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Food And Drug Administration Headquarters In Maryland
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Pharma company Aurinia falls after FDA official uses LinkedIn to call out lupus drug

Lupkynis, which was approved in 2021, is Aurinia’s primary source of revenue.

J. Edward Moreno

Aurinia Pharmaceuticals dropped on Monday after a Food and Drug Administration official criticized a method of evaluating drugs that was used to approve the companys flagship lupus medication.

George Tidmarsh, who has led the FDAs drug evaluation arm since July, said on LinkedIn that voclosporin, which is made by Aurinia under the brand name Lupkynis, has significant toxicity and has not been proven to benefit patients.

Specifically, he criticized the use of surrogate end points, which are indirect measures of patients health after taking a treatment that results in speedier trials. Tidmarsh said the FDA will be evaluating how it uses that kind of data for drug approval. Tidmarsh later deleted that post and in a subsequent post clarified that those were his personal views and not that of the FDA.

Screenshot 2025-09-29 at 3.57.01 PM
A screenshot of Tidmarsh's LinkedIn post. (Sherwood News)

Tidmarshs complete, since deleted LinkedIn post read:

CDER will be evaluating surrogate endpoints used for FDA approval. While there is no doubt that the use of such endpoints has benefited patients by bringing valuable treatments to patients sooner, there have been notable failures in confirmatory trials, such as those for exon skipping therapies in DMD. And for some diseases such as lupus nephritis, companies have not run trials to demonstrate a benefit on hard clinical endpoints like progression to end stage renal disease. So we have approved drugs with significant toxicity like voclosporin that has not been shown to provide a direct clinical benefit for patients. We will be taking a close look at the use of surrogate endpoints to see where we can further accelerate promising drugs faster while requiring companies to perform the trials necessary to confirm actual clinical benefit.

Lupkynis, which was approved in 2021, is Aurinias primary source of revenue. The company reported $235.1 million in sales last year, and analysts polled by FactSet have penciled in $270.5 million for 2025.

Aurinia fell as much as 21% after Tidmarsh’s post, and it ended the day down 16%.

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Nvidia and SK Hynix strike multiyear partnership on memory chips, AI data center build-out

Nvidia shares are modestly higher after it announced a multiyear partnership with SK Hynix on memory chips and building out AI data centers.

The agreement secures a long-term pipeline of memory chips for Nvidia. At the center of the partnership is the integration of SK Hynix’s high-bandwidth memory chips into Nvidia’s newly unveiled Vera central processing units. The Vera processor is Nvidia’s first stand-alone data center microprocessor designed to compete directly against traditional enterprise server lines.

The collaboration is also structured to reshape how semiconductors are manufactured. Under the terms of the agreement, SK Hynix will implement Nvidia’s CUDA-X library and PhysicsNeMo framework directly into its memory design and manufacturing workflows.

The announcement happened during a high-profile visit to Seoul by Nvidia CEO Jensen Huang, who arrived on June 5 to align with core infrastructure partners. Over the weekend, Huang met with SK Group Chairman Chey Tae-won, SK Hynix CEO Kwak Noh-Jung, and other top South Korean technology executives during a dinner meeting, according to Nvidia’s blog posts and Reuters.

Last week, SK Hynix told investors that its proposed US listing has received strong backing, which would potentially give US investors an alternative way to play the memory chip crunch.

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FuelCell Energy rises as AI data center pipeline overshadows Q2 miss

FuelCell Energy shares rebounded into positive territory during premarket trading, reversing an initial dip sparked by Q2 results that showed widening net losses and a year-over-year revenue decline.

Key numbers:

  • Revenue of $35.6 million (compared to analyst estimates of $40.56 million).

  • An adjusted loss per share of $1.45 (estimate: a $0.50 loss).

That revenue number marks a 5% decrease from the $37.4 million generated during the same quarter last year.

The company’s net loss expanded to $78.7 million, or $1.45 per share, compared to a loss of $38.8 million in the prior-year period. Management attributed the deeper loss primarily to a $42.6 million one-time impairment expense linked to essential equipment upgrades at its Groton Project facility.

While a 9.9% drop in total backlog initially added to the shares’ downward momentum, investors appeared to quickly pivot their attention to the company’s forward-looking metrics. FuelCell highlighted a 267% sequential jump in its sales pipeline, which has reached 4 gigawatts. The surge is driven by demand for its packaged 12.5-megawatt utility-grade power block solution tailored specifically for the booming AI data center market.

To support this high-growth data center strategy, FuelCell announced a major capacity expansion at its Torrington, Connecticut, manufacturing facility. The company plans to raise its annualized production ceiling from 350 MW to 500 MW, an infrastructure upgrade estimated to cost between $200 million and $275 million over the next 24 months.

Driven by the AI data center narrative, FuelCell Energy’s stock has risen over 130% year to date.

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Lilly says its next-gen GLP-1 shot drove 28.3% weight loss, reduced comorbidities

Eli Lilly has risen around 4% in premarket trading after reporting impressive trial results for its next-generation weight-loss drug over the weekend.

According to the results unveiled on Saturday, Lilly’s experimental weight-loss shot, retatrutide, helped patients lose 28.3% of their body weight at 80 weeks. That’s more than tirzepatide, Lilly’s weight-loss shot currently considered the most effective in the market, which helped people lose 26% of their weight over 88 weeks.

Retatrutide is a triple agonist, meaning it mimics three different hormones that promote weight loss, compared to one by Novo Nordisk’s semaglutide and two by tirzepatide. Lilly says it helps preserve more muscle mass than other weight-loss shots and also helped improve knee osteoarthritis pain and obstructive sleep apnea.

Lilly has said it would submit the drug for approval this year with the goal of getting it out to market in 2027. The jab could be the next big moneymaker for Lilly, which currently sells the most lucrative drug in the world but has had an underwhelming rollout of its oral weight-loss pill, which came to market earlier this year.

Retatrutide is already quite popular among those who experiment with peptides, or unapproved injectable drugs often sold online “for research purposes only.” For gym bros trying to attain a certain physique, a drug that has shown it can melt fat while preserving muscle is enticing.

But in a market full of knockoff drugs, will retatrutide enthusiasts pay full price for the drug when it officially goes to market?

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Marvell and Flex rise on S&P 500 inclusion announcement

Chipmaker Marvell Technology and electronics manufacturer Flex are jumping 7% and 3%, respectively, in premarket trading on Monday after S&P Dow Jones Indices announced late on Friday that the two companies are set to join the S&P 500 benchmark index.

Replacing Pool Corp. and Campbell’s in the S&P 500, Marvell and Flex’s addition will be effective from June 22, per a press release from the provider, which assesses and updates the index on a quarterly basis.

Marvell has been one of the leading candidates for inclusion across the last few quarterly index rebalances. The company has ballooned into a $230 billion chip giant of late, thanks to the wider AI boom, investors chasing momentum, and, yes, Jensen Huang. Flex, which has been part of the S&P MidCap 400 Index since 2024, has also grown recently, having played a part in the data center boom with a portfolio that spans across infrastructure and cooling systems.

With today’s premarket movement taken into account, MRVL has now risen almost 40% in the last week alone.

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