BioCentury | Mar 11, 2020
Regulation

Intarcia’s path uncertain after second regulatory stumble for diabetes implant

Massive fund-raising over the past decade positioned Intarcia to enter the market with ITCA 650, a matchstick-sized implant that delivers a GLP-1R agonist to Type II diabetes patients subcutaneously for six months. But now that...
BioCentury | Oct 8, 2019
Company News

After remedies to NDA, Intarcia’s diabetes implant under FDA review again

More than two years after well-funded Intarcia received a complete response letter from FDA, an NDA for the company’s implantable pump to treat Type II diabetes is back under the agency’s review. The new PDUFA...
BioCentury | Mar 5, 2019
Company News

Intarcia licenses Numab's autoimmune therapy

Ahead of an NDA resubmission for its Type II diabetes therapy, Intarcia exercised an option to license from Numab exclusive, worldwide rights to autoimmune disorder therapy, ND016. ND016 is a trispecific antibody fragment that blocks...
BioCentury | Feb 9, 2018
Company News

Intarcia terminates late-stage diabetes trials

Intarcia Therapeutics Inc. (Boston, Mass.) terminated two late-stage trials evaluating ITCA 650 in Type II diabetes, according to ClinicalTrials.gov. The company received a complete response letter from FDA in September for an NDA seeking approval...
BioCentury | Feb 2, 2018
Company News

Intarcia terminates Phase III diabetes trials

Intarcia Therapeutics Inc. (Boston, Mass.) terminated two late-stage trials earlier this week evaluating ITCA 650 in Type II diabetes, according to ClinicalTrials.gov. The company received a complete response letter from FDA in September for an...
BioCentury | Oct 20, 2017
Clinical News

Intarcia gets CRL for Type II diabetes candidate ITCA 650

FDA issued a complete response letter to an NDA for ITCA 650 from Intarcia Therapeutics Inc. (Boston, Mass.) to treat Type II diabetes. The company said it plans to resubmit the NDA after meeting with...
BioCentury | Aug 18, 2017
Financial News

Alzeca raises $11M in series A

Diagnostic imaging play Alzeca Biosciences Inc. (Houston, Texas) raised $11 million in a series A round. The round included $8 million in new money and $3 million through the conversion of convertible notes. ChemWerth Inc....
BioCentury | Aug 17, 2017
Financial News

Alzeca raises $11M in series A

Diagnostic imaging play Alzeca Biosciences Inc. (Houston, Texas) raised $11 million in a series A round. The round included $8 million in new money and $3 million through the conversion of convertible notes. ChemWerth Inc....
BioCentury | Dec 30, 2016
Financial News

Intarcia raises $206M, teams with Gates for HIV prophylaxis

Intarcia Therapeutics Inc. (Boston, Mass.) raised $206 million in the second close of a series EE round. The company expects a third and final close next quarter. Intarcia announced the $215 million first close in...
BioCentury | Dec 30, 2016
Company News

Intarcia, Bill & Melinda Gates Foundation deal

Bill & Melinda Gates Foundation partnered with Intarcia to develop an HIV prophylaxis that will combine Intarcia's implantable Medici delivery system with an HIV treatment. Intarcia received $50 million in equity from the foundation and...
Items per page:
1 - 10 of 214
BioCentury | Mar 11, 2020
Regulation

Intarcia’s path uncertain after second regulatory stumble for diabetes implant

Massive fund-raising over the past decade positioned Intarcia to enter the market with ITCA 650, a matchstick-sized implant that delivers a GLP-1R agonist to Type II diabetes patients subcutaneously for six months. But now that...
BioCentury | Oct 8, 2019
Company News

After remedies to NDA, Intarcia’s diabetes implant under FDA review again

More than two years after well-funded Intarcia received a complete response letter from FDA, an NDA for the company’s implantable pump to treat Type II diabetes is back under the agency’s review. The new PDUFA...
BioCentury | Mar 5, 2019
Company News

Intarcia licenses Numab's autoimmune therapy

Ahead of an NDA resubmission for its Type II diabetes therapy, Intarcia exercised an option to license from Numab exclusive, worldwide rights to autoimmune disorder therapy, ND016. ND016 is a trispecific antibody fragment that blocks...
BioCentury | Feb 9, 2018
Company News

Intarcia terminates late-stage diabetes trials

Intarcia Therapeutics Inc. (Boston, Mass.) terminated two late-stage trials evaluating ITCA 650 in Type II diabetes, according to ClinicalTrials.gov. The company received a complete response letter from FDA in September for an NDA seeking approval...
BioCentury | Feb 2, 2018
Company News

Intarcia terminates Phase III diabetes trials

Intarcia Therapeutics Inc. (Boston, Mass.) terminated two late-stage trials earlier this week evaluating ITCA 650 in Type II diabetes, according to ClinicalTrials.gov. The company received a complete response letter from FDA in September for an...
BioCentury | Oct 20, 2017
Clinical News

Intarcia gets CRL for Type II diabetes candidate ITCA 650

FDA issued a complete response letter to an NDA for ITCA 650 from Intarcia Therapeutics Inc. (Boston, Mass.) to treat Type II diabetes. The company said it plans to resubmit the NDA after meeting with...
BioCentury | Aug 18, 2017
Financial News

Alzeca raises $11M in series A

Diagnostic imaging play Alzeca Biosciences Inc. (Houston, Texas) raised $11 million in a series A round. The round included $8 million in new money and $3 million through the conversion of convertible notes. ChemWerth Inc....
BioCentury | Aug 17, 2017
Financial News

Alzeca raises $11M in series A

Diagnostic imaging play Alzeca Biosciences Inc. (Houston, Texas) raised $11 million in a series A round. The round included $8 million in new money and $3 million through the conversion of convertible notes. ChemWerth Inc....
BioCentury | Dec 30, 2016
Financial News

Intarcia raises $206M, teams with Gates for HIV prophylaxis

Intarcia Therapeutics Inc. (Boston, Mass.) raised $206 million in the second close of a series EE round. The company expects a third and final close next quarter. Intarcia announced the $215 million first close in...
BioCentury | Dec 30, 2016
Company News

Intarcia, Bill & Melinda Gates Foundation deal

Bill & Melinda Gates Foundation partnered with Intarcia to develop an HIV prophylaxis that will combine Intarcia's implantable Medici delivery system with an HIV treatment. Intarcia received $50 million in equity from the foundation and...
Items per page:
1 - 10 of 214