BASEL, Switzerland - Roivant Sciences (NASDAQ:ROIV) announced the promising results of the Phase 1b ATMOS study for mosliciguat, a potential first-in-class inhaled therapy for pulmonary hypertension associated with interstitial lung disease (PH-ILD). The study, which was presented at the European Respiratory Society Congress, showed that a single dose could lead to significant reductions in pulmonary vascular resistance (PVR).
The ATMOS study involved 38 patients with pulmonary hypertension (PH), who received varying doses of mosliciguat. The results indicated mean-max peak reductions in PVR from baseline of up to approximately 38%, which is one of the highest reductions observed in PH trials to date. The treatment was generally well-tolerated, with low rates of treatment-emergent adverse events (TEAEs).
Mosliciguat is designed for once-daily dosing through a dry powder inhaler (DPI), offering a potentially more convenient option for patients compared to current therapies that often require multiple doses per day. The targeted delivery to the lungs also aims to reduce the risk of serious adverse effects associated with systemic vasodilators.
The global Phase 2 PHocus study for mosliciguat is set to begin imminently, with plans to enroll approximately 120 patients with PH-ILD. This patient population, estimated at 200,000 across the U.S. and Europe, has limited or no approved treatment options, highlighting the significant unmet need that mosliciguat could address.
Roivant, which is also advancing other clinical stage molecules, created Pulmovant as a subsidiary to develop and commercialize mosliciguat after in-licensing the worldwide rights from Bayer (OTC:BAYRY). Bayer received an upfront payment of approximately $14 million, with up to an additional $280 million expected for future milestones, as well as sales-based royalties.
The announcement of mosliciguat's trial results follows the positive data release from another Roivant subsidiary, Immunovant (NASDAQ:IMVT), marking a week of significant clinical updates for the company.
The information in this article is based on a press release statement.
In other recent news, Immunovant, Inc. reported positive outcomes from its Phase 2a trial of batoclimab, a treatment for Graves' Disease. The trial demonstrated a 76% response rate in patients unresponsive to antithyroid drugs after 12 weeks of high-dose treatment. Furthermore, Immunovant is expected to initiate a pivotal trial for the treatment by December 31, 2024, according to recent developments.
Roivant Sciences, on the other hand, reported strong financial positioning with $18.4 million in product revenue from VTAMA and a robust $5.7 billion in cash and cash equivalents. Despite a slower than expected launch of Vtama for psoriasis, H.C. Wainwright maintained its 'Buy' rating for Roivant Sciences, revising its peak sales estimate for Vtama to $910 million.
In addition, Roivant has made significant clinical progress, completing enrollment for the Phase 3 study of brepocitinib in dermatomyositis and Immunovant's MG study. The company is also preparing for the launch of VTAMA in atopic dermatitis after year-end approval. These are just a few of the recent developments shaping the trajectory of Roivant Sciences in the biopharmaceutical industry.
InvestingPro Insights
As Roivant Sciences continues to make strides in the development of mosliciguat for pulmonary hypertension, the company's financial health and stock performance are key factors for investors to consider. With a market capitalization of $9.24 billion, Roivant shows a significant presence in the biopharmaceutical market. The company's aggressive share buyback strategy, as noted in an InvestingPro Tip, indicates management's confidence in the company's value and future prospects.
InvestingPro Data further reveals that Roivant's P/E ratio stands at 2.08, suggesting that the stock could be undervalued compared to earnings. However, a more comprehensive picture is painted by the adjusted P/E ratio from the last twelve months as of Q1 2025, which is -138.47, reflecting analysts' expectations of future challenges in profitability. This is corroborated by another InvestingPro Tip indicating that net income is expected to drop this year, and analysts do not anticipate the company will be profitable within the same timeframe.
Despite these challenges, Roivant's liquidity position appears solid, with more cash than debt on its balance sheet and liquid assets exceeding short-term obligations. This financial stability is essential for the company as it invests in the development of mosliciguat and prepares for the upcoming Phase 2 PHocus study.
For investors interested in further analysis and metrics on Roivant Sciences, InvestingPro offers additional insights and tips. Currently, there are several more InvestingPro Tips available, providing a deeper dive into the company's financial health and stock performance.
This article was generated with the support of AI and reviewed by an editor. For more information see our T&C.