Incyte Corp - INCY STOCK NEWS

Incyte announced that the European Commission has granted marketing authorization for Opzelura (ruxolitinib) cream, marking it as the first approved treatment for repigmentation in non-segmental vitiligo within the European Union.

This approval is based on positive Phase 3 trial results showing substantial improvements in facial and total body repigmentation with the treatment. Approximately 29.8% and 30.9% of patients achieved a 75% improvement in facial vitiligo after 24 weeks of treatment. The cream is designated for use in adults and adolescents aged 12 and older, addressing a significant unmet need for patients suffering from this chronic autoimmune disease.

No serious treatment-related side effects were reported, although acne at the application site was noted as a common reaction.

Incyte has announced its participation in two key investor conferences in May 2023. The company will present at the Bank of America 2023 Health Care Conference on May 10, 2023, at 10:40 a.m. (PDT), and at the 2023 RBC Capital Markets Global Healthcare Conference on May 16, 2023, at 10:30 a.m. (EDT). Both presentations will be available via live webcast at Investor.Incyte.com and can be replayed for 30 days following the events. Incyte, based in Wilmington, Delaware, specializes in developing proprietary therapeutics to address serious unmet medical needs.

MorphoSys and Incyte presented final five-year follow-up data from the Phase 2 L-MIND study at the American Association for Cancer Research Annual Meeting 2023. The study focused on the effectiveness of Monjuvi, an immunotherapy, combined with lenalidomide, in treating adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL). Key findings included an overall response rate of 57.5%, with a complete response in 41.2% of patients. Importantly, the median overall survival was reported at 33.5 months. No new safety concerns arose, with most adverse events being grade 1 or 2. This data reinforces Monjuvi's potential as a viable treatment option for patients who are not candidates for autologous stem cell transplants.

Incyte (NASDAQ:INCY) has announced its conference call and webcast scheduled for May 2, 2023, at 8:00 a.m. ET to discuss its Q1 2023 financial results. The press release for these results will be available earlier that day at 7:00 a.m. ET. Investors can access the call via domestic and international dial-in numbers or through an online webcast at Investor.Incyte.com. A replay of the conference call will be accessible for 30 days following the event. Incyte is a global biopharmaceutical company headquartered in Wilmington, Delaware, dedicated to addressing serious unmet medical needs through the development of innovative therapeutics.

Incyte announced that the Japanese Ministry of Health, Labour and Welfare has approved Pemazyre (pemigatinib) for treating myeloid/lymphoid neoplasms (MLNs) with FGFR1 fusion. This marks a significant step in providing a treatment option for Japanese patients with this rare cancer, affecting fewer than 100 people worldwide. The approval is based on the Phase 2 FIGHT-203 study, which showed a 62.5% complete response rate among 41 patients. Pemazyre previously received Orphan Drug Designation for rare diseases. It’s also the first targeted treatment for relapsed MLNs with FGFR1 rearrangement in the U.S., showcasing Incyte's commitment to addressing critical medical needs.

Incyte (Nasdaq: INCY) announced the U.S. FDA issued a complete response letter regarding the New Drug Application (NDA) for ruxolitinib extended-release (XR) tablets. The FDA did not approve the application in its current form, though acknowledged the NDA met bioequivalence objectives. Incyte plans to engage with the FDA to clarify the necessary steps for approval. CEO Hervé Hoppenot expressed disappointment but reaffirmed commitment to support patients with myeloproliferative neoplasms and graft-versus-host disease.

Incyte announced FDA approval of Zynyz (retifanlimab-dlwr) for treating adults with metastatic or locally advanced Merkel cell carcinoma (MCC). This marks the first regulatory approval of a PD-1 inhibitor based on the POD1UM-201 trial results, which showed a 52% objective response rate among chemotherapy-naïve patients. The approval was granted under accelerated conditions, potentially subject to further validation of clinical benefits. Zynyz is also being studied for other tumor types and in combination therapies. Serious adverse reactions occurred in 22% of patients, with fatigue and arrhythmia being the most common.

Incyte announced promising results from a Phase 2b trial of povorcitinib, an oral JAK1 inhibitor, for treating extensive nonsegmental vitiligo. Presented at the 2023 AAD Annual Meeting, the trial showed statistically significant improvements in total body and facial repigmentation at Week 24. The primary endpoint demonstrated a mean decrease in T-VASI scores: -19.1% for 15 mg, -17.8% for 45 mg, and -15.7% for 75 mg compared to a +2.3% increase in the placebo group (p<0.01). The treatment was generally well tolerated, with no serious adverse events related to the drug, underscoring its potential as an effective therapeutic option.

Incyte announced new results from the Phase 3 TRuE-V clinical trial program evaluating Opzelura (ruxolitinib) in patients with nonsegmental vitiligo. At Week 104, patients who had a high level of facial repigmentation maintained a durable response a year after treatment withdrawal. Continued treatment led to further improvements in facial and total body repigmentation. The results, presented at the 2023 American Academy of Dermatology Annual Meeting, indicate Opzelura's efficacy and safety, as well as its potential as a long-term treatment option for vitiligo.