Hit With Another FDA Complete Response Letter for Oclaiz

研报英文原文证据摘录

Hit With Another FDA Complete Response Letter for Oclaiz

esubmission (next c.1 month) with the

current manufacturer, which we see as a very unlikely scenario; or (2) 4Q26E resubmission

incorporating a second, validated CDMO, de-risking supply but pushing potential approval to

1H27E. The second manufacturer is available from 4Q26.

CAM2029 in GEP-NET remains on track: The CRL does not impact CAM2029’s development in

GEP-NET, where the Phase III SORENTO study continues to progress as planned. However, we

note that the manufacturing hurdle needs to be addressed seamlessly to ensure that, upon a

positive read-out, CAMX can submit GEP-NET for approval. Accrual of the 194 required events

are expected during 2H26E. GEP-NET (c.40% NPV) is the bigger opportunity for CAM2029. We

forecast $1.1bn unrisked WW peak CAM2029 sales in GEP-NET.

Shift toward patient-friendly novel therapies is accelerating: The commercial landscape for

acromegaly is undergoing a rapid shift toward patient-friendly administration, as evidenced

by the strong execution of Crinetics’ Palsonify launch, which delivered $10.3m in 1Q26 sales.

This early momentum, driven 70% active patients on reimbursed therapy and supported by

>60% payer coverage, validates the significant market appetite for alternatives to burdensome,

physician-administered SSAs. While Palsonify proves the switching dynamic, Oclaiz aims to

capture share by offering the clinical familiarity of octreotide with superior bioavailability and

a more convenient Q4W dosing profile that avoids fasting requirements of oral therapy. CAMX

assumes 25%-40% peak patient share, for $150-280m peak sales. Shan Hama * | Equity Analyst

+44 (0)20 7548 4084 | shama@jefferies.com

Key catalysts: Top-line data for Phase III SORENTO study of CAM2029 in GEP-NET 2H26E.