roivw - ROIVW STOCK NEWS

Roivant Sciences announced that its Phase 2 RESOLVE-Lung study of namilumab in chronic active pulmonary sarcoidosis failed to meet its primary and secondary endpoints. The study evaluated the efficacy and safety of namilumab, an investigational anti-GM-CSF monoclonal antibody administered monthly via subcutaneous injection. The primary endpoint measuring the proportion of subjects with a Rescue Event during the double-blind period was not met. Secondary endpoints, including changes in forced vital capacity, corticosteroid tapering success, and patient-reported outcomes, also showed no treatment benefit. As a result, Kinevant Sciences will discontinue further development of namilumab for sarcoidosis treatment.

Roivant Sciences reported Q2 2024 financial results and business updates. Key highlights include positive 52-week data from brepocitinib Phase 2 NEPTUNE study in non-infectious uveitis, FDA clearance of five IND applications for IMVT-1402, and the introduction of mosliciguat for pulmonary hypertension. The company closed Dermavant's sale to Organon for $184M cash, with potential additional milestone payments. Financial results show consolidated cash and marketable securities of $5.4B, R&D expenses of $143.1M (up from $114.8M YoY), and a net loss from continuing operations of $236.8M. The company continued share repurchases with $106M for the quarter.

Roivant (ROIV) has announced it will host a conference call and webcast on Tuesday, November 12, 2024, at 8:00 a.m. ET to discuss its financial results for the second quarter ended September 30, 2024, along with a business update. Interested participants can register online for the phone conference, and presentation materials will be accessible through the Investors section of Roivant's website. The webcast recording will be available for later viewing on the company's website.

Organon (NYSE: OGN) has completed its acquisition of Dermavant Sciences from Roivant (NASDAQ: ROIV). The acquisition includes VTAMA® (tapinarof) cream, 1%, a novel nonbiologic, non-steroidal topical therapy FDA-approved for plaque psoriasis treatment in adults. VTAMA is currently under FDA review for atopic dermatitis treatment in adults and children, with a decision expected in Q4 2024. The acquisition strengthens Organon's dermatology portfolio and expands its therapeutic offerings for chronic skin conditions affecting millions globally.

Organon (NYSE: OGN) has agreed to acquire Dermavant Sciences , a Roivant (NASDAQ: ROIV) company, for up to $1.2 billion. The deal includes Dermavant's VTAMA® (tapinarof) cream, a novel, non-steroidal topical therapy for plaque psoriasis in adults. VTAMA is also under FDA review for atopic dermatitis treatment. The acquisition aims to extend Organon's dermatology capabilities to the U.S. market.

Key terms include an upfront payment of $175 million, a $75 million milestone payment upon regulatory approval for atopic dermatitis, and up to $950 million in commercial milestone payments. Organon will also pay tiered royalties on net sales. The transaction is expected to close in Q4 2024, subject to regulatory approval.

Pulmovant, a Roivant company, presented positive proof-of-concept data from the Phase 1b ATMOS study of Mosliciguat in Pulmonary Hypertension at the European Respiratory Society Congress. Mosliciguat, a potential first-in-class, inhaled soluble Guanylate Cyclase (sGC) activator, showed promising results:

- Single dose led to sustained, clinically meaningful mean peak reduction in pulmonary vascular resistance (PVR) of up to 38%
- Once-daily dosing via dry powder inhaler was well tolerated
- Low rates of treatment-emergent adverse events observed

The global Phase 2 'PHocus' study in ~120 patients with PH associated with interstitial lung disease (PH-ILD) is set to begin soon. PH-ILD affects ~200,000 patients in the U.S. and Europe, with treatment options.

Roivant (Nasdaq: ROIV) unveiled mosliciguat, a potential first-in-class inhaled once-daily soluble Guanylate Cyclase (sGC) activator for pulmonary hypertension associated with interstitial lung disease (PH-ILD). The Phase 1b ATMOS study showed clinically meaningful reductions in pulmonary vascular resistance (PVR) of up to ~38% in PH patients. Mosliciguat was generally well-tolerated with low rates of adverse events.

The global Phase 2 'PHocus' study in ~120 PH-ILD patients is set to begin soon. PH-ILD affects ~200,000 patients in the U.S. and Europe, with treatment options. Roivant acquired worldwide rights to mosliciguat from Bayer for an upfront payment of ~$14.0 million, with potential additional payments of up to $280 million and tiered royalties.

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)