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This week, Bayer (BAYRY - Free Report) announced first-quarter 2025 results. Novo Nordisk (NVO - Free Report) and GSK plc (GSK - Free Report) announced licensing deals with smaller biotechs. The FDA granted approval to Merck’s (MRK - Free Report) drug, Welireg, for its third indication in the United States and AbbVie’s (ABBV - Free Report) Emrelis, its first internally developed solid tumor medicine.
Here's a recap of the week’s most important stories.
NVO to Co-Develop Septerna’s Oral Therapies for Obesity/Diabetes
Novo Nordisk signed a licensing deal with Septerna to co-develop oral therapies targeting GLP-1, GIP, and glucagon receptors for treating obesity, type II diabetes and other cardiometabolic diseases. The companies will jointly conduct R&D activities for four development programs. NVO will bear all research and development costs for the partnered programs. Under the deal, Septerna is eligible to receive around $2.2 billion from Novo Nordisk, including an upfront payment of $200 million and near-term milestone payments.
The deal strengthens NVO’s obesity pipeline, particularly oral pills. Novo has already filed a regulatory application with the FDA for an oral form of obesity medicine, Wegovy (25 mg), with a decision expected around year-end.
BAYRY Reports Q1 Earnings Decline, Cuts Sales Guidance for 2025
Bayer’s first-quarter core earnings of €2.49 per share declined 11.7% year over year. Sales of €13.74 billion decreased0.1% on a currency and portfolio-adjusted basis. Sales in the Crop Science segment decreased 3.3%. Pharmaceuticals segment sales increased 4.1%, while Consumer Health sales rose 2.5% on a currency and portfolio-adjusted basis.
In the Pharmaceuticals segment, sales of cancer drug Nubeqa and kidney drug Kerendia remained strong, offsetting the loss of exclusivity impact on sales of oral anticoagulant Xarelto. Sales at the Consumer Health business rose, driven by the Digestive Health category. The Crop Science business was hurt due to regulatory impacts in the United States.
Bayer cut its sales guidance for the year. Sales are expected to be in the range of €44.5-€46.5 billion in 2025, down slightly from the previously guided range of €45-€47 billion. The company also lowered its EBITDA before special items guidance to €9.2-€9.7 per share for 2025 from the previously expected range of €9.3-€9.8.
FDA Approves AbbVie’s New Lung Cancer ADC
The FDA granted accelerated approval to AbbVie’s antibody-drug conjugate, or ADC, telisotuzumab vedotin (Teliso-V) for previously treated advanced or metastatic, non-squamous non-small cell lung cancer (NSCLC) in adult patients with c-Met overexpression. Teliso-V, which will be marketed by the name of Emrelis, is the first-in-class therapy approved for the above-mentioned NSCLC patient group that often faces a poor prognosis and has limited treatment options. The approval was based on overall response rate (ORR) and duration of response data from the phase II LUMINOSITY study.
FDA Approves MRK’s Welireg for Rare Adrenal Tumors
Merck announced that the FDA has granted approval to Welireg for the treatment of patients with advanced pheochromocytoma and paraganglioma. Currently, there are no approved therapies for treating these rare adrenal tumors. The FDA approval was based on ORR data from the phase II LITESPARK-015 study. This approval marks the third indication for Welireg in the United States. Welireg is currently approved in the United States for patients with advanced renal cell carcinoma andsome von Hippel-Lindau disease-associated tumors.
Merck’s phase III ovarian cancer study on a Keytruda regimen met its primary endpoint by showing a statistically significant and clinically meaningful improvement in progression-free survival. The KEYNOTE-B96 study evaluated Keytruda in combination with chemotherapy (paclitaxel) with or without bevacizumab in patients with platinum-resistant recurrent ovarian cancer whose tumors expressed PD-L1 and in all comers. The study also met its secondary endpoint of overall survival for patients whose tumors express PD-L1. Keytruda is not presently approved to treat any indication in ovarian cancer.
GSK Buys Rights to Phase III-Ready Liver Disease Candidate
GSK announced that it is buying rights to clinical-stage biotech Boston Pharmaceuticals’ lead pipeline candidate, efimosfermin alfa, to treat and prevent the progression of steatotic liver disease (SLD). In phase II studies, efimosfermin alfa has shown the potential to reverse liver fibrosis and stop its progression in patients with metabolic dysfunction-associated steatohepatitis (“MASH”), a form of SLD.
SLD affects approximately 5% of the global population and represents an area of significant unmet medical need with limited treatment options. Efimosfermin, with its direct antifibrotic mechanism of action, has the potential to establish a new standard of care for treating MASH.
For the deal, GSK will make an upfront payment of $1.2 billion to Boston Pharmaceuticals, with the latter also being entitled to potential milestone payments of $800 million.
Trump’s Most Favored Nations Policy
This week, the Trump administration issued an executive order that will push drugmakers to offer prescription drugs to U.S. cash-pay consumers at lower prices. The executive order will see U.S. consumers paying the same amount as the nation that pays the lowest price for that drug. He termed this policy the “most favored nation policy.” The President feels that the cost of prescription drugs in the United States is higher than in any other country, sometimes even five to ten times higher. Trump believes the order will result in a 30% to 80% decrease in prescription drug prices in the United States.
The order mentioned that the Department of Health and Human Services (HHS) will create programs to let Americans buy drugs directly from pharmaceutical companies at the most-favored-nation, lowest price. The HHS was instructed to notify drug manufacturers of new price targets within 30 days.
The details of the order were limited and vague. The immediate impact of the order was not clear and questions remain about how to implement the order and the legality of the pricing negotiations.
Image: Bigstock
Pharma Stock Roundup: BAYRY Q1 Earnings, NVO & GSK's New Deals
This week, Bayer (BAYRY - Free Report) announced first-quarter 2025 results. Novo Nordisk (NVO - Free Report) and GSK plc (GSK - Free Report) announced licensing deals with smaller biotechs. The FDA granted approval to Merck’s (MRK - Free Report) drug, Welireg, for its third indication in the United States and AbbVie’s (ABBV - Free Report) Emrelis, its first internally developed solid tumor medicine.
Here's a recap of the week’s most important stories.
NVO to Co-Develop Septerna’s Oral Therapies for Obesity/Diabetes
Novo Nordisk signed a licensing deal with Septerna to co-develop oral therapies targeting GLP-1, GIP, and glucagon receptors for treating obesity, type II diabetes and other cardiometabolic diseases. The companies will jointly conduct R&D activities for four development programs. NVO will bear all research and development costs for the partnered programs. Under the deal, Septerna is eligible to receive around $2.2 billion from Novo Nordisk, including an upfront payment of $200 million and near-term milestone payments.
The deal strengthens NVO’s obesity pipeline, particularly oral pills. Novo has already filed a regulatory application with the FDA for an oral form of obesity medicine, Wegovy (25 mg), with a decision expected around year-end.
BAYRY Reports Q1 Earnings Decline, Cuts Sales Guidance for 2025
Bayer’s first-quarter core earnings of €2.49 per share declined 11.7% year over year. Sales of €13.74 billion decreased0.1% on a currency and portfolio-adjusted basis. Sales in the Crop Science segment decreased 3.3%. Pharmaceuticals segment sales increased 4.1%, while Consumer Health sales rose 2.5% on a currency and portfolio-adjusted basis.
In the Pharmaceuticals segment, sales of cancer drug Nubeqa and kidney drug Kerendia remained strong, offsetting the loss of exclusivity impact on sales of oral anticoagulant Xarelto. Sales at the Consumer Health business rose, driven by the Digestive Health category. The Crop Science business was hurt due to regulatory impacts in the United States.
Bayer cut its sales guidance for the year. Sales are expected to be in the range of €44.5-€46.5 billion in 2025, down slightly from the previously guided range of €45-€47 billion. The company also lowered its EBITDA before special items guidance to €9.2-€9.7 per share for 2025 from the previously expected range of €9.3-€9.8.
FDA Approves AbbVie’s New Lung Cancer ADC
The FDA granted accelerated approval to AbbVie’s antibody-drug conjugate, or ADC, telisotuzumab vedotin (Teliso-V) for previously treated advanced or metastatic, non-squamous non-small cell lung cancer (NSCLC) in adult patients with c-Met overexpression. Teliso-V, which will be marketed by the name of Emrelis, is the first-in-class therapy approved for the above-mentioned NSCLC patient group that often faces a poor prognosis and has limited treatment options. The approval was based on overall response rate (ORR) and duration of response data from the phase II LUMINOSITY study.
FDA Approves MRK’s Welireg for Rare Adrenal Tumors
Merck announced that the FDA has granted approval to Welireg for the treatment of patients with advanced pheochromocytoma and paraganglioma. Currently, there are no approved therapies for treating these rare adrenal tumors. The FDA approval was based on ORR data from the phase II LITESPARK-015 study. This approval marks the third indication for Welireg in the United States. Welireg is currently approved in the United States for patients with advanced renal cell carcinoma andsome von Hippel-Lindau disease-associated tumors.
Merck’s phase III ovarian cancer study on a Keytruda regimen met its primary endpoint by showing a statistically significant and clinically meaningful improvement in progression-free survival. The KEYNOTE-B96 study evaluated Keytruda in combination with chemotherapy (paclitaxel) with or without bevacizumab in patients with platinum-resistant recurrent ovarian cancer whose tumors expressed PD-L1 and in all comers. The study also met its secondary endpoint of overall survival for patients whose tumors express PD-L1. Keytruda is not presently approved to treat any indication in ovarian cancer.
GSK Buys Rights to Phase III-Ready Liver Disease Candidate
GSK announced that it is buying rights to clinical-stage biotech Boston Pharmaceuticals’ lead pipeline candidate, efimosfermin alfa, to treat and prevent the progression of steatotic liver disease (SLD). In phase II studies, efimosfermin alfa has shown the potential to reverse liver fibrosis and stop its progression in patients with metabolic dysfunction-associated steatohepatitis (“MASH”), a form of SLD.
SLD affects approximately 5% of the global population and represents an area of significant unmet medical need with limited treatment options. Efimosfermin, with its direct antifibrotic mechanism of action, has the potential to establish a new standard of care for treating MASH.
For the deal, GSK will make an upfront payment of $1.2 billion to Boston Pharmaceuticals, with the latter also being entitled to potential milestone payments of $800 million.
Trump’s Most Favored Nations Policy
This week, the Trump administration issued an executive order that will push drugmakers to offer prescription drugs to U.S. cash-pay consumers at lower prices. The executive order will see U.S. consumers paying the same amount as the nation that pays the lowest price for that drug. He termed this policy the “most favored nation policy.” The President feels that the cost of prescription drugs in the United States is higher than in any other country, sometimes even five to ten times higher. Trump believes the order will result in a 30% to 80% decrease in prescription drug prices in the United States.
The order mentioned that the Department of Health and Human Services (HHS) will create programs to let Americans buy drugs directly from pharmaceutical companies at the most-favored-nation, lowest price. The HHS was instructed to notify drug manufacturers of new price targets within 30 days.
The details of the order were limited and vague. The immediate impact of the order was not clear and questions remain about how to implement the order and the legality of the pricing negotiations.
Bayer and GSK have a Zacks Rank #2 (Buy) each, while Novo Nordisk, AbbVie, and Merck carry a Zacks Rank of 3 (Hold). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
The NYSE ARCA Pharmaceutical Index has declined 1.7% in the past five trading sessions.
Large Cap Pharmaceuticals Industry 5YR % Return
Large Cap Pharmaceuticals Industry 5YR % Return
Here’s how the eight major stocks performed in the previous five trading sessions.
Image Source: Zacks Investment Research
In the last five trading sessions, Novo Nordisk rose the most (2.0%) while J&J declined the most (3.9%).
In the past six months, AbbVie rose the most (11.4%) while Novo Nordisk declined the most (32.9%).
(See the last pharma stock roundup here: NVO & JAZZ’s Q1 Results, AZN’s Pipeline Update)
What's Next in the Pharma World?
Watch this space for regular pipeline and regulatory updates next week.