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AstraZeneca Faces Trial Setback While Scoring FDA Win and $2 Billion KRAS Deal

MarketDash Editorial Team
1 day ago
AstraZeneca's lung cancer combination therapy missed its Phase 3 goals, but the pharma giant balanced the news with an FDA breakthrough designation for Enhertu and a massive $2 billion licensing deal for a promising KRAS inhibitor.

AstraZeneca Plc (AZN) had a busy Monday, serving up the kind of mixed bag that's typical in pharmaceutical development—one setback, two wins, and a reminder that drug development is as much about portfolio management as it is about science.

Lung Cancer Combo Misses the Mark

The less-than-stellar news first: AstraZeneca released topline results from the LATIFY Phase 3 trial testing ceralasertib in combination with Imfinzi (durvalumab). The trial evaluated patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) who'd already exhausted prior immunotherapy and platinum-based chemotherapy—basically, patients who really need something that works.

Unfortunately, the combination didn't meet its primary endpoint of overall survival compared to standard-of-care docetaxel. These were patients without actionable genomic alterations, meaning they didn't have specific mutations that could be targeted with precision therapies. Finding effective treatments for this population remains a major challenge in oncology.

On the bright side, the combination was generally well tolerated, with a safety profile consistent with each medicine's known characteristics and no new safety concerns. That's something, at least—nobody wants a therapy that fails and causes unexpected problems.

Enhertu Earns FDA Breakthrough Status

Now for the good news. AstraZeneca and Daiichi Sankyo Co., Ltd. (DSNKY) announced that their blockbuster drug Enhertu (trastuzumab deruxtecan) has been granted Breakthrough Therapy Designation by the FDA for a new indication in early breast cancer.

The designation covers adult patients with HER2-positive early breast cancer who have residual invasive disease in the breast and/or axillary lymph nodes after neoadjuvant treatment—that's chemotherapy given before surgery—and who face a high risk of the cancer coming back. This is a critical patient population where preventing recurrence can mean the difference between cure and progression to metastatic disease.

The FDA based the breakthrough designation on results from the DESTINY-Breast05 Phase 3 trial, which were presented at the 2025 European Society for Medical Oncology Congress and published in The New England Journal of Medicine. Pretty impressive credentials.

This marks Enhertu's second positive trial in early breast cancer in 2025. The first, DESTINY-Breast11, evaluated patients with high-risk HER2-positive disease in the neoadjuvant setting and is currently under FDA review. If both indications get approved, Enhertu could significantly expand its already substantial market presence.

A $2 Billion Bet on KRAS Inhibition

Over the weekend, Jacobio Pharma announced an exclusive licensing agreement with AstraZeneca for JAB-23E73, a Pan-KRAS inhibitor that targets multiple KRAS mutation subtypes. The deal structure is typical for these arrangements: AstraZeneca gets exclusive development and commercialization rights outside China, while both companies will jointly develop and commercialize the drug within China.

Why does this matter? KRAS is the most frequently mutated oncogene in human cancers, present in roughly 23% of all cancer patients. For decades, KRAS was considered "undruggable," but recent scientific advances have made it a hot target in oncology. JAB-23E73 was developed using Jacobio's induced allosteric drug discovery platform and is designed to target multiple KRAS mutation subtypes—not just the most common ones.

The drug is currently in Phase I trials in both China and the United States, where it's already showing early signs of anti-tumor activity. That's promising but still very early-stage.

Financially, the deal is substantial. Jacobio receives $100 million upfront and is eligible for up to $1.915 billion in additional development and commercial milestone payments, plus tiered royalties on net sales outside China. AstraZeneca will handle all clinical development, regulatory submissions, and commercialization activities outside China.

AstraZeneca shares were up 0.40% at $90.79 at the time of publication on Monday. The stock is approaching its 52-week high of $94.01, suggesting investors are focusing more on the wins than the lung cancer miss.

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AstraZeneca Faces Trial Setback While Scoring FDA Win and $2 Billion KRAS Deal

MarketDash Editorial Team
1 day ago
AstraZeneca's lung cancer combination therapy missed its Phase 3 goals, but the pharma giant balanced the news with an FDA breakthrough designation for Enhertu and a massive $2 billion licensing deal for a promising KRAS inhibitor.

AstraZeneca Plc (AZN) had a busy Monday, serving up the kind of mixed bag that's typical in pharmaceutical development—one setback, two wins, and a reminder that drug development is as much about portfolio management as it is about science.

Lung Cancer Combo Misses the Mark

The less-than-stellar news first: AstraZeneca released topline results from the LATIFY Phase 3 trial testing ceralasertib in combination with Imfinzi (durvalumab). The trial evaluated patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) who'd already exhausted prior immunotherapy and platinum-based chemotherapy—basically, patients who really need something that works.

Unfortunately, the combination didn't meet its primary endpoint of overall survival compared to standard-of-care docetaxel. These were patients without actionable genomic alterations, meaning they didn't have specific mutations that could be targeted with precision therapies. Finding effective treatments for this population remains a major challenge in oncology.

On the bright side, the combination was generally well tolerated, with a safety profile consistent with each medicine's known characteristics and no new safety concerns. That's something, at least—nobody wants a therapy that fails and causes unexpected problems.

Enhertu Earns FDA Breakthrough Status

Now for the good news. AstraZeneca and Daiichi Sankyo Co., Ltd. (DSNKY) announced that their blockbuster drug Enhertu (trastuzumab deruxtecan) has been granted Breakthrough Therapy Designation by the FDA for a new indication in early breast cancer.

The designation covers adult patients with HER2-positive early breast cancer who have residual invasive disease in the breast and/or axillary lymph nodes after neoadjuvant treatment—that's chemotherapy given before surgery—and who face a high risk of the cancer coming back. This is a critical patient population where preventing recurrence can mean the difference between cure and progression to metastatic disease.

The FDA based the breakthrough designation on results from the DESTINY-Breast05 Phase 3 trial, which were presented at the 2025 European Society for Medical Oncology Congress and published in The New England Journal of Medicine. Pretty impressive credentials.

This marks Enhertu's second positive trial in early breast cancer in 2025. The first, DESTINY-Breast11, evaluated patients with high-risk HER2-positive disease in the neoadjuvant setting and is currently under FDA review. If both indications get approved, Enhertu could significantly expand its already substantial market presence.

A $2 Billion Bet on KRAS Inhibition

Over the weekend, Jacobio Pharma announced an exclusive licensing agreement with AstraZeneca for JAB-23E73, a Pan-KRAS inhibitor that targets multiple KRAS mutation subtypes. The deal structure is typical for these arrangements: AstraZeneca gets exclusive development and commercialization rights outside China, while both companies will jointly develop and commercialize the drug within China.

Why does this matter? KRAS is the most frequently mutated oncogene in human cancers, present in roughly 23% of all cancer patients. For decades, KRAS was considered "undruggable," but recent scientific advances have made it a hot target in oncology. JAB-23E73 was developed using Jacobio's induced allosteric drug discovery platform and is designed to target multiple KRAS mutation subtypes—not just the most common ones.

The drug is currently in Phase I trials in both China and the United States, where it's already showing early signs of anti-tumor activity. That's promising but still very early-stage.

Financially, the deal is substantial. Jacobio receives $100 million upfront and is eligible for up to $1.915 billion in additional development and commercial milestone payments, plus tiered royalties on net sales outside China. AstraZeneca will handle all clinical development, regulatory submissions, and commercialization activities outside China.

AstraZeneca shares were up 0.40% at $90.79 at the time of publication on Monday. The stock is approaching its 52-week high of $94.01, suggesting investors are focusing more on the wins than the lung cancer miss.