Enanta Pharmaceuticals Inc (ENTA) オプション

It would be great but given we just had a large insider buy few weeks ago, seems a far stretch?

Happy to be wrong though

Perhaps we will get news of a RSV partnership soon… March 13.

Thanks, Dewophile -

FYI -

https://ir.enanta.com/news-releases/news-release-details/enanta-pharmaceuticals-announces-positive-topline-results-edp

EDP-323

DDI study just listed yesterday

https://clinicaltrials.gov/study/NCT06847464?term=rsv%20enanta&aggFilters=status:rec&rank=3

I’m not worried about the opportunity in RSV. It’s akin to the flu so not like Covid where severity markedly decreased after an initial brutal wave bc it was a new virus
The peds market in RSV may never get an active vaccine after last years safety halt for MRNA and a moratorium on peds vaccine development. The adult market could get a bit smaller over time if ACIP loosens restrictions but that’s a longer way off now w RFK amd there will always be those who decline vaccination or have breakthrough despite vaccination

In the COVID run up I started buying more stock as I could tell the bar was low for Paxlovid.
And it seemed to me that they let the EUA run out before they had a chance to get a once a day, unboosted and more efficacious antiviral.
To be fair, after Delta, and after many had vaccinations or natural (albeit short term) immunity it was less of a 4 alarm fire.

But if a "delta" like strain re-emerged the world would find itself somewhat flatfooted and far less prepared than we should be.
So a layman like me wonders if it could have been handled better- but I'm in the cheap seats and have stayed mum.

In the same way I worried about the window of opportunity for Covid I'm now worried about the RSV window.

To be clear I am not buying into this conspiracy, I just wanted to clarify the argument for Vin.

Thanks dewophile. I see what the idea behind it was. I also don't buy it.

Got it. Makes sense that a lawyer would be conflicted out of certain cases (and then such an equivalent doesn’t in fact exist in pharma)

In the legal world there is often a mandatory waiting period before making the jump from one to the other, albeit it might be as short as 6 months in many cases.

Often, it's not corruption, but the appearance of impropriety, that is enough to do harm to the reputations of the regulating agencies in question.

Not a great look but I kind of get it. You do your civil service but then want to make money and there are only so many options. You probably know lawyers that have moved between the public and private sector in a similar vein e.g. SEC lawyer now at a private firm defending companies , sometimes the very same ones that they may have been looking into for violations ? (I could be wrong here but guessing it happens in other sectors is my point)

I’m ok w allowing paxlovid to stay on the market without another trial in immune experienced people. I’m also okay with using immunological markers as surrogates for boosters in vaccines (this is not exclusive to Covid vaccines either). What I’m not okay with is making companies include symptoms like sense of smell that were less common since omicron. You already have a tougher population (vaccinated prior infected and also lower risk if running a pbo trial ), why not let companies narrow down to the most common symptoms (sore throat fever cough fatigue congestion ). Is a stat sign reduction in these symptoms a prior i not meaningful?! Such bs and I think the FDA sabotaged the ability to get better drugs to patients period.
I also don’t see why a noninferiority trial couldn’t be run although that would have to be large. But ENTA in so many words via email told me that the regulatory environment was the impediment to progressing 235 a long time ago and they were hoping the stance would change and looking to the Ensitrelvir data package and how FDA would handle that. In the meantime ensitrelvir was stat sig on the symptom score used in Asia, numerically better in the FDA score and stat sig in prevention and it’s still not available.

At a lower level, I've read statistics that a majority of FDA reviewers end up at big pharma. Obviously not specifically PFE. But the point is, generally, it's not a great look.

I doubt there was any explicit quid pro quo but the FDA and CDC have been pretty lenient with PFE in terms of approval and requiring randomized trials. E.g., notwithstanding the fact that the US government contracted to buy more than $10 billion of Paxlovid, the FDA didn't manage to require a randomized trial in the actual population that drug was being given to (vaxed, prior infection, ...) and let them abandon the EPIC-SR trial. Similarly, though not relevant to ENTA, they approved COVID vax boosters based solely on mouse data and have never required a randomized trial showing actual benefit.

Ok—a singular case for an executive officer (rather than a non-employee director).

PFE’s hiring Patricia Cavazzoni (former head of CDER) is not symptomatic of a “revolving door” policy or a quid pro quo regarding Pavlovid, but rather is a singular case, IMO.

Singular case? What about Scott Gottlieb?

To be clear I am not buying into this conspiracy, I just wanted to clarify the argument for Vin. It's not totally outlandish but I agree w you that CDER/FDA was impartial (yet misguided) visa vie ENTA and others in the space

PFE’s hiring Patricia Cavazzoni (former head of CDER) is not symptomatic of a “revolving door” policy or a quid pro quo regarding Pavlovid, but rather is a singular case, IMO.

Cavazzoni resigned two days prior to Trump’s inauguration, for reasons related to the new administration. That’s the entire story as far as I can tell.

Bingo!!

“I made a comment about a serious conflict of interest regarding the CDER head that may have been a factor in the tanking of Enanta's stock.


Why in the world would it affect ENTA? “

Sounds like that poster may be checked out so I’ll take a stab. I think the suggestion is that CDER was in bed with PFE making the regulatory framework in Covid too challenging for new entrants to break in (thereby protecting paxlovid sales). Indeed the FDA insisted on using a Covid symptom score that may not have been optimal with the latest variants. Shionogi ran into this issue w ensitrelvir.

A British physician, Andrew Wakefield, published an article in Lancet around 25 years ago that postulated a link between the measles component of MMR and autism. He falsified the data and never disclosed that he received a huge sum from a lawyers group to find that link. The paper was eventually retracted and no link has ever been found between MMR and autism.

Yet Kennedy keeps lying that vaccines cause autism.

It is tragic that many children are being left unprotected against preventable diseases when there are safe and effective vaccines. Overwhelmingly, Americans have looked to the public health experts for information on vaccines and not to the Children's Health Fund or whatever RFK Jr organization is called. IMO, those public health experts bear the brunt of the responsibility for the current vaccine hesitancy that has led to decreased vaccination rates among children.

Kennedy keeps lying about vaccines. He among many others are the reason why vaccine skepticism is rising, to the detriment of the general population and individuals.

I made a comment about a serious conflict of interest regarding the CDER head that may have been a factor in the tanking of Enanta's stock.

Why in the world would it affect ENTA?

I post here infrequently and usually reluctantly. I thought the board may benefit form a different perspective regarding RFK Jr as I do believe there is a groupthink here that sometimes gets things very wrong. Going forward, I am not going to waste my time.

Post more often if you like. Nobody is saying you shouldn't. RFK Jr., is a proven liar and demagogue who has no business being head of HHS. Trying to look for some shred of positivity in that seems like a waste of time, but have at it. I will disagree when needed.

Neither you or Willy responded to that but instead ranted on about Greenland, planes falling out of the sky, Canadians booing our anthem. What a waste!

I am not ranting about Greenland, the guy in the White House is. I don't like planes falling out of the sky or people from our Northern neighbor and close ally Canada booing our national Anthem, but it is happening. It is indeed a waste.

I made a comment about a serious conflict of interest regarding the CDER head that may have been a factor in the tanking of Enanta's stock. Respectfully, I don’t think PFE’s hiring Patricia Cavazzoni (former head of CDER) had—or will have—any material effect on ENTA.

There are some valid points in your position, like the corrupting revolving door between industry and the regulators, but RFKJr is simply the wrong standard bearer.

No it is not. A British physician, Andrew Wakefield, published an article in Lancet around 25 years ago that postulated a link between the measles component of MMR and autism. He falsified the data and never disclosed that he received a huge sum from a lawyers group to find that link. The paper was eventually retracted and no link has ever been found between MMR and autism.

It is tragic that many children are being left unprotected against preventable diseases when there are safe and effective vaccines. Overwhelmingly, Americans have looked to the public health experts for information on vaccines and not to the Children's Health Fund or whatever RFK Jr organization is called. IMO, those public health experts bear the brunt of the responsibility for the current vaccine hesitancy that has led to decreased vaccination rates among children.

This is not the place for that discussion, however, as it has little to do with Enanta.

I made a comment about a serious conflict of interest regarding the CDER head that may have been a factor in the tanking of Enanta's stock. Neither you or Willy responded to that but instead ranted on about Greenland, planes falling out of the sky, Canadians booing our anthem. What a waste!

I post here infrequently and usually reluctantly. I thought the board may benefit form a different perspective regarding RFK Jr as I do believe there is a groupthink here that sometimes gets things very wrong. Going forward, I am not going to waste my time.

Is this also a victory for public health?

https://abcnews.go.com/Health/texas-measles-outbreak-grows-124-cases-unvaccinated/story?id=119158746

My *response* was to a post that may have also strayed a bit off topic.
also a huge win for public health in America.
Radford wrote about Kennedy's recent cabinet approval to HHS

I'm 100% in agreement with you about not using this board to massage facts or promote political agendas.
This may be a hard line to walk- considering the recent shutting down/shuttering of essential services (NIH/CDC/EPA)

Your post is went way off topic.

It is this type of relationship that RFK Jr has campaigned against
Kennedy posed as a consumer advocate while peddling (for his own personal gain) anti-vaccine conspiracies.

Kennedy and his ilk's anti-science messaging are the reason that measles is blowing up in Florida and Texas

also a huge win for public health in America.
Incorrect, wrong, false, nonsense. 🙂
Republicans heaped scorn on Michelle Obama for many of the same diet and exercise programs they now tout under Kennedy.
As in many if not all of the Trump cabinet appointments the idea is to dismantle safeguards, challenge the guardrails, privatize, and neuter protections while rewarding the upper tier of the 1%, their lobbyists and other ideologues and those agencies that provide the echo chamber for the easily hypnotized.
And yes, only since Enanta is working on antivirals it could benefit due to it's anti-virals under Kennedy AND at and the expense of American healthcare.
Even as we are under threat by Trump, Musk, and with republican congressional support to cut aid to Medicare, Medicaid and Social Security. The purpose of those cuts would be to fund more tax cuts to the wealthiest Americans and corporations while labeling recipients "parasites". [at least according to Musk, the worlds richest man and recipient of the largest amount of corporate welfare from taxpayers.]
Armored Cybertrucks?!? Just shoot me. 😀

What else? Like any other cabinet appointee, Kennedy was simply appointed to provide distraction, outrage (in Dems) and glee (by GOP) like virtually all of Trump's appointments. Now the Star Spangled Banner is being booed at sports events, we are at war with our longest and closest allies, we are threatening annexing Gaza, Greenland, Canada and Panama. Planes are falling from the sky literally as inflation is rising and the stock market has retreated.

Enanta has risen due to year end tax selling, or for the fact its been dead money for too long but has the potential to partner or merge.
Kennedy as catalyst? Perhaps, but trashing the CDC, EPA, NIH will have very negative effects on Americans health.

Ask yourself, what if Kennedy was in this position during covid? I'd guess we wouldn't have had vaccine coverage. What would that consequence have meant?

The head of CDER under Biden, Patrizia Cavazzoni, who came from Pfizer, has now returned to Pfizer as their CMO. The company with the most to lose from Enanta's anti-virals was certainly Pfizer. It is this type of relationship that RFK Jr has campaigned against, and if he follows through on that promise I would view it as very bullish for ENTA and also a huge win for public health in America.

Right, that is what RFK Jr, campaigned on. /s. He campaigned on attacking vaccines, attacking fluoridation of water and science.

"I think the stock actiion in ENTA has nothing to do with his nomination and it is just coincidence personally"

The head of CDER under Biden, Patrizia Cavazzoni, who came from Pfizer, has now returned to Pfizer as their CMO. The company with the most to lose from Enanta's anti-virals was certainly Pfizer. It is this type of relationship that RFK Jr has campaigned against, and if he follows through on that promise I would view it as very bullish for ENTA and also a huge win for public health in America.

Go, baby, GO!!

FLO

A new posted position at ENTA -

Financial Analyst/Senior Financial Analyst
https://theapplicantmanager.com/jobs?pos=ET975

Here's AI's interpretation:

Seeing "Financial Analyst" or "Senior Financial Analyst" listed as a position within a company is generally considered a good sign, indicating that the company is actively managing its finances, prioritizing data-driven decision making, and likely has a focus on growth and strategic planning, making it a positive indicator for the company's health.

Why it's a positive sign:

Financial Expertise:
These roles signify that the company has dedicated staff to analyze financial data, identify trends, and provide insights to management, which is crucial for making informed business decisions.

Growth Potential:
A company hiring for these positions is often looking to expand, as financial analysts are important for forecasting future performance and identifying potential areas for growth.

Structured Approach:
The presence of financial analysts suggests a company has a structured approach to budgeting, financial planning, and performance monitoring.
Career Progression:
A "Senior Financial Analyst" indicates a potential career path within the company, implying stability and opportunities for advancement within the finance department.

Be patient on this one. We are no where close to fair value and transformational news can hit literally any time. I am not considering selling until the market starts to ascribe positive value for the pipeline

I think he is bearish for biotech in general but that is a separate discussion
for ENTA specifically to the degree he puts his stamp and doesn't help expand RSV vaccines for example to younger older adults for whom it is approved but not recommended by ACIP it is bullish for an antiviral for this population
I think pediatric active vaccines have been shelved for some time to come anyway, but definitely not under RFKJ
not sure about the covid drug though 2 companies have next gen compounds working their way through that also have fewer DDIs etc. so will they push a third option?
I think the stock actiion in ENTA has nothing to do with his nomination and it is just coincidence personally

ENTA trading at a lower volume level today vs the past 7 days.

Is RFK Jr bullish for ENTA?

I think his appointment to head HHS very well may be. The Biden regime was all in for vaccines, particularly the mRNA vaccines. I have read somewhere that RFK Jr has stated that the FDA did not want a good anti-viral for Covid. Despite HHS spending billions to develop and purchase Molnupiravir and Paxlovid, neither of them are very good drugs. Paxlovid is the best anti-viral currently but has safety issues and marginal efficacy. Considering its excellent safety profile and the fact that it targets the same protease inhibitor as Paxlovid, you would expect EDP-235 to have been pushed into P3 expeditiously. Instead it seems that FDA was less than cooperative giving ENTA a solid P3 trial design.

Anyway, it is pure speculation on my part, but it is a fact that ENTA stock price is up 75% in the week since RFK Jr was confirmed.

Lol - you have won the most disgusting and yet most accurate award on describing our current situation 😂

OT Any thoughts on IOVA? Trading near all-time low @$5.65 and earnings next week.

I can’t even be cocky yet even if I want

Cocky?? My investment in ENTA was akin to feeling constipated 💩 and the last few days was a small bowel movement but plenty more is needed for me to feel fully relieved. 😂

I can’t even be cocky yet even if I want ;) Still have quite a bit of shares that are deep under water. But i reserve my right to be cocky if someone took us out at $40 in the near future 🥳

The boards getting cocky ;)

I'll be impressed once the PPS gets back above $40.00, just sayin.

My sentiment exactly
The 75 percent move from 4.8 looks impressive but not when you realize the MC went from 100M to 175M (ballpark). A 75M increase is really not much

Yawn 🥱

We are about half of cash equivalent value now and highly likely a RSV deal coming in next few months.

Really no where close to fair value.

Wake me up when we are at least double from here ;)

Hype!

Not the latest, however, as of January 31st there were 3.3M shorts outstanding with 9 days to cover. Obviously, this rise is now producing a short squeeze. Along with other positives mentioned, the move UP should continue.
https://www.nasdaq.com/market-activity/stocks/enta/short-interest

BTW - Baby Flo had .01 shares at the end of January. Since he is BROKE & would like to purchase an even 100 ENTA shares. Does anyone have JBOG's bank address for a loan? .

Nice😎

"The patent invalidation for their Hepatitis C drug." I have used Chat quite a bit, it makes mistakes all of the time. It can generate an autonomous response but it is not always intelligent.

Thx for sharing
have a nice weekend as well

JNJ had a fusion inhibitor that got dropped after lackluster results in phase 2 (peds data is published adult data reportedly not good as well)
They had an RSV vaccine that had good phase 2b data but company halted development in or after phase 3 I forget exact timing.
Not sure how interested they would be to get back into the RSV game but they certainly are heavy into immunology

Re: RSV deal - ChatGPT - Part 2

Then it tried to tailor this further based on Enanta’s financials and strategic goals. Obviously, some mistakes in the response... but still think its response is quite good and does provide some values.


Enanta Pharmaceuticals (NASDAQ: ENTA) is a clinical-stage biotechnology company specializing in small molecule drugs for viral infections and liver diseases. As of February 15, 2025, ENTA's stock is trading at $7.14, with an intraday high of $7.64 and a low of $7.10.

In the fiscal first quarter ended December 31, 2024, Enanta reported a net loss of $30.5 million, reflecting its ongoing investments in research and development. The company maintains a strong cash position, with $250 million in cash and marketable securities, providing a runway for its clinical programs.

Strategically, Enanta is focused on advancing its pipeline in virology and immunology, with a particular emphasis on its Respiratory Syncytial Virus (RSV) program. The company aims to bring innovative treatments to market, addressing significant unmet medical needs.

Given Enanta's financial standing and strategic objectives, a partnership for its RSV program would likely involve:

- **Upfront Payment**: $50M–$100M, providing immediate capital to support ongoing R&D activities.

- **Milestone Payments**: Up to $500M, contingent on achieving specific developmental and regulatory milestones.

- **Royalties**: Tiered royalties ranging from 10% to 20% on net sales, ensuring long-term revenue sharing.

These terms would align with Enanta's goal of accelerating the development and commercialization of its RSV therapy while maintaining financial stability.


Then, I questioned why it lowered the upfront payment:

Why I Adjusted to $50M–$100M (More Realistic for Enanta)
Stock Price & Market Cap: Trading at $7.14/share, Enanta has a market cap below $200M, limiting its negotiating power.
Cash Position: $250M in cash provides some runway, but Enanta is burning ~$30M per quarter, so they might accept a lower upfront to secure a deal.
Recent Court Loss (vs. Pfizer): The patent invalidation for their hepatitis C drug may weaken their leverage in negotiations.
Competitive RSV Landscape: Big pharma (PFE, GSK, AZN, MRK, SNY) already has RSV vaccines/therapies, which could reduce urgency to partner with Enanta.