Amgen's muscular disorder drug meets main goal in late-stage study
Amgen's Uplizna succeeds in study for muscle-weakening
Analysts say data from another experimental drug not 'competitive'
Shares fall 2% in extended trading on mixed datasets
Adds analyst comments in paragraphs 4, 10 and 11, trial data in paragraph 3, 8 and 9, exec comment in paragraph 6
By Bhanvi Satija and Puyaan Singh
Sept 24 (Reuters) -Amgen AMGN.O said on Tuesday that its drug helped improve daily activities including chewing and swallowing in patients suffering from a rare muscle-weakening disease, meeting the main goal of a late-stage study.
The company is testing its drug, inebilizumab or Uplizna, in patients suffering from myasthenia gravis, which is caused by an abnormal immune reaction that weakens the muscles that control the eyes, mouth, throat and limbs.
In the trial, patients receiving the drug showed an improvement of 4.2 points, or 1.9 when adjusted for placebo, on a commonly used scale for measuring disease impact on daily activities after 26 weeks.
Jefferies analyst Michael Yee said that the data was "a positive upside surprise" and came ahead of his expectations, especially given that the improvement in patients was seen after two doses.
Last year, the U.S. Food and Drug Administration approved Argenx SE's ARGX.BR under-the-skin injection, Vyvgart Hytrulo, as a convenient treatment option for myasthenia gravis.
Engagement with regulatory bodies for Uplizna is underway for use in myasthenia gravis patients and for another immune system-related condition, said Amgen's chief scientific officer James Bradner on a call with analysts.
Uplizna - if approved for myasthenia gravis - will also compete with another treatment, Soliris by AstraZeneca AZN.L.
Shares of the drugmaker fell over 2% to $323.64 in extended trading as it reported data from another experimental drug, rocatinlimab, that succeeded in a late-stage study in patients with atopic dermatitis or eczema.
About 33% of patients in the study showed a 75% or more improvement on an eczema severity index.
Results from this trial "appear to fall short" of already approved drugs like Eli Lilly's LLY.N Ebglyss and Sanofi SASY.PA-Regeneron's REGN.O blockbuster drug Dupixent, said BMO Capital Markets analyst Evan Seigerman.
Seigerman added that while a direct comparison was difficult, full data from Amgen's drug will be closely watched to assess its "competitive positioning."
Reporting by Mariam Sunny, Bhanvi Satija and Puyaan Singh in Bengaluru; Editing by Alan Barona and Shailesh Kuber
Related Assets
Latest News
Disclaimer: The XM Group entities provide execution-only service and access to our Online Trading Facility, permitting a person to view and/or use the content available on or via the website, is not intended to change or expand on this, nor does it change or expand on this. Such access and use are always subject to: (i) Terms and Conditions; (ii) Risk Warnings; and (iii) Full Disclaimer. Such content is therefore provided as no more than general information. Particularly, please be aware that the contents of our Online Trading Facility are neither a solicitation, nor an offer to enter any transactions on the financial markets. Trading on any financial market involves a significant level of risk to your capital.
All material published on our Online Trading Facility is intended for educational/informational purposes only, and does not contain – nor should it be considered as containing – financial, investment tax or trading advice and recommendations; or a record of our trading prices; or an offer of, or solicitation for, a transaction in any financial instruments; or unsolicited financial promotions to you.
Any third-party content, as well as content prepared by XM, such as: opinions, news, research, analyses, prices and other information or links to third-party sites contained on this website are provided on an “as-is” basis, as general market commentary, and do not constitute investment advice. To the extent that any content is construed as investment research, you must note and accept that the content was not intended to and has not been prepared in accordance with legal requirements designed to promote the independence of investment research and as such, it would be considered as marketing communication under the relevant laws and regulations. Please ensure that you have read and understood our Notification on Non-Independent Investment. Research and Risk Warning concerning the foregoing information, which can be accessed here.