Roivant Sciences (ROIV) reported growing momentum across its pipeline at the 12th Annual Cantor Fitzgerald Global Healthcare Conference on Wednesday, citing promising Phase II data for its inhaled pulmonary hypertension candidate mosliciguat and the recent U.S. launch of brepocitinib.
CEO Matt Gline said the day-old Phase II results for mosliciguat, an inhaled soluble guanylyl cyclase activator, showed the deepest-ever reduction in pulmonary vascular resistance observed in any pulmonary hypertension study. The data broadened the drug's profile beyond its initial indication of pulmonary arterial hypertension (PAH) to include PH-COPD overlap, idiopathic pulmonary fibrosis (IPF), and Groups 2, 4 and 5 pulmonary hypertension.
Roivant acquired mosliciguat from Bayer for approximately $15 million. Gline noted that phase III protocol planning began roughly six months ago and that enrollment is now underway. Patent protection on the asset extends into the mid-2040s, and Gline said the molecule has reached "approximately equal standing" alongside Roivant's other lead programs on a long-term basis. "If it worked, it was going to be obvious in hindsight that it was a good idea," he said of the Bayer acquisition.
Brepocitinib, marketed as LISRAYA, received FDA approval and launched in the United States about two weeks before the conference for the treatment of dermatomyositis. Gline cautioned that market expectations should anticipate a "slow and steady" rollout, emphasizing that brepocitinib is a dual JAK1/TYK2 inhibitor rather than a conventional single-target JAK inhibitor. Street sales estimates for the indication range from $2 billion to $4 billion. Roivant also plans near-term data readouts from its non-infectious uveitis program and continues to develop brepocitinib for cutaneous systemic sclerosis and localized scleroderma.
At subsidiary Immunovant, whose shares traded around $40 during the conference near a 52-week high of $42.50, Gline highlighted Phase II data for IMVT-1402, an FcRN-targeting therapy. Part 1 of the rheumatoid arthritis study showed strong ACR70 responses in patients with difficult-to-treat RA, with data from the randomized withdrawal portion still pending. Roivant owns 60% of Immunovant.
Immunovant is advancing two phase III trials of IMVT-1402 in Graves' disease, which targets a U.S. market estimated at 75,000 to 100,000 patients. Gline acknowledged inherent risk in being first in the indication, noting that a shorter Phase II study is expected to read out before the pivotal trials conclude in 2027. For non-infectious uveitis, he pointed to an average time to Humira treatment failure of 5.6 months as a benchmark for unmet need.
On operational constraints, Gline acknowledged that launching multiple phase III programs simultaneously is manpower-intensive. "We have a lot of manpower, but we don't have enough manpower to start eight studies all at once tomorrow," he said.
Roivant also confirmed its ownership stakes across its portfolio: 75% in Priovant, with Pfizer holding the remaining 25%, and 60% in Immunovant, with public investors owning 40%.
