Biotech Stock Roundup: Regeneron, Tesaro Drugs Approved, Vertex Scores Big in Study

Key highlights this week include FDA approval of two highly-awaited drugs – Regeneron REGN/Sanofi’s Dupixent and Tesaro’s TSRO Zejula. Both drugs have blockbuster potential. Vertex VRTX also got a boost with positive data being generated from a couple of late-stage studies.

Recap of the Week’s Most Important Stories

Regeneron, Sanofi Eczema Drug Approved: Regeneron and partner Sanofi gained FDA approval for their eczema treatment, Dupixent. This makes Dupixent the first and only biologic medicine to be approved for the treatment of adults with moderate-to-severe atopic dermatitis (AD) intolerant to or having an inadequate response to an existing therapy. There are about 300,000 adult patients in the U.S. The companies intend to target physicians who treat patients with this chronic and debilitating form of eczema and are experienced in prescribing biologics. Dupixent, which will be launched later this week, has been priced at a wholesale acquisition cost of $37,000 annually. Although the companies pointed out that the price is lower than the cost of biologic treatments for psoriasis, Dupixent could face some initial pricing hurdles given the current focus on drug pricing. Sanofi and Regeneron are working on optimizing patient access and reducing barriers to treatment.

Dupixent has blockbuster potential and is being investigated for other indications as well including asthma and nasal polyps. Regeneron is a Zacks Rank #3 (Hold) stock. You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.

Earlier-than-Expected FDA Nod for Tesaro Drug: Tesaro gained earlier-than-expected FDA approval for its ovarian cancer treatment, Zejula. Zejula got approved with a broad label and is the first and only PARP inhibitor to be approved for the maintenance treatment of women with recurrent ovarian cancer. Zejula also does not require BRCA mutation or other biomarker testing unlike currently available PARP inhibitors like AstraZeneca’s Lynparza and Clovis’ Rubraca. While Tesaro did not provide any pricing information, Zejula, which has blockbuster potential, will be launched in late April (Read more: Tesaro Wins FDA Approval for Ovarian Cancer Drug Zejula). According to an EvaluatePharma report, Zejula is one of the top drug launches this year with sales expected to reach $1.9 billion in 2022.

Vertex Gets a Boost with CF Data: Vertex, which holds a strong position in the cystic fibrosis (CF) market, got a boost with positive data from a couple of late-stage studies evaluating a combination of tezacaftor and Kalydeco (ivacaftor). Statistically significant improvements in lung function were observed in people with CF ages 12 and older who have certain mutations in the cystic fibrosis transmembrane conductance regulator (CFTR) gene.

Vertex plans to seek approval in the U.S. and EU in the third quarter of 2017 for the treatment of people with CF ages 12 and older who have two copies of the F508del mutation and in people who have one mutation that results in residual CFTR function and F508del mutation. So far in 2017, Vertex has outperformed the Zacks-categorized Medical-Biomedical/Genetics industry with shares gaining 21.7% compared to the industry gain of 6.4%.

Xenon Plunges on Acne Study Data: Xenon’s XENE shares were down more than 50% on news that the clinical-stage company’s experimental acne treatment, XEN801, failed to demonstrate efficacy in a mid-stage study. The company said that the topline results do not support the continued development of XEN801.

Alexion Appoints New CEO: Alexion ALXN has ended its quest for a new CEO with the Board appointing Ludwig N. Hantson, Ph.D., effective immediately. Dr. Hantson was earlier the President and CEO of Baxalta, which was subsequently acquired by Shire. Dr. Hantson will be succeeding David R. Brennan, who was the Interim CEO since Dec 2016.

Performance

Medical - Biomedical and Genetics Industry 5YR % Return

Medical - Biomedical and Genetics Industry 5YR % Return

The NASDAQ Biotechnology Index gained 1.4% over the last five trading sessions. Among major biotech stocks, Amgen AMGN declined 1.3% while Regeneron gained 3.1% during this period. Over the last six months, Celgene was up 17.6% while Gilead GILD was down 15% (See the last biotech stock roundup here: Amgen Down on Repatha Data, Nektar Surges on Pain Results).

What's Next in the Biotech World?

Watch out for the usual pipeline and regulatory updates.

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Alexion Pharmaceuticals, Inc. (ALXN): Free Stock Analysis Report
 
Vertex Pharmaceuticals Incorporated (VRTX): Free Stock Analysis Report
 
Regeneron Pharmaceuticals, Inc. (REGN): Free Stock Analysis Report
 
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