trending Market Intelligence /marketintelligence/en/news-insights/trending/4bl4reRaZGNI6i6gt2DBAw2 content
Log in to other products

Login to Market Intelligence Platform

 /


Looking for more?

Contact Us

Request a Demo

You're one step closer to unlocking our suite of comprehensive and robust tools.

Fill out the form so we can connect you to the right person.

If your company has a current subscription with S&P Global Market Intelligence, you can register as a new user for access to the platform(s) covered by your license at Market Intelligence platform or S&P Capital IQ.

  • First Name*
  • Last Name*
  • Business Email *
  • Phone *
  • Company Name *
  • City *
  • We generated a verification code for you

  • Enter verification Code here*

* Required

Thank you for your interest in S&P Global Market Intelligence! We noticed you've identified yourself as a student. Through existing partnerships with academic institutions around the globe, it's likely you already have access to our resources. Please contact your professors, library, or administrative staff to receive your student login.

At this time we are unable to offer free trials or product demonstrations directly to students. If you discover that our solutions are not available to you, we encourage you to advocate at your university for a best-in-class learning experience that will help you long after you've completed your degree. We apologize for any inconvenience this may cause.

In This List

FDA partially halts Ipsen's rare bone disorder studies in children; stock slides

COVID-19 Pandemic Likely To Cause US Telemedicine Boom

Gauging Supply Chain Risk In Volatile Times

S&P Global Market Intelligence

Cannabis: Hashing Out a Budding Industry

Segment

IFRS 9 Impairment How It Impacts Your Corporation And How We Can Help


FDA partially halts Ipsen's rare bone disorder studies in children; stock slides

Ipsen SA said the U.S. Food and Drug Administration partially halted phase 2 and phase 3 trials evaluating its drug palovarotene in patients with rare bone disorders under the age of 14, citing safety concerns.

Following the news, the company stock price fell 13.6% to close at €84.05 on the Euronext Paris stock exchange.

The French pharmaceutical company was testing palovarotene for treating fibrodysplasia ossificans progressiva, or FOP, which has no cure or treatment, as well as multiple osteochondromas, which is usually first diagnosed in patients around age 4. It also causes multiple benign tumors to develop on the bones, leading to limb deformity and restricted development as the children grow.

The decision applies to the patients under 14 who are part of palovarotene phase 2 trials — PVO-1A-202/204 and PVO-2A-201 — and a phase 3 trial called PVO-1A-301, Ipsen said in a Dec. 6 press release.

The FOP trials will continue for patients above the age of 14. However, the clinical studies evaluating palovarotene in patients with multiple osteochondromas primarily include children below the age of 14, so treatment will be stopped and no new patients will be added for the time being, the company added.

The U.S. FDA's decision is based on recent safety reports related to the trials, submitted by the French drugmaker. The company expects the regulator to request more information within the next month.

Ipsen had acquired palovarotene from Montreal-based Clementia Pharmaceuticals Inc. in a $1.31 billion cash deal in April.