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AN2 Therapeutics’ High-Stakes Gamble: Navigating FDA Approval for Epetraborole Amid Clinical Trial Uncertainties
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AN2 Therapeutics’ High-Stakes Gamble: Navigating FDA Approval for Epetraborole Amid Clinical Trial Uncertainties

AN2 Therapeutics, Inc. (ANTX) has disclosed a new risk, in the Innovation / R&D category.

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AN2 Therapeutics, Inc. faces significant business risk as it navigates the stringent approval process for its product candidate, epetraborole. The reliance on a single pivotal clinical trial for the treatment of refractory MAC lung disease presents uncertainty, especially given that the FDA may mandate additional trials beyond the company’s current plans. With the recent pause in Phase 3 enrollment due to lower-than-anticipated efficacy and the potential need for further data collection, the path to approval is fraught with challenges. Additionally, the company’s limited experience in NTM clinical trial design and execution could further complicate their regulatory journey.

The average ANTX stock price target is $7.00, implying 115.38% upside potential.

To learn more about AN2 Therapeutics, Inc.’s risk factors, click here.

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