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Moderna's turnaround plot, Icahn's plans for Grail, & the studies not getting published

April 12, 2023
National Biotech Reporter
Hello, everyone. Damian here with news of Moderna's grand ambitions, the latest in Illumina's proxy fight, and the uncertain future of a left-field Covid-19 treatment.

Financials

Moderna promises a swift rebound from its Covid slump

Moderna, whose revenues are expected to fall by nearly 75% in 2023, believes it can roughly triple its respiratory vaccine sales in just four years, an ambitious goal that will require a string of commercial successes.

At an investor event yesterday, Moderna said it expected to make between $8 billion and $15 billion in 2027 from its respiratory vaccines, which include the approved Covid-19 shot and late-stage vaccines for RSV and influenza. Wall Street seems skeptical. Moderna's share price fell about 3% yesterday and is down more than 10% on the year.

Meeting that goal will require Moderna to prevail in some crowded markets. Moderna's RSV vaccine is not expected to win FDA approval until 2024, at which point competing products from Pfizer and GSK will likely have been on the market for a year. And there's no guarantee the company's flu vaccine, which has produced mixed data, will be able to stand out among established competitors.


Grail

Icahn's Illumina fight has reached the Powerpoint stage

Screen Shot 2023-04-11 at 2.56.39 PM

Carl Icahn's escalating quest to depose Illumina's current management will soon be up for a shareholder vote, and his latest case against the company, delivered via presentation, sheds new light on his plans for its ill-fated acquisition of the testing firm Grail.

After a couple dozen slides devoted to Illumina's recent fall from grace (including the above illustration of CEO Francis deSouza's pay package), Icahn proposes how the company should get out of its cash-burning non-merger with Grail. The Icahn plan is to offer Illumina shareholders the right to buy ownership stakes in Grail, which would then be spun off into a standalone public company. That way, if management is right and Grail is destined for big things, shareholders can reap the rewards, but this time they'll have a choice.

Illumina's next chance to mount a counter-argument comes April 25, when the company will host its quarterly earnings call. Shareholders will get to vote at the company's as-yet-unscheduled annual meeting, which will likely take place in late May.



Covid-19

InflaRx is making a go of it

InflaRx, whose Covid-19 treatment won a surprising FDA authorization last week, is raising money in a stock sale, capitalizing on a left-field regulatory decision and entering a market of unclear size.

The company didn't disclose just how much cash it expected to raise in its offering. InflaRx, a thinly traded German firm, ended last year with less than $100 million. That sum was meant to last into 2025, but that was before the FDA decided to authorize the company's treatment, vilobelimab, for severely ill Covid-19 patients who are within 48 hours of starting mechanical ventilation.

InflaRx's stock price has more than doubled since vilobelimab's clearance, but it remains an open question just how lucrative the medicine might be, SVB Securities analyst Joseph Schwartz wrote in a note to clients — and whether a small company with no approved products can capitalize on whatever demand exists.


Research

MS drug studies are going unpublished

The results from more than one-third of late-stage multiple sclerosis clinical trials were never published in peer-reviewed journals, according to a new analysis — and negative studies were the most likely to never appear in print.

As STAT's Ed Silverman reports, the study, published in the Journal of Neurology, Neurosurgery & Psychiatry, looked at 150 Phase 3 and Phase 4 trials and found that 54 remained unpublished an average of six years after their completions.

"The medicines are expensive and have potential serious adverse effects, so it is critical that patients and doctors have access to the trial results when ascertaining these drugs' benefits and harms," said Alejandro Rivero-de-Aguilar, a neurologist and a professor at the University of Santiago de Compostela in Spain who was the lead author of the study.

Read more.


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  • Moderna fends off Arbutus appeal in Covid-19 vaccine patent fight, Reuters
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  • Abortion pill maker says access to drug hinges on FDA discretion, Bloomberg

Thanks for reading! Until tomorrow,


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