On Monday, BridgeBio Pharma shares (NASDAQ:BBIO), a $5.2 billion market cap biotechnology company, sustained a Buy rating and a price target of $49 from H.C. Wainwright. The firm's decision follows a recent announcement from BridgeBio regarding acoramidis, their treatment for a rare heart condition.
According to InvestingPro data, analysts maintain a strong bullish consensus on the stock, with price targets ranging from $36.40 to $70. Last Friday, the company revealed that the Committee for Medicinal Products for Human Use (CHMP) recommended marketing authorization for acoramidis in the European Union (EU). This recommendation is for treating wild-type or variant transthyretin amyloidosis in adult patients with cardiomyopathy (ATTR-CM).
Acoramidis, described as a selective small molecule and orally administered transthyretin (TTR) stabilizer, has shown to be effective in the Phase 3 ATTRibute-CM study. The study's results demonstrated clear cardiovascular benefits. The European Commission is expected to make its final approval decision, which is often in line with the CHMP's recommendation, potentially within the first half of 2025.
The significance of this positive opinion from the CHMP is underscored by the fact that acoramidis, under the brand name Attruby, received approval from the FDA on November 22, 2024. It is the first and only product approved in the United States for adults with ATTR-CM that specifies near-complete stabilization of TTR.
InvestingPro analysis shows the company maintains a healthy financial position with a current ratio of 3.19, indicating strong ability to meet short-term obligations as it prepares for commercial launch.
The ATTRibute-CM Phase 3 study, which compared acoramidis against a placebo, met its primary clinical endpoints. The treatment significantly reduced cardiovascular-related hospitalizations, improved survival rates, and maintained functional capacity and quality of life in patients. These compelling results have reinforced the analyst's confidence in the drug's potential.
In light of the anticipated U.S. market penetration and the expected approval in Europe, H.C. Wainwright reaffirms its positive outlook for BridgeBio Pharma. The firm's reiterated Buy rating and 12-month price target of $49 reflect the potential they see in acoramidis becoming a successful treatment for ATTR-CM on a global scale.
InvestingPro data reveals analysts expect revenue growth of over 22% for the current fiscal year, though the company is not yet profitable. The stock is currently trading near its InvestingPro Fair Value, suggesting balanced market expectations. For deeper insights into BridgeBio's financial health and growth prospects, investors can access the comprehensive Pro Research Report, available exclusively to InvestingPro subscribers.
In other recent news, BridgeBio Pharma has garnered significant attention following the FDA's approval of Attruby, an oral medication targeted at reducing cardiovascular death and hospitalization.
The approval was based on positive results from the ATTRibute-CM Phase 3 study, which demonstrated Attruby's significant reduction in death and cardiovascular-related hospitalizations. This approval led Scotiabank (TSX:BNS) analyst Greg Harrison to raise the price target on BridgeBio Pharma to $48.00, maintaining a Sector Outperform rating.
Moreover, TD (TSX:TD) Cowen has maintained a Buy rating on BridgeBio Pharma shares, highlighting the competitive pricing of Attruby, which is set 10% lower than its competitor, taf. This pricing strategy, coupled with the expectation that most patients will have zero or minimal co-pay expenses, is projected to encourage widespread adoption of the drug.
BMO (TSX:BMO) Capital Markets maintained a Market Perform rating on BridgeBio Pharma, noting the FDA approval of Attruby as a significant positive for the company. Piper Sandler also reiterated an Overweight rating on the stock, emphasizing the drug's competitive pricing and the inclusion of a mortality reduction claim on its label.
These recent developments reflect BridgeBio's active engagement in drug development and regulatory processes.
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