Yes, Loxo is still planning on seeking an accelerated OK, in case you had forgotten
Back in the spring, Loxo Oncology $LOXO was ready to pounce with an early snapshot of some clinical responses to its lead cancer drug, a common strategy among small public biotechs looking to raise their profile – and cash. Not surprisingly, it also immediately mapped out a plan to set up its Phase II study as a registrational study, SOP among biotechs capitalizing on the FDA’s open arms for quick approvals, when the early data are right.
The data helped the Stamford, CT-based biotech muscle its way into the spotlight at AACR as it touted evidence of tumor regression among 6 patients with TRK (tropomyosin receptor kinases) fusion genetic mutations.
So perhaps it was no great surprise when the biotech repackaged what had worked earlier in the year, adding a single partial response to its tally of Phase I indications of success and touting a specific timeline on an approval and a potential commercial launch.
The plan at Loxo is to report top line data on LOXO-101, now larotrectinib, in the second half of 2017. Presuming that the data are positive, it can plan to file in late 2017 or early 2018. And it’s looking to pick up a potentially lucrative voucher by filing for infantile fibrosarcoma, a rare pediatric cancer.
The update was carefully orchestrated to achieve maximum market response, looking for a bump without actually adding much in the way of new information. And it worked fine. Loxo’s stock jumped about 31% by mid-afternoon, which is just what the executive crew wanted to see.
Sometimes, it’s not what you say, but how you say it that matters.
“Since initiating our NAVIGATE Phase 2 trial in October 2015, we have been hard at work identifying TRK fusion patients and engaging with regulators to pursue a rapid path to market for larotrectinib,” said Josh Bilenker, MD, chief executive officer of Loxo Oncology. “Based on current enrollment and written regulatory correspondence, we are able to provide this exciting update for larotrectinib, and begin planning for a potential commercial launch. We look forward to sharing top-line data for the NDA dataset in concert with worldwide regulatory filings.”