Incyte Corp Stock Price, News & Analysis

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.

Incyte has scheduled a conference call to discuss its Q2 2021 financial results at 8:00 a.m. ET on August 3, 2021. The press release will be issued at 7:00 a.m. ET on the same day. For those unable to attend, a thirty-day replay will be available via specific U.S. and international dial-in numbers. Incyte, based in Wilmington, Delaware, focuses on developing treatments for serious unmet medical needs.

Incyte announces positive results from the Phase 3 REACH3 study published in The New England Journal of Medicine, demonstrating that ruxolitinib significantly improves outcomes in patients with steroid-refractory chronic graft-versus-host disease (GVHD) compared to best available therapy (BAT). Key findings include an overall response rate (ORR) of 49.7% versus 25.6% for BAT (P<0.001) and a best overall response (BOR) rate of 76.4% for ruxolitinib. The study indicates longer failure-free survival and improved self-reported symptoms. No new safety signals were observed. This data supports the company's supplemental New Drug Application to the FDA.

Incyte and MorphoSys announced a positive opinion from the European Medicines Agency’s CHMP recommending conditional marketing authorization for tafasitamab combined with lenalidomide for adult patients with relapsed/refractory diffuse large B-cell lymphoma (DLBCL) who can't undergo autologous stem cell transplantation (ASCT). This follows the FDA's approval in July 2020. Tafasitamab represents a crucial treatment option for the 30-40% of DLBCL patients who face poor prognoses. The final decision by the European Commission is awaited, with expectations to commercialize tafasitamab as Minjuvi in the EU.