IMNM - Quick Take - Varegacestat NDA Accepted; April 2027 PDUFA In Line With Our Base Case

研报英文原文证据摘录

IMNM - Quick Take - Varegacestat NDA Accepted; April 2027 PDUFA In Line With Our Base Case

Truist Securities

Equity Research Report July 8, 2026

HEALTHCARE: Biotech Immunome, Inc. (IMNM)

IMNM - Quick Take - Varegacestat NDA Accepted; April 2027 Supawat Thongthip, Ph.D.

212-401-4429 PDUFA In Line With Our Base Case

Supawat.Thongthip@truist.com

Gregory Renza, M.D. This morning, IMNM disclosed FDA acceptance of the NDA for varegacestat in desmoid

212-419-4617 tumors with a PDUFA date of April 28, 2027. We view both the review timeline and standard

Gregory.Renza@truist.com review as consistent with our base-case assumptions, which include a potential commercial

launch in 2027E. While varegacestat could enter the market ~3.5 years after Merck

Anish Nikhanj, Ph.D. KGaA's (MKKGY, NR) Ogsiveo (approved Nov. 2023), we view its best-in-class profile

212-326-3106 as supportive of a differentiated commercial position and meaningful market share

Anish.Nikhanj@truist.com capture as the desmoid tumor market continues to expand (see note and note).

Reiterate Buy.

We currently model 2027E varegacestat revenue of ~$66M which we view as appropriate

Current Price (Jul. 7, $24.39 given the April 2027 PDUFA date and ~6-7 months of potential commercialization. We note

2026) that Ogsiveo generated ~$172M during its first full 12 months on the market and is on track to

Stock Rating BUY potentially generate ~$329M in 2026 (~23% YoY per consensus) - a relatively healthy growth trajectory for the category, in our view. Additionally, we note that our thesis for varegacestat is Unchanged

also based on expansion of the overall GSI market, driven by a greater conversion of patients

Price Target $37.00 under observation toward active treatment (increasing to 50% from consensus assumption