Can we all just stop and have a group hug around
Great news Thursday: The company announced that the FDA designated the ferumoxytol resubmission as a Class 1 (two-month) response, which sets the approval decision date for Dec. 30.
This indicates that there are no major problems or significant issues outstanding and that the FDA is positively inclined to approve ferumoxytol (an injectable iron replacement therapy to treat anemia in patients with chronic kidney disease) sooner rather than later. If the opposite were true, the FDA would have classified Amag's response as a Class 2, giving the agency six months to complete the review.
Amag shares were soaring $14.90 Thursday to $33.26 on the news, signaling a sharp turnaround in investor sentiment since Oct. 20, when the FDA issued a complete response letter on ferumoxytol and asked Amag to submit additional information.
I've been an Amag bull for quite some time, although lately it's been a frustrating and painful position to hold. In a column last April I laid out the
contentious issues around ferumoxytol's FDA review
. On Oct. 20, I added Amag as a long pick to the
Unfortunately, worries over the ferumoxytol review, mainly tied to the drug's safety and the adequacy of Amag's approval package, have battered the stock ever since. The bear market didn't help. At one point this week, Amag was down more than 50% in the model portfolio.
I spoke briefly with Amag CEO Brian Pereira Thursday morning. Clearly, he was happy. He's not guaranteeing approval on Dec. 30 -- he'd be foolish to do so -- but throughout this process he's been resolute in his statements that the outstanding regulatory issues surrounding ferumoxytol were anticipated and would be addressed with alacrity. The company will launch ferumoxytol shortly after its approval, he says, which means January if the FDA comes through on Dec. 30.
Amag has been the one stock in the model portfolio that has kept me up at night. It's been a real struggle to remain optimistic and confident watching its shares fall day after day. Even with Thursday's bounce, the stock is still in the red on my ledger, which shows you just how deep a hole I've been in.
But I'm more than happy to take baby steps. Today is a great start. There could be profit-taking on this news and lingering doubts and concerns about ferumoxytol as the FDA's Dec. 30 action date draws closer. I'm more than willing now to stick with Amag through this approval process and launch because I believe the stock will climb higher over time.
One more note:
are all big players in the chronic kidney disease treatment market. As such, it wouldn't be a stretch to see one of them make an offer to acquire Amag in the future.
At the time of publication, Feuerstein's Biotech Select model portfolio was long AMAG.
Adam Feuerstein writes regularly for TheStreet.com. In keeping with TSC's editorial policy, he doesn't own or short individual stocks, although he owns stock in TheStreet.com. He also doesn't invest in hedge funds or other private investment partnerships. Feuerstein appreciates your feedback;
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