Baudax Bio Inc (NASDAQ: BXRX) is a pharmaceutical company focused on innovative products for hospitals and related settings. The Company has a pipeline of innovative pharmaceutical assets including two clinical-stage, novel neuromuscular blocking (NMBs) agents, one undergoing a Phase II clinical trial and an additional unique NMB undergoing a dose escalation Phase I clinical trial, as well as a proprietary chemical reversal agent specific to these NMBs, which is currently undergoing nonclinical and manufacturing studies to prepare for an expected IND filing in the summer of 2023. 

Baudax holds exclusive global rights to two new molecular entities, which are centrally acting Neuromuscular Blocking Agents (NMBs), BX1000, an intermediate duration of action NMB currently undergoing a Phase II clinical trial, and BX2000, an ultra-short acting NMB currently undergoing a Phase I clinical trial, as well as a proprietary blockade reversal agent, BX3000, currently being evaluated in preclinical studies intended to support an IND filing in 2023. BX3000 is an agent that is expected to rapidly reverse BX1000 and BX2000 blockade. All three agents are licensed from Cornell University.  

The Company believes these agents, when administered in succession, will allow for a rapid onset of centrally acting neuromuscular blockade, followed by a rapid reversal of the neuromuscular blockade with BX3000. These novel agents have the potential to meaningfully reduce time to onset of blocking and of reversal of blockade, reducing time in operating rooms or post operative suites (PACU), resulting in potential clinical and cost advantages, as well as valuable cost savings for hospitals and ambulatory surgical centers. 

In mid-2020, Baudax launched its first commercial product, ANJESO®, in the United States. ANJESO is the first and only 24-hour, intravenous, or IV, analgesia agent. The Company successfully completed three Phase III clinical trials, including two pivotal efficacy trials, a large double-blind Phase III safety trial and two Phase IIIb programs evaluating ANJESO’s clinical safety and efficacy along with its positive health economic impacts in specific surgical settings. For now, Baudax has discontinued commercial sales of ANJESO in December of 2022. 

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In January Baudax reported the successful outcome of its first interim analysis in a Phase II trial of BX1000 for neuromuscular blockade (NMB) in patients undergoing elective surgery. This randomized, double-blind, active-controlled clinical trial comparing three different doses of BX1000 to a standard dose of rocuronium is planned to enroll a total of 80 adult patients undergoing elective surgery utilizing total intravenous anesthesia. The primary efficacy endpoint is the proportion of patients meeting criteria for Good or Excellent intubating conditions using a standardized scale. Additionally, the trial is evaluating the safety and tolerability profile of BX1000 and rocuronium in this patient population. 

Baudax is led by CEO Gerri Henwood, a biotech executive who was the founder and Chief Executive Officer of IBAH, Inc., or IBAH, a contract research organization listed on NASDAQ. Ms. Henwood began her career with Smith Kline & French, now part of GlaxoSmithKline plc. In February Baudax reported its fourth quarter and annual financial results at which time the Company president and CEO Gerri Henwood stated:

“During our fourth quarter we refocused our priorities on our NMB portfolio, initiating our Phase II trial for BX1000 and advancing our Phase I dose escalation trial for BX2000. The encouraging interim data we announced from the BX1000 trial showed all patients treated to date have met the criteria for Good or Excellent intubating conditions at 60 seconds, and that BX1000 has been generally well tolerated. We believe these data speak to the potential of our NMB portfolio to improve patient management and deliver cost efficiencies in procedures where NMB is required. We expect to complete enrollment in the BX1000 trial during the first quarter of 2023, and to announce top line data early in the second quarter of 2023. Concurrently, BX2000, our ultrashort acting NMB, is continuing through its dose escalation study, which we expect to complete by the end of 2023. BX3000, our NMB reversal agent, remains on track, and we expect to complete the nonclinical and manufacturing studies needed to support an IND filing for BX3000, the NMB reversal agent in the summer of 2023. Data from these trials will provide us with insight on the profiles of the two blocking agents, which will contribute to decisions to move forward later in 2023.”

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Currently trading just under $2 after seeing a significant reversal off $1.25 BXRX has fallen a long way over the past year as the Company had to take its first commercial product, ANJESO® off the shelves in December. Also, they were forced to dilute the stock and executed a 1 for 40 reverse stock split in December further decimating the share price. From current levels BXRX is once again under accumulation as the Company completes a $4.7 million public offering. The Company is currently developing an intermediate-acting NMB, BX1000, an ultra- short acting NMB, BX2000, and a reversal agent specific to its NMBs, BX3000. Neuromuscular blocking agents are used as muscle paralyzing agents to facilitate intubation and provide skeletal muscle relaxation during surgery or mechanical ventilation.   We will be updating on BXRX when more details emerge so make sure you are subscribed to newsytrends.com by entering your email below.

Disclosure: we hold no position in BXRX either long or short and we have not been compensated for this article.