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ZGNX Leaps On Trial Data, NVO Gets It Right The 2nd Time, MNKD On Watch


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.

Read on...

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 $21.21, up 2.61%.

MannKind Corp. (MNKD) will host a conference call on Monday, October 2, 2017 to discuss Company developments at 9:00 AM (Eastern Time).

The FDA decision on the label change of the Company's Afrezza Inhaled Insulin, highlighting its unique PK: PD profile, supposed to have been announced by September 30, 2017, is still pending.

MNKD closed Friday's trading at $2.17, down 2.25%.

The FDA has approved Novo Nordisk's (NVO) Fiasp, a faster-acting insulin aspart, to improve glycemic control in adults with type 1 and type 2 diabetes.

Fiasp is a new formulation of NovoLog, in which the addition of niacinamide (vitamin B3) helps to increase the speed of the initial insulin absorption, resulting in an onset of appearance in the blood in approximately 2.5 minutes.

The Danish diabetes care giant, which was issued a Complete Response Letter last October, has found success for Fiasp in its second-go-around.

NVO closed Friday's trading at $48.15, up 0.17%.

The supplemental Biologics License Application for Perjeta, submitted by Roche Group's (RHHBY.OB) Genentech, has been granted priority review by the FDA, with a decision date set for January 28, 2018.

The Company is seeking approval of Perjeta in combination with Herceptin and chemotherapy for adjuvant (after surgery) treatment of HER2-positive early breast cancer.

Perjeta is already indicated for the combination treatment of HER2-positive metastatic breast cancer, and for the neoadjuvant treatment of breast cancer.

Sales of Perjeta, which were $1.9 billion in 2016, are expected to generate over $2.3 billion in 2017 and almost $5.2 billion in 2021, according to Bloomberg Intelligence.

RHHBY.OB closed Friday's trading at $32.00, up 0.53%.

Zogenix Inc. (ZGNX) surged as much as 193% on Friday, following positive top-line results from its pivotal phase III trial of ZX008 in Dravet Syndrome.

Dravet syndrome is a rare, catastrophic, lifelong form of epilepsy that begins in the first year of life with frequent and/or prolonged seizures. (Source: Dravet Syndrome Foundation).

In the trial, ZX008, at a dose of 0.8 mg/kg/day, was found to be superior to placebo as adjunctive therapy in the treatment of Dravet syndrome in children and young adults based on change in the frequency of convulsive seizures between the 6-week baseline observation period and the 14-week treatment period.

ZX008 0.8 mg/kg/day also demonstrated statistically significant improvements versus placebo in all key secondary measures, including the proportion of patients with clinically meaningful reductions in seizure frequency and longest seizure-free interval. The same analyses comparing a 0.2 mg/kg/day ZX008 dose versus placebo also demonstrated statistically significant improvement compared with placebo, according to the Company.

The second pivotal phase III trial of ZX008 in Dravet Syndrome is underway, with results expected in the first half of 2018.

ZGNX touched a 52-week high of $37.55 on Friday, before closing the day's trading at $35.05, up 172.23%.

by RTTNews Staff Writer

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