ASND May 2024 175.000 call
| Previous Close | 1.7500 |
| Open | 1.7500 |
| Bid | 0.0000 |
| Ask | 5.0000 |
| Strike | 175.00 |
| Expire Date | 2024-05-17 |
| Day's Range | 1.7500 - 1.7500 |
| Contract Range | N/A |
| Volume | |
| Open Interest | 320 |
ZacksFDA Delays Decision on Ascendis' (ASND) Hormone Therapy Filing
Per the FDA, the data submitted by Ascendis (ASND) for its hormone replacement therapy constitutes a major amendment to its previously-submitted data. A final decision is expected by Aug 14.
- Reuters
UPDATE 2-US FDA extends review of Ascendis Pharma's hormone disorder therapy
The U.S. Food & Drug Administration has extended its review of Ascendis Pharma's therapy to treat adult patients with a hormone disorder by three months, the company said on Tuesday. U.S.-listed shares of the company were down 6.6% in late afternoon trading. The health regulator notified that data submitted for the ongoing review of the therapy, called TransCon PTH, constituted "a major amendment" to the company's application seeking market approval.
GlobeNewswireAscendis Pharma Announces Extension of U.S. Food and Drug Administration Review Period for TransCon™ PTH for Adults with Hypoparathyroidism
- Prescription Drug User Fee Act (PDUFA) goal date extended by three months for further review of submission to August 14, 2024 COPENHAGEN, Denmark, May 14, 2024 (GLOBE NEWSWIRE) -- Ascendis Pharma A/S (Nasdaq: ASND) today announced that the U.S. Food and Drug Administration (FDA) notified the Company that information submitted in response to the FDA’s ongoing review of the New Drug Application (NDA) for TransCon PTH (palopegteriparatide) for adults with hypoparathyroidism constituted a major am
