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Progenics Talks Commercialization, Pipeline, And Milestones

John Engle profile picture
John Engle


  • On April 9, Progenics presented at an investor conference in Monaco.
  • The presentation covered the ongoing developments in commercialization planning for the launch of Azedra.
  • Pipeline developments were also discussed.
  • Little time was given to the subject of the PDUFA date extension; Azedra will face the FDA voteon July 30, instead of the previously scheduled April 30.
  • Approval prospects remain very high; the current market valuation fails to appreciate the potential of Azedra or Progenics’ pipeline.

On April 9th, Progenics Pharmaceuticals (NASDAQ:PGNX) delivered a presentation at the H.C. Wainwright Global Life Sciences Conference in Monte Carlo, Monaco.

CEO Mark Baker used his presentation time to discuss major developments in the company, especially the ongoing commercialization preparations for the launch of Azedra, an ultra-orphan drug candidate for the treatment of pheochromocytoma and paraganglioma two extremely rare and lethal adrenal cancers. He also spent significant time on the pipeline, especially 1404, an imaging agent currently in Phase 3 trials for non-invasive identification and diagnosis of prostate cancers, and 1095, a targeted small molecule radiotherapeutic that can prevent tumor growth and bone degradation in patients suffering late-stage prostate cancer.

The presentation gave some welcome color to the company’s outlook and to the potential of its remarkable product candidates. With an FDA decision on Azedra approval scheduled for July 30th, and Phase 3 data from the Phase 3 1404 trial expected in the third quarter, Progenics has several major catalysts inbound.

The next six months will be decisive for Progenics’ value proposition. Let’s take a look at what the latest investor event can tell us about the company’s outlook.

Commercial Preparation Forges Ahead

Mark Baker was eager to dive into a discussion of the commercialization preparations actively underway at Progenics to get Azedra into the market as rapidly as possible after approval. We have heard in previous conferences and earnings calls about the concentrated patient population, which will make the cost of patient acquisition low and necessitate only a small salesforce.

Adding further color to that outlook, Baker addressed the extremely important question of access:

“A very important element of our commercial effort will be around access, as we want all of the patients who suffer from these terrible cancers to have access to the drug. So working with the payers under

This article was written by

John Engle profile picture
Investment professional specializing in deep value opportunities, growth plays, special situations (long + short) across a range of asset classes and industries.Current Role(s): President, Almington Capital Merchant Bankers; Chief Investment Officer, The Cannabis Capital Group.Asset Classes: publicly traded securities (stocks + fixed income), private equity, real estate, venture capital, cannabis, fintech.https://subscriptions.seekingalpha.com/lp_premium_beat_the_market_4/?source=affiliate:42612986Education: MA, Trinity College Dublin (economics + philosophy); Diploma (finance), London School of Economics & Political Science; MBA, University of Oxford.

Analyst’s Disclosure: I am/we are long PGNX. I wrote this article myself, and it expresses my own opinions. I am not receiving compensation for it (other than from Seeking Alpha). I have no business relationship with any company whose stock is mentioned in this article.

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Comments (15)

I'm not sure if I'm misinterpreting the part about 1095, but I think you may be confused about the product & partnership. 1095 is progenics drug that is already in phase 1. The Bayer partnership is to use an aspect of 1095(the PMSA targeted antibody if I'm not mistaken), combined with Bayer's thorium conjugate. This makes the pipeline even more exciting since they have their own drug in development, as well as the partnership. Again, I may have just misread it, but it sounded like you were speaking about the 1095 as solely the Bayer partnered product.

Thanks for the article, I always enjoy your pieces.
Baker ran a ferry company prior to this....maybe he was waiting for the tide to change
yazzbro profile picture
I am a long holder in PGNX...Love their pipeline but, I think I have discussed this before..I am not really big on their management. If this company were managed a bit better Azedra would have been approved months ago.. They delayed the NDA filing of Azedra by three months because the facility wasn't up to snuff... And now they are hit with another delay because they were not prepared again. They also didn't actually do the topline Azedra results any justice with their presentation of it. I think analyst walked away with more questions on Azedra data than they received answers for. In fact, their presentation of Azedra data was so bad that several analyst called the data "suspect" and the stock price tumbled big time. It just seems like it's amateur hour over there at PGNX... But this isn't their exactly their first rodeo with the FDA approval process.. They went through this with Relistor.. They know what the FDA is looking for and how the process works.. So it's confusing to see PGNX management drop the ball with Azedra as much as they have.. If the FDA goes to the new PDUFA date which is the end of July now, this whole process would have taken just about a year seeing that PGNX was originally supposed to file the NDA last August. I don't know.. I really hope that the new data that PGNX submitted is what the FDA is looking for, otherwise PGNX will get a CRL and this will delay Azedra for at least another year. I have a feeling that PGNX made sure that the new data submitted was MORE than what the FDA was looking for.. Fingers crossed at least.. Nice article though..Thanks for keeping us abreast of what was covered at the latest conference...
Weren't the FDA filings for Relistor handled by Wyeth/Salix?
yazzbro profile picture
Yes they were but, PGNX was involved with the process..You would have thought they would have taken notes on how to get a drug from stage 3 to approval and what requirements the FDA would have had... It's hard to fathom that PGNX just sat on their hands through the whole process but, maybe they did...Who knows? That would explain a lot.
there is a genetic test for prostate cancer. which appears to be useful for watchful waiting decisions...it goes for 3-5k...looks like a lot of room for 1404 if I read this correctly
legos247 profile picture
where is the frequent commenter who talks down the Progenics management team? interested to hear his thoughts, seriously.
Thank you for the article John. As a shareholder I find it frustrating they have not mentioned the delay or gave clarity around it. I listened to the call and Baker asked for questions at the end and no one asked anything. Shocking. I am hoping they mention something on their next earnings call.
it makes no sense to say much. this market is nuts. SP can get destroyed if he farts too loud on the line. FDA has spoken. nothing to add at this point really.
like pgnx and dvax. thx for the article and keep me posted. glta
EagleFirst profile picture
Thank you, John... I nearly doubled down in the dip... Let's ride all the way to the finish line!
Note ... Cantor Fitzgerald has a $15 price target
Thanks for the update John.
If approval is given in July the recent dip in SP will be benign compared to the longer term potential.
Thank you for the update John, I did get out on the FDA reset, just seemed prudent at the time, this makes me feel better about getting back in....
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