Key updates in the biotech sector included earnings results from several companies like BioMarin BMRN and Sarepta, while Kite KITE saw its shares soaring on positive data on its lead pipeline candidate.
Recap of the Week’s Most Important Stories
Kite Shoots up on CAR-T Data: Kite, which reported a narrower-than-expected loss for the fourth quarter, saw its shares shoot up on positive topline data from a key study on its investigational CAR-T therapy, axicabtagene ciloleucel. Results from the primary analysis of the study in patients with chemorefractory aggressive non-Hodgkin lymphoma (NHL) showed that 41% of patients achieved a response including 36% who were in complete response (CR) at month 6. Kite said that the median overall survival (OS) has not been reached yet. The key takeaway from the data was the durability of response compared to data presented for month 3.
Kite expects to finish submitting its rolling BLA for axicabtagene ciloleucel in aggressive NHL by the end of this quarter while the EU application will be submitted this year. According to the company, the recently released data indicates that more than a third of patients with refractory aggressive NHL could be cured after a single infusion of axicabtagene ciloleucel.
Kite’s shares were up 24.5% on the data. Year to date (YTD), the company has outperformed the Zacks-categorized Medical-Biomedical/Genetics industry with shares shooting up 57.6% compared to the industry gain of 8.6%.
A Look at Some Earnings Results: Several companies like BioMarin, The Medicines Co., Sarepta and Exelixis EXEL reported fourth quarter results over the last few days. Both Exelixis (Read more: Exelixis Reports Q4 Earnings, Revenues Beat Y/Y) and BioMarin (Read more: BioMarin Q4 Loss Narrower than Expected; Sales Beat) topped estimates. Sarepta’s loss was narrower-than-expected while revenues were in line with expectations. However, the company’s revenue guidance fell short of expectations.
Exelixis Ties Up with Roche, Bristol-Myers for IO Combinations: Exelixis entered into a couple of clinical trial collaborations with Roche and Bristol-Myers. While the Roche collaboration will see the companies evaluating Exelixis’ TKI, Cabometyx, with Roche’s anti-PD-L1 immunotherapy, atezolizumab, in locally advanced or metastatic solid tumors, the Bristol-Myers deal will see the companies evaluating Cabometyx plus Bristol-Myers’ PD-1 immune checkpoint inhibitor Opdivo alone or in combination with Yervoy in first-line renal cell carcinoma. There could be additional studies in bladder cancer and hepatocellular carcinoma. With these deals, Exelixis is looking to expand the Cabometyx franchise through immuno-oncology (IO) combinations.
Amgen’s Kyprolis Fares Well in Head-to-Head Study: Amgen AMGN announced data from the head-to-head ENDEAVOR study which showed that patients with relapsed or refractory multiple myeloma lived 7.6 months longer when treated with Amgen’s Kyprolis and dexamethasone compared to those treated with Velcade and dexamethasone. While Kyprolis is already approved for this patient population, this overall survival data should help drive usage and boost sales. Kyprolis is one of the key products in Amgen’s portfolio that is expected to drive long term growth. The product brought in sales of $692 million in 2016. The multiple myeloma market is a growing but highly competitive market given the presence of new treatment options.
Celgene Blood Cancer Drug’s EU Label Expanded: Celgene’s CELG key revenue generator, Revlimid, can now be used in the EU as monotherapy for the maintenance treatment of adult patients with newly diagnosed multiple myeloma who have undergone autologous stem cell transplantation (ASCT). The label expansion makes Revlimid the first and only licensed maintenance treatment available for this patient population. The U.S. label for this patient population was expanded last week. Label expansion into this indication will be a significant driver of Revlimid sales. Revlimid sales, which came in at $6.974 billion in 2016, are expected in the range of $8 - $8.3 billion in 2017. Celgene is a Zacks Rank #2 (Buy) stock. You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
Medical - Biomedical and Genetics Industry 5YR % Return
Medical - Biomedical and Genetics Industry 5YR % Return
The NASDAQ Biotechnology Index was up 1.5% over the last five trading sessions. All major biotech stocks recorded gains with Vertex VRTX increasing 4.7% followed by Celgene which was up 3.4%. Over the last six months, Celgene was up 14.4% while Gilead GILD was down 9.8% (See the last biotech stock roundup here: Alexion Reports 4Q Results, Celgene MS Drug Looks Promising).
What's Next in the Biotech World?
Watch out for the usual pipeline and regulatory updates.
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Vertex Pharmaceuticals Incorporated (VRTX): Free Stock Analysis Report
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