Group 1 - Dr. Vinay Prasad, head of the Center for Biologics Evaluation and Research (CBER), will leave his position in April, which has led to positive sentiment among investors regarding his controversial decisions during his tenure [1][2] - Moderna's shares are trending higher, with the potential for its mRNA-1010 vaccine to qualify for full approval in adults aged 65 and older, potentially avoiding the need for an additional costly efficacy study [3] - Stocks of several companies, including Solid Biosciences Inc. (up 12.15% to $7.57), Capricor Therapeutics Inc. (up 9.07%), Crispr Therapeutics AG (up 2.80% to $58.08), and Sarepta Therapeutics Inc. (up 4.31% to $17.43), have seen increases following the news of Dr. Prasad's departure [3] Group 2 - The resignation of Dr. Prasad could be beneficial for rare disease sponsors seeking to utilize single-arm studies and external controls for regulatory approval, as he was involved in denying an expedited review path for AMT-130 gene therapy [2] - Analysts from William Blair noted that investors are optimistic about the changes in leadership at CBER, which may lead to a more favorable regulatory environment for certain treatments [2]
What's Going On With Moderna, Capricor, Other Biotech Stocks On Monday?