BPC April 14 update

Eli Lilly (LLY) and Incyte (INCY) issued Complete Response Letter for baricitinib

Price and Volume Movers

Although markets were closed Friday, some offices remained open as Good Friday is not a federal holiday. Two of which included Eli Lilly and Company (NYSE:LLY) and Incyte Corporation (NASDAQ:INCY).

The companies announced Friday that the FDA issued a Complete Response Letter (CRL) for the New Drug Application (NDA) of baricitinib in patients with moderate-to-severe rheumatoid arthritis (RA). The CRL follows a three month extension issued by the FDA earlier this January. The company informed investors that the FDA noted that additional clinical data are needed to determine the most appropriate doses and to further characterize safety concerns across treatment arms. The companies disagree with the Agency’s conclusions. The timing of a resubmission will be based on further discussions with the FDA.

“We are disappointed with this action. We remain confident in the benefit/risk of baricitinib as a new treatment option for adults with moderate-to-severe RA,” said Christi Shaw, president of Lilly Bio-Medicines. 


Pipeline updates below:

Pipeline Database Updates

Drug Stage Catalyst

CASI
ENMD-2076
Cancer - triple-negative breast cancer

Phase 2 Phase 2 initiated July 2012. Noted April 14, 2017 that further patient enrollment has been stopped.

INCY
Baricitinib
Rheumatoid arthritis

CRL Announced January 19 2016 that NDA Filing had been submitted. Three month delay announced January 13, 2017. CRL received April 14, 2017. Noted August 30, 2017 that NDA will be resubmitted before the end of January 2018.

LLY
Baricitinib
Rheumatoid arthritis

CRL Announced January 19 2016 that NDA Filing had been submitted. Three month delay announced January 13, 2017. CRL received April 14, 2017. Noted August 30, 2017 that NDA will be resubmitted before the end of January 2018.