Sanofi's Blood Clotting Drug Gets Positive CHMP Opinion

Shutterstock photo

Sanofi SNY announced that the Committee for Medicinal Products for Human Use ("CHMP") of the European Medicines Agency ("EMA") has issued a positive opinion recommending approval of Cablivi (caplacizumab). A marketing authorization application ("MAA") is seeking approval of the candidate for the treatment of patients experiencing an episode of acquired thrombotic thrombocytopenic purpura (aTTP), a rare blood-clotting disorder.

This is the first drug to receive CHMP recommendation for the treatment of aTTP. A potential approval by the European Medical Agency, expected in the coming months, will help the drug gain market share with first-mover advantage in this indication.

Sanofi added the candidate to its pipeline with the acquisition of Ablynx earlier in January.

The stock has lost 7% so far this year, underperforming the industry 's decrease of 5.1%.

The MAA was backed by positive data from phase II TITAN study and phase III HERCULES study evaluating Cablivi in combination with standard-of-care. Data showed that the combination achieved a significantly shorter time to platelet count response and significant reductions in aTTP-related death, recurrence of aTTP, or at least one major thromboembolic event.

A follow-up study is evaluating Cablivi in patients who have completed the HERCULES study for long-term safety and efficacy of the candidate.

A biologics license application is expected to be filed for Cablivi in the United States this year.

We note that Genentech, a subsidiary of Roche RHHBY and Biogen, Inc. BIIB are developing Rituxan in partnership which is currently being evaluated in a phase II study for the treatment of aTTP.

Sanofi is focused on strengthening its leadership in rare diseases and has made a few acquisitions this year so far in this regard. Albynx acquisition has also added an anti-Respiratory Syncytial Virus nanobody to Sanofi's pipeline. Apart from Albynx, Sanofi acquired Bioverativ, adding a hemophilia candidate. The company also obtained global rights for fitusiran from Alnylam Pharmaceuticals, Inc. ALNY , which is being developed for the treatment of hemophilia A and B.

Sanofi Price

Sanofi Price | Sanofi Quote

Sanofi currently carries a Zacks Rank #4 (Sell).

You can see the complete list of today's Zacks #1 Rank (Strong Buy) stocks here .

Today's Stocks from Zacks' Hottest Strategies

It's hard to believe, even for us at Zacks. But while the market gained +21.9% in 2017, our top stock-picking screens have returned +115.0%, +109.3%, +104.9%, +98.6%, and +67.1%.

And this outperformance has not just been a recent phenomenon. Over the years it has been remarkably consistent. From 2000 - 2017, the composite yearly average gain for these strategies has beaten the market more than 19X over. Maybe even more remarkable is the fact that we're willing to share their latest stocks with you without cost or obligation.

See Them Free>>

Want the latest recommendations from Zacks Investment Research? Today, you can download 7 Best Stocks for the Next 30 Days. Click to get this free report

Roche Holding AG (RHHBY): Free Stock Analysis Report

Sanofi (SNY): Free Stock Analysis Report

Alnylam Pharmaceuticals, Inc. (ALNY): Free Stock Analysis Report

Biogen Inc. (BIIB): Free Stock Analysis Report

To read this article on Zacks.com click here.

Zacks Investment Research

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

This article appears in: Investing , Business , Stocks
Referenced Symbols: RHHBY , SNY , ALNY , BIIB

More from Zacks.com




Equity Research

Research Brokers before you trade

Want to trade FX?