Akcea Therapeutics Jumps on European Marketing Approval

By Chris Lange Updated Jan 11, 9:10PM EST · Published Jul 11, 1:20PM EDT

Akcea Therapeutics Jumps on European Marketing Approval — © Sasiistock / Getty Images

Akcea Therapeutics Inc. (NASDAQ: AKCA) shares saw a nice bump on Wednesday after the company announced in conjunction with Ionis Pharmaceuticals, Inc. (NASDAQ: IONS) that they had received a marketing authorization approval from the European Commission (EC).

Specifically, this approval is for the treatment, Tegsedi, of stage 1 or stage 2 polyneuropathy in adult patients with hereditary transthyretin amyloidosis (hATTR). This follows the positive opinion recommending approval provided by the Committee for Medicinal Products for Human Use (CHMP) of European Medicines Agency (EMA).

The EC’s approval of Tegsedi was based on results from the Phase 3 NEURO-TTR study in patients with hATTR with symptoms of polyneuropathy. Results from that study demonstrated that patients treated with Tegsedi experienced significant benefit compared to patients treated with placebo.

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Paula Soteropoulos, CEO of Akcea, commented:

With the EC`s decision, TEGSEDI is now the world`s first and only RNA-targeted therapeutic approved for patients with hATTR amyloidosis. With subcutaneous delivery, TEGSEDI puts treatment in the patients` hands while bringing the significant benefits shown in the NEURO-TTR study in both measures of neuropathy and quality of life for people living with this serious and fatal disease. This is an important day for the hATTR amyloidosis community as we believe TEGSEDI enables people and their families impacted by this disease to move forward with their lives. Today is a milestone for Akcea with our first drug approval. It is an achievement we share with the courageous hATTR patient community in Europe and around the globe. We are ready to launch TEGSEDI along with our patient and physician support services across Europe.

Shares of Akcea were last seen up about 3% at $24.96, with a consensus analyst price target of $32.00 and a 52-week trading range of $1.05 to $33.99.

Ionis shares were trading at $45.00, with a consensus price target of $58.50 and a 52-week range of $39.07 to $65.51.

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About the Author Chris Lange →

Chris Lange is a writer for 24/7 Wall St., based in Houston. He has covered financial markets over the past decade with an emphasis on healthcare, tech, and IPOs. During this time, he has published thousands of articles with insightful analysis across these complex fields. Currently, Lange's focus is on military and geopolitical topics.

Lange's work has been quoted or mentioned in Forbes, The New York Times, Business Insider, USA Today, MSN, Yahoo, The Verge, Vice, The Intelligencer, Quartz, Nasdaq, The Motley Fool, Fox Business, International Business Times, The Street, Seeking Alpha, Barron’s, Benzinga, and many other major publications.

A graduate of Southwestern University in Georgetown, Texas, Lange majored in business with a particular focus on investments. He has previous experience in the banking industry and startups.