FDA Calendar: These Are the Upcoming FDA Drug Approvals 

By the end of this month, two pharmaceutical firms are set to receive a decision on their drug approval applications from the U.S. Food and Drug Administration (FDA), TipRanks’ FDA Calendar shows.

In this article, we highlight the two companies, detailing the drugs in the lineup for a decision, the function of these medications, and how Wall Street is currently rating these stocks.

Be sure to click on any ticker for in-depth research before making portfolio decisions. The chart below provides insight into how these two companies compare.

Ascendis Pharma (ASND) – This is a Danish biopharma company that specializes in developing therapies for cancer and other rare diseases, such as conditions that affect the hormone-producing glands in the body. It is the maker of Skytrofa, a once-weekly injection for children with low growth hormone, and Yorvipath, a drug that helps to restore the body’s calcium balance.

The FDA is set to decide on TransCon CNP, another once-weekly therapy by Ascendis, designed to promote bone growth in the body.

Kura Oncology, Inc. (KURA) – Kura is an American biopharma company that develops medications to target genetic drivers of cancer. Its leading product is Komzifti, a pill that helps treat a specific kind of blood cancer called acute myeloid leukemia (AML).

Kura is awaiting the FDA’s decision on Ziftomenib, a drug designed to treat AML.

Which Stock Offers the Most Upside?

Ascendis and Kura’s shares both currently have a Strong Buy consensus rating from analysts. However, in terms of upside potential, Kura’s shares comfortably lead, offering a massive upside of 136.20% at an average KURA price target of $26.88.

Ascendis’s shares with an average ASND price target of $260.15 offer about 23.13% upside.

Check out other companies with upcoming FDA drug application decisions.