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It's not clear what the barrier to entry is, or is going to be, on generic radiopharmaceuticals. Compound pharmacies licensed for nuclear medicine have handled this work in the past and are fully capable.
oc631 - thank you, fair restriction
So 7 years plus some of good revs to boost pipeline,
then maybe sell for generics. I would assume that
CMO process might be of interest for buyer later on.
Regardless, trading was also quite restricted,
failure to break above $6 properly. Quite boring, maybe waiting until news.
You should also mention that Azedra patents expire this year. How long after the 7-year exclusivity period can PGNX market the drug sans competition?
I like the company. Let's put it all on the table.
PGNX Recent Events & Catalysts
- 2018-05-02 RELISTOR® Injection Protected from Generic Competition Until 2024
- 2018-06-26 Completes Enrollment of Phase 2/3 Clinical Trial of PSMA-Targeted PET/CT Imaging Agent PyL™ in Prostate Cancer
-- 4Q18 P2/3 Data & Initiate 2nd P3
- 2018-07-30 FDA Approval for AZEDRA
- 2018-08-10 Closing Offering 9M @ $8.25/sh w/o Warrants!
-- Not even used any Warrants nor discount to lure investors in
- 2018-09-12 Ph3 Trial of 1404 failed 1 of 2 co-primary endpoints
- 2018-09-14 New Company Presentation Slides
- 2018-09-17 Addition of AZEDRA to NCCN Guidelines
-- The first and only FDA approved treatment of patients 12 and older with iobenguane scan positive, locally unresectable and metastatic pheochromocytoma or paraganglioma.
+++
Cash position now around $80M + $70M from offering = $150M,
maybe reduce $20M max for 3Q18 -> $130M
Liabilities Current $14.75M, Total $80M
Debt Current $5M, Total $48M
+++
Pipeline
Azedra Economics, having ODD
- US population 350M: 2-8 per million, leading to 700 - 2800 pts
- Addressable 15% 105 - 420 pts, up to 35% 245 - 980 pts.
- Plus recurrence of additional 16% 112 - 448 pts.
- Total min 217 - 1428 pts, 822 pts avg
"$147,000 for one therapeutic dose, bringing the total cost of treatment to just under $300,000", see https://www.fiercepharma.com/pharma/progenics-snags-fda-nod-for-300k-cancer-fighter-azedra
20% discounted WAC (2x $147k) = $235k per treatment:
- $51M for 217 pts - $336M for 1428 pts, $193M for 822 pts avg
This range matches well with w/ http://rjhealthsystems.com/2018/08/17/azedra-progenics-pharmaceuticals-inc-fda-approval-for-rare-tumors-of-the-adrenal-gland/
Catalysts
- Azedra Sales
- PyL ph2/3 data, initiated 2nd ph3
- PSMA-TTC ph1 by year-end (Bayer)
- PSMA-CADx Using 1404 data to develop & validate
Also
- Selling Azedra Ex-US Rights?
- Some rumors about selling Relistor to licensing partner?
NCCN Guidelines have been updated with AZEDRA, the first and only FDA approved treatment of patients 12 and older with iobenguane scan positive, locally unresectable and metastatic pheochromocytoma or paraganglioma.
That was quite fast and probably kicked off today's reversal - besides being traded 34% below offering price.
https://ir.progenics.com/news-releases/news-release-details/progenics-announces-addition-azedrar-iobenguane-i-131-national
ron- 5/2 RELISTOR® Injection Protected from Generic Competition Until 2024
thank you, so these royalties will still stream into company.
Any merit to rumors that Valeant will buy complete rights for Relistor?
https://www.prnewswire.com/news-releases/summary-judgment-granted-upholding-the-validity-of-formulation-patent-protecting-relistor-injection-300641653.html
vinm- yes, the capital raise was top notch,
especially since they didn't use any Warrants at all.
Besides, soon we get ownership updates etc.
PGNX Recent Events & Catalysts
- 7/31 AZEDRA Approval https://finance.yahoo.com/news/progenics-pharmaceuticals-announces-fda-approval-014637985.html
- 8/7 Closing Offering 9M @ $8.25/sh w/o Warrants! https://finance.yahoo.com/news/progenics-pharmaceuticals-announces-pricing-public-021256126.html
-- Not even used any Warrants nor discount to lure investors in
- 9/12 Ph3 Trial of 1404 failed 1 of 2 co-primary endpoints https://finance.yahoo.com/news/progenics-pharmaceuticals-reports-top-line-200100850.html
+++
Cash position now around $80M + $70M from offering = $150M,
maybe reduce $20M max for 3Q18 -> $130M
Liabilities Current $14.75M, Total $80M
Debt Current $5M, Total $48M
+++
9/14 Slides https://ir.progenics.com/static-files/9bb9897c-ee5a-401f-8376-c95ba5fe9f4b
Pipeline
Azedra Economics, having ODD
- US population 350M: 2-8 per million, leading to 700 - 2800 pts
- Addressable 15% 105 - 420 pts, up to 35% 245 - 980 pts.
- Plus recurrence of additional 16% 112 - 448 pts.
- Total min 217 - 1428 pts, 822 pts avg
"$147,000 for one therapeutic dose, bringing the total cost of treatment to just under $300,000", see https://www.fiercepharma.com/pharma/progenics-snags-fda-nod-for-300k-cancer-fighter-azedra
20% discounted WAC (2x $147k) = $235k per treatment:
- $51M for 217 pts - $336M for 1428 pts, $193M for 822 pts avg
This range matches well with w/ http://rjhealthsystems.com/2018/08/17/azedra-progenics-pharmaceuticals-inc-fda-approval-for-rare-tumors-of-the-adrenal-gland/
Catalysts
- Azedra Sales
- PyL ph2/3 data, initiated 2nd ph3
- PSMA-TTC ph1 by year-end (Bayer)
- PSMA-CADx Using 1404 data to develop & validate
Also
- Selling Azedra Ex-US Rights?
- Some rumors about selling Relistor to licensing partner?
I agree about this stock. Makes no sense. Even the way the market reacted after approval. Definitely strange. Manipulative? But then there were just to many institutions involved as holders. So I would tend to believe no manipulation as such.
Sometimes you have to look at the price of a company's stock stock price and say WTF, this makes no sense!!! This is one of these times. I added at $7.50 or so few weeks ago. If the price drops into the $6s, I will add again.
Looking like a bounce off of 7.55 to make a new high before heading back down again. ATM to take back below 8.50 after the new high.
WOW Management hates it's stock being over 8.50. More dilution @ 8.25 Glad I lightened up 9.20's Unreal management helps SHORTY cover from them hammering us on approval. UNREAL!!! Will be 100% out of the market soon. Shorts are in control of most stocks not in FANG or overall indexes like MSFT. Look out below when the dam breaks. Good luck to PGNX longs as shareholders before approval deserved better...
My English sounds about the same. I took profits at $8. One holding at $5.12 and another at $7.40. Not hanging out. Might go higher and might not. Otherwise my friend, I am out looking for another play in due time.
Oh well! Small profit better than none. Longs might do well yet.
I increased my PGNX holdings by 10% today at $7.52. I wish to thank those selling for providing me that low price.
Down 7% Are you f ing kidding me???
My apologies. I could hardly believe my eyes. FDA approved.
Link https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=209607
Another link about FDA approval of Azedra.
Ron, you beat me to it. Trading was halted at 3:02PM so we will have to wait until tomorrow to see how much money we made. Short interest increased a decent amount recently and with the low float this could get interesting.
https://finance.yahoo.com/news/fda-approves-first-treatment-rare-193100983.html
link for FDA approval. Just search for Azedra
https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=BasicSearch.process
Thank you for the fake news.
Approved according to FDA website.
PGNX
Out near the EOD @ $7.60. Was in for the run-up which was spoiled by a poor Bio day.
Good luck to anyone long. Potential is great.
PGNX
Maybe associated with the reversal today (together with the bio reversal):
_____________________________________________
3 Stocks That Could Double Your Money
[Motley Fool]
Cory Renauer, The Motley Fool
Motley FoolJuly 26, 2018
It isn't that hard to double your money if you're patient. If you had sunk money into an ETF that tracks the S&P 500 at the beginning of 2013, you would already have accomplished this feat without risking much in the process.
Developing new drugs to treat severe diseases can lead to overnight riches, and losses. These three biotech stocks could double impatient investors' money in the not so distant future if those investors don't mind accepting a great deal of risk. Here's how these three fledgling drugmakers will try to make it happen for their shareholders.
Progenics Pharmaceuticals, Inc.: Relieving pressure
Progenics Pharmaceuticals, Inc. (NASDAQ: PGNX) is eagerly awaiting an approval decision that the FDA is expected to hand down by the end of July. Investors are a little nervous because the agency delayed Azedra's decision earlier this year to allow for a late addition of some non-critical information.
If approved, Azedra would become the first available treatment for two rare forms of cancer that affect the adrenal glands and often cause sky-high blood pressure. During a trial underpinning Azedra's application, patients were able to control their blood pressure with less help from other drugs. More importantly, patients that were treated with two doses survived more than twice as long as those given a single dose.
Pills on top of cash.
Right now, Progenics sports a modest $558 million market cap that could double if Azedra eventually becomes standard care for patients with pheochromocytoma and paraganglioma. If approved, gaining popularity could take some time, which Progenics has plenty of.
Why this one's my favorite
Geron and Galectin could double, but they could also get pounded flat if their lead candidates suffer any mishaps. Progenics, though, can depend on a modest revenue stream from Relistor, plus it has a prostate cancer imaging agent entering late-stage development. Relistor's a drug for opioid-induced constipation that doesn't exactly make ends meet for Progenics, but it has limited the company's losses to $48 million over the past year.
Progenics finished March with around $87 million in cash, and Azedra's aimed at a small, but highly motivated population. If this small biotech needs to tap investors for more capital to launch it successfully, it probably won't need much.
_____________________________________________
https://finance.yahoo.com/news/3-stocks-could-double-money-125700832.html?soc_src=social-sh&soc_trk=tw
PGNX
Good to know!!! Thanks!!!
Highest short interest in 1 year:
Settlement Date Short Interest Avg Daily Share Volume Days To Cover
7/13/2018 11,011,114 762,636 14.438230
_____________________________________________________-
https://www.nasdaq.com/symbol/pgnx/short-interest
Close to 2nd support level:
Pivot Point 1st Resistance Point 8.27
8.22 14-3 Day Raw Stochastic at 50%
8.20 38.2% Retracement From 4 Week High
8.16 Price Crosses 9 Day Moving Average Stalls
8.11 38.2% Retracement From 13 Week High
8.08 50% Retracement From 4 Week High/Low
High 8.06 High
8.06 14-3 Day Raw Stochastic at 30%
8.04 Pivot Point
7.98 14-3 Day Raw Stochastic at 20%
Previous Close 7.96 Previous Close
7.95 38.2% Retracement From 4 Week Low
7.80 50% Retracement From 13 Week High/Low
7.78 3-10 Day MACD Oscillator Stalls
Pivot Point 1st Support Point 7.74
1-Month Low 7.55
Last 7.54 Last
Low 7.53 Low
7.52 Price Crosses 40 Day Moving Average Stalls
Pivot Point 2nd Support Point 7.51
7.49 38.2% Retracement From 13 Week Low
___________________________________________________
https://www.barchart.com/stocks/quotes/PGNX/cheat-sheet
PGNX
In @ $7.75. Thought it was a gift but has gone down to $7.57.
First time holding in a long time. Hoping for a bounce leading up to the catalyst.
PGNX
It won't be long until the FDA decision on Azedra is made. If it gets approved, then 1404 could provide the second of a one-two punch.
Hashing through phase 2 1404 info this weekend.
From phase 2 study: 1404, 102 patients. "The algorithm was fully automated and deterministic, resulting in 100% repeatability."
1404 sounds like a game changer for Prostate cancer treatment.
-------------------------------------------------------------------
Had to look up repeatability:
Repeatability or test–retest reliability[1] is the closeness of the agreement between the results of successive measurements of the same measurand carried out under the same conditions of measurement.
A measurement may be said to be repeatable when this variation is smaller than a pre-determined acceptance criterion.
$PGNX could spike hard any day now.
Summary Judgment Granted Upholding the Validity of Formulation Patent Protecting RELISTOR® Injectionhttps://finance.yahoo.com/news/summary-judgment-granted-upholding-validity-000500451.html
Bought my first taste back since selling last ER
6.42 is the 200DMA so it was close enough to buy but not all in. Just in case it breaks below it, which might happen with market correction. Will buy the dip if strong enough before ER.
Yeah it’s really crazy how similar the stories are between therf and Pgnx. Almost identical. Let’s hope pgnx gets the earlier than expected approval
Ron, that scenario for PGNX would suit me fine.
PGNX maintained with a strong buy rating at Needham. $14 PT
it's frustrating but this actually reminds me so much of THERF. With that company (i still hold shares), they already had one drug approved. This second one they were trying to get approved had BTD, fast track and orphan. Pdufa was set for early January but many thought it would be approved in october/november. company came out with the same PR where they furnished new info to the FDA and the FDA issued a 3 month delay. the stock sold off but then quickly recovered as cooler heads prevailed. there was no issue with the data, just additional manufacturing info the FDA needed to review. The FDA issued their standard 3 month delay letter. This was not a CRL. Anyway, the FDA ended up approving about a month ago which was about 1-2 months earlier than the 3 month delay would have put them at. Same here with PGNX.
Pretty high penalty in the stock price just for an three month delay.
Progenics Pharmaceuticals (PGNX unch) plunged over 19% in after-hours trading after the FDA said they were extending the review for Progenic's Azedra drag for three months until July 30.
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http://www.progenics.com/
http://finance.yahoo.com/q/ks?s=PGNX
Progenics Pharmaceuticals, Inc., a biopharmaceutical company, engages in the development and commercialization of therapeutic products for the treatment of unmet medical needs of patients with debilitating conditions and life-threatening diseases in the United States. It primarily focuses on the areas of gastroenterology, virology, and oncology. The company's development programs and product candidates include methylnaltrexone-subcutaneous, which completed Phase 3 clinical trial for the treatment of opioid-induced constipation; methylnaltrexone-intravenous, which is under Phase 3 clinical trial for the management of post-operative ileus; and Methylnaltrexone-Oral, a Phase 2 clinical trial oral form for the treatment of opioid-induced constipation. It is also developing PRO 140 Phase 1b clinical trial, designed to block HIV infection by inhibiting virus-cell binding; ProVax, a vaccine product candidate for the prevention of HIV infection or therapeutic treatment for HIV-positive individuals; and GMK Vaccine, a therapeutic vaccine, which is in Phase 3 clinical trial for the prevention of recurrence of melanoma. In addition, the company engages in a research program to discover treatments for hepatitis C, a chronic liver disease that block viral entry into cells. Further, Progenics Pharmaceuticals, through a joint venture with Cytogen Corporation, is developing in vivo immuno-therapies for treatment of prostate cancer, including a human monoclonal antibody-drug conjugate directed against prostate-specific membrane antigen (PSMA). The company's PSMA vaccine is in Phase 1 clinical testing. It has a collaboration agreement with Wyeth Pharmaceuticals to develop and commercialize subcutaneous, intravenous, and oral forms of methylnaltrexone. The company was incorporated in 1986 and is based in Tarrytown, New York.
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