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Tuesday, July 2, 2019

Veracyte started at Buy by Needham

Target $33

Bio-Techne upgraded to Buy from Neutral by Janney

Target to $270 from $200

Equillium started at Buy by Wainwright

Target $14

U.S. Physical Therapy increases quarterly dividend, sells unit

U.S. Physical Therapy (NYSE:USPHplans to increase Q3 and Q4 dividends for 2019 by an additional 11% to $0.30 per share from $0.27.
Additionally, the Company has sold its 50% interest in one physical therapy partnership to the group’s founders, for cash proceeds of $11.6M; the practice historically had financially under-performed.

Teva up 1% premarket on positive fremanezumab data

Teva Pharmaceutical Industries (NYSE:TEVA) perks up 1% premarket on light volume on the heels of additional data from a Phase 3 clinical trial, FOCUS, evaluating Ajovy (fremanezumab) for the prevention of migraine in adults who failed to respond adequately to two to four classes of preventative treatments. The results were presented at European Academy of Neurology Annual Congress in Oslo.
Treatment with fremanezumab, a calcitonin gene-related peptide (CGRP) antagonist, reduced the average monthly migraine days and sustained 50+% response rates over three months compared to placebo and reduced the use of acute headache medications.
Improvements in migraine symptoms (nausea, vomiting, photophobia, phonophobia), quality of life measures, depression and productivity were also noted.
Complete results will be submitted for publication later this year.
The FDA approved Ajovy in September 2018. The European Commission approved it in April of this year.

Amarin up 8% premarket on guidance boost

Citing increased demand for Vascepa (icosapent ethyl), Amarin (NASDAQ:AMRN) has raised its 2019 revenue guidance to $380M – 420M from $350M.
Q2 sales should be $97M – 101M while H1’s tally should be $170M – 174M.
It also plans to double the size of its U.S. salesforce. Recruiting is underway.
The FDA’s action date for its review of the company’s supplemental marketing application for a CV benefit claim for Vascepa is September 28.
Shares are up 8% premarket on light volume.

Monday, July 1, 2019

Gilead Intends to Submit Application for Rheumatoid Arthritis Med This Year

Gilead Sciences, Inc. (NASDAQ: GILD) today announced that at a recent pre-New Drug Application (NDA) meeting with the U.S. Food and Drug Administration (FDA), the company provided an update about the investigational, oral, selective JAK1 inhibitor filgotinib. The company discussed with the agency the Phase 3 FINCH studies, as well as the ongoing Phase 2 MANTA safety study assessing semen parameters with filgotinib treatment in men with moderately to severely active ulcerative colitis or Crohn’s disease. As a result of this discussion, a path forward has been established to submit the NDA for filgotinib as a treatment for rheumatoid arthritis in 2019.
Filgotinib is an investigational agent and not approved anywhere globally. Its efficacy and safety have not been established.