Acasti Pharma submits SAP to FDA for TRILOGY 2 Phase 3 trial of CaPre » 07:5907/3107/31/20
Acasti Pharma announced…
Acasti Pharma announced it has completed its revisions to the pre-specified Statistical Analysis Plan for the TRILOGY 2 Phase 3 trial of CaPre, and has filed it with the Food and Drug Administration. As previously disclosed, the Company, along with the academic Principal Investigator of the study, Dariush Mozaffarian M.D., Dr.P.H., and external clinical and statistical experts, conducted rigorous post-hoc analysis of TRILOGY 1 data. Analysis of the TRILOGY 1 data revealed a rapid, significant and sustained reduction in TG levels between screening and the time of patient randomization, which Acasti refers to as "Pre-randomization Triglyceride Normalization." This artefactual phenomenon affected both treatment groups, but was much greater in the placebo group, resulting in the large placebo effect and significant underestimation of the post-randomization treatment effect of the active drug, CaPre. The post-hoc analyses of the primary endpoint using a revised, single point baseline value from Week 0 corrected for a significant amount of the pre-randomization TG reduction in subjects that were most affected by the normalization phenomenon, and a meaningful efficacy trend for CaPre was observed. The Company provided all of the TRILOGY 1 background information and accompanying data to the FDA in a Type C briefing package, which was filed on April 29, 2020. As previously disclosed, the FDA provided Acasti with a written response to its Type C Meeting request and briefing package, and confirmed that it will require pivotal efficacy analyses for TRILOGY 2 to be performed on the full Intent to Treat population, as contemplated in the original Statistical Analysis Plan, and they supported the conduct of post-hoc analyses in TRILOGY 1 for exploratory purposes. Based on the FDA's feedback and input from key experts including Dr. Mozaffarian, Acasti finalized the Statistical Analysis Plan for TRILOGY 2 and has now submitted it to the FDA. The Company remains blinded to the TRILOGY 2 data, and remains on track to report topline TG data on or about August 31, 2020. The key secondary and exploratory endpoints from both TRILOGY 1 and TRILOGY 2 trials, and pooled results from both studies, are still expected within several weeks following the unblinding of TRILOGY 2 results. Acasti also announced it plans to host a conference call on or about August 31, 2020 to discuss the TRILOGY 2 topline results, as well as to provide an update on the timing for the reporting of the secondary and exploratory endpoints, and the pooled results from both TRILOGY studies. For this reason, the Company does not plan to host its usual quarterly conference call to discuss the financial results for the first fiscal quarter ended June 30, 2020, but expects to report and file its first fiscal quarter 2021 financial results on August 13, 2020.
|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
Fly Intel: Top five analyst upgrades » 10:0607/0607/06/20
INFY, KIM, TRQ, TNDM, ACST
Catch up on today's…
Catch up on today's top five analyst upgrades with this list compiled by The Fly: 1. Infosys (INFY) upgraded to Conviction Buy from Buy at Goldman Sachs with analyst Sumeet Jain saying he expects fiscal Q1 to be the trough quarter for Indian IT firms this year, both around sequential revenues and order books. 2. Turquoise Hill (TRQ) upgraded to Outperformer from Neutral at CIBC. 3. Tandem Diabetes (TNDM) upgraded to Buy from Neutral at Citi with analyst Joanne Wuensch saying the company has "multiple levers to pull" over the coming months to drive further upside to the stock, and diabetes names should continue to be in favor given the "dramatic move" towards better insulin management. 4. Kimco Realty (KIM) upgraded to Buy from Hold at Deutsche Bank. 5. Acasti Pharma (ACST) upgraded to Buy from Neutral at B. Riley FBR with analyst Mayank Mamtani saying post-hoc TRILOGY 1 analysis bodes favorably for a different placebo response for TRILOGY 2. This list is just a portion of The Fly's full analyst coverage. To see The Fly's full Street Research coverage, click here.
Acasti Pharma upgraded to Buy with $2 target at B. Riley FBR » 08:2507/0607/06/20
B. Riley FBR analyst…
B. Riley FBR analyst Mayank Mamtani upgraded Acasti Pharma to Buy from Neutral with a $2 price target ahead of the company's Phase III TRILOGY 2 top-line data readout in August. Post-hoc TRILOGY 1 analysis bodes favorably for a different placebo response for TRILOGY 2, Mamtani tells investors in a research note. The analyst believes regulatory uncertainty is already priced into shares of Acasti Pharma.
Acasti Pharma upgraded to Buy from Neutral at B. Riley FBR » 07:1207/0607/06/20
B. Riley FBR analyst…
B. Riley FBR analyst Mayank Mamtani upgraded Acasti Pharma to Buy from Neutral with a $2 price target.
|Over a month ago|
Acasti Pharma files $204.3M mixed securities shelf 06:3406/3006/30/20
Acasti Pharma to host conference call » 12:5506/2906/29/20
Conference call to…
Conference call to discuss the FDA response to its Type C Meeting request and briefing package will be held on June 29 at 1 pm. Webcast Link
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.
Acasti Pharma says 'substantial doubt' on ability to continue as going concern » 09:5906/2906/29/20
Cash and cash equivalents…
Cash and cash equivalents and short-term investments totaled $14.2M as of March 31, 2020, compared to $25.8M for the year ended March 31, 2019. Acasti believes that existing cash will fully fund the Company's operations into the first calendar quarter of 2021. Acasti projects that additional funds will be needed in the future for activities necessary to prepare for the commercial launch of CaPre if regulatory approval is received, including the scale-up of its manufacturing operations, the completion of the potential regulatory NDA submission package, and the expansion of business development and U.S. commercial launch activities. The Company is working towards development of strategic partner relationships, as well as actively seeking additional non-dilutive funds in the near future, but there can be no assurance as to when or whether Acasti will complete any strategic collaborations or non-dilutive financings. If the Company does not raise additional funds or find one or more strategic partners, it may not be able to realize its assets and discharge its liabilities in the normal course of business. As a result, there exists substantial doubt about the Company's ability to continue as a going concern, and therefore, realize its assets and discharge its liabilities in the normal course of business.