Incyte Genomics Inc - INCY STOCK NEWS

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.

On March 26, 2022, Eli Lilly released data from pivotal Phase 3 studies on OLUMIANT (baricitinib) for adults with severe alopecia areata, showing nearly 40% of patients on 4-mg achieved at least 80% scalp coverage at 52 weeks. Results indicate significant eyelash and eyebrow regrowth in those treated. The FDA granted priority review for OLUMIANT in February 2022, marking it as a potential first-in-disease treatment. Safety profiles were consistent over 52 weeks, with no new safety signals reported, reinforcing its promise as a key therapeutic option.

Incyte announced promising 52-week results from its pivotal Phase 3 TRuE-V clinical trials for ruxolitinib cream (Opzelura), targeting nonsegmental vitiligo in patients aged 12 and older. Key findings presented at the 2022 AAD Annual Meeting indicate that approximately 50% of patients achieved ≥75% improvement in facial Vitiligo Area Scoring Index at Week 52. Safety data showed no significant adverse reactions. These results further support the therapeutic potential of ruxolitinib cream, with FDA review expected by July 18, 2022.

Incyte announced that the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion recommending the approval of ruxolitinib (Jakavi) for treating acute and chronic graft-versus-host disease (GVHD) in patients aged 12 and older with inadequate responses to corticosteroids. This recommendation is based on successful Phase 3 REACH2 and REACH3 trials showing improved response rates of 62.3% and 49.7% for ruxolitinib compared to best available therapy. The European Commission is expected to make a final decision within two months.

Incyte announced the presentation of new data on ruxolitinib cream (Opzelura) for vitiligo and atopic dermatitis at the American Academy of Dermatology Annual Meeting from March 25-29, 2022, in Boston. The highlight includes 52-week results of the Phase 3 TRuE-V vitiligo program, demonstrating the cream's safety and efficacy in patients aged 12 and older. Incyte aims to emphasize its commitment to dermatological treatments through multiple Phase 3 studies during the event.

Incyte Corporation announced the extension of the FDA review period for the supplemental New Drug Application (sNDA) for ruxolitinib cream (Opzelura) intended for vitiligo treatment. The PDUFA action date is now set for July 18, 2022, allowing additional time to review data from ongoing Phase 3 studies. The TRuE-V trial program assesses the cream's safety and efficacy on over 600 patients aged 12 and older. Incyte aims to provide a vital treatment option as current therapies for repigmentation in vitiligo are lacking in the U.S.