FDA Delays Incyte’s Treatment for Graft-versus-host Disease

- February 7th, 2019

The original application decision was scheduled for February 24, but has been pushed back to May 24 by the US Food and Drug Administration.

Incyte (NASDAQ:INCY) revealed on Thursday (February 7) that the US Food and Drug Administration (FDA) has extended its review period of Incyte’s drug to treat acute graft-versus-host disease (GVHD).

The drug — named Jakafi — is looking to treat patients with GVHD who have insufficient response to corticosteroids, which are a class of steroid hormones. The FDA’s original target date to make a decision on the application was for February 24, but has now been pushed back to May 24, according to the release.

As per requests from the agency, Incyte submitted further data for its application, which resulted in the action date being extended by the FDA.

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Steven Stein, M.D. and chief medical officer of Incyte, said the company remains positive in its supplemental New Drug Application (sNDA) for Jakafi (ruxolitinib) and that it is “committed” to bringing the drug forward as a solid treatment option for GVHD.

GVHD is a condition that can occur after an allogenic stem cell transplant, which is the transfer of stem cells from a donor, according to Cancer.ca. The donor’s stem cells develop into a new immune system that can identify and destroy cancer cells, but can also attack healthy cells that results in damage to tissues and organs. Two types of GVHD exist — acute and chronic — and can affect various organ systems such as skin, gastrointestinal (digestive) tract and liver.

As it currently stands, FDA-approved treatments for both types of GVHD are few and far between and are only recently gaining traction from the agency. It was only in 2017 that the agency approved the first treatment for chronic GVHD, which was awarded to Pharmacyclics, a division of AbbVie (NYSE:ABBV).

That being said, treatment options for the disease have the potential to broaden, making Incyte’s application and approval by the FDA crucial for the company and its investors with competition on the horizon. Case in point, also on Thursday the agency granted Equillium (NASDAQ:EQ) Orphan Drug Designation for its drug EQ001 to treat acute GVHD. Thanks to the Orphan Drug Designations given to the drug, Equillium will be eligible for market exclusivity for up to seven years, if the drug is approved.

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Equillium’s Phase 1b/2 EQUATE clinical trial will initiate in early 2019 and will evaluate EQ001 in combination with coricosteroids for the first roll-out of patients with acute GVHD.

Incyte’s sNDA for Jakafi was first submitted to the FDA in August of last year, which was granted Priority Review and Breakthrough Therapy Designation. Jakafi has already been approved by the FDA to treat those with polycythemia vera (PV), which is a slow-growing blood cancer, who have had an inadequate response to or are intolerant to hydroxyurea, a medication that is used in sickle-cell disease.

Following Thursday’s announcement, shares of Incyte were down 1.95 percent to close the trading session at US$79.83. Based on 11 analyst ratings on TipRanks, the company is ranked a “Moderate Buy” with an average price target of US$90.11, which is a 12.88 percent increase from its current price. Incyte has a high estimate of US$110.00 and a low of US$74, with two analysts reiterating two different positions on Thursday.

Cantor Fitzgerald analyst Alethia Young reiterated a “Hold” position with a US$74 price target, while Reni Benjamin with firm Raymond James reissued a “Buy” position with an US$85 price target.

Don’t forget to follow @INN_LifeScience for real-time updates!

Securities Disclosure: I, Jocelyn Aspa, hold no direct investment interest in any company mentioned in this article.

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