Roivant Sciences - ROIVW STOCK NEWS

Zest Health has secured $13 million in seed funding to address unnecessary pharmaceutical spending in dermatology care. The company focuses on treating inflammatory skin diseases through a value-based virtual care platform. With approximately 40 million Americans affected by eczema and psoriasis facing long wait times, Zest aims to reduce reliance on expensive biologics, which currently drive over $40B in annual US spend and are growing at 15% annually.

The company's virtual platform delivers personalized care, combining prescription medications, over-the-counter solutions, and lifestyle interventions. Key performance metrics include: 80% of patients showing disease improvement based on BSA and DLQI measures, 90% patient preference rate compared to prior care, and an NPS of 83. The funding, provided by Roivant Health, will support scaling partnerships with health plans and employers.

Roivant (ROIV) has scheduled a conference call and webcast for Monday, February 10, 2025, at 8:00 a.m. ET to discuss its financial results for the third quarter ended December 31, 2024, 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 Following the live event, an archived version of the webcast will be accessible on the company's website.

Kinevant Sciences announced that its Phase 2 RESOLVE-Lung study of namilumab failed to demonstrate treatment benefits in patients with chronic active pulmonary sarcoidosis. The study evaluated the efficacy and safety of namilumab, an investigational anti-GM-CSF monoclonal antibody administered monthly via subcutaneous injection. The treatment failed to meet both its primary endpoint regarding Rescue Events and secondary endpoints, including changes in forced vital capacity, corticosteroid tapering success, and patient-reported outcomes. Following these results, Kinevant will discontinue further development of namilumab for sarcoidosis treatment but commits to publishing the study results to support future research.

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.