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Reading between the lines -
Is ENTA in preclinical, developmental work for animal medications? Or, am I stretching it?!!
New career post excerpts:
Scientist, Toxicology
Evaluate individual and programmatic study data (anatomic pathology, clinical pathology, in-life parameters, etc.) as to the potential toxicity of experimental compounds in different animal species....
Qualifications:
DVM/PhD (strongly preferred), DVM or PhD in Toxicology, Pathology, or related health science field
Solid foundation in animal and/or biomedical sciences, including toxicology, pathology, and physiology with proficient knowledge of developmental and reproductive biology
https://theapplicantmanager.com/jobs?pos=ET974
Yes so hard to predict level of respiratory illness in a given season so I would have thought they would need more time before adjusting guidance. However there is a summer surge of Covid now and they have nearly a month of Q3 data already
it looks like less than a day shorter symptom duration even on the restricted 6 symptom endpoint
VL curves do separate, but not by a lot and could be driven by the higher risk patients in the trial versus enanta
certainly based on symptom endpoint edp-235 looks more effective, especially given there were no high risk patients at all included, although I haven't compared the definitions for an apples to apples comparison
I have no idea if this resurrects any partnering prospects for 235
There is some new data from the phase 3 ensitrelvir study.
https://www.shionogi.com/content/dam/shionogi/global/investors/ir-library/presentation/2024/1q/E_FY2024_1Q%20financial%20result.pdf
Also PFE increased paxlovid guidance by 500M to 3.5 B
“I guess it depends what year is used for the damages”
My understanding is that it’s the entire lifetime of the infringement. And any time it was “willful” (enta notified pfe in June 2022) you are liable for up to 3x damages.
Pfe did close to 20 B in sales in 2022 so that’s where the 1 B comes from. They guided for 3B this year but that’s probably conservative. 6 percent is definitely on the high end I’m sure ENTA would settle for 2-3 percent. Pfe does risk treble damages so 3x for the duration of time they willfully infringed. So unless they think their case is a slam dunk if they don’t win summary judgment I would think there’s motivation to settle
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/
The publication of the results is recent but the failure of the trial is old news
Shionogi has a prevention trial that is nearly fully enrolled for ensitrelvir
Paxlovid comes up short again...
https://www.nejm.org/doi/full/10.1056/NEJMoa2309002
Oral Nirmatrelvir–Ritonavir as Postexposure Prophylaxis for Covid-19
Conclusions
In this placebo-controlled trial, postexposure prophylaxis with nirmatrelvir–ritonavir for 5 or 10 days did not significantly reduce the risk of symptomatic SARS-CoV-2 infection. (Funded by Pfizer; ClinicalTrials.gov number, NCT05047601.)
From BIOWORLD -
Infection
Enanta Pharmaceuticals describes new PL-pro
July 22, 2024
Enanta Pharmaceuticals Inc. has patented compounds acting as nonstructural protein 3 (nsp3, PL-pro; SARS-CoV-2) inhibitors reported to be useful for the treatment of asthma, SARS-CoV-2 infection (COVID-19), rhinovirus, norovirus and lung infections. [Subscription needed]
https://www.bioworld.com/articles/710689-enanta-pharmaceuticals-describes-new-pl-pro?v=preview
FWIW -
Friday, July 19, 2024 - A possible WIN for ENTA?
Reply to Response to Motion Fri 07/19 4:10 PM
SEALED REPLY in Support of 296 MOTION to Compel Defendant Pfizer Inc. to Produce Documents and Provide Deposition Testimony filed by Enanta Pharmaceuticals, Inc..(Cook, Savannah)
https://www.pacermonitor.com/public/case/44980990/Enanta_Pharmaceuticals,_Inc_v_Pfizer_Inc
me too
Given the biomarker data that can be generated in healthy volunteers it could happen pretty quickly, although THRD didn't have liver tox until a POC study bc that AE cropped up only after several weeks of dosing, so it could be after a longer phase 1b to get a good deal, and by then the competitive landscape will start to shape up. so it's probably a 2026 type of thing as a wild guess if all goes according to plan
ENTA will be behind THRD and BPMC in the oral kit space, but not by a lot and given the number of indications and commercial opportunity I would hope there is a place for more than one player (and you never know when someone will stumble). The drugs may also have different profiles that enable them to carve a place in the universe of mast cell mediated diseases
There ought to be prospective partners for an oral drug capable of addressing the various autoimmune indications you cited.
These are not small trials, and this is only one indication of many. they are in phase 2 in 3-4 other programs, probably to start phase 3 soon in CINDU (inducible urticaria), and the pipeline doesn't even mention asthma which is perhaps the largest indication but also costliest
So the bottom line is I think ENTA is going to have to partner this drug early on
CLDX has over 800M in cash
CLDX announces phase-3 CSU program for Barzolvolimab:
https://www.globenewswire.com/news-release/2024/07/16/2913721/24180/en/Celldex-Therapeutics-Initiates-Global-Phase-3-Program-for-Barzolvolimab-in-Patients-with-Chronic-Spontaneous-Urticaria.html
ENTA volume is high again today. I could get used to these $1 jumps in ENTA stock price. Could be momentum players piling in or a leak of good news. Obviously I prefer the latter but who knows!
It's difficult for me to know. The rate of ascent is good. Friday's volume was good too.
Per Finviz https://finviz.com/quote.ashx?t=ENTA&p=d
Perf Week 19.49%
Perf Half Y 34.00%
Perf YTD 70.03%
Sometimes money just rotates out and moves back in when a catalyst approaches.
And sometimes/often money jumps in leading up to a quarterly earnings report.
I will note our last high of about $16 dollars was the 3 months before the ENTA August ER.
I'm hopeful that in the coming weeks we will have a positive data release from RSV trials.
I'm very hopeful about some positive news on the ENTA/PFE covid patent litigation
Could be getting out of a short position
I'm surprised because every time I have looked the bid ask spread after hours is very wide. I wonder if some of the after hours volume involves negotiated trades
What has peeked my interest is the after-market trading. Approximately 2 weeks ago, I started accumulating shares en masse due to the fact that 100K- 300K+ additional shares were being traded in the after hours. Not sure if this has anything to do with the uptrend. However, psychologically - remember approximately 3 years ago the stock was $100+ PPS. Something very positive is happening - legal, clinical trials, M & A (with the new attorney on board) & the FLO Foundation is riding the wave!
https://www.nasdaq.com/market-activity/stocks/enta/after-hours
There’s been a lot of activity on the legal front that’s for sure. I would think a ruling on summary judgment is a couple months out still but that’s just a guess. Sure are a lot of documents to go through and more seem to be piling up every day
https://www.pacermonitor.com/public/case/44980990/Enanta_Pharmaceuticals,_Inc_v_Pfizer_Inc
Not sure why ENTA has jumped some 25% this week but I do like it! Maybe there has been a leak about ENTA getting a favorable ruling in their lawsuit against PFE or a settlement by PFE. A guy can dream, can't he??
HMPV
There is a cluster of kids admitted with HMPV in my area. ENTA stopped development of this asset, but it could be resurrected easily enough. This is bullish for MRNA IMO bc I know they are working on a combo vaccine incorporating this virus
IMHO - all these patents would be a significant value incentive for a merger or a buyout -
As of June 25, 2024 -
Apoptosis signal-regulating kinase 1 inhibitors and methods of use thereof
Abstract: The present invention discloses compounds of Formula (I), or pharmaceutically acceptable salts, ester, stereoisomer, tautomer, solvate, hydrate, or combination thereof: which inhibit the Apoptosis signal-regulating kinase 1 (ASK-1), which associated with autoimmune disorders, neurodegenerative disorders, inflammatory diseases, chronic kidney disease, cardiovascular disease. The present invention further relates to pharmaceutical compositions comprising the aforementioned compounds for administration to a subject suffering from ASK-1 related disease. The invention also relates to methods of treating an ASK-1 related disease in a subject by administering a pharmaceutical composition comprising the compounds of the present invention. The present invention specifically relates to methods of treating ASK-1 associated with hepatic steatosis, including non-alcoholic fatty liver disease (NAFLD) and non-alcohol steatohepatitis disease (NASH).
Type: Grant
Filed: December 2, 2022
Date of Patent: June 25, 2024
Assignee: Enanta Pharmaceuticals, Inc.
Inventors: Guoqiang Wang, Ruichao Shen, Jiang Long, Jun Ma, Xuechao Xing, Yong He, Brett Granger, Jing He, Bin Wang, Yat Sun Or
https://patents.justia.com/assignee/enanta-pharmaceuticals-inc
https://patents.justia.com/patent/12018017
A series of studies using ASK1-deficient mice have indicated that ASK1 plays important roles in many stress-related diseases, including cardiovascular and neurodegenerative diseases, suggesting that small compounds that inhibit ASK1 activity could possibly be used for the amelioration of the development and/or progression of these diseases.
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3491083/
O/T ----
We need some LEVITY here. One of my favorite movie scenes.
Might as well continue to list patents as they are granted. Who know what leverage they'll have in a potential acquisition or merger?
Hepatitis B antiviral agents
Patent number: 12011425
Abstract: The present invention discloses compounds of Formula (I), or pharmaceutically acceptable salts, esters, or prodrugs thereof: X-A-Y-L-R??(I) which inhibit the protein(s) encoded by hepatitis B virus (HBV) or interfere with the function of the HBV life cycle of the hepatitis B virus and are also useful as antiviral agents. The present invention further relates to pharmaceutical compositions comprising the aforementioned compounds for administration to a subject suffering from HBV infection. The invention also relates to methods of treating an HBV infection in a subject by administering a pharmaceutical composition comprising the compounds of the present invention.
Type: Grant
Filed: January 25, 2023
Date of Patent: June 18, 2024
Assignee: Enanta Pharmaceuticals, Inc.
Inventors: Yao-Ling Qiu, Xuri Gao, Jorden Kass, Hui Cao, Wei Li, Xiaowen Peng, Byung-Chul Suh, Yat Sun Or
https://patents.justia.com/assignee/enanta-pharmaceuticals-inc
RSV competition
Shionogi's L inhibitor challenge study expected to be completed by Q3 - exactly the same as ENTA
I view this as the stiffest competition to ENTA's RSV programs
https://www.shionogi.com/content/dam/shionogi/global/investors/ir-library/presentation/2024/e20240614.pdf
FWIW - Addendum - Barbara Fiacco - ENTA, if only -
Represented Dana-Farber as lead counsel in second case against Bristol-Myers Squibb and Ono Pharmaceuticals, asserting claims for unjust enrichment and unfair competition for depriving Dana-Farber of its co-ownership rights under eight patents directed to cancer immunotherapy. On the eve of trial, in the face of Dana-Farber’s claim for hundreds of millions of dollars in damages, Defendants settled, making a substantial lump sum payment to Dana-Farber and agreeing to make potential additional payments, contingent on future events.
https://foleyhoag.com/people/fiacco-barbara/#Experience
ENTA has an outstanding litigator in their representation - Barbara Fiacco
Quote - The following Foley Hoag partners were also recognized for excellence in the industry in the following jurisdictions, and were described by IAM as:
Barbara Fiacco (National) and Donald Ware (MA) ranked in the Gold tier for litigation.
“Two of the most high-quality trial lawyers Boston has to offer,” and “A formidable team in life sciences litigation, securing multiple victories for the Dana-Farber Cancer Institute, resulting in significant payouts as well as co-ownership of groundbreaking cancer treatment patents.”
https://foleyhoag.com/news-and-insights/news/2024/june/foley-hoag-10-partners-recognized-in-2024-edition-of-iam-patent-1000/
https://foleyhoag.com/people/fiacco-barbara/
Here's the latest. Appears that ENTA is progressing well as of June 13. Comments?
https://www.pacermonitor.com/public/case/44980990/Enanta_Pharmaceuticals,_Inc_v_Pfizer_Inc
Since the HMPV program has been dropped I am impressed with the persuasive marketing and sales success of the legal firm that serviced all of these patents. I have always acknowledged the giant patent portfolio of Enanta, but is it in vain? Vanity -- hmm?
Two more for the books -
Patent number: 12006291
Abstract: The present invention relates to processes for preparing a Compound (1): or a pharmaceutically acceptable salt or solvate thereof. Compound (1) is useful as in many pharmaceutical agents, especially is useful as key intermediate in the synthesis of certain SARS-CoV-2 3CLpro inhibitors.
Type: Grant
Filed: January 10, 2023
Date of Patent: June 11, 2024
Assignee: Enanta Pharmaceuticals, Inc.
Inventors: Kaicheng Zhu, Tao Wang, Jiajun Zhang, Hui Cao, Ruichao Shen, Guoqiang Wang, George G. Wu, Yat Sun Or
Antiviral heterocyclic compounds
Patent number: 12006326
Abstract: The present invention discloses compounds of Formula (I), or pharmaceutically acceptable salts, esters, or prodrugs thereof: which inhibit Human Respiratory Syncytial Virus (HRSV) or Human Metapneumovirus (HMPV) inhibitors. The present invention further relates to pharmaceutical compositions comprising the aforementioned compounds for administration to a subject suffering from HRSV or HMPV infection. The invention also relates to methods of treating an HRSV or HMPV infection in a subject by administering a pharmaceutical composition comprising the compounds of the present invention.
Type: Grant
Filed: August 24, 2022
Date of Patent: June 11, 2024
Assignee: Enanta Pharmaceuticals, Inc.
Inventors: Adam Szymaniak, Kevin McGrath, Jianming Yu, Tyler Mann, Long Nguyen, Kaicheng Zhu, In Jong Kim, Yat Sun Or
https://patents.justia.com/assignee/enanta-pharmaceuticals-inc
June 11, 2024
Enanta Pharmaceuticals gets grant for macrocyclic compounds inhibiting coronavirus replication
....the patent outlines methods for treating viral infections, particularly coronavirus infections, by administering the disclosed compound. The methods include oral, subcutaneous, intravenous, or inhalation administration of the compound. Additionally, the patent covers inhibiting viral 3C protease or viral 3CL protease in a subject by administering the compound. The patent specifies the treatment of various strains of coronaviruses, including 229E, NL63, OC43, HKU1, SARS-CoV, and MERS coronavirus, highlighting the broad spectrum of antiviral activity claimed in the patent.
https://www.pharmaceutical-technology.com/data-insights/enanta-pharmaceuticals-gets-grant-for-macrocyclic-compounds-inhibiting-coronavirus-replication/
both parties submitted motion for summary judgement - ENTA for damages arguing facts are undeniable so no need for trial, PFE that patent is invalid or obvious that they didn't infringe and toss the case
There were some posts about this on the board w DD opining that most likely neither party wins on summary judgement (although I suppose someone can win in part and case still goes to trial)
things are coming to a head
Summary judgment hearing for whom?
sounds like the time of the hearing was changed
Explanation needed. T.I.A.
Docket last updated: 10 hours ago
Thursday, June 06, 2024 Notice Setting or Resetting Hearing on Motion Thu 06/06 11:17 AM
ELECTRONIC NOTICE Resetting Daubert and Motion for Summary Judgment Hearing. Motion Hearing set for 7/31/2024 10:00 AM in Courtroom 11 (In person only) before Judge Denise J. Casper.
https://www.pacermonitor.com/public/case/44980990/Enanta_Pharmaceuticals,_Inc_v_Pfizer_Inc
The fact that an antiviral course is short makes it not that challenging from a medical standpoint to stop things like statins while taking paxlovid, so the impetus for an EUA path is not really that justified. however if you have a drug without DDIs it makes it a no brainer to just Rx that over another drug given the hassle of going though med lists and figuring out what to hold for a week or so
It would have been nice if 235 was granted EUA for use in populations where DDI is of concern.
I don't know but ensitrelvir suffers from DDIs much like paxlovid and EDP-235 doesn't so even if it were to gain approval in the west (more of an uphill battle after the recent phase 3 readout), EDP-235 should still have appeal based on DDI alone. This is why shionogi is bringing forward another PI that is closer to 235 in its profile. Perhaps ensitrelvir fares better in the EU from a regulatory standpoint who knows
I don't know that a partner will view 235 as having a good chance of approval if the FDA insists on the 15 symptom endpoint so ironically it is better IMO if ensitrelvir gets the nod from FDA on the narrower symptom subset bc again 235 has the DDI advantage (and perahps an efficacy advantage we have to see the data from SCORPIO-HR)
If ENTA were to prevail in the paxlovid litigation they have more interest in ensitrelvir not making it to market though
Legitimate question, I am not clowning around. Does everyone agree that Shionogi's COVID assets, are all going to be limited to markets in Japan and some parts of Asia? With Enanta dropping its improved COVID program, and not demonstrating any success in partnering its EDP 235 asset it seems like Paxlovid is the cat's meow for now and the future.
Shionogi R and D day slides:
https://www.shionogi.com/content/dam/shionogi/global/investors/ir-library/presentation/2024/E_final.pdf
No new info on ensitrelvir
Slide 46 discusses a new PI for covid with fewer drug interactions and no teratogenicity which should be entering phase 2 soon
Slide 48 discusses their L protein inhibitor for RSV which is in a human challenge study so same stage of development as ENTA's L inhibitor.
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