Why some investors shy away from biotech, in one chart

Two years ago, Amarin was a middling biotech company with a little-used heart drug whose shares went for about $3 each. Over the ensuing 24 months, it would shock the cardiology world, make its investors look prescient, and then crash right back to where it began, providing a stark illustration of what makes biotech often so maddening.

The latest twist came yesterday, when an appeals court issued a ruling that will expose Amarin's drug Vascepa to generic competition as soon as possible, undercutting its blockbuster potential before it had a chance to begin.

Amarin’s share price has fallen more than 75% since Vascepa’s major clinical victory, now trading just above its value back in fall 2018.

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Should the FDA commissioner resign?

How fast can vaccine trials move? And what do Chelsea Clinton and Chuck Grassley have in common?

We discuss all that and more this week on “The Readout LOUD,” STAT’s biotech podcast. First, Eric Topol of Scripps Research calls in to discuss his fiery criticism of FDA Commissioner Stephen Hahn and the future of the agency’s reputation.

Then, we talk to STAT’s Matthew Herper about how vaccines for Covid-19 might prove their worth before the end of the year. Finally, STAT’s op-ed page, First Opinion, hit a milestone this week, publishing its 2,000th piece, and First Opinion editor Patrick Skerrett joins us for a look behind the scenes and a glimpse at the future.

Listen here.

Catching up with $115 million of VC money

Private biotech companies tend to make a lot of noise when their investor wire transfers clear and then promptly go back to toiling in media silence. STAT’s Kate Sheridan tracked down a few of biotech’s recent check recipients to check on how things are going.

One, Pyxis Oncology, has quickly assembled a scientific staff and hired a former Pfizer executive to be its CEO. Another, Curamir Therapeutics, has advanced its RNA-based approach to treating cancer and expects to seek permission to start its first human trial next year. A third, Oncorus, has executed on its clinical goals but run into an unexpected challenge in the form of a trademark dispute with a similarly named European firm. 

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A competition to treat anemia just got complicated

Yesterday, the biotech company Akebia Therapeutics revealed some surprising news: The company’s in-development treatment for anemia failed its safety goal in a major trial. That was bad news for Akebia, whose shares fell nearly 75%, and ostensibly good news for a rival firm called FibroGen, which is developing a similar anemia treatment.

But despite the blow to a direct competitor, FibroGen’s stock price slipped, suggesting the market sees a more complicated story than might appear.

Both companies’ drugs work by blocking a bodily protein called hypoxia-inducible factor, or HIF. Doing so tricks the body into thinking it’s in a low-oxygen environment and thus producing more oxygen-carrying red blood cells, a discovery that won the Nobel Prize in medicine last year.

No HIF-targeting drug has won FDA approval, and because the treatments from Akebia and FibroGen are so similar, a setback for one could impact the other. The FDA might consider Akebia’s issues to be a risk for the whole class of drugs, Cowen analyst Yaron Werber wrote in a note to clients, meaning both drugs might carry black-box safety warnings once approved, which could limit prescriptions for FibroGen as well as Akebia.

More reads

• ‘Carnage’ in a lab dish shows how the coronavirus may damage the heart. (STAT)
• Hong Kong to surpass Nasdaq as king of biotech listings in five to 10 years, HKEX chief predicts. (South China Morning Post)
• Instead of eliminating drug rebates, use average sales price to set co-insurance levels. (STAT)
• Biofourmis raises $100 million for remote patient monitoring tools. (Boston Globe)