Analyst Says MannKind's (MNKD) Has an Uncertain Future
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Analysts at Leerink Swan issued a 2010 outlook for MannKind Corp. (Nasdaq: MNKD), a battleground stock which is attempting to win approval for its inhaled insulin product Afresa.
The firm said while MannKind could receive FDA approval in January leading to signing of a partnership and commercial launch later in 2010, timely approval is far from guaranteed.
There are two regulatory hurdles to approval, according to the firm. The first is the Afresa PDUFA date on 1/16/10 and the second one is the approval of the second generation inhaler device possibly in 4Q10. On this the firm said, "We believe the first regulatory hurdle is the higher risk one as the new device approval should be relatively straight forward. MNKD's current plan is to submit a sNDA for the new device in 2Q10 after the approval but if Afresa receives a complete response letter, it is possible that the new device filing could be included in a resubmission to the FDA."
On the stocks valuation, the firm said they have concerns even if Afresa gets approved it may not sell enough to justify the current price. They note Pfizer's Exubera, the first inhaled insulin was pulled from the market after a disappointing launch. "Although we believe Afresa is a better product than Exubera, physicians may be skeptical of inhaled insulins in light of the Exubera experience," the firm said. They are maintaining an Underperform rating.
Key events for MannKind include:
The firm said while MannKind could receive FDA approval in January leading to signing of a partnership and commercial launch later in 2010, timely approval is far from guaranteed.
There are two regulatory hurdles to approval, according to the firm. The first is the Afresa PDUFA date on 1/16/10 and the second one is the approval of the second generation inhaler device possibly in 4Q10. On this the firm said, "We believe the first regulatory hurdle is the higher risk one as the new device approval should be relatively straight forward. MNKD's current plan is to submit a sNDA for the new device in 2Q10 after the approval but if Afresa receives a complete response letter, it is possible that the new device filing could be included in a resubmission to the FDA."
On the stocks valuation, the firm said they have concerns even if Afresa gets approved it may not sell enough to justify the current price. They note Pfizer's Exubera, the first inhaled insulin was pulled from the market after a disappointing launch. "Although we believe Afresa is a better product than Exubera, physicians may be skeptical of inhaled insulins in light of the Exubera experience," the firm said. They are maintaining an Underperform rating.
Key events for MannKind include:
- PDUFA date for Afresa on 1/16/10
- submission of sNDA for 2nd generation inhaler in 2Q10
- potential partnership for Afresa in mid-10
- potential commercial launch of Afresa in 4Q10.
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