Why Incyte (INCY) Shares Are Falling Today - Incyte (NASDAQ:INCY)

The FDA issued a complete response letter (CRL) to Incyte Corporation INCY ruxolitinib extended-release (XR) tablets, a JAK1/JAK2 inhibitor, for once-daily (QD) use for certain types of myelofibrosis (MF), polycythemia vera (PV) and graft-versus-host disease (GVHD).
The complete response letter states that the FDA cannot approve the application in its present form.
The FDA acknowledged that the study submitted in the marketing application met its objective of bioequivalence based on area under the curve (AUC) parameters but identified additional requirements for approval.
Incyte intends to meet with the FDA to determine the appropriate next steps.
William Blair writes that from an immediate commercial perspective, the CRL has no near-term implications, nor does it impact Jakafi's assumptions through the current loss of exclusivity at the end of 2028.
The analyst writes that the QD formulation does have additional patent protection beyond 2028, which could have helped extend the tail of the franchise into the 2030s, and fixed-dose combinations (FDCs) are the crucial long-term revenue driver.
Though probably not insurmountable, the CRL is a blow to the LIMBER program, more so than the recent failure of the LIMBER-304 study.
BET and ALK2 programs still have a significant clinical trial runway, hopefully providing sufficient time to address the issues.
Suppose modifications are required to the extended-release formulation or additional clinical studies for QD ruxolitinib approval. In that case, it may delay the potential work on FDCs required to move into pivotal studies.
Price Action: INCY shares are down 5.21% at $68.49 on the last check Friday.

Market News and Data brought to you by Benzinga APIs

-

-

-

-

-

-

-

-

-

-

-

-

-

-

Second Setback For Incyte's LIMBER Program - Analyst Says 'Resolution Timelines Unclear To Assess Impact'