Enanta Pharmaceuticals Inc (ENTA) オプション

PFE is only one of many possible suitors - lots of folks have an ID presence, and immunology is hot
The company has done nothing since partnering in HCV so I understand the skepticism of some, but obviously I am firmly in the camp that there will be some sort of positive development near term (my near term includes waiting for the HR data which hopefully will still come in by the end of the year)

I guess by now, they have talked to all potential partners so really, they can't really do much about it...
Maybe someone will knock their door for it some days.. $PFE should just buy us out really, for the nth time.

I guess it is not dead dead, but it is not part of the business development goals for the year in the latest corporate presentation, so I think it is fair to say it is *mostly dead*

*Miracle max?

so I guess 235 is not completely dead dead, right?
Seems there is a pathway as long as you have money to throw at it?

I didn't realize GILD is looking at an oral prodrug of Remdesivir for RSV - looks like it is in phase 2 for HR adults and pediatrics
MOA seems to be much like lumicitabine that was dropped by JNJ due to preclinical tox, but it also had limited efficacy - nuke targeting the L protein
another competitor, but clearly there is still an appetite for an RSV antiviral among large pharma

Is there a market for new COVID-19 drugs?
Waning interest in the virus has drugmakers trying for new angle - March 10

Three antivirals are available in the US today: Pfizer’s Paxlovid, or nirmatrelvir with ritonavir; Gilead Sciences’ Veklury, or remdesivir; and Merck & Co.’s Lagevrio, or molnupiravir. All come with their own drawbacks. Paxlovid interacts negatively with a slew of common medications for diseases like arrhythmia and migraine, making it difficult for people with those conditions—many of whom are at a higher risk for COVID-19 complications precisely because of those conditions—to take it. Veklury has to be administered intravenously, and Lagevrio isn’t as effective as Paxlovid is, making it a last line of treatment.

Enanta CEO Jay Luly is hopeful that it’ll soon become clear to potential partners that EDP-235 has a market, in part because of these drawbacks.

“We firmly believe there is a need for a conveniently-dosed, safe and effective once-daily oral treatment with fewer drug-drug interactions (DDI) and an improved tolerability profile (doesn’t taste bad),” Luly says by email. “There is a very low uptake of boosters, leaving most of the population vulnerable to infection. The ultimate market for COVID treatments remains to be determined, but an improved antiviral with less DDI complications and better tolerability would certainly broaden the current multi-billion-dollar market.”

https://cen.acs.org/pharmaceuticals/market-new-COVID-19-drugs/103/i6

I added some shares today, FWIW.

We will see. Would be a very different company a year out.

I don't think they are going to shake up management at least through phase 1 of the kit inhibitor
once they get into POC they are going to want experts in those disease areas, and if RSV is totally partnered out I would think rotate those folks out

If they partner both then they may as well sell the company

Maybe the plan is to sell it actually, as if the plan is to run the immology further, we should expect a CEO succession plan soon, right?

I think that is their plan. If they partner both then they may as well sell the company

Will there be PR on $30M tax refund?

I wish ENTA can partner out RSV soon and keep the immology programme in house as long as possible. The upside will be quite unimaginable if they have some success there.

THRD is looking to partner up* but I’m not sure that is a good proxy for value of the kit drug bc their healthy volunteer data was a bit murky. *they announced a workforce reduction and are exploring “strategic options”
The LFT abnormality in the highest dose arm was of greater magnitude than the 2 placebo elevations. They also had more hematological toxicity than expected, especially at the highest dose level (where they did get to 80 percent reduction in mean tryptase). So they might be more limited in dosing moving forward.

https://ir.thirdharmonicbio.com/static-files/1ef636b6-3f8f-4c48-b0f8-0b4595844526

BPMC had a recent poster with their phase 1 data which seemed cleaner.

https://www.blueprintmedicines.com/wp-content/uploads/2025/03/Blueprint-Medicines-AAAAI-WAO-2025-BLU-808-Wild-Type-KIT-Safety-PK-Healthy-Volunteers-Poster.

Interesting to see addtional partnership around $ENTA's new focus area. One day, it will be with $ENTA I hope.
Or, $PFE just buy us out.

I think THRD licensed their drug(s) from NVS so interesting. Maybe they like this MOA better, maybe they regret the decision to outlicense the kit to THRD given the data CLDX has been able to produce, but now that THRD may be dead in the water probably not much sellers remorse there
I would think ENTA's drug is worth a comparable amount or more based on the fact c-kit is more derisked as a target than this (INCY recently had to halt their trials for preclinical tox at the POC stage - they paid 750M less than a year ago for a phase 1 asset for this target)

https://investor.incyte.com/news-releases/news-release-details/incyte-provides-update-early-phase-mrgprx2-and-mrgprx4-programs

NVS licenses Kyorin preclinical CSU compound_for $55M up-front and $833M total biobucks:

https://www.kyorin-pharm.co.jp/en/news/docs/KYORIN%20and%20Novartis%20Enter%20into%20a%20Global%20License%20Agreement%20for%20KRP-M223.pdf Under this agreement, KYORIN grants Novartis an exclusive worldwide license to develop, manufacture, and commercialize KRP-M223. KYORIN retains an option to commercialize in Japan and manufacture the product for the Japan market with Novartis retaining an option to co-promote with KYORIN in Japan.

KYORIN will receive an upfront payment of USD 55 million and is eligible to receive milestone payments of up to USD 777.5 million tied to the progress of development, approval, and commercialization of KRP- M223 as well as tiered royalties on net sales.

KRP-M223 is an MRGPRX2 antagonist for allergic and inflammatory diseases involving mast cells, such as chronic spontaneous urticaria. KYORIN has developed KRP-M223 which now is in the pre-clinical stage and Novartis will be responsible for global development. Immunology is a cash machine, evidently. Chronic diseases such as CSU are plainly more lucrative for drugmakers than acute illnesses.

O/T - Finally, after many, many years with GTCB, MNTA and now ENTA, I have finally won an OSCAR for best STAMINA & ANIMATED FILM FEATURE:



That's FLO not FLOW! Standing ovation, please.LOL

There is no such thing as a certainty in this business...

That would make me and my bank account very happy.

I hope you can bank on it soon. 3x overnight is possible if the right deal htis 😀

They'll be fine. Just need to partner up

That would make me and my bank account very happy.

They'll be fine. Just need to partner up

Hope they would get some sort of settlement before they exhausted all venue, it’s time to wrap this chapter up.

Maybe Enanta should have sold more stock, CLDX is taking their product through phase 3 and they have a lot of cash. I am not certain why CLDX believes in its product more than Enanta can believe in their RSV, and COVID products. At one time Enanta was touting their PL-pro candidates as pan viral including flu. noro, rhinoviruses, and COVID.

Was that for real, was there an expectation for legitimate success?

Appeal Update - Enanta Pharmaceuticals, Inc. v. Pfizer Inc.

Filing 1 Appeal docketed. Received: 02/04/2025. [1067471] Entry of Appearance is due on 02/20/2025. Certificate of Interest is due on 02/20/2025. Docketing Statement is due on 02/20/2025. Appellant's brief is due on 04/07/2025. [IMH] [Entered: 02/06/2025 03:26 PM]

https://dockets.justia.com/docket/circuit-courts/cafc/25-1427

By June (?) we might have a decision.

Well the first DDI trial for 938 was started almost in parallel to the challenge trial. For 323 there is a greater than one year gap. So it is fair to infer 323 moved from a more backup candidate role to one that indeed merits progression to the next phase. But we knew that already from the latest company communications.

My bad—I retract the previous post. This 48-patient DDI trial won't cost much to run, so we shouldn't infer anything in particular from its starting. Apologies for jumping the gun.

Hi, Dew, could you please enlarge your comment here? I'm not sure what you are saying about it being a big deal and whether it was a voluntary decision. Thanks!

EDP-323 DDI study just listed yesterday… This is a pretty big deal, IMO. It seems unlikely that ENTA would initiate such a trial on its own volition.

CLDX CSU update:

https://www.globenewswire.com/news-release/2025/02/27/3034268/24180/en/Celldex-Reports-Fourth-Quarter-and-Year-End-2024-Financial-Results-and-Provides-Corporate-Update.html A global Phase 3 program in chronic spontaneous urticaria (CSU) consisting of two Phase 3 trials (EMBARQ-CSU1 and EMBARQ-CSU2) was initiated in July and enrollment is ongoing…. EMBARQ-CSU1 and EMBARQ-CSU2 will enroll approximately 915 patients each across 40 countries and 500 sites.

… “Our Phase 3 studies in CSU have been met with great enthusiasm from the global medical community and are actively enrolling patients around the world,” [said CLDX’s CEO]. Note: CLDX’s CSU compound (barzolvolimab) is an antibody, so it addresses a somewhat different market than ENTA’s EPS-1421.

It would be great but given we just had a large insider buy few weeks ago, seems a far stretch?

Happy to be wrong though

Perhaps we will get news of a RSV partnership soon… March 13.

Thanks, Dewophile -

FYI -

https://ir.enanta.com/news-releases/news-release-details/enanta-pharmaceuticals-announces-positive-topline-results-edp

EDP-323

DDI study just listed yesterday

https://clinicaltrials.gov/study/NCT06847464?term=rsv%20enanta&aggFilters=status:rec&rank=3

I’m not worried about the opportunity in RSV. It’s akin to the flu so not like Covid where severity markedly decreased after an initial brutal wave bc it was a new virus
The peds market in RSV may never get an active vaccine after last years safety halt for MRNA and a moratorium on peds vaccine development. The adult market could get a bit smaller over time if ACIP loosens restrictions but that’s a longer way off now w RFK amd there will always be those who decline vaccination or have breakthrough despite vaccination

In the COVID run up I started buying more stock as I could tell the bar was low for Paxlovid.
And it seemed to me that they let the EUA run out before they had a chance to get a once a day, unboosted and more efficacious antiviral.
To be fair, after Delta, and after many had vaccinations or natural (albeit short term) immunity it was less of a 4 alarm fire.

But if a "delta" like strain re-emerged the world would find itself somewhat flatfooted and far less prepared than we should be.
So a layman like me wonders if it could have been handled better- but I'm in the cheap seats and have stayed mum.

In the same way I worried about the window of opportunity for Covid I'm now worried about the RSV window.

To be clear I am not buying into this conspiracy, I just wanted to clarify the argument for Vin.

Thanks dewophile. I see what the idea behind it was. I also don't buy it.

Got it. Makes sense that a lawyer would be conflicted out of certain cases (and then such an equivalent doesn’t in fact exist in pharma)

In the legal world there is often a mandatory waiting period before making the jump from one to the other, albeit it might be as short as 6 months in many cases.

Often, it's not corruption, but the appearance of impropriety, that is enough to do harm to the reputations of the regulating agencies in question.

Not a great look but I kind of get it. You do your civil service but then want to make money and there are only so many options. You probably know lawyers that have moved between the public and private sector in a similar vein e.g. SEC lawyer now at a private firm defending companies , sometimes the very same ones that they may have been looking into for violations ? (I could be wrong here but guessing it happens in other sectors is my point)

I’m ok w allowing paxlovid to stay on the market without another trial in immune experienced people. I’m also okay with using immunological markers as surrogates for boosters in vaccines (this is not exclusive to Covid vaccines either). What I’m not okay with is making companies include symptoms like sense of smell that were less common since omicron. You already have a tougher population (vaccinated prior infected and also lower risk if running a pbo trial ), why not let companies narrow down to the most common symptoms (sore throat fever cough fatigue congestion ). Is a stat sign reduction in these symptoms a prior i not meaningful?! Such bs and I think the FDA sabotaged the ability to get better drugs to patients period.
I also don’t see why a noninferiority trial couldn’t be run although that would have to be large. But ENTA in so many words via email told me that the regulatory environment was the impediment to progressing 235 a long time ago and they were hoping the stance would change and looking to the Ensitrelvir data package and how FDA would handle that. In the meantime ensitrelvir was stat sig on the symptom score used in Asia, numerically better in the FDA score and stat sig in prevention and it’s still not available.

At a lower level, I've read statistics that a majority of FDA reviewers end up at big pharma. Obviously not specifically PFE. But the point is, generally, it's not a great look.

I doubt there was any explicit quid pro quo but the FDA and CDC have been pretty lenient with PFE in terms of approval and requiring randomized trials. E.g., notwithstanding the fact that the US government contracted to buy more than $10 billion of Paxlovid, the FDA didn't manage to require a randomized trial in the actual population that drug was being given to (vaxed, prior infection, ...) and let them abandon the EPIC-SR trial. Similarly, though not relevant to ENTA, they approved COVID vax boosters based solely on mouse data and have never required a randomized trial showing actual benefit.

Ok—a singular case for an executive officer (rather than a non-employee director).

PFE’s hiring Patricia Cavazzoni (former head of CDER) is not symptomatic of a “revolving door” policy or a quid pro quo regarding Pavlovid, but rather is a singular case, IMO.

Singular case? What about Scott Gottlieb?

To be clear I am not buying into this conspiracy, I just wanted to clarify the argument for Vin. It's not totally outlandish but I agree w you that CDER/FDA was impartial (yet misguided) visa vie ENTA and others in the space

PFE’s hiring Patricia Cavazzoni (former head of CDER) is not symptomatic of a “revolving door” policy or a quid pro quo regarding Pavlovid, but rather is a singular case, IMO.

Cavazzoni resigned two days prior to Trump’s inauguration, for reasons related to the new administration. That’s the entire story as far as I can tell.

Bingo!!

“I made a comment about a serious conflict of interest regarding the CDER head that may have been a factor in the tanking of Enanta's stock.


Why in the world would it affect ENTA? “

Sounds like that poster may be checked out so I’ll take a stab. I think the suggestion is that CDER was in bed with PFE making the regulatory framework in Covid too challenging for new entrants to break in (thereby protecting paxlovid sales). Indeed the FDA insisted on using a Covid symptom score that may not have been optimal with the latest variants. Shionogi ran into this issue w ensitrelvir.