Analyst Andres Y. Maldonado of H.C. Wainwright reiterated a Buy rating on enGene Holdings, retaining the price target of $25.00.
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Andres Y. Maldonado’s rating is based on enGene’s recent advancements with its product, detalimogene, which has been selected for the FDA’s Chemistry, Manufacturing, and Controls Development and Readiness Pilot (CDRP) program. This selection, coupled with previous RMAT and Fast Track designations, indicates strong clinical and regulatory alignment, enhancing the company’s readiness for commercialization. The straightforward storage and administration of detalimogene are expected to facilitate rapid adoption in urology practices, particularly in community settings.
Furthermore, the company’s ability to manufacture detalimogene at a commercial scale, along with the additional FDA interactions provided by the CDRP, positions it well for a successful launch. The product’s efficacy, demonstrated by a 62% complete response rate at six months, and its logistical advantages over competitors, support its potential to capture significant market share in the NMIBC space. These factors collectively de-risk the launch trajectory and reinforce the Buy rating with a price target of $25.
According to TipRanks, Y. Maldonado is a 4-star analyst with an average return of 12.2% and a 50.57% success rate. Y. Maldonado covers the Healthcare sector, focusing on stocks such as Protara Therapeutics, Candel Therapeutics, and enGene Holdings.