Ascendis Pharma Surges on FDA Approval and NDA Hopes as Trading Volume Hits Top 500 Rank 53.55% Jump Driven by Skytrofa Milestone and Cash Burn Concerns

Ascendis Pharma (ASND) rose 0.60% on August 8, 2025, with a trading volume of $0.29 billion, up 53.55% from the prior day. The stock’s performance was influenced by recent regulatory developments and financial updates. On July 29, the U.S. Food and Drug Administration (FDA) approved Skytrofa (lonapegsomatropin-tcgd) for the treatment of growth hormone deficiency in adults, marking a key milestone for the company’s growth hormone therapy. Additionally, Ascendis’ TransCon CNP (carperitide) New Drug Application (NDA) remains under FDA priority review, with a Prescription Drug User Fee Act (PDUFA) decision date set for November 30, 2025. These regulatory updates highlight the company’s progress in its pipeline, though investors remain cautious given its cash burn of €38.9 million in Q2 2025 despite a 327% year-over-year revenue increase to €158 million.

The approval of Skytrofa expands Ascendis’ commercial footprint in rare diseases, a sector critical to its revenue growth. However, the company’s financials reveal ongoing challenges, including a net loss of €38.9 million for the quarter and a decline in cash reserves to €494 million. The TransCon CNP NDA, if approved, could address a significant unmet need in cardiovascular indications, but regulatory uncertainty persists. Analysts note that the stock’s performance will likely hinge on the November PDUFA outcome and the company’s ability to manage operational costs amid scaling its commercial infrastructure.

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