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The Readout Damian Garde & Meghana Keshavan

The target of a ‘criminal’ critique quietly confirmed some doubts

Earlier this month, when an anonymous short report about Applied Therapeutics circulated around the Internet, the company denounced it as “criminal activity” and demanded its author be prosecuted. Then, a week later, the company quietly edited its investor materials, lending weight to the author’s critique. 

As STAT’s Adam Feuerstein reports, it all stems from the company’s lead drug, AT-007, in development to treat an ultra-rare disorder. The anonymous report pointed out graphs, previously presented by Applied Therapeutics, that appeared inconsistent. Those graphs got amended a week later in a presentation posted to the company’s website, something Applied Therapeutics didn’t disclose.

Company CEO Shoshana Shendelman declined to be interviewed about the edited presentation. She also sold $1.4 million in company stock in the days before the amended graphs were made public.

Read more.

What if Moderna is actually undervalued?

A common subject of debate in biotech is whether Moderna’s valuation, which has roughly quadrupled due to its potential coronavirus vaccine, has departed from reality. Michael Yee, an analyst at Jefferies, entered the conversation with a novel take: Actually, Moderna shares are too cheap.

In a note to investors yesterday, Yee set a share price target that was about 45% higher than Moderna’s current value, suggesting the company, valued at about $7 billion as recently as January, is in fact worth $35 billion. Here’s Yee’s case: If Moderna’s vaccine works, it can make upward of $5 billion a year by charging as little as $50 a dose, regardless of how many competing products there may be. And that will set a financial and scientific safety net for the company’s many other projects, he argues.

Yee’s note sent Moderna’s share price up more than 17%, suggesting his case was fairly convincing on Wall Street. But it’s worth remembering that the “If” in the paragraph above is a weighty one. Not only does no one know if Moderna’s product will work; there’s still debate over the definition of “work” when it comes to vaccines for the novel coronavirus.

This could be why no one bought UniQure

For about 12 months, UniQure looked like an odds-on candidate for a high-dollar acquisition. Those odds soured in June when the company sold the rights to its lead gene therapy, suggesting to investors that major drug companies were reticent to pay the billions required to buy UniQure outright.

Now it looks like that reticence might have been wise. Yesterday, the U.S. Patent and Trademark Office sided with Pfizer in a dispute over the intellectual property behind UniQure’s gene therapy, which treats hemophilia B. The ruling declares that Pfizer “has demonstrated a reasonable likelihood of prevailing” in court and orders the two parties to argue it out in a process called inter partes review, or IPR.

Such IPR challenges have a mixed record of success, and it’s entirely possible UniQure will win out in the end. But the risk of Pfizer seizing a royalty on the company’s most advanced treatment brought its share price down about 5%. And it might have scared away potential buyers before UniQure inked its licensing deal.

The government is sticking to its ambitious vaccine timeline

The leaders of Operation Warp Speed, the federal effort to develop a coronavirus vaccine, aren’t backing down from their unprecedented plan to deliver millions of doses by the end of the year. Outside experts have called the timeline unrealistic, but one senior official believes the U.S.’s inability to contain the virus might accelerate the development of a vaccine.

Operation Warp Speed is funding the development of four vaccine candidates, each expected to enter Phase 3 trials in the coming months. That’s where the recent spike in coronavirus cases could be a benefit, a senior administration official said on a conference call with reporters yesterday.

“If there’s any silver lining in the outbreaks we’re currently seeing, it’s that we need 30,000 people in each of these trials, and we need to conduct them in areas where there are outbreaks,” the official said. “Somewhat paradoxically, the current outbreaks may help us get a vaccine faster.”

More reads

  • FDA refuses application for HIV drug from CytoDyn, raising more questions about its credibility. (STAT Plus)
  • Pandion Therapeutics plans to raise $94 million in an IPO. (Boston Globe)
  • Pharma trade group again scolds Gilead for misleading information about a rival HIV drug. (STAT Plus)

Thanks for reading! Until tomorrow,

Tuesday, July 14, 2020

STAT

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