|Over a week ago|
Amarin announces data from REDUCE-IT REVASC analysis of VASCEPA » 07:1507/2707/27/20
Amarin Corporation announced that data from the REDUCE-IT REVASC analysis, presented as an encore by Deepak L. Bhatt, M.D., M.P.H., Brigham and Women's Hospital Heart & Vascular Center and Harvard Medical School, at The American Society for Preventive Cardiology 2020 Virtual Summit on CVD Prevention, showed that administration of 4 g/day of VASCEPA resulted in a significant 34% reduction in first coronary revascularizations versus placebo. Similar reductions of 36% were observed in total, or first and subsequent, revascularizations. In newly presented data, an early coronary revascularization benefit signal was shown in a prespecified exploratory analysis, with sustained statistical significance attained by 11 months. Coronary revascularization procedures, such as stenting and coronary artery bypass grafts, are invasive, carry multiple risks, and can have significant direct and indirect costs. Patients with elevated triglycerides despite statin therapy have increased risk for ischemic events, including coronary revascularizations. These procedures, whether pre-scheduled or performed in an emergency, inevitably result in additional time spent in a healthcare setting. The analyses from the REDUCE-IT trial included several types of coronary revascularization in statin-treated patients with persistently elevated triglycerides, who also had either cardiovascular disease or diabetes and additional cardiovascular risk factors. Prespecified tertiary endpoint analyses showed that times to first revascularization events were significantly reduced by VASCEPA versus placebo across subtypes of intervention, including elective, urgent, and emergent revascularizations, which were reduced by 32%, 34%, and 38%, respectively. In post hoc analyses, VASCEPA significantly reduced percutaneous coronary intervention by 32% and CABG by 39% relative to placebo/ REDUCE-IT was not specifically powered to examine individual cardiovascular endpoints, therefore p-values presented for these revascularization analyses are nominal and exploratory with no adjustment for multiple comparisons. In addition, coronary revascularization as an endpoint can sometimes be considered subjective; however, these endpoints were adjudicated by an independent, blinded clinical endpoint committee. Results from the total coronary revascularization events analyses are consistent across the various recurrent event statistical models and are also consistent with the first coronary revascularization events results. Together, the REDUCE-IT first and total coronary revascularization events results support the robustness and consistency of the clinical benefit of VASCEPA therapy in reducing coronary revascularization. Funding from Amarin was provided to Brigham and Women's Hospital for Dr. Deepak L. Bhatt's work as the REDUCE-IT study chair and global principal investigator.
CADTH committee recommends reimbursement for Amarin's Vascepa » 16:0107/2007/20/20
The CADTH Canadian Drug…
The CADTH Canadian Drug Expert Committee recommends that icosapent ethyl be reimbursed to reduce the risk of CV events in statin-treated patients with elevated triglycerides, if certain conditions are met, according to a final recommendation document posted to the CADTH site. Icosapent ethyl is marketed under the brand name Vascepa. Reference Link
|Over a month ago|
Matinas BioPharma files $200M mixed securities shelf 17:4407/0207/02/20
Matinas BioPharma commences ENHANCE-IT enrollment, expects to resume EnACT » 16:2006/3006/30/20
Matinas BioPharma announced that it has commenced enrollment and started dosing patients in the ENHANCE-IT study and that it expects to resume dosing patients in the EnACT study imminently, following the recent receipt of necessary governmental and regulatory approvals in Uganda. Both studies had temporarily paused enrollment in March due to the COVID-19 pandemic.
Cantor Fitzgerald pharmaceuticals analysts hold analyst/industry conference call » 10:4306/2906/29/20
Pharmaceuticals Analysts, along with Zachary Silbersher, the founding partner of Kroub, Silbersher & Kolmykov (KSK), PLLC, discuss the likelihood that Amarin will win its appeal for Vascepa on an Analyst/Industry conference call to be held on June 29 at 11 am.
Notable open interest changes for June 23rd » 08:5506/2306/23/20
AAPL, AMRN, BAC, AAL
Monday's total option volume of 25.5 million contracts resulted in net open interest growth of 4.84 million calls and 3.73 million puts. Apple (AAPL), Amarin (AMRN), Bank of America (BAC) and American Airlines (AAL) saw the greatest growth. Top five new positions opened include 51k Ford (F) Aug-20 6 puts, 27k Amarin (AMRN) Sep-20 7 calls, 22k Amarin (AMRN) Sep-20 10 calls, 20k Amarin (AMRN) Sep-20 6 puts and 20k US Steel (X) Aug-20 7 puts.
Unusual call flow in option market yesterday » 07:3506/2306/23/20
Notable call activity was…
Notable call activity was cited Monday in US Steel (X) and Amarin (AMRN).
Double spread collar in Amarin opens bullish position » 12:0006/2206/22/20
Double spread collar in…
Double spread collar in Amarin opens bullish position. Shares little changed this morning near $6.80 with a 4-way spread on the ISE where a customer appears to have sold the Sep 5/6 put spread to buy the Sep 7/10 call spread a total of 20k times, opening on all legs. For the largest tranche of 15k, the net credit on the put spread was 27c and the debit on the call spread 77c, for a net debit of 50c, or about $1M on the package. Net delta on the package is nearly 670k shares, or 9% the average daily turnover in the name. Amarin shares dropped nearly 70% from over $13 to $4 on March 31 related to a court ruling. Today's trade could return a 500% gain to the buyer if shares were to return to double digit territory over the next three months.
Amarin doubling down on appeal after settlement with Apotex, says SVB Leerink » 09:1206/1706/17/20
SVB Leerink analyst Ami…
SVB Leerink analyst Ami Fadia notes that Amarin (AMRN) has settled Vascepa patent litigation with Apotex. While the analyst doesn't believe the U.S. Vascepa patent litigation settlement with Apotex provides any readthrough on the strength of Amarin's case in the ongoing appeal versus Hikma and Dr. Reddy's (RDY), it consolidates the fate of Apotex with the other generic filers and gives Amarin greater clarity on how generic competition in the U.S. will shape up post the appeals ruling. Fadia thinks the settlement puts more at stake for Amarin, and reflects management doubling down on the strength of its appeal's case, although she doesn't disagree with the decision given the risk/reward on the appeal is heavily skewed to the upside. The analyst continues to assign a 20% Probability of Success that Amarin wins the appeal. Fadia has an Outperform rating on Amarin's shares.
Amarin settlement with Apotex an 'incremental positive,' says Stifel » 08:2806/1706/17/20
AMRN, RDY, TEVA
Stifel analyst Derek…
Stifel analyst Derek Archila reiterates his Hold rating on Amarin (AMRN) shares after the company settled with Apotex regarding its ANDA application for generic Vascepa. Apotex cannot sell a generic version of Vascepa until August 2029, which is the same date as Amarin's settlement with Teva (TEVA), noted Archila. While this settlement with another generic ANDA filer is an "incremental positive," Archila doesn't see this a major stock moving catalyst since Apotex is not a party in the ongoing appeal of the district court's decision invalidating Vascepa's patents, he tells investors. He expects Amarin shares to remain range-bound until closer to the hearing on the Hikma and Dr. Reddy's (RDY) case later this year, added Archila.