Soligenix, Inc 8-K, filed Oct 29, 2021
Soligenix, Inc. (SNGX)
About this 8-K
Soligenix, Inc filed this 8-K on October 29, 2021.
Items reported
- Item 8.01: Other events
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Item 8.01. Other Events.
Due to disruptions caused by the global COVID-19 pandemic resulting in delays by the commercial active pharmaceutical ingredient contract manufacturer, Soligenix, Inc. (the “Company”) is unable to provide the pre-requisite amount of accrued stability data required to file its HyBryte™ (SGX301) new drug application (“NDA”) with the U.S. Food and Drug Administration (“FDA”) by the first half of 2022. Therefore, the timeline for anticipated NDA filing with the FDA is being adjusted to the second half of 2022 with corresponding potential FDA approval adjusted to the second half of 2023.
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SIGNATURE
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
| Soligenix, Inc. | |
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October 29, 2021 | By: | /s/ Christopher J. Schaber |
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| Christopher J. Schaber, Ph.D. |
| | President and Chief Executive Officer |
| | (Principal Executive Officer) |
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