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Wednesday, July 10, 2019

AngioDynamics +10% premarket on FQ4 results

AngioDynamics (ANGOQ4 results: Revenues: $96.3M (+9.1%).
Net Income: $58.9M; EPS: $1.54; Non-GAAP Net Income: $9.6M (+24.7%); Non-GAAP EPS: $0.25 (+25.0%); Quick Assets: $227.6M (+201.9%); CF Ops: $37.4M (-9.4%).
FY 2020 Guidance: Net Sales: $280M – 286M; Non-GAAP EPS: $0.25 – 0.30.
Shares are up 10% premarket.

Valeritas up 42% premarket as managed care providers pick up V-Go

Thinly traded nano cap Valeritas Holdings (NASDAQ:VLRX) is up 42% premarket on robust volume in reaction to its disclosure that Cigna, Humana and CVS Health have added its V-Go Wearable Insulin Delivery device to their managed care formularies.

Steris cut to Market Weight by KeyBanc

From Overweight

HCA upped to Buy from Neutral by Goldman Sachs

Target to $160 from $147

Community Healthcare Trust cut to Neutral from Buy by Janney

https://www.benzinga.com/stock/CHCT/ratings

Astellas launches new therapeutic option for rheumatoid arthritis

Astellas Pharma Inc. (TSE: 4503, President and CEO: Kenji Yasukawa, Ph.D., ‘Astellas’ ) today announced the launch of the Smyraf® 50 mg and 100 mg Tablets (generic name: peficitinib hydrobromide), an oral Janus kinase (JAK) inhibitor, in Japan for the treatment of rheumatoid arthritis (including prevention of structural joint damage) in patients who have an inadequate response to conventional therapies.
Smyraf®, which was discovered by Astellas, suppresses activation and proliferation of inflammatory cells involved in synovial inflammation and joint destruction in rheumatoid arthritis patients by inhibiting various inflammatory cytokine signaling pathways.
The number of rheumatoid arthritis patients in Japan is estimated to be approximately 0.6 to 1.0 million*1. Currently, disease-modifying antirheumatic drugs (DMARDs)*2including Methotrexate (MTX) and biologics, are used to treat rheumatoid arthritis. By providing Smyraf® as a new therapeutic option, Astellas will contribute to treatment of rheumatoid arthritis patients with an inadequate response to conventional therapy such as DMARDs.
Astellas reflected the impact from this launch in its financial forecasts of the current fiscal year ending March 31, 2020.

Sanofi: FDA to review potential treatment for multiple myeloma

The U.S. Food and Drug Administration (FDA) has accepted for review the Biologics License Application (BLA) for isatuximab for the treatment of patients with relapsed/refractory multiple myeloma (RRMM). The target action date for the FDA decision is April 30, 2020. Isatuximab is an investigational monoclonal antibody that targets a specific epitope on the CD38 receptor of a plasma cell.
The BLA is based on positive results from ICARIA-MM, an open-label pivotal Phase 3 clinical trial of isatuximab in patients with RRMM. ICARIA-MM is the first positive randomized Phase 3 trial to evaluate an antibody in combination with pomalidomide and dexamethasone. Results from this trial were presented at the 2019 American Society of Clinical Oncology Annual Meeting and the 2019 European Society of Hematology Annual Meeting.