. The words may identify forward-looking statements, but the absence of these words does not mean that a statement is not forward-looking. We intend these forward-looking statements to be covered by the safe harbor provisions for forward-looking statements contained in Section 27A of the Securities Act and Section 21E of the Exchange Act. Our forward-looking statements include, but are not limited to, statements regarding our or our management team's expectations, hopes, beliefs, intentions or strategies regarding the future, and statements that are not historical facts, including statements about the clinical and therapeutic potential of our product and product candidates, the availability and success of topline results from our ongoing clinical trials, any commercial potential of our product and product candidates following applicable regulatory approvals and the outcome of any pending litigation. In addition, any statements that refer to projections, forecasts or other characterizations of future events, results or circumstances, including any underlying assumptions, are forward-looking statements. Actual results may differ materially from those contemplated in these statements due to a variety of risks, uncertainties and other factors. Although we believe that our plans, intentions, expectations and strategies as reflected in or suggested by those forward-looking statements are reasonable, we can give no assurance that the plans, intentions, expectations or strategies will be attained or achieved. Furthermore, actual results may differ materially from those described in the forward-looking statements and will be affected by a number of risks, uncertainties and assumptions, including, but not limited to, those risks set forth in the Risk Factors section of our filings with the U.S. Securities and Exchange Commission. Moreover, we operate in a very competitive and rapidly changing environment in which new risks emerge from time to time. These forward-looking statements are based upon the current expectations and beliefs of our management as of the date of this press release, and are subject to certain risks and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements. Except as required by applicable law, we assume no obligation to update publicly any forward-looking statements, whether as a result of new information, future events or otherwise.

Recently Posted Jobs

Sign up to get curated job recommendations

Pulmovant is Hiring for 9 Jobs on Simplify!

Find jobs on Simplify and start your career today

Don't see your dream role? Check out thousands of other roles on Simplify. Browse all jobs →