Roivant Sciences Ltd

Stifel initiated coverage of Roivant Sciences with a Buy rating and a $51 price target on September 16, projecting roughly $9 billion in ownership-adjusted sales for the company by 2037. The call centers on Lisraya, or brepocitinib, which the FDA approved on August 27 for adults with dermatomyositis, making it the first FDA-approved oral treatment for the rare disease. Roivant is also evaluating brepocitinib in non-infectious uveitis, with Phase 3 topline data expected in the second half of 2026, in cutaneous sarcoidosis, with Phase 3 data expected in 2028, and in lichen planopilaris, where enrollment in Part 1 of a Phase 2b/3 study is on course. Beyond brepocitinib, the anti-FcRn antibody IMVT-1402 is advancing in several autoimmune indications with clinical updates expected in 2026, and mosliciguat posted positive Phase 2 results in pulmonary hypertension associated with interstitial lung disease, showing a 56.3% placebo-adjusted reduction in pulmonary vascular resistance at Week 16, prompting a Phase 3 program. Roivant reported $3.9 billion in cash, cash equivalents, restricted cash, and marketable securities at June 30, and in July Genevant and Arbutus received an aggregate $950 million payment from Moderna through a patent infringement settlement, with Genevant receiving $771.6 million. Hedge fund interest rose to 64 holders at the end of Q2 from 60 in Q1 and 52 in Q4, while short interest stood at 33.5 million shares as of August 31, equal to 5.09% of the public float.

Roivant Sciences shares surged 18% on September 8 after the biotech reported positive topline Phase 2 results for mosliciguat, an experimental treatment for pulmonary hypertension. In the PHocus trial, the drug produced a 56.3% placebo-adjusted reduction in pulmonary vascular resistance in patients with pulmonary hypertension associated with interstitial lung disease, well above the 20% threshold Leerink Partners analyst David Risinger had flagged as an important benchmark, along with a 35.2-meter placebo-adjusted improvement in six-minute walk distance at Week 16. Risinger said mosliciguat could potentially generate more than $10 billion in annual sales across multiple indications, a distinction that matters for Roivant's long-term growth strategy as it seeks to reduce reliance on a small number of products; Roivant has already secured U.S. approval for Lisraya. The company still must complete its Phase 3 PHrontier trial and show the benefits can be reproduced, and a disappointing late-stage result could trigger a significant valuation reset after the sharp post-results rally. Hedge fund holdings in Roivant rose to 64 in the second quarter from 60 in the first, though positioning was mixed, with QVT Financial cutting its exposure by 6% to approximately $839.6 million and Farallon Capital raising its stake by 48% to approximately $506.4 million.

Roivant Sciences shares rallied 24% after the pharma company reported positive Phase 2 trial results for its subsidiary Pulmovant's mosliciguat, which showed a clinically meaningful and statistically significant reduction in pulmonary vascular resistance in patients with pulmonary hypertension and interstitial lung disease. Meanwhile, Lockheed Martin edged up 0.7% after UBS upgraded the stock to buy, citing underappreciated earnings growth potential. Novartis tumbled 12% after its del-desiran drug failed to show significant improvement in a Phase 3 trial for myotonic dystrophy type 1. Peloton Interactive slid more than 4% following a Morgan Stanley downgrade to underweight, citing structural headwinds in fitness. Boston Scientific slipped over 2% after warning that a recent cyberattack likely impacted its 2026 sales and profit targets. Bloom Energy rose over 6% as it prepares to join the S&P 500 on Sept. 21, having gained about 190% this year on the AI data center buildout.

Roivant Sciences and Priovant Therapeutics have launched Lisraya, the first targeted oral treatment for dermatomyositis, at a list price of $35,000 for a 30-day supply, following FDA approval. The drug targets a US population of fewer than 5,000 patients, and Roivant, which owns 71% of Priovant, expects a full year of treatment to yield a net annual value in the low-to-mid $300,000 range per patient. Early prescriptions have already been received, and the companies project US market exclusivity until at least 2039. However, the high price and small patient pool pose access challenges, and management cautions that adoption will build gradually.

Roivant and Pulmovant announced that topline results from the Phase 2 PHocus study of mosliciguat in patients with pulmonary hypertension associated with interstitial lung disease will be presented at the European Respiratory Society International Congress 2026 on Tuesday, September 8, 2026, at 12:15 CEST, followed by an investor call and webcast at 8:00 a.m. ET the same day. The presentation will be given by Marc Humbert, MD, PhD, Professor of Respiratory Medicine at Université Paris-Saclay and Director of the French National Reference Center for Pulmonary Hypertension. Roivant, a commercial-stage biopharmaceutical company, is developing mosliciguat as an inhaled sGC activator for this condition. The company will host the investor call to discuss the results, with details available on its website.

Priovant Therapeutics, backed by Pfizer and Roivant Sciences, has received FDA approval for its lead asset, Lisraya (brepocitinib), for the treatment of dermatomyositis, a rare autoimmune disorder. The once-daily 30 mg pill is now available immediately in the U.S. as the first and only targeted therapy for this condition. The approval is based on data from the Phase 3 VALOR trial, which showed improvements across multiple disease areas as early as week four, sustained through the 52-week study. The TYK2/JAK1 inhibitor will be distributed through a limited network of specialty pharmacies, following a priority review granted in March with a target action date in Q3 2026.

Immunovant reported a cash balance of $797.8 million as of June 30, 2026, which management stated provides a runway to the potential commercial launch of IMVT-1402 in Graves' disease. Research and development expenses were $142.6 million for the quarter, compared to $101.2 million in the prior year, primarily due to increased clinical trial activities for IMVT-1402 and contract manufacturing costs. The company reported a net loss of $153.2 million, or $0.75 per common share, for the three months ended June 30, 2026, and a non-GAAP net loss of $139.4 million excluding $13.8 million in non-cash stock-based compensation. Management expects topline data from the proof-of-concept trial in cutaneous lupus erythematosus in the second half of 2026, and topline data for the potentially registrational trials in Graves' disease and myasthenia gravis in calendar year 2027. Roivant, the parent company, received an upfront payment of $950 million from the Moderna settlement, with $770 million allocated to Genevant and the remainder to Arbutus, and reported a cash balance of just under $4 billion prior to the receipt of the Moderna settlement funds.

Roivant Sciences reported first-quarter fiscal 2026 R&D expenses of approximately $200 million and a GAAP G&A expense of $166 million, while its cash position stood at just under $4 billion before receiving a $772 million settlement payment from Moderna. The company received the initial $950 million upfront payment, with approximately $770 million allocated to Genevant and the remainder to Arbutus. Roivant also repurchased approximately $200 million in shares during the quarter at an average price in the high $20s. The company initiated a Phase 3 study in cutaneous sarcoidosis for brepocitinib ahead of schedule and is on track for a potential launch of brepocitinib in dermatomyositis by the end of September.

Arbutus Biopharma and Genevant Sciences, a subsidiary of Roivant Sciences, have filed three international lawsuits against Pfizer and BioNTech over lipid nanoparticle technology used in the COVID-19 vaccine Comirnaty. The actions include a case in the Federal Court of Canada alleging infringement of Canadian Patent No. 2,721,333, and two lawsuits in the Unified Patent Court concerning European patents EP 4 241 767 and EP 4 495 237. The plaintiffs are seeking permanent injunctions and damages, and the new filings expand a legal battle that already includes a 2023 U.S. lawsuit over five related patents. In March, Moderna agreed to pay $950 million to settle a similar dispute with Arbutus and Genevant, and Arbutus confirmed receipt of $178 million from Moderna on July 8 under that settlement.

Roivant Sciences reported its financial results for the fourth quarter and full fiscal year 2026, ending with $4.3 billion in consolidated cash and marketable securities. The company also announced a $2.25 billion global settlement with Moderna, resolving pending patent-infringement litigation. In its clinical portfolio, Roivant reported positive results for IMVT-1402 in difficult-to-treat rheumatoid arthritis, with further updates expected later this year. Brepocitinib received Breakthrough Therapy Designation for cutaneous sarcoidosis, and its commercial launch for dermatomyositis is scheduled for late September 2026. Topline data for several other programs, including studies in non-infectious uveitis and pulmonary hypertension, are anticipated in the second half of 2026.