The major pipeline and regulatory updates in the biotech sector over the past week included Gilead Sciences’ GILD CAR T therapy Yescarta getting approval in Europe. Meanwhile, Amgen AMGN submitted an sNDA for its multiple myeloma drug, Kyprolis to the FDA.
Recap of the Week’s Most Important Stories:
Gilead’s Yescarta Gets EC Approval: Gilead’s chimeric antigen receptor T cell (CAR-T) therapy, Yescarta was approved by the European Commission (EC). Yescarta is approved in Europe as a treatment for adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) and primary mediastinal large B-cell lymphoma (PMBCL), after two or more lines of systemic therapy. CAR-T therapy harnesses a patient’s own immune system to fight certain types of blood cancer.
The initial uptake of Yescarta also looks encouraging. The drug was approved by the FDA in October 2017. Gilead will have to generate substantial revenues from its HIV franchise and Yescarta to offset HCV sales decline.
Gilead currently sports a Zacks Rank #1 (Strong Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.
Amgen Submits sNDA For Kyprolis: Amgen announced that it has submitted a sNDA to the FDA seeking approval for a once-weekly dosing option with respect to its multiple myeloma drug, Kyprolis, in combination with dexamethasone (Kd). The sNDA was based on positive data from the phase III study, A.R.R.O.W. The FDA will review the sNDA under the Oncology Center of Excellence Real-Time Oncology Review and Assessment Aid pilot programs, which will expedite the review process and ensure safe and effective treatments to patients as early as possible.
Kyprolis is already approved as a monotherapy as well as in combination with dexamethasone or with Celgene Corporations’ Revlimid (lenalidomide) plus dexamethasone for relapsed/refractory multiple myeloma affected patients, having received one to three lines of therapy.
Akcea, Ionis Plunge on CRL From the FDA: Shares of Akcea Therapeutics AKCA and Ionis Pharmaceuticals IONS plunged after the FDA issued a Complete Response Letter (CRL) from the Division of Metabolism and Endocrinology Products of the FDA regarding the New Drug Application (NDA) for Waylivra for the treatment of familial chylomicronemia syndrome (FCS). The contents of the letter were not disclosed.
Waylivra is designed to reduce the production of ApoC-III, a protein produced in the liver that plays a central role in the regulation of plasma triglycerides and may also affect other metabolic parameters. The drug is also under regulatory review in the EU and Canada for the treatment of FCS. In May 2018, the FDA’s Division of Metabolism and Endocrinology Products Advisory Committee voted 12-8 to support approval of Waylivra.
Kala’s Inveltys Gets FDA Approval: Kala Pharmaceuticals KALA announced that the FDA has approved its ocular corticosteroid Inveltys 1% for the treatment of post-operative inflammation and pain following ocular surgery. Per the company, Inveltys is the first twice-daily (BID) ocular corticosteroid approved for this indication. Notably, all other ocular steroids are only approved for four-times-a-day dosing. The drug will be launched in early 2019. The company also has one more candidate in its pipeline. Kala plans to submit a New Drug Application for KPI-121 0.25% for the temporary relief of signs and symptoms of dry eye disease in the second half of 2018.
Performance
Medical – Biomedical and Genetics Industry 5YR % Return
The NASDAQ Biotechnology Index inched up 2.39% over the last five trading sessions. Among the major biotech stocks, Regeneron has gained 3.04%. Over the past six months, Gilead has lost 1.9% while Biogen has rallied 22.4%. (See the last biotech stock roundup here: Biotech Stock Roundup: Label Expansion of Regeneron's Eylea, Vertex's Kalydeco)
What's Next in Biotech?
Stay tuned for regulatory updates and pipeline development news.
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