http://new.streetinsider.com Latest StreetInsider.com News Articles en-us Copyright 2026, StreetInsider.com rss@streetinsider.com (SI RSS) rss@streetinsider.com (SI RSS) Thu, 27 Aug 2026 15:29:36 -0400 http://blogs.law.harvard.edu/tech/rss http://www.streetinsider.com/images/rss_logo.gif http://new.streetinsider.com 143 28 0 1 2 3 21 22 23 Saturday Sunday http://www.streetinsider.com/FDA/FDA+approves+Roivant%27s+brepocitinib+pill+for+dermatomyositis/26989389.html <p>Roivant Sciences (Nasdaq: ROIV) announced that the U.S. Food and Drug Administration has approved LISRAYA (brepocitinib) 30 mg, a once-daily oral pill, for the treatment of adults with dermatomyositis, a rare systemic autoimmune disease. The drug is available immediately in the United States through a limited network of specialty pharmacies.</p> <p>LISRAYA is described by the company as a TYK2/JAK1 inhibitor and is the first targeted therapy approved specifically for dermatomyositis. The FDA had previously granted the drug Priority Review and Orphan Drug Designation.</p> <p>Approval was supported by data from the Phase 3 VALOR trial. In that study, 55% of patients treated with http://www.streetinsider.com/FDA/FDA+approves+Roivant%27s+brepocitinib+pill+for+dermatomyositis/26989389.html Thu, 27 Aug 2026 15:29:36 -0400 A.06822034 A.31368885 O.20026344 O.26308322 O.49918125 ROIV ROIVW http://www.streetinsider.com/FDA/FDA+approves+Roivant%27s+brepocitinib+pill+for+dermatomyositis/26989389.html <p>Roivant Sciences (Nasdaq: ROIV) announced that the U.S. Food and Drug Administration has approved LISRAYA (brepocitinib) 30 mg, a once-daily oral pill, for the treatment of adults with dermatomyositis, a rare systemic autoimmune disease. The drug is available immediately in the United States through a limited network of specialty pharmacies.</p> <p>LISRAYA is described by the company as a TYK2/JAK1 inhibitor and is the first targeted therapy approved specifically for dermatomyositis. The FDA had previously granted the drug Priority Review and Orphan Drug Designation.</p> <p>Approval was supported by data from the Phase 3 VALOR trial. In that study, 55% of patients treated with http://www.streetinsider.com/FDA/FDA+approves+Roivant%27s+brepocitinib+pill+for+dermatomyositis/26989389.html Thu, 27 Aug 2026 15:29:36 -0400 A.06822034 A.31368885 O.20026344 O.26308322 O.49918125 ROIV ROIVW http://www.streetinsider.com/FDA/FDA+approves+Roivant%27s+brepocitinib+pill+for+dermatomyositis/26989389.html <p>Roivant Sciences (Nasdaq: ROIV) announced that the U.S. Food and Drug Administration has approved LISRAYA (brepocitinib) 30 mg, a once-daily oral pill, for the treatment of adults with dermatomyositis, a rare systemic autoimmune disease. The drug is available immediately in the United States through a limited network of specialty pharmacies.</p> <p>LISRAYA is described by the company as a TYK2/JAK1 inhibitor and is the first targeted therapy approved specifically for dermatomyositis. The FDA had previously granted the drug Priority Review and Orphan Drug Designation.</p> <p>Approval was supported by data from the Phase 3 VALOR trial. In that study, 55% of patients treated with http://www.streetinsider.com/FDA/FDA+approves+Roivant%27s+brepocitinib+pill+for+dermatomyositis/26989389.html Thu, 27 Aug 2026 15:29:36 -0400 A.06822034 A.31368885 O.20026344 O.26308322 O.49918125 ROIV ROIVW http://www.streetinsider.com/FDA/FDA+approves+Roivant%27s+brepocitinib+pill+for+dermatomyositis/26989389.html <p>Roivant Sciences (Nasdaq: ROIV) announced that the U.S. Food and Drug Administration has approved LISRAYA (brepocitinib) 30 mg, a once-daily oral pill, for the treatment of adults with dermatomyositis, a rare systemic autoimmune disease. The drug is available immediately in the United States through a limited network of specialty pharmacies.</p> <p>LISRAYA is described by the company as a TYK2/JAK1 inhibitor and is the first targeted therapy approved specifically for dermatomyositis. The FDA had previously granted the drug Priority Review and Orphan Drug Designation.</p> <p>Approval was supported by data from the Phase 3 VALOR trial. In that study, 55% of patients treated with http://www.streetinsider.com/FDA/FDA+approves+Roivant%27s+brepocitinib+pill+for+dermatomyositis/26989389.html Thu, 27 Aug 2026 15:29:36 -0400 A.06822034 A.31368885 O.20026344 O.26308322 O.49918125 ROIV ROIVW http://www.streetinsider.com/FDA/FDA+approves+Roivant%27s+brepocitinib+pill+for+dermatomyositis/26989389.html <p>Roivant Sciences (Nasdaq: ROIV) announced that the U.S. Food and Drug Administration has approved LISRAYA (brepocitinib) 30 mg, a once-daily oral pill, for the treatment of adults with dermatomyositis, a rare systemic autoimmune disease. The drug is available immediately in the United States through a limited network of specialty pharmacies.</p> <p>LISRAYA is described by the company as a TYK2/JAK1 inhibitor and is the first targeted therapy approved specifically for dermatomyositis. The FDA had previously granted the drug Priority Review and Orphan Drug Designation.</p> <p>Approval was supported by data from the Phase 3 VALOR trial. In that study, 55% of patients treated with http://www.streetinsider.com/FDA/FDA+approves+Roivant%27s+brepocitinib+pill+for+dermatomyositis/26989389.html Thu, 27 Aug 2026 15:29:36 -0400 A.06822034 A.31368885 O.20026344 O.26308322 O.49918125 ROIV ROIVW http://www.streetinsider.com/FDA/FDA+approves+Roivant%27s+brepocitinib+pill+for+dermatomyositis/26989389.html <p>Roivant Sciences (Nasdaq: ROIV) announced that the U.S. Food and Drug Administration has approved LISRAYA (brepocitinib) 30 mg, a once-daily oral pill, for the treatment of adults with dermatomyositis, a rare systemic autoimmune disease. The drug is available immediately in the United States through a limited network of specialty pharmacies.</p> <p>LISRAYA is described by the company as a TYK2/JAK1 inhibitor and is the first targeted therapy approved specifically for dermatomyositis. The FDA had previously granted the drug Priority Review and Orphan Drug Designation.</p> <p>Approval was supported by data from the Phase 3 VALOR trial. In that study, 55% of patients treated with http://www.streetinsider.com/FDA/FDA+approves+Roivant%27s+brepocitinib+pill+for+dermatomyositis/26989389.html Thu, 27 Aug 2026 15:29:36 -0400 A.06822034 A.31368885 O.20026344 O.26308322 O.49918125 ROIV ROIVW http://www.streetinsider.com/FDA/FDA+approves+Roivant%27s+brepocitinib+pill+for+dermatomyositis/26989389.html <p>Roivant Sciences (Nasdaq: ROIV) announced that the U.S. Food and Drug Administration has approved LISRAYA (brepocitinib) 30 mg, a once-daily oral pill, for the treatment of adults with dermatomyositis, a rare systemic autoimmune disease. The drug is available immediately in the United States through a limited network of specialty pharmacies.</p> <p>LISRAYA is described by the company as a TYK2/JAK1 inhibitor and is the first targeted therapy approved specifically for dermatomyositis. The FDA had previously granted the drug Priority Review and Orphan Drug Designation.</p> <p>Approval was supported by data from the Phase 3 VALOR trial. In that study, 55% of patients treated with http://www.streetinsider.com/FDA/FDA+approves+Roivant%27s+brepocitinib+pill+for+dermatomyositis/26989389.html Thu, 27 Aug 2026 15:29:36 -0400 A.06822034 A.31368885 O.20026344 O.26308322 O.49918125 ROIV ROIVW http://www.streetinsider.com/Press+Releases/Roivant+Announces+FDA+Approval+of+LISRAYA%E2%84%A2+%28brepocitinib%29+for+Adults+with+Dermatomyositis%3B+Now+Available+in+the+U.S./26989382.html <ul type="disc"><li style="margin-bottom:8pt;">LISRAYA represents the first major therapeutic innovation in decades for adults with dermatomyositis (DM), a debilitating systemic autoimmune disease</li><li style="margin-bottom:8pt;">LISRAYA is a once-daily pill that directly targets key immune pathways implicated in dermatomyositis pathogenesis</li><li style="margin-bottom:8pt;">LISRAYA demonstrated robust efficacy on multiple measures of DM disease activity, accompanied by substantial steroid-sparing benefits, in the largest dermatomyositis clinical trial ever conducted</li><li style="margin-bottom:8pt;">LISRAYA is available immediately in the U.S.</li><li style="margin-bottom:8pt;">Eligible patients may pay as little as $0 per month through the LISRAYA My Compass Support program.</li><li style="margin-bottom:8pt;">Roivant will host an investor call to discuss these updates tomorrow, August 28, 2026, at 8:00 http://www.streetinsider.com/Press+Releases/Roivant+Announces+FDA+Approval+of+LISRAYA%E2%84%A2+%28brepocitinib%29+for+Adults+with+Dermatomyositis%3B+Now+Available+in+the+U.S./26989382.html Thu, 27 Aug 2026 15:29:00 -0400 A.06822034 A.31368885 O.20026344 O.26308322 O.49918125 ROIV ROIVW http://www.streetinsider.com/Press+Releases/Roivant+Announces+FDA+Approval+of+LISRAYA%E2%84%A2+%28brepocitinib%29+for+Adults+with+Dermatomyositis%3B+Now+Available+in+the+U.S./26989382.html <ul type="disc"><li style="margin-bottom:8pt;">LISRAYA represents the first major therapeutic innovation in decades for adults with dermatomyositis (DM), a debilitating systemic autoimmune disease</li><li style="margin-bottom:8pt;">LISRAYA is a once-daily pill that directly targets key immune pathways implicated in dermatomyositis pathogenesis</li><li style="margin-bottom:8pt;">LISRAYA demonstrated robust efficacy on multiple measures of DM disease activity, accompanied by substantial steroid-sparing benefits, in the largest dermatomyositis clinical trial ever conducted</li><li style="margin-bottom:8pt;">LISRAYA is available immediately in the U.S.</li><li style="margin-bottom:8pt;">Eligible patients may pay as little as $0 per month through the LISRAYA My Compass Support program.</li><li style="margin-bottom:8pt;">Roivant will host an investor call to discuss these updates tomorrow, August 28, 2026, at 8:00 http://www.streetinsider.com/Press+Releases/Roivant+Announces+FDA+Approval+of+LISRAYA%E2%84%A2+%28brepocitinib%29+for+Adults+with+Dermatomyositis%3B+Now+Available+in+the+U.S./26989382.html Thu, 27 Aug 2026 15:29:00 -0400 A.06822034 A.31368885 O.20026344 O.26308322 O.49918125 ROIV ROIVW http://www.streetinsider.com/Press+Releases/Roivant+Announces+FDA+Approval+of+LISRAYA%E2%84%A2+%28brepocitinib%29+for+Adults+with+Dermatomyositis%3B+Now+Available+in+the+U.S./26989382.html <ul type="disc"><li style="margin-bottom:8pt;">LISRAYA represents the first major therapeutic innovation in decades for adults with dermatomyositis (DM), a debilitating systemic autoimmune disease</li><li style="margin-bottom:8pt;">LISRAYA is a once-daily pill that directly targets key immune pathways implicated in dermatomyositis pathogenesis</li><li style="margin-bottom:8pt;">LISRAYA demonstrated robust efficacy on multiple measures of DM disease activity, accompanied by substantial steroid-sparing benefits, in the largest dermatomyositis clinical trial ever conducted</li><li style="margin-bottom:8pt;">LISRAYA is available immediately in the U.S.</li><li style="margin-bottom:8pt;">Eligible patients may pay as little as $0 per month through the LISRAYA My Compass Support program.</li><li style="margin-bottom:8pt;">Roivant will host an investor call to discuss these updates tomorrow, August 28, 2026, at 8:00 http://www.streetinsider.com/Press+Releases/Roivant+Announces+FDA+Approval+of+LISRAYA%E2%84%A2+%28brepocitinib%29+for+Adults+with+Dermatomyositis%3B+Now+Available+in+the+U.S./26989382.html Thu, 27 Aug 2026 15:29:00 -0400 A.06822034 A.31368885 O.20026344 O.26308322 O.49918125 ROIV ROIVW http://www.streetinsider.com/Press+Releases/Roivant+Announces+FDA+Approval+of+LISRAYA%E2%84%A2+%28brepocitinib%29+for+Adults+with+Dermatomyositis%3B+Now+Available+in+the+U.S./26989382.html <ul type="disc"><li style="margin-bottom:8pt;">LISRAYA represents the first major therapeutic innovation in decades for adults with dermatomyositis (DM), a debilitating systemic autoimmune disease</li><li style="margin-bottom:8pt;">LISRAYA is a once-daily pill that directly targets key immune pathways implicated in dermatomyositis pathogenesis</li><li style="margin-bottom:8pt;">LISRAYA demonstrated robust efficacy on multiple measures of DM disease activity, accompanied by substantial steroid-sparing benefits, in the largest dermatomyositis clinical trial ever conducted</li><li style="margin-bottom:8pt;">LISRAYA is available immediately in the U.S.</li><li style="margin-bottom:8pt;">Eligible patients may pay as little as $0 per month through the LISRAYA My Compass Support program.</li><li style="margin-bottom:8pt;">Roivant will host an investor call to discuss these updates tomorrow, August 28, 2026, at 8:00 http://www.streetinsider.com/Press+Releases/Roivant+Announces+FDA+Approval+of+LISRAYA%E2%84%A2+%28brepocitinib%29+for+Adults+with+Dermatomyositis%3B+Now+Available+in+the+U.S./26989382.html Thu, 27 Aug 2026 15:29:00 -0400 A.06822034 A.31368885 O.20026344 O.26308322 O.49918125 ROIV ROIVW http://www.streetinsider.com/Press+Releases/Roivant+Announces+FDA+Approval+of+LISRAYA%E2%84%A2+%28brepocitinib%29+for+Adults+with+Dermatomyositis%3B+Now+Available+in+the+U.S./26989382.html <ul type="disc"><li style="margin-bottom:8pt;">LISRAYA represents the first major therapeutic innovation in decades for adults with dermatomyositis (DM), a debilitating systemic autoimmune disease</li><li style="margin-bottom:8pt;">LISRAYA is a once-daily pill that directly targets key immune pathways implicated in dermatomyositis pathogenesis</li><li style="margin-bottom:8pt;">LISRAYA demonstrated robust efficacy on multiple measures of DM disease activity, accompanied by substantial steroid-sparing benefits, in the largest dermatomyositis clinical trial ever conducted</li><li style="margin-bottom:8pt;">LISRAYA is available immediately in the U.S.</li><li style="margin-bottom:8pt;">Eligible patients may pay as little as $0 per month through the LISRAYA My Compass Support program.</li><li style="margin-bottom:8pt;">Roivant will host an investor call to discuss these updates tomorrow, August 28, 2026, at 8:00 http://www.streetinsider.com/Press+Releases/Roivant+Announces+FDA+Approval+of+LISRAYA%E2%84%A2+%28brepocitinib%29+for+Adults+with+Dermatomyositis%3B+Now+Available+in+the+U.S./26989382.html Thu, 27 Aug 2026 15:29:00 -0400 A.06822034 A.31368885 O.20026344 O.26308322 O.49918125 ROIV ROIVW http://www.streetinsider.com/Press+Releases/Roivant+Announces+FDA+Approval+of+LISRAYA%E2%84%A2+%28brepocitinib%29+for+Adults+with+Dermatomyositis%3B+Now+Available+in+the+U.S./26989382.html <ul type="disc"><li style="margin-bottom:8pt;">LISRAYA represents the first major therapeutic innovation in decades for adults with dermatomyositis (DM), a debilitating systemic autoimmune disease</li><li style="margin-bottom:8pt;">LISRAYA is a once-daily pill that directly targets key immune pathways implicated in dermatomyositis pathogenesis</li><li style="margin-bottom:8pt;">LISRAYA demonstrated robust efficacy on multiple measures of DM disease activity, accompanied by substantial steroid-sparing benefits, in the largest dermatomyositis clinical trial ever conducted</li><li style="margin-bottom:8pt;">LISRAYA is available immediately in the U.S.</li><li style="margin-bottom:8pt;">Eligible patients may pay as little as $0 per month through the LISRAYA My Compass Support program.</li><li style="margin-bottom:8pt;">Roivant will host an investor call to discuss these updates tomorrow, August 28, 2026, at 8:00 http://www.streetinsider.com/Press+Releases/Roivant+Announces+FDA+Approval+of+LISRAYA%E2%84%A2+%28brepocitinib%29+for+Adults+with+Dermatomyositis%3B+Now+Available+in+the+U.S./26989382.html Thu, 27 Aug 2026 15:29:00 -0400 A.06822034 A.31368885 O.20026344 O.26308322 O.49918125 ROIV ROIVW http://www.streetinsider.com/Press+Releases/Roivant+Announces+FDA+Approval+of+LISRAYA%E2%84%A2+%28brepocitinib%29+for+Adults+with+Dermatomyositis%3B+Now+Available+in+the+U.S./26989382.html <ul type="disc"><li style="margin-bottom:8pt;">LISRAYA represents the first major therapeutic innovation in decades for adults with dermatomyositis (DM), a debilitating systemic autoimmune disease</li><li style="margin-bottom:8pt;">LISRAYA is a once-daily pill that directly targets key immune pathways implicated in dermatomyositis pathogenesis</li><li style="margin-bottom:8pt;">LISRAYA demonstrated robust efficacy on multiple measures of DM disease activity, accompanied by substantial steroid-sparing benefits, in the largest dermatomyositis clinical trial ever conducted</li><li style="margin-bottom:8pt;">LISRAYA is available immediately in the U.S.</li><li style="margin-bottom:8pt;">Eligible patients may pay as little as $0 per month through the LISRAYA My Compass Support program.</li><li style="margin-bottom:8pt;">Roivant will host an investor call to discuss these updates tomorrow, August 28, 2026, at 8:00 http://www.streetinsider.com/Press+Releases/Roivant+Announces+FDA+Approval+of+LISRAYA%E2%84%A2+%28brepocitinib%29+for+Adults+with+Dermatomyositis%3B+Now+Available+in+the+U.S./26989382.html Thu, 27 Aug 2026 15:29:00 -0400 A.06822034 A.31368885 O.20026344 O.26308322 O.49918125 ROIV ROIVW http://www.streetinsider.com/Globe+Newswire/Roivant+Announces+FDA+Approval+of+LISRAYA%E2%84%A2+%28brepocitinib%29+for+Adults+with+Dermatomyositis%3B+Now+Available+in+the+U.S./26989382.html <ul type="disc"><li style="margin-bottom:8pt;">LISRAYA represents the first major therapeutic innovation in decades for adults with dermatomyositis (DM), a debilitating systemic autoimmune disease</li><li style="margin-bottom:8pt;">LISRAYA is a once-daily pill that directly targets key immune pathways implicated in dermatomyositis pathogenesis</li><li style="margin-bottom:8pt;">LISRAYA demonstrated robust efficacy on multiple measures of DM disease activity, accompanied by substantial steroid-sparing benefits, in the largest dermatomyositis clinical trial ever conducted</li><li style="margin-bottom:8pt;">LISRAYA is available immediately in the U.S.</li><li style="margin-bottom:8pt;">Eligible patients may pay as little as $0 per month through the LISRAYA My Compass Support program.</li><li style="margin-bottom:8pt;">Roivant will host an investor call to discuss these updates tomorrow, August 28, 2026, at 8:00 http://www.streetinsider.com/Globe+Newswire/Roivant+Announces+FDA+Approval+of+LISRAYA%E2%84%A2+%28brepocitinib%29+for+Adults+with+Dermatomyositis%3B+Now+Available+in+the+U.S./26989382.html Thu, 27 Aug 2026 15:29:00 -0400 A.06822034 A.31368885 O.20026344 O.26308322 O.49918125 ROIV ROIVW http://www.streetinsider.com/Globe+Newswire/Roivant+Announces+FDA+Approval+of+LISRAYA%E2%84%A2+%28brepocitinib%29+for+Adults+with+Dermatomyositis%3B+Now+Available+in+the+U.S./26989382.html <ul type="disc"><li style="margin-bottom:8pt;">LISRAYA represents the first major therapeutic innovation in decades for adults with dermatomyositis (DM), a debilitating systemic autoimmune disease</li><li style="margin-bottom:8pt;">LISRAYA is a once-daily pill that directly targets key immune pathways implicated in dermatomyositis pathogenesis</li><li style="margin-bottom:8pt;">LISRAYA demonstrated robust efficacy on multiple measures of DM disease activity, accompanied by substantial steroid-sparing benefits, in the largest dermatomyositis clinical trial ever conducted</li><li style="margin-bottom:8pt;">LISRAYA is available immediately in the U.S.</li><li style="margin-bottom:8pt;">Eligible patients may pay as little as $0 per month through the LISRAYA My Compass Support program.</li><li style="margin-bottom:8pt;">Roivant will host an investor call to discuss these updates tomorrow, August 28, 2026, at 8:00 http://www.streetinsider.com/Globe+Newswire/Roivant+Announces+FDA+Approval+of+LISRAYA%E2%84%A2+%28brepocitinib%29+for+Adults+with+Dermatomyositis%3B+Now+Available+in+the+U.S./26989382.html Thu, 27 Aug 2026 15:29:00 -0400 A.06822034 A.31368885 O.20026344 O.26308322 O.49918125 ROIV ROIVW http://www.streetinsider.com/Globe+Newswire/Roivant+Announces+FDA+Approval+of+LISRAYA%E2%84%A2+%28brepocitinib%29+for+Adults+with+Dermatomyositis%3B+Now+Available+in+the+U.S./26989382.html <ul type="disc"><li style="margin-bottom:8pt;">LISRAYA represents the first major therapeutic innovation in decades for adults with dermatomyositis (DM), a debilitating systemic autoimmune disease</li><li style="margin-bottom:8pt;">LISRAYA is a once-daily pill that directly targets key immune pathways implicated in dermatomyositis pathogenesis</li><li style="margin-bottom:8pt;">LISRAYA demonstrated robust efficacy on multiple measures of DM disease activity, accompanied by substantial steroid-sparing benefits, in the largest dermatomyositis clinical trial ever conducted</li><li style="margin-bottom:8pt;">LISRAYA is available immediately in the U.S.</li><li style="margin-bottom:8pt;">Eligible patients may pay as little as $0 per month through the LISRAYA My Compass Support program.</li><li style="margin-bottom:8pt;">Roivant will host an investor call to discuss these updates tomorrow, August 28, 2026, at 8:00 http://www.streetinsider.com/Globe+Newswire/Roivant+Announces+FDA+Approval+of+LISRAYA%E2%84%A2+%28brepocitinib%29+for+Adults+with+Dermatomyositis%3B+Now+Available+in+the+U.S./26989382.html Thu, 27 Aug 2026 15:29:00 -0400 A.06822034 A.31368885 O.20026344 O.26308322 O.49918125 ROIV ROIVW http://www.streetinsider.com/Globe+Newswire/Roivant+Announces+FDA+Approval+of+LISRAYA%E2%84%A2+%28brepocitinib%29+for+Adults+with+Dermatomyositis%3B+Now+Available+in+the+U.S./26989382.html <ul type="disc"><li style="margin-bottom:8pt;">LISRAYA represents the first major therapeutic innovation in decades for adults with dermatomyositis (DM), a debilitating systemic autoimmune disease</li><li style="margin-bottom:8pt;">LISRAYA is a once-daily pill that directly targets key immune pathways implicated in dermatomyositis pathogenesis</li><li style="margin-bottom:8pt;">LISRAYA demonstrated robust efficacy on multiple measures of DM disease activity, accompanied by substantial steroid-sparing benefits, in the largest dermatomyositis clinical trial ever conducted</li><li style="margin-bottom:8pt;">LISRAYA is available immediately in the U.S.</li><li style="margin-bottom:8pt;">Eligible patients may pay as little as $0 per month through the LISRAYA My Compass Support program.</li><li style="margin-bottom:8pt;">Roivant will host an investor call to discuss these updates tomorrow, August 28, 2026, at 8:00 http://www.streetinsider.com/Globe+Newswire/Roivant+Announces+FDA+Approval+of+LISRAYA%E2%84%A2+%28brepocitinib%29+for+Adults+with+Dermatomyositis%3B+Now+Available+in+the+U.S./26989382.html Thu, 27 Aug 2026 15:29:00 -0400 A.06822034 A.31368885 O.20026344 O.26308322 O.49918125 ROIV ROIVW http://www.streetinsider.com/Globe+Newswire/Roivant+Announces+FDA+Approval+of+LISRAYA%E2%84%A2+%28brepocitinib%29+for+Adults+with+Dermatomyositis%3B+Now+Available+in+the+U.S./26989382.html <ul type="disc"><li style="margin-bottom:8pt;">LISRAYA represents the first major therapeutic innovation in decades for adults with dermatomyositis (DM), a debilitating systemic autoimmune disease</li><li style="margin-bottom:8pt;">LISRAYA is a once-daily pill that directly targets key immune pathways implicated in dermatomyositis pathogenesis</li><li style="margin-bottom:8pt;">LISRAYA demonstrated robust efficacy on multiple measures of DM disease activity, accompanied by substantial steroid-sparing benefits, in the largest dermatomyositis clinical trial ever conducted</li><li style="margin-bottom:8pt;">LISRAYA is available immediately in the U.S.</li><li style="margin-bottom:8pt;">Eligible patients may pay as little as $0 per month through the LISRAYA My Compass Support program.</li><li style="margin-bottom:8pt;">Roivant will host an investor call to discuss these updates tomorrow, August 28, 2026, at 8:00 http://www.streetinsider.com/Globe+Newswire/Roivant+Announces+FDA+Approval+of+LISRAYA%E2%84%A2+%28brepocitinib%29+for+Adults+with+Dermatomyositis%3B+Now+Available+in+the+U.S./26989382.html Thu, 27 Aug 2026 15:29:00 -0400 A.06822034 A.31368885 O.20026344 O.26308322 O.49918125 ROIV ROIVW http://www.streetinsider.com/Globe+Newswire/Roivant+Announces+FDA+Approval+of+LISRAYA%E2%84%A2+%28brepocitinib%29+for+Adults+with+Dermatomyositis%3B+Now+Available+in+the+U.S./26989382.html <ul type="disc"><li style="margin-bottom:8pt;">LISRAYA represents the first major therapeutic innovation in decades for adults with dermatomyositis (DM), a debilitating systemic autoimmune disease</li><li style="margin-bottom:8pt;">LISRAYA is a once-daily pill that directly targets key immune pathways implicated in dermatomyositis pathogenesis</li><li style="margin-bottom:8pt;">LISRAYA demonstrated robust efficacy on multiple measures of DM disease activity, accompanied by substantial steroid-sparing benefits, in the largest dermatomyositis clinical trial ever conducted</li><li style="margin-bottom:8pt;">LISRAYA is available immediately in the U.S.</li><li style="margin-bottom:8pt;">Eligible patients may pay as little as $0 per month through the LISRAYA My Compass Support program.</li><li style="margin-bottom:8pt;">Roivant will host an investor call to discuss these updates tomorrow, August 28, 2026, at 8:00 http://www.streetinsider.com/Globe+Newswire/Roivant+Announces+FDA+Approval+of+LISRAYA%E2%84%A2+%28brepocitinib%29+for+Adults+with+Dermatomyositis%3B+Now+Available+in+the+U.S./26989382.html Thu, 27 Aug 2026 15:29:00 -0400 A.06822034 A.31368885 O.20026344 O.26308322 O.49918125 ROIV ROIVW http://www.streetinsider.com/Globe+Newswire/Roivant+Announces+FDA+Approval+of+LISRAYA%E2%84%A2+%28brepocitinib%29+for+Adults+with+Dermatomyositis%3B+Now+Available+in+the+U.S./26989382.html <ul type="disc"><li style="margin-bottom:8pt;">LISRAYA represents the first major therapeutic innovation in decades for adults with dermatomyositis (DM), a debilitating systemic autoimmune disease</li><li style="margin-bottom:8pt;">LISRAYA is a once-daily pill that directly targets key immune pathways implicated in dermatomyositis pathogenesis</li><li style="margin-bottom:8pt;">LISRAYA demonstrated robust efficacy on multiple measures of DM disease activity, accompanied by substantial steroid-sparing benefits, in the largest dermatomyositis clinical trial ever conducted</li><li style="margin-bottom:8pt;">LISRAYA is available immediately in the U.S.</li><li style="margin-bottom:8pt;">Eligible patients may pay as little as $0 per month through the LISRAYA My Compass Support program.</li><li style="margin-bottom:8pt;">Roivant will host an investor call to discuss these updates tomorrow, August 28, 2026, at 8:00 http://www.streetinsider.com/Globe+Newswire/Roivant+Announces+FDA+Approval+of+LISRAYA%E2%84%A2+%28brepocitinib%29+for+Adults+with+Dermatomyositis%3B+Now+Available+in+the+U.S./26989382.html Thu, 27 Aug 2026 15:29:00 -0400 A.06822034 A.31368885 O.20026344 O.26308322 O.49918125 ROIV ROIVW http://www.streetinsider.com/FDA/FDA+approves+Priovant%27s+brepocitinib+for+dermatomyositis/26989379.html <p>Priovant Therapeutics announced that the U.S. Food and Drug Administration has approved LISRAYA (brepocitinib) 30 mg, a once-daily oral pill, for the treatment of adults with dermatomyositis (DM), a rare systemic autoimmune disease marked by progressive muscle weakness and skin lesions. The drug is now available in the U.S. through a limited network of specialty pharmacies.</p> <p>LISRAYA is a TYK2/JAK1 inhibitor and is the first targeted therapy approved for dermatomyositis, according to Priovant. The company is a subsidiary of Roivant Sciences (Nasdaq: ROIV).</p> <p>The FDA approval is based on results from the Phase 3 VALOR trial. In that study, 55% of patients http://www.streetinsider.com/FDA/FDA+approves+Priovant%27s+brepocitinib+for+dermatomyositis/26989379.html Thu, 27 Aug 2026 15:28:54 -0400 A.06822034 A.31368885 A.50216947 O.20026344 O.26308322 O.49918125 O.54692258 ROIV ROIVW http://www.streetinsider.com/FDA/FDA+approves+Priovant%27s+brepocitinib+for+dermatomyositis/26989379.html <p>Priovant Therapeutics announced that the U.S. Food and Drug Administration has approved LISRAYA (brepocitinib) 30 mg, a once-daily oral pill, for the treatment of adults with dermatomyositis (DM), a rare systemic autoimmune disease marked by progressive muscle weakness and skin lesions. The drug is now available in the U.S. through a limited network of specialty pharmacies.</p> <p>LISRAYA is a TYK2/JAK1 inhibitor and is the first targeted therapy approved for dermatomyositis, according to Priovant. The company is a subsidiary of Roivant Sciences (Nasdaq: ROIV).</p> <p>The FDA approval is based on results from the Phase 3 VALOR trial. In that study, 55% of patients http://www.streetinsider.com/FDA/FDA+approves+Priovant%27s+brepocitinib+for+dermatomyositis/26989379.html Thu, 27 Aug 2026 15:28:54 -0400 A.06822034 A.31368885 A.50216947 O.20026344 O.26308322 O.49918125 O.54692258 ROIV ROIVW http://www.streetinsider.com/FDA/FDA+approves+Priovant%27s+brepocitinib+for+dermatomyositis/26989379.html <p>Priovant Therapeutics announced that the U.S. Food and Drug Administration has approved LISRAYA (brepocitinib) 30 mg, a once-daily oral pill, for the treatment of adults with dermatomyositis (DM), a rare systemic autoimmune disease marked by progressive muscle weakness and skin lesions. The drug is now available in the U.S. through a limited network of specialty pharmacies.</p> <p>LISRAYA is a TYK2/JAK1 inhibitor and is the first targeted therapy approved for dermatomyositis, according to Priovant. The company is a subsidiary of Roivant Sciences (Nasdaq: ROIV).</p> <p>The FDA approval is based on results from the Phase 3 VALOR trial. In that study, 55% of patients http://www.streetinsider.com/FDA/FDA+approves+Priovant%27s+brepocitinib+for+dermatomyositis/26989379.html Thu, 27 Aug 2026 15:28:54 -0400 A.06822034 A.31368885 A.50216947 O.20026344 O.26308322 O.49918125 O.54692258 ROIV ROIVW http://www.streetinsider.com/FDA/FDA+approves+Priovant%27s+brepocitinib+for+dermatomyositis/26989379.html <p>Priovant Therapeutics announced that the U.S. Food and Drug Administration has approved LISRAYA (brepocitinib) 30 mg, a once-daily oral pill, for the treatment of adults with dermatomyositis (DM), a rare systemic autoimmune disease marked by progressive muscle weakness and skin lesions. The drug is now available in the U.S. through a limited network of specialty pharmacies.</p> <p>LISRAYA is a TYK2/JAK1 inhibitor and is the first targeted therapy approved for dermatomyositis, according to Priovant. The company is a subsidiary of Roivant Sciences (Nasdaq: ROIV).</p> <p>The FDA approval is based on results from the Phase 3 VALOR trial. In that study, 55% of patients http://www.streetinsider.com/FDA/FDA+approves+Priovant%27s+brepocitinib+for+dermatomyositis/26989379.html Thu, 27 Aug 2026 15:28:54 -0400 A.06822034 A.31368885 A.50216947 O.20026344 O.26308322 O.49918125 O.54692258 ROIV ROIVW