Today’s Daily Dose brings you news about AveXis’ progress with AVXS-101 for patients with spinal muscular atrophy Type 1; Insys’ advancement of its pipeline; FDA clearance of K2M Group’s YUKON OCT Spinal System; MannKind’s conference call; regulatory approval of Novo Nordisk’s faster-acting insulin aspart in the U.S. and Zogenix’ phase III trial of ZX008 in Dravet Syndrome.
AveXis Inc. (AVXS) has been given the go-ahead by the FDA to initiate its planned pivotal trial of AVXS-101 for patients with spinal muscular atrophy Type 1 using the intravenous formulation produced by the company’s Good Manufacturing Practice commercial manufacturing process.
The trial, dubbed STR1VE, will be initiated immediately. The trial will enroll a minimum of 15 patients with SMA Type 1 who are less than six months of age at the time of gene therapy, and who have one or two copies of the SMN2 backup gene as determined by genetic testing and bi-allelic SMN1 gene deletion or point mutations, noted the Company.
AVXS closed Friday’s trading at $96.73, up 4.92%.
INSYS Therapeutics Inc. (INSY) has filed a New Drug Application for a novel formulation of buprenorphine as a sublingual spray for the management of moderate-to-severe acute pain with the FDA.
Saeed Motahari, president and CEO of INSYS said, “Our NDA for buprenorphine sublingual spray marks another major milestone for the company’s R&D pipeline. This submission to the FDA supports our goal of filing one NDA every year for the next five years as we execute on our collective vision and expand our product portfolio.”
INSY closed Friday’s trading at $8.88, up 0.45%.
K2M Group Holdings Inc. (KTWO) has received FDA clearance for its YUKON OCT Spinal System.
YUKON OCT offers surgeons an advanced system aimed at facilitating fusion with posterior fixation in the occipito-cervico-thoracic regions of the spine with the goal of helping to achieve three-dimensional spinal balance, according to the Company.
KTWO closed Friday’s trading at…