Auriga Upgrades Affymax, Inc. (AFFY) to Buy, Raises Price Target By 50%
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Price: $0.00 --0%
Rating Summary:
3 Buy, 3 Hold, 0 Sell
Rating Trend: = Flat
Today's Overall Ratings:
Up: 6 | Down: 4 | New: 9
Rating Summary:
3 Buy, 3 Hold, 0 Sell
Rating Trend: = Flat
Today's Overall Ratings:
Up: 6 | Down: 4 | New: 9
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Auriga upgraded shares of Affymax, Inc. (NASDAQ: AFFY) to a Buy rating today as they are on track to submit a New Drug Application for Hematide during 2Q11. They are raising their price target on the company to $10 from $5.
The firm reports that some advantages of the drug are namely once-monthly dosing and pricing flexibility, makes it an attractive option for dialysis providers. They are estimating that Hematide could capture 18% share of the $2.7B ESA market, which 91% of is currently controlled by AMGN (NYSE: AMGN). Two dialysis providers, Davita (DVA, NR) and Fresenius (FMS, NR), manage about 70% of U.S. dialysis patients.
Auriga comments that, "Given the PEARL 1 & 2 safety findings, AFFY and Takeda will submit all the data, but will only seek approval for treatment of anemia in dialysis patients. Importantly, in the eyes of clinicians and FDA, pre-dialysis and dialysis are two distinct and very different patient populations. The program was the largest pre-approval clinical dataset done for an ESA agent. As such, we believe the FDA will be receptive to the approach and will accept the NDA, triggering a $10MM milestone payment. We expect an advisory panel will review and support Hematide (possible 2H11). Hematide could be approved in mid-2012."
An arbitration panel determined AFFY and Johnson & Johnson (NYSE: JNJ) co-own certain IP related to ESAs. The decision is being appealed to the Federal Court, and in any case, will not impact AFFY's launch in the US.
For more ratings news on Affymax, Inc. click here and for the rating history of Affymax, Inc. click here.
Shares of Affymax, Inc. closed at $6.61 yesterday.
The firm reports that some advantages of the drug are namely once-monthly dosing and pricing flexibility, makes it an attractive option for dialysis providers. They are estimating that Hematide could capture 18% share of the $2.7B ESA market, which 91% of is currently controlled by AMGN (NYSE: AMGN). Two dialysis providers, Davita (DVA, NR) and Fresenius (FMS, NR), manage about 70% of U.S. dialysis patients.
Auriga comments that, "Given the PEARL 1 & 2 safety findings, AFFY and Takeda will submit all the data, but will only seek approval for treatment of anemia in dialysis patients. Importantly, in the eyes of clinicians and FDA, pre-dialysis and dialysis are two distinct and very different patient populations. The program was the largest pre-approval clinical dataset done for an ESA agent. As such, we believe the FDA will be receptive to the approach and will accept the NDA, triggering a $10MM milestone payment. We expect an advisory panel will review and support Hematide (possible 2H11). Hematide could be approved in mid-2012."
An arbitration panel determined AFFY and Johnson & Johnson (NYSE: JNJ) co-own certain IP related to ESAs. The decision is being appealed to the Federal Court, and in any case, will not impact AFFY's launch in the US.
For more ratings news on Affymax, Inc. click here and for the rating history of Affymax, Inc. click here.
Shares of Affymax, Inc. closed at $6.61 yesterday.
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