The Readout Damian Garde & Meghana Keshavan

Roivant is worth $7.3 billion

At least according to the blank-check agreement the company just signed, one that will take the multipronged unicorn public this year if everything works out.

The agreement, disclosed yesterday, will see Roivant Sciences merge with a SPAC called Montes Archimedes Acquisition Corp., founded by private equity investor Jim Momtazee. Roivant gets the $411 million Montes raised in its initial public offering last year, plus another $200 million in new financing from a group of investors that includes Fidelity, Viking Global, SoftBank, and Palantir Technologies.

The deal would satisfy Roivant’s long-held ambition to go public. The company, which made its name in-licensing medicines from other drug companies, has recently expanded its business to include in-house discovery of new medicines. Roivant’s goal is to become an evolutionary drug developer, one that can “do the nimble entrepreneurial thing on the development side while benefiting from the scale of a big pharma company,” CEO Matthew Gline said.

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Sarepta’s next-gen Duchenne treatment shows promise in small study

Sarepta Therapeutics’ second-generation medicine for Duchenne muscular dystrophy appeared to be more potent than the company’s first approved drug, albeit with greater toxicity.

As STAT’s Adam Feuerstein reports, a monthly infusion of the investigational SRP-5051 produced eight times more of the muscle protein dystrophin compared to weekly infusions of Exondys 51, which won approval in 2016. The data come from just four patients, and two of them developed severe cases of low magnesium, which Sarepta said it would monitor going forward.

SRP-5051 is the first of a string of medicines designed to produce more dystrophin than Sarepta’s initial treatments. And the results, while preliminary, are of particular importance to Sarepta after the company’s efforts to develop a gene therapy for Duchenne ran into significant setbacks earlier this year.

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Regeneron’s cash cow dodges another threat

A topic of fascination on Wall Street is just how long Regeneron Pharmaceuticals can keep reaping billions from Eylea, its top-selling treatment for macular degeneration. There have been many would-be market disruptors, but none has managed to unseat Regeneron’s biggest product. Now it appears Eylea is getting a stay on biosimilar competition, too.

The news is that Sandoz, Novartis’s generics division, is developing a biosimilar to Eylea. The silver lining for Regeneron is that Sandoz is running a full Phase 3 trial on its version of the injectable treatment, suggesting regulators weren’t willing to consider a rapid approval based on an equivalence study alone. That means Eylea wouldn’t face biosimilar competition until 2024 or 2025, according to SVB Leerink analyst Geoffrey Porges.

It also gives Regeneron more time to expand the rest of its business. Eylea accounts for about $5 billion a year, more than half of Regeneron’s annual revenue. Dupixent, the company’s fast-growing auto-immune treatment, is on pace to put up similar numbers, but forestalling another threat to Eylea grants Regeneron more breathing room on the balance sheet.

Vaxart and the power of a press release

Vaxart, the company developing an oral vaccine for Covid-19, began yesterday as a billion-dollar company. At 8 a.m., the company put out a press release saying that its planned Phase 2 study would be delayed due to a manufacturing issue, and shares opened about 10% down. At noon, the company hosted a conference call with a Stanford University immunologist to go over its Phase 1 data, and the company’s stock price continued to sink. By 4 p.m., Vaxart was down 25%.

Then, at 5:06 p.m., Vaxart issued a press release that simply recapped its conference call, bearing the headline “New Data from Vaxart Oral Covid-19 Vaccine Phase 1 Study Suggests Broad Cross-Reactivity against Other Coronaviruses.” Within half an hour, Vaxart’s stock regained all of the value it had lost, rising 25% in after-hours trading.

It’s unclear why the same information would be bad for the stock when spoken out loud but good for the stock when written online, but Vaxart completed a valuation round trip in a single day. The Phase 2 trial is expected to start in the middle of this year.

More reads

  • European Commission fines a Merck KGaA unit for providing misleading info prior to a merger. (STAT+)
  • FDA is set to authorize Pfizer-BioNTech vaccine for those 12-15 years old by early next week. (New York Times)
  • Avrobio retools Fabry gene therapy plans after competing drug's full approval shuts pathway to an accelerated nod. (Endpoints)
  • Biden’s Medicaid pressure tactics could put his team at odds with hospitals. (STAT)

Thanks for reading! Until tomorrow,

Tuesday, May 4, 2021


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