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Biotech Stock Roundup: Gilead Gets FDA Nod for HCV Drug, Regulus Hit by Clinical Hold

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Gilead (GILD - Free Report) once again showed its expertise in the hepatitis C virus (HCV) segment by gaining FDA approval for yet another drug, Epclusa. However, another company, Regulus (RGLS - Free Report) suffered a setback related to its experimental HCV treatment.  

Recap of the Week’s Most Important Stories

1. Gilead got some good news for both its key franchises – HIV and HCV. The company gained European approval for its HIV treatment, Odefsey, the second single tablet regimen containing the Descovy backbone and the third product in the company’s new TAF portfolio to gain approval in Europe (Read more: Gilead's HIV Treatment Odefsey Gains Approval in EU).   

Meanwhile, Gilead continues to expand its blockbuster HCV franchise. The company gained FDA approval for Epclusa, the first all-oral, pan-genotypic, single tablet regimen for the treatment of adults with genotype 1-6 chronic HCV. Epclusa is also approved for use in certain other patient populations (Read more: Why Is Gilead Sciences Stock Gaining Today?).

2. Regulus suffered a setback with the company receiving a verbal notice from the FDA placing its IND for experimental HCV treatment, RG-101, on clinical hold. The clinical hold was placed after the company reported a second serious adverse event (SAE) of jaundice in an early-stage study. The news led to a 49.3% decline in the company’s stock price.

Meanwhile, AbbVie (ABBV - Free Report) decided to terminate its collaboration with Infinity Pharma for the development and commercialization of experimental cancer treatment, duvelisib. Efforts to restructure the partnership proved futile and resulted in global rights to the treatment being returned to Infinity. AbbVie’s decision was not exactly unexpected considering top-line data from the phase II DYNAMO study, while positive, fell short of expectations.

Meanwhile, Infinity said it will be cutting its workforce by 58% and will close certain studies that were being conducted on duvelisib. The company will explore strategic options for the duvelisib program, and will focus on submitting a NDA in the fourth quarter of 2016.

3. The Medicines Company (MDCO - Free Report) got a boost with its experimental antibiotic, Carbavance, meeting FDA as well as EMA pre-specified primary endpoints in a late-stage study (TANGO I) in patients with complicated urinary tract infections (cUTI). Plans are on to seek FDA approval early next year. Carbavance is one of the four candidates in the company’s pipeline that are estimated to have blockbuster potential (Read more: The Medicines Co.'s Carbavance Scores in Phase III Study).

4. GW Pharma’s (GWPH - Free Report) shares are up on positive data from a late-stage study on Epidiolex for the treatment of Lennox-Gastaut syndrome (LGS), a rare and severe form of childhood-onset epilepsy. Earlier this year, Epidiolex had fared well in another late-stage study that was conducted for Dravet syndrome. The company expects to file for FDA approval in the first half of 2017 (Read more: GW Pharmaceuticals Stock Up on Positive Epidiolex Data).

5. Clinical-stage biotech company Xencor (XNCR - Free Report) has signed up with Novartis for the development and commercialization of a couple of pipeline candidates focused on cancer. The deal will see Xencor getting an upfront payment of $150 million and sharing development costs with Novartis. Importantly, Xencor could earn up to $2.41 billion in the form of milestone payments as well as royalties. The deal is a major positive as it not only provides Xencor with a strong partner, it will also bring in funds.  


The NASDAQ Biotechnology Index was down 1.63% over the last five trading days. Weakness reflected uncertainty regarding the impact of Brexit on biotech stocks especially companies which generate significant sales in the EU.



Among major biotech stocks, Gilead gained 0.6% over the last five trading days while Alexion (ALXN - Free Report) was impacted by the Brexit sell-off with shares declining 7.4%. Over the last six months, Alexion lost 39.2%.

What's Next in the Biotech World?

Watch out for the usual pipeline updates and data presentations from biotech companies.

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