Thursday, February 7, 2019
Solid Biosciences to move forward after disappointing DMD data
Solid Biosciences’ (SLDB) data this morning from the first six patients to take its experimental gene therapy for Duchenne muscular dystrophy, SGT-001, falls below the expectations of Wall Street analysts, Matthew Herper of STAT reports. lan Ganot, the co-founder and CEO of Solid, told him, “Look, as background, we are a company that was formed to discover, develop, and deliver meaningful therapies for patients with DMD. We believe SGT-001 has the potential to be a meaningful therapy for patients with DMD, and obviously are committed to move forward as fast as we can.” A rival gene therapy being developed by Sarepta Therapeutics (SRPT) has shown much more dramatic results in terms of the amount of modified dystrophin produced and apparent benefits to patients, Herper writes. Ganot, however, says Solid is encouraged simply that there are signs of expression even at the starting dose.
Amag Pharmaceuticals reports Q4 EPS (64c), consensus ($1.09)
Reports Q4 revenue $88.1M, consensus $98.92M. In the fourth quarter of 2018, sales of Makena totaled $46.9 million, compared with $100.4 million in the same period last year; sales of Feraheme and MuGard increased 33% to $35.3 million, compared with $26.6 million in the same period last year; and sales of Intrarosa totaled $5.9 million, compared with $1.5 million in the same period last year.
Medtronic receives FDA approval for expanded indication for Pipeline Flex
Medtronic plc announced that it has received U.S. FDA approval on an expanded indication for its Pipeline Flex embolization device. Previously indicated for the endovascular treatment of adults with large or giant wide-necked intracranial aneurysms in the internal carotid artery from the petrous to the superior hypophyseal segments, the new indication opens options for patients with small or medium, wide-necked brain aneurysms in the territory from the petrous to the terminus of the internal carotid artery.
Omega Healthcare downgraded to Hold following 12% year-to-date rally at Stifel
Stifel analyst Chad Vanacore downgraded Omega Healthcare to Hold from Buy and maintained his $39 price target, citing valuation with the stock having risen 12% since the beginning of the year. The company’s restructuring is substantially complete and the timing of its investments is skewed to the back half of the year, Vanacore noted.
Karyopharm announces FDA meeting to review selinexor data
Karyopharm announced that the Oncologic Drugs Advisory Committee, or ODAC, of the FDA is scheduled to review data supporting the company’s new drug application, or NDA, requesting accelerated approval for selinexor, an oral selective inhibitor of nuclear export, or SINE, compound, at a meeting. The proposed indication to be discussed at this upcoming ODAC meeting is for selinexor in combination with dexamethasone for the treatment of patients with refractory multiple myeloma who have received at least three prior therapies and whose disease is refractory to at least one proteasome inhibitor, or PI, one immunomodulatory agent, or IMiD, and one anti-CD38 monoclonal antibody, and to their most recent treatment regimen. The company has also submitted a marketing authorization application, or MAA, to the European Medicines Agency, or EMA, for selinexor requesting conditional approval for the treatment of patients with relapsed or refractory multiple myeloma who have received at least three prior lines of therapy and whose disease is refractory to at least one PI, one IMiD, and one anti-CD38 monoclonal antibody, and to their most recent treatment regimen. The selinexor MAA has been granted accelerated assessment by the EMA’s Committee for Medicinal Products for Human Use.
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