Enanta Pharmaceuticals Inc (ENTA) 시세

I would imagine funds have patent experts to call on, so I'm not banking on victory here but you never know

I am not banking on it either but would sure be enjoyable!!

Baird Reiterates Outperform Rating on Enanta Pharmaceuticals (ENTA)

September 27, 2024 6:56 AM EDT
Baird analyst Brian Skorney reiterated an Outperform rating and $26.00 price target on Enanta Pharmaceuticals (NASDAQ: ENTA).The analyst commented: "Incrementally ... [needs subscription]

https://www.streetinsider.com/Analyst+Comments/Baird+Reiterates+Outperform+Rating+on+Enanta+Pharmaceuticals+%28ENTA%29/23770589.html

Thx for the info
Obviously nice to see enanta win the motion but the market doesn't seem to think they have much chance. I would imagine funds have patent experts to call on, so I'm not banking on victory here but you never know

Yes, I know this is not a short-term trading vehicle, but day after day down days gets old. I too was thinking this might be an end of quarter thing. GLTA

Some funds have been pressuring the stock

I hope their plan is to get it done before q3 (end of sept)

Unlike RVNC, this company has excellent balance sheet and management.

The only thing I am not clear on is why some M&A or partnership still hasn’t happened yet

I know many think we need to wait for peds but some can get a deal without it.


Maybe management wants to maximize their leverage as they can afford to wait

Will see


I pretty much topped up so just sit and whine here lol

Ok ENTA, let’s start your run!

My interpretation - a WIN for ENTA in the infringement suit -

MOTION to Compel Defendant Pfizer Inc. to Produce Documents and Provide Deposition Testimony filed by Enanta Pharmaceuticals, Inc. - granted by judge -

Docket last updated: 6 hours ago
Thursday, September 26, 2024
372 order Order on Motion for Miscellaneous Relief Thu 09/26 2:00 PM
Magistrate Judge Jennifer C. Boal: ELECTRONIC ORDER entered GRANTING 371 Motion for leave to obtain sealed transcript. (Hutchins, Aaron)
371 motion Miscellaneous Relief Thu 09/26 11:59 AM
Joint MOTION for Leave to Obtain Sealed Transcript re 370 Terminate Hearings,,,, Motion Hearing,,, by Enanta Pharmaceuticals, Inc..(Fiacco, Barbara)
https://www.pacermonitor.com/public/case/44980990/Enanta_Pharmaceuticals,_Inc_v_Pfizer_Inc

Motion for leave - when a judge gives permission to do something that is not usually allowed in court.

ENTA updated corporate slides (9/26/24)

https://ir.enanta.com/static-files/0b9a9564-339c-4501-8c98-eab636846bf4

The latest version of ENTA’s corporate slide set is identical to the previous version (from 8/5/24) except that:

• Old slides #17-19 pertaining to EDP-323 are been superseded by new slides #17-21, which include data from the phase-2a “challenge” study.

• The “2024 Key Catalysts” slide (old #37, new #39) shows that ENTA reported data from the EDP-323 challenge study.

I think it depends on 938 data in peds and also what shionogi challenge results look like
they might if only to keep pace with shionogi for a MOA that might be a tad superior (at least on virology but clinically who knows if 938 robust may see no difference clinically for the majority of patients even those at high risk

Do you think they will do ped study for 323?

CC slides for EDP-323 challenge study:

https://ir.enanta.com/static-files/dff51245-4767-47ff-a0b2-0eab26135627

The question was why would this drug succeed in real world settings while other drugs with successful challenge results failed. It's why I wrote this 2 days ago:

I do want to remind you that several drugs have had positive challenge study results and failed real world trials, so again I just don't think the Q3 release is market moving

The company said other drugs like fusion inhibitors have low barriers to resistance (yes even with only 5 days therapy this emerges). In the past the company has also said because fusion inhibitors do nothing for already infected cells, so if you get to patients later with a high population of infected cells it doesn't work versus challenge where you can tx super early

I think ENTA now has a suite of options, let's see the peds data in Q4 and see how Shionogi's challenge data with their L inhibitor compares to 323. I think if ENTA gets good peds data odds of success in phase 3 jump and they could partner the portfolio in a heartbeat. This might not happen before phase 3, but they certainly need to partner at least ex-US at some point and there should be plenty of bidders pending the Q4 data IMO

Market yawns

Unbelievable

I missed the entire answer to the last question? Why might this be better than other drugs (like EDP-938).

Hopefully, Market will wake up and start to ascribe a positive value to ENTA RSV program.

Right now, market says it is worth about Negative 200mm dollars

Now, the question is what would they do with 323 and 928 now that 323 data is also excellent

I guess we will only know after 928 data is out.

How can these combo not worth at least the price tag PFE paid for ReViral ?

Update - Enanta Vs. Pfizer

Wednesday, September 25, 2024

Electronic Clerk's Notes for proceedings held before Magistrate Judge Jennifer C. Boal: Motion Hearing held on September 25, 2024 re296 MOTION to Compel Defendant Pfizer Inc. to Produce Documents and Provide Deposition Testimony filed by Enanta Pharmaceuticals, Inc. The Court heard arguments from the parties and took the matter under advisement. (Court Reporter: SEALED Digital Recording) To order a copy of this Digital Recording, The parties should first seek leave of the Court. If approved, please then go to https://forms.mad.uscourts.gov/Audio.html. For a transcript of this proceeding, contact mad_transcripts@mad.uscourts.gov. (Attorneys present: Barbara A. Fiacco, Jeremy A. Younkin, Stuart Knight & Taylor R. Davis for Plaintiff. Ben Picozzi, Wyley S. Proctor & Thomas H.L. Selby for Defendant.) Hutchins, Aar

https://www.pacermonitor.com/public/case/44980990/Enanta_Pharmaceuticals,_Inc_v_Pfizer_Inc

Thank you, Randy.

From the company - direct -

Enanta Pharmaceuticals Announces Positive Topline Results for EDP-323 in a Phase 2a Human Challenge Study of Healthy Adults Infected With Respiratory Syncytial Virus (RSV)
Sep 26, 2024

Treatment With Once-Daily EDP-323 Met Primary and Secondary Endpoints, Achieving Highly Statistically Significant Reductions in Both Viral Load and Clinical Symptoms Compared to Placebo
Favorable Safety and Tolerability Observed
Conference Call and Webcast to Discuss Data at 8:30 a.m. ET Today
WATERTOWN, Mass.--(BUSINESS WIRE)--Sep. 26, 2024-- Enanta Pharmaceuticals, Inc. (NASDAQ:ENTA), a clinical-stage biotechnology company dedicated to creating best-in-class small molecule drugs for virology and immunology indications, today announced positive topline results from a Phase 2a human challenge study of EDP-323 in healthy adults infected with respiratory syncytial virus (RSV). These data demonstrated that EDP-323 was generally safe and well-tolerated and achieved an 85-87% reduction in viral load area under the curve (AUC) by qRT-PCR (p

https://www.stocktitan.net/news/ENTA/enanta-pharmaceuticals-announces-positive-topline-results-for-edp-nn68l1h9boxa.html

The price trend has not been friendly lately. Anyone adding here? 🚀

...I thought ENTA's new candidate is targeting the same condition?True, ENTA has a CSU program, but the program is in the preclinical stage and the lead compound has not been selected yet. (That’s expected to happen in 4Q24.)

Moreover, CLDX’s CSU compound is an antibody, so it addresses a somewhat different market than the small-molecule CSU drug(s) ENTA is developing.

So, all told, the CLDX news today is only minimally consequential to ENTA’s current share price.

Both CLDX and ENTA are seeking an immunological solution for Chronic Spontaneous Urticaria, to my understanding.

Thanks, somehow I thought ENTA's new candidate is targeting the same condition?

looks like CLDX recovered quite a bit - ended up down 12%
I have to think the cc and subsequent conversations with management allayed some investor concerns

I doubt that CLDX's data had a material affect on ENTA's share price today.

So I guess ENTA was up and down because the result was good enough (71% of patients (150 mg Q4W) achieved complete response at Week 52) but also not good enough in a sense (8-13% AE vs 4%) vs the baseline?

CLDX—(-20%)—reports phase-2 CSU data_for barzolvolimab—25%_dropout_rate_and hair-color changes_in_6_patients:

https://finance.yahoo.com/news/celldex-therapeutics-presents-landmark-52-144500144.html

CC slides (slide #6 contains AE info):
https://ir.celldex.com/static-files/104cb8ec-550b-42d3-aef6-3c9d9c9d9fdb

In most cases where a court issues a judgment of patent infringement, the royalty on past sales applies to future sales, until patent expiration.

The drawback would be increased spend because it wouldn't be instead of the 938 phase 3 assuming good data but in addition otherwise you delay bringing any drug to market
Reviral essentially just had challenge data when they were bought and the peds phase 2 was terminated shortly thereafter. I do think PFE could be a potential partner Reviral had an N inhibitor preclinical similar to 938 that was then shelved

also from RBC (last report before they discountined coverage)

Potential upside for shares could come from a patent infringement suit with PFE, though this
will take some time and battling PFE’s legal team will likely continue to be difficult. Recall
that ENTA had sued PFE, claiming that Paxlovid had infringed upon ENTA’s ’953 patent, with an
argument that our KOL thought had some merit. However, so far, the Court has ruled in favor of
PFE in the Markman hearing and compelled ENTA to supplement its infringement theory, both
of which we believed to be potential setbacks for ENTA. The latest timeline indicates that fact
discovery will close on November 17, 2023, expert depositions will be completed by April 22,
2024, and the trial is expected to get under way by mid-2024 (with a May 10, 2024 deadline
for Daubert motions). We believe that given the current COVID-19 dynamics, any potential outyear Paxlovid royalty value from a lawsuit victory would also be somewhat diminished; while we
believe a win for ENTA would be worth as much as $7/share and maintains upside optionality
for shares in the face of ENTA’s internal pipeline challenges, it will likely take some time to play
out, and given initial developments, we see it as relatively low likelihood.

From my July 27, 2024 post -

FWIW -

It still is a big IF that ENTA wins summary judgment against PFIZER. Even a mediated settlement is quite positive.

Back in June of 2022, RBC Capital Markets analyst Brian Abrahams states -

"A typical royalty rate might be in the 6% range, which on sales of Paxlovid's magnitude, could be more than $1 billion annually in its peak years and may speak to why it might be worth Enanta's time and expenses to pursue this," he said in a report to clients.

https://www.investors.com/news/technology/enta-stock-launches-as-enanta-causes-a-kerfuffle-for-pfizer-paxlovid/

What would be the drawback of pushing for a combo trial? How likely the combo would be worse than single trial given the 938 and 323 have different mechanics?

Also how is the current status of ENTA RSV programme compared to ReVirals a year or two ago?

I think back then ENTA didn’t have the infants data?

You think PFE would be interested to partner with Enta on RSV for competitive reason?

Ok but I would think there isn’t that much to say until 938 data are out. If the 938 data are robust there may not be much of a need to progress 323 although the company has alluded to possible combination for the rare difficult / severe case. The other relevant data to know before making a decision on 323 is the challenge study results from Shionogi which is also not due until Q4. If the company is compelled to move both drugs forward (for competitive reasons as much as anything) I hope they partner the assets.

In the 3% royalty scenario, would the 3% be applied to future sales as well?

Re: Paxlovid settlement estimate

Let's estimate what ENTA would be due from PFE if ENTA prevailed in a trial. Including PFE's guidance for 2024, PFE will have sold about $12B of Paxlovid in the US market from product inception (Dec 2021) to 12/31/24. Let's apply a 3% royalty rate, which is pretty conservative for a patent-infringement case. Then the cumulative royalties due to ENTA would be (0.03)($12B) = $360M, plus interest.

(If the court found PFE to be guilty of willfull infringement, it could award ENTA treble damages, or about $1B plus interest. However, few patent-infringement suits result in treble damages, so this outcome is a longshot.)

If a win at trial would result in an award to ENTA of $360M plus interest, a settlement of $150M to ENTA (the estimate you cited from a sell-side analyst) seems like a lower bound. A settlement of $200-250M is more likely, IMO.

alert, you ask questions which are impossible to answer. Suggest you wait till after the chickens are hatched, before counting ‘em. Best wishes.

Paxlovid patent lawsuit

Any estimate on what a settlement would look like if it happens?

iIRC, rbc estimates about 5 bucks per share or about 150mm, is that low?

I dunno… as dewophile messaged earlier, a disappointing 323 trial may actually cause the stock to move higher, given a possible reduction in p3 trial costs going forward

Hope they can conclude this chapter sooner rather than later, especially if it’s a moon shoot, they are spending quite a bit of SG&A on this.

I guess can be very rewarding if they do see a good chance on getting a settlement or favourable ruling on this.

Market cap is 230mm, a 200mm settlement payment will double the shares

And I think we can potentially see a much larger sum, only PFE and ENTA know better

I would think a positive challenge study results would at least help convince the market that the RSV pipeline is not a negative asset.

ENTA committed to having a CC for the EDP-323 "challenge" study results. This info is in the 8/5/24 PR announcing the FY3Q24 results (#msg-174869263).

I have no clue if there will be a call along with the challenge study results, but I do want to remind you that several drugs have had positive challenge study results and failed real world trials, so again I just don't think the Q3 release is market moving

There are motions in front of the judge to dismiss the case or settle the matter without trial, but if the case proceeds to trial enanta has said the timing should be around year end

When will we get an update on the patent case?

Is it going to full trial soon? Or it will be ruled without trial?

I guess both sides will appeal unless they have a settlement

Ie this will drag on for a while, correct?

We were told end of 3rd quarter, so on or before 30 September. Since they are going to have a call, I expect to hear an announcement of the call this week. ENTA, it’s time to go UP!

So we have 4 business days left in Sept... do you guys think we will see the data by end of Sept or will be slip to early Oct?

Volume heavy again. Seems some funds liquidating recently after the run up

Hopefully done soon

I bought all I wanted higher

Sigh

New QT study posted for zelicapavir (938)

https://clinicaltrials.gov/study/NCT06601192?term=Edp-938&page=1&rank=2

It looks like a brokered trade to move volume without unduly affecting share price

Company update soon… The company will provide its next update with the release of the EDP-323 challenge study results, expected in late third quarter of 2024.

Weird indeed. The couple reports I read didnt give much odd for enta to win the case. Why would a law firm make it a showcase?

I guess any exposure is good exposure?