Shares in Intersect ENT (NSDQ:XENT) fell slightly today even though the drug-device company met expectations on Wall Street with its 4th quarter results. The Menlo Park, Calif.-based company pared losses to -$4.8 million, or -17¢ per share, on sales of $24.2 million for the 3 months ended Dec. 31, for bottom-line growth of 15.8% on sales growth […]
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DexCom beats Street with Q4 earnings
Shares in DexCom Inc. (NSDQ:DXCM) rose today after the medical device maker met expectations on Wall Street with its 4th quarter results. The San Diego-based company posted a loss of -$7.4 million, or -9¢ per share, on sales of $171.2 million for the 3 months ended Dec. 31, for bottom-line loss of -593.3% on sales growth […]
BioCardia, Johns Hopkins treats first patient with CardiAmp cell therapy in Phase III trial
Johns Hopkins, the Maryland Stem Cell Research Fund and BioCardia (NSDQ:BCDA) said today that the 1st patient has been treated in a pivotal Phase III trial of the CardiAmp cell-based therapy for the treatment of ischemic heart failure. The investigational therapy was designed to deliver a dose of a patient’s own bone marrow cells directly […]
FDA asks Titan for more info before clinical trial of ropinirole implant
Titan Pharmaceuticals (NSDQ:TTNP) said today that the FDA put a hold on the clinical trial of its ropinirole implant and told the company to submit more information to the federal watchdog. After it completed an initial review of the implant’s Investigational New Drug application, the FDA asked Titan for final release test data on its ropinirole […]
Insulet slides on Q4 earnings miss
Insulet (NSDQ:PODD) shares are under pressure this morning after the diabetes company missed expectations for its 4th-quarter earnings, despite beating Wall Street’s consensus sales forecast. Billerica, Mass.-based Insulet narrowed its losses by -66.6%, to -$9.1 million, or -16¢ per share, on sales growth of 23.6% to $103.6 million for the 3 months ended Dec. 31, compared […]
TearLab readies for reverse split
Shares in TearLab Corp. (NSDQ:TEAR) said last week that its board approved a 1-for-1o reverse split of its common stock. The company’s shares have fallen nearly 20% since the beginning of the month. The San Diego, Calif.-based company’s move reduced the total number of authorized shares of its common stock from 95 million t0 9.5 […]
Elixir Medical’s DeSyne stent tops Medtronic’s Endeavor after 5 years
Elixir Medical‘s novolimus-eluting stent, DeSyne, outperformed Medtronic‘s (NYSE:MDT) zotarolimus-eluting stent, Endeavor, according to long-term data from Elixir’s Excella II trial. The study enrolled 210 patients with 2 or more de novo lesions in 2 different epicardial vessels. Researchers randomly assigned patients in a 2:1 ratio to the novolimus-eluting stent or the zotarolimus-eluting stent. The device emits a low […]
Clearside bails on AMD, all-in on diabetic macular edema
Clearside Biomedical (NSDQ:CLSD) said today it will redirect its R&D efforts from its pre-clinical axitinib wet age-related macular degeneration therapy to its Zuprata diabetic macular edema treatment. The Alpharetta, Ga.-based company said that recent trial results from other companies investigating combination therapies for wet AMD have led Clearside to reconsider its proprietary suspension formulation of […]
Report finds pharma companies limited January list price hikes
Drug-makers didn’t raise list prices for as many drugs in January compared to last year and they initiated fewer hikes of 10% or more, according to analysis by Raymond James & Associates. Although 5.5% of price increases reached the 10% level in January this year, 15% did last year and 20% did 2 years ago. […]
OncoSec wins fast track designation for electroporation combo therapy
OncoSec Medical (NSDQ:ONCS) said today that it won Fast Track Designation from the FDA for its ImmunoPulse IL-12 electroporation gene therapy for the treatment of metastatic melanoma. The biotech company’s electroporation device is designed to locally deliver DNA-based interleukin-12 to stimulate the immune system and fight off cancer cells. The ImmunoPulse device delivers a sequence […]
