Get the Latest Investment Ideas Delivered Straight to Your Inbox. Subscribe


Baudax Shares Rise as FDA Approves NDA for Its Non-Opioid Pain Medication

Share on Stocktwits


Shares of Baudax Bio traded more than 20% higher and set a new 52-week high price after reporting that the FDA approved the company's non-opioid ANJESO™ drug for management of moderate to severe pain.

Specialty pharmaceutical company Baudax Bio Inc. (BXRX:NASDAQ), which is engaged in the development of therapeutics for acute care settings, yesterday announced that "the U.S. Food and Drug Administration (FDA) has approved the New Drug Application (NDA) for ANJESO™ (meloxicam injection), which is indicated for the management of moderate to severe pain, alone or in combination with other non-NSAID analgesics."

Gerri Henwood, President and CEO of Baudax Bio commented, "The approval of ANJESO marks a major advancement in the treatment landscape for managing moderate to severe pain...With our nation currently in the midst of a national opioid epidemic, we are thrilled to be able to offer a novel, non-opioid therapeutic option with the potential to meaningfully impact the acute pain treatment paradigm. We expect to make ANJESO available to physicians and patients in late April or early May 2020."

The company's Chief Medical Officer Stewart McCallum, M.D. remarked, "The safety and efficacy of ANJESO have been well-established through several mid- and late-stage clinical studies...Moreover, data from our Phase III safety trial demonstrated that ANJESO is well tolerated and impacted opioid consumption compared to placebo, further highlighting its value to patients, providers and health systems."

Dr. Keith Candiotti chair of the Department of Anesthesiology, Perioperative Medicine and Pain Management at the University of Miami added, "The approval of ANJESO marks an important achievement for the medical community given the unmet need for non-opioid options in the pain treatment landscape...ANJESO has the potential to serve as a meaningfully differentiated analgesic alternative."

The company advised that ANJESO is indicated for use in adults for the management of moderate-to-severe pain, alone or in combination with non-NSAID analgesics. The firm explained that "ANJESO™ (meloxicam) injection is a proprietary, long-acting, preferential COX-2 inhibitor that possesses analgesic, anti-inflammatory and antipyretic activities, which are believed to be related to the inhibition of cyclooxygenase type 2 pathway (COX-2) and subsequent reduction in prostaglandin biosynthesis."

Baudax expects that ANJESO will be available in the U.S. in late April or early May 2020. The firm noted that ANJESO has already been studied in several comprehensive Phase 3 clinical trials studying the safety and efficacy of use following Bunionectomy and Abdominoplasty surgeries and as well as other major surgical procedures including total hip and knee replacements, spinal, GI, hernia repair, and gynecologic surgeries.

Baudax Bio is based in Malvern, PA and is a specialty pharmaceutical company that focuses on developing therapeutics for acute care settings. The firms indicates that its lead drug ANJESO (IV meloxicam) is a non-opioid which has the potential to overcome many of the issues associated with commonly prescribed opioid therapeutics without having addictive qualities while maintaining meaningful analgesic effects for relief of pain.

Baudax Bio has a market capitalization of around $75.5 million with approximately 9.436 million shares outstanding and a short interest of about 9.0%. BXRX shares opened greater than 23% higher today at $9.85 (+$1.851, +23.14%) over yesterday's $7.999 closing price and reached a new intraday 52-week high price this morning of $10.14. The stock has traded today between $8.66 and $10.14 per share and is currently trading at $8.965 (+$0.966, +12.08%).


1) Stephen Hytha compiled this article for Streetwise Reports LLC and provides services to Streetwise Reports as an independent contractor. He or members of his household own securities of the following companies mentioned in the article: None. He or members of his household are paid by the following companies mentioned in this article: None.
2) The following companies mentioned in this article are billboard sponsors of Streetwise Reports: None. Click here for important disclosures about sponsor fees.
3) Comments and opinions expressed are those of the specific experts and not of Streetwise Reports or its officers. The information provided above is for informational purposes only and is not a recommendation to buy or sell any security.
4) The article does not constitute investment advice. Each reader is encouraged to consult with his or her individual financial professional and any action a reader takes as a result of information presented here is his or her own responsibility. By opening this page, each reader accepts and agrees to Streetwise Reports' terms of use and full legal disclaimer. This article is not a solicitation for investment. Streetwise Reports does not render general or specific investment advice and the information on Streetwise Reports should not be considered a recommendation to buy or sell any security. Streetwise Reports does not endorse or recommend the business, products, services or securities of any company mentioned on Streetwise Reports.
5) From time to time, Streetwise Reports LLC and its directors, officers, employees or members of their families, as well as persons interviewed for articles and interviews on the site, may have a long or short position in securities mentioned. Directors, officers, employees or members of their immediate families are prohibited from making purchases and/or sales of those securities in the open market or otherwise from the time of the interview or the decision to write an article until three business days after the publication of the interview or article. The foregoing prohibition does not apply to articles that in substance only restate previously published company releases.
6) This article does not constitute medical advice. Officers, employees and contributors to Streetwise Reports are not licensed medical professionals. Readers should always contact their healthcare professionals for medical advice.

Want to read more about Biotechnology / Pharmaceuticals investment ideas?
Get Our Streetwise Reports Newsletter Free and be the first to know!

A valid email address is required to subscribe