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BridgeBio Stock Up on FDA Approval of Cardiovascular Drug
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BridgeBio Pharma, Inc. (BBIO - Free Report) recently announced that it obtained FDA approval for its pipeline candidate acoramidis for the treatment of adults with transthyretin amyloidosis cardiomyopathy (ATTR-CM) to reduce cardiovascular death and cardiovascular-related hospitalization.
The candidate has been approved under the brand name Attruby.
BBIO stock surged 16.1% on the FDA approval of the drug.
BridgeBio’s shares have lost 32.6% in the year-to-date period against the industry's growth of 10.9%.
Image Source: Zacks Investment Research
BBIO Gets a Boost With Drug Approval
Attruby is an orally-administered near-complete stabilizer of transthyretin (TTR).
The FDA approval is based on positive results from the phase III ATTRibute-CM study, in which Attruby significantly reduced death and cardiovascular-related hospitalization and improved quality of life.
The approval came ahead of the targeted action date of Nov. 29.
Per BBIO, Attruby is the first and only approved product with a label specifying near-complete stabilization of TTR. Through near-complete TTR stabilization, Attruby has been shown to preserve the native function of TTR as a transport protein of thyroxine and vitamin A and to demonstrate benefit on cardiovascular outcomes.
The drug was generally well-tolerated. The most common side effects were mild and included diarrhea and abdominal pain that were resolved without drug discontinuation.
The approval boosts BBIO’s portfolio given the potential of the targeted market (market opportunity $15-120 billion). Transthyretin cardiac amyloidosis is a progressive disease with a poor prognosis when left untreated.
BridgeBio has also submitted a Marketing Authorization Application to the European Medicines Agency. A decision is expected in 2025. The company has granted exclusive rights to Bayer to commercialize acoramidis for ATTR-CM in Europe.
The other two approved drugs in BBIO’s portfolio are Nulibry (fosdenopterin) for the treatment of molybdenum cofactor deficiency (MoCD) type and Truseltiq (infigratinib) for the treatment of cholangiocarcinoma.
BBIO to Face Competition for Attruby
While the ATTR-CM market has potential, the uptake of Atturby will face challenges from already approved pharma giant Pfizer's (PFE - Free Report) drugs, Vyndaqel and Vyndamax.
Vyndaqel and Vyndamax are also transthyretin stabilizers indicated for the treatment of the cardiomyopathy of wild-type or hereditary transthyretin-mediated amyloidosis in adults to reduce cardiovascular mortality and cardiovascular-related hospitalization.
Pfizer’s Vyndaqel family (global revenues from Vyndaqel, as well as revenues for Vyndamax in the United States and Vynmac in Japan) generated sales of $1.4 billion in the third quarter of 2024, up 62% year over year.
Moreover, Alnylam Pharmaceuticals, Inc. (ALNY - Free Report) is also looking to get vutrisiran approved for the treatment of ATTR-CM. The FDA recently accepted ALNY’s application for the same and set a target action date of Mar 23, 2025.
We note that Vutrisiran is already approved for the treatment of the polyneuropathy of hereditary ATTR amyloidosis in adults under the brand name Amvuttra.
Intellia Therapeutics, Inc. (NTLA - Free Report) , a clinical-stage gene editing company, is evaluating nexiguran ziclumeran (nex-z) for the treatment of ATTR-CM.
Nex-z is an investigational in vivo CRISPR-based therapy being developed in collaboration with Regeneron. NTLA recently announced positive new data from the ongoing phase I study of nex-z in patients with ATTR amyloidosis.
Image: Bigstock
BridgeBio Stock Up on FDA Approval of Cardiovascular Drug
BridgeBio Pharma, Inc. (BBIO - Free Report) recently announced that it obtained FDA approval for its pipeline candidate acoramidis for the treatment of adults with transthyretin amyloidosis cardiomyopathy (ATTR-CM) to reduce cardiovascular death and cardiovascular-related hospitalization.
The candidate has been approved under the brand name Attruby.
BBIO stock surged 16.1% on the FDA approval of the drug.
BridgeBio’s shares have lost 32.6% in the year-to-date period against the industry's growth of 10.9%.
Image Source: Zacks Investment Research
BBIO Gets a Boost With Drug Approval
Attruby is an orally-administered near-complete stabilizer of transthyretin (TTR).
The FDA approval is based on positive results from the phase III ATTRibute-CM study, in which Attruby significantly reduced death and cardiovascular-related hospitalization and improved quality of life.
The approval came ahead of the targeted action date of Nov. 29.
Per BBIO, Attruby is the first and only approved product with a label specifying near-complete stabilization of TTR. Through near-complete TTR stabilization, Attruby has been shown to preserve the native function of TTR as a transport protein of thyroxine and vitamin A and to demonstrate benefit on cardiovascular outcomes.
The drug was generally well-tolerated. The most common side effects were mild and included diarrhea and abdominal pain that were resolved without drug discontinuation.
The approval boosts BBIO’s portfolio given the potential of the targeted market (market opportunity $15-120 billion). Transthyretin cardiac amyloidosis is a progressive disease with a poor prognosis when left untreated.
BridgeBio has also submitted a Marketing Authorization Application to the European Medicines Agency. A decision is expected in 2025. The company has granted exclusive rights to Bayer to commercialize acoramidis for ATTR-CM in Europe.
The other two approved drugs in BBIO’s portfolio are Nulibry (fosdenopterin) for the treatment of molybdenum cofactor deficiency (MoCD) type and Truseltiq (infigratinib) for the treatment of cholangiocarcinoma.
BBIO to Face Competition for Attruby
While the ATTR-CM market has potential, the uptake of Atturby will face challenges from already approved pharma giant Pfizer's (PFE - Free Report) drugs, Vyndaqel and Vyndamax.
Vyndaqel and Vyndamax are also transthyretin stabilizers indicated for the treatment of the cardiomyopathy of wild-type or hereditary transthyretin-mediated amyloidosis in adults to reduce cardiovascular mortality and cardiovascular-related hospitalization.
Pfizer’s Vyndaqel family (global revenues from Vyndaqel, as well as revenues for Vyndamax in the United States and Vynmac in Japan) generated sales of $1.4 billion in the third quarter of 2024, up 62% year over year.
Moreover, Alnylam Pharmaceuticals, Inc. (ALNY - Free Report) is also looking to get vutrisiran approved for the treatment of ATTR-CM. The FDA recently accepted ALNY’s application for the same and set a target action date of Mar 23, 2025.
We note that Vutrisiran is already approved for the treatment of the polyneuropathy of hereditary ATTR amyloidosis in adults under the brand name Amvuttra.
Intellia Therapeutics, Inc. (NTLA - Free Report) , a clinical-stage gene editing company, is evaluating nexiguran ziclumeran (nex-z) for the treatment of ATTR-CM.
Nex-z is an investigational in vivo CRISPR-based therapy being developed in collaboration with Regeneron. NTLA recently announced positive new data from the ongoing phase I study of nex-z in patients with ATTR amyloidosis.
BBIO’s Zacks Rank
BridgeBio currently carries a Zacks Rank #3 (Hold). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.