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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.
Baudax Bio, Inc. (NASDAQ: BXRX) announced that CEO Gerri Henwood will present at the Oppenheimer Fall Healthcare Life Sciences & Medtech Summit on September 22, 2020, at 3:20 p.m. ET. A live webcast will be available on Baudax Bio's website, with a replay accessible for 30 days post-event. The company focuses on therapeutics for acute care, having launched its product ANJESO® in June 2020. ANJESO, approved by the FDA for moderate to severe pain management, is a non-opioid IV NSAID that potentially addresses common opioid-related issues.
Baudax Bio (BXRX) announced a Group Purchasing Agreement with Premier Inc. effective August 2020. This agreement offers Premier members special pricing for ANJESO (meloxicam) injection, designed for moderate to severe pain management. CEO Gerri Henwood emphasized that this partnership will enhance ANJESO’s usage among healthcare providers, leveraging Premier's extensive network of approximately 4,000 hospitals. ANJESO is a non-opioid, long-acting COX-2 inhibitor approved by the FDA in February 2020, showcasing a potential alternative to traditional opioid therapies.
Baudax Bio, Inc. (NASDAQ: BXRX) has appointed Arnold Baskies, M.D. and Andrew Drechsler to its Board of Directors. Dr. Baskies, a renowned surgical oncologist, brings extensive clinical expertise, while Mr. Drechsler adds over 20 years of financial acumen in the life sciences sector. Their appointments come at a crucial time for Baudax as it seeks to enhance commercialization efforts for its product ANJESO, a non-opioid treatment for moderate to severe pain. Both directors express enthusiasm for contributing to the company's growth and the advancement of its product pipeline.
Baudax Bio, Inc. (NASDAQ:BXRX) commenced the U.S. commercial launch of ANJESO, its intravenous COX-2 preferential NSAID, following FDA approval in February 2020. Key developments include receiving a J-code from CMS to facilitate reimbursement starting October 2020 and executing contracts with Vizient and a top Integrated Delivery Network. Financial results for Q2 2020 show a net loss of $30.4 million ($1.72 per share) on $350,000 in product revenue. The company also secured a $50 million credit facility to support the ANJESO launch amidst challenges posed by the COVID-19 pandemic.
Baudax Bio (NASDAQ: BXRX) announced a permanent J-code for ANJESO (meloxicam) injection, effective October 1, 2020, facilitating reimbursement across various care settings. The J-code (J1738) aims to streamline reimbursement for outpatient providers, enhancing patient access to this non-opioid treatment option. Approved by the FDA in February 2020, ANJESO offers analgesic benefits without the addictive risks associated with opioids. The establishment of this J-code supports Baudax’s commercial strategy and improves accessibility for patients in need.
Baudax Bio (NASDAQ:BXRX) presented new Phase IIIb clinical data for its product ANJESO® at the ASCRS 2020 Annual Meeting. This data indicates significant improvements in patient outcomes when ANJESO is administered before colorectal surgery, including a 35% reduction in opioid use, 59% faster time to bowel sounds, and 27% quicker hospital discharge. ANJESO, a non-opioid analgesic, is aimed at enhancing recovery while minimizing opioid-related side effects. The results support ongoing commercial efforts and physician education initiatives regarding ANJESO.
Baudax Bio (NASDAQ: BXRX) announced a Pharmacy Supplier Agreement with Vizient, effective July 1, 2020, for its non-opioid pain management drug, ANJESO. This agreement, which allows Vizient's members—including over 50% of U.S. acute care providers—to benefit from significant savings, enhances patient access to ANJESO. Since its launch in June 2020, ANJESO has received strong clinician interest, and Baudax is expanding its commercial reach to Vizient members. The company emphasizes that this agreement is crucial for improving patient access and lowering healthcare costs.
Baudax Bio (Nasdaq: BXRX) announced on July 3, 2020, the approval of stock option grants for 57 newly-hired employees, totaling 450,816 shares and 119,923 restricted stock units. The options have an exercise price of $4.15 per share, based on the June 30, 2020 closing price, and will vest over four years. This equity award, part of the NASDAQ Rule 5635(c)(4) inducement exception, aims to incentivize employees as part of their compensation package. Baudax Bio is focused on acute care therapeutics and recently received FDA approval for its product, ANJESO™, for pain management.
Baudax Bio (NASDAQ: BXRX) has launched ANJESO™ (meloxicam) injection for managing moderate to severe pain, following FDA approval on February 20, 2020. The company has deployed 50 sales representatives in acute care settings across the U.S. Additionally, the Centers for Medicare and Medicaid Services (CMS) approved a reimbursement code (C9059), effective July 1, 2020, enhancing ANJESO's market access. ANJESO is the first once-daily IV analgesic, offering up to 24 hours of pain relief, and marks a significant advancement in non-opioid pain management.
Baudax Bio (NASDAQ:BXRX) has secured a credit facility of up to $50 million from Marathon Asset Management to support the commercial launch of ANJESOTM (meloxicam) injection and for working capital. This non-dilutive financing enhances Baudax's financial flexibility and supports its growth strategy. The loan, with a fixed interest rate of 13.5%, allows Baudax to draw funds in five tranches upon achieving revenue milestones. Additionally, Marathon received warrants for 527,100 shares at $4.59 each as part of the agreement.
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