Breaking News
0
Ad-Free Version. Upgrade your Investing.com experience. Save up to 40% More details

Galapagos' Osteoarthritis Candidate Gets Fast Track Status

By Zacks Investment ResearchStock MarketsNov 28, 2018 05:19AM ET
www.investing.com/analysis/galapagos-osteoarthritis-candidate-gets-fast-track-status-200363284
Galapagos' Osteoarthritis Candidate Gets Fast Track Status
By Zacks Investment Research   |  Nov 28, 2018 05:19AM ET
Saved. See Saved Items.
This article has already been saved in your Saved Items
 

Galapagos NV (NASDAQ:GLPG) announced that the FDA has granted Fast Track designation to its pipeline candidate GLPG1972/S201086 for the treatment of osteoarthritis (OA). GLPG1972/S201086 is already being evaluated in a phase II study (ROCCELLA) conducted by Galapagos and partner Servier to treat knee osteoarthritis patients.

The FDA grants Fast Track designation to expedite development and faster review of a candidate, which is being developed to treat serious and unmet medical conditions. With this designation, a candidate is expected to be granted a priority review, once it files a new drug application.

Galapagos is developing investigational molecule GLPG1972/S201086 with the potential to become a first-in-class disease-modifying osteoarthritis drug (DMOAD).

Galpagos signed a collaboration agreement with Servier for GLPG1972/S201086 in 2010. Galapagos has full U.S. commercial rights to the candidate, with Servier retaining the ex-U.S. rights. Per the agreement, Galapagos is will receive development, regulatory and other milestone payments along with royalties upon commercialization outside the United States.

Shares of the company have increased 4.4% year to date against the industry’s decline of 17.7%.

Galapagos and Servier initiated the global 52-week ROCCELLA study in June this year. The primary objective of ROCCELLA is to evaluate the efficacy of at least one dose of GLPG1972/S201086 compared to placebo in reducing cartilage loss after 52 weeks of treatment. Galapagos will be responsible for conducting the ROCCELLA study in the United States, where 300 patients are expected to be enrolled. Servier will run the study in all other countries.

In June 2016, the company announced that GLPG1972 was generally well tolerated in healthy human volunteers in a phase I first-in-human study. In this study, dosing with GLPG1972 reduced ARGS neoepitope, a biomarker for cartilage breakdown via the ADAMTS-5 pathway, by up to 60% in these volunteers within two weeks.

In another phase Ib studyin osteoarthritis patients in the United States, similar findings were seen over a four-week period. GLPG1972/S201086 was well tolerated and reduced, in a dose-dependent manner, the ARGS neoepitope blood levels by up to 50%.

We remind investors that Regeneron Pharmaceuticals, Inc. (NASDAQ:REGN) and Teva Pharmaceutical Industries Ltd. (NYSE:TEVA) are also developing fasinumab for treating OA in late-stage studies. Pfizer (NYSE:PFE) and partner Lilly are also evaluating tanezumab (subcutaneous) in a late-stage study for the treatment of OA pain of the knee or hip.

Zacks Rank

Galapagos carries a Zacks Rank #3 (Hold). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.

More Stock News: This Is Bigger than the iPhone!

It could become the mother of all technological revolutions. Apple (NASDAQ:AAPL) sold a mere 1 billion iPhones in 10 years but a new breakthrough is expected to generate more than 27 billion devices in just 3 years, creating a $1.7 trillion market.

Zacks has just released a Special Report that spotlights this fast-emerging phenomenon and 6 tickers for taking advantage of it. If you don't buy now, you may kick yourself in 2020.

Click here for the 6 trades >>



Pfizer Inc. (PFE): Free Stock Analysis Report

Galapagos NV (GLPG): Free Stock Analysis Report

Regeneron Pharmaceuticals, Inc. (REGN): Free Stock Analysis Report

Teva Pharmaceutical Industries Ltd. (TEVA): Free Stock Analysis Report

Original post

Zacks Investment Research
Galapagos' Osteoarthritis Candidate Gets Fast Track Status
 

Related Articles

Galapagos' Osteoarthritis Candidate Gets Fast Track Status

Add a Comment

Comment Guidelines

We encourage you to use comments to engage with other users, share your perspective and ask questions of authors and each other. However, in order to maintain the high level of discourse we’ve all come to value and expect, please keep the following criteria in mind:  

  •            Enrich the conversation, don’t trash it.

  •           Stay focused and on track. Only post material that’s relevant to the topic being discussed. 

  •           Be respectful. Even negative opinions can be framed positively and diplomatically. Avoid profanity, slander or personal attacks directed at an author or another user. Racism, sexism and other forms of discrimination will not be tolerated.

  • Use standard writing style. Include punctuation and upper and lower cases. Comments that are written in all caps and contain excessive use of symbols will be removed.
  • NOTE: Spam and/or promotional messages and comments containing links will be removed. Phone numbers, email addresses, links to personal or business websites, Skype/Telegram/WhatsApp etc. addresses (including links to groups) will also be removed; self-promotional material or business-related solicitations or PR (ie, contact me for signals/advice etc.), and/or any other comment that contains personal contact specifcs or advertising will be removed as well. In addition, any of the above-mentioned violations may result in suspension of your account.
  • Doxxing. We do not allow any sharing of private or personal contact or other information about any individual or organization. This will result in immediate suspension of the commentor and his or her account.
  • Don’t monopolize the conversation. We appreciate passion and conviction, but we also strongly believe in giving everyone a chance to air their point of view. Therefore, in addition to civil interaction, we expect commenters to offer their opinions succinctly and thoughtfully, but not so repeatedly that others are annoyed or offended. If we receive complaints about individuals who take over a thread or forum, we reserve the right to ban them from the site, without recourse.
  • Only English comments will be allowed.

Perpetrators of spam or abuse will be deleted from the site and prohibited from future registration at Investing.com’s discretion.

Write your thoughts here
 
Are you sure you want to delete this chart?
 
Post
Post also to:
 
Replace the attached chart with a new chart ?
1000
Your ability to comment is currently suspended due to negative user reports. Your status will be reviewed by our moderators.
Please wait a minute before you try to comment again.
Thanks for your comment. Please note that all comments are pending until approved by our moderators. It may therefore take some time before it appears on our website.
 
Are you sure you want to delete this chart?
 
Post
 
Replace the attached chart with a new chart ?
1000
Your ability to comment is currently suspended due to negative user reports. Your status will be reviewed by our moderators.
Please wait a minute before you try to comment again.
Add Chart to Comment
Confirm Block

Are you sure you want to block %USER_NAME%?

By doing so, you and %USER_NAME% will not be able to see any of each other's Investing.com's posts.

%USER_NAME% was successfully added to your Block List

Since you’ve just unblocked this person, you must wait 48 hours before renewing the block.

Report this comment

I feel that this comment is:

Comment flagged

Thank You!

Your report has been sent to our moderators for review
Disclaimer: Fusion Media would like to remind you that the data contained in this website is not necessarily real-time nor accurate. All CFDs (stocks, indexes, futures) and Forex prices are not provided by exchanges but rather by market makers, and so prices may not be accurate and may differ from the actual market price, meaning prices are indicative and not appropriate for trading purposes. Therefore Fusion Media doesn`t bear any responsibility for any trading losses you might incur as a result of using this data.

Fusion Media or anyone involved with Fusion Media will not accept any liability for loss or damage as a result of reliance on the information including data, quotes, charts and buy/sell signals contained within this website. Please be fully informed regarding the risks and costs associated with trading the financial markets, it is one of the riskiest investment forms possible.
Continue with Google
or
Sign up with Email