Baudax Bio announces PDUFA date for intravenous meloxicam » 07:1301/2201/22/20
Baudax Bio announced that…
Baudax Bio announced that the U.S. Food and Drug Administration has set a PDUFA goal date of February 20, 2020 for its decision on the New Drug Application for intravenous meloxicam for the management of moderate to severe pain. The assignment of this PDUFA goal date follows the FDA's acceptance of Baudax's latest complete response package relating to its 2019 complete response letter and appeal filing, seeking approval for IV meloxicam. In October 2019, Baudax received a written decision from the FDA granting the appeal of the CRL the Company had previously received relating to its IV meloxicam NDA.
|Over a month ago|
Baudax Bio management to meet with JMP Securities » 04:5512/1612/16/19
Meeting to be held in…
Meeting to be held in Dallas, TX on December 16 hosted by JMP Securities.
Corsair Capital reports 8.77% passive stake in Baudax Bio » 17:3412/1212/12/19
Corsair Capital disclosed…
Corsair Capital disclosed a 8.77% stake in Baudax Bio, which represents over 820K shares. The filing does not allow for activism.
Baudax Bio management to meet with JMP Securities » 08:1612/1212/12/19
Meeting to be held in…
Meeting to be held in Dallas, TX on December 16 hosted by JMP Securities.
Baudax Bio files $125M mixed securities shelf 17:2912/0612/06/19
Baudax Bio initiated with a Buy at Janney Montgomery Scott » 07:2411/2211/22/19
Janney Montgomery Scott…
Janney Montgomery Scott analyst Esther Hong initiated coverage of Baudax Bio with a Buy rating and $12 fair value estimate. The company's key product is Anjeso, a proprietary long-acting intravenous formulation of meloxicam, an established non-opioid pain reliever available through an oral formulation, Hong tells investors in a research note. The analyst sees a "high probability" of FDA approval in Q1 of 2020 and estimates U.S. sales of $355M. Further, Baudax also has an earlier stage pipeline, which presents optionality and will enter phase 1 clinical trials next year, adds the analyst.
Baudax Bio initiated with an Overweight at Piper Jaffray » 06:0111/2211/22/19
Piper Jaffray analyst…
Piper Jaffray analyst David Amsellem initiated coverage of Baudax Bio with an Overweight rating and $12 price target. The analyst believes Anjeso, the company's intravenous form of the non-steroidal anti-inflammatory drug meloxicam, will emerge as a valued addition to a post-operative pain management arena "that is very much in need of more non-opioid options."
Baudax Bio announces launch as company focused on non-opioid analgesics » 07:1511/2111/21/19
Baudax Bio (BXRX)…
Baudax Bio (BXRX) announced its launch as an independent, publicly traded pharmaceutical company focused on advancing non-opioid analgesics and other products for the hospital and other acute care settings. Beginning tomorrow, November 22, 2019, Baudax will trade on the NASDAQ Capital Market under the ticker symbol "BXRX." When-issued trading under the symbol "BXRXV" continues until market close today. Baudax launches with $19M in funding from Recro Pharma (REPH), its former parent company, and holds the rights to a pipeline of pharmaceutical assets, including: IV Meloxicam - Baudax holds exclusive global rights to IV meloxicam, a post-Phase 3 non-opioid analgesic developed for the treatment of moderate to severe pain. If approved, IV meloxicam will be a novel IV non-opioid option for the management of moderate to severe pain. IV meloxicam successfully completed three Phase III clinical studies, including two Phase III efficacy studies and one Phase III safety study, four Phase II clinical studies, as well as other safety studies. Baudax recently received a written decision from the FDA granting an appeal for a Complete Response Letter the Company received relating to its IV meloxicam New Drug Application. Baudax is now in the process of preparing a comprehensive response to the FDA that includes proposed labeling and certain other information. Two Neuromuscular Blocking Agents and A Reversal Agent - Baudax holds exclusive global rights to two novel neuromuscular blocking agents and a proprietary chemical reversal agent specific to these NMBs which were licensed from Cornell University in 2017. The reversal agent is a proprietary agent that rapidly reverses the NMB compounds. Used together, these agents allow for a very rapid induction of neuromuscular blockade for surgical settings, followed by a rapid reversal of the neuromuscular blockade. These novel agents have the potential to meaningfully reduce procedure recovery time in operating room or post-acute care settings, resulting in valuable cost savings to hospitals and ambulatory surgical centers. RP-1000 is an intermediate duration clinical-stage NMB drug candidate with one completed Phase I trial and with plans to initiate an additional dose escalation Phase I trial in the first half of 2020. RP-2000 is an ultra-short acting NMB drug candidate which is currently completing early pre-clinical and drug product work. Intranasal Dexmedetomidine - Baudax holds rights to intranasal dexmedetomidine, a non-opioid alpha-2 adrenergic agonist being developed for possible uses in pain or sedation. IV dexmedetomidine has a long history of use in the U.S. and Europe as a short-term sedative with both analgesic or anxiolytic properties and is widely used in intensive care unit settings and for procedural sedation. Baudax's Dex-IN demonstrated pain relief and a favorable tolerability profile in early-stage, placebo-controlled clinical studies. Baudax is pursuing potential product partnering for Dex-IN. Baudax Bio is led by a team of pharmaceutical industry veterans, including: Gerri Henwood, President and CEO, who brings over three decades of senior leadership experience in biopharmaceuticals, healthcare and life sciences, including as Founder, President and CEO of both Recro Pharma. Ryan Lake, CFO, who brings almost 20 years of senior financial and life sciences leadership experience. He also currently serves as the CFO for Recro Pharma. Stewart McCallum, MD, CMO, who brings over 20 years of pharmaceutical and healthcare industry experience. Prior to Baudax, Dr. McCallum served as CMO of Recro Pharma.
Recro Pharma announces effectiveness of Baudax Bio Registration Statement » 07:2811/1311/13/19
Recro Pharma announced…
Recro Pharma announced that the U.S. Securities and Exchange Commission has declared effective the Registration Statement on Form 10 filed by Baudax Bio Inc. Recro expects to complete the separation of Baudax Bio into an independent, publicly traded pharmaceutical company focused on advancing promising, non-opioid analgesics and other products for acute care settings on November 21, 2019. Recro's board of directors approved the planned separation of Recro and Baudax Bio on November 5, 2019, and declared a special dividend distribution of one share of Baudax Bio common stock for every two and one half shares of Recro common stock held as of the close of business on November 15, 2019, the record date for the distribution. Shareholders will receive cash in lieu of fractional shares. The special dividend distribution is expected to be paid on November 21, 2019. There is no current market for Baudax Bio common stock. NASDAQ has approved the listing of Baudax Bio common stock on the NASDAQ Capital Market under the symbol "BXRX." NASDAQ has advised that Baudax Bio common stock will begin trading on a "when-issued" basis under the symbol "BXRXV" on November 14, 2019. Additionally, Recro expects that starting on November 14, 2019, common stock of Recro will trade on the NASDAQ Capital Market in two markets: "regular-way" under the symbol "REPH" and in the "ex-distribution" market under the symbol "REPHV." Shares of Recro common stock trading under "REPH" will carry the right to receive shares of Baudax Bio common stock, if held as of the close of business on November 15, 2019. Shares of Recro common stock trading under "REPHV" will not carry the right to receive shares of Baudax Bio as part of the special dividend distribution. If shares of Recro common stock are sold in the "regular-way" market after November 15, 2019 but before the distribution date, the shareholder is selling the right to receive shares of Baudax Bio common stock with respect to such Recro shares as part of the distribution. Recro shareholders are encouraged to consult with their financial advisors regarding the specific consequences of selling Recro common stock on or before that date. Following the distribution, regular-way trading will commence on NASDAQ for Baudax Bio under the symbol "BXRX" and will continue for Recro under the symbol "REPH." Following the separation, Baudax Bio will be an independent, publicly traded pharmaceutical company focused on advancing promising, non-opioid analgesics and other products for acute care settings.
Recro Pharma price target raised to $23 from $17 at Stephens » 07:5711/1211/12/19
Stephens analyst Jacob…
Stephens analyst Jacob Johnson raised his price target on Recro Pharma (REPH) to $23 from $17 following the company's Q3 report and FY19 guidance raise. While CDMO business posted results that were well ahead of his expectations, on the Acute Care side the FDA granted the company's appeal for its IV Meloxican drug, which raises the odds of approval in his view, Johnson tells investors. The analyst, who concluded that both sides of the company are positioned well ahead of next week's spin-out of its Acute Care business segment, Baudax Bio (BXRX), keeps an Overweight rating on Recro shares. Post the planned spin, which has a November 15 record date, Johnson said he would value standalone Recro Pharma at $18 per share, as he attributes $5 per share in value to the Acute Care segment, assuming IV Meloxicam approval.