Phase 2 registration-intent trial enrolling Part 2a dose confirmation arms Topline data from DENALI Part 2 anticipated by year end 2026 with the potential to support an accelerated approval, subject to FDA feedback SAN DIEGO, April 28, 2025 (GLOBE NEWSWIRE) -- Zentalis® Pharmaceuticals, Inc. (Nasdaq: ZNTL), a clinical-stage biopharmaceutical company developing a potentially first-in-class and best-in-class WEE1 inhibitor for patients with ovarian cancer and other tumor types, today announced that the first patient has been dosed in Part 2 of the Phase 2 DENALI clinical trial (NCT05128825) of azenosertib in patients with Cyclin E1+ platinum-resistant ovarian cancer (PROC). As previously disclosed, the Company aligned with the U.S. Food and Drug Administration (FDA) on the design of DENALI Part 2, which allows for seamless enrollment in the two parts of the trial: Part 2a is designed to confirm the primary dose-of-interest with a target enrollment of approximately 30 patients at each of two dose levels: 400mg QD 5:2 and 300mg QD 5:2 (intermittent daily dosing on a five days on, two days off dosing schedule).

New Investors Take Over the Strategic Leadership as Headquarters Move to Bogotá, Marking the Start of a New Chapter of Growth, Execution, and Transformation under Enhanced Governance

Corcept Therapeutics Incorporated's relacorilant met the primary endpoint in the phase 3 ROSELLA study for platinum-resistant ovarian cancer patients, boosting shares by over 90% the very same day. Upcoming catalysts include full trial data release at a medical conference, NDA filing in Q3 2025, and MAA submission to the EMA shortly afterward. Relacorilant also targets hypercortisolism with endogenous Cushing's Syndrome patients with an FDA PDUFA date set for December 30, 2025, based on positive GRACE, GRADIENT, and phase 2 study data.

MIAMI and BARRANQUILLA, Columbia, Feb. 03, 2025 (GLOBE NEWSWIRE) -- Procaps Group, S.A. (NASDAQ: PROC) (“Procaps” or the “Company”), a leading integrated LatAm healthcare and pharmaceutical services company, today announced that the Company received a notice from The Nasdaq Stock Market LLC (“Nasdaq”) that it has determined to delist the Company's ordinary shares on Nasdaq. The delisting is a result of the Company's failure to demonstrate compliance with Nasdaq Listing Rules 5250(c)(1) and 5250(c)(2) for failing to file periodic and interim financial reports. As a result of the forgoing, the Company's ordinary shares are expected to commence trading on the Expert Market operated by the OTC Markets Group, Inc. (“OTC”), commencing on February 4, 2025.

MIAMI and BARRANQUILLA, Columbia, Jan. 03, 2025 (GLOBE NEWSWIRE) -- Procaps Group, S.A. (NASDAQ: PROC) (“Procaps” or the “Company”), a leading integrated LatAm healthcare and pharmaceutical services company, today announced that, as anticipated, on December 31, 2024, the Company received notice from The Nasdaq Stock Market LLC (“Nasdaq”) of an additional filing delinquency relating to the Company's interim financial statements for the period ended June 30, 2024.

MIAMI and BARRANQUILLA, Colombia, Dec. 20, 2024 (GLOBE NEWSWIRE) -- Procaps Group, S.A. (NASDAQ: PROC) (“Procaps” or the “Company”), a leading integrated LatAm healthcare and pharmaceutical services company, today announced significant outcomes from its recent Shareholders Meeting and subsequent Board of Directors meeting. These include changes to the Board composition, restructuring of Board committees, and updates to its executive leadership team.

MIAMI and BARRANQUILLA, Colombia , Dec. 03, 2024 (GLOBE NEWSWIRE) -- Procaps Group, S.A. (NASDAQ: PROC) (“Procaps” or the “Company”), a leading integrated LatAm healthcare and pharmaceutical services company, today announced the successful execution of key strategic transactions and governance updates aimed at strengthening its financial position and supporting long-term growth objectives.

MIAMI and BARRANQUILLA, Colombia, Nov. 15, 2024 (GLOBE NEWSWIRE) -- Procaps Group, S.A. (NASDAQ: PROC) (“Procaps” or the “Company”), announced today that, on November 13, 2024, the Company received formal notice from the Listing Qualifications Department (the “Staff”) of The Nasdaq Stock Market LLC (“Nasdaq”) that, based upon the Company's failure to timely file the Form 20-F for the fiscal year ended December 31, 2023 (the “Form 20-F”) with the U.S. Securities and Exchange Commission (the “SEC”), the Company no longer satisfied Nasdaq Listing Rule 5250(c)(1) (the “Filing Rule”) and its securities are therefore subject to suspension and delisting unless the Company timely requests a hearing before and a further stay of any suspension action at least pending the ultimate conclusion of the hearings process from the Nasdaq Hearings Panel (the “Panel”).

MIAMI and BARRANQUILLA, Colombia, Oct. 10, 2024 (GLOBE NEWSWIRE) -- Procaps Group, S.A. (NASDAQ: PROC) (“Procaps” or the “Company”), a leading integrated LatAm healthcare and pharmaceutical services, today issued the below letter to shareholders from José Antonio Vieira, CEO of Procaps, providing critical updates on the Company's ongoing independent investigation, financial restatement, governance enhancements, and commitment to long-term stability.

MIAMI and BARRANQUILLA, Colombia, Sept. 18, 2024 (GLOBE NEWSWIRE) -- Procaps Group, S.A. (NASDAQ: PROC) (“Procaps” or the “Company”), a leading integrated LatAm healthcare and pharmaceutical services, today issued the below letter to shareholders from José Antonio Vieira, CEO of Procaps, with updates on the Company's restructuring and strategic plan projects.