Last check, Aprea Therapeutics Inc. (APRE) shares dropped -7.67% to $3.97 in after-hours trading. Last session, APRE stock closed at $4.30, an increase of 2.63% or $0.11. The APRE stock fluctuated between $4.16 and $4.38 throughout the day. APRE stock exchanged 0.75 million shares, below the company’s 50-day volume of 4.31 million and below its Year-to-date volume of 2.25 million.

APRE stock dropped -85.53% over the last 12 months, and in the past week, it lost -0.92%. Within the last three months, APRE stock has increased by 0.94%, and over the last six months, APRE stock has decreased by -32.60%. So far this year, APRE stock lost -12.60%. After announcing the holding of a clinical trial, APRE stock plummeted.

Which APRE Stock trial was paused?

Boston-based Aprea Therapeutics manufactures biopharmaceutical products. The APRE research facility in Stockholm, Sweden is dedicated to developing and commercializing novel medicines for cancer that can reactivate mutant tumor suppressor proteins, such as p53. Prenetapopt (APR-246) is APRE’s leading product candidate in the role of treatment of hematologic malignancies and solid tumors. For myelodysplastic syndromes (MDS), Eprenetapopt has received Breakthrough Therapy, Orphan Drug, and Fast Track designations from the FDA.

The U.S. Food and Drug Administration (FDA) has temporarily suspended clinical trials for a lead product of Aprea Therapeutics, announced APRE in a press release yesterday.

• APRE was evaluating eprenetapopt combined with azacitidine in trials for myeloid malignancies.
• Clinical trials in lymphoid malignancies and solid tumors will continue to be conducted by APRE, as will the APR-548 trial.
• The APRE’s myeloid malignancy programs, which include trials for MDS, AML and post-transplant maintenance, all have completed enrollment of about 20 patients receiving eprenetapopt in combination with azacitidine.
• Treatment can be continued for patients who are benefiting from it.
• Since APRE is still under a partial clinical hold, it cannot enroll more patients to these trials.
• In order to address the specific questions raised by the FDA, and work towards resolving the partial clinical hold as soon as possible, APRE plans to work closely with the FDA.
• The APRE described patient safety as its top priority.
• APRE believes eprenetapopt remains a promising therapeutic option based on the data it has collected.

Discussion of the issue in a conference call:

On August 6, 2021 at 8:30 AM (ET), APRE will host a webcast conference call to discuss this announcement. Information about the connection can be found on APRE’s website, under Events. In its trials for myeloid malignancies, Aprea Therapeutics (APRE) says it is working closely with the FDA to review data specific to eprenetapopt as well as azacitidine. APRE will provide an update as additional information is available.