BridgeBio: PDUFA Date Expected In November 2024 Could Shift Momentum

Core Viewpoint - BridgeBio Pharma has received FDA acceptance for its New Drug Application (NDA) of Acoramidis for treating transthyretin amyloid cardiomyopathy (ATTR-CM), with a PDUFA date set for November 29, 2024, indicating a positive outlook for the company [2][3][8] Regulatory Developments - The FDA accepted the NDA for Acoramidis, and no advisory committee will be convened for its review [3] - The European Medicines Agency (EMA) also accepted the Marketing Authorization Application (MAA) for Acoramidis, enhancing the potential for market entry in Europe [3] - The company has plans for further regulatory submissions in other territories in the coming years [3] Licensing and Financials - BridgeBio has entered a licensing agreement with Bayer for the European rights to Acoramidis, receiving an upfront payment of $300 million and potential future milestone payments and royalties [3][5] - As of June 30, 2024, BridgeBio reported cash and equivalents of $587.2 million, bolstered by various financial transactions [5] Clinical Trial Success - The phase 3 ATTRibute-CM study met its primary endpoint with statistical significance, indicating Acoramidis may offer advantages over existing treatments [3] - The study involved 632 patients and demonstrated a Win Ratio of 1.8 with a p-value of p<0.0001 [3] Market Competition - The transthyretin amyloidosis treatment market is projected to reach $11.2 billion by 2032, with Pfizer's Vyndamax currently dominating the market [4] - BridgeBio aims to capture 25% to 40% of the ATTR-CM market share, contingent on competitive pricing and efficacy advantages [4][8] Future Prospects - A program update for BBP-631, aimed at treating congenital adrenal hyperplasia (CAH), is expected in August 2024, which will determine the future of this candidate [2][7]