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“Is this typical of pre-acquisition activities?”
My thinking is more inline with cutting costs to extend their cash while they continue to execute on the business plan. I don’t envision a buyout. JMHO
I cannot find additional information on this, but I did notice several weeks ago that most of the open positions had been removed from the company's website. Can you direct me to the source for this statement of trimming the headcount.
Is this typical of pre-acquisition activities?
Correct. Only had 9 enrolled over the last 3 years.
ENTA halts enrollment/trial for RSV transplant patients
ENTA updated corporate slide set (9/12/23):
https://ir.enanta.com/static-files/0b9a9564-339c-4501-8c98-eab636846bf4
Differences between the 9/12/23 corporate slide set and the 8/7/23 version are relatively minor. (In the bullet points below, I’ve omitted mention of slides that were merely re-sequenced with no changes to the content.)
• New slide 7 has additional info about the unmet medical need for an RSV treatment.
• Regarding the EDP-938 phase-2 clinical trials, new slides 14-15 replace old slides 13-15. ENTA discontinued the RSVTx trial in immunocompromised transplant patients because there weren’t enough transplant recipients infected with RSV to enroll the trial. (The RSVPEDs [pediatric] and RSVHR [high-risk adult] trials are continuing without change.)
• Old slide 30, which showed the performance of the placebo arms in various COVID trials, has been deleted.
• New slides 25 and 26 (which had no counterparts in the old slide set) show graphs of the EDP-235 SPRINT trial’s Total Symptom Score for all 14 prespecified symptoms among all ITT patients (slide 25) and patients treated within three days of symptom onset (slide 26). These two new slides supersede old slide 26, which showed Total Symptom Score for a post-hoc subset of 6 of the 14 prespecified symptoms.
• New slide 27 has the same content as old slide 27, a graph of the time to symptom improvement for a subset of 6 symptoms, but the header has been corrected to fix a clerical error in the old slide.
I was drawn into investing thru HCV.
Gilead paid 11 billion for a fabulous asset and generated a lot of income.
The only *problem* (some thought) it was a cure, and in time the treatment numbers dropped.
Covid on the other hand spins off variants that evade current vaccines.
Thus Covid may have a longer run than initially expected and repeat customers.
W/ regards to HCV, Enanta had little leverage and didn't get a large share in HCV profits.
It may be that this recent Covid surge- if there is continued negotiation w/ a potential partner- this surge may be a benefit.
Maybe Enanta won't accept a first low ball offer.
(that's a reason I wondered if they pulled the preclinical candidate from their slides)
No announced agreement doesn't equal failure- it may mean a better offer coming.
Rising Covid hospitalizations are probably also be getting investor's attention.
Not only has the share price come up the volume is encouraging too.
we are on the same page wrt enta/luly etc
Even if the likelihood is very small, I was just speculating that perhaps one possibility for amending the pipeline in a rather peculiar way is to lower the likelihood of government scrutiny if PFE were in fact in discussions w ENTA about an acquisition. I am probably overthinking it anyway bc it would be a small transaction that almost never results in antitrust concerns, and we are talking about a super early program, which I have never seen anyone have to divest regardless of the size of the transaction.
Pavlovid weekly prescriptions have increased fourfold from their 2Q23 nadir, according to PFE’s CCO on today’s MS webcast. Weekly prescriptions are now running at about 60% of the peak 2023 level reached in January.
https://event.webcasts.com/viewer/event.jsp?ei=1630426&tp_key=a1d42d6790
Yes if PFE were making overtures to ENTA bc they dropped their RSV-N, they want the lawsuit to go away, etc (I mean it makes strategic sense), it might be easier to not raise any scrutiny if you are also getting the only 2 PLpro projects in the wings
mind you I have never heard of FTC action for super early stage projects, or for small buyouts like this would be , but could covid be different? TBH I doubt it, but it crossed my mind bc it really doesn't make sense to announce the project earlier this year and suddenly remove it from the pipeline chart so it jsut got me thinking that is all
dewophile,
I agree with you. ENTA could just keep the product listed in development without spending any appreciable amount of money on it.
At the risk of sounding like a self serving conspiracy theorist I was just thinking it may be a bad look to let someone corner the covid market
What is your (possibly) far-fetched theory? TIA
They can pause the program and still keep it listed on their slide deck, if anything to project they still have more in the tank as the street is writing them off
I have another theory but it may be far fetched
why would ENTA drop a super early stage program in which no one is expecting to hear much for a long time from their slide deck?
If they want to signal to the market that they are further extending their cash runway dropping an early preclinical program isn't exactly going to move the needle
FYI PFE happens to be working on a PlPRO (https://www.pfizer.com/news/press-release/press-release-detail/pfizer-and-clear-creek-bio-collaborate-research-program).
The Wells Fargo chat yesterday was valuable and informative......, well, if you knew nothing about ENTA.
The questions asked were mostly about RSV.
Not a triple witching event this time and I am all ears for possible reasons.
Could Shionogi make their Xocova by Viiv Healthcare's HIV mechanism?
Thanks.
Regardless of what happens with Covid, RSV Hep B/C etc.it appears a favorable settlement could propel the stock price 2X-4X from here.
Re: PLPro program
There was no announcement, but ENTA removed the PLPro program from the pipeline chart on slide 5 of the latest slide set (https://ir.enanta.com/static-files/0b9a9564-339c-4501-8c98-eab636846bf4 ).
The PLPro program was only in the discovery phase—not yet in preclinical development—and ENTA had not even selected a lead candidate for the program. I.e., very little money has been spent to date on this program. It should be a simple matter for ENTA to reinstate the PLPro program if developments with EDP-235 warrant such an action.
The Biktarvy patent settlement you cited can be considered a lower bound for the economics of a potential settlement of ENTA’s patent suit against PFE with respect to Paxlovid, IMO.
Regarding the merits of the two cases, I don’t have an educated opinion on how they compare.
As an infused drug, GILD’s Veklury addresses a distinct market from Paxlovid and other oral antivirals.
Dew...how similar are ENTA's claims against PFE compared to GSK/ViiV's patent suit against Gilead's Biktarvy?
How likely or unlikely is the possibility that an ENTA/PFE settlement would be more or less than Gileads settlement?
Paxlovid's sales to date are substantially higher than Gilead's Biktarvy at the settlement date...are they not?
https://viivhealthcare.com/hiv-news-and-media/news/press-releases/2022/january/gsk-announces-settlement-between-viiv-healthcare-and-gilead-sciences/
Is there anyone who has an insight with Veklury of Gilead? I've just noticed its' revenue is higher than Paxlovid and Lagevrio. and it's got the FDA approval for liver patients on 24th, August.
But Enanta didn't even mention Veklury in their presentation which compares the drug efficacy.
Thank you in advance.
https://www.gilead.com/news-and-press/press-room/press-releases/2023/8/fda-approves-veklury-remdesivir-to-treat-covid19-in-people-with-mild-to-severe-hepatic-impairment-with-no-dose-adjustment
Thank you for the update. I'm looking forward to seeing the result of this. I think this is an important issue with Enanta. Do you have any insight on this kind of case?
Is there any reference case you know? I wonder if Enanta won over Pfizer, what percentage of the Paxlovid's previous revenue could we get? Additionally, are you expecting Paxlovid to suspend sales after Enanta win?
It's on hold pending developments for EDP-235.
PLpro inhibitor? Did Enanta drop their PLpro inhibitor program? Can anyone offer any insight? Thank you in advance.
Pfizer - Enanta Patent Case Looks like a very long timeline.
The following was posted yesterday at https://www.pacermonitor.com/public/case/44980990/Enanta_Pharmaceuticals,_Inc_v_Pfizer_Inc
Judge Denise J. Casper: ELECTRONIC ORDER entered granting122 Joint MOTION for Extension of Time - Joint Motion to Modify Schedule. Deadline for substantial completion of document discovery by September 15, 2023. Close of fact discovery by November 17, 2023. Deadline for initial expert reports on issues as to which party bears the burden of proof by January 12, 2024. Deadline for rebuttal expert reports as to which party does not bear the burden of proof by March 1, 2024. Deadline for completion of expert depositions by April 12, 2024. Deadline for summary judgment motions and Daubert motions May 10, 2024. Deadline to file oppositions to summary judgment motions and oppositions to Daubert motions March 31, 2024. Deadline to file replies in support of summary judgment motions and replies in support of Daubert motions June 14, 2024. Status Conference set for 12/4/2023 02:45 PM in Courtroom 11 Related [+] before Judge Denise J. Casper. (Currie, Haley)
Done!! Incredibly curious what if anything will be shared update wise on the 235 project. Cheers to all for a wonderful Labor Day weekend. Off to northern Wisconsin & the UP of Michigan for a few days of fishing, kayaking, campfires and a few nice bottles of wine with friends. Peace….
rwwine,
Ha, ha, you just beat me to it. Why don't you post that on the Biotech Values site too?
Hopefully, they will be talking about developments in partnerships for EDP-235.
Enanta Pharmaceuticals to Participate in Investor Conferences in September
August 31, 2023, 7:00 AM EDT
WATERTOWN, Mass.--(BUSINESS WIRE)--Enanta Pharmaceuticals, Inc. (NASDAQ: ENTA), a clinical-stage biotechnology company dedicated to creating small molecule drugs for viral infections, today announced that members of management will participate in four investor conferences being webcast in September and provide a business update:
Wells Fargo Securities Healthcare Conference: Fireside Chat at 2:15 p.m. ET on September 7, 2023
H.C. Wainwright 25th Annual Global Investment Conference: Presentation at 4:30 p.m. ET on September 12, 2023
Baird Global Healthcare Conference: Fireside Chat at 1:25 p.m. ET on September 13, 2023
2023 Cantor Global Healthcare Conference: Fireside Chat at 8:45 a.m. ET on September 26, 2023
A live webcast of each event will be accessible by visiting the “Events and Presentations” section on the “Investors” page of Enanta’s website at www.enanta.com. A replay of the webcasts will be available following the presentation and will be archived for at least 30 days.
About Enanta Pharmaceuticals, Inc.
Enanta is using its robust, chemistry-driven approach and drug discovery capabilities to become a leader in the discovery and development of small molecule drugs for the treatment of viral infections. Enanta’s research and development programs include clinical candidates for the following disease targets: respiratory syncytial virus (RSV), SARS-CoV-2 (COVID-19) and hepatitis B virus (HBV). Enanta is also conducting research on a single agent targeting both RSV and human metapneumovirus (hMPV).
Glecaprevir, a protease inhibitor discovered by Enanta, is part of one of the leading treatment regimens for curing chronic hepatitis c virus infection and is sold by AbbVie in numerous countries under the tradenames MAVYRET® (U.S.) and MAVIRET® (ex-U.S.) (glecaprevir/pibrentasvir). Please visit www.enanta.com for more information.
View source version on businesswire.com: https://www.businesswire.com/news/home/20230831535787/en/
Contacts
Media and Investors?Jennifer Viera?617-744-3848?jviera@enanta.com
Thank you. Is the reason you think it won't get approval at least not for a long time because Xocova is teratogenic like the thalidomide(Contergan) case? Good thing we talked this time :)
Shinogi's drug Ensitrelvir (Xocova) won't be getting approval in the US, at least not for a long time. The other drug is in phase 3 but no data is around yet and didn't meet primary endpoints in their 2021 phase 2 which had 1/3 of high risk patients yet you assume that will be approved next year.
https://www.fiercebiotech.com/biotech/atea-and-roche-s-covid-19-antiviral-flunks-phase-2-prompting-switch-will-delay-pivotal-data
I see you are another poster who has only made a small number of posts, all on the ENTA board. Nothing suspicious about that. /s
When Xocova and Atea's Sunrise comes out in U.S. market on 2024 or 2025. It will probably be before EDP-235's roll out.
Would it be weird thinking like one of each could substitute Paxlovid? Then EDP-235 wouldn't get as much market space to penetrate?
IMO, it is ritonavir that the most serious issue of Paxlovid. And both of them don't have ritonavir as far as I've seen.
Plus, EDP-514 has higher EC50 than Aligos drug, which means it has a less effective result as I understood. What do you think we could expect from this HBV treatment's result?
Many of_those points apply_to_the RSV program too:
With vaccine approvals for RSV for infants and seniors, and now at the time of pregnancy (congrats Pfizer), the final missing piece of this problem is an effective therapeutic. I had a good conversation with Jay Luly about this a couple of weeks ago. https://t.co/E1VY6gSpzK
— Brad Loncar (@bradloncar) August 21, 2023
I continue to have faith in Enanta for a few reasons;
1) While it has not been tested extensively EDP-235 still looks to be superior to Paxlovid and appears to be the best in class protease inhibitor.
2) Other larger pharmas continue development in the space and COVID is not going away. A best in class drug should have a good profitable run.
3) As in the past, new variants continue to arrive, have potential for evading vaccines which cannot keep pace with the continuous COVID adaptations.
4) Issues (opportunities) with long COVID, rebound, prophylaxis are still needing a solution.
5) Per my earlier post a large number of Americans are vaccine hesitant. The government is no longer supplying free pandemic vaccinations and so we will see reduced compliance and higher and more serious outcomes than are necessary.
-You do not need a "delta" variant to require the need for an improved antiviral; just new variants and lower compliance coupled with vaccines which are imperfectly suited to newer variants.
Obviously, all of this is my humble opinion, and the above pertain ONLY to COVID.
They only address the present need for an improved PI.
6) If Enanta has a good follow on COVID candidate that can be effective and has a different MOA it could possibly have two profitable COVID drugs and a longer deeper pipeline.
That is why I mentioned it because the annual flu vaccine is still required. It is not clear if the two are being treated differently because the disease risk is different, or if it is because the vaccine risk is different.
What about the flu vaccine at Michigan? You suggested the requirements for the Covid vaccine was being treated differently than those for influenza vaccines, Berkeley treats them the same.
Michigan Medicine has updated its COVID-19 vaccination policy, no longer requiring the vaccine or an approved exemption as a condition of employment. ... The change aligns with the policies at other health systems and comes in advance of the upcoming release of an updated COVID-19 vaccine.
The message does not say anything about requiring the updated vaccine when it is available.
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