CareDx announced the publication of data demonstrating the clinical utility of measuring AlloSure in repeat kidney transplant recipients in the American Journal of Transplantation. AlloSure is the first donor-derived cell-free DNA test to assess allograft health and is broadly available to transplant patients. Previous publications demonstrating the clinical value of AlloSure were based on first-time or single kidney transplant recipients, or SKTR; the current study is the first study to include repeat kidney transplant recipients, or RKTR. In patients without evidence of rejection, the median readouts of AlloSure were significantly lower than threshold levels for rejection in both SKTR and RKTR. In patients with active rejection, AlloSure levels were similarly elevated in SKTR and RKTR patients alike.
Thursday, December 20, 2018
Amarin shares will bounce back on 2019 catalysts, says Jefferies
After hosting meetings with management, Jefferies analyst Michael Yee says Amarin represents one of the few “de-risked” standalone blockbuster drugs in the smid-cap Biotech space. Following the stock’s pullback from of $23 to $15, Amarin will “bounce and go back up,” predicts the analyst. He sees 2019 catalysts from “scripts and sales ramp to FDA approval.” Further, a potential takeout is a “wildcard,” writes Yee in a note titled “The Big Fish In A Big Pond? Update from Mgmt Meetings…” The analyst keeps a Buy rating on Amarin with a $30 price target.
No change in talc litigation risk for Johnson & Johnson, says Wells Fargo
Wells Fargo analyst Larry Biegelsen notes that the NY Times reported that Johnson & Johnson has lost its bid to overturn the $4.7B in a talc trial in St. Louis in July 2018. After checking with the company, the analyst is “able to confirm” that the decision relates to the trial judge denying Johnson & Johnson’s post trial motion to set aside the $4.7B verdict. Biegelsen understands that the company had to file this motion in order to file its actual appeal of the decision with the appellate court. As such, he believes the judge’s decision should not materially affect the overall talc situation for Johnson & Johnson. Wells Fargo has an Outperform rating on the shares.
Retrophin completes patient enrollment for Phase 3 FORT study
Retrophin announced completion of patient enrollment in the pivotal Phase 3 FORT Study, which is evaluating the safety and efficacy of fosmetpantotenate for the treatment of pantothenate kinase-associated neurodegeneration, or PKAN, a rare, progressive neurodegenerative genetic disorder. The FORT Study is designed to be registration-enabling in the U.S. and Europe, and top-line results are expected in Q3 of 2019.
https://thefly.com/landingPageNews.php?id=2839887
eHealth initiated at RBC Capital
eHealth initiated with an Outperform at RBC Capital. RBC Capital analyst George Hill initiated eHealth with an Outperform rating and a price target of $57, saying his thesis on the stock reflects a “unique way to invest in the convergent trends of the aging population, Medicare Advantage growth, healthcare’s vertical integration trend, healthcare consumerism and technology.” The analyst is positive on the company’s position as an “online marketplace for the comparison and enrollment in health insurance plans, with a focus on the rapidly growing Medicare Advantage market” and expects it to generate 20% annual revenue growth with faster earnings for the next several years.
https://thefly.com/landingPageNews.php?id=2839905
Spectrum 34% selloff today ‘clearly overdone,’ says Jefferies
Jefferies analyst Roger Song is a “bit surprised” the FDA did not grant Breakthrough Therapy Designation to Spectrum Pharmaceuticals’ poziotinib given the drug’s “impressive” overall response rate and durability versus current options. However, the company is confident that the planned accelerated approval pathway remains unchanged, Song tells investors in a research note. And the analyst continues to believe an ORR of 25%-30% could support an approval. The after-market selloff of 34% is “clearly overdone” as pivotal data could emerge within 6-12 months followed by a potential first-line indication approval, says the analyst. He keeps a Buy rating on Spectrum with a $25 price target. The stock in premarket trading is down $3.64 to $6.80.
https://thefly.com/landingPageNews.php?id=2839935
Xeris granted ODD for investigational ready-to-use liquid glucagon by EMA
Xeris Pharmaceuticals announced that it has received Orphan Medicinal Product designation from the European Medicines Agency for its investigational ready-to-use liquid glucagon as a treatment for non-insulinoma pancreatogenous hypoglycaemia syndrome, a spectrum of metabolic conditions, which includes post-bariatric hypoglycemia. A similar orphan designation was granted by the FDA in January 2018. The EU orphan designation is associated with a 10-year commercial exclusivity for this indication.
https://thefly.com/landingPageNews.php?id=2839949
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