Enanta Pharmaceuticals Inc (ENTA) News

Ok alert…ENTA is now clear to make its run to $18, and mirror the 21June - 12 July move.

Oct 1
Today marks the beginning of #RSVAwarenessMonth, a cause that aligns with our ever-important mission at Enanta. We are committed to developing an antiviral treatment for RSV.

slide 13 may need to be updated. PFE stopped their phase 2/3 trial in adults per an update posted a couple weeks ago. Total enrollment since the trial started recruiting in January was 6 patients out of a planned 2715. I was surprised at the size of the planned trial until I saw that the primary endpoint was proportion of patients with RSV -related hospitalization or death. Powering for say progression to lower respiratory tract disease would have enabled a smaller trial. Anyway the drug seems to be going no where (as expected) although they are still enrolling in the pediatric setting (well behind Enanta now)

https://clinicaltrials.gov/study/NCT06079320?term=sisunatovir&aggFilters=status:rec%20act%20ter&rank=1&tab=history&a=4&b=11#version-content-panel

As I have been saying Shionogi is the main threat but they are a ways behind with trials in community acquired infected patients slated to start some time next year

Looks well timed hopefully it stays that way.
Shana tova

Dr. Or's background/resume' gives me solid confidence in our investment -

Dr. Or and his team discovered glecaprevir, the protease inhibitor in AbbVie’s successful combination treatment for hepatitis C virus currently marketed as MAVYRET®. He is leading Enanta’s ongoing research on antivirals for hepatitis B virus, respiratory syncytial virus, human metapneumovirus and SARS-CoV-2, as well as the non-viral liver disease nonalcoholic steatohepatitis.

Further, Dr. Or has managed Enanta’s research and development collaborations with Shionogi, Abbvie and Novartis.

He has co-authored more than 100 publications and is listed as a co-inventor on over 260 filed U.S. patent applications.

Read more:
https://www.enanta.com/yat-sun-or-ph-d/

ENTA up today on higher than normal volume.

Reviral tried but their N inhibitor got scrapped (probably preclinical tox signal)
Shionogi partnered for an L inhibitor that probably will have good challenge study data but again about 1-2 years behind 938

I added shares today at $9.9573.

Ha, ha. We are on the same wave-length although I bought earlier and at $10.12. That EDP-323 data can't be a negative despite what the market says.

Developing small-molecule antiviral drugs requires expertise! Many companies tried and failed in HCV.

I think ENTA explanation on why their mechanism would do better in real world makes quite a bit of sense

Almost seems intuitive in a way, so why other companies didn’t use the same mechanism?

I don't know what the short-term price movements will be, but at under $10 the opportunity was too good to pass up.

You think recent selling would be done soon as the quarter ends..

I added shares today at $9.9573.

Real world vs Challenge studies… and the interplay in developing an anti-viral. To my understanding the upcoming peds trial and the trial w/ senior / unhealthy adults will be real world studies. In both of these groups it is presumed that the resistance to the RSV virus will be low relative to the resistance levels of healthy adults. My interest is piqued when the discussion turns to what might be expected in the real world studies, given the positive challenge study results. Of course, In reality we don’t know until the trials are completed. Ya know it is rather amazing how Enanta manages to compete with huge corporations.

Furthermore -

Enanta's RSV antiviral crushes viral load in challenge study

Enanta Pharmaceuticals has linked its respiratory syncytial virus (RSV) antiviral to significant reductions in viral load and symptoms in a phase 2a challenge study. The biotech said the results cleared the bar set by its other candidate, opening up opportunities to test the molecules as single agents and in combination.

Previously, Enanta reported data from a challenge study of its N-protein inhibitor zelicapavir. The data led to further development of the candidate. In parallel, Enanta advanced a L-protein inhibitor, EDP-323. The EDP-323 challenge study had essentially the same design as the zelicapavir trial and was run at the same location, potentially allowing Enanta to make a more accurate comparison than is typically possible.

Scott Rottinghaus, M.D., chief medical officer at Enanta, said in a statement that the EDP-323 data raise “the high bar set by zelicapavir.” In a study of 142 healthy adults inoculated with RSV, EDP-323 lowered viral load area under the curve (AUC) by 85% at the high dose and 87% at the low dose compared to placebo.

Those reductions caused the trial to meet its primary endpoint. Enanta also reported hits on two of the secondary endpoints. The biotech linked the two doses of EDP-323 to reductions in viral culture AUC of 98% and 97% compared to placebo; and to symptom reductions of 66% on the high dose and 78% on the low dose, again compared to placebo.

Enanta’s press release lacks a discussion of the next steps, beyond a high-level reference to the potential for the distinct mechanisms of EDP-323 and zelicapavir to support single-agent and combination studies. Tara Kieffer, Ph.D., chief product strategy officer at Enanta, provided additional details of how the two molecules may be used at an event run by Cantor Fitzgerald last week.

Kieffer said hard-to-treat patients, such as people who are severely immunocompromised, may benefit from combination therapy. Combining the drugs could also support use of the antivirals longer after the start of symptoms.

Clinical data on zelicapavir are due in the fourth quarter. The back-to-back data drops will allow Enanta “to take a look at the portfolio and make the best decisions about how we might move forward these compounds,” Kieffer said.

The compounds are moving toward a market that is already served by RSV vaccines that can prevent infection and, in doing so, reduce the number of people who may need an antiviral. However, Enanta sees an ongoing need for antivirals in both the pediatric and adult populations, with Kieffer saying babies and children will go on to get RSV infection after protection wanes and noting low vaccine use in adults.

https://www.fiercebiotech.com/biotech/enantas-rsv-antiviral-crushes-viral-load-challenge-study

938 (N inhibitor) is 1-2 years ahead 323 (L) is one quarter ahead of Shionogi L inhibitor.
Then there is PFE fusion inhibitor but that’s not as serious a threat IMO

It appears Enanta is further along in their development of RSV molecule than is Shionogi.

Enanta Pharmaceuticals Gains Buy Rating on Strong Clinical Results for EDP-323 - September 26, 2024

In a report released today, Roy Buchanan from JMP Securities reiterated a Buy rating on Enanta Pharmaceuticals (ENTA – Research Report), with a price target of $22.00.

Roy Buchanan has given his Buy rating due to a combination of factors surrounding Enanta Pharmaceuticals’ promising clinical trial results and the potential of their drug candidate, EDP-323. The Phase 2a challenge trial for EDP-323 showcased significant viral load reductions that are competitive with, if not superior to, other similar treatments, which were also reflected in substantial symptom improvements compared to placebo. Buchanan’s confidence is also bolstered by the safety profile of EDP-323, which displayed no serious adverse events, suggesting a favorable risk-reward balance for the drug.
Additionally, Buchanan’s optimism is fueled by the strategic decisions of Enanta Pharmaceuticals to continue with the current dosing strategy in upcoming trials, given the high drug levels achieved relative to the effective concentration. The anticipation for further clinical data from the pediatric trial of zelicapavir adds to the positive outlook, as it could further validate the company’s approach. Enanta’s development plans are robust and not dependent on a single study outcome, indicating a strong commitment to advancing their treatment options for respiratory syncytial virus (RSV).

https://markets.businessinsider.com/news/stocks/enanta-pharmaceuticals-gains-buy-rating-on-strong-clinical-results-for-edp-323-1033802172

The # of analysts in the 323 data call tells us the program has potential. But the questions from the analysts also tells us they are still skeptical, to a point where the lead investigator put the question about to the analyst.

Maybe the ped data will bring the needed confidence.

Price swing is the norm for ENTA

Impossible to comprehend market valuation here… did you notice 79K shares traded in after hours and some post an after-hour close of $10.55? I need to learn more about RSV, the market potential, etc.

$20 for cash and remaining royalties
$6 for for RSV, 325, potential settlement and immunology program, etc


Seems more than reasonable

But yet we are at $10.

Hard to comprehend. The fun of bio value investing I guess

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.