Merck MRK announced that EMA’s Committee for Medicinal Products for Human Use (“CHMP”) recommended granting conditional approval to its oral HIF-2α inhibitor, Welireg (belzutifan), for use in two indications associated with renal cell carcinoma (“RCC”).

The CHMP recommended Welireg to treat adult patients with von Hippel-Lindau (“VHL”) disease who require therapy for associated RCC, central nervous system hemangioblastomas or pancreatic neuroendocrine tumors, not requiring immediate surgery. This committee also endorsed the drug for a second indication to treat adult patients with advanced RCC who have received at least two lines of therapy, which include anti-PD-1 and VEGF-targeted therapies.

A final decision from the European Commission on both indications is expected in the first quarter of 2025. If approved, Welireg will be the first systemic treatment for patients with VHL disease-associated tumors in the European Union.

Positive Results Supporting CHMP Nod to MRK’s Welireg

The positive opinion from CHMP for both indications is supported by data from two separate clinical studies, namely phase II LITESPARK-004 and phase III LITESPARK-005. While the first study evaluated Welireg in VHL disease-associated tumors, the other study assessed the drug for treating patients with third or later-line advanced RCC.

The LITESPARK-004 study achieved its major efficacy endpoint, treatment with Welireg achieved an objective response rate (“ORR”) of 49% in patients with VHL-associated RCC.

Data from the LITESPARK-005 study showed that treatment with Welireg achieved statistically significant and clinically meaningful improvement in progression-free survival, one of the study’s dual primary endpoints. The study also achieved its secondary endpoint of statistically significant improvement in ORR.

Welireg is already approved in the United States for similar indications, also supported by data from the above-mentioned studies.

MRK Stock’s Price Performance

Year to date, Merck’s shares have lost 6.5% against the industry’s 6.3% growth.

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More on MRK’s Welireg

The LITESPARK-004 and LITESPARK-005 studies are part of Merck's comprehensive late-stage development program on Welireg in RCC. The program comprises three other late-stage studies–LITESPARK-011, LITESPARK-012 and LITESPARK-022. While LITESPARK-011 and LITESPARK-012 evaluate Welireg in the second-line and treatment-naïve advanced disease settings, respectively, LITESPARK-022 evaluates Welireg in the adjuvant setting.

Apart from RCC, Merck is also evaluating the drug in separate mid-stage studies for multiple other cancer indications–endometrial, esophageal, hepatocellular carcinoma and prostate.

Merck’s oncology portfolio is highly dependent on Keytruda, its blockbuster anti-PD-1 therapy, which accounted for nearly 45% of the company’s revenues in the first nine months of 2024. With concerns over Keytruda’s potential loss of exclusivity post-2028, approval of drugs like Welireg in other geographies should enable the company to narrow down its dependence on the anti-PD-1 therapy for revenues.

MRK’s Zacks Rank

Merck currently carries a Zacks Rank #3 (Hold).

Merck & Co., Inc. Price

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Our Key Picks Among Biotech Stocks

Some better-ranked stocks from the sector are Castle Biosciences CSTL, CytomX Therapeutics CTMX and Spero Therapeutics SPRO, each sporting a Zacks Rank #1 (Strong Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.

In the past 60 days, 2024 estimates for Castle Biosciences have improved from a loss of 58 cents per share to earnings of 34 cents. During the same timeframe, loss per share estimates for 2025 have narrowed from $2.13 to $1.84. Year to date, shares of Castle Biosciences have surged 33.8%.

CSTL’s earnings beat estimates in each of the trailing four quarters, delivering an average surprise of 172.72%.

In the past 60 days, estimates for CytomX Therapeutics’ 2024 loss per share have narrowed from 29 cents to 5 cents. Estimates for 2025 loss per share have narrowed from 56 cents to 35 cents during the same timeframe. Year to date, CTMX stock has lost 28.4%.

CytomX’s earnings beat estimates in two of the trailing four quarters and missed the mark in the other two, delivering an average surprise of 115.70%.

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SPRO’s earnings beat estimates in two of the trailing four quarters and missed the mark in the other two, delivering an average surprise of 94.42%.

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