Merck, IMV Update Data from Phase 2 Lymphoma Combo Study

IMV Inc. (Nasdaq: IMV; TSX: IMV), the clinical stage immuno-oncology corporation, today announced that the 2019 International Conference on Malignant Lymphoma (ICML) will publish an abstract on the company’s combination immunotherapy trial titled, ‘Phase 2 Study: DPX-Survivac with Intermittent Low Dose Cyclophosphamide and Pembrolizumab in Patients with recurrent/refractory Diffuse Large B-Cell Lymphoma – The SPiReL trial.’

‘DLBCL is our first indication for DPX-Survivac in combination with Merck’s’ Keytruda (pembrolizumab) and we have been encouraged by the previously announced early data in this patient population with rapidly progressing cancer and short life expectancy,’ said Frederic Ors, Chief Executive Officer at IMV. ‘Given the high level of unmet need in recurrent/refractory DLBCL, we look forward to working with our partners at Sunnybrook Research Institute to provide an update on this important program.’ ICML will publish the full trial-in-progress abstract on June 12, 2019 via the 15-ICML ABSTRACT BOOK, a supplement to Hematological Oncology. IMV will provide an update on the Phase 2 clinical data related to this study at that time.

https://www.marketscreener.com/MERCK-AND-COMPANY-13611/news/Merck-and-IMV-to-Provide-Updated-Data-from-Phase-2-Study-Evaluating-DPX-Survivac-in-Combination-wi-28542535/

FDA OKs Genentech Kadcyla for Adjuvant Early Breast Cancer Treatment

Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), today announced that the U.S. Food and Drug Administration (FDA) has approved Kadcyla (ado-trastuzumab emtansine) for adjuvant (after surgery) treatment of people with HER2-positive early breast cancer (EBC) who have residual invasive disease after neoadjuvant (before surgery) taxane and Herceptin (trastuzumab)-based treatment.

‘This approval is a significant treatment advance for HER2-positive early breast cancer. By working closely with the FDA and participating in the Real-Time Oncology Review pilot program, we are able to make Kadcyla available for people with residual invasive disease after neoadjuvant therapy much sooner than anticipated,’ said Sandra Horning, M.D., chief medical officer and head of Global Product Development. ‘With every step forward in reducing the risk of disease recurrence, we come closer to the goal of helping each person with early breast cancer have the greatest opportunity for cure.’

The goal in treating EBC is to provide people with the best chance for a cure, which may involve treatment before and after surgery as part of a comprehensive treatment approach. While we come closer to this goal with each advance, many people still have a disease recurrence in the long term. Neoadjuvant treatment is given before surgery with the goal of shrinking tumors and helping to improve surgical outcomes. Adjuvant treatment is given after surgery and aims to eliminate any remaining cancer cells in the body to help reduce the risk of the cancer returning.

https://www.marketscreener.com/ROCHE-HOLDING-68997/news/Roche-Genentech-FDA-Approves-Genentech-s-Kadcyla-for-Adjuvant-Treatment-of-People-with-HER2-Posi-28542690/

Teva to Present New Long-Term Data on Migraine Med at AAN

Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA) today announced results from new long-term analyses of the efficacy and safety of fremanezumab, being presented at the 71st Annual Meeting of the American Academy of Neurology (AAN) in Philadelphia from May 4-10, 2019.

The findings, presented across 13 abstracts at this year’s meeting, describe the primary and other key endpoints, as well as pooled and subgroup data from a 52-week, multicenter, randomized, double-blind, parallel group long-term extension study that evaluated fremanezumab in adults with migraine. The results presented include data on the efficacy of fremanezumab observed through 12 months of treatment in patients with migraine, including populations with inadequate responses to multiple classes of preventive medications, quality of life and the safety profile.

‘We are pleased to join the neurology community at this year’s AAN meeting and share these long-term data results on fremanezumab as a preventive treatment option for patients living with migraine,’ said Danny McBryan, Senior Vice President, Head of Global Medical Affairs and Pharmacovigilance at Teva. ‘These data, studied in a wide range of migraine patient populations, add to our growing body of evidence about fremanezumab, and further demonstrate our ongoing commitment to improving the lives of those who suffer from migraine.’

https://www.marketscreener.com/TEVA-PHARMACEUTICAL-INDUS-56537293/news/Teva-Pharmaceutical-Industries-to-Present-New-Long-Term-Data-on-Efficacy-and-Safety-of-Fremanezuma-28542694/

Axsome to Expedite Development for Major Depressive Disorder Treatment

Previously completed active-controlled ASCEND trial in MDD now considered as pivotal; sufficient with ongoing STRIDE-1 Phase 3 trial for NDA in MDD

Target randomization for STRIDE-1 Phase 3 trial reached; screening to continue to build required NDA safety database

Initiation of placebo-controlled Phase 3 trial in MDD anticipated in 2Q 2019; provides additional NDA path with ASCEND trial and builds required NDA safety database

Topline results of both STRIDE-1 Phase 3 trial in TRD and planned placebo-controlled Phase 3 trial in MDD expected in 2H 2019

AXS-05 has potential to be first oral NMDA receptor antagonist with multimodal activity for the treatment of depression

Company to host conference call today at 8:00 AM Eastern

Axsome Therapeutics, Inc.(NASDAQ: AXSM), a clinical-stage biopharmaceutical company developing novel therapies for the management of central nervous system (CNS) disorders, today announced that the development status and plan for AXS-05 in the treatment of major depressive disorder (MDD) and treatment resistant depression (TRD) have been expedited following a Breakthrough Therapy meeting with the U.S. Food and Drug Administration (FDA). AXS-05 is a novel, oral, investigational NMDA receptor antagonist with multimodal activity.

As part of the expedited development program, the Company’s previously completed ASCEND trial in MDD is now considered sufficient with the ongoing STRIDE-1 Phase 3 trial in TRD, if positive, to support the filing of an NDA (New Drug Application) for approval of AXS-05 for the treatment of MDD. Alternatively, Axsome may file an NDA for AXS-05 for the treatment of MDD with the completed ASCEND trial and a placebo-controlled Phase 3 trial of AXS-05 in MDD. Axsome intends to initiate this placebo-controlled Phase 3 MDD trial in the second quarter of 2019.

Axsome will host a conference call and webcast today at 8:00 AM Eastern to discuss the expedited development plan for AXS-05 in the treatment of major depressive disorder following a Breakthrough Therapy meeting with the FDA. To participate in the live conference call, please dial (844) 698-4029 (toll-free domestic) or (647) 253-8660 (international), and use the conference ID 3977129. The live webcast can be accessed on the “Webcasts & Presentations” page of the “Investors” section of the Company’s website at axsome.com. A replay of the webcast will be available for approximately 30 days following the live event.

https://www.marketscreener.com/AXSOME-THERAPEUTICS-INC-24949017/news/Axsome-Therapeutics-Announces-Expedited-Development-and-Pivotal-Status-for-AXS-05-in-the-Treatment-28542762/

Pfizer: FDA OKs Transthyretin Amyloid Cardiomyopath Med

Pfizer Inc. (NYSE:PFE) announced today that the U.S. Food and Drug Administration (FDA) has approved both VYNDAQEL^® (tafamidis meglumine) and VYNDAMAX™(tafamidis) for the treatment of the cardiomyopathy of wild-type or hereditary transthyretin-mediated amyloidosis (ATTR-CM) in adults to reduce cardiovascular mortality and cardiovascular-related hospitalization. VYNDAQEL and VYNDAMAX are two oral formulations of the first-in-class transthyretin stabilizer tafamidis, and the first and only medicines approved by the FDA to treat ATTR-CM.

Transthyretin amyloid cardiomyopathy is a rare, life-threatening disease characterized by the buildup of abnormal deposits of misfolded protein called amyloid in the heart and is defined by restrictive cardiomyopathy and progressive heart failure. Previously, there were no medicines approved to treat ATTR-CM; the only available options included symptom management, and, in rare cases, heart (or heart and liver) transplant. It is estimated that the prevalence of ATTR-CM is approximately 100,000 people in the U.S. and only one to two percent of those patients are diagnosed today.

https://www.marketscreener.com/PFIZER-23365019/news/Pfizer-U-S-FDA-Approves-VYNDAQEL-and-VYNDAMAX-trade-for-Use-in-Patients-with-Transthyretin-Amyl-28542830/

Epizyme reports Q1 EPS (39c), consensus (46c)

Reports Q1 revenue $7.9M, consensus $2.16M. Reports cash, cash equivalents and marketable securities were $371.1M as of March 31, as compared to $247.9M as of March 31, 2018.
https://thefly.com/landingPageNews.php?id=2903507

ResMed upgraded to Buy from Neutral at UBS

https://thefly.com/landingPageNews.php?id=2903483