This Day On The Street
Continue to site right-arrow
ADVERTISEMENT
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

Why Spectrum Fell on Beleodaq Approval but Will Rocket on Melphalan Approval

NEW YORK (TheStreet) -- Food and Drug Administration approvals can be a very exciting investment sport. Sometimes they can get too exciting and trip you up even if you make the right call. That's why, when playing the FDA approval game, investors need to keep in mind two things: the bottom-line numbers, and the degree of certainty of those numbers.

Case in point: Spectrum Pharmaceuticals (SPPI - Get Report) . Look what happened to this stock in late June to early July.

Read More: 10 Stocks Carl Icahn Loves

SPPI 6-Month Chart

In late June, the FDA was on the verge of announcing its decision on Spectrum's latest pipeline candidate Beleodaq. Beleodaq is a chemotherapy that preferentially kills tumor cells in certain subsets of Non-Hodgkin's lymphoma.

As decision day closed in, investors placed bets that Beleodaq would be approved. On July 3, it was. Then Spectrum fell 26% in one month.

What happened? What seems to be the case here is that novice biotech investors started placing bets on approval without keeping the hard numbers in mind. Beleodaq is not a first-line treatment. It is for relapsed NHL and is specifically most effective for a subtype called angioimmunoblastic T-cell lymphoma, which accounts for 1% to 2% of all NHL cases. There are around 550,000 NHL cases in the U.S. per year, which puts the rare form at between 5,000 and 10,000 cases a year. Minus first-line treatments, there's not much left.

Some FDA approvals will obviously bring companies major revenue. Some, however, may not, and it is important to differentiate between the two. Although we don't know what the numbers will be on Beleodaq yet, the Spectrum's fall since the Beleodaq approval seems to suggest they won't be stellar. But luckily for those who bought at the top and are still hanging on, there is hope for Spectrum yet.

Read More: Bill Ackman to Sue U.S. Over Fannie, Freddie Mortgage Profits

To see why, let's look at what's happened since the stock bottomed on Aug. 4. Simply, sales picked up more than 40%, and the quarterly loss shrank unexpectedly to 6 cents a share. Its other drugs came through for the quarter, and shares broke back through $8. Investors have not yet lost faith.

1 of 2

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
To begin commenting right away, you can log in below using your Disqus, Facebook, Twitter, OpenID or Yahoo login credentials. Alternatively, you can post a comment as a "guest" just by entering an email address. Your use of the commenting tool is subject to multiple terms of service/use and privacy policies - see here for more details.
Submit an article to us!
SYM TRADE IT LAST %CHG
SPPI $5.91 0.00%
AAPL $124.25 0.00%
FB $81.66 0.00%
GOOG $542.56 0.00%
TSLA $187.59 0.00%

Markets

DOW 17,698.18 -77.94 -0.44%
S&P 500 2,059.69 -8.20 -0.40%
NASDAQ 4,880.2280 -20.6570 -0.42%

Partners Compare Online Brokers

Free Reports

Top Rated Stocks Top Rated Funds Top Rated ETFs