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Merck (MRK), Seagen Keytruda-Padcev sBLAs Get FDA Priority Tag
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Merck (MRK - Free Report) along with partner Astellas Pharma and Seagen announced that the FDA has accepted supplemental biologics license applications (sBLAs) seeking approval for the combination use of Seagen’s antibody-drug conjugate, Padcev plus Merck’s blockbuster PD-L1 inhibitor, Keytruda in a bladder cancer indication.
The sBLAs sought approval of Padcev in combination with Keytruda for the treatment of locally advanced or metastatic urothelial cancer, the most common type of bladder cancer, in patients who are not eligible to receive cisplatin-containing chemotherapy.
With the FDA granting priority review to the sBLAs, a decision is expected in April 21, 2023. The respective sBLAs are based on efficacy and safety data from some cohorts of the phase Ib/II EV-103 study (also known as KEYNOTE-869).
Merck stock has risen 42.8% this year so far compared with an increase of 10.7% for the industry.
Image Source: Zacks Investment Research
Shares of Seagen have lost 13.9% so far this year compared with the industry’s decrease of 21.1%.
Image Source: Zacks Investment Research
Merck and Seagen are evaluating Padcev and Keytruda in multiple stages of urothelial cancer, including two phase III studies in muscle-invasive bladder cancer.
Seagen’s Padcev is approved for the treatment of patients with advanced/metastatic urothelial cancer who had received treatment with both a checkpoint inhibitor (PD-1/PD-L1) and platinum-based chemotherapy or those patients who are ineligible for cisplatin-containing chemotherapy.
In the first nine months of 2022, Padcev generated sales worth $329.0 million, reflecting an increase of 33% year over year.
Merck’s Keytruda is already approved for the treatment of many cancers globally. The drug recorded sales of $15.48 billion in the first nine months of 2022, up 23% year over year.
Earnings per share estimates for Sanofi’s 2022 earnings have increased from $4.02 per share to $4.27 while that for 2023 has jumped from $4.22 per share to $4.31 in the past 60 days. Sanofi’s stock is down 6.2% in the year-to-date period.
Sanofi beat earnings expectations in all the trailing four quarters. The company delivered a four-quarter earnings surprise of 9.50%, on average.
Estimates for Gilead’s 2022 earnings per share have increased from $6.57 per share to $7.09, while that for 2023 have jumped from $6.48 per share to $6.78 in the past 60 days. Gilead’s stock is up 19% in the year-to-date period.
Gilead beat earnings expectations in three of the trailing four quarters. The company delivered a four-quarter earnings surprise of 0.36%, on average.
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Merck (MRK), Seagen Keytruda-Padcev sBLAs Get FDA Priority Tag
Merck (MRK - Free Report) along with partner Astellas Pharma and Seagen announced that the FDA has accepted supplemental biologics license applications (sBLAs) seeking approval for the combination use of Seagen’s antibody-drug conjugate, Padcev plus Merck’s blockbuster PD-L1 inhibitor, Keytruda in a bladder cancer indication.
The sBLAs sought approval of Padcev in combination with Keytruda for the treatment of locally advanced or metastatic urothelial cancer, the most common type of bladder cancer, in patients who are not eligible to receive cisplatin-containing chemotherapy.
With the FDA granting priority review to the sBLAs, a decision is expected in April 21, 2023. The respective sBLAs are based on efficacy and safety data from some cohorts of the phase Ib/II EV-103 study (also known as KEYNOTE-869).
Merck stock has risen 42.8% this year so far compared with an increase of 10.7% for the industry.
Image Source: Zacks Investment Research
Shares of Seagen have lost 13.9% so far this year compared with the industry’s decrease of 21.1%.
Image Source: Zacks Investment Research
Merck and Seagen are evaluating Padcev and Keytruda in multiple stages of urothelial cancer, including two phase III studies in muscle-invasive bladder cancer.
Seagen’s Padcev is approved for the treatment of patients with advanced/metastatic urothelial cancer who had received treatment with both a checkpoint inhibitor (PD-1/PD-L1) and platinum-based chemotherapy or those patients who are ineligible for cisplatin-containing chemotherapy.
In the first nine months of 2022, Padcev generated sales worth $329.0 million, reflecting an increase of 33% year over year.
Merck’s Keytruda is already approved for the treatment of many cancers globally. The drug recorded sales of $15.48 billion in the first nine months of 2022, up 23% year over year.
Zacks Rank & Stocks to Consider
Both Merck and Seagen have a Zacks Rank #3 (Hold). Some better-ranked large drugmakers are Sanofi (SNY - Free Report) and Gilead Sciences (GILD - Free Report) , both carrying a Zacks Rank #2 (Buy) at present. You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
Earnings per share estimates for Sanofi’s 2022 earnings have increased from $4.02 per share to $4.27 while that for 2023 has jumped from $4.22 per share to $4.31 in the past 60 days. Sanofi’s stock is down 6.2% in the year-to-date period.
Sanofi beat earnings expectations in all the trailing four quarters. The company delivered a four-quarter earnings surprise of 9.50%, on average.
Estimates for Gilead’s 2022 earnings per share have increased from $6.57 per share to $7.09, while that for 2023 have jumped from $6.48 per share to $6.78 in the past 60 days. Gilead’s stock is up 19% in the year-to-date period.
Gilead beat earnings expectations in three of the trailing four quarters. The company delivered a four-quarter earnings surprise of 0.36%, on average.