This Day On The Street
Continue to site
This account is pending registration confirmation. Please click on the link within the confirmation email previously sent you to complete registration.
Need a new registration confirmation email? Click here

Biotech Stock Mailbag: MAP Pharma, Affymax

BOSTON ( TheStreet) -- A question about MAP Pharmaceuticals (MAPP) and the FDA's rejection of its inhaled migraine drug, Levadex, leads this week's Biotech Stock Mailbag.

Via Twitter, @recervan asks, "Adam, have you ever seen a CRL like MAPP where the price goes up? Very weird."

Strange, indeed. FDA drug rejections typically cause significant and sudden stock declines. I can't say the MAP Pharma situation is unprecedented, but it's certainly unusual to see a stock fall just slightly following an FDA rejection, particularly for a one-product, cash-burning company like MAP Pharma. At one point on Tuesday, the first trading day after Monday night's FDA announcement, MAP Pharma shares traded briefly in the green.

Since then, the stock has started to weaken. On Thursday, MAP Pharma closed at $15.25, down 11% since Levadex was rejected.

Investors seem to be sticking with MAP Pharma because they believe Levadex's approval is now "de-risked." FDA's only lingering concerns are related to the manufacturing of the inhaler and the way it's used by migraine patients -- issues that are easily resolved. Importantly, FDA has no concerns about the efficacy of inhaled DHE (the active ingredient in Levadex) to treat migraines nor did the agency raise unaddressed problems with the safety of inhaled DHE, particularly when it comes to lung function or side effects, according to MAP Pharma.

Let me repeat that last bit with emphasis: according to MAP Pharma. You got that? It's important, of course, because only MAP Pharma knows the content of the FDA's complete response letter. We don't get to see the letter, which means you have to believe MAP Pharma executives are telling us the truth.

Which is a good segue into a comment from @shaneblackmon regarding my questioning of MAP Pharma's execs on Tuesday morning's conference call.

"@adamfeuerstein asking dumb questions about the SPA [Special Protocol Assessment]. When the issues of the CRL have absolutely NOTHING to do with phase 3 trials. Moron."

The credibility of MAP Pharma's executives is important. If CEO Tim Nelson and his team are being straight with us about the simple requirements necessary to get Levadex approved, then the optimism that's buoying the stock is easier to justify.
1 of 4

Check Out Our Best Services for Investors

Action Alerts PLUS

Portfolio Manager Jim Cramer and Director of Research Jack Mohr reveal their investment tactics while giving advanced notice before every trade.

Product Features:
  • $2.5+ million portfolio
  • Large-cap and dividend focus
  • Intraday trade alerts from Cramer
Quant Ratings

Access the tool that DOMINATES the Russell 2000 and the S&P 500.

Product Features:
  • Buy, hold, or sell recommendations for over 4,300 stocks
  • Unlimited research reports on your favorite stocks
  • A custom stock screener
Stocks Under $10

David Peltier uncovers low dollar stocks with serious upside potential that are flying under Wall Street's radar.

Product Features:
  • Model portfolio
  • Stocks trading below $10
  • Intraday trade alerts
14-Days Free
Only $9.95
14-Days Free
Dividend Stock Advisor

David Peltier identifies the best of breed dividend stocks that will pay a reliable AND significant income stream.

Product Features:
  • Diversified model portfolio of dividend stocks
  • Updates with exact steps to take - BUY, HOLD, SELL
Trifecta Stocks

Every recommendation goes through 3 layers of intense scrutiny—quantitative, fundamental and technical analysis—to maximize profit potential and minimize risk.

Product Features:
  • Model Portfolio
  • Intra Day Trade alerts
  • Access to Quant Ratings
Real Money

More than 30 investing pros with skin in the game give you actionable insight and investment ideas.

Product Features:
  • Access to Jim Cramer's daily blog
  • Intraday commentary and news
  • Real-time trading forums
Only $49.95
14-Days Free
14-Days Free
AFFY $0.08 0.00%
AAPL $93.74 0.00%
FB $117.58 0.00%
GOOG $693.01 0.00%
TSLA $240.76 0.00%


Chart of I:DJI
DOW 17,773.64 -57.12 -0.32%
S&P 500 2,065.30 -10.51 -0.51%
NASDAQ 4,775.3580 -29.9330 -0.62%

Free Reports

Top Rated Stocks Top Rated Funds Top Rated ETFs