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This week, Pfizer (PFE - Free Report) issued its financial guidance for 2025. Sanofi (SNY - Free Report) and Teva Pharmaceutical’s (TEVA - Free Report) inflammatory bowel disease (IBD) study on their candidate, duvakitug (TEV’574), met its primary endpoints. Merck (MRK - Free Report) inked an exclusive global licensing deal with China’s Hansoh Pharma for the latter’s oral GLP-1-based obesity candidate. AbbVie (ABBV - Free Report) also announced an acquisition in the immunology space.
Here's a recap of the week’s most important stories.
Pfizer Issues 2025 Financial Outlook
Pfizer announced encouraging guidance for 2025. In 2025, Pfizer expects to record total revenues between $61.0 billion and $64.0 billion. On an operational basis, revenues in 2025 are expected to rise in a range of approximately flat to 5% from the midpoint of 2024 guidance, excluding the impact of approximately $1.2 billion of non-recurring revenues for Paxlovid.
Adjusted earnings are expected in the range of $2.80-$3.00, representing expected operational growth (excluding the Fx impact) in the range of 10%-18% year over year from the midpoint of the 2024 guidance, excluding the impact of certain non-recurring items.
Pfizer also maintained its previously issued financial guidance for 2024. In 2024, Pfizer expects total revenues in the range of $61.0-$64.0 billion, while adjusted earnings are expected in the range of $2.75-$2.95 per share.
Sanofi, Teva’s IBD Candidate Meets Primary Goal in Study
Sanofi and Teva’s phase IIb study evaluating their pipeline candidate, duvakitug (TEV’574), for treating ulcerative colitis (UC) and Crohn’s disease (CD), met its primary endpoints. UC and CD are the most common forms of IBD, a space gaining immense popularity.
In the study called RELIEVE UCCD study, 47.8% of patients with UC treated with a high dose of duvakitug, a TL1A inhibitor, and 36.2% of patients treated with a low dose of the drug achieved clinical remission compared to 20.45% on placebo at week 14. In patients with CD, 26.1% treated with low-dose and 47.8% treated with high-dose duvakitug achieved endoscopic response compared to 13.0% on placebo at week 14. The data exceeded the companies’ internal expectations. The companies believe that duvakitug has the potential to become a differentiated medicine for IBD patients.
Teva and Sanofi plan to begin a phase III program on duvakitug, pending regulatory discussions. Sanofi will lead the phase III clinical development program.
Merck Enters Obesity Space With Hansoh Pharma Deal
Merck announced that it is in-licensing exclusive global rights to develop, manufacture and commercializea preclinical GLP-1 receptor agonist, HS-10535, from Chinese biotech Hansoh Pharma. For the exclusive deal, Merck will make an upfront payment of $112 million to Hansoh Pharma, with the latter also being entitled to receive up to $1.9 billion in milestone payments and royalties on sales. Hansoh has an option to co-promote or solely commercialize HS-10535 in China. This deal marks Merck’s entry into the lucrative obesity market.
Merck announced that it is discontinuing two clinical development programs evaluating fixed-dose combinations of its cancer candidates, vibostolimab and favezelimab with Keytruda. Merck is discontinuing the phase III KeyVibe studies (KeyVibe-003 and KeyVibe-007) evaluating the fixed-dose combination of vibostolimab, an anti-TIGIT antibody and Keytruda in a non-small cell lung cancer indication based on the recommendation of an independent Data Monitoring Committee. Both the studies met the pre-specified futility criteria for the primary endpoint of overall survival. Merck is also ending the phase III KeyVibe-006 study and other vibostolimab studies.
Separately, Merck has also decided to end the development program on favezelimab. The company will stop enrolment in the phase III KEYFORM-008 evaluating the fixed-dose combination of favezelimab and Keytruda for certain patients with relapsed or refractory classical Hodgkin lymphoma.
The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) gave a positive opinion recommending approval of Merck’s novel HIF-2α inhibitor, Welireg, for two indications. The CHMP has recommended approving Welireg for certain previously treated patients with advanced renal cell carcinoma and certain patients with von Hippel-Lindau disease-associated tumors. Welireg is already approved for both indications in the United States.
The FDA accepted Merck’s biologics license application seeking approval of clesrovimab (MK-1654), its prophylactic monoclonal antibody to protect infants from respiratory syncytial virus (RSV) disease during their first RSV season. The FDA decision is expected on June 10, 2025.
Merck’s two pivotal phase III studies evaluating a once-daily, oral, two-drug, single-tablet regimen of doravirine and islatravir met efficacy success criteria for non-inferiority to comparator antiretroviral therapies in adults with virologically suppressed HIV-1.
AbbVie to Buy Nimble to Strengthen Immunology Pipeline
AbbVie announced a definitive agreement to acquire private biotech Nimble Therapeutics, which will add the latter’s lead pipeline candidate, an oral peptide IL23R inhibitor, in preclinical development for psoriasis. The acquisition will strengthen AbbVie’s immunology pipeline.
Nimble is also making other oral peptide-based therapeutics for autoimmune diseases, leveraging its proprietary peptide synthesis platform. To acquire Nimble, AbbVie will make a cash payment of $200 million, with the former also being entitled to some potential milestone payments.
The NYSE ARCA Pharmaceutical Index declined 2.23% in the past five trading sessions.
Image: Bigstock
Pharma Stock Roundup: PFE's 2025 Outlook, MRK & ABBV's M&A Deals
This week, Pfizer (PFE - Free Report) issued its financial guidance for 2025. Sanofi (SNY - Free Report) and Teva Pharmaceutical’s (TEVA - Free Report) inflammatory bowel disease (IBD) study on their candidate, duvakitug (TEV’574), met its primary endpoints. Merck (MRK - Free Report) inked an exclusive global licensing deal with China’s Hansoh Pharma for the latter’s oral GLP-1-based obesity candidate. AbbVie (ABBV - Free Report) also announced an acquisition in the immunology space.
Here's a recap of the week’s most important stories.
Pfizer Issues 2025 Financial Outlook
Pfizer announced encouraging guidance for 2025. In 2025, Pfizer expects to record total revenues between $61.0 billion and $64.0 billion. On an operational basis, revenues in 2025 are expected to rise in a range of approximately flat to 5% from the midpoint of 2024 guidance, excluding the impact of approximately $1.2 billion of non-recurring revenues for Paxlovid.
Adjusted earnings are expected in the range of $2.80-$3.00, representing expected operational growth (excluding the Fx impact) in the range of 10%-18% year over year from the midpoint of the 2024 guidance, excluding the impact of certain non-recurring items.
Pfizer also maintained its previously issued financial guidance for 2024. In 2024, Pfizer expects total revenues in the range of $61.0-$64.0 billion, while adjusted earnings are expected in the range of $2.75-$2.95 per share.
Sanofi, Teva’s IBD Candidate Meets Primary Goal in Study
Sanofi and Teva’s phase IIb study evaluating their pipeline candidate, duvakitug (TEV’574), for treating ulcerative colitis (UC) and Crohn’s disease (CD), met its primary endpoints. UC and CD are the most common forms of IBD, a space gaining immense popularity.
In the study called RELIEVE UCCD study, 47.8% of patients with UC treated with a high dose of duvakitug, a TL1A inhibitor, and 36.2% of patients treated with a low dose of the drug achieved clinical remission compared to 20.45% on placebo at week 14. In patients with CD, 26.1% treated with low-dose and 47.8% treated with high-dose duvakitug achieved endoscopic response compared to 13.0% on placebo at week 14. The data exceeded the companies’ internal expectations. The companies believe that duvakitug has the potential to become a differentiated medicine for IBD patients.
Teva and Sanofi plan to begin a phase III program on duvakitug, pending regulatory discussions. Sanofi will lead the phase III clinical development program.
Merck Enters Obesity Space With Hansoh Pharma Deal
Merck announced that it is in-licensing exclusive global rights to develop, manufacture and commercializea preclinical GLP-1 receptor agonist, HS-10535, from Chinese biotech Hansoh Pharma. For the exclusive deal, Merck will make an upfront payment of $112 million to Hansoh Pharma, with the latter also being entitled to receive up to $1.9 billion in milestone payments and royalties on sales. Hansoh has an option to co-promote or solely commercialize HS-10535 in China. This deal marks Merck’s entry into the lucrative obesity market.
Merck announced that it is discontinuing two clinical development programs evaluating fixed-dose combinations of its cancer candidates, vibostolimab and favezelimab with Keytruda. Merck is discontinuing the phase III KeyVibe studies (KeyVibe-003 and KeyVibe-007) evaluating the fixed-dose combination of vibostolimab, an anti-TIGIT antibody and Keytruda in a non-small cell lung cancer indication based on the recommendation of an independent Data Monitoring Committee. Both the studies met the pre-specified futility criteria for the primary endpoint of overall survival. Merck is also ending the phase III KeyVibe-006 study and other vibostolimab studies.
Separately, Merck has also decided to end the development program on favezelimab. The company will stop enrolment in the phase III KEYFORM-008 evaluating the fixed-dose combination of favezelimab and Keytruda for certain patients with relapsed or refractory classical Hodgkin lymphoma.
The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) gave a positive opinion recommending approval of Merck’s novel HIF-2α inhibitor, Welireg, for two indications. The CHMP has recommended approving Welireg for certain previously treated patients with advanced renal cell carcinoma and certain patients with von Hippel-Lindau disease-associated tumors. Welireg is already approved for both indications in the United States.
The FDA accepted Merck’s biologics license application seeking approval of clesrovimab (MK-1654), its prophylactic monoclonal antibody to protect infants from respiratory syncytial virus (RSV) disease during their first RSV season. The FDA decision is expected on June 10, 2025.
Merck’s two pivotal phase III studies evaluating a once-daily, oral, two-drug, single-tablet regimen of doravirine and islatravir met efficacy success criteria for non-inferiority to comparator antiretroviral therapies in adults with virologically suppressed HIV-1.
AbbVie to Buy Nimble to Strengthen Immunology Pipeline
AbbVie announced a definitive agreement to acquire private biotech Nimble Therapeutics, which will add the latter’s lead pipeline candidate, an oral peptide IL23R inhibitor, in preclinical development for psoriasis. The acquisition will strengthen AbbVie’s immunology pipeline.
Nimble is also making other oral peptide-based therapeutics for autoimmune diseases, leveraging its proprietary peptide synthesis platform. To acquire Nimble, AbbVie will make a cash payment of $200 million, with the former also being entitled to some potential milestone payments.
The NYSE ARCA Pharmaceutical Index declined 2.23% 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, Pfizer rose the most (1.5%), while Novo Nordisk declined the most (4.8%).
In the past six months, while AbbVie rose the most (0.7%), Novo Nordisk declined the most (27.1%).
(See the last pharma stock roundup here: LLY’s Zepbound Success, FDA Updates for MRK, JNJ)
What's Next in the Pharma World?
Watch this space for regular pipeline and regulatory updates next week.
Pfizer, Merck, AbbVie, Sanofi and Teva each have a Zacks Rank #3 (Hold). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.