Incyte Corp - INCY STOCK NEWS

Incyte announces the appointment of Susanne Schaffert, Ph.D., to its Board of Directors. Schaffert brings over 26 years of experience from Novartis AG, including her most recent role as President of Novartis Oncology. Incyte's CEO, Hervé Hoppenot, emphasized the value of her extensive expertise in commercial and development sectors to support the company's growth. Schaffert expressed enthusiasm for her new role, focusing on scientific innovation and developing new medications for patient needs.

Incyte announced FDA approval for Pemazyre (pemigatinib) treating adults with relapsed or refractory myeloid/lymphoid neoplasms (MLNs) featuring FGFR1 rearrangement, a rare and aggressive blood cancer affecting under 1 in 100,000 people in the U.S. This follows Pemazyre's earlier approval for cholangiocarcinoma in 2020. The approval was based on the Phase 2 FIGHT-203 study, showing a 78% complete response rate in patients with chronic phase disease. Potential side effects include hyperphosphatemia and ocular toxicity.

Incyte announced multiple abstracts from its dermatology portfolio will be presented at the EADV Congress from September 7-10, 2022. Highlights include data on the FDA-approved ruxolitinib cream for vitiligo and the oral JAK1 inhibitor povorcitinib, advancing into Phase 3 for hidradenitis suppurativa. Key presentations include efficacy and safety analyses of ruxolitinib cream and insights from the VALIANT study on vitiligo's mental health impacts. The MAA for ruxolitinib cream is under review by the EMA, reinforcing Incyte’s focus on innovative dermatological treatments.

Incyte will present at the Morgan Stanley 20th Annual Global Healthcare Conference on September 12, 2022, at 12:30 p.m. EDT in New York. The presentation will be available via live webcast on Investor.Incyte.com and will be accessible for replay for 30 days. Based in Wilmington, Delaware, Incyte is a global biopharmaceutical company dedicated to addressing serious unmet medical needs through innovative therapeutics. For more information, visit Incyte.com.

Incyte reported its Q2 2022 financial results, showing a significant 29% increase in total revenues to $911 million year-over-year. Product revenues of $664 million grew by 15%, with Jakafi leading at $598 million (+13% Y/Y). The company raised its full-year guidance for Jakafi to $2.36 to $2.40 billion. Notable approvals for Opzelura in vitiligo and Olumiant for alopecia areata enhance growth prospects. However, operational costs surged, with SG&A expenses rising 50% due to commercial activities.

Incyte has announced the FDA approval of Opzelura (ruxolitinib) cream 1.5%, the first and only topical treatment for nonsegmental vitiligo in patients aged 12 and older. Based on Phase 3 TRuE-V clinical trials, approximately 30% of patients achieved significant improvements in facial repigmentation at Week 24, increasing to 50% by Week 52. Opzelura is significantly impactful as it addresses a major unmet medical need, with potential for broad market appeal. An investor conference call is scheduled for July 19, 2022.

Incyte has scheduled its Q2 2022 financial results conference call for August 2, 2022, at 8:00 a.m. ET. The press release detailing these results will be available earlier on the same day at 7:00 a.m. ET. Investors can dial in using the domestic number 877-407-3042 or international number 201-389-0864, with the conference ID 13731520. A replay will be available for thirty days. Interested parties can also access the live webcast with slides via Incyte's investor website.

Eli Lilly and Incyte announced that the FDA has approved OLUMIANT (baricitinib) as the first systemic treatment for adults with severe alopecia areata. Available in 1 mg, 2 mg, and 4 mg doses, OLUMIANT has shown promising results in clinical trials, with 32-35% of patients achieving over 80% scalp coverage. The approval follows the BRAVE-AA1 and BRAVE-AA2 trials, involving 1,200 patients. While the treatment offers hope for patients, it comes with serious risks, including infections and cardiovascular events. Manufacturers are also working on patient access programs to help with costs.

Pfizer, MorphoSys, and Incyte announced a clinical trial collaboration to explore the immunotherapeutic combination of Pfizer's TTI-622 with MorphoSys's Monjuvi and lenalidomide for patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) not eligible for autologous stem cell transplantation. Pfizer will lead a multicenter Phase 1b/2 study, which is set to take place in North America, Europe, and Asia-Pacific. The initiative addresses significant unmet medical needs in DLBCL treatment and follows promising preclinical data regarding TTI-622's potential efficacy.