On Monday, BridgeBio Pharma (NASDAQ:BBIO) maintained a favorable outlook from analysts after the company received early approval for its new drug. Piper Sandler reiterated an Overweight rating on the stock, with a steady price target of $46.00. The approval for acoramidis (Attruby), intended for the treatment of ATTR-CM, was granted ahead of the scheduled Prescription Drug User Fee Act (PDUFA) date of November 29.
The analyst noted that the drug's label includes a claim of reducing mortality, which is considered a best-case scenario for the company. The approval came late Friday and positions BridgeBio Pharma to start marketing its new treatment. Attruby has been priced annually at $244.5K, which is approximately 9% lower than its competitor, Vyndamax.
BridgeBio Pharma has already prepared a fully staffed sales force to launch Attruby. This strategic move could give the company an advantage in reaching the market effectively. The early approval may also have a positive impact on the company's financial performance, with current consensus estimates for the fourth quarter at $0.7 million and $96 million projected for 2025. Piper Sandler's own estimates are set higher at $115 million for 2025, although they acknowledge a broad range of forecasts for next year, varying from $33 million to $167 million.
The early FDA approval and the preparedness of BridgeBio Pharma's sales team are expected to facilitate a strong market entry for Attruby. With the drug's competitive pricing and the inclusion of a mortality reduction claim on its label, BridgeBio Pharma seems well-positioned to capitalize on its new treatment option for ATTR-CM patients.
In other recent news, BridgeBio Pharma has been in the spotlight with significant developments. The company received FDA approval for its drug, Attruby, for the treatment of a heart condition known as ATTR-CM, leading H.C. Wainwright to raise its price target on BridgeBio's shares to $49. This approval follows the ATTRibute-CM Phase 3 study's findings that showed Attruby significantly reduced death and cardiovascular-related hospitalizations.
Additionally, BridgeBio has reported promising results from its Phase 1/2 CANaspire trial for BBP-812, a gene therapy for Canavan disease, indicating potential improvement in motor function for patients. The company has also completed enrollment for its Phase 3 FORTIFY study of BBP-418, a potential treatment for Limb-girdle Muscular Dystrophy Type 2I/R9.
Citi, H.C. Wainwright, BMO Capital, and Piper Sandler have maintained their respective Buy, Market Perform, and Overweight ratings on BridgeBio. Other recent developments include the discontinuation of BridgeBio's BBP-631 gene therapy program, expected to save over $50 million in research and development, and the formation of a joint venture named GondolaBio, backed by a $300 million investment from a consortium of investors.
InvestingPro Insights
BridgeBio Pharma's recent FDA approval for Attruby aligns with several key financial metrics and analyst insights. According to InvestingPro data, the company's market capitalization stands at $4.43 billion, reflecting investor confidence in its potential. The company's revenue for the last twelve months as of Q3 2023 was $217.76 million, with an impressive revenue growth of 2209.77% over the same period.
InvestingPro Tips highlight that analysts anticipate sales growth in the current year, which is consistent with the expected launch of Attruby. This projection is particularly significant given the drug's competitive pricing and early approval. However, it's worth noting that analysts do not anticipate the company to be profitable this year, which is reflected in the negative P/E ratio of -7.79.
Another relevant InvestingPro Tip indicates that BridgeBio's liquid assets exceed short-term obligations, suggesting financial stability as the company enters the commercialization phase for Attruby. This could be crucial for supporting the launch and marketing efforts mentioned in the article.
For investors seeking a more comprehensive analysis, InvestingPro offers 5 additional tips that could provide further insights into BridgeBio Pharma's financial health and market position.
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