BridgeBio Pharma (BBIO) snagged Food and Drug Administration approval for a rival to Pfizer‘s (PFE) blockbuster heart drug, and BridgeBio stock catapulted by double digits.
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The approval came through late Friday, a week ahead of expectations. BridgeBio can now launch its drug, acoramidis, as a branded treatment called Attruby, for patients with transthyretin amyloid cardiomyopathy, or ATTR-CM. In this condition, abnormal protein builds up on the heart, causing damage.
Attruby will rival Pfizer’s drug, Vyndaqel. Last year, Vyndaqel generated $3.32 billion in sales, growing 36%. This year, analysts polled by FactSet expect the Pfizer drug to bring in $5.33 billion in sales.
BridgeBio stock surged 16.1% to 27.19. BBIO stock hit a two-month high, topping its 50-day and 200-day moving averages, according to MarketSurge. Pfizer stock rose 2% to 26.17.
BridgeBio Stock Faces Split Views
Analysts offered split views on the approval and landscape for ATTR-CM treatments.
Alnylam Pharmaceuticals (ALNY) is soon likely to ask the FDA to approve its drug, Amvuttra, for ATTR-CM treatment. Intellia Pharmaceuticals (NTLA) and Regeneron Pharmaceuticals (REGN) are teamed up on a gene-editing treatment for the disease.
“We expect the competition landscape to become further crowded in the coming years,” Wedbush analyst David Nierengarten said in a report on Intellia stock.
William Blair analyst Myles Minter noted BridgeBio Pharma could struggle to differentiate Attruby from Vyndaqel. The label for Attruby indicates it can reduce the risk of cardiovascular death or related hospitalizations. But it doesn’t say Attruby can reduce the risk of death for any cause. But Pfizer has been able to show exactly that for Vyndaqel.
“We continue to view a reduction in all-cause mortality on label as a necessary distinction to gain major market share in ATTR-CM alongside Pfizer’s (Vyndaqel),” he said in a note. “Given the lack of all-cause mortality data included in the Attruby label, we believe Pfizer could start marketing more specifically around mortality benefit claims.”
But, he noted, Attruby will go for a slightly lower wholesale acquisition cost of around $244,500 a year vs. $267,987 annually for Vyndaqel. Both price tags are higher than the $194,291 suggested by the Institute for Clinical and Economic Review, a nonprofit that weighs the cost vs. benefits of drugs.
‘Best-Case Label’
But Mizuho Securities analyst Salim Syed says Attruby received the “best-case label.”
“Same indication as Pfizer’s (Vyndaqel) label + a bunch of key data in the label details + absence of other details that we believe potentially work against Alnylam’s (Amvuttra),” he said in a report. “Stock was trading ex-acoramidis prior to approval and investors were incredibly nervous going into this print — stock should be $30+ on relief.”
He kept his outperform rating and 53 price target on BBIO stock.
Follow Allison Gatlin on X, the platform formerly known as Twitter, at @IBD_AGatlin.
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