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Immunovant (Nasdaq: IMVT) has revealed promising six-month remission data for batoclimab in treating uncontrolled Graves' disease. In a proof-of-concept study, approximately 80% (17/21) of patients maintained normal thyroid function six months after treatment cessation, with 50% (8/17) of responders achieving anti-thyroid drug (ATD) free remission.
The study involved a 24-week treatment period with batoclimab administered subcutaneously, followed by a 24-week off-treatment follow-up. The treatment demonstrated strong durability, with an additional 30% (5/17) of responding patients requiring only minimal ATD doses. Safety and tolerability were consistent with previous batoclimab studies.
Two potentially registrational trials for IMVT-1402, the company's lead compound, are currently enrolling patients, with topline results expected in 2027.
Roivant Sciences (Nasdaq: ROIV) reported Q1 2025 financial results and business updates. The company maintained a strong financial position with $4.5 billion in consolidated cash and marketable securities as of June 30, 2025. Key highlights include completion of a $1.5 billion share repurchase program, reducing outstanding shares by over 15%, and board approval for an additional $500 million buyback program.
Financial results showed R&D expenses increased to $152.9 million from $120.5 million year-over-year, while G&A expenses rose to $134.0 million. The company reported a net loss from continuing operations of $273.9 million ($0.33 per share).
Clinical progress remains on track with multiple milestone readouts expected, including brepocitinib's Phase 3 VALOR study in dermatomyositis in H2 2025 and IMVT-1402's advancement in six indications.
Roivant (Nasdaq: ROIV) has scheduled a conference call and webcast for Monday, August 11, 2025, at 8:00 a.m. ET to discuss its financial results for the first quarter ended June 30, 2025, and provide a business update. Investors can access the call by registering through an online link, and presentation materials will be available in the Investors section of Roivant's website. The webcast recording will be archived on the company's website following the event.
Roivant (ROIV) has scheduled a conference call and webcast for Thursday, May 29, 2025, at 8:00 a.m. ET to discuss its financial results for the fourth quarter and fiscal year ended March 31, 2025, along with a business update. Interested participants can register for the phone conference through an online registration link. The presentation materials and webcast access will be available in the Investors section of Roivant's website under "Events & Presentations." Following the event, an archived version of the webcast will be accessible on the company's website.
Immunovant (IMVT) announced significant leadership changes and expansion of its IMVT-1402 development program. Eric Venker, M.D., currently President and COO of Roivant, has been appointed as Immunovant's CEO, replacing Pete Salzmann who retired from his role as CEO and Director. Additionally, Tiago Girao was appointed as CFO, succeeding Renee Barnett.
The company revealed two new indications for IMVT-1402: Sjögren's Disease (SjD) and Cutaneous Lupus Erythematosus (CLE). An IND has been cleared for a potentially registrational program in SjD, with studies expected to begin in summer 2025. A proof-of-concept study has been initiated in CLE, marking the drug's sixth indication.
The company confirms its current cash balance will support operations through the expected Graves' Disease readout in 2027. These changes are part of a broader strategic transition with Roivant increasing its operational involvement and strategic oversight of Immunovant.
Immunovant (IMVT) has announced positive results from two key clinical studies. The Phase 3 study of batoclimab in Myasthenia Gravis (MG) met its primary endpoint, showing significant improvements in MG-ADL scores: a 5.6-point improvement in the higher dose arm (74% IgG reduction) and a 4.7-point improvement in the lower dose arm (64% IgG reduction).
The initial results from Period 1 of the Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) Phase 2b study demonstrated an average improvement of 1.8 in adjusted INCAT disability scores across batoclimab arms. Notably, an 84% responder rate was observed in patients achieving over 70% IgG reduction.
Both studies confirmed that deeper IgG reductions correlated with better clinical outcomes. The company plans to initiate pivotal studies for their lead asset IMVT-1402 in both MG and CIDP indications.
Roivant has scheduled an important investor webcast for Wednesday, March 19, 2025, at 8:00 AM ET to discuss important clinical trial results. The presentation will focus on two key areas:
- Results from the Phase 3 study of batoclimab in Myasthenia Gravis (MG)
- Initial findings from the Phase 2b study in Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)
The webcast will feature presentations from Pete Salzmann, CEO of Immunovant, and Matt Gline, CEO of Roivant. Investors can register for the event through the company's website, and the presentation will be archived for future viewing under the 'Events & Presentations' section at investor.roivant.com/news-events/events.
Roivant (ROIV) reported financial results for Q3 2024 with consolidated cash, equivalents, restricted cash, and marketable securities of $5.2 billion. The company announced expansion of brepocitinib development into cutaneous sarcoidosis, with Phase 2 study initiation expected in Q2 2025.
Key financial metrics include R&D expenses increasing to $141.6 million from $108.1 million year-over-year, and G&A expenses rising to $141.5 million from $128.2 million. The company reported a loss from continuing operations of $208.9 million, compared to income of $5.1 billion in the same period last year.
Notable developments include Immunovant's $450 million private placement, bringing Roivant's ownership to 57%, and the initiation of pivotal trials for IMVT-1402 in Graves' disease and rheumatoid arthritis. Multiple clinical milestones are expected in 2025, including batoclimab results in myasthenia gravis and CIDP by March 31, 2025.