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Biotech Stock Roundup: Pricing Concerns Hit Biotech Stocks, EU Nod for Regeneron's Praluent

Once again, pricing concerns overshadowed all other developments in the biotech sector over the last five trading days. The NASDAQ Biotechnology Index was down a sharp 13.5% with investors remaining jittery about possible legislative action regarding escalating prices of drugs (See the last biotech stock roundup here: Clinton's Tweet Shakes Biotech Stocks, Amgen In Pipeline-Boosting Deals ).

Recap of the Week's Most Important Stories

1. The biotech sector, which saw a major selloff ever since Democratic presidential candidate Hillary Clinton tweeted about the increasing cost of drugs, remains under pressure as concerns regarding price control refuse to abate. The situation worsened when earlier this week, House Democrats submitted an application seeking a subpoena requiring Valeant Pharmaceuticals to provide documents relating to massive price increases for a couple of drugs (Nitropress' 212% hike and Isuprel's 525% hike) acquired by the company. Concerns remain that biotech companies with high priced drugs may face similar action.

2. Regeneron REGN and partner Sanofi scored another win with their PCSK9 inhibitor, Praluent, gaining EU approval. Praluent, already available in the U.S., is one of the most highly-awaited new treatments to gain approval this year. (Read more: Regeneron/Sanofi's PCSK9 Inhibitor Praluent Approved in EU ).

3. It's been a busy week across the pond with quite a few companies gaining positive opinions from the EMA's Committee for Medicinal Products for Human Use (CHMP) for their experimental treatments that are currently under EU review. So, while Vertex VRTX got positive opinions for its cystic fibrosis drugs - Orkambi and Kalydeco (label expansion), the CHMP is also in favor of approving Gilead's GILD once-daily single tablet regimen, Genvoya.

Other products that got a positive opinion from the CHMP include Biogen's BIIB hemophilia A treatment, Elocta and Celgene's CELG blood cancer treatment, Vidaza (label expansion) among others.

4. Incyte INCY got a shot in the arm with the company and its partner Eli Lilly reporting positive data on their oral JAK inhibitor, baricitinib, from a phase III rheumatoid arthritis study. Baricitinib not only showed non-inferiority to a commonly used treatment, it was found to be superior. This makes it the third positive study for baricitinib.

Results from another phase III study should be out later this year. The companies could be in a position to file for and gain approval next year and add a potential blockbuster drug to their portfolio.

5. AbbVie ABBV has decided to move its JAK1 inhibitor, ABT-494, into phase III studies by year end following the release of positive mid-stage data on rheumatoid arthritis. The company also said that it won't in-license the Galapagos JAK1 inhibitor, filgotinib (Read more: AbbVie Updates on Viekirax and Rheumatoid Arthritis Pipeline ).

Performance

All major biotech stocks were down over the last five trading days with the NASDAQ Biotechnology Index declining 13.5% during this period. While Regeneron recorded a decline of 14.8% during this period, Biogen recorded a decline of 35.3% over the last six months .

Company Last Week Last 6 Months
AMGN -8.30% -16.90%
BIIB -6.97% -35.28%
GILD -9.87% -4.23%
CELG -10.43% -11.24%
REGN -14.78% -0.59%
ALXN -7.22% -18.18%
VRTX -12.74% -17.04%

What's Next in the Biotech World?

Watch out for the usual pipeline and regulatory updates from biotech companies this week.

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VERTEX PHARM (VRTX): Free Stock Analysis Report

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GILEAD SCIENCES (GILD): Free Stock Analysis Report

CELGENE CORP (CELG): Free Stock Analysis Report

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The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc.


The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc.

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