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Details:
The partnership aims to expand the sales network supporting Zynrelef (bupivacaine and meloxicam) extended-release solution, the first and only dual-acting local anesthetic, for post-operative pain.
Lead Product(s): Bupivacaine,Meloxicam
Therapeutic Area: Neurology Product Name: Zynrelef
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Heron Therapeutics
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Partnership January 07, 2024
Details:
The Company intends to use the net proceeds from this offering for pipeline development activities including, Anjeso (meloxicam), a nonsteroidal anti-inflammatory drug (NSAID) to treat symptoms of Osteoarthritis, Rheumatoid Arthritis, and Moderate-to-Severe Pain.
Lead Product(s): Meloxicam
Therapeutic Area: Neurology Product Name: Anjeso
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: H.C. Wainwright & Co.
Deal Size: $4.0 million Upfront Cash: Undisclosed
Deal Type: Public Offering April 26, 2023
Details:
ZYNRELEF is the first and only dual-acting local anesthetic that delivers a fixed-dose combination of the local anesthetic bupivacaine and a low dose of nonsteroidal anti-inflammatory drug meloxicam.
Lead Product(s): Bupivacaine,Meloxicam
Therapeutic Area: Neurology Product Name: Zynrelef
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable December 29, 2022
Details:
ANJESO (meloxicam) is a nonsteroidal anti-inflammatory drug (NSAID). It is a sterile opaque, pale-yellow, aqueous dispersion containing the active pharmaceutical ingredient meloxicam for intravenous administration.
Lead Product(s): Meloxicam
Therapeutic Area: Neurology Product Name: Anjeso
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: H.C. Wainwright & Co.
Deal Size: $5.0 million Upfront Cash: Undisclosed
Deal Type: Public Offering December 06, 2022
Details:
ANJESO (meloxicam) is a long-acting NSAID with preferential COX-2 inhibition that possesses anti-inflammatory, analgesic, and antipyretic activities, which are believed to be related to the inhibition of COX and subsequent reduction in prostaglandin biosynthesis.
Lead Product(s): Meloxicam
Therapeutic Area: Neurology Product Name: Anjeso
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: H.C. Wainwright & Co.
Deal Size: $5.0 million Upfront Cash: Undisclosed
Deal Type: Public Offering December 02, 2022
Details:
AXS-07 is a novel, oral, rapidly absorbed, multi-mechanistic investigational medicine for the acute treatment of migraine, consisting of MoSEIC™ meloxicam and rizatriptan.
Lead Product(s): Meloxicam,Rizatriptan Benzoate
Therapeutic Area: Neurology Product Name: AXS-07
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable September 29, 2022
Details:
The Company intends to use the net proceeds from this offering for pipeline development activities including its lead product Anjeso having meloxicam and for other general corporate purposes.
Lead Product(s): Meloxicam
Therapeutic Area: Neurology Product Name: Anjeso
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: H.C. Wainwright & Co.
Deal Size: $6.2 million Upfront Cash: Undisclosed
Deal Type: Public Offering September 01, 2022
Details:
AXS-07 is a novel, oral, rapidly absorbed, multi-mechanistic investigational medicine for the acute treatment of migraine, consisting of MoSEIC™ meloxicam and rizatriptan.
Lead Product(s): Meloxicam,Rizatriptan Benzoate
Therapeutic Area: Neurology Product Name: AXS-07
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable September 01, 2022
Details:
The Company intends to use the net proceeds from this offering for pipeline development activities including its lead product Anjeso (meloxicam) and general corporate purposes.
Lead Product(s): Meloxicam
Therapeutic Area: Neurology Product Name: Anjeso
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: H.C. Wainwright & Co.
Deal Size: $6.2 million Upfront Cash: Undisclosed
Deal Type: Public Offering August 29, 2022
Details:
ANJESO®(meloxicam), the first and only 24-hour, intravenous (IV) COX-2 preferential non-steroidal anti-inflammatory (NSAID) for the management of moderate to severe pain.
Lead Product(s): Meloxicam
Therapeutic Area: Neurology Product Name: Anjeso
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable August 22, 2022
Details:
ZYNRELEF (bupivacaine) is first and only therapy for pain management to be rigorously tested demonstrated superiority to bupivacaine solution, and sustained postoperative pain relief for up to 72 hours and decreased need for opioids, with more patients opioid-free.
Lead Product(s): Bupivacaine,Meloxicam
Therapeutic Area: Neurology Product Name: Zynrelef
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable June 14, 2022
Details:
Baudax Bio currently intends to use the net proceeds from the offering for the commercialization of ANJESO®, pipeline development activities and general corporate purposes.
Lead Product(s): Meloxicam
Therapeutic Area: Neurology Product Name: Anjeso
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: H.C. Wainwright & Co.
Deal Size: $2.0 million Upfront Cash: Undisclosed
Deal Type: Public Offering May 17, 2022
Details:
New interim data from Phase 2 study suggests ZYNRELEF (bupivacaine) was well-tolerated and may effectively manage postpartum pain and minimize postoperative opioid use in women undergoing Caesarean sections.
Lead Product(s): Bupivacaine,Meloxicam
Therapeutic Area: Neurology Product Name: Zynrelef
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable May 16, 2022
Details:
ZYNRELEF is first and only therapy of dual-acting fixed-dose combination of local anesthetic bupivacaine and a low dose of meloxicam, for postoperative pain management to be rigorously tested in Phase 3 studies and demonstrate superiority to bupivacaine solution.
Lead Product(s): Bupivacaine,Meloxicam
Therapeutic Area: Neurology Product Name: Zynrelef
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable March 17, 2022
Details:
Anjeso (meloxicam) injection, a preferential COX-2 inhibitor that possesses analgesic, anti-inflammatory, and antipyretic activities, which are believed to be related to the inhibition of COX-2 and subsequent reduction in prostaglandin biosynthesis.
Lead Product(s): Meloxicam
Therapeutic Area: Neurology Product Name: Anjeso
Highest Development Status: Phase IVProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable March 08, 2022
Details:
ANJESO (meloxicam) injection is a long-acting, preferential COX-2 inhibitor that possesses analgesic, anti-inflammatory and antipyretic activities, which are related to the inhibition of cyclooxygenase type 2 pathway and subsequent reduction in prostaglandin biosynthesis.
Lead Product(s): Meloxicam
Therapeutic Area: Neurology Product Name: Anjeso
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable March 02, 2022
Details:
The Company currently intends to use the net proceeds from this Offering for the commercialization of ANJESO, pipeline development activities, and general corporate purposes.
Lead Product(s): Meloxicam
Therapeutic Area: Neurology Product Name: Anjeso
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: H.C. Wainwright & Co.
Deal Size: $10.0 million Upfront Cash: Undisclosed
Deal Type: Public Offering February 24, 2022
Details:
AXS-07 is a novel, oral, rapidly absorbed, multi-mechanistic investigational medicine for the acute treatment of migraine, consisting of MoSEIC™ meloxicam and rizatriptan. The NDA is supported by results from two Phase 3 trials of MOMENTUM and INTERCEPT.
Lead Product(s): Meloxicam,Rizatriptan Benzoate
Therapeutic Area: Neurology Product Name: AXS-07
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable September 14, 2021
Details:
ZYNRELEF is an extended-release solution of bupivacaine and meloxicam that is indicated in adults for soft tissue or periarticular instillation to produce postsurgical analgesia for up to 72 hours after bunionectomy, open inguinal herniorrhaphy, and total knee arthroplasty.
Lead Product(s): Bupivacaine,Meloxicam
Therapeutic Area: Neurology Product Name: Zynrelef
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable July 28, 2021
Details:
Proceeds from the sale of the Notes will be used for the commercial launch of ZYNRELEFTM (bupivacaine and meloxicam) extended-release solution, as well as for general working capital.
Lead Product(s): Bupivacaine,Meloxicam
Therapeutic Area: Neurology Product Name: Zynrelef
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: J. Wood Capital Advisors LLC
Deal Size: $150.0 million Upfront Cash: Undisclosed
Deal Type: Financing May 25, 2021
Details:
ZYNRELEF, the first and only extended-release dual-acting local anesthetic (DALA), delivers a fixed-dose combination of the local anesthetic bupivacaine and a low dose of the nonsteroidal anti-inflammatory drug (NSAID) meloxicam.
Lead Product(s): Bupivacaine,Meloxicam
Therapeutic Area: Neurology Product Name: Zynrelef
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable May 13, 2021
Details:
Baudax Bio currently intends to use the net proceeds from the offering for the commercialization of ANJESO®, pipeline development activities and general corporate purposes.
Lead Product(s): Meloxicam
Therapeutic Area: Neurology Product Name: Anjeso
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: H.C. Wainwright & Co
Deal Size: $13.4 million Upfront Cash: Undisclosed
Deal Type: Agreement January 21, 2021
Details:
Meloxicam capsules, 5 mg and 10 mg, is the generic equivalent of Vivlodex capsules, 5 mg and 10 mg, of Zyla Life Sciences US, Inc., and indicated for management of osteoarthritis (OA) pain.
Lead Product(s): Meloxicam
Therapeutic Area: Musculoskeletal Product Name: Undisclosed
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable December 28, 2020
Details:
The NDA for HTX-011 was resubmitted based on the outcome and final minutes of a Type A End-of-Review meeting with the FDA in September, which was conducted to obtain clarity on the information needed to address the Complete Response Letter (CRL) issued by the FDA in June 2020.
Lead Product(s): Bupivacaine,Meloxicam
Therapeutic Area: Neurology Product Name: Zynrelef
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable November 13, 2020
Details:
Zynrelef is a non-opioid, dual-acting analgesic, utilizing a fixed-dose combination of the local anesthetic bupivacaine with a low dose of the nonsteroidal anti-inflammatory drug meloxicam.
Lead Product(s): Bupivacaine,Meloxicam
Therapeutic Area: Neurology Product Name: Zynrelef
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable September 28, 2020
Details:
AXS-07, the Company’s novel, oral, multi-mechanistic investigational medicine for the acute treatment of migraine, rapidly relieved and substantially reduced relapse of migraine pain, as compared to the potent active comparator rizatriptan, in the MOMENTUM Phase 3 trial.
Lead Product(s): Meloxicam,Rizatriptan Benzoate
Therapeutic Area: Neurology Product Name: AXS-07
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable September 24, 2020
Details:
The results of the Phase 3 MOMENTUM trial were one of the 12 selected abstracts. The Phase 3 Momentum Trial evaluated efficacy and safety of AXS-07 for the acute treatment of migraine.
Lead Product(s): Meloxicam,Rizatriptan Benzoate
Therapeutic Area: Neurology Product Name: AXS-07
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable September 17, 2020
Details:
More than 90% of patients receiving HTX-011, along with postoperative over-the-counter acetaminophen and ibuprofen, remained opioid-free throughout the 72-hour period following hernia repair surgery.
Lead Product(s): Bupivacaine,Meloxicam
Therapeutic Area: Neurology Product Name: Zynrelef
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable September 16, 2020
Details:
HTX-011 is the first and only extended–release local anesthetic to demonstrate in Phase 3 studies significantly reduced pain and opioid use through 72 hours compared to bupivacaine solution.
Lead Product(s): Bupivacaine,Meloxicam
Therapeutic Area: Neurology Product Name: Zynrelef
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable September 08, 2020
Details:
The new agreement allows Premier members, at their discretion, to take advantage of special pricing and terms pre-negotiated by Premier for ANJESO (meloxicam) injection, for the management of moderate to severe pain, alone or in combination with other non-NSAID analgesics.
Lead Product(s): Meloxicam
Therapeutic Area: Neurology Product Name: Anjeso
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Baudax Bio
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Agreement August 25, 2020
Details:
Centers for Medicare and Medicaid Services (CMS) established a new permanent J-code for ANJESO (meloxicam) injection facilitating reimbursement in the hospital outpatient, ambulatory surgery center and physician office settings of care.
Lead Product(s): Meloxicam
Therapeutic Area: Neurology Product Name: Anjeso
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable August 06, 2020
Details:
The data published virtually this year by the ASCRS supports the use of ANJESO® administered preoperatively as part of an Enhanced Recovery After Surgery protocol to patients prior to undergoing colorectal surgery.
Lead Product(s): Meloxicam
Therapeutic Area: Neurology Product Name: Anjeso
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable July 30, 2020
Details:
The CHMP's positive opinion is based on the results of Heron's two Phase 3 studies of ZYNRELEF.
Lead Product(s): Bupivacaine,Meloxicam
Therapeutic Area: Neurology Product Name: Zynrelef
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable July 24, 2020
Details:
Baudax Bio has entered into a Pharmacy Supplier Agreement with Vizient, Inc. effective as of July 1, 2020, to offer ANJESO (meloxicam) injection, a non-opioid option for managing moderate to severe pain.
Lead Product(s): Meloxicam
Therapeutic Area: Neurology Product Name: Anjeso
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Vizient
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Agreement July 20, 2020
Details:
ANJESO Is The Only Approved 24-Hour, Intravenous COX-2 Preferential NSAID that Offers Once-Daily Dosing. It was approved by the U.S. Food and Drug Administration (FDA) on February 20, 2020.
Lead Product(s): Meloxicam
Therapeutic Area: Neurology Product Name: Anjeso
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable June 15, 2020
Details:
HTX-011 reduced pain and opioid use after primary total knee arthroplasty, The study met all primary and key secondary endpoints, with HTX-011 demonstrating statistically significant reductions in pain intensity following surgery.
Lead Product(s): Bupivacaine,Meloxicam
Therapeutic Area: Orthopedics/Orthopedic Surgery Product Name: Undisclosed
Highest Development Status: Phase IIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable June 04, 2020
Details:
Proceeds from the facility will generally be used to support the commercial launch of ANJESOTM (meloxicam) injection, and for working capital purposes.
Lead Product(s): Meloxicam
Therapeutic Area: Neurology Product Name: Undisclosed
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: JMP Securities
Deal Size: $50.0 million Upfront Cash: Undisclosed
Deal Type: Credit Facility June 01, 2020
Details:
The study initiation follows clearance from the US Food and Drug Administration (FDA) of Heron's Investigational New Drug (IND) application for HTX-034 for the treatment of postoperative pain.
Lead Product(s): Bupivacaine,Meloxicam
Therapeutic Area: Neurology Product Name: Undisclosed
Highest Development Status: Phase I/ Phase IIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable May 18, 2020
Details:
Two virtual posters highlight new ANJESO clinical results, along with health resource utilization data, when administered preoperatively following Total Knee Arthroplasty.
Lead Product(s): Meloxicam
Therapeutic Area: Neurology Product Name: Undisclosed
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable April 23, 2020
Details:
AXS-07 met the co-primary endpoints of freedom from migraine pain and freedom from most bothersome symptoms as compared to placebo.
Lead Product(s): Meloxicam,Rizatriptan Benzoate
Therapeutic Area: Neurology Product Name: Undisclosed
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable April 06, 2020
Details:
Baudax intends to use the net proceeds of the proposed offering for the launch and the commercialization of ANJESO™, pipeline development activities, and general corporate purposes.
Lead Product(s): Meloxicam
Therapeutic Area: Neurology Product Name: Undisclosed
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: JMP Securities LLC
Deal Size: $25.0 million Upfront Cash: Undisclosed
Deal Type: Public Offering March 24, 2020
Details:
The Phase 3, randomized, double-blind, placebo-controlled trial is evaluating the early treatment of migraine with AXS-07. AXS-07.
Lead Product(s): Meloxicam,Rizatriptan Benzoate
Therapeutic Area: Neurology Product Name: Undisclosed
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable February 20, 2020
Details:
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.
Lead Product(s): Meloxicam
Therapeutic Area: Neurology Product Name: Undisclosed
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable January 22, 2020
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