PTGX - An FDA gamble, but less of a gamble than I thought

PTGX - Protaganist Therepeutics

PTGX is a drug development company with 1 drug (Rusfertide/PTG-300) in phase 3 trial, 1 drug (PTG-100) in phase 2 trial, and 1 drug (PTG-200) that was in phase 2 trial, but was terminated in 2018 (company notes human error contributed to the decision to terminate). They also have a further 3 Catalysts (pre-drugs) in phase 1 and 2 trials testing for efficacy. The company reported q3 earnings in JUN2021, resulting in a revenue of 2.27M and a net income of -30.84M, as of that report the company had 192.41M Cash on hand. These numbers may seem bad at the moment, but we will talk about them more later.


PTGX developed a propriatary platform to discover and develop novel peptide-based therapeutics, and is that platform is where the drugs currently in development come from. This company has not brought any product to market yet, and I think we should be aware of that at the outset. That being said, let’s talk about what they have in the pipeline at the moment:

PTG-300(Rusfertide) - This is the one we all know about, it is an injectable hepcidin mimetic being tested in 2 seperate phase 2 trials, one for polycythemia vera (a condition that causes overproduction of blood cells in the body), and a second one for hereditary hemochromatosis (genetic disorder that causes the body to build up too much iron in the skin and organs and can cause severe liver disease and other problems). PTG-300 was granted an orphan drug designation by the FDA in June 2020. This award grants special permissions for novel drugs that treat rare diseases affecting fewer than 200,000 patients in the USA, and gives the company extra tax credits for development, annual grant funding, and a waiver of prescription drug user fee act filing fees, among other benifits. This is the drug currently on FDA hold following the RasH2 study, however I have found a 3rd study for this drug that has either not been updated, or has not stopped recruitment.

PTG-200 - This was a drug being tested for ulcerative colitis and was terminated after phase 2b trial. It may or may not be currently re-looked at or trialed for use in Chrons Disease. To be honest there really isn’t a lot of information about this drug, but it may end up being something to keep an eye out for.

PTG-100 - Currently has an ongoing and recruiting phase 1 trial for Celiac Disease through Stanford University. Small scale effecacy testing of 30 patients over a 42 day period. Again, early days we shall see what happens in future.

PN-943 - Phase 2 trial, 150 participants expected, expected to conclude June 2022. Looks like the 2nd bite at the apple for PGTX when it comes to Ulcerative Colitis, no data on effecacy yet as the trial has not completed, but it has made it into phase 2 so that’s a pretty good sign long term.

PN-232 and PN-235 - Phase 1 Saftey studies and dosage studies. These are drugs just starting out, not much here honestly.

Other potential factors:

EPS expected Nov 03.

PTG-300 FDA Hold

Now to the bugbear in the room, the FDA hold. We honestly can’t know too much about this at the moment, especially as it’s such new news and the FDA is likely gathering info, sifting through it and will report back once they have their findings. We do know the FDA is supposed to respond within 30 days, but a response may mean they give reccomendations or that they will send out a team to examine the process of the trial etc. We do however have some precident for this, there have been several research trial drugs that this sort of thing has happened to, and once a treatment is being given to a patient, discontinuing that treatment is not what anyone wants. Generally regulatory bodies move as quickly as they can to get patients and providers back on track if possible. The average time based on some talking with 2 Oncology Research Nurses and a bit of digging myself is 4 months with some taking as little as 1-2 weeks and some taking over a year to get back on track. This does not mean the trial could not be terminated, so keep that in mind.

The consensus from the nurses was that the people running the trial would likely have to recieve training and the participants would need additional long-term screening and to reassert their willingness to continue the trial after being informed of the potential risks. That being said, their condition already creates cancer risks and this drug could reduce those, making it a potentially (sort of) acceptable trade. I would guess that the company, trial runners, and FDA are reaching out to the participants to inform them, talk over their options and decide if they continue or not. The FDA is likely also going back over all the information and structure of the drug to double check their work and see if the findings make sense.

TLDR: This company has quite a bit of potential long term, but not enough far enough along to bring the stock price up significantly unless the FDA hold is lifted, barring other news. I believe that a long play, APR2022 call at between 25 and 40 dollars would be a decent bet, as there really isn’t a way to know when the news will drop one way or the other. In the meantime the other drugs in trial and speculation on the FDA hold may very well continue to push the stock price up overall while we wait, making this a very strange play.

In the end, it’s your money, do what you want, best of luck to you, and remember to take your profits!

Edit: Updated timeline and potential price target: conservative estimate(likely the better option if playing this): 1-6 months FDA hold released after study rework, (note only one atudy needs to start back up to indicate others will follow) and study will likely, based on the one updated study, be extedned for saftey. Price target based solely on previous stock price and a little bit of dd into other companies that have gone through this, is between 25-30 initially. Hopium estimate: FDA hold released in as little as 1-4 weeks and market overreaction causes short term spike to 35+ before settling down over the next few days.


FDA hold was just released this morning. Currently at $31/share.

1 Like

wow thanks for the long DD, This morning the price went to roof cause of FDA release.

Congrats on this play!


great fda play, love the gains!


Wow grats my dudes! I took profits long ago but glad to see this finally jump!