NGM Biopharmaceuticals reports Q2 EPS (38c), consensus (31c) » 16:1008/1208/12/20
Reports Q2 revenue…
FDA grants accelerated approval to NS Pharma's DMD treatment Viltepso » 14:2008/1208/12/20
The U.S. Food and Drug…
The U.S. Food and Drug Administration granted accelerated approval to Viltepso injection for the treatment of Duchenne muscular dystrophy, or DMD, in patients who have a confirmed mutation of the DMD gene that is amenable to exon 53 skipping. The FDA is granting the approval to NS Pharma. "This is the second FDA-approved targeted treatment for patients with this type of mutation. Approximately 8% of patients with DMD have a mutation that is amenable to exon 53 skipping," the FDA stated. Previously, on December 12, 2019, Sarepta Therapeutics announced that the U.S. Food and Drug Administration had approved Vyondys 53, an antisense oligonucleotide from Sarepta's phosphorodiamidate morpholino oligomer platform, indicated for the treatment of Duchenne muscular dystrophy in patients with a confirmed mutation amenable to exon 53 skipping.
Eloxx Pharmaceuticals resumes enrollment in Phase 2 CF trial of ELX-02 » 07:3408/1208/12/20
Sarepta management to meet virtually with Cantor Fitzgerald » 04:5508/1208/12/20
Virtual Meetings to be…
Sarepta, University of Florida collaborate for rare genetic disease therapies » 08:5108/1108/11/20
Sarepta Therapeutics and…
Sarepta Therapeutics and the University of Florida announced a strategic collaboration to enable cutting-edge research for novel genetic medicines. Through the agreement, Sarepta will fund multiple research programs at the University, and will have an exclusive option to further develop any new therapeutic compounds that result from the funded research programs. Through the collaboration, currently unique to UF, funding has been allocated for four innovative projects. These projects include exploratory research in novel gene therapy vectors, next-generation capsids and gene editing technologies as well as work in new therapeutic areas in degenerative genetic diseases. The goal is to foster early relationships with experts and accelerate the scientific advancements that lead to the development of transformational precision genetic medicines for patients in need.
PTC Therapeutics price target lowered to $75 from $85 at Cantor Fitzgerald » 07:1108/1108/11/20
Cantor Fitzgerald analyst…
Cantor Fitzgerald analyst Alethia Young lowered the firm's price target on PTC Therapeutics (PTCT) to $75 from $85 and keeps an Overweight rating on the shares after adjusting for the quarter and the Royalty Pharma (RPRX) deal. While PTC has sold 43% of its royalties to Royalty Pharma, Young still thinks there is upside to the future risdiplam royalty stream relative to the Street expectations.
Sarepta management to meet virtually with Cantor Fitzgerald » 04:5508/1108/11/20
Virtual Meetings to be…
Virtual Meetings to be held on August 11-12 hosted by Cantor Fitzgerald.
PTC Therapeutics files automatic mixed securities shelf 16:2008/1008/10/20
Amarin Perform rating affirmed at Oppenheimer after FDA approves Vascepa generic » 15:1808/1008/10/20
Oppenheimer analyst Leland Gershell reiterated a Perform rating and $7 price target on Amarin (AMRN) after the FDA's Orange Book was updated to reflect the addition of Dr. Reddy's (RDY) generic form of Vascepa. Gershell said that while he has little insight on the prospects that either company will launch at risk while the patent appeal process continues, he believes it is "reasonable" to conclude that the addition of a second generic player will only raise any likelihood of this scenario.
Dr. Reddy's receives FDA approval for generic version of Icosapent Ethyl » 14:3408/1008/10/20
Icosapent Ethyl is sold…
Icosapent Ethyl is sold by Amarin (AMRN) under the brand name Vascepa. Amarin has an ongoing appeal versus Hikma and Dr. Reddy's (RDY) related to Vascepa. Reference Link