BridgeBio Pharma's Attruby (acoramidis) has garnered increased confidence from analysts following its recent FDA approval for the treatment of transthyretin amyloid cardiomyopathy (ATTR-CM). The positive sentiment is driven by the drug's early approval, favorable pricing strategy, and promising adoption rates among physicians.
Analyst Reaffirmations and Price Target Adjustments
TD Cowen reaffirmed a Buy rating on BridgeBio shares, citing Attruby's effectiveness in reducing cardiovascular hospitalizations and deaths, achieving near-complete stabilization for patients, a benefit not observed with tafamidis. H.C. Wainwright also raised its price target on BridgeBio to $49.00, maintaining a Buy rating, following the FDA approval. Piper Sandler confirmed its Overweight rating with a price target of $46.00.
Competitive Pricing and Market Adoption
Attruby's pricing is set at $18,759.12 for a 28-day supply, approximately $244,500 annually, which is 10% lower than tafamidis ($268,000 annually) and significantly less than Amvuttra. This competitive pricing, coupled with minimal co-pay expenses for most patients, is projected to encourage widespread adoption. A Key Opinion Leader (KOL) survey conducted by TD Cowen indicates that over 30% of first-line patients are likely to be treated with Attruby.
Clinical Data and Mechanism of Action
The FDA approval of Attruby was based on the ATTRibute-CM Phase 3 study, which demonstrated a significant reduction in death and cardiovascular-related hospitalizations. Attruby is an orally-administered drug designed to emulate a "rescue mutation" of the TTR gene, stabilizing the native TTR tetramer and addressing the root cause of ATTR-CM.
Medicare Coverage Considerations
Piper Sandler highlighted the implications of potential approval for ALNY's Amvuttra in ATTR-CM, noting the differences in Medicare drug coverage under Part B and Part D. Amvuttra would fall under Part B coverage, while Attruby is covered under Part D. This distinction is significant as Medicare covers an estimated 80% of ATTR-CM patients. Payer consultants suggest a potentially higher liability for insurers with a Part B drug compared to a Part D medication, which may influence market adoption.
Pipeline Developments Beyond Attruby
BridgeBio is also advancing its pipeline with gene therapy programs. Encouraging results were reported from the Phase 1/2 CANaspire trial for BBP-812, a gene therapy for Canavan disease, suggesting potential improvements in motor function. Enrollment has been completed for the Phase 3 FORTIFY study of BBP-418, a potential treatment for Limb-girdle Muscular Dystrophy Type 2I/R9. The company discontinued its BBP-631 gene therapy program, expected to save over $50 million in research and development, and formed a joint venture named GondolaBio, backed by a $300 million investment.
