This Day On The Street
Continue to site
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

Biotech Calendar: Key FDA Action Dates

Allos Therapeutics (ALTH)
Drug/indication: Pralatrexate for peripheral T-cell lymphoma
FDA decision date: Sept. 24

Allos expects the FDA to convene an advisory panel meeting to review pralatrexate, although a meeting has not been formally announced. The scheduling of the advisory meeting may delay the FDA's approval decision.

Amgen (AMGN)
Drug/indication: Denosumab for osteoporosis
FDA advisory panel date: Aug. 13
FDA decision date: Oct. 19

Denosumab is the most important drug in the company's late-stage pipeline. Approval for osteoporosis, and later for certain cancer indications, could re-invigorate earnings growth after a couple of flat years. Denosumab's safety profile will be the focus of the Aug. 13 advisory panel meeting.

Acorda Therapeutics (ACOR - Get Report)
Drug/indication: Fampridine for multiple sclerosis
FDA decision date: Oct. 22

Fampridine improves nerve function and is being developed to improve the walking abilities of patients with multiple sclerosis.

GTx (GTXI)
Drug/indication: Acapodene for prostate cancer
FDA decision date: Oct. 30

Acapodene is designed to reduce bone fractures in prostate cancer patients being treated with androgen deprivation therapy.

Transcept Pharmaceuticals (TSPT - Get Report)
Drug/indication: Intermezzo for insomnia
FDA decision date: Oct. 30

Intermezzo is a dissolvable, low-dose form of the sleep aid Ambien which will be marketed for people who awake in the middle of the night but can't fall back to sleep.

Cadence Pharmaceuticals (CADX)
Drug/indication: Acetevance for acute pain/fever
FDA decision date: Nov. 13

Acetevance is an injectable form of the painkiller acetaminophen for use in hospitals.

Somaxon Pharmaceuticals (SOMX)
Drug/indication: Silenor for insomnia
FDA decision date: Dec. 4

The FDA refused to approve Silenor last February, requesting additional clinical information from Somaxon. The company resubmitted Silenor in June.

3 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
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
CADX $0.00 0.00%
CTIC $1.96 0.51%
ACOR $33.12 -1.13%
AUXL $36.47 -0.16%
TSPT $28.87 -1.06%

Markets

DOW 18,080.14 +21.45 0.12%
S&P 500 2,117.69 +4.76 0.23%
NASDAQ 5,092.0850 +36.0220 0.71%

Partners Compare Online Brokers

Free Reports

Top Rated Stocks Top Rated Funds Top Rated ETFs