2025-06-05-Jefferies-AKRO_ZLAB_DNLI_OLMA_VRDN_-杰富瑞医疗会议首日CEO炉边谈话_9页_112kb

报告摘要

Equity Research Summary

Biotechnology, USA
June 4, 2025

AKRO

CE0 fired the KLK Inhibitor (GX-19) clinical strategy and is advancing the F4 program for NAFLD/NASH.
Registration meeting with FDA expected by July 1, with data leading to commercial launch in H1 2026.
Phase III enrollment progressing rapidly in primary and secondary indications; F2/3 data expected in H1 2027.
AKRO is considered a top pick as a highly de-risked M&A candidate in the RP market.

ZLAB

DLL3 ADC Phase I trial achieved 67% ORR (n=33 pts) with the go-forward RP2D (1.6mpk) giving 79% ORR in 2L pts.
Safety profile improved; no CRS or neurotoxicity, enabling community setting use.
Pivotal Phase II randomized study expected enrollment by YE 2025, data by 2026, potential market in 2027.
Despite Q1 revenue miss ($106M vs est $118M), management maintains FY 2025 sales guidance.

DNLI

HUNTER: Rolling BLA submitted, PDUFA target Jan 2026 for Rare Disease designation. Clinical trial progressing; minor price discount expected from re-negotiation.
RARE: Seeking regulatory update for Sanfilippo syndrome; under the same review team as HUNTER.
Pipeline includes two IND filings this year, targeting Pompe, Alzheimer’s, and Parkinson’s programs.

OLMA

Phase III SERENA-6 trial reports ORR benefit in FL (ESR1mut pts) but dates limited due to delay in treatment arms.
OPERA-01 (2L+) trial topline data expected in 2026; SERD competition (PFE, AZN) closely monitored.
KAT6/fulvestrant combo Phase I showing 37% ORR may improve with SERD inclusion.

VRDN

Veligroto860 for TED filing H2 2025 pending Phase III follow-up data; Breakthrough granted for rapid response.
SubQ formulation believed equivalent to IV; Phase I HV trial expected Jan 2026.
Launch acceleration possible with Priority Review if eligible.

Summary

The report highlights potential catalysts across the pipeline: frontline SERD optimism, oncology registrations, VA, and hepatitis C data. Mgmts maintain confidence despite quarterly headwinds. Top picks include high-risk/high-reward programs with strategic mergers on the horizon.

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