Biopharma Week in Review
We are initiating our Biopharma Week in Review. In this report, we will review coverage items and last week’s biopharma news for meaningful clinical data, regulatory updates, research innovation, and M&A. We published an initiation of coverage on Ainos, Inc. (AIMD). Link is accessible in our full report. Mustang Bio, Inc. (MBIO) presented a positive Phase 1/2 update on MB-106 (CD20 CAR-T) in Waldenstrom macroglobulinemia (WM) at EHA 2024. In 10 heavily, pretreated, BTKi-refractory patients, MB-106 showed 90% ORR, including 3 CR, 2 VGPR, and 4 PR. CRS and ICANS were all mild to moderate. One CR patient remains in remission after 31 months, suggesting a highly durable response. MBIO was up 477% on last Monday. Aerovate Therapeutics, Inc. (AVTE) reported AV-101 did not meet the primary endpoint in the Phase 2b portion of the Phase 2b/3 IMPAHCT study. A high dose of AV-101 (70mg BID) showed a -57.0 PVR improvement over placebo but did not reach stat sig (p=0.3685). Secondary endpoints were also not met, including a 6MWD test. Aerovate will close the Phase 3 portion and stop enrollment. AVTE ended down 93% on last Monday. Mirum Pharmaceuticals, Inc. (MIRM) reported positive interim results for volixibat Phase 2b (VANTAGE) in PBC. Volixibat, an oral IBAT inhibitor, achieved significant improvement in the itch scale (ItchRO) primary endpoint versus placebo (-2.32, p=0.0026) and in pruritis (-3.82, p
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