Baudax Bio, Inc. (NASDAQ: BXRX) is engaged as a pharmaceutical company, which is focused on developing innovative products for use in hospital and clinical settings. Shares of the pharma company are rallying 31% through early trading on Friday, December 9, 2022. Over the past three months, Baudax Bio has seen average daily volume of 73,860 shares. However, volume of 20.71 million shares or dollar volume of around $110.59 million, has already exchanged hands through early trading.
Shares of Baudax Bio are gaining after the company announced it has launched Phase 2 clinical studies of BX1000 evaluating the candidate’s ability to treat neuromuscular blockade (NMB) in patients undergoing elective surgery. The Phase 2 study is a randomized, double-blind trial that will enroll 80 adult patients between the ages of 18 and 65 and who have recently undergone elective surgery using total intravenous anesthesia (TIVA).
Patients in the trial will undergo an electric surgery with an IV line for anesthesia and study drug administration. Once patients has been anesthetized, neuromuscular monitoring will begin using electromyography (EMG). Within 3-5 minutes of being administered, the randomized NMB treatment will be administered as an IV bolus. Clinical operators will then monitor “intubating conditions,” which serves as the endpoint for NDA approval for NMB agents.
“The initiation of this Phase II clinical study in patients undergoing elective surgery is an important step for the overall NMB program, and we look forward to data on BX1000’s safety, tolerability, and neuromuscular blocking profile,” said Gerri Henwood, Baudax Bio’s President and Chief Executive Officer. “We believe that BX1000, in combination with BX3000 (reversal agent), may permit precise control of the time patients are under neuromuscular paralysis. This could be significantly impactful for patients, surgeons, and anesthesiologists by enhancing safety, and possibly saving time and reducing costs related to delayed recovery from neuromuscular paralysis following surgical procedures. To date, no serious adverse events have been reported in the first group of patients enrolled and efficacy parameters have been recorded. We look forward to announcing the completion of the pre-planned first interim analysis of the BX1000 Phase 2 surgery trial early in 2023, with a target of completing full study enrollment by the end of March, 2023.”
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