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Pharma Stock Roundup: LLY's Zepbound Success, FDA Updates for MRK, JNJ
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This week, Eli Lilly’s (LLY - Free Report) popular obesity drug, Zepbound showed better weight loss than Novo Nordisk’s Wegovy in a head-to-head study. The FDA granted Breakthrough Therapy designation to Merck’s (MRK - Free Report) candidate sacituzumab tirumotecan (Sac-TMT) for a lung cancer indication and approved AstraZeneca’s (AZN - Free Report) blockbuster cancer drug, Imfinzi for a new indication. The FDA also accepted Roche’s (RHHBY - Free Report) supplemental filing seeking expanded use of its drug, Columvi. J&J (JNJ - Free Report) also filed an application with the FDA, seeking approval of Tremfya for children.
Here's a recap of the week’s most important stories.
LLY’s Zepbound Outperforms NVO’s Wegovy in Weight Loss Study
Lilly’s obesity drug, Zepbound, showed an average weight loss of 20.2%, which was superior to 13.7% for Novo Nordisk’s Wegovy (semaglutide) in a first-ever head-to-head obesity study, SURMOUNT-5. This represents a 47% greater relative weight loss for Zepbound users compared to Wegovy. Participants given Zepbound lost an average of 50.3 lbs (22.8 kg) compared to 33.1 lbs (15.0 kg) for those taking Wegovy. Additionally, in a key secondary endpoint, 31.6% of those taking Zepbound achieved a weight loss of at least 25% of their body weight, compared to 16.1% for Wegovy users.
In the study, Zepbound showed superior results across the primary endpoint and all five key secondary endpoints, and its safety profile was consistent with previous studies.
Lilly announced a $3 billion expansion plan for its manufacturing facility in Wisconsin, which the company acquired in April. The investment is expected to help meet the growing demand for Mounjaro and Zepbound by expanding the company’s injectable product manufacturing network. Since 2020, Lilly has committed more than $23 billion for manufacturing capacity for Zepbound and Mounjaro in the United States and Europe
FDA’s Breakthrough Tag to MRK’s Lung Cancer ADC
The FDA granted Breakthrough Therapy designation to Merck pipeline candidate, sacituzumab tirumotecan (Sac-TMT), for the treatment of certain patients with previously treated advanced or metastatic nonsquamous non-small cell lung cancer (NSCLC) with EGFR mutations. Sac-TMT is a TROP2-directed antibody drug conjugate (ADC) that Merck is developing in partnership with Chinese company, Kelun-Biotech.
Sac-TMT was recently approved in China for a breast cancer indication. Kelun-Biotech owns rights to develop, manufacture and commercialize sac-TMT in Greater China. Merck is currently developing sac-TMT as a monotherapy and in combination with Keytruda in 10 phase III studies across various solid tumors.
FDA Approves AZN’s Imfinzi for Aggressive Lung Cancer
The FDA granted approval to AstraZeneca’s Imfinzi for treating limited-stage small cell lung cancer (LS-SCLC), an aggressive form of lung cancer, in the United States. The approval was based on data from the ADRIATIC phase III study for LS-SCLC patients whose disease has not progressed following concurrent platinum-based chemotherapy and radiation therapy. Imfinzi was also earlier granted Breakthrough Therapy Designation by the FDA for the same indication.
Imfinzi, either as a monotherapy or in combination with chemotherapy, is presently approved for stage III non-small cell lung cancer, extensive-stage SCLC, locally advanced or metastatic biliary tract cancer and endometrial cancer that is mismatch repair deficient and in combination with Imjudo in unresectable hepatocellular carcinoma in some countries.
J&J Seeks FDA Approval for Tremfya for Pediatric Use
J&J filed two supplemental biologics license applications (sBLAs) seeking approval of Tremfya in pediatric patients 6 years and older with moderate-to-severe plaque psoriasis and for children 5 years of age and older with active juvenile psoriatic arthritis. Tremfya, an IL-23 inhibitor, is already approved to treat certain adult patients with plaque psoriasis and active psoriatic arthritis in several countries, including the United States and the EU. Tremfya is also approved to treat moderately to severely active ulcerative colitis while it is under review in the EU for the same. Tremfya is under review in the United States and EU for the other inflammatory bowel disease condition, Crohn’s disease.
FDA Accepts Roche’s Columvi sBLA for Aggressive Lymphoma
The FDA accepted for review Roche’s sBLA seeking expanded use of Columvi (glofitamab) in combination with chemotherapy for second-line relapsed or refractory (R/R) diffuse large B-cell lymphoma (DLBCL). A final decision from the regulatory body is expected on July 20, 2025. The sBLA was based on data from the phase III STARGLO study. Roche is also seeking approval for similar use of Columvi in the EU and some other countries.
Columvi is already approved in the United States, EU and several other countries for third-line R/R DLBCL.
The NYSE ARCA Pharmaceutical Index rose 0.5% in the past five trading sessions.
Image: Bigstock
Pharma Stock Roundup: LLY's Zepbound Success, FDA Updates for MRK, JNJ
This week, Eli Lilly’s (LLY - Free Report) popular obesity drug, Zepbound showed better weight loss than Novo Nordisk’s Wegovy in a head-to-head study. The FDA granted Breakthrough Therapy designation to Merck’s (MRK - Free Report) candidate sacituzumab tirumotecan (Sac-TMT) for a lung cancer indication and approved AstraZeneca’s (AZN - Free Report) blockbuster cancer drug, Imfinzi for a new indication. The FDA also accepted Roche’s (RHHBY - Free Report) supplemental filing seeking expanded use of its drug, Columvi. J&J (JNJ - Free Report) also filed an application with the FDA, seeking approval of Tremfya for children.
Here's a recap of the week’s most important stories.
LLY’s Zepbound Outperforms NVO’s Wegovy in Weight Loss Study
Lilly’s obesity drug, Zepbound, showed an average weight loss of 20.2%, which was superior to 13.7% for Novo Nordisk’s Wegovy (semaglutide) in a first-ever head-to-head obesity study, SURMOUNT-5. This represents a 47% greater relative weight loss for Zepbound users compared to Wegovy. Participants given Zepbound lost an average of 50.3 lbs (22.8 kg) compared to 33.1 lbs (15.0 kg) for those taking Wegovy. Additionally, in a key secondary endpoint, 31.6% of those taking Zepbound achieved a weight loss of at least 25% of their body weight, compared to 16.1% for Wegovy users.
In the study, Zepbound showed superior results across the primary endpoint and all five key secondary endpoints, and its safety profile was consistent with previous studies.
Lilly announced a $3 billion expansion plan for its manufacturing facility in Wisconsin, which the company acquired in April. The investment is expected to help meet the growing demand for Mounjaro and Zepbound by expanding the company’s injectable product manufacturing network. Since 2020, Lilly has committed more than $23 billion for manufacturing capacity for Zepbound and Mounjaro in the United States and Europe
FDA’s Breakthrough Tag to MRK’s Lung Cancer ADC
The FDA granted Breakthrough Therapy designation to Merck pipeline candidate, sacituzumab tirumotecan (Sac-TMT), for the treatment of certain patients with previously treated advanced or metastatic nonsquamous non-small cell lung cancer (NSCLC) with EGFR mutations. Sac-TMT is a TROP2-directed antibody drug conjugate (ADC) that Merck is developing in partnership with Chinese company, Kelun-Biotech.
Sac-TMT was recently approved in China for a breast cancer indication. Kelun-Biotech owns rights to develop, manufacture and commercialize sac-TMT in Greater China. Merck is currently developing sac-TMT as a monotherapy and in combination with Keytruda in 10 phase III studies across various solid tumors.
FDA Approves AZN’s Imfinzi for Aggressive Lung Cancer
The FDA granted approval to AstraZeneca’s Imfinzi for treating limited-stage small cell lung cancer (LS-SCLC), an aggressive form of lung cancer, in the United States. The approval was based on data from the ADRIATIC phase III study for LS-SCLC patients whose disease has not progressed following concurrent platinum-based chemotherapy and radiation therapy. Imfinzi was also earlier granted Breakthrough Therapy Designation by the FDA for the same indication.
Imfinzi, either as a monotherapy or in combination with chemotherapy, is presently approved for stage III non-small cell lung cancer, extensive-stage SCLC, locally advanced or metastatic biliary tract cancer and endometrial cancer that is mismatch repair deficient and in combination with Imjudo in unresectable hepatocellular carcinoma in some countries.
J&J Seeks FDA Approval for Tremfya for Pediatric Use
J&J filed two supplemental biologics license applications (sBLAs) seeking approval of Tremfya in pediatric patients 6 years and older with moderate-to-severe plaque psoriasis and for children 5 years of age and older with active juvenile psoriatic arthritis. Tremfya, an IL-23 inhibitor, is already approved to treat certain adult patients with plaque psoriasis and active psoriatic arthritis in several countries, including the United States and the EU. Tremfya is also approved to treat moderately to severely active ulcerative colitis while it is under review in the EU for the same. Tremfya is under review in the United States and EU for the other inflammatory bowel disease condition, Crohn’s disease.
FDA Accepts Roche’s Columvi sBLA for Aggressive Lymphoma
The FDA accepted for review Roche’s sBLA seeking expanded use of Columvi (glofitamab) in combination with chemotherapy for second-line relapsed or refractory (R/R) diffuse large B-cell lymphoma (DLBCL). A final decision from the regulatory body is expected on July 20, 2025. The sBLA was based on data from the phase III STARGLO study. Roche is also seeking approval for similar use of Columvi in the EU and some other countries.
Columvi is already approved in the United States, EU and several other countries for third-line R/R DLBCL.
The NYSE ARCA Pharmaceutical Index rose 0.5% 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 Merck declined the most (1.4%).
In the past six months, while AbbVie rose the most (4.0%), Novo Nordisk declined the most (23.8%).
(See the last pharma stock roundup here: Pharma Stock Roundup: RHHBY to Buy PSTX, MRK, AZN See Pipeline Success)
What's Next in the Pharma World?
Watch this space for regular pipeline and regulatory updates next week.
AstraZeneca, Lilly, Merck, J&J and Roche have a Zacks Rank #3 (Hold) each. You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.