The Week's Worst Clinical Failures

See which companies suffered the worst clinical setbacks last week.

Mar 26, 2014 at 2:30PM

While there were plenty of winners last week, two losers stand out. The first failure belongs to GlaxoSmithKline (NYSE:GSK). This giant is leading the industry with 20 new molecular entity approvals over the past six years. But its recent failure shows how the complexities of human biology can bring down even the best.

The largest miss last week wasn't necessarily a failure at all. The FDA gave Geron (NASDAQ:GERN) another lesson in regulator unpredictability.

Strike 2
Last fall, cancer vaccine MAGE-A3 from GlaxoSmithKline failed a late-stage trial by not significantly extending disease-free survival in melanoma patients. Last week, the vaccine failed similar endpoints for sufferers of non-small cell lung cancer.

Shares of GlaxoSmithKline finished the week down almost 3% following the news, but its partner for the vaccine really took it on the chin. Agenus (NASDAQ:AGEN) closed out the week down more than 16% following the announcement. The company's tree-bark derived QS-21 Stimulon adjuvant is a component of Glaxo's vaccine. It also comprises a one-third Agenus' core technology portfolio.

GlaxoSmithKline isn't giving up on the vaccine yet. Investigators will continue both trials in hopes of finding a genetic subset of the patient population that shows a stronger response.

Hold on
The ballad of imetelstat hit a sour note earlier this month when the FDA slapped a full clinical hold on trials sponsored by Geron. The company's shares sank more than 60% following the announcement. Last week the agency stepped in on an investigator-sponsored trial at the Mayo Clinic. In both trials the regulator cited signs of liver damage as the reason for intervention.

There are rays of hope for Geron and imetelstat. The regulator placed a probationary partial-hold on the investigator-sponsored trial with myelofibrosis patients. Those that clearly display clinical benefit will be allowed to continue with the treatment. More importantly, the FDA wants proof that liver enzyme elevations are reversible.

In the conference call following the first hold, Geron CEO, John Scarlett tried to assure analysts that wouldn't be a problem. The company noticed elevations in the past and adjusted dosing temporarily, which led to a reversal.

A lack of effective myelofibrosis therapies might soften the FDA's stance. At the moment, Incyte's (NASDAQ:INCY) Janus kinase, or JAK inhibitor, Jakafi is the only approved treatment, but several companies have similar drugs in late-stage development.

Last year, Gilead Sciences (NASDAQ:GILD) acquired momelotinib, along with YM Biosciences. Gilead has since advanced the JAK inhibitor into late stage trials. While these drugs alleviate symptoms, their ability to slow progression of the disease is unproven.

Imetelstat is a first-in-class telomerase inhibitor that actually caused a complete response in some myelofibrosis patients. Given that imetelstat is the only therapy proven to slow progression of a potentially fatal disease, I would be surprised if the FDA let minor, potentially reversible liver damage keep it off the market.

Unfortunately, the FDA can be full of surprises. If the FDA doesn't lift the hold, Geron is in serious trouble, as imetelstat is the company's sole product candidate.

6 growth stocks without the question marks
They said it couldn't be done. But David Gardner has proved them wrong time, and time, and time again with stock returns like 926%, 2,239%, and 4,371%. In fact, just recently one of his favorite stocks became a 100-bagger. And he's ready to do it again. You can uncover his scientific approach to crushing the market and his carefully chosen six picks for ultimate growth instantly, because he's making this premium report free for you today. Click here now for access.

Cory Renauer has no position in any stocks mentioned. The Motley Fool recommends Gilead Sciences. Try any of our Foolish newsletter services free for 30 days. We Fools may not all hold the same opinions, but we all believe that considering a diverse range of insights makes us better investors. The Motley Fool has a disclosure policy.

1 Key Step to Get Rich

Our mission at The Motley Fool is to help the world invest better. Whether that’s helping people overcome their fear of stocks all the way to offering clear and successful guidance on complicated-sounding options trades, we can help.

Feb 1, 2016 at 4:54PM

To be perfectly clear, this is not a get-rich action that my Foolish colleagues and I came up with. But we wouldn't argue with the approach.

A 2015 Business Insider article titled, "11 websites to bookmark if you want to get rich" rated The Motley Fool as the #1 place online to get smarter about investing.

"The Motley Fool aims to build a strong investment community, which it does by providing a variety of resources: the website, books, a newspaper column, a radio [show], and [newsletters]," wrote (the clearly insightful and talented) money reporter Kathleen Elkins. "This site has something for every type of investor, from basic lessons for beginners to investing commentary on mutual funds, stock sectors, and value for the more advanced."

Our mission at The Motley Fool is to help the world invest better, so it's nice to receive that kind of recognition. It lets us know we're doing our job.

Whether that's helping the entirely uninitiated overcome their fear of stocks all the way to offering clear and successful guidance on complicated-sounding options trades, we want to provide our readers with a boost to the next step on their journey to financial independence.

Articles and beyond

As Business Insider wrote, there are a number of resources available from the Fool for investors of all levels and styles.

In addition to the dozens of free articles we publish every day on our website, I want to highlight two must-see spots in your tour of

For the beginning investor

Investing can seem like a Big Deal to those who have yet to buy their first stock. Many investment professionals try to infuse the conversation with jargon in order to deter individual investors from tackling it on their own (and to justify their often sky-high fees).

But the individual investor can beat the market. The real secret to investing is that it doesn't take tons of money, endless hours, or super-secret formulas that only experts possess.

That's why we created a best-selling guide that walks investors-to-be through everything they need to know to get started. And because we're so dedicated to our mission, we've made that available for free.

If you're just starting out (or want to help out someone who is), go to, drop in your email address, and you'll be able to instantly access the quick-read guide ... for free.

For the listener

Whether it's on the stationary exercise bike or during my daily commute, I spend a lot of time going nowhere. But I've found a way to make that time benefit me.

The Motley Fool offers five podcasts that I refer to as "binge-worthy financial information."

Motley Fool Money features a team of our analysts discussing the week's top business and investing stories, interviews, and an inside look at the stocks on our radar. It's also featured on several dozen radio stations across the country.

The hosts of Motley Fool Answers challenge the conventional wisdom on life's biggest financial issues to reveal what you really need to know to make smart money moves.

David Gardner, co-founder of The Motley Fool, is among the most respected and trusted sources on investing. And he's the host of Rule Breaker Investing, in which he shares his insights into today's most innovative and disruptive companies ... and how to profit from them.

Market Foolery is our daily look at stocks in the news, as well as the top business and investing stories.

And Industry Focus offers a deeper dive into a specific industry and the stories making headlines. Healthcare, technology, energy, consumer goods, and other industries take turns in the spotlight.

They're all informative, entertaining, and eminently listenable ... and I don't say that simply because the hosts all sit within a Nerf-gun shot of my desk. Rule Breaker Investing and Answers contain timeless advice, so you might want to go back to the beginning with those. The other three take their cues from the market, so you'll want to listen to the most recent first. All are available at

But wait, there's more

The book and the podcasts – both free ... both awesome – also come with an ongoing benefit. If you download the book, or if you enter your email address in the magical box at the podcasts page, you'll get ongoing market coverage sent straight to your inbox.

Investor Insights is valuable and enjoyable coverage of everything from macroeconomic events to investing strategies to our analyst's travels around the world to find the next big thing. Also free.

Get the book. Listen to a podcast. Sign up for Investor Insights. I'm not saying that any of those things will make you rich ... but Business Insider seems to think so.

Compare Brokers