Every 8-K that Roivant Sciences Ltd. (ROIV) has filed with the SEC in the last 24 months is listed below, newest first, and each one links through to the document itself with the summary and the scores our analysis gives it.
A 8-K covers material events a company has to report between its quarterly reports, so if you follow ROIV and want that one kind of document rather than the whole filing history, this is the page to keep. The company's other filings, of every form, are on the full ROIV filings page.
Roivant Sciences Ltd. (ROIV) reported positive topline results from its Phase 2 PHocus trial of mosliciguat in pulmonary hypertension associated with interstitial lung disease (PH-ILD) and has initiated the Phase 3 PHrontier trial. PH-ILD is described as a progressive, life‑threatening condition with significant unmet medical need.
PHocus met its primary endpoint with a placebo‑adjusted pulmonary vascular resistance (PVR) reduction of 56.3% at Week 16 (‑51.3% mosliciguat vs. +6.6% placebo; p<0.0001). Key secondary endpoints also favored mosliciguat, including a placebo‑adjusted improvement in six‑minute walk distance of 35.2 meters at Week 16 (p=0.0027) and a placebo‑adjusted NT‑proBNP reduction of 357.7 pg/mL, corresponding to a 53.2% decline from baseline (p=0.0002). Exploratory Week 24 data showed further gains in walk distance (+52.7 meters) and NT‑proBNP (‑487.1 pg/mL; ‑75.9%).
Mosliciguat was observed to be well tolerated with adverse events consistent with PH‑ILD; cough incidence was 12.1% on mosliciguat versus 18.2% on placebo. The global Phase 2 study enrolled 135 patients across 87 sites in 20 countries, and the Phase 3 PHrontier trial is planned to enroll approximately 375 patients with PH‑ILD.
Roivant Sciences Ltd. (ROIV), through its consolidated affiliate Priovant, announces U.S. FDA approval and immediate commercial launch of LISRAYA (brepocitinib) as an oral TYK2/JAK1 inhibitor indicated for treatment of dermatomyositis in adult patients. The wholesale acquisition cost is $35,000 for a 30‑count bottle of 30 mg tablets, and a limited distribution specialty pharmacy network plus the My Compass Support hub are active, with eligible patients able to pay as little as $0 per month.
Approval is supported by the Phase 3 VALOR trial in 241 adults, where brepocitinib 30 mg showed a mean Total Improvement Score of 46.5 vs 31.2 for placebo and higher TIS40 and TIS60 response rates, along with meaningful steroid‑sparing effects. Literature and claims analyses suggest tens of thousands of potential U.S. dermatomyositis patients. Roivant owns 71% of Priovant (65% on a fully diluted basis) and consolidates 100% of Priovant’s revenues and expenses, with non‑controlling interest adjustments, and expects U.S. brepocitinib exclusivity at least until 2039.
Roivant Sciences Ltd. (ROIV) announced that the U.S. FDA has approved LISRAYA™ (brepocitinib) 30 mg, a once-daily oral pill, for the treatment of adults with dermatomyositis, based on data from its subsidiary Priovant Therapeutics’ Phase 3 VALOR trial, the largest dermatomyositis study conducted.
LISRAYA is described as a first-in-class TYK2/JAK1 inhibitor and the first and only targeted therapy approved for dermatomyositis. In VALOR, 55% of LISRAYA patients achieved moderate-or-better improvement on the myositis Total Improvement Score with minimal or no steroid use vs 30% on placebo over 52 weeks. Among those on ≥7.5 mg/day steroids at baseline, 62% tapered to ≤2.5 mg/day and 45% discontinued steroids entirely (vs 38% and 29% on placebo).
The approval follows FDA Priority Review and Orphan Drug Designation. LISRAYA carries a boxed warning for serious infections, mortality, malignancy, major adverse cardiovascular events, and thrombosis, and is not recommended in severe hepatic or renal impairment or in pregnancy. The drug is immediately available in the U.S. via specialty pharmacies, with a support program through which eligible patients may pay as little as $0 per month.
Roivant Sciences Ltd. reported results for the three months ended June 30, 2026, with revenue of $1.4 million and a net loss of $290.6 million, compared with a $273.9 million net loss a year earlier. R&D expenses rose to $202.0 million and G&A to $165.5 million, driven in part by bonuses linked to the Moderna settlement. Non-GAAP net loss was $243.7 million, up from $170.1 million.
The company reported consolidated cash, cash equivalents, restricted cash and marketable securities of $3.9 billion as of June 30, 2026, excluding the $950 million payment Genevant and Arbutus received from Moderna in July under a $2.25 billion patent settlement, with an additional $1.3 billion contingent on a favorable Section 1498 appeal. Roivant repurchased 7.3 million common shares for approximately $208.7 million, and states this liquidity supports cash runway into profitability.
Operationally, Roivant is preparing for the potential U.S. launch of brepocitinib in dermatomyositis by the end of September 2026, has initiated a Phase 3 trial in cutaneous sarcoidosis, and continues late-stage development in non-infectious uveitis and lichen planopilaris. IMVT-1402 and mosliciguat programs remain on track, with multiple topline data readouts expected from 2026 through 2028, while Genevant pursues additional lipid nanoparticle patent actions against Pfizer and BioNTech.
Roivant Sciences Ltd. reported fourth-quarter and full-year results for the period ended March 31, 2026, and outlined key pipeline and legal milestones. For the quarter, income from continuing operations was $355.7 million, driven largely by a $770.2 million gain from a global litigation settlement with Moderna.
For the full year, Roivant posted a $397.9 million loss from continuing operations and a non-GAAP loss of $747.7 million, reflecting heavy investment in R&D and share-based compensation. The company held $4.3 billion in cash, cash equivalents and marketable securities as of March 31, 2026, which it states supports a cash runway into profitability.
Operationally, Roivant highlighted strong preliminary IMVT-1402 data in difficult-to-treat rheumatoid arthritis, FDA Priority Review for brepocitinib in dermatomyositis, Breakthrough Therapy Designation in cutaneous sarcoidosis and rapid enrollment for mosliciguat in pulmonary hypertension associated with interstitial lung disease. The Moderna settlement totals $2.25 billion, including a $950 million non-contingent payment due in July 2026 and a contingent $1.3 billion payment tied to a Section 1498 appeal outcome.
Roivant Sciences Ltd. reported preliminary unaudited consolidated cash, cash equivalents and marketable securities of approximately $4.3 billion as of March 31, 2026. The company repurchased 3,956,362 common shares during the quarter for about $109.7 million, excluding fees and commissions.
Roivant announced a new seamless Phase 2b/3 trial of brepocitinib in lichen planopilaris, adding a fourth late-stage indication alongside dermatomyositis, non-infectious uveitis and cutaneous sarcoidosis. The FDA granted Priority Review to brepocitinib’s NDA in dermatomyositis, with a PDUFA target action date in Q3 2026.
The company also reported topline results from Immunovant’s two Phase 3 studies of batoclimab in thyroid eye disease, which did not meet the primary endpoint of ≥2mm proptosis responder rate at Week 24. Safety was consistent with prior data, and Immunovant plans to continue developing FcRn blocker IMVT-1402, including potentially registrational Graves’ disease studies with topline data expected in calendar year 2027.
Roivant Sciences Ltd. filed an amended current report to attach the full Settlement Agreement between its subsidiary Genevant Sciences GmbH, Arbutus Biopharma Corp., Genevant Sciences Ltd. and Moderna, Inc. and ModernaTx, Inc.. The agreement, dated March 3, 2026, resolves all patent infringement litigation worldwide related to Genevant/Arbutus lipid nanoparticle delivery technology used in Moderna’s vaccines.
The complete Settlement Agreement is now included as Exhibit 10.1, with certain immaterial or confidential portions, exhibits and schedules omitted under Regulation S‑K provisions.
Roivant Sciences reported that its subsidiary Genevant Sciences and partner Arbutus Biopharma entered into a $2.25 billion global settlement with Moderna to resolve all U.S. and international patent disputes over lipid nanoparticle technology used in COVID-19 vaccines, including Spikevax.
Under the settlement, Moderna will pay Genevant/Arbutus a $950 million noncontingent lump sum on or before July 8, 2026, plus a potential $1.3 billion contingent lump sum depending on the outcome of an appeal relating to 28 U.S.C. § 1498, with possible prorating and repayment mechanics if later overturned. The agreement also grants Moderna a fully paid-up, royalty-free, irrevocable, non-exclusive worldwide license and covenants not to sue for specified vaccines and patents.
Roivant’s board also expanded its common share repurchase program to up to $1.0 billion, inclusive of a previously announced $500 million authorization. Repurchases, funded from cash and cash equivalents, may occur via tender offers, open-market purchases, or privately negotiated transactions and can be suspended or discontinued at any time.
Roivant Sciences, through its subsidiary Priovant Therapeutics, announced that the FDA has accepted the New Drug Application for brepocitinib to treat dermatomyositis and granted it Priority Review. The FDA set a PDUFA target action date in the third quarter of 2026, and the company expects a U.S. launch at the end of September 2026 if approved.
The Priority Review decision is based on positive Phase 3 VALOR data in 241 patients, where the 30 mg dose showed statistically significant and clinically meaningful improvement over placebo on the primary Total Improvement Score endpoint at Week 52 and all nine key secondary endpoints. Safety data across more than 2,000 subjects suggest a profile similar to approved JAK and TYK2 inhibitors, although serious infections were more frequent with the 30 mg dose and required medical management.
Roivant Sciences reported a larger quarterly loss while highlighting major pipeline progress. For the quarter ended December 31, 2025, loss from continuing operations was $313.7 million, compared with $208.9 million a year earlier, on modest revenue of $2.0 million. Research and development expenses rose to $165.4 million and general and administrative expenses to $175.1 million, both driven largely by higher share-based compensation and program spending. Non-GAAP loss from continuing operations was $167.0 million. Roivant held $4.5 billion in cash, cash equivalents, restricted cash and marketable securities as of December 31, 2025, which the company says supports a cash runway into profitability. Clinically, Roivant announced strongly positive Phase 2 data for brepocitinib in cutaneous sarcoidosis, including a 22.3‑point mean CSAMI-A improvement at Week 16 versus 0.7 on placebo, and filed an NDA for brepocitinib in dermatomyositis. Multiple late-stage trials for brepocitinib, IMVT‑1402 and mosliciguat are fully enrolled with topline readouts expected in 2026, and Immunovant raised about $550 million in gross proceeds. Roivant also reported progress in Genevant’s LNP litigation against Moderna, with a favorable summary judgment decision and a U.S. jury trial scheduled for March 2026.
Roivant Sciences (ROIV) furnished quarterly results via an 8‑K. The company reported that it issued a press release announcing financial results for the fiscal quarter ended September 30, 2025, which is attached as Exhibit 99.1. The disclosure under Item 2.02 is provided as “furnished,” not “filed,” and will only be incorporated into other filings if expressly referenced.
Roivant Sciences Ltd. reported that its subsidiary Priovant Therapeutics achieved positive results in the Phase 3 VALOR study of brepocitinib in dermatomyositis, a serious autoimmune muscle disease. The company released a detailed press release and an investor presentation describing these Phase 3 results.
Roivant also scheduled a conference call and webcast at 8:00 a.m. E.D.T. on September 17, 2025 to discuss the VALOR data, and posted the related presentation on the investor relations section of its website. These materials are furnished as exhibits to the report, giving investors additional information on the study outcome.
Roivant Sciences Ltd. reported the results of shareholder votes demonstrating routine corporate governance outcomes. Shareholders re-elected the individuals named to serve as Class I directors to hold office until the annual general meeting following the fiscal year ending March 31, 2028. Shareholders also approved, on a non-binding advisory basis, the compensation of the company’s named executive officers as disclosed in the proxy statement. The advisory vote tallied 316,651,402 votes in favor, 203,244,184 against and 64,550,276 abstentions; there were 44,227,813 broker non-votes reported. The filing includes the cover page interactive data file as an exhibit.
Roivant Sciences Ltd. reported that it has provided an update on the Graves’ Disease development program at its subsidiary, Immunovant, Inc. The company issued a press release and made it available as an exhibit, focusing on Immunovant’s proof-of-concept study in Graves’ Disease.
Roivant also posted an investor presentation covering the update on Immunovant’s Graves’ Disease proof-of-concept study on its investor relations website and scheduled a conference call and webcast to discuss remission data from Immunovant’s Graves’ Disease trial at 4:30 p.m. E.D.T. Both the press release and the presentation are included as exhibits to the report, while the website content itself is not incorporated.
Roivant Sciences Ltd. filed a Current Report on Form 8-K stating that on August 11, 2025 the company issued a press release announcing its financial results for the fiscal quarter ended June 30, 2025. The press release is attached to the report as Exhibit 99.1 and an Inline XBRL cover page is included as Exhibit 104.
The filing clarifies that the information in the Item 2.02 section and the attached exhibit is not deemed "filed" under Section 18 of the Exchange Act and will not be incorporated by reference into other filings except by express reference. The report is signed by Keyur Parekh as Authorized Signatory on August 11, 2025, and identifies the company’s Nasdaq trading symbol as ROIV.
Roivant Sciences (NASDAQ:ROIV) announced a new $500 million share repurchase program in addition to their previous $1.5 billion program from April 2024. The earlier program, which had $205 million remaining capacity as of March 31, 2025, has now been fully exhausted. The new repurchase program will be funded through available cash and has no expiration date.
The company maintains flexibility in executing the buyback through various methods including open market transactions, tender offers, or private negotiations. Implementation will depend on factors such as share price, market conditions, and alternative investment opportunities. The program can be suspended or discontinued at any time.