On Monday, BridgeBio Pharma (NASDAQ:BBIO) received a boost from H.C. Wainwright after the firm raised its price target on the stock to $49.00 from the previous $43.00, while keeping a Buy rating on the shares. This adjustment follows the recent FDA approval of BridgeBio's drug, Attruby, for the treatment of a heart condition known as ATTR-CM.
The FDA's endorsement is grounded on the ATTRibute-CM Phase 3 study's findings, which indicated that Attruby significantly curtailed death and cardiovascular-related hospitalizations, as well as enhanced the quality of life for patients. Attruby, an orally-administered drug, is recognized as the sole approved treatment that claims near-complete stabilization of transthyretin (TTR), a protein associated with ATTR-CM.
BridgeBio announced the FDA approval late on Friday of last week, noting that Attruby is designed to emulate a "rescue mutation" of the TTR gene, which directly addresses the root cause of ATTR-CM by stabilizing the native TTR tetramer. This stabilization is crucial for maintaining the protein's normal function, which includes the transportation of thyroxine and vitamin A.
In light of the FDA approval, H.C. Wainwright has updated the probability of Attruby's launch to 100%, up from the previous 85%, and anticipates that BridgeBio will begin recording sales of the drug early in the next year. Attruby has been priced at $18,759.12 for a 28-day supply, which equates to an annual cost of approximately $244,500 – slightly lower than the competing drug tafamidis, which is listed at $268,000.
The firm also revised its terminal growth rate for BridgeBio to 1% from 5%, while maintaining a discount rate of 10%. These model changes have led to the reaffirmation of the Buy rating and the increased price target for BridgeBio's shares.
In other recent news, BridgeBio Pharma has been making significant strides in genetic disease research. The company has reported promising results from its Phase 1/2 CANaspire trial, focused on BBP-812, a gene therapy for Canavan disease. This data suggests that BBP-812 might improve motor function for patients with Canavan disease. BridgeBio has also completed enrollment for its Phase 3 FORTIFY study of BBP-418, a potential treatment for Limb-girdle Muscular Dystrophy Type 2I/R9. Additionally, the company's investigational drug, acoramidis, has shown encouraging results in a post-hoc analysis of the Phase 3 ATTRibute-CM study.
Several analyst firms, including Citi, H.C. Wainwright, BMO (TSX:BMO) Capital, and Piper Sandler, have maintained their respective Buy, Market Perform, and Overweight ratings on BridgeBio. Citi has reiterated its Buy rating and $45.00 stock price target for BridgeBio, citing the company's ongoing research and development efforts.
Other recent developments include the discontinuation of BridgeBio's BBP-631 gene therapy program, projected to save over $50 million in research and development. The FDA has also granted Breakthrough Therapy Designation to BridgeBio's oral drug candidate infigratinib, aimed at treating children with achondroplasia. Furthermore, BridgeBio has formed a joint venture named GondolaBio, backed by a $300 million investment from a consortium of investors, aiming to expedite the development of new therapies.
InvestingPro Insights
Recent InvestingPro data provides additional context to BridgeBio Pharma's (NASDAQ:BBIO) financial position following the FDA approval of Attruby. The company's market capitalization stands at $4.43 billion, reflecting investor expectations for the newly approved drug. Despite the significant revenue growth of 2209.77% over the last twelve months, BridgeBio's operating income remains negative at -$516.2 million, underscoring the importance of Attruby's successful commercialization.
InvestingPro Tips highlight that analysts anticipate sales growth in the current year, aligning with expectations for Attruby's market entry. However, the company is not expected to be profitable this year, which is consistent with its current financial metrics. BridgeBio's liquid assets exceeding short-term obligations provide some financial flexibility as it prepares for the drug launch.
For investors seeking a more comprehensive analysis, InvestingPro offers 6 additional tips that could provide valuable insights into BridgeBio's future performance and market position.
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