Incyte Genomics Inc - INCY STOCK NEWS

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.

Incyte (NASDAQ:INCY) has announced multiple abstracts that will be presented during the American Association for Cancer Research (AACR) Annual Meeting 2023, taking place from April 14-19 in Orlando, Florida. Key presentations include findings on pemigatinib in previously-treated solid tumors and five-year results from the L-MIND study of tafasitamab in DLBCL. Notable oral presentations include insights into the development of INCB123667 for breast cancers, as well as the final results of tafasitamab. The meeting will allow virtual access to on-demand sessions until July 19, 2023. For more details, visit the AACR website.

Caris Life Sciences announced a strategic research partnership with Incyte Corporation on March 7, 2023, to enhance precision medicine approaches for Incyte's oncology pipeline. This partnership leverages Caris' advanced molecular science solutions, including comprehensive profiling and AI capabilities, to improve patient outcomes. Initially focusing on two therapeutic programs, Incyte has the option to expand to four. This collaboration aims to optimize clinical trial strategies and discover novel biomarkers, reinforcing Incyte's commitment to developing innovative cancer treatments.

Incyte announced the presentation of new long-term data from the Phase 3 TRuE-V trials for Opzelura (ruxolitinib) cream, focused on vitiligo, at the upcoming 2023 AAD Annual Meeting in New Orleans. Two late-breaking oral presentations will detail durability and long-term response, with safety and efficacy data from a Phase 2b study of povorcitinib (INCB54707) also highlighted. Incyte will host an in-person event on March 18, 2023, to discuss these key findings. Opzelura is the first FDA-approved treatment for repigmentation in nonsegmental vitiligo and shows promise for other dermatological conditions.

Incyte announced the discontinuation of the Phase 3 LIMBER-304 trial after an independent data monitoring committee determined it was unlikely to meet its primary endpoint. This trial evaluated the efficacy and safety of parsaclisib combined with ruxolitinib in patients with myelofibrosis who did not respond adequately to ruxolitinib alone. The decision to halt the study was not due to safety concerns. Incyte will review the data and is expected to present findings at a future scientific meeting. The primary endpoint was the reduction in spleen volume, with secondary endpoints including symptom score changes and overall survival.

Incyte announced a positive opinion from the CHMP recommending the approval of ruxolitinib cream (Opzelura) for treating non-segmental vitiligo, marking it as the first treatment for repigmentation available in the EU. With about 1.5 million patients affected in Europe, the recommendation is based on Phase 3 trial data showing significant improvements in facial and total body repigmentation. The European Commission will review the opinion, which, if approved, will provide a critical treatment option for patients aged 12 and older, addressing a significant unmet medical need in dermatology.