Karyopharm Gets FDA Extension of Review Period for Myeloma NDA

Karyopharm Therapeutics Inc. (Nasdaq: KPTI), a clinical-stage pharmaceutical company, today announced that the U.S. Food and Drug Administration (FDA) has extended the Prescription Drug User Fee Act (PDUFA) action date for the New Drug Application (NDA) for selinexor. The NDA, which is currently under Priority Review by the FDA, is seeking accelerated approval for selinexor in combination with dexamethasone for the treatment of patients with relapsed refractory multiple myeloma who have received at least three prior therapies and whose disease is refractory to at least one proteasome inhibitor (PI), one immunomodulatory agent (IMiD), and one anti-CD38 monoclonal antibody. The previously disclosed April 6, 2019 PDUFA date has been extended by three months to July 6, 2019.

On February 26, 2019, the FDA’s Oncologic Drugs Advisory Committee (ODAC) met to discuss the selinexor NDA and voted 8 to 5 recommending that the FDA wait for the results from Karyopharm’s randomized, open-label, Phase 3 BOSTON study evaluating selinexor in patients with relapsed or refractory multiple myeloma, before making a final decision regarding approval.  Although the FDA considers the recommendation of this panel, the final decision regarding the approval of the product is made by the FDA solely, and the recommendations by the panel are non-binding.

Following the ODAC meeting, at the FDA’s request,  Karyopharm submitted additional, existing clinical information as an amendment to the NDA, which allowed the FDA to extend the PDUFA action date by three months. “We look forward to the continued collaboration with FDA in trying to meet the needs of patients with relapsed refractory multiple myeloma,” said Sharon Shacham, PhD, MBA, Founder, President and Chief Scientific Officer of Karyopharm.

https://www.marketscreener.com/KARYOPHARM-THERAPEUTICS-I-14825950/news/Karyopharm-Therapeutics-Announces-FDA-Extension-of-Review-Period-for-Selinexor-New-Drug-Applicatio-28167465/

Magenta Therapeutics initiated at Raymond James

Magenta Therapeutics initiated with an Outperform at Raymond James. Raymond James analyst Dane Leone initiated Magenta Therapeutics with an Outperform rating and a price target of $22. The analyst has three key reasons for recommending the stock: First, MGTA-456 has produced encouraging clinical results and “has an opportunity to significantly increase the utilization of cord blood units within transplant procedures.” Second, MGTA-145 has the potential to improve patient outcomes and reduce costs associated with stem cell mobilization. Third, C200 can help alleviate a key headwind for the adoption of cell-based gene therapy.
https://thefly.com/landingPageNews.php?id=2879607

Amgen initiated with an Outperform at BMO Capital

BMO Capital analyst Do Kim initiated Amgen with an Outperform and $228 price target. Kim views shares are undervalued, and said concerns over the declining legacy franchises have overshadowed the emergent early lifecycle commercial drugs and promising late- and early-stage pipeline. The analyst views Amgen as a core biotech holding, as a stable dividend and aggressive stock buybacks provide a defensive investment, with meaningful pipeline opportunities for long-term growth.

https://thefly.com/landingPageNews.php?id=2879486

Gilead initiated with an Outperform at BMO Capital

BMO Capital analyst Matthew Luchini started Gilead Sciences with an Outperform rating and $78 price target. The company’s HIV franchise should remain dominant for at least the next several years while a growing dividend and continued buybacks “provide investors with a baseline return,” Luchini tells investors in a research note. Further, the analyst believes current levels provide an attractive entry point.

https://thefly.com/landingPageNews.php?id=2879506

FDA accepts Adamis’ NDA of higher dose naloxone injection product candidate

Adamis Pharmaceuticals announced that the U.S. Food and Drug Administration has accepted for review the company’s New Drug Application for its higher naloxone injection product candidate for the treatment of opioid overdose. On March 14, 2019, Adamis received FDA correspondence relating to the company’s NDA stating that the Agency had completed its filing review and had determined that the NDA was sufficiently complete to permit a substantive review. The FDA further provided a target agency action date of October 31.
https://thefly.com/landingPageNews.php?id=2879585

Hanger sees FY19 revenue $1.075B-$1.105B, consensus $1.07B

Sees FY19 adjusted EBITDA $121M-$126M.
https://thefly.com/landingPageNews.php?id=2879509

Xeris Pharmaceuticals doses first patient in Phase 2 EIH trial

Xeris Pharmaceuticals announced that it has now begun dosing patients in a Phase 2 trial with its ready-to-use, room-temperature stable liquid glucagon in patients with Type 1 diabetes who experience episodes of exercise-induced hypoglycemia. “Many individuals with diabetes treated with insulin experience EIH and the complexity of managing it is a major barrier to the adoption of regular physical activity. And unfortunately, today there are no approved therapies to prevent EIH. This research will help us understand the potential for ready-to-use glucagon to offer real-world benefit in reducing or preventing these challenging events during exercise,” said Dr. Ronnie Aronson, MD, FRCPC, FACE, endocrinologist and chief medical officer of LMC Diabetes & Endocrinology, Toronto, Canada. Dr. Aronson is the principal investigator on the EIH trial.
https://thefly.com/landingPageNews.php?id=2879517