Baudax Bio Inc. (NASDAQ: BXRX) was a huge gainer in yesterday’s trading session, and closed the day with gains of 21.16%. This followed the company’s announcement that, the FDA had set February 20th, 2020 as the date for its decision on the NDA for the company’s intravenous (IV) meloxicam. IV Meloxicam is the company’s therapy for managing pain. The PDUFA date comes after the FDA accepted the company’s complete response in relation to the 2019 complete response letter, and appeal for the approval of Intravenous IV meloxicam.
Commenting on this, CEO Gern Henwood stated that, the company was happy to accept the latest response. He added that, they believed it addressed their issues, including a proposal for the labeling of intravenous IV meloxicam in managing moderate to severe pain either when used alone, or when used together with any other analgesics. He added that, the company will be working in close partnership with the FDA as they continue to review the treatment’s NDA, towards the PDUFA, announced date.
The company holds exclusive worldwide rights for Intravenous IV meloxicam a non-opioid analgesic whose NDA is pending. In the event that it gets approved, IV Meloxicam will be the new IV non-opioid alternative for people dealing with severe pain. The treatment has already gone through 3 clinical studies and this includes two phase 3 studies on efficacy, and one of safety. The treatment’s main active ingredient has properties that exhibit anti-inflammatory activity.
Looking at its price action in yesterday’s session, it was a continuation of the uptrend that started back in 2019. The stock opened trading at $7.94 and traded between a low of $7.69 and a high of $9 before closing the day at $8.53. Volumes in the day stood at 775.29k.
About Baudax Bio Inc.
Baudax Bio Inc. is a specialty biopharma company that develops therapies for acute care. It is based in Malvern, Pennsylvania.