AstraZeneca announced looming approval for two drugs in Europe and an FDA review for a third med, leading AZN stock to inch higher Monday.
Specifically, advisors to the European Medicines Agency recommended approval for severe asthma and generalized myasthenia gravis treatments. The latter is an autoimmune and neuromuscular condition. In the U.S., the Food and Drug Administration will review AstraZeneca's Enhertu in patients with a form of breast cancer. Enhertu is already approved to treat some cancers.
On today's stock market, AZN stock rose 1.4% to 66.16.
AZN Stock: New Paradigm In Cancer?
The FDA review could be groundbreaking in cancer treatment. AstraZeneca is hoping to win approval for Enhertu in breast cancer patients with low levels of HER2. HER2, or human epidermal growth factor 2, is a gene that makes a protein found on the surface of breast cells.
So far, Enhertu is only approved for patients with high levels of that protein. But the final-phase test showed a survival benefit for patients with a low HER2 level. An approval could open up the use case for Enhertu, developed by AstraZeneca and Japan's Daiichi Sankyo.
For more than two decades, only breast cancer patients with high levels of HER2 have been able to use HER2-directed treatments, Susan Galbraith, AstraZeneca's executive vice president of oncology, said in a written statement.
"If approved, Enhertu will redefine how we classify and treat metastatic breast cancer, enabling patients whose tumors have lower levels of HER2 expression the opportunity to benefit from a HER2-directed therapy," she said.
The FDA is due to make its decision in the fourth quarter, and could spark AZN stock.
Advisors Recommend Two Drugs
In Europe, the Committee for Medicines Products for Human Use makes recommendations based on a drug's benefits and risks. The committee issued a positive view on AstraZeneca's Tezspire for patients with severe asthma who don't respond to corticosteroids and another medicine.
The committee also recommended that the European Union approve Ultomiris, a treatment for generalized myasthenia gravis. Ultomiris, acquired alongside Alexion Pharmaceuticals, is already approved in the U.S. for that use. Like Tezspire in asthma, patients would add Ultomiris onto standard treatments.
Last month, AZN stock broke out of a double-bottom base with a buy point at 67.50. Since then, shares have fallen below their entry, according to MarketSmith.com. Monday's move helped buoy AZN stock closer to retaking its buy point.
Follow Allison Gatlin on Twitter at @IBD_AGatlin.
