Novartis

Novartis’s Kymriah does not meet primary endpoint in late-stage study

(Reuters) – Novartis (NOVN.S) said its Kymriah CAR-T therapy did not meet its primary endpoint of event-free survival in a phase III study in patients with aggressive B-cell non-Hodgkin lymphoma (NHL) after relapse or lack of response to first-line treatment.

The safety profile was consistent with the established safety profile of Kymriah and Novartis will complete a full evaluation of the BELINDA study data, the Swiss drugmaker said in a statement on Tuesday.

ZKB, which rates the stock overweight, called the news negative in a note to investors.

“With a positive outcome, the consensus for peak sales would probably have gone above $2 billion from currently a little over $1 billion,” analyst Laurent Flamme wrote.

FILE PHOTO: The company’s logo is seen at the new cell and gene therapy factory of Swiss drugmaker Novartis in Stein, Switzerland, November 28, 2019. REUTERS/Arnd Wiegmann/File Photo

“With the approved indications, however, $1 billion in peak sales is still possible.”

Novartis shares were indicated to open 0.71% lower, according to pre-market indications by bank Julius Baer .

Reporting by Silke Koltrowitz and Michael Shields Editing by Riham Alkousaa

Our Standards: The Thomson Reuters Trust Principles.

 

Reuters source:

https://www.reuters.com/business/healthcare-pharmaceuticals/novartiss-kymriah-does-not-meet-primary-endpoint-phase-iii-study-2021-08-24