Europe Approves Merck's Cancer Drug For Two Indications

On Tuesday, the European Commission (EC) conditionally approved Merck & Co Inc’s MRK Welireg (belzutifan), an oral hypoxia-inducible factor-2 alpha (HIF-2α) inhibitor, as monotherapy for:

• Adult patients with von Hippel-Lindau (VHL) disease who require therapy for associated, localized renal cell carcinoma (RCC), central nervous system (CNS) hemangioblastomas, or pancreatic neuroendocrine tumors (pNET), and for whom localized procedures are unsuitable;
• Adult patients with advanced clear cell RCC that progressed following two or more lines of therapy.

The approval of these two indications is based on results from the LITESPARK-004 and LITESPARK-005 trials, respectively.

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This marks Welireg’s first approval in the European Union (EU). Welireg is now approved in over 30 countries for certain adult patients with previously treated advanced RCC and in more than 40 countries for adult patients with certain eligible VHL disease-associated tumors.

The conditional approval of Welireg will be valid for one year, subject to yearly renewal, pending additional clinical data from LITESPARK-004 and another ongoing Phase 2 trial of WELIREG in patients with certain VHL disease-associated tumors.

The FDA approved Welireg in August 2021 for adult patients with VHL disease who require therapy for associated RCC, CNS hemangioblastomas or pNET not requiring immediate surgery based on the results from LITESPARK-004.

Welireg was approved in the U.S. in December 2023 for adult patients with advanced RCC following a PD-1 or PD-L1 inhibitor and a VEGF-tyrosine kinase inhibitor based on the results from LITESPARK-005.

Merck Stock Prediction For 2025

Equity research analysts on and off Wall Street typically use earnings growth and fundamental research as a form of valuation and forecasting. But many in trading turn to technical analysis as a way to form predictive models for share price trajectory.

Some investors look to trends to help forecast where they believe a stock could trade at a certain point in the future. Looking at Merck, an investor could make an assessment about a stock's long term prospects using a moving average and trend line. If they believe a stock will remain above the moving average, which many believe is a bullish signal, they can extrapolate that trend into the future using a trend line. For Merck & Co, the 200-day moving average sits at $112.21, according to Benzinga Pro, which is above the current price of $81.79. For more on charts and trend lines, see a description here.

Traders believe that when a stock is above its moving average, it is a generally bullish signal, and when it crosses below, it is a more negative signal. Investors could use trend lines to make an educated guess about where a stock could trade at a later date if conditions remain stable.

Price Action: MRK stock is down 1.30% to $81.93 at the last check on Tuesday.

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Photo courtesy of Merck.