Amgen (AMGN) to See Low Impact from Parsabiv CRL; Leerink Affirms at 'Market Perform'
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Leerink affirms its Market Perform rating and $201 price target on Amgen (Nasdaq: AMGN) after Amgen announced earlier this week that the U.S. Food and Drug Administration (FDA) issued a Complete Response Letter for the New Drug Application (NDA) for Parsabiv (etelcalcetide) for the treatment of secondary hyperparathyroidism (sHPT) in adult patients with chronic kidney disease (CKD) on hemodialysis.
The firm commented today:
Wednesday evening Amgen announced it received a Complete Response Letter (CRL) for Parsabiv (etelcalcetide) for the treatment of secondary hyperparathyroidism (SHPT) in patients suffering from chronic kidney disease (CKD) on hemodialysis. The company did not disclose the reasons for the CRL and announced it was reviewing the letter in anticipation of a post-action meeting some time later this year. While we have no insights as to the basis of the CRL, we suspect it is about the drug’s safety. Parsabiv is a long acting IV version of Sensipar, the company’s oral calcimimetic facing imminent patent expiry. The IV version appears to be associated with more hypocalcemia (low serum calcium levels), and more symptomatic hypocalcemia, some increase in hyperkalemia (elevated potassium levels), and a signal for increased risk of cardiac rhythm disturbances (such as QT prolongation).
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