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Biotech Stock Roundup: Gilead's HIV Drug Approved, Regeneron Up on Positive Data

Key highlights in the biotech sector this week include the FDA approval of Gilead’s GILD third TAF-based HIV treatment as well as an acquisition announcement by the company. Meanwhile, Regeneron REGN could well have another blockbuster treatment in its portfolio with its experimental eczema treatment doing well in a couple of late-stage studies. And, once again acquisition rumors have surfaced – this time, Medivation MDVN is rumored to be a takeover target.

Recap of the Week’s Most Important Stories

1. Gilead gained FDA approval for yet another of its HIV treatments, Descovy. Descovy, which is considered to have blockbuster potential, is the third TAF-based HIV therapy in Gilead’s portfolio. While the FDA approval of Descovy is good news for the company, Gilead continues to work on expanding its pipeline.

The company said that it will be spending up to $1.2 billion to acquire Nimbus Apollo, Inc. and its acetyl-CoA carboxylase (ACC) inhibitor program. With this acquisition, Gilead will be gaining an ACC inhibitor being developed for the treatment of non-alcoholic steatohepatitis (NASH), a serious liver disease (Read more: Gilead Descovy Wins FDA Nod, To Buy Nimbus Liver Program).

2. Regeneron and Sanofi’s experimental eczema treatment, dupilumab, met the primary endpoints in a couple of late-stage studies. Plans are on to submit regulatory applications in the third quarter of the year. If approved, the drug could bring in blockbuster sales (Read more: Regeneron, Sanofi Up, Eczema Drug Tops Phase III Studies).

3. Medivation’s shares, which had declined on pricing concerns regarding its prostate cancer drug Xtandi (Read more: Medivation Prostate Cancer Drug Xtandi under Pricing Attack), saw its shares rebounding on acquisition rumors. With Xtandi bringing in multi-million dollar sales and being developed for additional indications, Medivation has often been considered an acquisition target.

4. Intercept’s ICPT shares are up on briefing documents released ahead of an FDA advisory panel meeting to be held on Apr 7 for the company’s obeticholic acid (OCA). Intercept is seeking FDA approval for the treatment of primary biliary cirrhosis (PBC) in combination with ursodeoxycholic acid (UDCA) in adults with an inadequate response to UDCA, or as monotherapy in patients unable to tolerate UDCA.

5. A couple of major biotech companies, AbbVie ABBV and Biogen BIIB, got positive CHMP opinions for their marketing applications in the EU. AbbVie got a positive opinion for the use of Humira for the treatment of moderately to severely active Crohn's disease in pediatric patients (6 years onwards) who have not responded adequately to conventional therapy or are intolerant to or have contraindications for such therapies (Read more: AbbVie Up, Wins CHMP Backing for Humira's Expanded Use).

Meanwhile, Biogen’s Flixabi, a biosimilar version of Remicade, got a favorable opinion. Flixabi is being developed by Biogen’s joint venture with Samsung BioLogics and approval would make it the second anti-TNF biosimilar to be commercialized and manufactured by Biogen in the EU.


Alexion ALXN gained (10.03%) the most last week among major biotech stocks, while Regeneron shares were up 9.88%. Meanwhile, Vertex lost 26.51% over the last six months with Amgen recording a gain (7.64%) during this period.

CompanyLast WeekLast 6 Months

The NASDAQ Biotechnology Index was up 5.15% over the last five trading days (See the last biotech stock roundup here: Gilead & Biogen's Patent Woes, Amgen Scores Win in Patent Litigation).

What's Next in the Biotech World?

An FDA advisory panel will be meeting this week to review Intercept’s regulatory application for OCA.

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ALEXION PHARMA (ALXN): Free Stock Analysis Report
REGENERON PHARM (REGN): Free Stock Analysis Report
GILEAD SCIENCES (GILD): Free Stock Analysis Report
MEDIVATION INC (MDVN): Free Stock Analysis Report
BIOGEN INC (BIIB): Free Stock Analysis Report
ABBVIE INC (ABBV): Free Stock Analysis Report
INTERCEPT PHARM (ICPT): Free Stock Analysis Report
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