October 31, 2018 1:29pm
NTLA is DOWN and falling -$1.53 or -8.29% to $16.99
Right again … after "earnings call"
Now NTLA plans to seek FDA approval in 2020 to start a clinical trial of the rare disease treatment, which uses gene editing technology known as CRISPR/Cas9.
NTLA had originally planned to file the so-called IND application with the FDA by the end of 2019.
During the Q3 earnings call, CEO John Leonard declined to specify when in 2020 – NTLA hopes to file. During the investor call, Leonard likewise said that Intellia has not run into any issues with immune responses, but could counteract them if necessary. "Given the short treatment course that we anticipate, that shouldn't be a problem for a patient. We can immuno-suppress, if necessary, but right now, it is not a major issue for us," Leonard said. "I don't measure progress by the first IND date, but by the medicine we are able to deliver." <Allison DeAngelis, BBJ>
The delay was announced one day after new research was published using human blood samples that suggested that CRISPR/Cas9 can trigger an immune response that inhibits treatments from working.
- The research published Tuesday in the journal Nature found that 96% of patients had immunity against the technology, with 85% producing immune system antibodies. Research published in January in Nature also showed that a majority of patients developed immune antibodies.
A company spokesperson said the IND delay had nothing to do with any immune system concerns, without addressing the research paper directly –
Their investor communication is Bull S--- personified!
Come “clean” with investors!!!