J&J JNJ began the earnings season for the drug and biotech sector this week. Pfizer PFE announced the discontinuation of its danuglipron weight loss pill program. The European Commission granted marketing authorization for the expanded use of Roche’s RHHBY cancer drug, Columvi. Sanofi SNY provided an update on its respiratory pipeline.
Here's a recap of the week’s most important stories.
J&J Begins Pharma Q1 Earnings Season With a Beat
J&J beat first-quarter estimates for both earnings and sales. Adjusted earnings of $2.77 per share rose 2.2% from the year-ago period. Sales of $21.89 billion rose 2.4% from the year-ago quarter. Innovative Medicines segment sales rose 2.3% year over year to $13.87 billion. MedTech segment sales came in at $8.02 billion, up 2.5% from the year-ago period.
The company raised its sales expectations for 2025 to reflect the addition of schizophrenia drug Caplyta from the Intra-Cellular Therapies acquisition.
The sales guidance was raised from a range of $89.2 billion-$90.0 billion to $91.0 billion-$91.8 billion. The adjusted earnings per share guidance was maintained in the range of $10.50-$10.70.
In 2025, J&J estimates tariff-related costs of approximately $400 million, mainly from China. These newly proposed and existing tariffs are expected to mainly impact its MedTech business. The $400 million tariff impact does not include the potential tariff on pharma imports. The company did not provide any estimate for the potential pharmaceutical tariff impact.
PFE Ends Development of GLP-1 Pill Danuglipron for Obesity
Pfizer is discontinuing the development of its GLP-1R agonist, danuglipron, which it was developing as a weight loss pill. Pfizer took the decision after one of the participants in the dose-optimization studies developed a potentially drug-induced liver injury, which resolved after danuglipron was discontinued. The dose optimization studies met the key pharmacokinetic goals and determined a formulation and dose. The overall frequency of liver enzyme elevations in the dose optimization studies was similar to other GLP-1-based drugs. However, due to the liver-injury incident, Pfizer will not move forward with phase III studies on the candidate.
Pfizer had earlier faced a setback related to danuglipron. In December 2023, Pfizer said that it would not move forward with phase III studies on the twice-daily formulation of danuglipron due to several gastrointestinal side effects seen in a phase IIb study. Back then, Pfizer said it would focus on the once-daily formulation of danuglipron. Pfizer will now focus on its earlier-stage oral obesity candidates, which are years away from the market.
The U.S. Centers for Disease Control and Prevention’s (CDC) Advisory Committee on Immunization Practices (ACIP) recommended the expanded use of Pfizer and GSK’s respiratory syncytial virus (RSV) vaccines, Abrysvo and Arexvy, respectively, in adults aged 50 to 59 at increased risk of severe RSV disease. At present, ACIP recommends these vaccines for use in all adults aged 75 and older and high-risk adults aged 60 to 74. The updated ACIP recommendation lowered the recommended age for RSV vaccination from 60 to 50 for high-risk adults.
The ACIP’s recommendation is pending final approval by the director of the CDC and the Department of Health and Human Services.
Arexvy and Abrysvo are approved by the FDA for use in all individuals aged 60 and above. Arexvy is also approved for high-risk individuals aged 50-59, while Abrysvo is approved for high-risk adults aged 18-59 in the United States.
European Commission Approves Second-Line Use of Roche’s Columvi
The European Commission granted approval to the expanded use of Roche’s drug Columvi (glofitamab) in combination with chemotherapy (gemcitabine and oxaliplatin) for second-line relapsed or refractory (R/R) diffuse large B-cell lymphoma (DLBCL). The approval was based on data from the phase III STARGLO study. Roche is also seeking approval for a similar use of Columvi in the United States and some other countries. The FDA’s decision is expected by July 20.
Columvi is already approved in the United States, EU and several other countries for third-line R/R DLBCL.
Sanofi Gives Update on Respiratory Candidates
Sanofi announced preliminary data from the TIDE-Asthma phase II study on its investigational monoclonal antibody amlitelimab in adults with moderate-to-severe asthma. In the study, though amlitelimab showed efficacy in heterogeneous inflammatory asthma, it failed to meet the primary endpoint of annualized exacerbation rate at week 48 at the highest dose level.
At week 60, amlitelimab led to nominally significant and clinically meaningful reductions in asthma exacerbations at the medium dose tested and a numerically greater reduction in exacerbations at the high dose. In the study, amlitelimab also led to a nominally significant and clinically meaningful improvement in secondary endpoints of lung function and asthma control.
Sanofi’s another respiratory candidate, lunsekimig, is currently being studied for asthma and chronic rhinosinusitis with nasal polyps in phase II studies. Sanofi plans to study lunsekimig for chronic obstructive pulmonary disease (COPD) with a phase II/III study expected to begin this year.
For another respiratory candidate, itepekimab, Sanofi plans to expand clinical studies beyond COPD into chronic rhinosinusitis. Itepekimab is currently being evaluated in two phase III studies for COPD.
J&J, Pfizer, Sanofi and Roche carry a Zacks Rank #3 (Hold) each. 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
Large Cap Pharmaceuticals Industry 5YR % Return
Here’s how the eight major stocks performed in the previous five trading sessions.
Zacks Investment Research
Image Source: Zacks Investment Research
In the last five trading sessions, Novartis rose the most (5.5%) while Merck declined the most (6.6%).
In the past six months, all the stocks have been in the red, with Novo Nordisk declining the most (46.2%).
(See the last pharma stock roundup here: EU Nod to Expanded Use of ABBV, AZN Drugs & More)
What's Next in the Pharma World?
Watch this space for regular pipeline and regulatory updates next week.
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