In spending more than $2 billion researching Alzheimer’s disease treatments, the biotech giant Biogen made a risky bet. Rivals have racked up failure after failure in the space.
That bet paid off on Monday, when the Food and Drug Administration approved its Alzheimer’s drug, called Aduhelm.
The approval itself, as well as the new and controversial approach that the FDA took to greenlight the drug, is reigniting interest in Alzheimer’s research, sending the stock of Biogen and other biotechs soaring. The decision signals that it may be easier to get drugs for neurologic disorders like Alzheimer’s approved in the future.
“In our view, FDA neuro division is becoming more flexible, supportive and conducive in getting neurology drugs approved, as evidenced by today’s approval as well as the FDA’s favorable comments during Biogen’s advisory committee meeting,” Jefferies analyst Andrew Tsai wrote in a note. “We envision investor appetite to rise in Alzheimer’s as a whole.”
Aduhelm is the first drug to hit the market that targets amyloid beta, a sticky plaque that builds up in the brains of some Alzheimer’s disease patients and is thought to impair memory and cognition.
The concept of treating Alzheimer’s by clearing out this plaque has fallen out of favor over the last couple of years. For one, although Aduhelm reduced clinical trial participants’ plaque levels, it wasn’t clear that it stopped or even improved memory loss.
Still, the FDA approval is a win for the so-called amyloid theory. Biogen saw its stock surge by nearly 40% — a gain of almost $20 billion to the Massachusetts biotech’s market value.
Insider identified nine additional life science companies that have likely seen their fortunes improve, thanks to the FDA’s controversial decision.
Biogen and partner Eisai have another treatment in the works
Aduhelm is only one of the treatments that Biogen and Japanese drug company Eisai have been developing over the last decade. The pair are currently running two late-stage trials of another potential therapy called BAN2401 or lecanemab. The drug also targets amyloid, in the hopes of slowing down Alzheimer’s progression.
The pair expect to have results from at least one trial by the second quarter of 2022.
Eisai’s stock price was up 56% on Monday.
Eli Lilly could accelerate its drug development following the Aduhelm verdict
Most Big Pharma companies axed their Alzheimer’s disease drug programs during the 2010s. Not Eli Lilly, which is currently running a late-stage clinical trial of another amyloid-targeting therapy.
Like Biogen, Eli Lilly’s drug development journey has not been straightforward. The company reported in March that its drug, donanemab, reduced participants’ amyloid levels in a mid-stage trial and slowed down the rate of cognitive decline by 32%. But it missed the mark on several secondary tests of memory and cognition.
Bernstein analyst Ronny Gal said that Biogen’s approval opens up a path for Lilly to accelerate its donanemab plans. It may only need to show that the drug reduces plaques and succeeds in one clinical trial. FDA usually requires two successful trials.
Lilly’s stock was up 10% on Monday, a jump in market value of about $20 billion.
Roche also has a late-stage Alzheimer’s program
The Swiss pharmaceutical giant Roche could be another leading contender to quickly get a drug similar to Aduhelm to market.
Roche is developing gantenerumab, an antibody that also targets amlyoid beta. Results from a late-stage study are expected in the second half of 2022. One of the world’s largest drugmakers, Roche saw its market capitalization swell by about $10 billion Monday.
AC Immune’s study to prevent Alzheimer’s is due to produce results in 2022
Roche’s drug development subsidiary, Genentech, is partnering on another Alzheimer’s drug program with AC Immune, a Swiss biotech firm.
This amyloid-beta-targeting drug is now in a mid-stage study in Colombia, trying to show it can help prevent the disease among people with a specific type of genetic mutation that makes them likely to develop Alzheimer’s. The company expects to have results next year.
AC Immune saw its stock price jump by more than 25% on Monday.
Prothena could have a drug like Aduhelm, but more potent
The biotech company Prothena saw a surge of attention on Monday, as its stock jumped 30% following the Aduhelm news.
Even though its research on Alzheimer’s is still in the earliest stages — Prothena has yet to start human studies — Wall Street analysts said there’s reason for excitement around its drug candidate. PRX012.
Information from lab studies of PRX012 “suggests several potential advantages” over Biogen’s drug, RBC Capital Markets analyst Kennen MacKay wrote on Monday. Overall, the drug could be significantly more potent at blocking amyloid beta.
The key question for Prothena and other small biotechs is whether the FDA will be as flexible in the future for other amyloid-targeting drugs as it was for Aduhelm.
“While we anticipate there will be some debate whether FDA has truly lowered the bar, today’s news is clearly a positive for [Prothena],” Jefferies analyst Michael Yee wrote.
New treatments could mean new opportunities for diagnostics companies like Quanterix
Biogen’s drug approval could be good for diagnostic companies like Quanterix. Quanterix has developed a blood test that can detect proteins linked to Alzheimer’s disease.
Up to this point, there hasn’t been much of a market for Alzheimer’s diagnostics, because there were no treatments that could address the underlying biological characteristics of the disease. But Aduhelm could change that.
It’s a long-term goal, analysts say. Neurologist and diagnostic expert James Brewer told Insider he doesn’t think blood-based Alzheimer’s diagnoses have been vetted enough for widespread use. Right now, doctors diagnose the disease by talking to patients and testing their memory and cognition.
But a reinvigoration of medical research on Alzheimer’s could present new opportunities for Quanterix. It also gave the company an 11% stock price bump.
The need for brain scans could drive interest in certain diagnostics companies, like RadNet
Companies that provide brain scans could also benefit from the Aduhelm approval, particularly ones that offer PET scans that can better detail which types of patients are most likely to benefit from the drug.
The massive pool of Alzheimer’s patients could make a big difference for smaller diagnostics players like RadNet. In a note previewing the Aduhelm decision, Jefferies analyst Brian Tanquilut said RadNet could stand to see an uptick in revenue by providing PET scans.
Tanquilut said RadNet makes up 3% of the PET-scan market. The company could stand to benefit even more since it isn’t hospital-based, and some insurers are moving to limit coverage for scans delivered in hospitals to people who aren’t hospitalized.
RadNet’s stock jumped 11% Monday.
Newly public Athira is driving another treatment approach
Even some drug candidates not focused on amyloid beta could see a boost from the FDA’s openness and the likely renewed interest in the space.
Seattle-based Athira Pharma is developing ATH-1017, a potential Alzheimer’s treatment that is now in a mid-stage study with results expected in 2022. The company recently raised $85 million in a Series B round last June and went public in September, raising an additional $204 million.
“Bottom line, the FDA ultimately serves as the gatekeeper, and a more amenable FDA should mean decreased regulatory risk,” Jefferies analyst Andrew Tsai wrote in a Monday research note to investors.
Tsai also noted that ATH-1017 could potentially be combined with Aduhelm or other Alzheimer’s treatments down the line, because the drug works in a different way. Athira’s stock was up 4% Monday.
Alzheon is developing an oral treatment and an Alzheimer’s test
Massachusetts drug company Alzheon has a clear pathway to drug approval following the Aduhelm approval. Alzheon launched a late-stage trial on June 4 of a drug that targets one form of amyloid beta, known as oligomers.
Alzheon’s drug could be given as a twice-a-day pill, rather than by infusion like Aduhelm.
If all goes well, Alzheon hopes to file for FDA approval in 2025. In addition to the drug, Alzheon recently announced that it is developing a diagnostic test that would measure amyloid levels in cerebrospinal fluid. That fluid would be collected from a spinal tap.
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