Incyte Corp Stock Price, News & Analysis

Incyte announced FDA approval for Opzelura (ruxolitinib) cream, the first topical JAK inhibitor for treating mild to moderate atopic dermatitis (AD) in patients aged 12 and older. Approval was based on the TRuE-AD clinical trial, where nearly 54% of patients achieved significant treatment success at week 8. Common side effects include nasopharyngitis and diarrhea. Over 21 million Americans suffer from AD, highlighting the market potential of Opzelura. The company plans to support patients through the IncyteCARES program and recently scheduled an investor conference call for September 22, 2021.

Nimble Therapeutics has expanded its strategic research collaboration with Incyte to discover additional novel peptide therapies. CEO Jigar Patel highlighted this collaboration as a validation of Nimble's capabilities in peptide therapeutics. Under the agreement, Nimble will receive an upfront payment and reimbursement for certain research costs and may be eligible for milestone payments and royalties. Incyte retains exclusive rights to develop and commercialize any peptides discovered during the collaboration and has options for further expansion.

Incyte announced that data from the Phase 3 TRuE-V program of ruxolitinib cream for treating vitiligo will be presented during a late-breaking oral presentation at the EADV 30th Anniversary Congress from September 29 to October 2, 2021. Both TRuE-V1 and TRuE-V2 studies met primary and key secondary endpoints. The highlights include safety and efficacy results for ruxolitinib cream, which shows potential as an effective treatment for patients with vitiligo and atopic dermatitis. This development underscores Incyte's commitment to addressing unmet medical needs in dermatology.

Incyte and MorphoSys AG have received conditional marketing authorization from the European Commission for Minjuvi (tafasitamab) in combination with lenalidomide. This approval is intended for adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) who are ineligible for autologous stem cell transplant. The decision is supported by positive data from the L-MIND study, showing an overall response rate of 56.8%. Approximately 16,000 patients are diagnosed annually with this condition in the EU.

Incyte (Nasdaq:INCY) announced its participation in the Morgan Stanley 19th Annual Global Healthcare Conference on September 13, 2021, at 11:45 a.m. ET. The presentation will be available via a live webcast, and a replay will be accessible for 90 days afterward.

Incyte, a biopharmaceutical company based in Wilmington, Delaware, focuses on addressing significant unmet medical needs through innovative therapeutics. For further details, visit Incyte.com.

Incyte and InnoCare have announced a collaboration for the development and commercialization of tafasitamab in Greater China. Incyte will receive an upfront payment of US$35 million and has the potential to earn up to US$82.5 million in milestones and royalties. InnoCare will develop and commercialize tafasitamab in hematology and oncology across mainland China, Hong Kong, Macau, and Taiwan. This partnership aims to expedite access to this FDA-approved treatment for eligible patients, leveraging InnoCare's local expertise.

Incyte reports robust Q2 2021 performance, with GAAP revenue rising to $705.7 million, a 3% year-over-year increase. Key growth drivers include Jakafi product revenues, which rose 12% to $529.1 million. Notably, Pemazyre achieved a staggering 373% increase in revenues. Non-GAAP net income was $178.8 million, or $0.80 per diluted share. The company provided updated guidance, raising Jakafi revenue expectations to $2.125-$2.170 billion. Updates on ongoing clinical trials and drug approvals, including ruxolitinib and tafasitamab, signal continued advancement in their development portfolio.

Eli Lilly and Incyte announced that in a sub-study of the COV-BARRIER trial, the use of baricitinib in critically ill COVID-19 patients on mechanical ventilation showed a 46% reduction in 28-day mortality compared to placebo. Specifically, the mortality rate was 39.2% for baricitinib versus 58% for placebo. No new safety issues were reported, and adverse event rates were comparable between groups. The FDA has broadened the Emergency Use Authorization for baricitinib for treating COVID-19 in hospitalized adults and pediatric patients requiring respiratory support.

Incyte Corporation (Nasdaq:INCY) received a Complete Response Letter (CRL) from the FDA regarding its Biologics License Application for retifanlimab, an intravenous PD-1 inhibitor aimed at treating advanced squamous cell carcinoma of the anal canal (SCAC). The FDA stated that the application cannot be approved in its current form due to the need for additional data demonstrating clinical benefit. Incyte plans to review the letter and coordinate with the FDA on next steps. The BLA submission was based on Phase 2 trial data.