>>CV Therapeutics Announces Eight Abstracts Accepted for Presentation at the European Society of Cardiology Congress 2007
Wednesday August 22, 7:00 am ET
PALO ALTO, Calif., Aug. 22 /PRNewswire-FirstCall/ -- CV Therapeutics, Inc. (Nasdaq: CVTX - News) announced today that eight abstracts, including a clinical trial update session on anti-arrhythmia data from the MERLIN TIMI-36 study, have been accepted for presentation at the European Society of Cardiology (ESC) Congress 2007 taking place in Vienna, Austria from September 1-5, 2007.
A clinical trial update session entitled, The Effect of Ranolazine, a Novel Anti-anginal Agent with Electrophysiologic Properties, on the Incidence of Tachyarrhythmias: Results from the MERLIN-TIMI 36 Randomized Controlled Trial, is scheduled for presentation Wednesday, September 5 at 9:45 a.m. Central European Summer Time (CEST).
Other accepted abstracts include:
Ranexa® (ranolazine extended-release tablets):
Clinical Outcomes in Patients with Diabetes or the Metabolic Syndrome Presenting with Non- ST-elevation Acute Coronary Syndrome in the MERLIN- TIMI 36 Trial; Poster, Sunday, September 2, 8:30 a.m.-12:30 p.m. CEST
Cost of Angina:
Recurrent Angina Following Revascularization - Frequency, Patient Characteristics and Costs; Poster, Wednesday, September 5, 8:30 a.m. - 12:30 p.m. CEST
Late Sodium Current:
Reduction of Repolarization Reserve Unmasks the Role of Late Sodium Current in Rabbit Isolated Hearts; Poster, Sunday, September 2, 8:30 a.m. - 12:30 p.m. CEST
Mechanism of Ranolazine Block of Cardiac Na Channels; Poster, Monday, September 3, 2:00 - 6:00 p.m. CEST
Regadenoson
Results from Two Randomized, Double-blind, Placebo-controlled Trials Evaluating the Safety of Regadenoson in Patients with Reactive Airways Disease; Poster, Tuesday, September 4, 2:00 - 6:00 p.m. CEST
Side Effect Profile and Tolerability of Regadenoson Myocardial Perfusion Scintigraphy in Women; Poster, Tuesday, September 4, 2:00 - 6:00 p.m. CEST
Superior Safety Profile of Regadenoson Versus Adenosine in Patients with Chronic Obstructive Pulmonary Disease Undergoing Radionuclide Myocardial Perfusion Imaging; Poster, Tuesday, September 4, 2:00 - 6:00 p.m. CEST
In addition, on Tuesday, September 4, CV Therapeutics is sponsoring an EBAC (European Board for Accreditation in Cardiology) educational program, Targeting Myocardial Ischaemia-Future Opportunities for Improved Outcomes, chaired by Dr. Phillip Poole-Wilson of the United Kingdom and Dr. Eugene Braunwald of the United States. On Monday, September 3, CV Therapeutics is sponsoring a FOCUS Cardiology Practice Session, Chronic Stable Angina Management.
Additional information regarding the ESC Congress 2007 can be accessed at escardio.org <<
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>>Ranexa(R) Added to New ACC/AHA Guidelines on Unstable Angina/Non ST-Elevation Myocardial Infarction (UA/NSTEMI)
Wednesday August 15, 7:00 am ET
PALO ALTO, Calif., Aug. 15 /PRNewswire-FirstCall/ -- CV Therapeutics, Inc. (Nasdaq: CVTX - News) announced today that new guidelines, developed jointly by the American College of Cardiology Foundation and the American Heart Association and published in this week's issue of Circulation, state that, "ranolazine may be safely administered for symptom relief after UA/NSTEMI."
Ranexa® (ranolazine extended-release tablets) is indicated for the treatment of chronic angina in patients who have not achieved an adequate response with other antianginal drugs, and should be used in combination with amlodipine, beta-blockers or nitrates. The product has not been determined by regulatory authorities to be safe and effective for any other use.<<
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And they also launched the 1000mg tablet of Ranexa last week. There seems to be a lot of IV in the September options, and huge OI in the Sep and Oct calls, while the put/call ratios are teeny. The only event I know of that might be significant in that time frame is the expected sNDA for Ranexa label expansion based on safety signals observed in MERLIN. This is widely expected, though. Dicier is the FDA's reaction to said filing, but that probably won't be known until late this year, with an actual decision due next year. Meanwhile Third Point hasn't said anything public, but apparently has helped push the company towrds restructuring and seeking strategic alternatives -- though it might have done that anyhow.
I'm very tempted to sell the IV, perhaps with a straddle write. Anyone know of upcoming events that could blindside me?
TIA & Cheers, Tuck |
