IPSEN (=) : Camurus’ Octreotide CRL flags FDA hurdle for Amneal’s Somatuline generic

研报英文原文证据摘录

IPSEN (=) : Camurus’ Octreotide CRL flags FDA hurdle for Amneal’s Somatuline generic

EQUITIES

PHARMACEUTICALS

IPSEN NEUTRALPRICE* EUR155.1  TARGET PRICE EUR170 (UPSIDE 10%)

FLASH NOTE

Camurus’ Octreotide CRL flags FDA hurdle for Amneal’s Somatuline

generic

11 JUNE 2026 Securities Research Report Production time: 07:34* (London time)

Research Analyst & Publishing Entities

Victor Floch BNP Paribas London Branch (+44) 203 430 8707 victor.floch@uk.bnpparibas.com

What happened?

Camurus has received a second CRL from the FDA for CAM2029 (Oclaiz), its long-acting subcutaneous octreotide for

acromegaly. We believe that this new CRL underscores the regulatory and manufacturing hurdles facing sandostatin

analogues and could act as a positive catalyst for Ipsen’s shares while we await the FDA’s Q3 decision on Amneal’s

lanreotide generic. We reiterate our Neutral rating on Ipsen which reflects lingering uncertainties around (1)

corabotase's (IPN10200) clinical profile and ownership/go-to-market strategy, (2) the need for a transformative/dilutive

M&A with focus on mainstream indications raising execution risk, (3) 2026 residual clinical risks notably from the high

hurdle faced by Bylvay's BOLD P3, as well as (4) additional competitive risk on Onivyde.

BNPP View:

– Camurus has received a second CRL from the FDA for CAM2029 (Oclaiz), its long-acting subcutaneous

octreotide for acromegaly – the first CRL having been issued in October 2024. While no clinical efficacy or safety

concerns have been raised, both CRLs issued to Camurus stem from cGMP observations identified during an

FDA inspection of a third-party contract manufacturing facility in September 2024.

– We see Camurus CRLs as a reminder that somatostatin analogues – considered among the most technically