Phase I
The FDA placed a clinical hold on the program due to a determination that there is insufficient information to support dose escalation with the product.
Tarsus announced positive topline data from its Phase III clinical trial of TP-03 Demodex blepharitis, along with the commencement of an underwritten public offering of $50 million of shares of its common stock.
As May gets off to a slow start for the FDA calendar, a few companies have important target action dates.
Alnylam announced another delay, this one caused by a much more sinister reason – the invasion of Ukraine, now heading into its third month and causing disruption on a multi-faceted and global scale.
Bryostatin-1 increases antigen expression on the surface of cancer cells, enabling them to be seen and killed by IO agents.
Zentalis Pharmaceuticals announced that Pfizer made a $25 million equity investment in the company.
Exogene nets $2 million to propel the development of its AI platform for T-cell receptor discovery and Healome spins out to deploy a ‘pro-healing’ platform with a focus on ocular surface diseases.
All development and commercialization rights for MP0310, a clinical stage immunomodulator intended to treat solid tumors, will be reverted to Molecular Partners.
Editas Medicine snagged Rare Pediatric Disease designation for its experimental beta thalassemia gene therapy, while VBL received Fast Track designation for an ofra-vec combination in ovarian cancer.
Gamida Cell reported that the FDA had lifted its clinical hold on its cryopreserved formulation of GDA-201. It expects to launch a Phase I/II drug trial for those indications this year.
PRESS RELEASES