These Drugs Stocks Will Win FDA Approval
BOSTON (TheStreet) -- TheStreet's 2012 FDA Drug Approval Contest is in full swing, with 23 of the 59 contestants a perfect 4-0 so far.
Forty-six percent of contestants are predicting an FDA rejection of Korlym versus 42% who are forecastingapproval. The remaining 10% predict an FDA delay. Like I said, the Korlym approval decision is set for Friday.The four drugs approved by FDA -- fromAmylin(AMLN_), Vertex(VRTX_),Roche-Curis(CRIS_) andTeva(TEVA_)-BioSante(BPAX_) -- have been relative layups. The challenging drug approval decisions lie ahead, starting tomorrow with Corcept Therapeutics(CORT_) and its Korlym therapy for Cushing's Syndrome. This is where the contest should start to get interesting.
Of the 23 contestants with perfect 4-0 records so far (I'm included in this illustrious group), 52% say Korlym gets rejected; 35% predict approval and 13% say no decision.
Here's how the approval predictions play out for the remaining drug approval decisions:
Columbia Labs(CBRX_): Approval 5%; Rejection 88%; No decision 7%.
Discovery Labs(DSCO_): Approval 47%; Rejection 49%; No decision 3%.
Astex Pharma(ASTX_): Approval 36%; Rejection 46%; No decision 18%.
NeurogesX(NSGX): Approval 47%; Rejection 46%; No decision 7%.
MAP Pharma(MAPP_): Approval 37%; Rejection 59%; No decision 3%.
Affymax(AFFY_): Approval 68%; Rejection 22%; No decision 10%.
Chelsea Therapeutics(CHTP_): Approval 53%; Rejection 43%; No decision 3%.
Vivus(VVUS_) (Qnexa): Approval 49%; Rejection 39%; No decision 12%.
Amgen(AMGN_): Approval 53%; Rejection 42%; No decision 5%.
Vivus (Avanafil): Approval 76%; Rejection 19%; No decision 5%.
Note: Cell Therapeutics(CTIC_) was removed from the contest given the withdrawal of the pixantrone filing.
Discovery Labs(DSCO_): Approval 47%; Rejection 49%; No decision 3%.
Astex Pharma(ASTX_): Approval 36%; Rejection 46%; No decision 18%.
NeurogesX(NSGX): Approval 47%; Rejection 46%; No decision 7%.
MAP Pharma(MAPP_): Approval 37%; Rejection 59%; No decision 3%.
Affymax(AFFY_): Approval 68%; Rejection 22%; No decision 10%.
Chelsea Therapeutics(CHTP_): Approval 53%; Rejection 43%; No decision 3%.
Vivus(VVUS_) (Qnexa): Approval 49%; Rejection 39%; No decision 12%.
Amgen(AMGN_): Approval 53%; Rejection 42%; No decision 5%.
Vivus (Avanafil): Approval 76%; Rejection 19%; No decision 5%.
Note: Cell Therapeutics(CTIC_) was removed from the contest given the withdrawal of the pixantrone filing.
One more note: One contestant has yet to get a single drug-approval decision correct. He/she is a lousy 0-4. I'll spare this person any further embarrassment by withholding their identity.
--Written by Adam Feuerstein in Boston.
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