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Thursday, August 1, 2019

Nektar up on breakthrough therapy tag

Nektar Therapeutics (NASDAQ:NKTR) is up 5% premarket on light volume in reaction to U.S. Breakthrough Therapy designation for bempegaldesleukin (NKTR-214), combined with Bristol-Myers Squibb’s (NYSE:BMY) Opdivo (nivolumab), for previously untreated patients with unresectable/metastatic melanoma.
Breakthrough Therapy status provides for more intensive guidance from the FDA on development, the involvement of more senior agency personnel and a rolling review of the marketing application.
A Phase 1/2 study, PIVOT-02, is ongoing.
Bempegaldesleukin is a CD122-preferential IL-2 pathway agonist designed to activate and proliferate certain cancer-killing immune cells.

Ultragenyx files U.S. application for rare dissease med

Ultragenyx (NASDAQ:RARE) has submitted a marketing application to the FDA seeking approval of triheptanoin (UX007) for the treatment of long-chain fatty acid oxidation disorders (LC-FAOD), a group of inherited diseases in which the body is unable to metabolize long-chain fatty acids into energy. The indication has Rare Pediatric Disease Designation and Fast Track status.
UX007 is a purified pharmaceutical-grade form of triheptanoin, a triglyceride compound, that provides patients with medium-length odd-chain fatty acids which increase the intermediate substrates in the Krebs cycle, a key energy-generating process, which produces new glucose.

Genetic testers rally on insurance coverage for Myriad’s GeneSight

Genetic testing services providers are in the green after UnitedHealthcare instituted coverage for Myriad Genetics’ GeneSight test for major depressive disorder.
NeoGenomics (NEO +5.3%), Invitae (NVTA +0.9%), Fulgent Genetics (FLGT+12.8%)
Liquid biopsy services providers are enjoying a bump as well: Biocept (BIOC+1.9%), Bio-Techne (TECH +1.6%), Anixa Biosciences (ANIX +1.9%), OncoCyte (OCX +0.3%), Guardant Health (GH +1.9%)

Welltower target raised to $87 from $78 by Stifel

Maintains Buy

Vertex target upped to $230 from $217 by Piper

Maintains Overweight

United Therapeutics upped to Buy from Neutral by Ladenburg

Target to $106 from $103

Humana target upped to $341 from $315 by Piper

Maintains Overweight