Year
DEALS // DEV.
Country
Therapeutic Area
Study Phase
Deal Type
Product Type
Dosage Form
Lead Product
Target
Lead Product(s) : Avasopasem manganese
Therapeutic Area : Immunology
Study Phase : Phase III
Sponsor : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Galera Schedules Type A Meeting with FDA to Discuss Next Steps for Avasopasem
Details : GC4419 (avasopasem manganese) is a selective dismutase mimetic in development for the reduction of radiotherapy-induced severe oral mucositis in patients with locally advanced head and neck cancer.
Brand Name : GC4419
Molecule Type : Small molecule
Upfront Cash : Not Applicable
September 18, 2023
Lead Product(s) : Avasopasem manganese
Therapeutic Area : Immunology
Highest Development Status : Phase III
Sponsor : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Lead Product(s) : Avasopasem manganese
Therapeutic Area : Immunology
Study Phase : Phase III
Sponsor : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Galera Receives Complete Response Letter from U.S. FDA for Avasopasem Manganese
Details : Avasopasem manganese is a selective dismutase mimetic in development for the reduction of radiotherapy-induced severe oral mucositis in patients with locally advanced head and neck cancer.
Brand Name : GC4419
Molecule Type : Small molecule
Upfront Cash : Not Applicable
August 09, 2023
Lead Product(s) : Avasopasem manganese
Therapeutic Area : Immunology
Highest Development Status : Phase III
Sponsor : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Galera Announces FDA Orphan Drug Designation Granted to Rucosopasem for Pancreatic Cancer
Details : GC4711 (rucosopasem) is a next-generation selective dismutase mimetic in clinical development to augment the anti-cancer efficacy of stereotactic body radiation therapy (SBRT) in patients with pancreatic cancer and lung cancer.
Brand Name : GC4711
Molecule Type : Small molecule
Upfront Cash : Not Applicable
May 18, 2023
Galera Announces FDA Orphan Drug Designation Granted to Rucosopasem for Pancreatic Cancer
Details : GC4711 (rucosopasem) is a next-generation selective dismutase mimetic in clinical development to augment the anti-cancer efficacy of stereotactic body radiation therapy (SBRT) in patients with pancreatic cancer and lung cancer.
Brand Name : GC4711
Molecule Type : Small molecule
Upfront Cash : Not Applicable
May 18, 2023
Lead Product(s) : Avasopasem manganese
Therapeutic Area : Gastroenterology
Study Phase : Phase III
Sponsor : Piper Sandler
Deal Size : $30.0 million
Deal Type : Public Offering
Details : The proceedings will be used to fund pre-commercialization activities related to avasopasem manganese and advance the development of avasopasem and rucosopasem. Galera’s selective dismutase mimetic product candidate GC4419 is being developed for radiat...
Brand Name : GC4419
Molecule Type : Small molecule
Upfront Cash : Undisclosed
February 15, 2023
Lead Product(s) : Avasopasem manganese
Therapeutic Area : Gastroenterology
Highest Development Status : Phase III
Sponsor : Piper Sandler
Deal Size : $30.0 million
Deal Type : Public Offering
Lead Product(s) : Avasopasem manganese
Therapeutic Area : Gastroenterology
Study Phase : Phase III
Sponsor : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Details : GC4419 (avasopasem manganese) is an investigational selective dismutase mimetic drug in development as a radioprotector in combination with radiation therapy (RT), with the goal to reduce side effects from radiation therapy.
Brand Name : GC4419
Molecule Type : Small molecule
Upfront Cash : Not Applicable
February 15, 2023
Lead Product(s) : Avasopasem manganese
Therapeutic Area : Gastroenterology
Highest Development Status : Phase III
Sponsor : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Lead Product(s) : Avasopasem manganese
Therapeutic Area : Gastroenterology
Study Phase : Phase III
Sponsor : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Galera Submits New Drug Application for Avasopasem for Severe Oral Mucositis
Details : Avasopasem manganese (avasopasem, or GC4419), is a selective small molecule dismutase mimetic in development for the reduction of radiotherapy-induced severe oral mucositis (SOM) in patients with locally advanced head and neck cancer.
Brand Name : GC4419
Molecule Type : Small molecule
Upfront Cash : Not Applicable
December 12, 2022
Lead Product(s) : Avasopasem manganese
Therapeutic Area : Gastroenterology
Highest Development Status : Phase III
Sponsor : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Lead Product(s) : Avasopasem manganese
Therapeutic Area : Gastroenterology
Study Phase : Phase III
Sponsor : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Details : Avasopasem manganese (avasopasem, or GC4419) is selective small molecule dismutase mimetic in development for reduction of radiotherapy-induced SOM in patients with locally advanced HNC and for reduction of radiotherapy-induced esophagitis in patients wi...
Brand Name : GC4419
Molecule Type : Small molecule
Upfront Cash : Not Applicable
October 26, 2022
Lead Product(s) : Avasopasem manganese
Therapeutic Area : Gastroenterology
Highest Development Status : Phase III
Sponsor : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Lead Product(s) : Avasopasem manganese
Therapeutic Area : Gastroenterology
Study Phase : Phase III
Sponsor : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Galera to Present at 2022 American Society for Radiation Oncology (ASTRO) Annual Meeting
Details : Avasopasem manganese (GC4419) is an investigational selective dismutase mimetic drug in development as a radioprotector in combination with radiation therapy (RT), with the goal to reduce side effects from radiation therapy.
Brand Name : GC4419
Molecule Type : Small molecule
Upfront Cash : Not Applicable
September 26, 2022
Lead Product(s) : Avasopasem manganese
Therapeutic Area : Gastroenterology
Highest Development Status : Phase III
Sponsor : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Lead Product(s) : Rucosopasem
Therapeutic Area : Oncology
Study Phase : Phase I/ Phase II
Sponsor : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Galera Announces Results from PI Stage of GRECO-1 Trial of Rucosopasem
Details : Rucosopasem in combination with SBRT appeared well tolerated. The most frequent adverse events were fatigue, cough, and nausea, which are common in patients with lung cancer receiving radiotherapy.
Brand Name : GC4711
Molecule Type : Small molecule
Upfront Cash : Not Applicable
June 29, 2022
Lead Product(s) : Rucosopasem
Therapeutic Area : Oncology
Highest Development Status : Phase I/ Phase II
Sponsor : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
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