Fri, Jun. 3, 7:37 AM
- Bayer (OTCPK:BAYRY) and Espoo, Finland-based Orion expand their 2014 agreement to jointly develop BAY-1841788 (ODM-201) in prostate cancer, currently in Phase 3 development (ARAMIS study) for the treatment of high-risk non-metastatic castration-resistant prostate cancer.
- The new indication will be for the treatment of newly diagnosed metastatic hormone-sensitive prostate cancer, in combination with docetaxel, in men who are starting first-line hormone therapy.
- A Phase 3 study, called ARASENS, will begin enrolling patients in late Q4. The double-blind, placebo-controlled trial will randomize ~1,300 subjects 1:1 to receive either BAY-1841788 (ODM-201) or placebo in combination with an androgen deprivation therapy of the investigator's choice started no more than 12 weeks before randomization. The primary endpoint is overall survival.
- BAY-1841788 is an oral androgen receptor antagonist.
- Prostate cancer-related tickers: (NASDAQ:MDVN)(OTCPK:ALPMY)(NYSE:VRX)(NASDAQ:TTHI)(NASDAQ:EDAP)(NASDAQ:TKAI)(NYSE:JNJ)(NASDAQ:TSRO)(NYSE:AZN)(NASDAQ:EGRX)(NASDAQ:OGXI)
Wed, May 18, 8:11 AM| Wed, May 18, 8:11 AM | 1 Comment
Wed, May 18, 7:04 AM
Fri, Apr. 15, 9:50 AM
- EDAP TMS SA (EDAP -0.3%) has closed its previously announced $11.5M direct placement of 3,283,284 ordinary shares in the form of American Depositary Shares (ADSs) at $3.50 per share plus an associated warrant for one ordinary share (as an ADS). Net proceeds will fund the acceleration of HIFU commercial activities in the U.S., including hiring additional sales, marketing and support personnel and a ramp-up of marketing programs.
- The company's Ablatherm Integrated Imaging HIFU (high-intensity focused ultrasound) system was granted 510(k) clearance in November 2015 for the treatment of prostate cancer via ablating (removing tissue by vaporizing) the tissue.
Thu, Apr. 7, 9:35 AM
- Lyon, France-based EDAP TMS SA (EDAP -7.7%) inks agreements with institutional investors for the direct placement of 3,283,284 ordinary shares at $3.50 per share, generating gross proceeds of ~$11.5M. Investors will also receive one two-year warrant to purchase one ordinary share at $4.50 for each share acquired. The warrants are exercisable in six months. Closing date is April 14.
- Shares are down 11% on light volume.
Mon, Apr. 4, 9:13 AM
Mon, Apr. 4, 7:22 AM
- EDAP TMS S.A. (EDAP) Q4 results (€): Revenues: 11.8M (+81.5%); R&D Expense: 0.6M (-5.0%); SG&A: 3.1M (+6.9%); Operating Income: 1.6M (+260.0%); Net Income: 5.1M (+296.2%); EPS: 0.18 (+263.6%).
- FY2015 results: Revenues: 32.3M (+20.5%); R&D Expense: 2.7M (-6.9%); SG&A: 10.6M (+6.0%); Operating Income: 0.5M (+129.4%); Net Loss: (1.7M) (-240.0%); Loss Per Share: (0.07) (-250.0%); Quick Assets: 14.6M (+31.5%).
- No guidance given.
Mon, Apr. 4, 7:04 AM
Nov. 19, 2015, 8:16 AM
- EDAP TMS S.A. (EDAP +0.7%) Q3 results (€): Revenues: 6.4M (-7.2%); R&D Expense: 0.6M (-14.3%); SG&A: 2.2M (-8.3%); Operating Loss: (0.3M) (-200.0%); Net Loss: (4.8M) (-172.7%); Loss Per Share: (0.19) (-173.1%); Quick Assets: 11.1M (-4.3%).
- No guidance given.
Nov. 18, 2015, 5:59 PM
- EDAP TMS S.A. (NASDAQ:EDAP): Q3 EPS of -€0.19 vs. €0.26 in 3Q14
- Revenue of €6.4M ( -7.2% Y/Y )
Nov. 9, 2015, 9:14 AM
Oct. 12, 2015, 5:37 PM
Oct. 2, 2015, 12:40 PM
Oct. 1, 2015, 3:24 PM
- Buy-and-hold investors in thinly traded nano cap EDAP TMS SA (EDAP -29.5%) appear to be an endangered species today. Shares bottomed at $3.05, down almost 50% from the high of $6.00 several days ago, before recovering a bit. Volume is heavy - 12x higher than normal.
- No particular news accounts for the selling although prices were recently extended almost 50% above the 50-day EMA on the daily chart.
- The company has yet to secure 510(k) clearance in the U.S. for its Ablatherm HIFU (High Intensity Focused Ultrasound) for the treatment of prostate cancer, despite being approved in the EU, Canada, Australia and certain other countries. In July, the FDA sent a letter to EDAP requesting additional information in response to its Direct De Novo 510(k) petition. The company is working on providing the information as soon as it can.
Oct. 1, 2015, 12:40 PM
Sep. 25, 2015, 12:44 PM
EDAP TMS SA develops, produces and markets minimally invasive medical devices for urological diseases. HIFU treatment is shown to be a minimally invasive and effective treatment option with a low occurrence of side effects. Ablatherm-HIFU is generally recommended for patients with localized... More
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