July 31 Quick Takes: FDA approves MorphoSys’ tafasitamab; Truvian, AbbVie, Boehringer, Lilly, Alector, Henlius-Accord, Ascletis, Roche, Merck

MorphoSys follows Kress’ first big deal with U.S. approval

FDA granted accelerated approval to Monjuvi tafasitamab-cxix from MorphoSys AG (Xetra:MOR; NASDAQ:MOR) and Incyte Corp. (NASDAQ:INCY) in combination with lenalidomide to treat patients with relapsed or refractory diffuse large B cell lymphoma (DLBCL) not eligible for autologous stem cell transplant. The therapy was the subject of the first major deal under MorphoSys’ new CEO Jean-Paul Kress (see “MorphoSys Nets $900M Up Front in Global Deal with Incyte”).
Truvian serology test receives EUA
Truvian Sciences Inc. said its Easy Check COVID-19 IgM/IgG antibody test was granted Emergency Use Authorization by FDA. The test has a sensitivity rate of 98.4% and a specificity of 98.9% with no cross-reactivity to other prevalent viruses.
AbbVie’s migraine therapy headed for FDA
The Phase III ADVANCE trial of atogepant, an orally administered small molecule CGRP receptor antagonist, met its primary endpoint of decreased mean monthly migraine days. AbbVie Inc. (NYSE:ABBV) plans to move forward with regulatory submissions in the U.S. and other countries (see “Atogepant Phase IIb/III to Prevent Migraine”). ...