Track the companies that matter to you. It's FREE! Click one of these fan favorites to get started: Apple; Google; Ford.



FDA Lifts Clinical Hold on Curis Cancer Drug, Shares Surge

Watch stocks you care about

The single, easiest way to keep track of all the stocks that matter...

Your own personalized stock watchlist!

It's a 100% FREE Motley Fool service...

Click Here Now

Curis' (NASDAQ: CRIS  ) cancer drug just got a second lease on life. Now the Lexington, Mass.-based company will have to make something of it.

Curis said today that the FDA has lifted the partial clinical hold on CUDC-427, the experimental cancer drug it licensed from Genentech a few years ago. The FDA's decision takes CUDC-427 out of limbo; Curis can now go ahead and proceed with the early-stage trial it had been running before it was slapped with the partial hold in November.

Shares of Curis surged about 21% in pre-market trading on Monday before fading back to a roughly 11% gain.

"We have worked diligently with the FDA and anticipate reopening of the monotherapy Phase 1 study as soon as possible," Curis' president and chief operating officer, Ali Fattaey, said in a statement.

Curis picked up CUDC-427 in November 2012 when it paid South San Francisco-based Genentech $9.5 million up front and lined up $30 million in debt financing from a fund managed by New York-based Pharmakon Advisors to move the program forward. The experimental drug is supposed to block proteins that help cancer cells avoid apoptosis, or programmed cell death.

Curis kicked off a phase 1 trial of CUDC-427 in the third quarter of 2013, evaluating the drug in patients with advanced and refractory solid tumors or lymphomas and trying to find the right dose to use in a mid-stage study. But that effort came to a screeching halt in November due to safety concerns. The liver enzymes of one patient in the trial spiked under treatment, and didn't subside after discontinuing the drug. That patient suffered liver failure about a month later and died. The FDA promptly froze the CUDC-427 study. Shares of Curis plummeted.

Genentech saw troubling signs in an early study of CUDC-427, before it licensed the drug to Curis -- a few patients saw their liver enzyme levels increase during that phase 1 trial. Curis has said, however, that that didn't lead to any serious health problems.

Curis couldn't restart its trial until it gave the FDA detailed data about all patients treated with CUDC-427 and submitted a protocol amendment that the agency agreed with. Though the hold has now been lifted, Curis didn't detail how it plans to change the study. Curis wants to test CUDC-427 as a monotherapy and in tandem with capecitabine (Xeloda) in patients with certain types of breast cancer.

Curis' only approved drug also comes from a deal with Genentech. It worked together with Genentech on vismodegib (Erivedge), a treatment for a common form of skin cancer called basal cell carcinoma. The company is about to give investors a look at some of its other prospects shortly, however. Curis will present some data from its early studies of CUDC-427 and a few other in-house drug candidates at the American Association for Cancer Research's annual meeting in early April.

Three stocks poised to be multibaggers
The one sure way to get wealthy is to invest in a groundbreaking company that goes on to dominate a multibillion-dollar industry. Our analysts have found multi-bagger stocks time and again. And now they think they've done it again with three stock picks that they believe could generate the same type of phenomenal returns. They've revealed these picks in a new free report that you can download instantly by clicking here now.

This article originally appeared on Xconomy, along with:

Read/Post Comments (0) | Recommend This Article (1)

Comments from our Foolish Readers

Help us keep this a respectfully Foolish area! This is a place for our readers to discuss, debate, and learn more about the Foolish investing topic you read about above. Help us keep it clean and safe. If you believe a comment is abusive or otherwise violates our Fool's Rules, please report it via the Report this Comment Report this Comment icon found on every comment.

Be the first one to comment on this article.

Sponsored Links

Leaked: Apple's Next Smart Device
(Warning, it may shock you)
The secret is out... experts are predicting 458 million of these types of devices will be sold per year. 1 hyper-growth company stands to rake in maximum profit - and it's NOT Apple. Show me Apple's new smart gizmo!

DocumentId: 2896717, ~/Articles/ArticleHandler.aspx, 8/29/2015 3:17:20 PM

Report This Comment

Use this area to report a comment that you believe is in violation of the community guidelines. Our team will review the entry and take any appropriate action.

Sending report...


Xconomy is dedicated to providing business and technology leaders with timely, insightful, close-to-the-scene information about the local personalities, companies, and technological trends that best exemplify today’s high-tech economy. Find out more at

Today's Market

updated 18 hours ago Sponsored by:
DOW 16,643.01 -11.76 -0.07%
S&P 500 1,988.87 1.21 0.06%
NASD 4,828.33 15.62 0.32%

Create My Watchlist

Go to My Watchlist

You don't seem to be following any stocks yet!

Better investing starts with a watchlist. Now you can create a personalized watchlist and get immediate access to the personalized information you need to make successful investing decisions.

Data delayed up to 5 minutes

Related Tickers

8/28/2015 4:00 PM
CRIS $2.59 Up +0.09 +3.60%
Curis, Inc. CAPS Rating: ***