Phase I

Roivant Sciences announced it has discontinued development of several assets following a pipeline reprioritization.
The FDA has placed Astellas Pharma’s Phase I/II FORTIS trial on clinical hold after one of its study participants experienced a serious adverse event.
While it was a relatively quiet week for clinical trial announcements overall, BioSpace takes a look at some of the more intriguing ones.
Intellia Therapeutics and Regeneron Pharmaceuticals presented positive interim data from an ongoing Phase I trial of NTLA-2001 for transthyretin (ATTR) amyloidosis.
BridgeBio released early data from its Phase I/II CANaspire clinical trial, indicating that BBP-812 might be a promising gene therapy for the ultra-rare Canavan disease.
Athira Pharma is putting a positive spin on its topline data from a Phase II trial of fosgonimeton, emphasizing positive subgroup analysis, but it missed the primary endpoint.
Decentralized clinical trials may cost more upfront, but can have huge returns on the back end, according to speakers at Informa Connect’s Decentralized Clinical Trials meeting.
The week began with positive updates in the vaccine development space against various infectious diseases from Emergent, Merck, Affinivax and Ocugen.
Olema president and CEO Sean Bohen spoke with BioSpace about why he believes his company’s approach with a SERD and ER antagonist can successfully treat an advanced form of breast cancer.
Genmab and AbbVie announce positive data in large b-cell lymphoma, Intra-Cellular’s bipolar depression candidate hits the endpoint in Phase III and more.
PRESS RELEASES