BridgeBio's Pipeline Update

can you get bridgebio's pipelie

BridgeBio Pharma's pipeline includes a range of development programs, from early science to advanced clinical trials. Some key highlights from their recent updates include:

1. Acoramidis: They are planning to file a New Drug Application (NDA) with the U.S. Food and Drug Administration (FDA) for acoramidis by the end of 2023. This drug is intended for treating transthyretin amyloid cardiomyopathy (ATTR-CM), and the data presented supports its differentiated profile for use in contemporary care of ATTR-CM.

2. KRAS Programs: They have three leading KRAS programs advancing, including BBO-8520, a first-in-class direct KRASG12C (ON) inhibitor, which is on track for an Investigational New Drug (IND) application in 2023. Other programs in this area, such as PI3Kα:RAS breaker candidate BBO-10203 and pan-KRAS program, are on track for IND and Development Candidate (DC) nomination, respectively, in 2024.

3. Gene Therapy Treatments: BridgeBio has signed a multi-year partnership with National Resilience, Inc. to advance BBP-631, BBP-812, and future gene therapy treatments. This partnership aims to reduce manufacturing costs and expedite the development of gene therapies.

4. Infigratinib: After terminating a previous collaboration agreement with Helsinn, BridgeBio is pursuing the development, manufacture, and commercialization of infigratinib for non-oncology indications, such as achondroplasia, excluding China, Hong Kong, and Macau.

5. Broader Pipeline: BridgeBio's pipeline encompasses more than 15 ongoing clinical trials across over 20 disease states. They focus on genetic diseases and cancers with clear genetic drivers, leveraging scientific advances in genetic medicine to develop new drug therapies.

These programs demonstrate BridgeBio's commitment to advancing treatments for genetic diseases and cancers, with a focus on transformative medicines that can make a significant impact in these areas.

Look for other companies that also mentioned ATTR in their filings

Several companies have mentioned transthyretin (ATTR) amyloidosis in their recent filings. Here's a summary of their involvement:

1. Intellia Therapeutics, Inc.

   • Intellia is advancing NTLA-2001, an in vivo, systemically delivered, investigational CRISPR-based therapy for the treatment of ATTR amyloidosis.
   • The FDA cleared the NTLA-2001 Phase 3 IND application for ATTR amyloidosis with cardiomyopathy (ATTR-CM). The MAGNITUDE Phase 3 trial is on track to initiate by year-end.

2. Ionis Pharmaceuticals, Inc.

   • Ionis is progressing with eplontersen, which is under regulatory review in the EU and Canada for hereditary ATTR polyneuropathy (ATTRv-PN).
   • Ionis also completed enrollment for the Phase 3 CARDIO-TTRansform study of eplontersen in patients with ATTR cardiomyopathy (ATTR-CM).

3. Alnylam Pharmaceuticals, Inc.

   • Alnylam reported on their product revenues including the impact of their work on ATTR amyloidosis.
   • They received a Complete Response Letter from the U.S. FDA for Patisiran for the treatment of ATTR amyloidosis's cardiomyopathy component.

4. Pfizer Inc.

   • Pfizer's financial reporting mentions Vyndaqel, a drug for ATTR-CM and polyneuropathy, as part of their significant product revenues.

5. Prothena Corp Public Ltd Co

   • Prothena's pipeline includes a focus on ATTR amyloidosis, as part of their work on neurodegenerative and rare peripheral amyloid diseases.
   • They have a potential milestone agreement pertaining to their ATTR amyloidosis business.

6. Verve Therapeutics, Inc.

   • Verve acknowledges the development of alternative approaches by others, including Intellia Therapeutics, which is working on NTLA-2001 for the treatment of ATTR amyloidosis.

7. BridgeBio Pharma, Inc.

   • BridgeBio reported positive results from the ATTRibute-CM Phase 3 study of acoramidis for patients with ATTR-CM. They are planning to file a New Drug Application (NDA) for acoramidis with the FDA.

These companies are actively involved in developing treatments for ATTR amyloidosis, with several products in various stages of clinical trials and regulatory review.

when did Bridgebio report positive results for acoramidis ?

BridgeBio Pharma reported positive results from the ATTRibute-CM Phase 3 study of acoramidis in August 2023. This study was for patients with transthyretin amyloid cardiomyopathy (ATTR-CM), and the results were presented at the European Society of Cardiology (ESC) Congress.