Incyte Corp - INCY STOCK NEWS

Incyte (Nasdaq:INCY) will present at the 43rd Annual Goldman Sachs Global Healthcare Conference on June 14, 2022, at 8:00 a.m. PDT / 11:00 a.m. EDT in Rancho Palos Verdes. The presentation will be available via a live webcast on the company's investor website, with a replay accessible for 30 days. Incyte is a Wilmington, Delaware-based biopharmaceutical company committed to developing proprietary therapeutics to address serious unmet medical needs.

Eli Lilly and Incyte announced a positive opinion from the European Medicines Agency's CHMP for OLUMIANT (baricitinib) to treat adults with severe alopecia areata. This opinion signals the potential for the first oral treatment and JAK inhibitor for severe alopecia areata in the EU, pending final approval from the European Commission, expected in the next 1-2 months. The judgment is based on the successful Phase 3 BRAVE-AA1 and BRAVE-AA2 trials, involving 1,200 patients, showing significant efficacy compared to placebo. The FDA has granted priority review for the same indication in the U.S.

The FDA has approved OLUMIANT (baricitinib), marking it as the first and only JAK inhibitor authorized for treating hospitalized adults with COVID-19 requiring oxygen support. Recommended dosing is 4 mg once daily for up to 14 days. This approval is based on positive results from Phase 3 studies ACTT-2 and COV-BARRIER, where OLUMIANT showed effectiveness without new safety concerns. Approximately one million patients have already received OLUMIANT globally since its emergency use in November 2020. Caution is advised due to risks of serious infections and other severe adverse events.

Incyte announced that the European Commission has approved Jakavi (ruxolitinib) for patients aged 12 and older with steroid-refractory acute or chronic graft-versus-host disease (GVHD). This marks the first approved treatment in Europe for this condition after inadequate steroid response. Clinical trials showed Jakavi's superiority over best available therapy, achieving an overall response rate of 62% versus 39% for acute GVHD, and 50% versus 26% for chronic GVHD. The approval follows a positive opinion from the EMA in March 2022, based on the results of the Phase 3 REACH2 and REACH3 studies.

Incyte will present at the 2022 RBC Capital Markets Healthcare Conference on May 17, 2022, at 10:30 a.m. ET in New York. The presentation will be available via live webcast on Investor.Incyte.com and can be replayed for 30 days. Based in Wilmington, Delaware, Incyte is a global biopharmaceutical company committed to addressing serious unmet medical needs through proprietary therapeutics. For more information, visit Incyte.com.

Incyte reported Q1 2022 financial results, highlighting a 20% year-over-year revenue increase to $728 million, with Jakafi net revenues at $544 million (+17% Y/Y). The company raised its 2022 revenue guidance for Jakafi to $2.33-$2.40 billion. The launch of Opzelura cream has been robust, treating over 38,000 new patients. Positive 52-week data for ruxolitinib cream in vitiligo was presented at AAD 2022. GAAP net income was $37.99 million with basic EPS of $0.17. The company maintains strong growth prospects with a solid pipeline.

Incyte has formed a strategic alliance with Maruho Co., Ltd. for the development and commercialization of ruxolitinib cream in Japan, targeting autoimmune and inflammatory dermatology conditions. Under this agreement, Maruho will provide an upfront payment and may grant Incyte royalties and milestone payments. Maruho will manage the development and exclusive commercialization of ruxolitinib cream, which has shown promise in treating conditions like atopic dermatitis and vitiligo. The partnership aims to address significant unmet medical needs in Japan.

Incyte announced that the European Medicines Agency’s CHMP has issued a positive opinion recommending marketing authorization for capmatinib (Tabrecta) to treat adults with advanced non-small cell lung cancer (NSCLC) featuring MET exon 14 skipping. This pivotal recommendation is based on the Phase 2 GEOMETRY mono-1 study, demonstrating a 51.6% overall response rate in second-line patients. METex14 skipping occurs in 3-4% of NSCLC cases, highlighting a significant therapeutic need. Incyte is set to gain over $500 million in milestones plus royalties of 12-14% on net sales by Novartis, who holds exclusive rights to the drug.

Incyte has announced its first quarter financial results conference call, set for 8:00 a.m. ET on May 3, 2022. The call will follow a press release scheduled for 7:00 a.m. ET on the same day. Investors can join the conference via domestic and international dial-in numbers, with a conference ID of 13728884. A replay will be available for 30 days, and the live webcast will be accessible on Investor.Incyte.com for 90 days. Incyte focuses on developing therapeutics for unmet medical needs.