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

Genta's Drug Timeline Likely Will Be Delayed

Genta (GNTA) is delaying the release of late-stage trial results for its experimental cancer drug Genasense, according to a Wall Street sell-side analyst.

Genasense data will now be released at a medical conference this fall, instead of this summer, as expected, says U.S. Bancorp Piper Jaffray analyst Peter Ginsberg in a research note published Thursday morning. Ginsberg says Genta executives confirmed the delay.

Earlier this month, TheStreet.com reported that Genta was still enrolling patients in all three of its Phase III clinical trials for Genasense, which would likely delay the reporting of results and push back efforts to get the drug reviewed by the Food and Drug Administration.

Genta shares were off $1.22, or just under 10%, to $11.27 in recent Thursday trading. The stock has traded as low as $10.78.

According to Ginsberg's research note, Genta is delaying the release of Genasense data at the request of its partner, Aventis (AVE). The Franco-German drug firm wants the data published at a major medical meeting, which won't happen until the fall. The exact medical meeting is not identified, but it's likely the American Society of Hematology annual meeting, which is held in December.

"As such, we now project an NDA filing in early 2003 rather than our previous expectation for a late 2002 filing," Ginsberg writes. He maintains his strong buy rating on Genta but is reducing his price target from $30 to $26. He also removed Genasense revenue from his 2003 financial model and reduced the drug's sales estimates in 2004. Ginsberg's firm has a banking relationship with the company.

Genta executives did not return phone calls seeking comment and the company has not yet issued a press release on the apparent pushback in Genasense's development timeline. This, in itself, seems to raise significant Regulation FD issues.

As recently as May 2, Genta CEO Ray Warrell told investors to expect Genasense results this summer, allowing the company to file an approval application to the FDA by the end of the year.

But an investigation by TheStreet.com uncovered that more than a dozen cancer research centers across the country are still enrolling patients in all three Genasense clinical trials. The drug is being developed initially as a treatment for melanoma, or skin cancer, and two types of blood cancers: multiple myeloma and chronic lymphocytic leukemia.

Genta's Warrell acknowledged that patients were still being accepted in the trials, but he insisted that this would not force a delay in the company's timelines.

Despite lowering his near-term financial expectations, Ginsberg remains very optimistic about Genasense's success. "As typically occurs when a partnership is struck, the pharmaceutical partner's plans for the product differ to some extent from the plans of the developer," he writes. "In the case of Genasense, it appears that such discussions may lead to a delay in the drug's filing, but we believe this timing issue to be much less important than the benefits that Aventis can provide."

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
Options Profits

Our options trading pros provide over 100 monthly option trading ideas and strategies to help you become a well-seasoned trader.

Product Features:
  • Actionable options commentary and news
  • Real-time trading community
SYM TRADE IT LAST %CHG
AAPL $109.27 -1.00%
FB $88.26 0.12%
GOOG $600.70 -0.92%
TSLA $241.93 -1.48%
YHOO $31.58 -2.95%

Markets

Chart of I:DJI
DOW 16,102.38 -272.38 -1.66%
S&P 500 1,921.22 -29.91 -1.53%
NASDAQ 4,683.9190 -49.5780 -1.05%

Free Reports

Top Rated Stocks Top Rated Funds Top Rated ETFs