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Baudax Bio, Inc. - BXRX STOCK NEWS

Welcome to our dedicated page for Baudax Bio news (Ticker: BXRX), a resource for investors and traders seeking the latest updates and insights on Baudax Bio stock.

Baudax Bio, Inc. (NASDAQ: BXRX) is a specialized pharmaceutical company focused on developing and commercializing innovative products designed to meet the needs of hospital and acute care settings. The company's lead product candidate is an intravenous form of meloxicam, a non-opioid analgesic that has completed Phase III clinical trials for the management of moderate to severe pain. Current research includes Phase IIIB clinical trials aiming to assess opioid consumption, pain intensity, and the length of hospital stay in colorectal and orthopedic surgery patients. These trials also evaluate various pharmacoeconomic parameters.

Beyond meloxicam, Baudax Bio is advancing a pipeline of early-stage product candidates including RP1000, an intermediate-acting neuromuscular blocking agent (NMBA) in Phase I clinical trials, and RP2000, an ultra-short-acting NMBA currently in pre-clinical trials. The company is also developing a reversal agent for these NMBAs and DEX-IN, a proprietary intranasal formulation of dexmedetomidine.

Recently, Baudax Bio announced that the U.S. FDA has granted orphan drug designation to its lead clinical candidate TI-168 for the treatment of Hemophilia A with inhibitors. TI-168 is a next-generation Treg therapy designed to address Hemophilia A patients with FVIII inhibitors effectively.

Founded in 2019 and based in Malvern, Pennsylvania, Baudax Bio continues to push forward with its mission to develop meaningful therapeutic solutions for acute care settings, drawing on robust clinical research and innovative therapeutic approaches.

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Baudax Bio (NASDAQ: BXRX) announced a public offering of 3,478,262 shares of common stock, priced at $1.15 per share, along with accompanying warrants. This offering is expected to generate gross proceeds of approximately $4 million, which will be used for pipeline development and general corporate purposes. The offering includes Series A-5 and A-6 warrants, both priced at $1.15, with different expiration dates. The closing is anticipated around May 1, 2023, pending customary conditions. H.C. Wainwright & Co. acts as the exclusive placement agent. These securities are offered under a registration statement now effective with the SEC.

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Baudax Bio, Inc. (Nasdaq:BXRX) has announced positive results from its Phase 2 clinical trial of BX1000 for neuromuscular blockade in elective surgery patients. All patients in the three treatment cohorts achieved good or excellent intubation conditions at 60 seconds, with no severe adverse events reported. The randomized, double-blind trial involved 80 patients, comparing BX1000 across three doses against a standard dose of rocuronium. Results showed a dose-response relationship, indicating that BX1000 may offer comparable efficacy to the standard treatment. The company plans to submit a New Drug Application by the end of 2025 and will continue to develop its neuromuscular blockade agents.

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Baudax Bio (Nasdaq: BXRX) announced a virtual webinar on April 25, 2023, featuring key opinion leaders discussing the Phase 2 trial results of BX1000, a neuromuscular blocking agent (NMB), for patients undergoing elective surgery. The trial is a randomized, double-blind, active-controlled study comparing BX1000 doses against a standard dose of rocuronium in 80 adult patients. The event aims to provide insights on BX1000's potential advantages in surgical settings. Baudax is developing two NMBs, BX1000 and BX2000, along with a proprietary reversal agent, BX3000, expected to advance to IND filing in 2023. These agents may improve surgical efficiency and reduce operating room time. The company is committed to enhancing hospital-related products and developing its clinical pipeline.

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Baudax Bio, Inc. (Nasdaq:BXRX) reported promising results from the second interim analysis of its Phase 2 trial for BX1000, a neuromuscular blocking agent. In total, 41 subjects met criteria for good or excellent intubating conditions within 60 seconds. The trial involves 80 adult patients undergoing elective surgery and compares BX1000 against rocuronium. Results showed safe administration with no severe adverse events. Baudax anticipates completing enrollment soon and expects to release top-line data in late April or early May. These developments could improve surgical practices and patient outcomes.

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Baudax Bio (Nasdaq:BXRX) has initiated a Phase II trial for BX1000, showing positive interim results with all 20 patients meeting the criteria for good intubating conditions. The company expects to complete enrollment in Q1 2023 and announce top-line data in early Q2 2023. Progress continues on BX2000 and BX3000, with expected completion of related studies by late 2023. Baudax Bio has secured $5 million through a public offering, but has discontinued the commercialization of ANJESO due to unfavorable market conditions. For Q4 2022, the company reported a net loss of $9.2 million and anticipates challenges ahead with its NMB products.

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Baudax Bio (NASDAQ:BXRX) announced positive results from the interim analysis of its Phase II trial for BX1000, a neuromuscular blockade agent. In the study involving 20 patients, all met the criteria for Good or Excellent intubating conditions at 60 seconds. The trial evaluates BX1000 against a standard dose of rocuronium, aiming to enhance surgical efficiency and cost savings. No severe adverse events occurred, reinforcing the agent's safety profile. The company expects to complete enrollment by Q1 and release topline results by April 2023, as it continues to advance its innovative pipeline.

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Baudax Bio (NASDAQ:BXRX) has initiated a Phase II clinical study to evaluate BX1000, a neuromuscular blocker, in approximately 80 adult patients undergoing elective surgery with total intravenous anesthesia. The trial aims to assess safety, tolerability, and intubation conditions, which are critical for future NDA approval. The company anticipates completing full enrollment by the end of March 2023 and conducting an interim analysis early in 2023. Positive early results indicate no serious adverse events, enhancing the potential market impact of BX1000 in surgical settings.

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Baudax Bio has successfully closed its public offering, issuing 1,042,787 shares at $4.795 each, resulting in gross proceeds of approximately $5 million. This includes Series A-3 and A-4 warrants, both with an exercise price of $4.50. The funds will support working capital and pipeline development. Existing warrants were also amended to reduce their exercise price to $4.50. The offering was facilitated by H.C. Wainwright & Co., and details can be found in the SEC registration statement.

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FAQ

What is the market cap of Baudax Bio (BXRX)?

The market cap of Baudax Bio (BXRX) is approximately 950.3K.

What is the primary focus of Baudax Bio, Inc.?

Baudax Bio focuses on developing and commercializing products for hospital and acute care settings.

What is Baudax Bio's lead product candidate?

The lead product candidate is an intravenous form of meloxicam, a non-opioid pain management drug.

What other products are in Baudax Bio's pipeline?

Their pipeline includes RP1000, an intermediate-acting NMBA, RP2000, an ultra-short-acting NMBA, and a proprietary intranasal formulation of dexmedetomidine, DEX-IN.

What recent regulatory milestone has Baudax Bio achieved?

Baudax Bio's lead clinical candidate TI-168 received orphan drug designation from the U.S. FDA for treating Hemophilia A with inhibitors.

Where is Baudax Bio headquartered?

Baudax Bio is headquartered in Malvern, Pennsylvania.

When was Baudax Bio incorporated?

Baudax Bio was incorporated in 2019.

What is the status of meloxicam's clinical trials?

Meloxicam has completed Phase III clinical trials and is in Phase IIIB trials for colorectal and orthopedic surgery applications.

What is TI-168?

TI-168 is a next-generation Treg therapy for Hemophilia A with inhibitors, recently granted orphan drug designation by the FDA.

Who can I contact for investor relations information?

For investor relations information, you can contact Mike Moyer at LifeSci Advisors via email at mmoyer@lifesciadvisors.com.

Are there any other clinical trials Baudax Bio is involved in?

Yes, Baudax Bio is involved in Phase I clinical trials for RP1000 and pre-clinical trials for RP2000.

Baudax Bio, Inc.

Nasdaq:BXRX

BXRX Rankings

BXRX Stock Data

950.33k
43.59M
0.02%
2.68%
3.9%
Biotechnology
Healthcare
Link
United States
Malvern