The crash in Affymax's stock price ($14.20 to $2.42) wasn't much of a surprise. Article in the WSJ Feb 25: "At this point, the assumption is that the drug never comes back to the market, and that if it does come back to the market, it's not as successful as we'd all envisioned it would be," Piper Jaffray analyst Ian Somaiya said. "That's what the stock's pricing in today."
Some more facts:
1. Some 0.2% or 50 patients had hypersensitivity reactions.
2. At least 5 deaths, 3 tied to hypersensitivity
3. 19 serious hypersensitivity reactions
We are unlikely to be seeing peginesatide again, but the question is what effect will this have on the regulatory scrutiny for other ESAs. My guess is that things will slow down for all new classes of ESAs except for ESA biosimilars.
Some more facts:
1. Some 0.2% or 50 patients had hypersensitivity reactions.
2. At least 5 deaths, 3 tied to hypersensitivity
3. 19 serious hypersensitivity reactions
We are unlikely to be seeing peginesatide again, but the question is what effect will this have on the regulatory scrutiny for other ESAs. My guess is that things will slow down for all new classes of ESAs except for ESA biosimilars.
