Key highlights of the week include FDA’s refusal to file letter for Celgene Corp.’s CELG ozanimod, Gilead Sciences, Inc.’s GILD collaboration with Sangamo Therapeutics, Inc. for using the latter’s technology and positive CHMP opinion for Amgen Inc.’s AMGN Xgeva. Incyte Corp. INCY beat on revenues on strong Jakafi sales in fourth-quarter 2017.
Recap of the Week’s Most Important Stories
FDA Refuses Ozanimod NDA: Following the announcement of the receipt of a Refusal to File letter from the FDA regarding its New Drug Application (“NDA”) for multiple sclerosis candidate ozanimod, shares of Celgene are down in pre-market trading The candidate is being developed for the treatment of patients with relapsing forms of multiple sclerosis.
However, the FDA determined that the nonclinical and clinical pharmacology sections in the NDA were inadequate to allow a complete review. Hence, Celgene will request a Type A meeting with the FDA to ascertain the additional information needed for resubmission of the NDA.
The news comes as a great disappointment for investors as Celgene is taking desperate attempts to bolster its portfolio and reduce overdependence on lead drug, Revlimid. The company recently obtained antitrust clearance for its impending Juno acquisition. Celgene is a Zacks Rank #3 (Hold) stock. You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
Gilead Collaborates with Sangamo: Gilead’s Kite has entered into a collaboration agreement with Sangamo Therapeutics, Inc. Per the agreement, Kite will use Sangamo’s ZFN technology to modify genes to develop next-generation cell therapies for autologous and allogeneic use in oncology. In lieu, Sangamo will receive an upfront payment of $150 million and up to $3.01 billion in potential milestone payments.
Sangamo is also entitled to receive tiered royalties on sales of the potential future products resulting from the collaboration. On the other hand, Kite will be responsible for all development, manufacturing and commercialization of products under the collaboration. Sangamo shares skyrocketed to a high of $25.40 on the news of the collaboration as investors had lots to cheer for given Gilead’s expertise in the biotech field.
CHMP Positive on Amgen’s Xgeva Label Expansion: The Committee for Medicinal Products for Human Use (“CHMP”) of the European Medicines Agency has given a positive opinion to expand the current indication for Amgen’s Xgeva to include skeletal-related events in patients with multiple myeloma. Given the positive results of the phase III study, ‘482, the candidate should get approval for the aforementioned indication.
The study results showed Xgeva successfully met the primary endpoint, demonstrating non-inferiority to zoledronic acid in delaying the time to first on-study skeletal-related event in patients with multiple myeloma. The FDA already approved the company’s Supplemental Biologics License Application for XGEVA to expand the currently approved indication for the prevention of skeletal-related events in patients with bone metastases from solid tumors to include patients with multiple myeloma in January 2018.
Vertex Initiates Phase III Triple Combination Study for CF: Vertex Pharmaceuticals Inc. VRTX, a leader in cystic fibrosis (“CF”) market, announced the initiation of a phase III study, VX-659, tezacaftor and Kalydeco as an investigational triple combination regimen for patients suffering from CF who have one F508del mutation and one minimal function mutation. The study is being conducted to support the submission of a NDA in the United States using data from the four-week primary efficacy endpoint together with safety data through 12 weeks of treatment.
Earlier in the month, the FDA approved Symdeko for the treatment of the underlying cause of CF in patients aged 12 or older who have two copies of the F508del mutation in the cystic fibrosis transmembrane conductance regulator gene or who have at least one mutation that is responsive to tezacaftor/ivacaftor.
Performance
Medical – Biomedical and Genetics Industry 5YR % Return
The NASDAQ Biotechnology Index gained 0.79% over the last five trading sessions. Among major biotech stocks, Vertex gained 3.04%. Over the last six months, Regeneron lost 33.02% while Amgen gained 9.72% (see the last biotech stock roundup here: Biotech Stock Roundup: AbbVie Q4 Results Impress, Ablynx to be Acquired by Sanofi).
What's Next in the Biotech World?
Stay tuned for more regulatory and pipeline updates as we approach the last leg of this earnings season.
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