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Pharma Stock Roundup: NVO's Obesity Study Failure, FDA Nod to PFE, LLY
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This week, Novo Nordisk (NVO - Free Report) announced disappointing data from a phase III study on a novel obesity candidate. The FDA approved Eli Lilly’s (LLY - Free Report) Zepbound for treating moderate-to-severe obstructive sleep apnea (OSA) and Pfizer’s (PFE - Free Report) Braftovi for combination use in first-line colorectal cancer. AstraZeneca (AZN - Free Report) and partner Daiichi Sankyo voluntarily withdrew their marketing authorization application (MAA), seeking approval of their TROP2-directed DXd antibody drug conjugate, datopotamab deruxtecan (Dato-DXd) in the EU for a lung cancer indication. Sanofi (SNY - Free Report) expanded its existing collaboration with partner SK biosciences for next-generation pneumococcal conjugate vaccines.
Here's a recap of the week’s most important stories.
FDA Approves LLY’s Zepbound for Sleep Apnea
The FDA granted approval to Lilly’s popular obesity drug, Zepbound (tirzepatide) for its second indication, moderate-to-severe OSA, a common sleep-related breathing disorder that causes repeated interruptions in breathing (apnea) or shallow breathing (hypopnea) during sleep. With the approval, Zepbound became the first and only prescription drug approved for treating adults with moderate-to-severe OSA and obesity. Zepbound’s approval for OSA was based on data from SURMOUNT-OSA phase III studies. Lilly’s regulatory application seeking approval of Zepbound for OSA is also under review in the EU.
NVO Novel Obesity Treatment Disappoints in Phase III Study
Novo Nordisk’s phase III REDEFINE 1 study evaluating its next-gen subcutaneous obesity treatment candidate, CagriSema, met its primary endpoint. CagriSema is a fixed-dose combination of a long-acting amylin analogue, cagrilintide (2.4 mg) and semaglutide (2.4 mg).
Top-line data from the phase III REDEFINE 1 study showed that treatment with CagriSema led to a weight loss of 22.7% after 68 weeks compared to a reduction of 11.8% with cagrilintide, 16.1% with semaglutide and 2.3% with placebo alone. However, the weight loss of 22.7% fell short of expectations, as the company had previously guided for 25% weight loss at 68 weeks. Shares of NVO declined on the news.
AZN Withdraws MAA for Dato-DXd for NSCLC Indication
AstraZeneca and partner Daiichi Sankyo voluntarily withdrew their MAA seeking approval of Dato-DXd in the EU based on the recommendation of the Committee for Medicinal Products for Human Use of the European Medicines Agency (EMA). The MAA was for Dato-DXd for treating nonsquamous non-small cell lung cancer (NSCLC) based on data from the TROPION-Lung01 phase III study.
In the United States also, last month, AstraZeneca/Daiichi Sankyo withdrew their earlier application seeking accelerated approval of Dato-DXd for nonsquamous NSCLC and instead filed a new biologics license application (BLA) for Dato-DXd for previously treated advanced EGFR-mutated NSCLC. The new BLA was based on data from the TROPION-Lung05 phase II study. The companies are also seeking approval for Dato-DXd for HR+ HER2- breast cancer in both the United States and the EU.
The European Commission approved AstraZeneca’s Tagrisso for an expanded use in unresectable EGFR-mutated NSCLC in patients whose tumors have exon 19 deletions or exon 21 (L858R) mutations based on data from the phase III LAURA study. The FDA had approved Tagrisso for a similar use in September.
FDA Approves Pfizer’s Braftovi for First-Line Colorectal Cancer
The FDA approved Pfizer’s Braftovi in combination with Erbitux (cetuximab) and mFOLFOX6 as the first-line treatment of metastatic colorectal cancer with BRAF mutations. The approval for the Braftovi combination regimen was based on data from the phase III BREAKWATER study.
At present Braftovi in combination with Erbitux is approved for BRAF-mutated metastatic colorectal cancer in patients who have received prior therapy.
The companies also announced that they have expanded their agreement to develop, license and commercialize next-generation PCVs for treating invasive pneumococcal disease (“IPD”) in pediatric and adult patient populations. The latest deal builds on the existing collaboration between SNY and SK bioscience to develop and commercialize PCV21. For the expanded deal, Sanofi will make an upfront payment of €50 million to SK bioscience, while the latter will also be eligible to receive certain development and commercial milestone payments.
The NYSE ARCA Pharmaceutical Index declined 1.7% in the past five trading sessions.
Image: Bigstock
Pharma Stock Roundup: NVO's Obesity Study Failure, FDA Nod to PFE, LLY
This week, Novo Nordisk (NVO - Free Report) announced disappointing data from a phase III study on a novel obesity candidate. The FDA approved Eli Lilly’s (LLY - Free Report) Zepbound for treating moderate-to-severe obstructive sleep apnea (OSA) and Pfizer’s (PFE - Free Report) Braftovi for combination use in first-line colorectal cancer. AstraZeneca (AZN - Free Report) and partner Daiichi Sankyo voluntarily withdrew their marketing authorization application (MAA), seeking approval of their TROP2-directed DXd antibody drug conjugate, datopotamab deruxtecan (Dato-DXd) in the EU for a lung cancer indication. Sanofi (SNY - Free Report) expanded its existing collaboration with partner SK biosciences for next-generation pneumococcal conjugate vaccines.
Here's a recap of the week’s most important stories.
FDA Approves LLY’s Zepbound for Sleep Apnea
The FDA granted approval to Lilly’s popular obesity drug, Zepbound (tirzepatide) for its second indication, moderate-to-severe OSA, a common sleep-related breathing disorder that causes repeated interruptions in breathing (apnea) or shallow breathing (hypopnea) during sleep. With the approval, Zepbound became the first and only prescription drug approved for treating adults with moderate-to-severe OSA and obesity. Zepbound’s approval for OSA was based on data from SURMOUNT-OSA phase III studies. Lilly’s regulatory application seeking approval of Zepbound for OSA is also under review in the EU.
NVO Novel Obesity Treatment Disappoints in Phase III Study
Novo Nordisk’s phase III REDEFINE 1 study evaluating its next-gen subcutaneous obesity treatment candidate, CagriSema, met its primary endpoint. CagriSema is a fixed-dose combination of a long-acting amylin analogue, cagrilintide (2.4 mg) and semaglutide (2.4 mg).
Top-line data from the phase III REDEFINE 1 study showed that treatment with CagriSema led to a weight loss of 22.7% after 68 weeks compared to a reduction of 11.8% with cagrilintide, 16.1% with semaglutide and 2.3% with placebo alone. However, the weight loss of 22.7% fell short of expectations, as the company had previously guided for 25% weight loss at 68 weeks. Shares of NVO declined on the news.
AZN Withdraws MAA for Dato-DXd for NSCLC Indication
AstraZeneca and partner Daiichi Sankyo voluntarily withdrew their MAA seeking approval of Dato-DXd in the EU based on the recommendation of the Committee for Medicinal Products for Human Use of the European Medicines Agency (EMA). The MAA was for Dato-DXd for treating nonsquamous non-small cell lung cancer (NSCLC) based on data from the TROPION-Lung01 phase III study.
In the United States also, last month, AstraZeneca/Daiichi Sankyo withdrew their earlier application seeking accelerated approval of Dato-DXd for nonsquamous NSCLC and instead filed a new biologics license application (BLA) for Dato-DXd for previously treated advanced EGFR-mutated NSCLC. The new BLA was based on data from the TROPION-Lung05 phase II study. The companies are also seeking approval for Dato-DXd for HR+ HER2- breast cancer in both the United States and the EU.
The European Commission approved AstraZeneca’s Tagrisso for an expanded use in unresectable EGFR-mutated NSCLC in patients whose tumors have exon 19 deletions or exon 21 (L858R) mutations based on data from the phase III LAURA study. The FDA had approved Tagrisso for a similar use in September.
FDA Approves Pfizer’s Braftovi for First-Line Colorectal Cancer
The FDA approved Pfizer’s Braftovi in combination with Erbitux (cetuximab) and mFOLFOX6 as the first-line treatment of metastatic colorectal cancer with BRAF mutations. The approval for the Braftovi combination regimen was based on data from the phase III BREAKWATER study.
At present Braftovi in combination with Erbitux is approved for BRAF-mutated metastatic colorectal cancer in patients who have received prior therapy.
SNY’s 21-valent Pneumococcal Jab Enters Phase III
Sanofi and partner SK biosciences announced that they have commenced a phase III program on their partnered 21-valent pneumococcal conjugate vaccine (PCV21).
The companies also announced that they have expanded their agreement to develop, license and commercialize next-generation PCVs for treating invasive pneumococcal disease (“IPD”) in pediatric and adult patient populations. The latest deal builds on the existing collaboration between SNY and SK bioscience to develop and commercialize PCV21. For the expanded deal, Sanofi will make an upfront payment of €50 million to SK bioscience, while the latter will also be eligible to receive certain development and commercial milestone payments.
The NYSE ARCA Pharmaceutical Index 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, AbbVie rose the most (2.6%), while Novo Nordisk declined the most (19.0%).
In the past six months, too, while AbbVie rose the most (6.5%), Novo Nordisk declined the most (39.5%).
(See the last pharma stock roundup here: Pharma Stock Roundup: PFE’s 2025 Outlook, MRK & ABBV’s M&A Deals)
What's Next in the Pharma World?
Watch this space for regular pipeline and regulatory updates next week.
Pfizer has a Zacks Rank #2 (Buy), while Lilly, Sanofi, AstraZeneca and Novo Nordisk have a Zacks Rank #3 (Hold) each. You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.