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FDA Accepts Merck's Filing for Subcutaneous Version of Keytruda
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Merck (MRK - Free Report) announced that the FDA has accepted its regulatory filing seeking approval for the subcutaneous (under the skin or SC) formulation of the blockbuster drug Keytruda (pembrolizumab).
This filing seeks the agency’s nod for the SC version across all solid tumor indications for which the drug’s intravenous (into the vein or IV) version is already approved.
A final decision is expected by Sept. 23, 2025.
More on MRK’s Keytruda SC Filing
The regulatory filing is supported by data from the pivotal phase III 3475A-D77 study that evaluated Keytruda SC against the IV version (both versions administered in combination with chemotherapy) for the first-line treatment of adult patients with metastatic non-small cell lung cancer. As announced by Merck in November, the study achieved its primary endpoints, showing that the treatment with the SC version of the drug was at least as effective as the IV version.
Alongside the above news, Merck also provided detailed results on the secondary endpoints of the 3475A-D77 study. Data from the study showed that patients treated with Keytruda SC achieved an objective response rate of 45.4% compared with 42.1% for the IV version. The results were also comparable for the duration of response and progression-free survival endpoints. Though overall survival outcomes have yet to be reached for either of the arms, these results indicate no significant loss of efficacy with Keytruda SC.
Merck also announced results from a time and motion study conducted alongside the 3475A-D77 study. Data from this observational study showed that SC formulation reduced patient in-chair time by 49.7% and treatment room time by 47.4% compared with the IV version. Treatment with Keytruda SC also cut healthcare professionals' active treatment time by 45.7%, streamlining administration and improving efficiency.
A regulatory filing for Keytruda SC is also under review in the European Union, supported by the above results.
MRK Stock’s Performance
Year to date, Merck’s shares have lost nearly 11% against the industry’s 3% growth.
Image Source: Zacks Investment Research
How Would Keytruda SC’s Approval Benefit Merck?
Keytruda is a key revenue driver for the company, accounting for nearly 46% of its total 2024 revenues. Sales of this flagship cancer drug rose 18% to $29.5 billion, driven by continued strong momentum in metastatic indications and rapid uptake across earlier-stage launches. However, investors have expressed concerns over the potential loss of exclusivity of the IV version after 2028. Keytruda IV is currently approved for more than 40 distinct indications.
Merck’s intent behind this filing seems clear. It hopes that the approval of Keytruda SC can help protect against the potential generic erosion of the drug’s IV formulation. The SC version would receive protection by entirely new patents.
An approval of the SC version also benefits both patients and physicians. Delivering a drug SC instead of IV can significantly reduce administration time and improve patient convenience. If approved, Merck expects to administer Keytruda SC in about two minutes compared with the IV version, which takes more than 30 minutes.
The shift from IV to SC could also ease the burden on healthcare facilities, making treatment more accessible and potentially boosting adoption rates.
In the past 60 days, estimates for ANI Pharmaceuticals’ 2025 earnings per share (EPS) have risen from $5.54 to $6.35. EPS estimates for 2026 have increased from $6.75 to $7.21 during the same period. Year to date, shares of ANIP have risen 26%.
ANIP’s earnings beat estimates in each of the trailing four quarters, delivering an average surprise of 17.32%.
In the past 60 days, estimates for CytomX Therapeutics’ 2025 EPS have improved from a loss of 31 cents to a profit of 25 cents. During the same timeframe, estimates for loss per share for 2026 have narrowed from 65 cents to 31 cents. Year to date, shares of CytomX have lost 40%.
CTMX’s earnings beat estimates in three of the trailing four quarters and missed the mark once, delivering an average surprise of 180.70%.
Estimates for 89bio’s loss per share have narrowed from $2.93 to $1.98 for 2025 in the past 60 days. During the same time frame, loss per share estimates for 2026 have improved from $3.06 to $2.15. ETNB’s shares have gained 15% year to date.
89bio’s earnings missed estimates in three of the trailing four quarters and beat the mark on one occasion, delivering an average negative surprise of 46.18%.
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FDA Accepts Merck's Filing for Subcutaneous Version of Keytruda
Merck (MRK - Free Report) announced that the FDA has accepted its regulatory filing seeking approval for the subcutaneous (under the skin or SC) formulation of the blockbuster drug Keytruda (pembrolizumab).
This filing seeks the agency’s nod for the SC version across all solid tumor indications for which the drug’s intravenous (into the vein or IV) version is already approved.
A final decision is expected by Sept. 23, 2025.
More on MRK’s Keytruda SC Filing
The regulatory filing is supported by data from the pivotal phase III 3475A-D77 study that evaluated Keytruda SC against the IV version (both versions administered in combination with chemotherapy) for the first-line treatment of adult patients with metastatic non-small cell lung cancer. As announced by Merck in November, the study achieved its primary endpoints, showing that the treatment with the SC version of the drug was at least as effective as the IV version.
Alongside the above news, Merck also provided detailed results on the secondary endpoints of the 3475A-D77 study. Data from the study showed that patients treated with Keytruda SC achieved an objective response rate of 45.4% compared with 42.1% for the IV version. The results were also comparable for the duration of response and progression-free survival endpoints. Though overall survival outcomes have yet to be reached for either of the arms, these results indicate no significant loss of efficacy with Keytruda SC.
Merck also announced results from a time and motion study conducted alongside the 3475A-D77 study. Data from this observational study showed that SC formulation reduced patient in-chair time by 49.7% and treatment room time by 47.4% compared with the IV version. Treatment with Keytruda SC also cut healthcare professionals' active treatment time by 45.7%, streamlining administration and improving efficiency.
A regulatory filing for Keytruda SC is also under review in the European Union, supported by the above results.
MRK Stock’s Performance
Year to date, Merck’s shares have lost nearly 11% against the industry’s 3% growth.
Image Source: Zacks Investment Research
How Would Keytruda SC’s Approval Benefit Merck?
Keytruda is a key revenue driver for the company, accounting for nearly 46% of its total 2024 revenues. Sales of this flagship cancer drug rose 18% to $29.5 billion, driven by continued strong momentum in metastatic indications and rapid uptake across earlier-stage launches. However, investors have expressed concerns over the potential loss of exclusivity of the IV version after 2028. Keytruda IV is currently approved for more than 40 distinct indications.
Merck’s intent behind this filing seems clear. It hopes that the approval of Keytruda SC can help protect against the potential generic erosion of the drug’s IV formulation. The SC version would receive protection by entirely new patents.
An approval of the SC version also benefits both patients and physicians. Delivering a drug SC instead of IV can significantly reduce administration time and improve patient convenience. If approved, Merck expects to administer Keytruda SC in about two minutes compared with the IV version, which takes more than 30 minutes.
The shift from IV to SC could also ease the burden on healthcare facilities, making treatment more accessible and potentially boosting adoption rates.
MRK’s Zacks Rank
Merck currently carries a Zacks Rank #3 (Hold).
Merck & Co., Inc. Price
Merck & Co., Inc. price | Merck & Co., Inc. Quote
Key Picks Among Biotech Stocks
Some better-ranked stocks from the sector are ANI Pharmaceuticals (ANIP - Free Report) , CytomX Therapeutics (CTMX - Free Report) and 89bio (ETNB - Free Report) . While ANIP and CTMX sport a Zacks Rank #1 (Strong Buy) each at present, ETNB carries a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.
In the past 60 days, estimates for ANI Pharmaceuticals’ 2025 earnings per share (EPS) have risen from $5.54 to $6.35. EPS estimates for 2026 have increased from $6.75 to $7.21 during the same period. Year to date, shares of ANIP have risen 26%.
ANIP’s earnings beat estimates in each of the trailing four quarters, delivering an average surprise of 17.32%.
In the past 60 days, estimates for CytomX Therapeutics’ 2025 EPS have improved from a loss of 31 cents to a profit of 25 cents. During the same timeframe, estimates for loss per share for 2026 have narrowed from 65 cents to 31 cents. Year to date, shares of CytomX have lost 40%.
CTMX’s earnings beat estimates in three of the trailing four quarters and missed the mark once, delivering an average surprise of 180.70%.
Estimates for 89bio’s loss per share have narrowed from $2.93 to $1.98 for 2025 in the past 60 days. During the same time frame, loss per share estimates for 2026 have improved from $3.06 to $2.15. ETNB’s shares have gained 15% year to date.
89bio’s earnings missed estimates in three of the trailing four quarters and beat the mark on one occasion, delivering an average negative surprise of 46.18%.