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Immunovant (Nasdaq: IMVT) reported positive results from its Phase 2a trial of batoclimab in Graves' Disease. Key findings include:
- 76% response rate with high-dose batoclimab at week 12
- 56% ATD-free response rate at week 12
- Strong correlation between IgG lowering and clinical outcomes
Market research indicates 25-30% of Graves' Disease patients are uncontrolled on antithyroid drugs (ATDs) annually. Immunovant received FDA clearance for IMVT-1402's IND, with a pivotal trial expected to start by year-end 2024. The company believes these results validate the unmet medical need and demonstrate strong response rates in patients uncontrolled on ATDs, potentially positioning IMVT-1402 as a first-in-class and best-in-class treatment for Graves' Disease.
Roivant (Nasdaq: ROIV) reported financial results for Q1 2024 and provided a business update. Key highlights include:
- Immunovant completed enrollment in batoclimab pivotal myasthenia gravis trial
- Brepocitinib advancing to Phase 3 in non-infectious uveitis
- VTAMA net product revenue of $18.4M for Q1
- Consolidated cash of $5.7B as of June 30, 2024
Upcoming milestones:
- VTAMA PDUFA for atopic dermatitis in Q4 2024
- Namilumab Phase 2 data in sarcoidosis in Q4 2024
- Brepocitinib Phase 3 data in dermatomyositis in 2H 2025
- Multiple Immunovant clinical readouts expected through 2025
Q1 2024 financials:
- R&D expenses: $133.2M
- SG&A expenses: $148.5M
- Net income: $57.5M ($0.13 per share)
Roivant (Nasdaq: ROIV) has announced it will host a live conference call and webcast on Thursday, August 8, 2024, at 8:00 a.m. ET to report its financial results for the first quarter ended June 30, 2024, and provide a business update. Interested parties can register for the conference call online. The presentation and webcast details will be available in the Investors section of Roivant's website under 'Events & Presentations'. An archived version of the webcast will be accessible on the company's website after the conference call concludes.
Roivant (Nasdaq: ROIV) reported its Q4 and FY2024 results, highlighting strong performance in clinical trials and significant debt reductions.
Key points include:
- Brepocitinib showed the best treatment failure rates in non-infectious uveitis (NIU), supporting a pivotal program initiation in H2 2024.
- VTAMA net product revenue reached $75.1M, with over 385,000 prescriptions since launch.
- Roivant renegotiated Dermavant’s debt, reducing potential cash payments by over $300M, with $225M savings expected over the next three fiscal years.
- The company has $6.6B in cash, supporting a runway into profitability.
- A $1.5B share repurchase program was approved, reducing outstanding shares by 9%.
- Net loss for Q4 was $108M, while annual R&D expenses decreased by $23.5M.
Roivant (Nasdaq: ROIV) announced a live conference call and webcast scheduled for 8:00 a.m. ET on May 30, 2024, to discuss its fourth-quarter and fiscal year results ending March 31, 2024. The company will also provide a business update during this session. Investors can register online for the conference call. The presentation will be available under the 'Events & Presentations' section of Roivant’s website, where the archived webcast will also be accessible post-call.
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