Pfizer Inc (PFE) オプション

PFE independent director bought $500K of stock on the open market yesterday:

https://www.sec.gov/Archives/edgar/data/78003/000122520825001778/xslF345X05/doc4.xml

TALZENNA + XTANDI is the first PARP inhibitor plus ARPI combination to demonstrate statistically significant and clinically meaningful improvement in overall survival (OS) in patients with metastatic castration-resistant prostate cancer (mCRPC) regardless of HRR mutation status
TALZENNA + XTANDI improved median OS by almost 9 months in unselected patients (Cohort 1) and by 14 months in patients selected for HRR mutations (Cohort 2) versus standard of care XTANDI
NEW YORK--(BUSINESS WIRE)--Pfizer Inc. (NYSE: PFE) today announced positive results from the Phase 3 TALAPRO-2 study of TALZENNA® (talazoparib), an oral poly ADP-ribose polymerase (PARP) inhibitor, in combination with XTANDI® (enzalutamide), an androgen receptor pathway inhibitor (ARPI), demonstrating a statistically significant and clinically meaningful improvement in overall survival (OS) compared to placebo plus XTANDI in patients with metastatic castration-resistant prostate cancer (mCRPC), with or without homologous recombination repair (HRR) gene mutations. The TALAPRO-2 results will be presented at the American Society of Clinical Oncology Genitourinary (ASCO GU) Cancers Symposium in San Francisco and featured in the ASCO GU official Press Program.




The TALAPRO-2 study evaluated two sets of patients, unselected (cohort 1) and selected for HRR gene-mutations (cohort 2). Overall survival was a prespecified, alpha-protected key secondary endpoint. After more than four years of median follow-up (52.5 months), the median OS in cohort 1 was 45.8 months with TALZENNA in combination with XTANDI, and 37.0 months with XTANDI and placebo (Hazard Ratio [HR] of 0.80; 95% Confidence Interval [CI], 0.66-0.96; p=0.015), representing a 20% reduction in the risk of death. This represents a nearly 9-month gain in median OS versus standard of care XTANDI. Data from cohort 1 will be presented today at ASCO GU in an oral presentation (Abstract LBA18) by Dr. Neeraj Agarwal, global lead investigator for TALAPRO-2.

In Cohort 2, a statistically significant and clinically meaningful improvement in OS was observed in patients with HRR-mutated mCRPC. At a median follow-up of 44.2 months, the median OS was 45.1 months with TALZENNA in combination with XTANDI, and 31.1 months with XTANDI and placebo (HR of 0.62; 95% CI, 0.48-0.81; p=0.0005), a 38% reduction in the risk of death. This result represents a 14-month gain in median OS versus standard of care XTANDI in a patient population with a historically poor prognosis. The OS improvement in the HRR-mutated population was observed in patients in both BRCA and non-BRCA gene alterations. Dr. Karim Fizazi, Institut Gustave Roussy, University of Paris-Saclay will share data from Cohort 2 at ASCO GU today (Abstract LBA141).

“Since its approval, TALZENNA in combination with XTANDI has redefined the standard of care for those living with homologous recombination repair gene-mutated mCRPC. These latest data from TALAPRO-2 are extremely compelling, demonstrating that the combination significantly extended overall survival, in patients selected and unselected for HRR gene alterations, potentially shifting the treatment paradigm for all men living with mCRPC,” said Roger Dansey, M.D., Chief Oncology Officer, Pfizer. “Although definitive conclusions cannot be drawn across studies, these results appear to represent the longest median overall survival reported in a randomized, controlled Phase 3 trial in mCRPC. We look forward to continuing to work with global authorities to potentially update the TALZENNA label with these results.”

“TALAPRO-2 is the first study demonstrating a significant and clinically meaningful survival benefit using a combination of PARP and androgen receptor inhibitors in mCRPC,” said Neeraj Agarwal, M.D., FASCO, Professor and Presidential Endowed Chair of Cancer Research at Huntsman Cancer Institute, University of Utah, and global lead investigator for TALAPRO-2. “Survival rates in metastatic castration-resistant prostate cancer are poor due to the advanced and aggressive stage of the disease. Today’s results demonstrate the potential for TALZENNA in combination with XTANDI to be a practice-changing treatment to help improve patient survival in mCRPC.”

At the time of the final analysis, updated radiographic progression free survival (rPFS) and other secondary efficacy endpoints demonstrated maintained clinical benefit in both cohorts and were consistent with the primary analyses previously reported and published in The Lancet and Nature Medicine.

In addition to the FDA, these data have been shared with the European Medicines Agency (EMA) and other global health authorities to support potential updates of the approved labels for TALZENNA.

The safety profile of TALZENNA plus XTANDI was generally consistent with the known safety profile of each medicine. The most common all-cause adverse events in the TALZENNA group (=30% of patients) were anemia, neutropenia, and fatigue, and the most common (=10% of patients) grade 3–4 adverse events were anemia (49%) and neutropenia (19.3%). Adverse events were generally manageable with dose modification and supportive care.





https://www.biospace.com/press-releases/pfizers-talzenna-in-combination-with-xtandi-improves-survival-outcomes-in-metastatic-castration-resistant-prostate-cancer

What does the confirmation of RFK Jr. mean

~~~ For FDA and Big pharma ~~~
(23:50)

Follow the data

This is historic - RFK Jr. Confirmed as HHS Head: A Pivotal Moment (0:01)

- Censorship and Corruption in Government Agencies (1:34)

- Proposed Reforms and Legal Actions Against the FDA (2:24)

- Impact on the Nutrition Industry and Big Pharma (7:56)

- Concerns About Heavy Metals and GMOs (12:03)

- Calls for Criminal Prosecutions and Systemic Reform (17:16)

For more updates, visit: http://www.brighteon.com/channel/hrreport NaturalNews

Senate confirms RFK Jr. as HHS secretary in 52-48 vote

https://www.foxnews.com/politics/senate-confirms-robert-f-kennedy-jr-serve-trumps-health-secretary

Currently, Pfizer's stock is trading at just 18 times trailing earnings. And based on analyst projections, it's at a forward price-to-earnings multiple of less than 9

FDA approves PFE’s Adcetris for third-line DLBCL as addend to Revlimid/Rituxan:

https://www.businesswire.com/news/home/20250207460554/en DLBCL is the most common and aggressive type of LBCL and is difficult to treat. More than 25,000 cases of DLBCL are diagnosed each year in the United States, accounting for more than 25% of all lymphoma cases. In the phase-3 trial supporting approval, the HR for OS was an impressive 0.63.

A paper inadvertently published on the website of an ASCO conference revealed good results for mevrometostat in treating castration-resistant prostate cancer.
Pfizer’s experimental drug mevrometostat cut disease progression rates in half in combination with standard hormone therapy, according to an article describing data from a Phase I trial of metastatic castration-resistant prostate cancer that appeared on Monday morning on the website for the ASCO Genitourinary Cancers Symposium.

The only issue is that the team from Pfizer wasn’t going to speak about the data until Thursday. Later in the day Monday, the conference published a full study abstract.

In addition to reducing disease progression rates, mevrometostat cut the risk of death by 49% in trial participants, all of whom had already received hormone treatment and one round of chemotherapy, according to reporting from Endpoints News.

Adverse effects were diarrhea (78% of patients), decreased appetite (58.5%) and dysgeusia (58.5%).

Pfizer is currently recruiting for two Phase III trials, MEVPRO-1 and MEVPRO-2, testing mevrometostat, an inhibitor of the oncoprotein EZH2, in prostate cancer as well.

Castration-resistant prostate cancer is a common form of prostate cancer, often treated with androgen deprivation therapy and chemotherapy.

The results, although announced prematurely, should be welcome news for Pfizer. Analysts were already buoyant on the company, with Guggenheim analysts writing in an investor note early Monday morning, before the leak, that Pfizer beat their fourth quarter 2024 expectations as well as consensus estimates.

Pfizer has a number of critical updates from its oncology pipeline coming down the pike this year. Phase III data for vepdegestrant in treating breast cancer and danuglipron for obesity are expected later this quarter, as well as Padcev in combination with pembrolizumab for bladder cancer sometime this year. On Monday, Pfizer announced data showing that Padcev in combination with Merck’s Keytruda reduced the risk of death by 49% in urothelial cancer compared to chemotherapy.

https://www.biospace.com/drug-development/leaked-conference-article-shows-pfizers-positive-phase-i-prostate-cancer-data

https://meetings.asco.org/abstracts-presentations/243221

https://www.biospace.com/press-releases/pfizer-and-astellas-padcev-enfortumab-vedotin-ejfv-plus-keytruda-pembrolizumab-shows-long-term-efficacy-in-first-line-treatment-of-locally-advanced-or-metastatic-urothelial-cancer-la-muc

The turn is in...

As Pfizer's CEO Albert Bourla said about the acquisition of Seagen, "We are not buying the golden eggs. We are acquiring the goose that is laying the golden eggs."

This smaller, cancer-focused drugmaker was already developing an impressive number of products for its size. With the backing of the much larger Pfizer, that innovative wheel should spin even faster.

https://www.fool.com/investing/2025/02/09/is-now-a-good-time-to-buy-the-dip-on-pfizer/

Pfizer is the 2nd largest recipient of USAID

Don't call it a comeback: Pfizer returns to Super Bowl with ad pledging to 'knock out' cancer

https://www.fiercepharma.com/marketing/pfizer-returns-super-bowl-ad-pledging-knock-out-cancer

Open to debate

Facts don't lie

From Pfizer documents

Excellent breakdown

And explanation

Of adverse reactions

has an attractive dividend yield of 6.3%, higher than most blue-chip stocks

PHMPT submitted a Freedom of Information Act Request

To the FDA

For all of the data within Pfizer’s COVID-19 vaccine biological product file

PHMPT has now sued the FDA for not releasing the data

Dividend secured...

Pfizer says it has at least $10B available for deals in 2025, with a focus on pipeline!

Open to debate

On anything posted

Facts don't lie

No fear

Definitely not. And now comes this latest pub from the Annals of Internal Medicine via the Veterans Administration.
Seems all the so called conspiracy theories are turning out to be conspiracy facts. We really do have a corrupt health system and poor health outcomes despite outspending every other country on the planet. Change anyone?
https://petermcculloughmd.substack.com/p/breaking-sixth-study-confirms-negative?publication_id=1119676&post_id=156495587&isFreemail=true&r=x7hm&triedRedirect=true

Should not be difficult

It is what it is

PFE 4Q24 CC transcript:

https://finance.yahoo.com/news/pfizer-pfe-q4-2024-earnings-190018063.html

9 and 7 cases.... per million. It's not a hard side to take

Are vaccines the solution to every problem?

Difficult to know whose side to take

Without the proper information on safety and efficacy.

PFE reports 4Q24 results—reiterates 2025 guidance:

https://s28.q4cdn.com/781576035/files/doc_financials/2024/q4/Q4-2024-PFE-Earnings-Release-Final.pdf

4Q24 highlights

• 4Q24 revenue was $17.8B, +21% YoY. After adjusting for the 4Q23 Paxlovid writedown, 4Q24 revenue was +11% YoY.

• 4Q24 oncology sales were $4.1B, +27% YoY, including a $915M contribution from legacy Seagen products.

• 4Q24 Comirnaty and Paxlovid sales were $3.4B (-62% YoY) and $727M (no meaningful growth rate due to 4Q23 writedown), respectively.

• 4Q24 Abrysvo sales were $198M, -62% YoY; however, Abrysvo sales in the maternal indication increased sharply.

• 4Q24 GAAP and non-GAAP EPS were $0.07 and $0.63, respectively. The GAAP figure includes a $2.9B non-cash asset-impairment writedown relating to various products.

2025 guidance for revenue and non-GAAP remains as announced in December (#msg-175541136).


4Q24 CC slides:
https://s28.q4cdn.com/781576035/files/doc_financials/2024/q4/Q4-2024-Earnings-Charts-FINAL.pdf

4Q24 CC prepared remarks (synched with slides): https://s28.q4cdn.com/781576035/files/doc_financials/2024/q4/Q4-2024-Earnings-Conference-Call-Prepared-Remarks-FINAL.pdf

Pfizer Reports Strong Full-Year 2024 Results And Reaffirms 2025 Guidance

Full-Year 2024 Revenues of $63.6 Billion, Reflecting 7% Year-over-Year Operational Growth


https://s28.q4cdn.com/781576035/files/doc_financials/2024/q4/Q4-2024-PFE-Earnings-Release-Final.pdf

Dividend secure and growing:
https://x.com/bertrandbio/status/1886743796269863091?s=46&t=LlT_XF0d8mmt91T7m8nn8Q

Pfizer’s BRAFTOVI® Combination Regimen Significantly Improved Progression-Free Survival and Overall Survival in Phase 3 BREAKWATER Trial

Pfizer says new colorectal cancer data could support full approval of Braftovi

https://www.pfizer.com/news/press-release/press-release-detail/pfizers-braftovir-combination-regimen-significantly

Pfizer Inc. will present the latest results from its leading genitourinary (GU) portfolio at the American Society of Clinical Oncology Genitourinary (ASCO GU) Cancers Symposium taking place February 13-15 in San Francisco, California. Data from more than 20 company-sponsored, investigator-sponsored, and collaborative research abstracts, including five oral presentations, highlight advancements in developing new standards of care within prostate and bladder cancer across the company’s core scientific modalities, including small molecules and antibody-drug conjugates.

https://www.stocktitan.net/news/PFE/pfizer-to-showcase-advancements-across-genitourinary-cancers-at-asco-4m71mveugfbl.html

Scientists estimate that the COVID vaccine saved 3 million lives and prevented 18 million hospitalizations.

President Trump called it "one of the greatest miracles of the ages."

RFK Jr. asked the FDA to revoke the emergency use of vaccines.

$MRNA
$PFE

https://x.com/SenSanders/status/1884991168460534022?ref_src=twsrc%5Etfw%7Ctwcamp%5Etweetembed%7Ctwterm%5E1884991168460534022%7Ctwgr%5E41efa3783bf583914279bce85e9325050c2fc862%7Ctwcon%5Es1_&ref_url=https%3A%2F%2Fwww.thedailybeast.com%2Fbernie-sanders-corners-robert-f-kennedy-jr-did-covid-vaccine-save-lives%2F

https://www.thedailybeast.com/bernie-sanders-corners-robert-f-kennedy-jr-did-covid-vaccine-save-lives/

But newbies look as well, Moderna's killer jab is worse than fuzzy Pfizers. What's going on here?
I expect Pfizer will hit Moderna hard with this info... or not? Why not?
https://kirschsubstack.com/p/breaking-official-czech-record-level?publication_id=548354&post_id=156125860&isFreemail=true&r=x7hm&triedRedirect=true


Now you know part of the real story. Who is protecting who?

These are turbulent times and to be wary and cautious may not be a bad idea.
https://dailynewscycle.com/pfizer-to-pay-60m-in-false-claims-settlement-for-drug-kickbacks-doj-announces/
For any newbies, Pfizer has not a great reputation.

trading just under 9 times forward earnings estimates right now$$$$$$$$

Pfizer avoids board nominations from Starboard as proxy fight rolls on

https://www.fiercepharma.com/pharma/pfizers-board-left-untouched-annual-meeting-proxy-fight-starboard-rolls-bloomberg

Trump HHS secretary nominee RFK Jr to stress he's not 'anti-vaccine' at confirmation hearing
And in his opening statement at his confirmation hearing, Kennedy will spotlight that "all of my kids are vaccinated, and I believe vaccines have a critical role in healthcare."

https://www.foxnews.com/politics/scoop-trump-health-secretary-nominee-rfk-jr-stress-confirmation-hearing-hes-not-anti-vaccine

PFE will report its fourth-quarter and full-year 2024 earnings on Feb. 4, before market open.

It's all about right and wrong. It is coming down to that. PFE will pay the piper.

New era has emerged. Let's see how all this plays out. The past has a way of catching up if overlooked.

Pfizer would be smart to somehow make amends for past mistakes in regards to mRna and continue on their
path to cutting out on unneeded collaborations. My price target for re-entering on the long side is $22-24 for
purposes of flipping only. I always hold back a few shares just in case. New personnel at the FDA is not going
to make things easier as we enter into the new year.

https://www.benzinga.com/insights/analyst-ratings/25/01/43281053/pfizer-stock-a-deep-dive-into-analyst-perspectives-6-ratings
Where it goes nobody knows.

Pfizer to Showcase Advancements Across Genitourinary Cancers at ASCO GU Cancers Symposium


https://www.pfizer.com/news/press-release/press-release-detail/pfizer-showcase-advancements-across-genitourinary-cancers?cid=tw_pbg_onco_asco-gu-2025_0125&ttype=tw&linkId=729229623

News https://www.businesswire.com/news/home/20250124736884/en/Pfizer%E2%80%99s-BRAFTOVI%C2%AE-Combination-Regimen-Demonstrates-Improved-Response-in-Patients-with-BRAF-V600E-Mutant-Metastatic-Colorectal-Cancer

I anticipate a deal getting struck with someone just prior to or at 12 week top line data read out. I have seen many cases where acquisition occurs prior to FDA approval. Arena Pharmaceuticals (Acquired by Pfizer in 2022) - Arena had a strong focus on immune-inflammatory and CNS-related disorders. Etrasimod, a drug for immune-inflammatory diseases, was a key focus, though Pfizer valued the potential across multiple therapeutic areas. Acquisition Price: $6.7 billion.

Going to be interesting.

Good idea, moms. We have both MNMD and PFE in our portfolios. PFE's expensive acquisition of SGEN(very profitable for us) has been slow to bring enough revenue to the balance sheet to solve PFE's problem being termed a laggard in pharma-land. HLS in Canada terminated a contract with PFE that involved its marketing of AMRN's Vascepa to Canadian GPs, a contract that I had hoped would evolve into PFE acquiring our 225k shares of AMRN by now. PFE CEO Bourla was at DAVOS this past week. We should see whether any deals were struck shortly, I think.

So why would they ever want to hide this info? Well, if the published it like they are supposed to, and follow their guidelines then no one would be upset and they would just say NO!! I am not taking that shit no way Jose.
https://icandecide.org/press-release/breaking-ican-acquires-critical-fda-safety-reports-concerning-covid-19-vaccines-after-years-of-litigation/

Time will tell
So I ask you. Would you be curious to know .....
A whole lot of so called professionals need to go to jail... or worse.
https://kirschsubstack.com/p/breaking-ican-acquires-critical-fda?publication_id=548354&post_id=155479991&isFreemail=true&r=x7hm&triedRedirect=true Certain protective laws

Were reversed

Immunity

Being one

Accountably

Coming to a theater

Near you

they need to do something good to turn the ship around. the company can certainly look forward to more scrutiny now that there is a new sheriff in town.

PFE raises $3.1B cash by paring HLN stake (as reported yesterday by Bloomberg). After the sale PFE’s HLN stake is reduced from 15% to 7.3%, which means that PFE has another (roughly) $3B source of capital whenever it wants.

This is a long way from where it once was. Yet the company is hemorrhaging. Still they up the dividend to slow the bleeding.
This is a long way from over. The biggest scam in world history just won't go away.
https://givemefive.news/dod-ignored-herd-immunity-data-before-vaccine-mandate/

has announced that it will be paying its dividend of $0.43 on the 7th of March, an increased payment from last year's comparable dividend. This makes the dividend yield 6.5%, which is above the industry average

$PFE

so it seems

is that in competition with Keytruda?