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SEATTLE - Atossa Therapeutics, Inc. (NASDAQ:ATOS), currently trading at $1.01 and showing strong momentum with a 68% gain over the past six months, announced Monday an amendment to its Phase 2 EVANGELINE study of (Z)-endoxifen in premenopausal women with newly diagnosed early-stage ER+/HER2- breast cancer, aiming to reduce costs and accelerate data collection. According to InvestingPro analysis, the company, valued at $130 million, has demonstrated significant price momentum recently.
The clinical-stage biopharmaceutical company has modified the study to a single-arm, open-label, non-registrational design that will decrease the patient total from 214 to 40-65 participants. The amended protocol includes a two-stage futility design for patients with initial Ki-67 levels above 10%, allowing for earlier go/no-go decisions based on short-interval endpoints.
"This amendment is about efficiency, focus, and financial discipline," said Steven Quay, M.D., Ph.D., Atossa’s Chairman and Chief Executive Officer, in a press release statement.
The company indicated the changes are intended to extend its operating runway while maintaining its safety oversight protocols. Patient safety data collection and Data Safety Monitoring Committee oversight will remain unchanged. With an overall Financial Health Score of "FAIR" from InvestingPro, which offers comprehensive analysis through its Pro Research Reports covering 1,400+ US stocks, the company’s focus on operational efficiency appears timely.
The streamlined trial will consist of two cohorts: Cohort A will assess Week-4 Ki-67 response rates in a signal-seeking approach, while Cohort B will evaluate Week-24 objective response using RECIST 1.1 criteria with central review.
Previously presented data from the EVANGELINE run-in phase showed an 86% Week-4 Ki-67 response rate (defined as Ki-67 ≤10%) across evaluated (Z)-endoxifen dose levels. The company noted that published comparators report a 41% response rate with tamoxifen and a 78% response rate with an aromatase inhibitor and ovarian function suppression in similar settings.
The EVANGELINE study is being conducted across multiple U.S. medical centers, including Mayo Clinic locations, Dana-Farber Cancer Institute, and Northwestern University.
Atossa emphasized that the amendment aligns with its strategy to focus resources on NDA-enabling activities for (Z)-endoxifen planned for 2026.
In other recent news, Atossa Therapeutics has been actively advancing its breast cancer treatment initiatives. The company announced it has received positive feedback from the U.S. Food and Drug Administration (FDA) regarding its proposed dose optimization trial for (Z)-endoxifen, aimed at treating estrogen receptor-positive, HER2-negative metastatic breast cancer. This feedback has affirmed key elements of Atossa’s clinical development plan, potentially accelerating its timeline toward an Investigational New Drug (IND) submission by the fourth quarter of 2025. Additionally, Atossa has requested a Type C meeting with the FDA to discuss strategies for accelerating the development of low-dose (Z)-endoxifen for breast cancer risk reduction. H.C. Wainwright has reiterated its Buy rating and $7.00 price target on Atossa, reflecting confidence in the company’s regulatory strategy for Z-endoxifen. In leadership news, Janet R. Rea has been appointed as Senior Vice President of Research and Development to lead the company’s late-stage clinical and regulatory programs. These developments highlight Atossa’s continued efforts to advance its breast cancer treatment pipeline.
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