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MENLO PARK, Calif. - AN2 Therapeutics , Inc. (NASDAQ:ANTX), a clinical-stage biopharmaceutical company currently valued at $33.46 million, has submitted an amended statistical analysis plan to the FDA, designating the Quality of Life - Bronchiectasis (QOL-B) respiratory domain patient-reported outcome (PRO) as the primary efficacy endpoint for its Phase 3 EBO-301 trial. According to InvestingPro analysis, the company appears undervalued based on its Fair Value metrics, despite its shares being down 18% year-to-date. The company aims to unblind and discuss Phase 3 data with the FDA in the second quarter of 2025 to explore potential registration pathways for their drug, epetraborole, in treating refractory non-tuberculous mycobacteria (NTM) lung disease.
The decision to select QOL-B as the primary endpoint was influenced by Phase 2 results, which suggested a meaningful clinical improvement in patients with limited treatment options. This aligns with the FDA’s 2023 Guidance for Industry on NTM drug development, which recommends PRO-based clinical outcome measures in registrational trials. With analyst price targets ranging from $1 to $5, InvestingPro subscribers can access detailed analysis and additional insights about the company’s development pipeline and market potential.
AN2 Therapeutics plans to compare the Phase 3 data with the Phase 2 findings, where epetraborole showed nominal statistical superiority over placebo. The company expects to release top-line results from the Phase 3 study in Q2 2025, pending any FDA feedback.
The QOL-B instrument was also used as the primary efficacy measure in Insmed (NASDAQ:INSM)’s confirmatory study of Arikayce, setting a precedent for its use. AN2 Therapeutics’ approach follows this precedent, potentially strengthening their case for FDA approval.
In August 2024, AN2 Therapeutics reported topline results from Phase 2 and halted the ongoing Phase 3 portion of the trial. They then initiated a full review of the Phase 2 data. Ninety-seven subjects completed treatment in Phase 3, and the data remains blinded for analysis.
AN2 Therapeutics specializes in developing small molecule therapeutics from its boron chemistry platform, with a pipeline that includes treatments for Chagas disease, NTM, and melioidosis, as well as early-stage programs for infectious diseases and oncology.
This article is based on a press release statement from AN2 Therapeutics, Inc. The company’s forward-looking statements involve risks and uncertainties, and actual results could differ materially from those anticipated. AN2 does not undertake any obligation to update the information except as required by law. Investors can find comprehensive financial analysis, including the company’s Financial Health Score of FAIR and upcoming earnings report on March 27, 2025, through InvestingPro’s detailed research reports, which provide deep-dive analysis of 1,400+ US stocks.
In other recent news, JMP Securities has maintained a Market Outperform rating on AN2 Therapeutics, keeping a consistent price target of $5.00. This decision comes as the company prepares for significant milestones, including discussions with the FDA and the anticipated unblinding of Phase 3 data for its lead drug candidate, epetraborole, around mid-year. The focus is on epetraborole’s potential in treating Mycobacterium avium complex non-tuberculosis mycobacteria, a serious respiratory condition. Analyst Roy Buchanan from JMP Securities expressed confidence in the company’s progress, citing positive patient-reported outcomes and a favorable safety profile observed in earlier trials. The reaffirmed price target is based on a risk-adjusted, discounted cash flow analysis, reflecting optimism about future regulatory and clinical developments. AN2 Therapeutics’ ongoing dialogue with the FDA is seen as a critical step in advancing epetraborole through the regulatory pathway. The outcomes of these discussions and the Phase 3 study results are eagerly anticipated by investors and could significantly influence the company’s trajectory. As the year progresses, the biopharmaceutical company’s advancements remain closely monitored by analysts and the medical community.
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