Let's Make Constipation Work For Us! PGNX

Discussion in 'Stocks' started by stonedinvestor, Mar 18, 2007.

  1. Here's an opportunity in PGNX folks! Down 4% on some news from a competitor ADLR~ they updated their timeline for a product that treats constipation like PGNX's does~ it's a race to toilet bowl nirvana in stock land. How quickly we forget the good vibe after PGNX's recent earnings.
    4Q Results
    Thursday March 15,
    NEW YORK (AP) -- Shares of drug developer Progenics Pharmaceuticals Inc. rose Thursday after the company said it narrowed its fourth-quarter loss on a jump in reimbursement for research and development activities.

    The stock rose $1.16 cents, or 5.1 percent, to close at $23.76 on the Nasdaq Stock Market.

    The company reported a fourth-quarter loss narrower than Wall Street expected. Revenue jumped to $21.9 million from $2 million from a partnership with Wyeth over oral methylnaltrexone, a treatment for constipation caused by pain medication.

    Piper Jaffray analyst Caroline Stewart reaffirmed an "Outperform" rating with a $28 price target, citing the company's fourth-quarter revenue and cash position.

    "The company ended the year with $149 million in cash and equivalents, in our view enough to support operations through the launch of all three planned formulations of lead candidate methylnaltrexone," she wrote in a note to investors.

    RBC Capital Markets analyst Michael Yee reaffirmed a "Outperform" rating with a $35 price target, citing positive expectations for the company.

    "We continue to believe Progenics is at an important juncture as partner Wyeth reiterated its expectation to file a new drug application for methylnaltrexone this quarter," Yee wrote. "If a Priority Review is granted, approval could come in the third quarter."

    Citigroup analyst Dr. Yaron Werber reaffirmed a "Buy" rating with a $33 price target, citing a positive outlook for the company's product pipeline.

    >> I'll shout out to the hedge fund monday to see if they are still in it- was a fave'. & I'll have some info on the other player in this great race- ADLR.
  2. This is how PGNX came down here to begin with.
    Progenics Pharmaceuticals Tumbles on Testing Delay for Painkiller

    NEW YORK (AP) -- Shares of Progenics Pharmaceuticals Inc. plunged Wednesday after the company said it will start testing a new formulation of oral methylnaltrexone, a treatment for constipation caused by pain medication.

    Progenics and Wyeth, its partner in developing the drug, said Tuesday that mid-stage trials showed oral methylnaltrexone was safe, but not effective enough to advance to late-stage testing.

    Intravenous and injectable versions of the drug were more successful in clinical tests. If new tests on the oral version are successful, the companies could file a new drug application with the Food and Drug Administration in late 2009 or early 2010.

    Stifel Nicolaus & Co. analyst Edward Nash lowered his 2010 revenue estimate for Progenics, projecting a one-year delay in the drug's launch. He believes the drug will take market share from Adolor Corp.'s Entereg, an oral treatment. Nash set a "Buy" rating and $33 price target for Progenics shares.

    "We see this as a temporary delay for oral methylnaltrexone and do not view it as permanently damaging to the eventual market opportunity of the oral formulation drug," he said.

    Piper Jaffray & Co. analyst Caroline Stewart said the delay could be good news for Adolor. She lowered her price target on Progenics shares from $34 to $28.

    Progenics shares fell $4.27, or 16 percent, to $22.43 on the Nasdaq Stock Market.

    Wyeth shares gave up 11 cents to $49.24 on the New York Stock Exchange.

    Adolor stock lost 9 cents to $6.78 on the Nasdaq.

    >> so 2009 or early 2010 here. let's check on ADLR... to be continued.
  3. Drugmaker Adolor (Nasdaq: ADLR) started this week off right with shares up 26% after it announced the path forward for its lead drug candidate, Entereg.

    Entereg is a treatment for gastrointestinal-related disorders. Last year, Adolor failed to gain marketing approval of Entereg as a treatment for postoperative ileus (this bowel disorder, which is often occurs after surgery, is also known as POI). The company's shares are still down nearly 70% from its 52-week high. At an investor conference earlier this week, Adolor further elucidated its plans for the drug this year.

    As a treatment for POI, next quarter Adolor still plans on submitting a response to the second approvable letter it received last year. With an expected six-month FDA review, Adolor and partner GlaxoSmithKline (NYSE: GSK) will get the thumbs-up or -down on the drug in the fourth quarter of this year.

    Of course, if Progenics Pharmaceuticals (Nasdaq: PGNX) gets approval of its competing therapy this year, Adolor won't be the first company to get a crack at treating POI. Not by the timetable we just read!

    Annual costs of treating POI are hard to come by, as no effective treatments for it are available. But the costs are estimated to be nearly $1.5 billion in the U.S. for hospital-related expenses alone.

    Adolor's new update this week came in regards to the timeline for Entereg as a treatment for opioid-induced bowel dysfunction (OBD). Adolor announced that GSK was sticking with the program and planning to run another clinical trial before filing for marketing approval in this indication. No other details were given, except that this new clinical trial will begin next quarter and the timeline will be updated then.

    Except for some statistically insignificant cardiac events, the drug has been shown to be safe in thousands of patients over multiple clinical trials. Results from a potentially make-it-or-break-it study that could help solidify the safety profile of Entereg will be out in the second quarter.

    >> Wow folks this certainly seems more timely perhaps I should of started off this thread with ADLR- down 70% hummm, if we got only half of that back.
    But that's investing always be ready to shift your views.

    To be continued...
  4. Then of course there's this priority review possibility for PGNX. A Priority Review is granted, approval could come in the third quarter. That would sink ADLR. The play then might be to ride ADLR now and then switch to PGNX when they start submitting- I personally think they WILL get priority review from the clinicals I have read. Boy if you played this right going long one and short the other it's pack up the books early this year.
    To Be Continued...
  5. And here is the bear case against ADLR. It's all about study 314.

    Study 314 is the fifth Entereg Phase 3 trial conducted in POI. Previous studies gave confounding results with some (studies 302 and 308) missing the primary endpoint. The mixed Phase 3 results prompted the FDA to hold off Ok'ing the ADLR compound.

    In the Letter, the FDA indicated that, before the application may be approved, it will be necessary to provide additional proof of efficacy to support use of Entereg following bowel resection surgery. The FDA indicated that this may be achieved by demonstrating statistically significant results in at least one additional clinical study, and indicated that this could be addressed with positive results from Adolor's ongoing Study 314. The FDA also indicated that the company must provide justification that the median reduction in time to gastrointestinal (GI) recovery seen in bowel resection patients treated with Entereg is clinically meaningful.�?

    With positive data from 314 in hand, Adolor will submit its response to the FDA. However, do the data address the issue surrounding clinical meaningfulness? The company’s decision to report differences in mean outcomes rather than median provided a more favorable assessment of the data given the inherent skewness. To illustrate this point, the mean time to recovery in 314 showed a 19.8 hour improvement over placebo; however the median time exhibited a 16 hour improvement in recovery. In the pooled data, the difference was similar, 18.3 hours versus 16 hours for placebo. For the DOW endpoint, the pooled data showed a mean difference of 18.4 hours while the median difference was 20 hours. No significant difference there. However, the difference in the 314 study was quite large: The mean difference in DOW was 17.6 hours whereas the median difference was only 8 hours. Although the 314 study was by all accounts a success, the interpretation of the data and statistical analysis used to derive those data does not make an Entereg approval a slam dunk. Coupled with the confounding data of Entereg’s previous four clinical studies, Adolor still has a significant hurdle to overcome at the FDA. Given today’s giddy price action, I don’t think investors fully comprehend the inherent risks in the stock.....

    OOOOO Constipation never felt so good did it?

    Well certainly if you had bought Adolor stock $6.78 and when we spotlighted it before the conference. Like an idiot I waited. It's now APPROACHING NINE DOLLARS FOLKS!!!

    PLEASE I have a lot of stocks in my coverage / stoned / universe and sometimes one get;'s through the cracks... now we had laid out a great plan here buy ADLR and then if need be rotate into competitor PGNX if they get expedited status. Then why oh why did we not get the job done here.

    Well I certainly could have used a heads up from some ET's on ADLR but it's my own damn fault.
    700 Share Limit Order ADLR @ $8.75. Damn It!
  7. YES ADLR CRASHED! Thank the G I'm out! But it took down my fantasy portfolio hard. Now razr is on the board with his call on PGNX which I agree with. Here's my thread which as usual tackles the problem before anyone else is thinking about it--

    our CB on PGNX is amazingly just $2 ago! Still lots of time.....