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Maybe PFE's lawsuit win against PUMA spooked or confused ENTA investors.
https://finance.yahoo.com/news/federal-judge-rejects-patent-claims-211116499.html
in a more serious note, it seems today AI names and some of the big techs are rebounding.. and that probably drawing money out from small caps ($IWM and bio index, etc...). I am kind of glad that RVNC is sold, otherwise, day like today, it will probably be down 10% randomly.
because I moved some RVNC money to ENTA?
No clue
Latest earnings from competitors in the KiT Space (but this is a few days ago and regardless nothing material):
THRD phase 1 readout for kit inhibitor from q1 2025 (previously I thin q2). BPMC started phase 1 for their candidate but this was expected
Any reason for ENTA falling 7% today other than normal market ups and downs? I bot 2500 shares today.
Looks like PFE lost a similar motion back in may:
“Magistrate Judge Jennifer C. Boal: ORDER entered. re 160 MOTION to Compel Production of Documents Improperly Withheld as Privileged filed by Pfizer Inc. (Hutchins, Aaron)”
Im hoping all of this info that each side seems to want to keep suppressed means that there is enough here to need to go to trial
Enanta Pharmaceuticals, Inc. v. Pfizer Inc.
Friday, August 09, 2024
367 Notice Setting or Resetting Hearing on Motion Fri 08/09 9:15 AM
ELECTRONIC NOTICE Setting Hearing on Motion296 MOTION to Compel Defendant Pfizer Inc. to Produce Documents and Provide Deposition Testimony : Motion Hearing set for September 25, 2024 at 11:30 AM in Courtroom 14 (In person only) before Magistrate Judge Jennifer C. Boal. Plaintiff Enanta Pharmaceuticals, Inc. has filed a motion to, among other things, compel Pfizer to produce an April 6, 2022 email as well as the attachments to that email. Docket No. 296. Defendant Pfizer, Inc. maintains that the email is privileged and has offered to submit the email ex parte for in camera review. See Docket No. 334 at 17. No later than August 22, 2024, Pfizer shall submit the email and attachments for in camera review. The documents must be submitted in hard copy at the Clerk's Office and marked DO NOT DOCKET, SUBMITTED FOR IN CAMERA REVIEW. (Hutchins, Aaron)
https://www.pacermonitor.com/public/case/44980990/Enanta_Pharmaceuticals,_Inc_v_Pfizer_Inc
Inch by inch, we're getting there -
Barbara A. Fiacco - ENTA's Attorney - additional info -
She has represented leading pharmaceutical and life sciences clients in significant patent infringement lawsuits that have resulted in summary judgment or other favorable outcomes for her clients. Barbara also represents these clients in trade secret, inventorship, and technology transfer disputes as well as other commercial litigation.
Barbara is a Past President of the American Intellectual Property Law Association (AIPLA) and a Past President of the United States section of the International Association for the Protection of Intellectual Property (AIPPI-US), serving from 2019 to 2020. She has held a number of leadership roles in AIPLA and has represented this premier intellectual property law association in testimony on behalf of AIPLA before the Senate Judiciary Committee’s Subcommittee on Intellectual Property as well as in amicus briefs to the Supreme Court.
https://foleyhoag.com/people/fiacco-barbara/
FWIW - Patents Assigned to Enanta Pharmaceuticals, Inc.
Hepatitis B antiviral agents
Patent number: 12054493
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 7, 2021
Date of Patent: August 6, 2024
Assignee: Enanta Pharmaceuticals, Inc.
Inventors: Yao-Ling Qiu, Xuri Gao, Wei Li, Hui Cao, Meizhong Jin, Jorden Kass, Xiaowen Peng, Yat Sun Or
My daughter, Little FLO, found this on X August 6 -
Congratulations to members of Team Enanta for their publication in
@NatureComms
highlighting the preclinical data of EDP-235, Enanta’s 3CL protease inhibitor, in development for the treatment of #COVID-19. Thanks to everyone who made this publication possible and to first author Michael Rhodin who gives us permission to share this link.
Article Published: 01 August 2024
The small molecule inhibitor of SARS-CoV-2 3CLpro EDP-235 prevents viral replication and transmission in vivo
https://www.nature.com/articles/s41467-024-50931-8. This is the full, in-depth article - FANTASTIC!!
Thanks to biocqr for the original heads-up.
Shionogi said the challenge study for their polymerase inhibitor should wrap up in Q4. I do think this is the most significant competitor even though PFE's fusion inhibitor is more advanced bc of the poor track record for prior fusion inhibitors.
Nice to see they completed enrollment of the peds study - that is the more significant event
Enanta Pharmaceuticals: Fiscal Q3 Earnings Snapshot
Associated Press Finance
Mon, Aug 5, 2024, 4:09 PM EDT
WATERTOWN, Mass. (AP) — WATERTOWN, Mass. (AP) — Enanta Pharmaceuticals Inc. (ENTA) on Monday reported a loss of $22.7 million in its fiscal third quarter.
The Watertown, Massachusetts-based company said it had a loss of $1.07 per share.
The results exceeded Wall Street expectations. The average estimate of five analysts surveyed by Zacks Investment Research was for a loss of $1.49 per share.
The biotechnology company posted revenue of $18 million in the period, also surpassing Street forecasts. Five analysts surveyed by Zacks expected $17.3 million.
https://finance.yahoo.com/news/enanta-pharmaceuticals-fiscal-q3-earnings-200950084.html
ENTA reports FY3Q24* financials—EDP-323 “challenge-study” data_due_Sep_2024 (study complete)—Zelicapavir RSVPEDs phase-2 data due calendar 4Q24:
https://ir.enanta.com/news-releases/news-release-details/enanta-pharmaceuticals-reports-financial-results-its-fiscal-40
• 6/30/24 cash = $272.6M, a decrease of $27.7M from the cash balance at 3/31/24.
• FY2Q24 royalty revenue was $18.0M, +5% QoQ and -5% YoY. Note: 54.5% of ENTA’s Mavyret royalties are payable to OMERS (Canada’s largest pension fund), and this amount is treated for accounting purposes as an amortization of debt (see discussion in #msg-172603887).
• FY2Q24 R&D expenses were $28.7M, slightly below the quarterly run rate of the lower bound of ENTA’s FY2024 guidance of $125-145M given three months ago.
• FY1Q24 SG&A expenses were $13.4M, consistent with ENTA’s FY2024 guidance of $50-60M given three months ago. Legal expenses for the Paxlovid lawsuit against PFE were a material portion of the SG&A expenses for the quarter.
• ENTA reiterated that its cash and expected royalty revenue are sufficient to fund operations until 6/30/27 (end of FY3Q27).
*ENTA’s fiscal year ends on September 30.
Thanks
The pan-coronavirus potential of the drug is emphasized in this paper, something Enanta has never really leaned into in any presentation to investors
PS: some small bios would have released a PR when data is published, although this is just preclinical and ENTA management was never one to put out a bunch of frivolous PRs (they even decided 3 months ago not to hold a cc with tomorrow's earnings release so they are very much in a we will wait until we have something meaningful to say mode)
The Shionogi transcript is now available and has this interesting item:
FYI Shionogi just said they sold 10billion yen (66M) worth of their covid drug in July. I would imagine paxlovid sales are surging now as well
Thanks, that new link worked. So Ensitrelvir shows anti-viral effects when assayed via nasal swabs but doesn't do much for symptom relief. I agree that seems to indicate that EDP-235 is superior. Now we just have to find someone willing got risk a few hundred million to confirm that. We should look under our sofa cushions and see if we can help raised the money. 🤣
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
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