July 22 Company Quick Takes: Vertex submits NDA for triple combo; plus VenatoRX and Biohaven

Vertex submits NDA for cystic fibrosis triple combo
Vertex Pharmaceuticals Inc. (NASDAQ:VRTX) submitted an NDA seeking Priority Review for a triple combination of elexacaftor (VX-445), tezacaftor and ivacaftor to treat cystic fibrosis. The company is seeking concurrent approval for two populations of CF patients ages 12 and older that were evaluated in Phase III trials: those with one ΔF508 mutation and one minimal function mutation, and patients with two ΔF508 mutations. The triple combination has breakthrough therapy designation in the U.S. (see "Why Vertex Picked Elexacaftor for CF Triple Combo Regimen").

VenatoRx partners with U.S. agencies for antibiotic development
VenatoRx Pharmaceuticals Inc. (Malvern, Penn.) will collaborate with HHS's Assistant Secretary for Preparedness and Response (ASPR) and the U.S. Department of Defense’s Defense Threat Reduction Agency (DTRA) to develop the company's VNRX-5133 in combination with cefepime for drug-resistant infections, such as pneumonia and bioterrorism pathogens. ASPR's Biomedical Advanced Research and Development Authority (BARDA) will provide up to $20.7 million over two years to VenatoRx to support an NDA for the combination to treat complicated urinary tract infections (cUTIs). The contract can be extended to provide up to a total of $86.8 million over six years. ...