FDA Rejection Of Amgen Drug Does Nothing To Change Baird's Outlook On The Stock

Amgen, Inc. AMGN has received a CRL [complete response letter] in relation to Parsabiv, a calcimimetic under review by the FDA for secondary hyperthyroidism. This unexpected development is likely to have only a “minimal material impact” on the stock, Baird’s Brian P. Skorney said in a report. He maintained a Neutral rating on the company, with a price target of $157.

Lack Of Rejection Details

Amgen has not provided an explanation for the CRL or its next steps, apart from intending to meet with the FDA later this year to discuss the letter. “Parsabiv is one of only a few drugs in late-stage development that the company has actively discussed in the last year, but recently, talk around the company's migraine program (AMG 334) has come to the forefront,” analyst Skorney wrote.

Related Link: Gabelli & Co. Initiates Coverage On Amgen At Hold

Parsabiv Efficacy

Parsabiv’s efficacy was similar to that of Sensipar, the company's approved secondary hyperthyroidism drug for patients on dialysis.

“In the head-to-head study, Parsabiv was non-inferior to Sensipar on the primary endpoint of proportion of patients achieving >30% reduction in mean pre-dialysis serum intact parathyroid hormone (PTH) levels, and bested Sensipar on the secondary endpoints,” Skorney mentioned.

Potential Safety Concerns?

While Parsabiv showed a slightly lower rate of serious adverse events, it did exhibit a higher incidence of hypocalcemia, cardiac failure, and fatal adverse events.

“It is possible that the modest increase in these adverse events outweighed the benefits provided on secondary endpoints and in the differing administration, in the FDA's opinion. It's also possible that this is just a minor CMC issue and can be quickly resolved,” the analyst commented.

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