Not so fast for some accelerated approvals
The US conditional approval pathway has enjoyed years of expansion, but now the FDA is trying to put the toothpaste back into the tube.
Immunogen’s Mirasol trial goes down to the wire
Full data from mirvetuximab’s Soraya study make investors nervous as readout of the Mirasol confirmatory trial looms.
Sutro’s folate challenge to Immunogen hits a problem
In a battle of anti-folate receptor α projects STRO-002 outperforms mirvetuximab, but Sutro investors are not celebrating.
Biopharma developments over the Christmas period
Investors nursing a fall in biotech indices now have to digest the failure of Bridgebio's acoramidis in 2021’s last important catalyst.
Smaller companies set for third-quarter catalysts
The third quarter will see important data for Travere, Radius and Sio Gene, among other small developers.
After Immunogen and Sutro, Bristol buys into the folate story
The deal puts more support behind targeting folate receptor α, a long troubled target, with antibody-drug conjugates.