Orphazyme (ORPH) addresses recent trading activity, not aware of any material change
- Wall Street falls with Amazon; S&P 500 posts sixth straight month of gains
- Amazon (AMZN) Plunges After Missing Sales and Guidance Expectations, Analysts Slash PTs to Reflect Weaker Guidance
- Pinterest (PINS) Tops Profit and Sales Views, But Shares Plunges Over 20% on a Big Monthly User Miss to Prompt Two Downgrades
- 'I'm CEO.' New Book Outlines Merger Conversations Between Elon Musk and Tim Cook
- Bullard: Fed should taper this fall, go "fairly rapidly" to end early 2022
Get instant alerts when news breaks on your stocks. Claim your 1-week free trial to StreetInsider Premium here.
Orphazyme A/S (ORPHA.CO; ORPH), a late-stage biopharmaceutical company pioneering the heat shock protein response for the treatment of rare diseases, today announced that American Depositary Shares (ADSs) representing its ordinary shares on Nasdaq US have since June 10, 2021 experienced extreme volatility in price and trading volume. The company is not aware of any material change in its clinical development programs, financial condition or results of operations that would explain such price volatility or trading volume that has occurred since June 10, 2021. Investors who purchase the company’s ADS or shares may lose a significant portion of their investments if the price of such securities subsequently declines.
Orphazyme’s applications for arimoclomol (to be branded MIPLYFFATM)1 for Niemann-Pick disease type C (NPC) are under priority review with the U.S. Food and Drug Administration, with an expected PDUFA action date of June 17 2021, as well as with the European Medicines Agency, with an opinion from the Committee for Medicinal Products for Human Use (CHMP) expected later this year.
Serious News for Serious Traders! Try StreetInsider.com Premium Free!
You May Also Be Interested In
- ERYTECH (ERYP) More than Doubles as FDA Grants Fast Track Designation for Eryaspase in Hypersensitive ALL
- ERYTECH (ERYP) Halted on LUDP, Up 107%
- Regeneron (REGN) Says FDA Expands Use of REGEN-COV
Create E-mail Alert Related CategoriesCorporate News, Hot Corp. News, Momentum Movers, Trader Talk
Related EntitiesPDUFA, FDA
Sign up for StreetInsider Free!
Receive full access to all new and archived articles, unlimited portfolio tracking, e-mail alerts, custom newswires and RSS feeds - and more!