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Immunovant Reports Financial Results for the Quarter and Fiscal Year Ended March 31, 2020 and Announces Plans for Phase 3 Registrational Trial of IMVT-1401 in Myasthenia Gravis
Based on compelling proof-of-biology for anti-FcRn agents in Myasthenia Gravis (MG), Immunovant has begun preparations to initiate a Phase 3 registrational
About this update from Immunovant, Inc.
[{"type":"text","content":"Based on compelling proof-of-biology for anti-FcRn agents in Myasthenia Gravis (MG), Immunovant has begun preparations to initiate a Phase 3 registrational trial of IMVT-1401 in MGIMVT-1401’s development program is entirely based on a subcutaneous injection formatCash balance as of June 29, 2020, is approximately $280.4 million NEW YORK, June 29, 2020 (GLOBE NEWSWIRE) -- Immunovant, Inc. (Nasdaq: IMVT), a clinical-stage biopharmaceutical company focused on enabling normal lives for patients with autoimmune diseases, today reported financial results for its fiscal fourth quarter and fiscal year ended March 31, 2020. As of today, June 29, 2020, Immunovant’s cash balance is approximately $280.4 million. “We recently strengthened our balance sheet, facilitating the continued advancement of IMVT-1401 as we progress towards our goal of enabling normal lives for patients with autoimmune diseases,” said Pete Salzmann, M.D., Chief Executive Officer of Immunovant. \n In March, Immunovant announced positive clinical results from ASCEND GO-1, a Phase 2a trial of IMVT-1401 in Thyroid Eye Disease (TED), which reaffirmed IMVT-1401’s prior safety and pharmacodynamic findings and demonstrated encouraging potential efficacy for patients with TED. Complementing these findings, two recent successful studies for other drug candidates with the same mechanism of action provided strong clinical validation in MG and demonstrated a within-study relationship between the degree of IgG lowering and the magnitude of clinical benefit in MG. With proof-of-biology now established for anti-FcRn agents in MG, Immunovant has chosen to accelerate Phase 3 development of IMVT-1401 in MG. “Immunovant expects to engage the FDA on the design and conduct of the pivotal program and we expect the Agency’s feedback to be an important part of the final plan,” said Dr. Salzmann. In light of the challenges created by COVID-19, including some clinical sites closing enrollment for new patients, Immunovant has taken several actions to ensure patient safety and quality trial execution. “During the past three months, our very experienced clinical development team has successfully maintained open lines of communication with our sites. Based on this strong link, we can report that new patients enrolled in our programs during calendar Q2 did not miss any in-person clinic visits during...