Phase II
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.
Shares of Praxis Precision Medicines are falling after the company announced the FDA has placed a clinical hold on the company’s IND Application for its experimental epilepsy drug, Prax-222.
A roundup of last week’s top clinical trial updates and news.
Moderna has made the official request to the FDA to approve its COVID-19 for use in children ages 6 months to 5 years. Moderna also announced the location of its first non-U.S. mRNA manufacturing facility.
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