Incyte's (INCY) Pemazyre Gets Approval to Treat MLNs in Japan
Incyte INCY announced that it has received approval for treating patients with myeloid or lymphoid neoplasms (MLNs) using Pemazyre (pemigatinib) in Japan. The drug is already approved in the country for the treatment of unresectable biliary tract cancer patients with an FGFR2 fusion gene.
Shares of Incyte have plunged 11.1% compared with the industry’s 14.9% decline.
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Pemigatinib is a selective fibroblast growth factor receptor (FGFR) inhibitor, indicated for treating MLN. Pemazyre is the first targeted therapy for MLNs, a rare and aggressive group of cancers estimated to affect fewer than 100 patients worldwide.
The approval of Pemazyre was based on the phase II FIGHT-203 study that evaluated the safety and efficacy of Pemazyre in MLN with an FGFR1 rearrangement.
Pemazyre is approved in Europe and the United States and is indicated for treating adults with previously-treated, unresectable, locally-advanced or metastatic cholangiocarcinoma with an FGFR2 fusion or other rearrangements.
Pemazyre was granted Orphan Drug Designation for the second time by the Ministry of Health, Labour and Welfare. Previously, it was for cholangiocarcinoma, a type of biliary tract cancer, and now it’s for MLNs. The designated orphan drugs are eligible for priority review for marketing authorizations to ensure supply to clinical settings at the earliest opportunity.
Incyte has three other approved products, Jakafi (ruxolitinib), Monjuvi (tafasitamab-cxix) and Iclusig (ponatinib), as well as numerous clinical development programs in its portfolio. In addition, a phase II open-label study evaluates pemigatinib in glioblastoma and relapsed or refractory advanced non-small cell lung cancer.
Recently, Incyte received a complete response letter for the new drug application for ruxolitinib extended-release (XR) tablets, which stated that the FDA could not approve the application in its present form. Shares fell on the same.
Earlier this month, the company obtained an accelerated approval of Zynyz (Retifanlimab-Dlwr) for treating metastatic or recurrent locally advanced merkel cell carcinoma. Approval of additional drugs will add an incremental stream of revenues and reduce the company’s dependence on Jakafi.
Incyte Corporation Price and Consensus
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Zacks Rank & Stocks to Consider
Currently, Incyte has a Zacks Rank #3 (Hold).
Some better-ranked stocks in the same sector are CRISPR Therapeutics CRSP, Kala Pharmaceuticals KALA and Jasper Therapeutics JSPR, each carrying a Zacks Rank #2 (Buy). You can see the complete list of today's Zacks #1 Rank (Strong Buy) stocks here.
Loss per share estimates for CRISPR Therapeutics have narrowed from $8.21 to $7.54 for 2023 in the past 60 days.
CRSP's earnings beat estimates in two of the last four quarters and missed the mark in the other two, the average surprise being 3.19%. CRSP’s shares have plunged 30.9% in the past year.
Loss per share estimates for Kala Pharmaceuticals have narrowed from $19.67 to $15.35 for 2023 and from $14.41 to $13.12 for 2024 in the past 60 days. KALA’s shares have plunged 82.2% in the past year.
KALA’s earnings beat estimates in two of the last four quarters and missed the mark in the other two, the average surprise being 11.56%.
Loss per share estimates for Jasper Therapeutics have narrowed from $1.42 to 61 cents for 2023 and from $1.6 to 59 cents for 2024 in the past 60 days. JSPR's shares have plunged 42.9% in the past year.
JSPR's earnings beat estimates in three of the last four quarters and met the mark in one, the average surprise being 3.51%.
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