Here’s a quick review of our lead stories from Aug. 10 – Aug. 14. Missed an issue? You can find all of the back issues here.
Fresh off raising $640 million in private financing earlier this summer, Germany's Curevac BV burst onto the public market Friday with a $213.3 million Nasdaq IPO. Priced at a top-of-range $16 per share (NADAQ:CVAC), the company's stock rose more than 249% to close at $55.90 Aug. 14, buoyed by enthusiasm for its mRNA vaccine program against SARS-CoV-2. Majority shareholder and longtime Curevac backer Dievini Hopp Biotech Holding GmbH & Co. KG invested €100 million (US$118.3 million) in the company through a concurrent private placement.
While the FDA’s Oncologic Drugs Advisory Committee (ODAC) shared some of the agency’s concerns about uncertainties surrounding Mesoblast Ltd.’s Ryoncil (remestemcel-L), it voted 9-1 Aug. 13 that the mesenchymal stromal cell product showed evidence of efficacy as a treatment for steroid-refractory acute graft-vs.-host disease in children.
The U.S. government bought 100 million doses of mRNA-1273 from Moderna Inc., of Cambridge, Mass., with a new award worth up to $1.525 billion, a deal that drops the implied cost per dose below that of several other companies receiving funding through the government program.
Reports out of Russia that the country approved a COVID-19 vaccine came with more questions than answers, as some in the rest of the world fretted over the apparently paltry degree of testing. Though the product has not completed phase III trials – human research thus far has involved only two groups of volunteers of 38 people each – Russia President Vladimir Putin is said to have declared Gam-COVID-Vac adequately studied.
Mark Wilcox, professor of medical microbiology at the University of Leeds, said Seres Therapeutics Inc.’s top-line phase III data with oral microbiome therapeutic SER-109 against recurrent Clostridium difficile infection are “about as good as it gets” in the tough-to-treat patient population.