Articles from Roivant Sciences

BASEL, 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.

BASEL, Switzerland and LONDON and NEW YORK, Dec. 03, 2024 (GLOBE NEWSWIRE) --  Kinevant Sciences, a clinical-stage biopharmaceutical company developing new medicines for rare inflammatory and autoimmune diseases, today announced its Phase 2 study failed to show treatment benefit in patients with chronic active pulmonary sarcoidosis. The Phase 2 RESOLVE-Lung study (NCT05314517) evaluated the efficacy and safety of namilumab, an investigational anti-GM-CSF monoclonal antibody administered once-monthly as a subcutaneous injection, in participants with chronic active pulmonary sarcoidosis.

BASEL, Switzerland and LONDON and NEW YORK, Dec. 03, 2024 (GLOBE NEWSWIRE) -- Kinevant Sciences, a clinical-stage biopharmaceutical company developing new medicines for rare inflammatory and autoimmune diseases, today announced its Phase 2 study failed to show treatment benefit in patients with chronic active pulmonary sarcoidosis. The Phase 2 RESOLVE-Lung study (NCT05314517) evaluated the efficacy and safety of namilumab, an investigational anti-GM-CSF monoclonal antibody administered once-monthly as a subcutaneous injection, in participants with chronic active pulmonary sarcoidosis.

BASEL, 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.

BASEL, 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.

The acquisition expands Organon’s dermatology capabilities with a nonbiologic, non-steroidal topical treatment in the U.S.

VTAMA cream is a novel, non-steroidal topical therapy approved for treatment of plaque psoriasis in adults and is under FDA review for an additional indication to treat atopic dermatitis

WALTHAM, Mass., Sept. 10, 2024 (GLOBE NEWSWIRE) -- Pulmovant, a Roivant (Nasdaq: ROIV) company, today announced the presentation of data from the proof-of-concept Phase 1b ATMOS1 study during the ERS Congress in Vienna, Austria. ATMOS (NCT03754660) evaluated mosliciguat, a potential first-in-class, inhaled sGC activator with targeted delivery to the lungs and once-daily administration, in PH patients.

BASEL, Switzerland and LONDON and NEW YORK, Sept. 10, 2024 (GLOBE NEWSWIRE) -- Roivant (Nasdaq: ROIV) today announced its previously undisclosed pipeline program mosliciguat, a potential first-in-class, inhaled, once-daily sGC activator with targeted delivery to the lungs via dry powder inhaler, at Pulmovant. Pulmovant presented data from the proof-of-concept Phase 1b ATMOS study during the ERS Congress in Vienna, Austria.

NEW YORK, Sept. 09, 2024 (GLOBE NEWSWIRE) -- Immunovant, Inc. (Nasdaq: IMVT), a clinical-stage immunology company dedicated to enabling normal lives for people with autoimmune diseases, today reported positive results from the Phase 2a trial of batoclimab in Graves’ Disease. Immunovant also disclosed data from several proprietary market research studies that showed a consistent unmet need among ATD treated patients who are intolerant to, uncontrolled on or relapsed after ATDs. Finally, Immunovant also announced alignment with the U.S. Food & Drug Administration (FDA) and Investigational New Drug Application (IND) clearance with initiation of a pivotal trial of IMVT-1402 in GD expected by December 31, 2024.

BASEL, 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.

BASEL, 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.

BASEL, 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.

BASEL, 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.

BASEL, Switzerland and LONDON and NEW YORK, April 02, 2024 (GLOBE NEWSWIRE) -- Roivant (Nasdaq: ROIV) and Priovant Therapeutics today announced positive results from the Phase 2 study (NEPTUNE) evaluating brepocitinib in non-anterior non-infectious uveitis (NIU), showing the strongest efficacy data in NIU observed to date. Roivant also announced that its board of directors has authorized a share repurchase program for up to $1.5 billion of the company’s common shares, including the repurchase of all 71.3 million shares held by Sumitomo Pharma at a purchase price of $9.10 per share. The aggregate purchase price for the Sumitomo Pharma transaction is approximately $648.4 million and will reduce Roivant’s shares outstanding as of February 9, 2024 by approximately 9%.

BASEL, 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.

BASEL, 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.

NEW YORK, Dec. 20, 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 results from the initial cohort of patients in an ongoing 24-week Phase 2 clinical trial of batoclimab in patients with Graves’ disease meaningfully exceeded 50% response rates.

BASEL, Switzerland and LONDON and NEW YORK, Dec. 14, 2023 (GLOBE NEWSWIRE) -- Roivant (Nasdaq: ROIV) announced today the completion of the previously announced acquisition by Roche (SIX: RO, ROG; OTCQX: RHHBY) of Telavant, for an upfront payment of approximately $7.1 billion. Telavant holds the rights in the US and Japan to RVT-3101, a promising new therapy in development for people suffering from inflammatory bowel disease, including ulcerative colitis and Crohn’s disease. Prior to the closing of the transaction, Roivant owned 75% of the issued and outstanding shares of common stock and preferred stock of Telavant, on an as-converted basis. An additional payment of $150 million in cash is payable upon the completion of a near-term milestone.

NEW YORK, Nov. 28, 2023 (GLOBE NEWSWIRE) -- Immunovant, Inc. (Nasdaq: IMVT), a clinical-stage immunology company dedicated to enabling normal lives for people with autoimmune diseases, today announced initial data from 600 mg MAD cohort of a Phase 1 clinical trial of IMVT-1402 in healthy adults. The results show that four subcutaneously administered doses of 600 mg produced a mean IgG reduction similar to high dose batoclimab, but with minimal changes in albumin and LDL-C similar to those in placebo, confirming the potential of IMVT-1402 as a best-in-class neonatal fragment crystallizable receptor (FcRn) inhibitor.

BASEL, Switzerland and LONDON and NEW YORK, Nov. 27, 2023 (GLOBE NEWSWIRE) -- Roivant (Nasdaq: ROIV) and Priovant today announced the Phase 2 study evaluating oral brepocitinib in adult patients with moderate to severe active lupus did not meet its primary endpoint of Systemic Lupus Erythematosus Responder Index change of 4 (SRI-4) at Week 52. Priovant plans to disclose the study data at a future date.

BASEL, Switzerland and LONDON and NEW YORK, Nov. 13, 2023 (GLOBE NEWSWIRE) -- Roivant (Nasdaq: ROIV) today reported its financial results for the second quarter ended September 30, 2023, and provided an update on the business.

BASEL, Switzerland and LONDON and NEW YORK, Nov. 10, 2023 (GLOBE NEWSWIRE) -- Roivant (Nasdaq: ROIV) today announced the appointment of Mayukh Sukhatme, M.D., to its Board of Directors, effective immediately. Dr. Sukhatme will fill a newly created Class III seat on the Board of Directors, increasing the Board of Directors to eight members in total.

BASEL, 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.

BASEL, Switzerland and LONDON and NEW YORK, Oct. 23, 2023 (GLOBE NEWSWIRE) -- Roivant (Nasdaq: ROIV) announced today the entry into a definitive agreement with Roche (SIX: RO, ROG; OTCQX: RHHBY) to acquire Telavant Holdings, Inc. (Telavant), a Roivant company, owned by Roivant Sciences Ltd. and Pfizer Inc. The agreement includes the development, manufacturing and commercialization rights in the US and Japan for RVT-3101, a novel TL1A directed antibody. RVT-3101 is a promising new therapy in development for people suffering from inflammatory bowel disease, including ulcerative colitis and Crohn’s disease. Inflammatory bowel disease is a group of chronic gastrointestinal disorders with almost 8 million people diagnosed worldwide and 80% of all individuals not experiencing lasting remission.1 Given the antibody’s novel mode of action targeting both inflammation and fibrosis, it has potential to be applied in multiple other diseases.

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 IgG in initial data from a Phase 1 clinical trial in healthy adults, with no dose-related changes in serum albumin or LDL-C, bolstering IMVT-1402 as a potential best-in-class neonatal fragment crystallizable receptor (FcRn) inhibitor.

BASEL, Switzerland and LONDON and NEW YORK, Sept. 11, 2023 (GLOBE NEWSWIRE) -- Roivant (Nasdaq: ROIV) today announced that it completed the redemption of its outstanding public warrants (the “Public Warrants”) and private placement warrants (the “Private Placement Warrants” and, together with the Public Warrants, the “Warrants”) that remained outstanding following 5:00 p.m. New York City Time on September 1, 2023 (the “Redemption Date”) for a redemption price of $0.10 per Warrant (the “Redemption Price”).

BASEL, Switzerland and LONDON and NEW YORK, Aug. 17, 2023 (GLOBE NEWSWIRE) -- Roivant (Nasdaq: ROIV) today announced the “Redemption Fair Market Value” to be used in connection with the previously announced redemption of its outstanding public warrants (the “Public Warrants”) and private placement warrants (the “Private Placement Warrants” and, together with the Public Warrants, the “Warrants”). The Redemption Fair Market Value will be used to determine the number of Roivant common shares (the “Common Shares”) that will be issued in connection with a Make-Whole Exercise (as defined below) of a Warrant, subject to the terms of the Warrant Agreement (as defined below).

BASEL, Switzerland and LONDON and NEW YORK, Aug. 14, 2023 (GLOBE NEWSWIRE) -- Roivant (Nasdaq: ROIV) today reported its financial results for the first quarter ended June 30, 2023, and provided an update on the business.

BASEL, 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.

BASEL, Switzerland and LONDON and NEW YORK, Aug. 02, 2023 (GLOBE NEWSWIRE) -- Roivant (Nasdaq: ROIV) today announced that it will redeem all of its outstanding public warrants (the “Public Warrants”) and private placement warrants (the “Private Placement Warrants” and, together with the Public Warrants, the “Warrants”) to purchase Roivant’s common shares (the “Common Shares”) pursuant to its Warrant Agreement dated September 30, 2021 with Equiniti Trust Company, LLC (formerly American Stock Transfer & Trust Company, LLC) as successor warrant agent (the “Warrant Agent”) (the “Warrant Agreement”), that remain outstanding following 5:00 p.m. New York City Time on September 1, 2023 (the “Redemption Date”) for a redemption price of $0.10 per Warrant (the “Redemption Price”).

NEW YORK and BASEL, Switzerland, July 27, 2023 (GLOBE NEWSWIRE) -- Telavant, a clinical-stage biopharmaceutical company dedicated to developing and commercializing innovative therapeutics to help patients living with inflammatory and fibrotic diseases, announced today the initiation of the TAHOE study, a Phase 2 clinical trial of RVT-3101 for the treatment of moderate to severely active CD, with first patient dosed.

Joining Adobe, Spotify, Nvidia, Morgan Stanley, and many others

BASEL, Switzerland, and LONDON, and NEW YORK, June 28, 2023 (GLOBE NEWSWIRE) -- Roivant (Nasdaq: ROIV) today reported its financial results for the fourth quarter and fiscal year ended March 31, 2023, and provided an update on the business.

BASEL, Switzerland, and LONDON, and NEW YORK, June 28, 2023 (GLOBE NEWSWIRE) -- Roivant (Nasdaq: ROIV) today reported its financial results for the fourth quarter and fiscal year ended March 31, 2023, and provided an update on the business.

BASEL, 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.

BASEL, Switzerland and LONDON and NEW YORK and BOSTON, June 22, 2023 (GLOBE NEWSWIRE) -- Roivant Sciences (Nasdaq: ROIV) today announced positive results from the chronic period of the TUSCANY-2 Phase 2b study of RVT-3101, a once-monthly subcutaneously administered anti-TL1A antibody.

BASEL, Switzerland and LONDON and NEW YORK and BOSTON, June 21, 2023 (GLOBE NEWSWIRE) -- Roivant Sciences (Nasdaq: ROIV) today announced that it will host a live investor call and webcast at 8:00 AM ET on Thursday, June 22 to review results from the chronic period of TUSCANY-2, a large global Phase 2b study of RVT-3101 (anti-TL1A antibody) in ulcerative colitis.

LONG BEACH, Calif. and BASEL, Switzerland, May 16, 2023 (GLOBE NEWSWIRE) -- Dermavant Sciences, a Roivant Sciences (Nasdaq: ROIV) company dedicated to developing and commercializing innovative therapeutics in immuno-dermatology, today announced positive results from ADORING 1, the second of two double-blind, randomized, vehicle-controlled Phase 3 studies to evaluate the efficacy and safety of topical VTAMA® (tapinarof) cream, 1% in adults and pediatric subjects down to 2 years old with moderate to severe atopic dermatitis (AD).

LONG BEACH, Calif. and BASEL, Switzerland, March 15, 2023 (GLOBE NEWSWIRE) -- Dermavant Sciences, a Roivant Sciences (Nasdaq: ROIV) company dedicated to developing and commercializing innovative therapeutics in immuno-dermatology, today announced positive results from ADORING 2, one of two double-blind, randomized, vehicle-controlled Phase 3 studies to evaluate the efficacy and safety of topical VTAMA® (tapinarof) cream, 1% in pediatric subjects down to 2 years old and adult subjects with atopic dermatitis (AD).

BASEL, Switzerland and LONDON and NEW YORK and BOSTON, March 14, 2023 (GLOBE NEWSWIRE) -- Roivant Sciences (Nasdaq: ROIV) today announced that it will host a live investor call and webcast at 8:00 AM ET on Wednesday, March 15 to review topline results from the ADORING 2 study, one of two replicate Phase 3 studies in atopic dermatitis.

PVTX-321 and PVTX-405 Achieve Development Candidate Nomination

BOSTON, March 07, 2023 (GLOBE NEWSWIRE) -- Covant Therapeutics, an innovative covalent drug discovery company incubated by Roivant Sciences (Nasdaq: ROIV), today announced the formation of its Scientific Advisory Board (SAB). Covant uses its unprecedented high-throughput chemoproteomics platform to discover novel small molecule therapeutics against hard-to-drug immunology and oncology targets.

BASEL, Switzerland and LONDON and NEW YORK and BOSTON, Feb. 21, 2023 (GLOBE NEWSWIRE) -- Roivant Sciences (Nasdaq: ROIV) today announced that its founder Vivek Ramaswamy has stepped down from the company’s board of directors to focus on his U.S. presidential campaign.

BASEL, Switzerland and LONDON and NEW YORK and BOSTON, Feb. 13, 2023 (GLOBE NEWSWIRE) -- Roivant Sciences (Nasdaq: ROIV) today reported its financial results for the third quarter ended December 31, 2022, and provided an update on the Company’s operations.

BASEL, Switzerland and LONDON and NEW YORK and BOSTON, Feb. 02, 2023 (GLOBE NEWSWIRE) -- Roivant Sciences (Nasdaq: ROIV) today announced the pricing of an upsized underwritten public offering of 26,666,666 of its common shares at a price to the public of $7.50 per share. All of the common shares to be sold in the offering are to be sold by Roivant. The gross proceeds to Roivant from the offering, before deducting the underwriting discounts and commissions and other offering expenses, are expected to be $200 million. In addition, Roivant has granted the underwriters a 30-day option to purchase up to an additional 3,999,999 common shares on the same terms and conditions. The offering is expected to close on February 7, 2023, subject to customary closing conditions.

BASEL, Switzerland and LONDON and NEW YORK and BOSTON, Feb. 01, 2023 (GLOBE NEWSWIRE) -- Roivant Sciences Ltd. (Nasdaq: ROIV) announced today that it has commenced an underwritten public offering of $150 million of common shares. In addition, Roivant expects to grant the underwriters a 30-day option to purchase up to an additional $22.5 million of common shares. All of the common shares are being offered by Roivant. The proposed offering is subject to market conditions and other factors, and there can be no assurance as to whether or when the offering may be completed, or as to the actual size or terms of the offering.

BASEL, Switzerland and LONDON and NEW YORK and BOSTON, Jan. 30, 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 Monday, February 13, 2023, to report its financial results for the third quarter ended December 31, 2022 and provide a corporate update.

BASEL, Switzerland and LONDON and NEW YORK and BOSTON, Jan. 04, 2023 (GLOBE NEWSWIRE) -- Roivant Sciences (Nasdaq: ROIV) today announced positive results from the induction period of the TUSCANY-2 Phase 2b study of RVT-3101 (previously PF-06480605), a once monthly subcutaneously administered anti-TL1A antibody which demonstrated statistically significant and clinically meaningful efficacy results at each dose tested. RVT-3101 was well tolerated and showed a favorable safety profile. RVT-3101 will progress into registrational studies as a potential best-in-class and first-in-class subcutaneous therapy in ulcerative colitis.

BASEL, Switzerland and LONDON and NEW YORK and BOSTON, Dec. 01, 2022 (GLOBE NEWSWIRE) -- Roivant Sciences (Nasdaq: ROIV) and Pfizer Inc. (NYSEPFE) today announced formation of a new Vant to develop and commercialize PF-06480605 (now RVT-3101). RVT-3101 is a fully human monoclonal antibody targeting TL1A, which is currently in Phase 2b development in ulcerative colitis (UC). The Vant has the exclusive option to collaborate with Pfizer on a next-generation TL1A directed antibody which recently entered Phase 1.   

BASEL, Switzerland and LONDON and NEW YORK and BOSTON, Nov. 14, 2022 (GLOBE NEWSWIRE) -- Roivant Sciences Ltd. (Nasdaq: ROIV) today reported its financial results for the second quarter ended September 30, 2022 and provided an update on the Company’s operations.

NEW YORK and BASEL, Switzerland, Nov. 10, 2022 (GLOBE NEWSWIRE) -- Affivant, a biotechnology company dedicated to developing novel immune-oncology approaches to activate and enable the innate immune system to fight cancer, will present a poster at the 37th Annual Meeting of The Society for Immunotherapy of Cancer (SITC) highlighting preclinical data for AFVT-2101 (previously AFM32).

BASEL, Switzerland and LONDON and NEW YORK and BOSTON, Nov. 08, 2022 (GLOBE NEWSWIRE) -- Roivant Sciences Ltd. (Nasdaq: ROIV), a next-generation biopharmaceutical company dedicated to improving the delivery of healthcare to patients, announced today the pricing of its primary and secondary public offering of 30,000,000 common shares of Roivant, consisting of 20,000,000 common shares offered by Roivant and 10,000,000 common shares offered by the selling shareholders at a price to the public of $5.00 per share for total gross proceeds of $150 million, consisting of total gross proceeds to Roivant of approximately $100 million and total gross proceeds to the selling shareholders of approximately $50 million. In addition, Roivant has granted the underwriter a 30-day option to purchase up to $22.5 million additional common shares. Roivant expects its cash position will be sufficient to fund its operating expenses and capital expenditure requirements into the second half of calendar year 2025. Roivant will not receive any of the proceeds from the sale of its common shares by the selling shareholders. The offering is expected to close on November 10, 2022, subject to customary closing conditions.

BASEL, Switzerland, LONDON, NEW YORK, and BOSTON, Nov. 07, 2022 (GLOBE NEWSWIRE) -- Roivant Sciences Ltd. (Nasdaq: ROIV), a next-generation biopharmaceutical company dedicated to improving the delivery of healthcare to patients, announced today the commencement of a proposed underwritten public offering of $150,000,000 of common shares. Roivant expects to grant the underwriter a 30-day option to purchase up to $22.5 million of additional common shares. The offering is subject to market conditions and other factors, and there can be no assurance as to whether or when the offering may be completed, or as to the actual size or terms of the offering.

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.