ROIV earnings
Roivant Sciences Ltd. (ROIV) earnings releases and earnings dates - real-time wire coverage of every quarterly report.
Recent earnings items
- Roivant Reports Financial Results for the Fourth Quarter and Fiscal Year Ended March 31, 2026 and Provides Business UpdateIMVT-1402 showed clinically meaningful response rates of 72.7% ACR20, 54.5% ACR50 and 35.8% ACR70 at Week 16 in the open label period of its trial in difficult-to-treat rheumatoid arthritis (D2T RA); Immunovant will provide further updates on this program in the second half of calendar year 2026 Brepocitinib granted Breakthrough Therapy Designation for the treatment of cutaneous sarcoidosis (CS) based on positive Phase 2 data; potentially registrational trial of brepocitinib in lichen planopilaris (LPP) enrolled its first subjects in March 2026 Commercial launch of brepocitinib in dermatomyositis (DM) is expected by the end of September 2026, and topline Phase 3 data for brepocitinib in no
- Roivant to Report Financial Results for the Fourth Quarter and Fiscal Year Ended March 31, 2026 and Provide Business Update on Wednesday, May 20, 2026BASEL, Switzerland and LONDON and NEW YORK, May 11, 2026 (GLOBE NEWSWIRE) -- Roivant (NASDAQ:ROIV) today announced that it will host a live conference call and webcast at 8:00 a.m. ET on Wednesday, May 20, 2026, to report its financial results for the fourth quarter and fiscal year ended March 31, 2026, and provide a business update. To access the conference call by phone, please register online using this registration link. The presentation and webcast details will also be available under "Events & Presentations" in the Investors section of the Roivant website at https://investor.roivant.com/news-events/events. The archived webcast will be available on Roivant's website after the confere
- Immunovant to Report Financial Results for the Fourth Quarter and Fiscal Year Ended March 31, 2026, and Provide Business Update on Wednesday, May 20, 2026DURHAM, N.C., May 11, 2026 (GLOBE NEWSWIRE) -- Immunovant (Nasdaq: IMVT) today announced that it will report its financial results for the fourth quarter and fiscal year ended March 31, 2026, and provide a business update at 8:00 a.m. ET on Wednesday, May 20, 2026. To access the Roivant (NASDAQ:ROIV) conference call by phone, please register online using this registration link. The presentation and webcast details will also be available under "News & Events" in the Investors section of the Immunovant website at https://www.immunovant.com/investors/news-events/ir-calendar. The archived webcast will be available on Immunovant's website after the conference call. About Immunovant Immunova
- Roivant Announces Expansion of Brepocitinib Development Program with New Phase 2b/3 Trial in Lichen Planopilaris (LPP) and Phase 3 Study Results for Batoclimab in Thyroid Eye Disease (TED)Lichen planopilaris (LPP) is a highly morbid inflammatory scalp disorder that causes generally irreversible scarring hair loss, often accompanied by profound pain, itch, and burning sensations; no FDA-approved therapies exist for LPP, highlighting a critical unmet therapeutic needLPP marks the fourth indication in brepocitinib's expanding late-stage development programMultiple lines of evidence, including strong mechanistic rationale and clinically meaningful results in an investigator-initiated placebo-controlled study of brepocitinib in LPP, support rapid development of brepocitinib in this indicationA seamless Phase 2b/3 potentially registrational trial of brepocitinib in LPP enrolled its
- Genevant Sciences and Arbutus Biopharma Announce $2.25 Billion Global Settlement With ModernaModerna to pay Genevant and Arbutus $950 million upfront and an additional $1.3 billion contingent upon a favorable resolution of Moderna's Section 1498 appealIf the $1.3 billion payment is realized, this settlement will be the largest disclosed patent settlement paid in the pharmaceutical industry and the second largest in any industrySettlement holds Moderna accountable for infringement and provides for the court to enter judgment of no invalidity on the four Genevant/Arbutus patents asserted in the caseGenevant grants Moderna a global non-exclusive license to its LNP delivery technology for SM-102-containing mRNA vaccines for infectious disease and a covenant not to sue for certain Geneva
- Roivant Announces Genevant Sciences' and Arbutus Biopharma's $2.25 Billion Global Settlement With ModernaModerna to pay Genevant and Arbutus $950 million upfront and an additional $1.3 billion contingent upon a favorable resolution of Moderna's Section 1498 appealIf the $1.3 billion payment is realized, this settlement will be the largest disclosed patent settlement paid in the pharmaceutical industry and the second largest in any industrySettlement holds Moderna accountable for infringement and provides for the court to enter judgment of no invalidity on the four Genevant/Arbutus patents asserted in the caseGenevant grants Moderna a global non-exclusive license to its LNP delivery technology for SM-102-containing mRNA vaccines for infectious disease and a covenant not to sue for certain Geneva
- Roivant Announces Positive Phase 2 Results for Brepocitinib in Cutaneous Sarcoidosis (CS) and Reports Financial Results for the Third Quarter Ended December 31, 2025Brepocitinib 45 mg significantly improved cutaneous sarcoidosis disease activity, achieving a 22.3-point improvement in mean CSAMI-A at Week 16 versus a 0.7-point improvement in placebo (Δ21.6 P<0.0001). Brepocitinib demonstrated rapid, deep and sustained improvements across all other efficacy endpoints measured with consistent safety profilePriovant plans to progress CS to a pivotal program with a Phase 3 study starting in calendar year 2026 following engagement with the FDA, representing the third indication with a pivotal program for brepocitinib New Drug Application (NDA) was submitted to the FDA for brepocitinib in dermatomyositis (DM). Topline data from Phase 3 studies in non-infectiou
- Immunovant to Report Financial Results for the Third Quarter Ended December 31, 2025, and Provide Business Update on Friday, February 6, 2026DURHAM, N.C. and NEW YORK, Jan. 23, 2026 (GLOBE NEWSWIRE) -- Immunovant (NASDAQ:IMVT) today announced that it will report its financial results for the third quarter ended December 31, 2025, and provide a business update at 8:00 a.m. ET on Friday, February 6, 2026. To access the Roivant (NASDAQ:ROIV) conference call by phone, please register online using this registration link. The presentation and webcast details will also be available under "News & Events" in the Investors section of the Immunovant website at https://www.immunovant.com/investors/news-events/ir-calendar. The archived webcast will be available on Immunovant's website after the conference call. About ImmunovantImmunovant,
- Roivant to Report Financial Results for the Third Quarter Ended December 31, 2025, and Provide Business Update on Friday, February 6, 2026BASEL, Switzerland and LONDON and NEW YORK, Jan. 23, 2026 (GLOBE NEWSWIRE) -- Roivant (NASDAQ:ROIV) today announced that it will host a live conference call and webcast at 8:00 a.m. ET on Friday, February 6, 2026, to report its financial results for the second quarter ended December 31, 2026, and provide a business update. To access the conference call by phone, please register online using this registration link. The presentation and webcast details will also be available under "Events & Presentations" in the Investors section of the Roivant website at https://investor.roivant.com/news-events/events. The archived webcast will be available on Roivant's website after the conference call.
- Roivant Reports Financial Results for the Second Quarter Ended September 30, 2025, and Provides Business UpdateBASEL, Switzerland and LONDON and NEW YORK, Nov. 10, 2025 (GLOBE NEWSWIRE) -- Roivant (NASDAQ:ROIV) today reported its financial results for the second quarter ended September 30, 2025, and provided a business update. Brepocitinib 30 mg demonstrated clinically meaningful and statistically significant improvement compared to placebo on the primary endpoint and all nine key secondary endpoints in Phase 3 VALOR study in dermatomyositis (DM), with NDA filing planned for the first half of calendar year 2026Brepocitinib program continues to advance with rapid enrollment in Phase 3 study in non-infectious uveitis (NIU) and proof-of-concept trial in cutaneous sarcoidosis (CS), with readouts expec
- Roivant to Report Financial Results for the Second Quarter Ended September 30, 2025, and Provide Business Update on Monday, November 10, 2025BASEL, Switzerland and LONDON and NEW YORK, Oct. 27, 2025 (GLOBE NEWSWIRE) -- Roivant (NASDAQ:ROIV) today announced that it will host a live conference call and webcast at 8:00 a.m. ET on Monday, November 10, 2025, to report its financial results for the second quarter ended September 30, 2025, and provide a business update. To access the conference call by phone, please register online using this registration link. The presentation and webcast details will also be available under "Events & Presentations" in the Investors section of the Roivant website at https://investor.roivant.com/news-events/events. The archived webcast will be available on Roivant's website after the conference call.
- Immunovant to Report Financial Results for the Second Quarter Ended September 30, 2025, and Provide Business Update on Monday, November 10, 2025NEW YORK, Oct. 27, 2025 (GLOBE NEWSWIRE) -- Immunovant (NASDAQ:IMVT) today announced that it will report its financial results for the second quarter ended September 30, 2025, and provide a business update at 8:00 a.m. ET on Monday, November 10, 2025. To access the Roivant (NASDAQ:ROIV) conference call by phone, please register online using this registration link. The presentation and webcast details will also be available under "News & Events" in the Investors section of the Immunovant website at https://www.immunovant.com/investors/news-events/ir-calendar. The archived webcast will be available on Immunovant's website after the conference call. About Immunovant Immunovant, Inc. is a cl
- Roivant and Priovant Announce Positive Phase 3 VALOR Study Results for Brepocitinib in 52-Week Placebo-Controlled Trial in Dermatomyositis (DM)Once-daily oral brepocitinib 30 mg demonstrated clinically meaningful and statistically significant improvement compared to placebo on the primary endpoint and all nine key secondary endpoints, including measurements of skin disease, muscle disease, steroid-sparing effect, and rapidity of onsetOn the primary endpoint, brepocitinib 30 mg achieved a week 52 mean Total Improvement Score (TIS) of 46.5 compared to 31.2 for placebo (p=0.0006), even with nearly twice as many patients coming off background steroids on brepocitinib 30 mg compared to placeboMore than two thirds of brepocitinib 30 mg patients experienced at least a moderate response (TIS≥40), and nearly half experienced a major respon
- Roivant Unveils Durability and Treatment-Free Six-month Remission Data with Potential to Change Treatment Paradigm for Uncontrolled Graves' Disease PatientsFirst-ever potentially disease-modifying therapy for uncontrolled Graves' disease patientsOf 21 patients who entered the six-month off-treatment follow-up period, ~80% (17/21) demonstrated response, resulting in normal thyroid function (T3 and T4 less than the upper limit of normal) at the end of the six-month follow-up periodOf the 17 responders to therapy, ~50% (8/17) achieved anti-thyroid drug (ATD) free remission at six months following end of batoclimab treatmentTwo potentially registrational trials for IMVT-1402 in Graves' disease are currently enrolling with topline readouts expected in 2027Roivant to host investor call to discuss these updates today, September 3, 2025, at 4:30 p.m. E
- Roivant Reports Financial Results for the First Quarter Ended June 30, 2025, and Provides Business UpdateBASEL, Switzerland and LONDON and NEW YORK, Aug. 11, 2025 (GLOBE NEWSWIRE) -- Roivant (NASDAQ:ROIV) today reported its financial results for the first quarter ended June 30, 2025, and provided a business update. Brepocitinib VALOR Phase 3 study in dermatomyositis (DM) remains on track for topline data readout in the second half of calendar year 2025, with last patient last visit completed in July; Roivant and Priovant hosted an investor event on brepocitinib in June to share details about the ongoing VALOR study, including pooled/blinded baseline data, clinical endpoints details and successful steroid tapering dataBrepocitinib program continues to advance with rapid enrollment in non-infe
- Roivant to Report Financial Results for the First Quarter Ended June 30, 2025, and Provide Business Update on Monday, August 11, 2025BASEL, Switzerland and LONDON and NEW YORK, July 28, 2025 (GLOBE NEWSWIRE) -- Roivant (NASDAQ:ROIV) today announced that it will host a live conference call and webcast at 8:00 a.m. ET on Monday, August 11, 2025, to report its financial results for the first quarter ended June 30, 2025, and provide a business update. To access the conference call by phone, please register online using this registration link. The presentation and webcast details will also be available under "Events & Presentations" in the Investors section of the Roivant website at https://investor.roivant.com/news-events/events. The archived webcast will be available on Roivant's website after the conference call. About
- Roivant and Priovant to Host Investor Video Conference at 1:00 PM ET on Tuesday, June 17 on Brepocitinib and the Unmet Medical Need in DermatomyositisBASEL, Switzerland and LONDON and NEW YORK, June 09, 2025 (GLOBE NEWSWIRE) -- Roivant (NASDAQ:ROIV) and Priovant Therapeutics today announced that they will host a live investor video conference at 1:00 PM ET on Tuesday, June 17 on brepocitinib, the unmet medical need for patients with dermatomyositis (DM) and the potential role brepocitinib could play in improving the lives of patients with DM. To access the video conference, please register online using this registration link. The presentation and conference details will also be available under "Events & Presentations" in the Investors section of the Roivant website at https://investor.roivant.com/news-events/events. The archived webcas
- Roivant Reports Financial Results for the Fourth Quarter and Fiscal Year Ended March 31, 2025, and Provides Business UpdateBASEL, Switzerland and LONDON and NEW YORK, May 29, 2025 (GLOBE NEWSWIRE) -- Roivant (NASDAQ:ROIV) today reported its financial results for the fourth quarter and fiscal year ended March 31, 2025, and provided a business update. Brepocitinib program progressing well with rapid enrollment in non-infectious uveitis (NIU) Phase 3 study and first patients dosed in cutaneous sarcoidosis (CS) proof-of-concept trial, with readouts expected in the first half of calendar year 2027 and second half of calendar year 2026, respectivelyBrepocitinib's VALOR Phase 3 study evaluating its use in patients with dermatomyositis (DM) is fully enrolled and on track for topline data readout in the second half of
- Roivant to Report Financial Results for the Fourth Quarter and Fiscal Year Ended March 31, 2025 and Provide Business Update on Thursday, May 29, 2025BASEL, Switzerland and LONDON and NEW YORK, May 15, 2025 (GLOBE NEWSWIRE) -- Roivant (NASDAQ:ROIV) today announced that it will host a live conference call and webcast at 8:00 a.m. ET on Thursday, May 29, 2025, to report its financial results for the fourth quarter and fiscal year ended March 31, 2025, and provide a business update. To access the conference call by phone, please register online using this registration link. The presentation and webcast details will also be available under "Events & Presentations" in the Investors section of the Roivant website at https://investor.roivant.com/news-events/events. The archived webcast will be available on Roivant's website after the conferen
- Immunovant Announces Next Phase of Growth with Roivant Including Changes to its Leadership Team and Additional Indications Sjögren's Disease (SjD) and Cutaneous Lupus Erythematosus (CLE) for IMVT-1402Eric Venker, M.D. (currently President and COO of Roivant) appointed as CEO of Immunovant and Tiago Girao appointed as CFO of ImmunovantPete Salzmann, M.D. retired from his role as Immunovant CEO and DirectorLeadership change is part of a broader strategic transition with Roivant increasing operational involvement and strategic oversight of Immunovant IND cleared for a potentially registrational program for IMVT-1402 in SjD, its fifth and potentially best-in-class indication with positive in-class competitor data from Phase 2 studies suggesting a correlation between depth of IgG reduction and degree of clinical improvement; study expected to initiate in summer 2025Proof-of-concept study of
- Roivant Announces Positive Results for Batoclimab Myasthenia Gravis (MG) and Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) StudiesPivotal study in MG met primary endpoint of change from baseline in MG-ADL in AChR+ population at 12 weeks, with a 5.6 point improvement in the higher dose arm (with 74% mean IgG reduction) and a 4.7 point improvement in the lower dose arm (with 64% mean IgG reduction) Initial CIDP results from Period 1, following standard of care washout, demonstrate a mean improvement in the adjusted INCAT disability score of 1.8 across batoclimab arms and an 84% responder rate in those patients who achieved an IgG lowering greater than 70% In both batoclimab studies, deeper IgG reductions correlated with better clinical outcomes across a range of assessments and timepoints INDs active for both MG and C
- Roivant to Host Investor Webcast at 8:00 AM ET on Wednesday, March 19 to Review Results from Batoclimab Myasthenia Gravis (MG) and Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) ProgramsNEW YORK, March 18, 2025 (GLOBE NEWSWIRE) -- Immunovant, Inc. (NASDAQ:IMVT), a clinical-stage immunology company dedicated to enabling normal lives for people with autoimmune diseases, today announced that it will host an investor webcast on Wednesday, March 19th at 8:00 a.m. ET to review results from its Phase 3 study of batoclimab in MG and initial results from its Phase 2b study in CIDP. Pete Salzmann, M.D., MBA, Chief Executive Officer of Immunovant, will be joined by Matt Gline, Chief Executive Officer of Roivant, for the call. Webcast DetailsThe company will host a webcast at 8:00 a.m. ET on Wednesday, March 19. Please click here to register for the event. The live webcast
- Roivant Reports Financial Results for the Third Quarter Ended December 31, 2024, and Provides Business UpdateBASEL, Switzerland and LONDON and NEW YORK, Feb. 10, 2025 (GLOBE NEWSWIRE) -- Roivant (NASDAQ:ROIV) today reported its financial results for the third quarter ended December 31, 2024, and provided a business update. Brepocitinib to be developed in third indication, cutaneous sarcoidosis (CS), an orphan indication with high unmet need; Phase 2 study initiation expected in second quarter of calendar year with topline data in second half of calendar year 2026IMVT-1402 development is rapidly progressing with six Investigational New Drug (IND) applications cleared and pivotal studies in Graves' disease (GD) and difficult-to-treat rheumatoid arthritis (D2T RA) initiatedBatoclimab topline resu
- Roivant to Report Financial Results for the Third Quarter Ended December 31, 2024 and Provide Business Update on Monday, February 10, 2025BASEL, Switzerland and LONDON and NEW YORK, Jan. 29, 2025 (GLOBE NEWSWIRE) -- Roivant (NASDAQ:ROIV) today announced that it will host a live conference call and webcast at 8:00 a.m. ET on Monday, February 10, 2025, to report its financial results for the third quarter ended December 31, 2024, and provide a business update. To access the conference call by phone, please register online using this registration link. The presentation and webcast details will also be available under "Events & Presentations" in the Investors section of the Roivant website at https://investor.roivant.com/news-events/events. The archived webcast will be available on Roivant's website after the conference call.
- Roivant Reports Financial Results for the Second Quarter Ended September 30, 2024, and Provides Business UpdateBASEL, Switzerland and LONDON and NEW YORK, Nov. 12, 2024 (GLOBE NEWSWIRE) -- Roivant (NASDAQ:ROIV) today reported its financial results for the second quarter ended September 30, 2024, and provided a business update. Brepocitinib 52-week data from the Phase 2 NEPTUNE study in non-infectious uveitis (NIU) showed potential best-in-indication efficacy sustained to one year; first patients enrolled in Phase 3 NIU program IMVT-1402 cleared five Investigational New Drug (IND) applications across a range of therapeutic areas and FDA divisions, including the potentially registrational trial for difficult-to-treat rheumatoid arthritis (D2T RA) expected to initiate by March 31, 2025Batoclimab pro
- Roivant to Report Financial Results for the Second Quarter Ended September 30, 2024 and Provide Business Update on Tuesday, November 12, 2024BASEL, Switzerland and LONDON and NEW YORK, Oct. 29, 2024 (GLOBE NEWSWIRE) -- Roivant (NASDAQ:ROIV) today announced that it will host a live conference call and webcast at 8:00 a.m. ET on Tuesday, November 12, 2024, to report its financial results for the second quarter ended September 30, 2024, and provide a business update. To access the conference call by phone, please register online using this registration link. The presentation and webcast details will also be available under "Events & Presentations" in the Investors section of the Roivant website at https://investor.roivant.com/news-events/events. The archived webcast will be available on Roivant's website after the conference call
- Roivant Unveils New Pipeline Program Mosliciguat, A Potential First-In-Class and Best-In-Category Inhaled Once-Daily Soluble Guanylate Cyclase (sGC) ActivatorMosliciguat, a potential first-in-class and best-in-category inhaled soluble Guanylate Cyclase (sGC) activator with targeted delivery to the lungs and once-daily administration, is being developed for pulmonary hypertension associated with interstitial lung disease (PH-ILD), which affects ~200,000 patients in the U.S. and Europe; PH-ILD prevalence is meaningfully greater than that of pulmonary arterial hypertension (PAH) with limited to no treatment optionsIn the Phase 1b ATMOS study, presented today at the European Respiratory Society (ERS) Congress, a single dose of inhaled mosliciguat in pulmonary hypertension (PH) patients (N=38) led to sustained, clinically meaningful mean-max reduction
- Roivant Reports Financial Results for the First Quarter Ended June 30, 2024, and Provides Business UpdateBASEL, Switzerland and LONDON and NEW YORK, Aug. 08, 2024 (GLOBE NEWSWIRE) -- Roivant (NASDAQ:ROIV) today reported its financial results for the first quarter ended June 30, 2024, and provided a business update. Immunovant completed enrollment in batoclimab pivotal myasthenia gravis (MG) trial; topline results and initiation of a potentially registrational program in MG for IMVT-1402 on track for fiscal year end (March 31, 2025)Brepocitinib development in non-infectious uveitis (NIU) is progressing to Phase 3 following a successful end of Phase 2 meeting with the FDA Brepocitinib Phase 3 VALOR study enrollment in dermatomyositis (DM) is complete and on track to report topli
- Roivant to Report Financial Results for the First Quarter Ended June 30, 2024, and Provide Business Update on Thursday, August 8, 2024BASEL, Switzerland and LONDON and NEW YORK, July 25, 2024 (GLOBE NEWSWIRE) -- Roivant (NASDAQ:ROIV) today announced that it will host a live conference call and webcast at 8:00 a.m. ET on Thursday, August 8, 2024, to report its financial results for the first quarter ended June 30, 2024, and provide a business update. To access the conference call by phone, please register online using this registration link. The presentation and webcast details will also be available under "Events & Presentations" in the Investors section of the Roivant website at https://investor.roivant.com/news-events/events. The archived webcast will be available on Roivant's website after the conference call. A
- Roivant Reports Financial Results for the Fourth Quarter and Fiscal Year Ended March 31, 2024, and Provides Business UpdateBASEL, Switzerland and LONDON and NEW YORK, May 30, 2024 (GLOBE NEWSWIRE) -- Roivant (NASDAQ:ROIV) today reported its financial results for the fourth quarter and fiscal year ended March 31, 2024, and provided a business update. Once-daily brepocitinib produced the best Treatment Failure rates observed to date among studies in active non-infectious uveitis (NIU), supporting initiation of a pivotal program in NIU in the second half of calendar year 2024Brepocitinib is well positioned to support a potential multi-blockbuster franchise in rare and orphan autoimmune disease with an ongoing pivotal study in dermatomyositis on track to read out in calendar year 2025Following a recently complete
- Roivant to Report Financial Results for the Fourth Quarter and Fiscal Year Ended March 31, 2024, and Provide Business Update on Thursday, May 30, 2024BASEL, Switzerland and LONDON and NEW YORK, May 16, 2024 (GLOBE NEWSWIRE) -- Roivant (NASDAQ:ROIV) today announced that it will host a live conference call and webcast at 8:00 a.m. ET on Thursday, May 30, 2024, to report its financial results for the fourth quarter and fiscal year ended March 31, 2024, and provide a business update. To access the conference call by phone, please register online using this registration link. The presentation and webcast details will also be available under "Events & Presentations" in the Investors section of the Roivant website at https://investor.roivant.com/news-events/events. The archived webcast will be available on Roivant's website after the conferen
- Roivant Announces Positive NEPTUNE Study Results for Brepocitinib in NIU, as well as Board Authorization for up to $1.5 Billion Share Repurchase Program, Including Repurchase of Entire Sumitomo Pharma Stake for $648 MillionRoivant's board of directors has approved a share repurchase program for up to $1.5 billion of the company's common shares, including an agreed repurchase of the entire Sumitomo Pharma stake for $648 millionSumitomo Pharma repurchase reduces shares outstanding by 9%In the Phase 2 NEPTUNE study of once-daily oral brepocitinib in non-infectious uveitis (NIU), the 45 mg results represent the best Treatment Failure rates observed to date among active NIU studies measuring this registrational endpoint29% of subjects receiving brepocitinib 45 mg and 44% of subjects receiving brepocitinib 15 mg met the pre-specified primary efficacy endpoint of Treatment Failure at week 24 (lower failure rates refl
- Roivant Reports Financial Results for the Third Quarter Ended December 31, 2023, and Provides Business UpdateBASEL, Switzerland and LONDON and NEW YORK, Feb. 13, 2024 (GLOBE NEWSWIRE) -- Roivant (NASDAQ:ROIV) today reported its financial results for the third quarter ended December 31, 2023, and provided a business update. Roivant completed the sale of Telavant to Roche for $7.1B with an additional $150M in cash payable upon the completion of a near-term milestoneBatoclimab produced positive results in Graves' disease with response rates meaningfully exceeding 50% in the initial cohort of an ongoing 24-week Phase 2 trialVTAMA® (tapinarof) cream, 1% net product revenue was $20.7M for the quarter ended December 31, 2023, with over 300,000 prescriptions written by approximately 14,000 unique prescr
- Roivant to Report Financial Results for the Third Quarter Ended December 31, 2023, and Provide Business Update on Tuesday, February 13, 2024BASEL, Switzerland and LONDON and NEW YORK, Jan. 30, 2024 (GLOBE NEWSWIRE) -- Roivant (NASDAQ:ROIV) today announced that it will host a live conference call and webcast at 8:00 a.m. ET on Tuesday, February 13, 2024, to report its financial results for the third quarter ended December 31, 2023, and provide a business update. To access the conference call by phone, please register online using this registration link. The presentation and webcast details will also be available under "Events & Presentations" in the Investors section of the Roivant website at https://investor.roivant.com/news-events/events. The archived webcast will be available on Roivant's website after the conference call.
- Roivant Announces Positive IMVT-1402 Initial 600 mg MAD Results that Confirm Best-in-Class PotentialResults from the 600 mg MAD cohort for IMVT-1402 similar to previously disclosed results from the 300 mg MAD cohort for IMVT-1402IMVT-1402 was observed to deliver dose dependent and deep IgG reductions similar to batoclimab in its Phase 1 studyIMVT-1402 600 mg was observed to deliver placebo-like impact on albumin and low-density lipoprotein cholesterol (LDL-C), similar to the previously disclosed 300 mg MAD cohort dataPotential best-in-class profile enables broad and exciting portfolio of indications, taking advantage of IgG reduction we expect will reach 80% with continued weekly dosing of 600 mg delivered by simple subcutaneous injection NEW YORK, Nov. 28, 2023 (GLOBE NEWSWIRE) -- Immu
- Roivant to Report Financial Results for the Second Quarter Ended September 30, 2023, and Provide Business Update on Monday, November 13, 2023BASEL, LONDON, and NEW YORK, Oct. 30, 2023 (GLOBE NEWSWIRE) -- Roivant (NASDAQ:ROIV) today announced that it will host a live conference call and webcast at 8:00 a.m. ET on Monday, November 13, 2023, to report its financial results for the second quarter ended September 30, 2023, and provide a business update. To access the conference call by phone, please register online using this registration link. The presentation and webcast details will also be available under "Events & Presentations" in the Investors section of the Roivant website at https://investor.roivant.com/news-events/events. The archived webcast will be available on Roivant's website after the conference call. About Roivant
- Roche Enters Into a Definitive Agreement to Acquire Telavant Including Rights to Novel TL1A Directed Antibody (RVT-3101) for the Treatment of Inflammatory Bowel Disease From RoivantRoche will gain the rights to develop, manufacture and commercialize RVT-3101 in the US and Japan for the treatment of inflammatory bowel disease and potentially multiple other diseasesRVT-3101 is a Phase 3-ready antibody with first-in-class and best-in-disease potential, a novel mode of action and strong Phase 2b data in ulcerative colitisRoche will also obtain an option to enter into a global collaboration with Pfizer on a next-generation p40/TL1A directed bispecific antibody, currently in Phase 1Under the terms of the agreement, Roche will pay a purchase price of $7.1 billion upfront and a near-term milestone payment of $150 millionRoivant will host an investor call at 8AM ET on Monday, O
- Roivant Announces Positive Initial IMVT-1402 Phase 1 SAD and 300 mg Subcutaneous MAD ResultsIMVT-1402 subcutaneous (SC) doses achieved peak Immunoglobulin G (IgG) reductions that are similar to those previously observed with batoclimabNo decrease in serum albumin below baseline or increase in low-density lipoprotein cholesterol (LDL-C) above baseline was observed after 4 weeks of dosing in the 300 mg multiple-ascending dose (MAD) SC cohortIMVT-1402 is being developed as a simple SC injection NEW YORK, Sept. 26, 2023 (GLOBE NEWSWIRE) -- Immunovant, Inc. (NASDAQ:IMVT), a clinical-stage immunology company dedicated to enabling normal lives for people with autoimmune diseases, today announced that subcutaneously administered doses of IMVT-1402 produced dose-dependent reductions in
- Roivant Reports Financial Results for the First Quarter Ended June 30, 2023, and Provides Business UpdateRVT-3101 demonstrated improved efficacy results from the induction to chronic period in the TUSCANY-2 Phase 2b study in ulcerative colitis and was well tolerated with a favorable safety profile across all dosesFirst patient has been dosed in the TAHOE study, a global Phase 2 trial of RVT-3101 in Crohn's disease, with topline data from the induction portion expected in the fourth quarter of calendar year 2024Initial data from the Phase 1 clinical trial of IMVT-1402 remains on track for September 2023 (single-ascending dose) and October / November 2023 (multiple-ascending dose)VTAMA® (tapinarof) net product revenue was $16.7M for the quarter ended June 30, 2023, with nearly 200,000 prescriptio
- Roivant to Report Financial Results for the Quarter Ended June 30, 2023, and Provide Business Update on Monday, August 14, 2023BASEL, Switzerland and LONDON and NEW YORK, Aug. 03, 2023 (GLOBE NEWSWIRE) -- Roivant (NASDAQ:ROIV) today announced that it will host a live conference call and webcast at 8:00 a.m. ET on Monday, August 14, 2023, to report its financial results for the quarter ended June 30, 2023, and provide a business update. To access the conference call by phone, please register online using this registration link. The presentation and webcast details will also be available under "Events & Presentations" in the Investors section of the Roivant website at https://investor.roivant.com/news-events/events. The archived webcast will be available on Roivant's website after the conference call. About Roivan
- Roivant Reports Financial Results for the Fourth Quarter and Fiscal Year Ended March 31, 2023, and Provides Business UpdateRVT-3101 demonstrated improved efficacy results from the induction to chronic period in the TUSCANY-2 Phase 2b study in ulcerative colitis and was well tolerated with a favorable safety profile across all dosesA Phase 2 study of RVT-3101 in Crohn's disease has been initiated with topline data expected in the fourth quarter of calendar year 2024VTAMA® (tapinarof) net product revenue was $13.7M for the quarter and $28.0M for the fiscal year ended March 31, 2023, with over 170,000 prescriptions written by approximately 11,000 unique prescribers since launchVTAMA® gross-to-net yield was 25% for the quarter ended March 31, 2023, and as of June 2023, coverage has been expanded to 125 million US co
- Roivant to Report Financial Results for the Fourth Quarter and Fiscal Year Ended March 31, 2023, and Provide Business Update on Wednesday, June 28, 2023BASEL, Switzerland and LONDON and NEW YORK and BOSTON, June 26, 2023 (GLOBE NEWSWIRE) -- Roivant Sciences (NASDAQ:ROIV) today announced that it will host a live conference call and webcast at 8:00 a.m. ET on Wednesday, June 28, 2023, to report its financial results for the fourth quarter and fiscal year ended March 31, 2023, and provide business update. To access the conference call by phone, please register online using this registration link. The presentation and webcast details will also be available under "Events & Presentations" in the Investors section of the Roivant website at https://investor.roivant.com/news-events/events. The archived webcast will be available on Roivant's websi
- Roivant Reports Chronic Period Data for RVT-3101 from the TUSCANY-2 Phase 2b Study in Ulcerative Colitis, Demonstrating Improved Efficacy from the Induction to Chronic PeriodThis is the first-ever long-duration data reported for an anti-TL1A antibodyAt the expected Phase 3 once-monthly subcutaneous dose in the overall population, RVT-3101 treatment resulted in improved Clinical Remission1 (36% at week 56 vs. 29% at week 14) and Endoscopic Improvement2 (50% vs. 36%)At the expected Phase 3 once-monthly subcutaneous dose in the biomarker positive population, RVT-3101 treatment resulted in improved Clinical Remission (43% at week 56 vs. 33% at week 14) and Endoscopic Improvement (64% vs. 47%)Across all patients dosed in the chronic period, RVT-3101 treatment produced clinically meaningful efficacy results, which improved between the induction and chronic period acro
- Roivant Reports Positive Topline Results from ADORING 2 Atopic Dermatitis Phase 3 Trial of VTAMA® (tapinarof) Cream, 1% Once Daily in Adults and Children as Young as 2 Years Old46.4% of subjects receiving VTAMA cream, 1% achieved the primary endpoint of Validated Investigator Global Assessment for Atopic Dermatitis (vIGA-ADTM) response of clear (0) or almost clear (1) with at least a 2-grade improvement from baseline at Week 8, versus 18.0% on vehicle (P<0.0001)All secondary endpoints were met with a high degree of statistical significance, including 59.1% of subjects treated with VTAMA cream who achieved the key secondary endpoint of EASI75 (P<0.0001)Meaningful impact on the key secondary endpoint of pruritus (itch) was demonstrated with 52.8% of subjects ≥12 years old, with a baseline PP-NRS score ≥4, achieving a ≥4-point reduction in the PP-NRS at Week 8 (P=0.00
- Dermavant Reports Positive Topline Results from ADORING 2 Atopic Dermatitis Phase 3 Trial of VTAMA® (tapinarof) Cream, 1% Once Daily in Adults and Children as Young as 2 Years Old- 46.4% of subjects receiving VTAMA cream, 1% achieved the primary endpoint of Validated Investigator Global Assessment for Atopic Dermatitis (vIGA-ADTM) response of clear (0) or almost clear (1) with at least a 2-grade improvement from baseline at Week 8, versus 18.0% on vehicle (P<0.0001) - All secondary endpoints were met with a high degree of statistical significance, including 59.1% of subjects treated with VTAMA cream who achieved the key secondary endpoint of EASI75 (P<0.0001) - Meaningful impact on the key secondary endpoint of pruritus (itch) was demonstrated with 52.8% of subjects ≥12 years old, with a baseline PP-NRS score ≥4, achieving a ≥4-point reduction in the PP-NRS at Wee
- Roivant Announces Statistically Significant and Clinically Meaningful Results from the Induction Period of TUSCANY-2, a Large Global Phase 2b Study of Subcutaneous RVT-3101 for the Treatment of Ulcerative Colitis in Both the Overall and the Biomarker Positive Patient PopulationsRVT-3101 demonstrated statistically significant and clinically meaningful efficacy at each dose testedAcross all patients treated with RVT-3101, the clinical remission and endoscopic improvement rates were 32% and 40%, respectively. Similar results were observed at the expected Phase 3 doseAt the expected Phase 3 dose, among patients who were positive for a biomarker that was prospectively defined in TUSCANY-2, clinical remission and endoscopic improvement rates were 40% and 56%, respectively. Approximately 60% of patients were identified as positive for this biomarkerAt the expected Phase 3 dose, among patients who had been previously treated with biologics and who were biomarker positive,
- Roivant Sciences Reports Financial Results for the Second Quarter Ended September 30, 2022 and Provides Business UpdateExpected cash runway extended into the second half of calendar year 2025First major PBM/payer contract signed for VTAMA, effective October 1Over 54,000 VTAMA prescriptions written by approximately 6,400 prescribers since launch show strong demand, with fiscal Q2 2022 net product revenue of $5.0 millionUnveiled IMVT-1402, a next generation anti-FcRn which showed deep IgG lowering similar to batoclimab with no or minimal impact observed on albumin and LDL (low-density lipoprotein) levels in animal studiesCompleted enrollment for potentially registrational trial for brepocitinib in systemic lupus erythematosus (SLE), with topline data on track to be announced in the second half of calendar year
- Roivant Sciences to Report Financial Results for the Second Quarter Ended September 30, 2022 on Monday, November 14, 2022 and Present at Upcoming ConferencesInvestor call and webcast scheduled for Monday, November 14 at 8:00 a.m. ESTRoivant will present at investor conferences in November BASEL, Switzerland and LONDON and NEW YORK and BOSTON, Oct. 18, 2022 (GLOBE NEWSWIRE) -- Roivant Sciences (NASDAQ:ROIV) today announced that it will host a live conference call and webcast at 8:00 a.m. EST on Monday, November 14, 2022 to report its financial results for the second quarter ended September 30, 2022 and provide a corporate update. To access the conference call by phone, please register online using this registration link. A webcast of the call will also be available under "Events & Presentations" in the Investors section of the Roivant w
- Roivant Sciences Reports Financial Results for the First Quarter Ended June 30, 2022 and Provides Business UpdateEarly launch data for VTAMA® (tapinarof) with approximately 14,000 prescriptions written by more than 3,000 unique prescribers in initial eleven weeks of launch shows strong demand for first topical novel chemical entity for plaque psoriasis in 25 yearsThe Journal of the American Academy of Dermatology (JAAD) published the Phase 3 long-term extension study highlighting the unique mechanism for the remittive effect of VTAMA showing mean duration off-therapy for patients achieving PGA=0 was 130 daysDermavant's Japanese partner reported positive Phase 3 data for tapinarof for the treatment of atopic dermatitis (AD), including statistically significant results on the IGA and EASI scores, and pla
- Roivant Sciences to Report Financial Results for the Quarter Ended June 30, 2022 on Monday, August 15, 2022Investor call and webcast scheduled for Monday, August 15 at 8:00 a.m. EDTRoivant will host an investor day on Wednesday, September 28 at 11:00 a.m. EDT BASEL, Switzerland and LONDON and NEW YORK and BOSTON, Aug. 03, 2022 (GLOBE NEWSWIRE) -- Roivant Sciences (NASDAQ:ROIV), a biopharmaceutical company dedicated to improving the delivery of healthcare to patients, today announced that it will host a live conference call and webcast at 8:00 a.m. EDT on Monday, August 15, 2022 to report its financial results for the first quarter ended June 30, 2022 and provide a corporate update. To access the conference call by phone, please register online using this registration link. A webcast of the ca