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Biotech Stock Roundup: Amgen's Data on Repatha, Catalyst Soars on Firdapse Data

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The biotech sector reacted favorably to President Donald Trump’s selection of Dr. Scott Gottlieb to head the FDA. His nomination is being viewed as a positive with expectations that the drug approval process will be streamlined during his tenure.

Recap of the Week’s Most Important Stories

Amgen Presents Data on PCSK9 Inhibitor: Amgen’s (AMGN - Free Report) PCSK9 inhibitor, Repatha, was found to significantly cut down the need for low-density lipoprotein cholesterol (LDL-C) apheresis in adult patients. Secondary endpoints were also achieved. Apheresis is an invasive procedure involving the removal of LDL-C from a patient's plasma through a special machine. Repatha could represent an alternative treatment option for patients who need apheresis, which can be a time consuming and burdensome process (Read more: Amgen's Repatha Meets Primary Endpoint in Phase III Study).

Amgen also presented encouraging four-year follow up data on Repatha from the OSLER-1 study in JAMA Cardiology. Repatha, when added to standard of care (SOC), achieved median LDL-C reductions of 57%, with no new safety concerns.

Favorable PTAB Ruling for Acorda’s Ampyra: Acorda (ACOR - Free Report) got a bit of a breather with the United States Patent and Trademark Office (USPTO) Patent Trials and Appeal Board (PTAB) upholding four of the company’s patents protecting its flagship drug, Ampyra. The patents were challenged via the inter partes review (IPR) process and are set to expire between 2025 and 2027.

While this decision is a bit of good news for Acorda, the company is still awaiting a decision from the U.S. District Court for the District of Delaware regarding a patent infringement lawsuit involving these four patents as well as another patent (Read more: Acorda's Four Ampyra Patents Upheld by PTAB, Shares Rise).

AbbVie HCV Treatment under Priority Review in Japan: AbbVie’s (ABBV - Free Report) investigational hepatitis C virus (HCV) treatment regimen, glecaprevir/pibrentasvir (G/P), has been granted priority review in Japan. If approved, G/P would provide most of the HCV patients in Japan with a shorter, eight week, once-daily, ribavirin-free treatment option. G/P is currently under accelerated assessment in the EU and priority review in the U.S. AbbVie is a Zacks Rank #3 (Hold) stock. You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.

Catalyst Shoots Up on Firdapse Data: Catalyst Pharma’s (CPRX - Free Report) shares shot up 32.5% on positive top-line data from an investigator sponsored study on Firdapse for the treatment of myasthenia gravis (MG) patients with anti-MuSK antibodies (MuSK-MG). MuSK-MG is an ultra-rare sub-population of MG patients for which there are currently no FDA approved therapies. Catalyst intends to discuss these results with the FDA to determine the regulatory path forward including a pivotal study for this patient population.

Incyte Up on Acquisition Rumors: Incyte’s (INCY - Free Report) shares were up more than 10% over the last week on rumors that Gilead (GILD - Free Report) could buy the company. Incyte has often been considered an acquisition target thanks to the commercial potential of Jakafi and the company’s deep and promising pipeline. While Jakafi is expected to bring in peak sales of $2 billion, Olumiant also represents blockbuster potential if all goes well for the drug which is approved in the EU and under FDA review. Another pipeline candidate with immense commercial potential is epacadostat, which is in phase III development for melanoma. Epacadostat is being evaluated for several other types of cancer as well. Incyte’s early-stage pipeline is also progressing well. So far in 2017, Incyte has outperformed the Zacks-categorized Medical-Biomedical/Genetics industry with shares gaining 52.2% compared to the industry gain of 9.7%.

Performance

Medical - Biomedical and Genetics Industry 5YR % Return

The NASDAQ Biotechnology Index gained 1.5% over the last five trading sessions with the sector reacting positively to President Trump’s FDA nominee. Among major biotech stocks, Regeneron (REGN - Free Report) was up 4.3% while Alexion declined 4.2% on news that the company is cutting its workforce by 7%. Over the last six months, Celgene was up 18.2% while Gilead was down 13.2% (See the last biotech stock roundup here: Trump Tweet Hits Biotech Stocks, Concert Gains on Vertex Deal).

What's Next in the Biotech World?

Watch out for the usual pipeline and regulatory updates.

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