2024-04-23 17:20:16 ET
Summary
- Abeona Therapeutics Inc. stock dropped by over half after receiving a Complete Response Letter from the FDA regarding its Biologics License Application for pz-cel.
- The FDA identified manufacturing issues that need to be resolved, delaying the potential approval of pz-cel. However, no issues were raised regarding efficacy and safety, nor are more trials required.
- Despite the setback, Abeona Therapeutics may present a buying opportunity as it bottoms out, with estimated peak revenue of over $500 million in the U.S. assuming approval.
- The biggest risk to a long thesis will be a likely need to raise funds within the next year.
- The company has some leeway regarding the timing of any capital raise, so I expect it to occur at higher prices than today.
Abeona Therapeutics Inc. ( ABEO ) dropped by more than half on Tuesday after the company received a Complete Response Letter from the FDA in response to the Company’s Biologics License Application for pz-cel. In one day, ABEO erased nearly a year's worth of gains that had been building on positive speculation that pz-cel would gain approval at next month's PDUFA. Those hopes were dashed as the FDA identified manufacturing issues that the company must take the next several weeks to address....
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Abeona Therapeutics Tanks On CRL From The FDA, But All Hope Is Not Lost