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Details:
Through the acquisition, Gilead expand its liver portfolio with CymaBay’s investigational, MBX-8025 (seladelpar), an oral, selective peroxisome proliferator-activated receptor delta (PPARδ) agonist for the treatment of primary biliary cholangitis (PBC) including pruritus.
Lead Product(s): Seladelpar
Therapeutic Area: Hepatology (Liver, Pancreatic, Gall Bladder) Product Name: MBX-8025
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Gilead Sciences
Deal Size: $4,300.0 million Upfront Cash: $4,300.0 million
Deal Type: Acquisition March 22, 2024
Details:
MBX-8025 (seladelpar) is an investigational first-in-class oral, selective peroxisome proliferator-activated receptor delta (PPARδ) agonist which is being evaluated for the treatment of Primary Biliary Cholangitis.
Lead Product(s): Seladelpar
Therapeutic Area: Hepatology (Liver, Pancreatic, Gall Bladder) Product Name: MBX-8025
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 March 04, 2024
Details:
Through the acquisition, Gilead expand its liver portfolio with CymaBay’s investigational, MBX-8025 (seladelpar), an oral, selective peroxisome proliferator-activated receptor delta (PPARδ) agonist for the treatment of primary biliary cholangitis (PBC) including pruritus.
Lead Product(s): Seladelpar
Therapeutic Area: Hepatology (Liver, Pancreatic, Gall Bladder) Product Name: MBX-8025
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Gilead Sciences
Deal Size: $4,300.0 million Upfront Cash: $4,300.0 million
Deal Type: Acquisition February 12, 2024
Details:
MBX-8025 (seladelpar) is an investigational first-in-class oral, selective peroxisome proliferator-activated receptor delta (PPARδ) agonist which is being evaluated for the treatment of Primary Biliary Cholangitis.
Lead Product(s): Seladelpar
Therapeutic Area: Hepatology (Liver, Pancreatic, Gall Bladder) Product Name: MBX-8025
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 12, 2024
Details:
MBX-8025 (seladelpar) is an investigational treatment for people with PBC, is a first-in-class oral, selective peroxisome proliferator-activated receptor delta (PPARδ) agonist which is being evaluated for the treatment of Primary Biliary Cholangitis.
Lead Product(s): Seladelpar
Therapeutic Area: Hepatology (Liver, Pancreatic, Gall Bladder) Product Name: MBX-8025
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 December 15, 2023
Details:
MBX-8025 (seladelpar) is a first-in-class oral, selective peroxisome proliferator-activated receptor (PPAR) delta agonist, or delpar, shown to regulate critical metabolic and liver disease pathways in indications with high unmet medical need.
Lead Product(s): Seladelpar
Therapeutic Area: Hepatology (Liver, Pancreatic, Gall Bladder) Product Name: MBX-8025
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 October 23, 2023
Details:
MBX-8025 (seladelpar) is a first-in-class oral, selective peroxisome proliferator-activated receptor (PPAR) delta agonist, or delpar, shown to regulate critical metabolic and primary biliary cholangitis pathways in indications with high unmet medical need.
Lead Product(s): Seladelpar
Therapeutic Area: Hepatology (Liver, Pancreatic, Gall Bladder) Product Name: MBX-8025
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 21, 2023
Details:
CymaBay anticipates using the net proceeds to fund ongoing development of MBX-8025, including clinical trials targeting market expansion. Seladelpar is a first-in-class investigational, PPAR-δ agonist, for the treatment of people with primary biliary cholangitis.
Lead Product(s): Seladelpar
Therapeutic Area: Hepatology (Liver, Pancreatic, Gall Bladder) Product Name: MBX-8025
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Piper Sandler
Deal Size: $258.7 million Upfront Cash: Undisclosed
Deal Type: Public Offering September 14, 2023
Details:
CymaBay anticipates using the net proceeds to fund ongoing development of MBX-8025, including clinical trials targeting market expansion. Seladelpar is a first-in-class investigational, PPAR-δ agonist, for the treatment of people with primary biliary cholangitis.
Lead Product(s): Seladelpar
Therapeutic Area: Hepatology (Liver, Pancreatic, Gall Bladder) Product Name: MBX-8025
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Piper Sandler
Deal Size: $225.0 million Upfront Cash: Undisclosed
Deal Type: Public Offering September 11, 2023
Details:
MBX-8025 (seladelpar) is a first-in-class oral, selective peroxisome proliferator-activated receptor (PPAR) delta agonist, or delpar, shown to regulate critical metabolic and primary biliary cholangitis pathways in indications with high unmet medical need.
Lead Product(s): Seladelpar
Therapeutic Area: Hepatology (Liver, Pancreatic, Gall Bladder) Product Name: MBX-8025
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 07, 2023
Details:
MBX-8025 (seladelpar) is a first-in-class oral, selective peroxisome proliferator-activated receptor (PPAR) delta agonist, or delpar, shown to regulate critical metabolic and liver disease pathways in indications with high unmet medical need.
Lead Product(s): Seladelpar
Therapeutic Area: Hepatology (Liver, Pancreatic, Gall Bladder) Product Name: MBX-8025
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 August 10, 2023
Details:
CymaBay anticipates using the net proceeds from the offering to fund ongoing development of MBX-8025 (seladelpar), including clinical trials targeting market expansion, and for working capital and general corporate purposes.
Lead Product(s): Seladelpar
Therapeutic Area: Hepatology (Liver, Pancreatic, Gall Bladder) Product Name: MBX-8025
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Piper Sandler
Deal Size: $84.9 million Upfront Cash: Undisclosed
Deal Type: Public Offering January 30, 2023
Details:
CymaBay anticipates using the net proceeds from the offering to fund ongoing development of MBX-8025 (seladelpar), including clinical trials targeting market expansion, and for working capital and general corporate purposes.
Lead Product(s): Seladelpar
Therapeutic Area: Hepatology (Liver, Pancreatic, Gall Bladder) Product Name: MBX-8025
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Piper Sandler
Deal Size: $85.0 million Upfront Cash: Undisclosed
Deal Type: Public Offering January 24, 2023
Details:
CymaBay anticipates using the net proceeds from the offering to fund ongoing development of MBX-8025 (seladelpar), including clinical trials targeting market expansion, and for working capital and general corporate purposes.
Lead Product(s): Seladelpar
Therapeutic Area: Hepatology (Liver, Pancreatic, Gall Bladder) Product Name: MBX-8025
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Piper Sandler
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Public Offering January 23, 2023
Details:
Under the terms of the agreement, Kaken receives an exclusive license to develop, commercialize and market MBX-8025 (seladelpar), a first-in-class treatment for people with primary biliary cholangitis (PBC), in Japan for PBC.
Lead Product(s): Seladelpar
Therapeutic Area: Hepatology (Liver, Pancreatic, Gall Bladder) Product Name: MBX-8025
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Kaken Pharmaceuticals
Deal Size: $162.4 million Upfront Cash: $34.0 million
Deal Type: Collaboration January 08, 2023
Details:
MBX-8025 (seladelpar) is a first-in-class oral, selective PPARδ agonist shown to regulate critical metabolic and liver disease pathways in indications with high unmet medical need.
Lead Product(s): Seladelpar
Therapeutic Area: Hepatology (Liver, Pancreatic, Gall Bladder) Product Name: MBX-8025
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 November 04, 2022
Details:
MBX-8025 (seladelpar) is a first-in-class oral, selective PPARδ agonist shown to regulate critical metabolic and liver disease pathways in indications with high unmet medical need.
Lead Product(s): Seladelpar
Therapeutic Area: Hepatology (Liver, Pancreatic, Gall Bladder) Product Name: MBX-8025
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 August 01, 2022
Details:
MBX-8025 (Seladelpar) is a first-in-class oral, selective PPARδ agonist shown to regulate critical metabolic and liver disease pathways in indications with high unmet medical need.
Lead Product(s): Seladelpar
Therapeutic Area: Hepatology (Liver, Pancreatic, Gall Bladder) Product Name: MBX-8025
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 June 08, 2022
Details:
Data were presented demonstrating that MBX-8025 (seladelpar) treatment throughout 2 years resulted in a decrease in PBC GLOBE score and predicted improved transplant-free survival.
Lead Product(s): Seladelpar
Therapeutic Area: Hepatology (Liver, Pancreatic, Gall Bladder) Product Name: MBX-8025
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 May 23, 2022
Details:
MBX-8025 (seladelpar) is a first-in-class oral, selective PPARδ agonist shown to regulate critical metabolic and liver disease pathways in indications with high unmet medical need.
Lead Product(s): Seladelpar
Therapeutic Area: Hepatology (Liver, Pancreatic, Gall Bladder) Product Name: MBX-8025
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 May 11, 2022
Details:
An interim primary efficacy analysis of ALP change from baseline at Week 8 found that seladelpar, a selective PPARδ agonist, treatment provided 26%, 33%, and 41% reductions for the 2 mg, 5 mg and 10 mg doses, respectively (all p<0.005).
Lead Product(s): Seladelpar
Therapeutic Area: Hepatology (Liver, Pancreatic, Gall Bladder) Product Name: MBX-8025
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 04, 2022
Details:
RESPONSE global phase 3 clinical research study evaluating the safety and efficacy of MBX-8025 (seladelpar) selective PPAR delta agonist for treatment of people with PBC has demonstrated ability to decrease bile acid synthesis and inflammation in phase 2 clinical studies.
Lead Product(s): Seladelpar
Therapeutic Area: Hepatology (Liver, Pancreatic, Gall Bladder) Product Name: MBX-8025
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 01, 2022
Details:
In preclinical and phase 2 clinical studies, seladelpar has demonstrated the ability to decrease bile acid synthesis and inflammation, which are detrimental consequences of PBC.
Lead Product(s): Seladelpar
Therapeutic Area: Hepatology (Liver, Pancreatic, Gall Bladder) Product Name: Undisclosed
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: CymaBay Therapeutics
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable November 02, 2021
Details:
Seladelpar is a potent, selective, orally active peroxisome proliferator-activated receptor delta (PPARδ) agonist in development for the treatment of people with PBC and other liver diseases.
Lead Product(s): Seladelpar
Therapeutic Area: Hepatology (Liver, Pancreatic, Gall Bladder) Product Name: Undisclosed
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: CymaBay Therapeutics
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable November 02, 2021
Details:
Seladelpar is a first-in-class oral, selective PPARδ agonist shown to regulate critical metabolic and liver disease pathways in indications with high unmet medical need.
Lead Product(s): Seladelpar
Therapeutic Area: Hepatology (Liver, Pancreatic, Gall Bladder) Product Name: MBX-8025
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Abingworth
Deal Size: $100.0 million Upfront Cash: Undisclosed
Deal Type: Financing August 02, 2021
Details:
Three patients with cirrhosis experienced an SAE, all unrelated to seladelpar. Efficacy, tolerability, and safety in patients with compensated cirrhosis were comparable to that of non-cirrhotic patients.
Lead Product(s): Seladelpar
Therapeutic Area: Hepatology (Liver, Pancreatic, Gall Bladder) Product Name: MBX-8025
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 June 21, 2021
Details:
CymaBay Therapeutics will deliver two seladelpar presentations during the NASH-TAG Conference being held March 11th – 13th. CymaBay is developing seladelpar, a potent, selective, orally active PPARδ agonist for patients with primary biliary cholangitis (PBC).
Lead Product(s): Seladelpar
Therapeutic Area: Hepatology (Liver, Pancreatic, Gall Bladder) Product Name: MBX-8025
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 March 11, 2021
Details:
Results highlight the potential for seladelpar to offer patients an efficacious and safe second line treatment option. Seladelpar demonstrated anti-cholestatic, anti-inflammatory, and anti-pruritic activity through 3 and 6 months.
Lead Product(s): Seladelpar
Therapeutic Area: Hepatology (Liver, Pancreatic, Gall Bladder) Product Name: MBX-8025
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 November 16, 2020
Details:
The oral presentation titled “ENHANCE: Safety and Efficacy of Seladelpar in Patients with Primary Biliary Cholangitis (PBC) – A Phase 3 International, Randomized, Placebo-Controlled Study,” 1 will be delivered by Professor Gideon Hirschfield, MD, University of Toronto.
Lead Product(s): Seladelpar
Therapeutic Area: Hepatology (Liver, Pancreatic, Gall Bladder) Product Name: MBX-8025
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 November 02, 2020
Details:
Presentation will highlight results from a 52-Week multi-center double-blind randomized Phase 2 Study of Seladelpar, in Patients with Nonalcoholic Steatohepatitis (NASH).
Lead Product(s): Seladelpar
Therapeutic Area: Hepatology (Liver, Pancreatic, Gall Bladder) Product Name: MBX-8025
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 October 01, 2020
Details:
This electronic presentation highlights the efficacy, safety, and tolerability of seladelpar over 1 year of open-label treatment.
Lead Product(s): Seladelpar
Therapeutic Area: Hepatology (Liver, Pancreatic, Gall Bladder) Product Name: MBX-8025
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 August 27, 2020
Details:
The study demonstrated seladelpar to be efficacious, safe and well-tolerated . 78.2% of patients on seladelpar 10 mg versus 12.5% on placebo achieved the primary composite outcome after only 3 months.
Lead Product(s): Seladelpar
Therapeutic Area: Hepatology (Liver, Pancreatic, Gall Bladder) Product Name: MBX-8025
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 August 03, 2020
Details:
CymaBay had halted all studies of seladelpar after liver biopsies showed some patients in a phase 2b NASH trial had inflamed and destroyed liver cells, a condition known as interface hepatitis.
Lead Product(s): Seladelpar
Therapeutic Area: Hepatology (Liver, Pancreatic, Gall Bladder) Product Name: MBX-8025
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 23, 2020
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