Zenas Biopharma (ZBIO) PT Lowered to $48 at Jefferies, 'we see clear path for approval (BLA submission planned in 2Q and MAA in 2H26')

Jefferies analyst Roger Song lowered the price target on Zenas Biopharma (NASDAQ: ZBIO) to $48.00 (from $62.00) while maintaining a Buy rating.

The analyst comments "We caught up with mgmt. While HR came lower than expected, ~73% Tx protection w/ ~56% risk reduction suggests obex highly effective (in slightly tougher-to-treat pts vs. comp trial) and was appreciated by KOL. Safety was strong/ better. Along with other key differentiations including MOA of inhibition (depletion), at-home sub, payer dynamics, obex could be well-positioned to be 1L Tx, in large ~$3B IgG4-RD market with only comp initial launch trending well. Bottom line. The HR of ~0.44 was a surprise based on our stat analysis (PREVIEW). With relatively comparable design/ baseline, INDIGO enrolled more recurrent pts vs. MITIGATE (~67% vs. ~54%), which could have negatively impacted HR, as in MITIGATE, HR of recurrent vs. newly Dx was ~0.2 vs. 0.0. While HR was clearly lower than expectations by the Street, we see clear path for approval (BLA submission planned in 2Q and MAA in 2H26), supported by a successful Ph3, and potential 1L/ broad use in a large ~$3B US market, with key drivers: 1) advantageous inhibitory MOA vs. depleting, which could be better for this elderly pt population (~40% 65+yo) that has need for regular vaccination, high risk for infection, and need for management of co-morbidity, and better for sequential Tx including Uplizna as a B cell depleter. 2) Strong safety/ tolerability, with lower than pbo SAE, infection, and low/ pbo-comparable ISR, supports risk/ benefit profile and earlier line of Tx. 3) At home subq administration could be preferred by pts/ accessible to broad population, without the need for IV center or ped-med for infusion AEs. 4) Monthly subq drug could have more favorable economics to payers/ pts vs. Q6M IV comp drug, with lower OOP cost under Part D pharmacy benefit (vs. Part B medical benefit) and w/o lump sum in the first month."

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