27.08.2021 17:09

Incyte (INCY), MorphoSys Win EC Approval for Lymphoma Drug

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Incyte INCY and partner MorphoSys AG MOR recently announced that the European Commission (“EC”) has granted conditional marketing authorization to tafasitamab under the brand name Minjuvi.Tafasitamab is a humanized Fc-modified cytolytic CD19 targeting monoclonal antibody.The drug has been approved in combination with Bristol Myers’ BMY Revlimid (lenalidomide) followed by Minjuvi monotherapy, for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) who are not eligible for autologous stem cell transplant (ASCT).An approval was in the cards as the European Medicines Agency’s Committee for Medicinal Products for Human Use gave a positive opinion recommending the conditional marketing authorization of Minjuvi in June 2021.The conditional approval is based on positive results from the L-MIND study evaluating the safety and efficacy of Minjuvi in combination with Revlimid as a treatment for patients with relapsed or refractory DLBCL who are not eligible for ASCT. The results showed best objective response rate (ORR) of 56.8% (primary endpoint), including a complete response (CR) rate of 39.5% and a partial response rate (PR) of 17.3%, as assessed by an independent review committee.We remind investors that both the companies share global development rights to tafasitamab. While Incyte has exclusive commercialization rights to tafasitamab outside the United States, both the companies co-market the drug under the brand name Monjuvi in the United States. Incyte will market the drug under the brand name Minjuvi in the EU.In Europe, approximately 16,000 patients are diagnosed with relapsed or refractory DLBCL annually.The approval will generate an incremental stream of revenues for Incyte.Shares of the company have lost 12.8% in the year so far against the industry’s 0.7% growth.Image Source: Zacks Investment ResearchIncyte’s performance in the second quarter was encouraging as lead drug Jakafi sales recorded growth after a soft first quarter. The uptake of Pemazyre is also gaining traction. The company’s efforts to diversify its revenue base are encouraging as well.However, the company has suffered a few setbacks of late. The FDA extended the review period for Incyte’s new drug application (NDA) for ruxolitinib cream for the treatment of atopic dermatitis (AD).  The FDA also issued a complete response letter (CRL) for the biologics license application (BLA) for its intravenous PD-1 inhibitor, retifanlimab, for the treatment of adult patients with locally advanced or metastatic squamous cell carcinoma of the anal canal (SCAC) who have progressed on, or who are intolerant of platinum-based chemotherapy.Incyte currently has a Zacks Rank #3 (Hold). A better-ranked stock in the biotech sector is Repligen Corporation RGEN which sports a Zacks Rank #1 (Strong Buy).  You can see the complete list of today’s Zacks #1 Rank stocks here.Earnings estimates for Repligen for 2021 are up 50 cents in the past 30 days.  The stock is up 42.6% in the year so far. Bitcoin, Like the Internet Itself, Could Change EverythingBlockchain and cryptocurrency has sparked one of the most exciting discussion topics of a generation. Some call it the “Internet of Money” and predict it could change the way money works forever. If true, it could do to banks what Netflix did to Blockbuster and Amazon did to Sears. Experts agree we’re still in the early stages of this technology, and as it grows, it will create several investing opportunities.Zacks’ has just revealed 3 companies that can help investors capitalize on the explosive profit potential of Bitcoin and the other cryptocurrencies with significantly less volatility than buying them directly.See 3 Crypto-Related Stocks Now >>Want the latest recommendations from Zacks Investment Research? Today, you can download 7 Best Stocks for the Next 30 Days. Click to get this free report Bristol Myers Squibb Company (BMY): Free Stock Analysis Report Incyte Corporation (INCY): Free Stock Analysis Report Repligen Corporation (RGEN): Free Stock Analysis Report MorphoSys AG Unsponsored ADR (MOR): Free Stock Analysis Report To read this article on Zacks.com click here. Zacks Investment Research
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Analysen zu Incyte Corp.

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03.05.2019Incyte Equal WeightBarclays Capital
24.01.2019Incyte BuyGabelli & Co
01.10.2018Incyte NeutralCantor Fitzgerald
09.04.2018Incyte HoldGabelli & Co
05.04.2018Incyte OverweightBarclays Capital
24.01.2019Incyte BuyGabelli & Co
05.04.2018Incyte OverweightBarclays Capital
02.01.2018Incyte OutperformRBC Capital Markets
10.04.2017Incyte BuyGabelli & Co
07.04.2017Incyte OverweightBarclays Capital
03.05.2019Incyte Equal WeightBarclays Capital
01.10.2018Incyte NeutralCantor Fitzgerald
09.04.2018Incyte HoldGabelli & Co
21.11.2017Incyte Sector PerformRBC Capital Markets
15.09.2017Incyte Sector PerformRBC Capital Markets
04.04.2006Incyte underperformWachovia Sec

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