BMO Capital maintained a Market Perform rating on shares of BridgeBio Pharma (NASDAQ:BBIO) with a steady price target of $37.00. The firm's stance comes in light of regulatory developments surrounding Onpattro, a drug designed for the treatment of ATTR-CM, a heart condition.
Onpattro had previously met its primary endpoint in a non-cardiovascular outcomes trial, known as Apollo-B, but faced challenges due to the stringent benchmarks established by existing standard-of-care medications and the scrutiny of the FDA's Cardiorenal division.
BridgeBio Pharma is also in the process of seeking approval for Acoramidis, another treatment for ATTR-CM. BMO Capital anticipates that the FDA might convene an Advisory Committee (AdCom) to deliberate on Acoramidis, particularly because it did not show a statistically significant benefit in all-cause mortality, which is a secondary endpoint. The current standard of care has demonstrated a significant benefit in this area, which could influence the FDA's assessment.
The firm suggests that if an AdCom for Acoramidis is announced by approximately November 22, 2023, it could potentially result in a 30-40% decrease in BridgeBio Pharma's stock value. Conversely, such an announcement is expected to have a positive impact on Alnylam Pharmaceuticals, with an estimated 5-10% increase in its stock value.
BMO Capital's analysis reflects the complexities of drug approval processes and the high standards set by both existing treatments and the FDA. BridgeBio Pharma's path to approval for Acoramidis remains uncertain as the industry awaits further developments and potential regulatory discussions later in the year.
In other recent news, BridgeBio Pharma has received Breakthrough Therapy Designation from the U.S. Food and Drug Administration (FDA) for its oral drug candidate infigratinib, aimed at treating children with achondroplasia.
Concurrently, BridgeBio has announced the discontinuation of its BBP-631 gene therapy program, a move projected to save over $50 million in research and development. Analyst firms including H.C. Wainwright, Piper Sandler, Oppenheimer, Mizuho, and TD Cowen have maintained positive ratings for BridgeBio, following recent developments in the company's investigational drug, acoramidis.
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