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CURRENT REPORT
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| Item 8.01 | Other Events. |
Baudax Bio, Inc. (“Baudax” or the “Company”) is a pharmaceutical company primarily focused on innovative products for hospital and related settings. As previously disclosed, the Company is focused on development of new molecular entities which are neuromuscular blocking (“NMB”) agents and a proprietary NMB reversal agent. The Company believes that, assuming that target product profiles are met in clinical development, the combined NMB and reversal agent products represent an opportunity to further improve patient management and time and cost efficiency for surgical cases where NMB usage is appropriate.
BX 1000, an intermediate acting NMB, is currently enrolling patients to a phase 2 clinical trial in abdominal surgical conditions with a preplanned first interim analysis expected early in 2023, and with a goal to complete enrollment in the full study by the end of the first quarter of 2023. BX 2000, an ultrashort acting NMB, is in a dose escalation study in healthy volunteers which the Company plans to complete in 2023. BX 3000 is a proprietary reversal agent which chemically breaks the BX 1000 and BX 2000 molecules and inactivates them. Baudax is conducting preclinical studies for BX 3000 to support an IND filing anticipated for the summer of 2023.
Consistent with this strategic focus, as previously disclosed, the Company eliminated the dedicated commercial personnel for the Company’s first commercial product, ANJESO (IV meloxicam) and on December 28, 2022, the discontinuation of sale of ANJESO was acknowledged by FDA via listing in the Orange Book. The Company continues to evaluate alternative approaches to the monetization of ANJESO both in the United States and outside the United States.
SIGNATURES
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, thereunto duly authorized.
| Baudax Bio, Inc | ||
| By: | /s/ Gerri A. Henwood | |
| Name: | Gerri A. Henwood | |
| Title: | President and Chief Executive Officer | |
Date: December 30, 2022