Citi analyst Liav Abraham believes expectations heading into November’s FDA panel on Alkermes’ depression drug are low, implying a favorable risk-reward heading into the event. While key opinion leaders have expressed concerns around ALKS 5461’s “mixed” clinical data, they acknowledge the need for alternative therapeutic options in the adjunctive major depressive disorder space given, Abraham tells investors in a research note. The analyst sees reasons for the panel to vote either way ahead of the release of the briefing documents. She keeps a Buy rating on Alkermes.
Friday, September 21, 2018
Citi opens 30 day catalyst watch for Epizyme
Citi analyst Robyn Karnauskas opened a 30 day catalyst watch for Epizyme in anticipation of an FDA decision on the partial hold on Tazemetostat. In the best case scenario, the analyst expects the partial hold to be lifted at the end of the 30 day period without any further delay. She notes that We note that Tazemetostat has been investigated in multiple indications, administered to 750 patients, and shown an overall positive safety profile with only a single case of secondary lymphoma. The analyst keeps a Buy rating on Epizyme.
Agenus closes $15M partial royalty monetization with Xoma
Agenus (AGEN) announced the closing of its non-dilutive royalty transaction with Xoma (XOMA), where Xoma purchased a minority interest in the royalties and milestones that Agenus is eligible to receive from Incyte (INCY) and Merck (MRK). Agenus received $15M at closing and retains the majority (67%) of all future royalties and 90% of all milestones from Incyte and Merck. Agenus also remains eligible to receive up to an additional $450M and $85.5M in potential development, regulatory and commercial milestones from Incyte and Merck, respectively.
Cardinal Health price target raised to $60 from $56 at RBC Capital
RBC Capital analyst George Hill raised his price target on Cardinal Health to $60 on slight adjustment of his rolled-forward model related to the timing of the company’s earnings. The analyst keeps his Sector Perform rating however and warns that operational issues in its Medical business will weight on the results while its brand drug business also proves to be “optimistic”. Hill further contends that Cardinal Health’s brand drug pricing increase may come in below expectations, lowering FY19 EPS view to $4.79 from $4.87 which is below its current guidance range of $4.90-$5.15.
Spark Therapeutics announces CHMP approval recommendation for Luxturna
Spark Therapeutics (ONCE) announced that the Committee for Medicinal Products for Human Use, or CHMP, of the European Medicines Agency, or EMA, adopted a positive opinion recommending approval of Luxturna, a one-time gene therapy for the treatment of adult and pediatric patients with vision loss due to inherited retinal dystrophy caused by confirmed biallelic RPE65 mutations and who have sufficient viable retinal cells. The positive CHMP opinion is based on data from a Phase 1 clinical trial, its follow-up trial and a Phase 3 trial that together enrolled 43 participants with inherited retinal disease caused by mutations on both copies of the RPE65 gene. The Phase 3 trial was the first randomized, controlled Phase 3 gene therapy trial for a genetic disease. Spark Therapeutics has received orphan product designation for Luxturna from EMA for the treatment of inherited retinal dystrophies. A marketing authorization decision from the European Commission is anticipated approximately within two months. If approved, the authorization will be valid in all 28-member states of the European Union, as well as Iceland, Liechtenstein and Norway. In January, Spark Therapeutics entered into a licensing and supply agreement with Novartis (NVS) to commercialize Luxturna when and if approved in Europe and all markets outside the U.S.
Novartis receives positive CHMP opinion for Gilenya
Novartis announced the Committee for Medicinal Products for Human Use, or CHMP, of the European Medicines Agency, or EMA, has recommended approval of Gilenya for the treatment of children and adolescents 10 to 17 years of age with relapsing remitting forms of multiple sclerosis, or RRMS. If approved, Gilenya is expected to be the first oral disease-modifying therapy indicated for these patients based on a randomized controlled clinical study. The younger patient population experiences two-to-three times as many relapses as adults, often leading to a more severe prognosis and earlier disability compared to adult-onset MS. If approved, Gilenya would address the urgent need faced by these young people. This market authorization would expand the age range of Gilenya, one of the most prescribed MS treatments worldwide. Gilenya was previously approved for adults with RRMS aged 18 years and older in Europe.
Sandoz receives positive CHMP opinion for proposed biosimilar pegfilgrastim
Sandoz, a Novartis, announced that the Committee for Medicinal Products for Human Use of the European Medicines Agency has adopted a positive opinion for marketing authorization of its proposed biosimilar pegfilgrastim, a long-acting version of supportive oncology care medicine filgrastim. Sandoz is committed to increasing patient access to high-quality biosimilars, with five marketed and seven approved biosimilars in Europe. Pegfilgrastim is a long-acting form of filgrastim, a biosimilar medicine that stimulates the production of white blood cells and stem cells. Sandoz is seeking approval for use of biosimilar pegfilgrastim in the same indication as the reference medicine, for the prevention of chemotherapy-induced infection, known as febrile neutropenia, which includes fever brought on by low neutrophils. The comprehensive data package, submitted as part of the Marketing Authorization Application, includes analytical, preclinical, and clinical data, which demonstrate that Sandoz biosimilar pegfilgrastim matches the reference medicine in terms of safety, efficacy and quality. Febrile neutropenia is a serious and possibly life-threatening condition that can develop in people with cancer who receive chemotherapy. Despite treatment advances, febrile neutropenia may pose risks to a person’s chemotherapy treatment plan, with consequences such as dose reductions, discontinuation of treatment or changing to a less effective regimen. The European Commission takes binding decisions on the authorization of medicines valid throughout the EU. It bases its decisions on scientific assessments by the CHMP, ensuring that medicines comply with high quality, safety and efficacy standards. If approved by the EC, the centralized marketing authorization will be valid in the 28 countries that are members of the EU. Norway, Iceland and Liechtenstein, as members of the European Economic Area, will take corresponding decisions based on the EC’s recommendation.
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