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Investing.com - H.C. Wainwright has reiterated its Buy rating and $7.00 price target on Atossa Genetics (NASDAQ:ATOS), currently trading at $0.81, following the company’s announcement about regulatory strategy for its Z-endoxifen breast cancer treatment. According to InvestingPro data, the company maintains a strong liquidity position with more cash than debt on its balance sheet.
Atossa Genetics, with a market capitalization of $104.25 million, requested a Type C meeting with the FDA to discuss potential accelerated regulatory pathways for low dose Z-endoxifen for breast cancer risk reduction. The company aims to align with FDA requirements to support a new drug application across multiple settings including adjuvant, ductal carcinoma in situ, and high-risk women without cancer. InvestingPro analysis reveals the company maintains a healthy current ratio of 9.17, though it’s currently experiencing accelerated cash burn.
Based on a review of Z-endoxifen data and existing scientific literature by regulatory experts, Atossa believes it may be possible to shorten the approval process by multiple years while significantly reducing trial costs. Type C meetings allow companies to seek FDA guidance on various drug development aspects outside specific milestones.
Atossa expects to provide an update on the meeting results by the end of 2025, potentially alongside updates for its FDA-aligned, Project Optimus-compliant Phase 2 dose optimization trial of Z-endoxifen in ER+/HER2- metastatic breast cancer.
The company anticipates submitting an Investigational New Drug application in mid-fourth quarter of 2025 as it pursues a strategy leveraging regulatory synergy across various breast cancer treatment settings. With analyst price targets ranging from $4 to $7.50, investors can access comprehensive analysis and additional insights through InvestingPro’s detailed research reports, which cover over 1,400 US stocks including Atossa Genetics.
In other recent news, Atossa Therapeutics, Inc. has received positive feedback from the U.S. Food and Drug Administration (FDA) regarding its proposed dose optimization trial for (Z)-endoxifen. The FDA’s response affirmed key elements of Atossa’s clinical development plan for treating estrogen receptor-positive, HER2-negative metastatic breast cancer. This constructive feedback has eliminated the need for a scheduled pre-Investigational New Drug (IND) meeting, potentially accelerating the company’s timeline for an IND submission targeted for 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. The company expects to update shareholders on the outcome of this meeting before the end of 2025. A favorable outcome could potentially shorten approval timelines and reduce clinical trial costs. These developments mark significant steps forward in Atossa’s efforts to advance its breast cancer treatment initiatives.
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