Elevar Therapeutics Announces Lirafugratinib (Lyrfigtu) Added to NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines) as Second-line Therapy for Cholangiocarcinoma with FGFR2 Fusion or Other Rearrangement

On November 3, 2026 Elevar Therapeutics, Inc., a majority-owned subsidiary of HLB Co., Ltd. and a fully integrated biopharmaceutical company dedicated to elevating treatment experiences and outcomes for cancer patients, reported that lirafugratinib (Lyrfigtu) has been added to the National Comprehensive Cancer Network (NCCN) Clinical Practice Guidelines in Oncology1 (NCCN Guidelines) as a Category 2A (useful in certain circumstances) preferred subsequent-line therapy for disease progression in cholangiocarcinoma (CCA) with FGFR2 fusion or other rearrangement.

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"The NCCN Guidelines are an important tool in helping clinicians determine the optimal treatment options for their patients," said Rose Lai, M.D., senior vice president of clinical development at Elevar Therapeutics. "We are pleased that lirafugratinib was promptly added to the guidelines upon FDA approval."

Elevar, on Sept. 23, 2026, announced the U.S. Food and Drug Administration (FDA) approval of lirafugratinib (Lyrfigtu) based on the Phase 1/2 ReFocus trial (NCT04526106), in which lirafugratinib demonstrated a confirmed objective response rate (ORR) of 46% (95% CI 36, 55), and a median duration of response of 11.8 months (95% CI 7.5, 13.0) in patients with the proposed indication. Median progression-free survival was 11.3 months (95% CI, 9.2, 14.8), with a 12-month rate of 49.2%. Its safety profile in the clinical data was shown to be manageable through dose adjustments.

Lyrfigtu is expected to be available to patients in the U.S. by Q4 2026.

Important Safety Information for LYRFIGTU (lirafugratinib)

Warnings and Precautions:

Ocular Toxicity

LYRFIGTU can cause retinal pigment epithelial detachment (RPED), which may cause symptoms such as blurred vision.

Among 385 patients who received LYRFIGTU, RPED occurred in 31% of patients, including Grade 3 events in 1.8%. The median time to first onset was 57 days. RPED led to dose interruption in 15% of patients and dose reduction in 10%.

Perform a comprehensive ophthalmological examination, including OCT of the macula, prior to initiation of therapy, every 2 months for the first 13 months, and every 4 months thereafter. For onset of visual symptoms, obtain ophthalmologic evaluation urgently, with follow-up every 3 weeks until resolution or discontinuation of LYRFIGTU. Withhold, reduce the dose, or discontinue LYRFIGTU based on severity.

Among 385 patients who received LYRFIGTU, blurred vision occurred in 18% of patients with Grade 3 events in 1.3% of patients.

Dry eye occurred in 38% of patients. Treat patients with ocular demulcents as needed.

Among 385 patients who received LYRFIGTU, corneal toxicity/keratitis occurred in 11% of patients. Treat patients with ocular demulcents as needed.

Hyperphosphatemia and Soft Tissue Mineralization

LYRFIGTU can cause hyperphosphatemia leading to soft tissue mineralization, calcinosis, nonuremic calciphylaxis, and vascular calcification.

Hyperphosphatemia occurred in 21% of patients. The median time to onset was 15 days. Hyperphosphatemia led to dose interruption in one (0.3%) patient and no permanent discontinuation. Monitor serum phosphate throughout treatment and manage as clinically appropriate.

Embryo-Fetal Toxicity

Based on its mechanism of action and findings from animal studies, LYRFIGTU can cause fetal harm or loss of pregnancy when administered to a pregnant woman.

Advise pregnant women of the potential risk to a fetus. Advise females of reproductive potential to use effective contraception during treatment and for 6 months after the last dose. Advise males with female partners of reproductive potential to use effective contraception during treatment and for 3 months after the last dose.

Contraindications:

None.

Adverse reactions:

Serious adverse reactions occurred in 32% of patients. Serious adverse reactions reported in ≥2% of patients were infection (6%), pneumonia (3.4%), fatigue (2.6%), and hemorrhage (2.6%). A fatal adverse reaction of hemorrhage occurred in one patient.

The most common adverse reactions (≥20%) were nail toxicity, palmar-plantar erythrodysesthesia syndrome, stomatitis, alopecia, dry eye, dry mouth, fatigue, dysgeusia, retinal pigment epithelial detachment, constipation, dry skin, infection, rash, abdominal pain, hemorrhage, blurred vision, diarrhea, musculoskeletal pain, nausea, and decreased appetite.

The most common laboratory abnormalities (≥20%) were increased phosphate, increased alanine aminotransferase, increased creatinine, decreased hemoglobin, decreased sodium, decreased lymphocytes, increased blood bilirubin, increased aspartate aminotransferase, decreased platelets, increased glucose, decreased leukocytes, increased alkaline phosphatase, decreased albumin, decreased phosphate, decreased neutrophils, decreased bicarbonate.

Reporting Suspected Adverse Events: To report SUSPECTED ADVERSE REACTIONS, contact Elevar Therapeutics at 1-866-4ELEVAR or contact the FDA at 1-800-FDA-1088, or visit www.fda.gov/medwatch.

Please see full Prescribing Information, including Patient Information, for Lyrfigtu. For more information about Elevar, visit ElevarTX.com.

About LYRFIGTU (Lirafugratinib)

Lyrfigtu (lirafugratinib, aka RLY-4008) is a potent, selective and oral small molecule inhibitor of FGFR2, a receptor tyrosine kinase that is frequently altered in certain cancers. FGFR2 is one of four members of the FGFR family, a set of closely related proteins with highly similar protein sequences and properties. Lyrfigtu is currently being evaluated in a clinical trial to enroll additional patients with previously treated, advanced or metastatic solid tumors other than CCA harboring FGFR2 fusion or rearrangement, who have not been treated with prior FGFR inhibitors. Elevar has an exclusive license to lirafugratinib from Relay Therapeutics, Inc. for commercialization worldwide.

(Press release, Elevar Therapeutics, NOV 3, 2026, View Source [SID1234674121])

Xilio Therapeutics to Present at the Stifel 2026 Healthcare Conference

On November 3, 2026 Xilio Therapeutics, Inc. (Nasdaq: XLO), a clinical-stage biotechnology company discovering and developing masked immuno-oncology therapies for people living with cancer, reported that company management will present at the Stifel 2026 Healthcare Conference on Tuesday, November 10, 2026 at 2:40 p.m. ET.

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A live webcast can be accessed under "Events & Presentations" in the Investors & Media section of the Xilio Therapeutics website at ir.xiliotx.com. A replay of the webcast will be archived on the website for 30 days following the presentation.

(Press release, Xilio Therapeutics, NOV 3, 2026, View Source [SID1234674120])

Avacta to Present the pre|CISION® Dual Payload Candidate AVA6207 at the 2026 EORTC-NCI-AACR Symposium

On November 3, 2026 Avacta Therapeutics (AIM: AVCT, "the Company", "Avacta"), a life sciences company developing innovative, targeted oncology drugs, reported it will present AVA6207, its Next-Generation pre|CISION dual payload peptide-drug conjugate (PDC), in a poster at the 38th EORTC-NCI-AACR (Free EORTC-NCI-AACR Whitepaper) Symposium on Molecular Targets and Cancer Therapeutics, taking place in Barcelona, Spain, from November 18-20.

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AVA6207 uses the Company’s pre|CISION PDC technology to deliver two synergistic payloads directly to tumor cells in a single molecule, combining two complementary mechanisms to combat highly resistant cancers. This dual payload molecule functions by inhibiting topoisomerase I (TOP1i), inducing severe DNA damage, while simultaneously inhibiting Ataxia Telangiectasia and Rad3-related (ATR) kinase through an ATR inhibitor (ATRi), thus blocking the DNA damage response to prevent cancer cells from repairing TOP1i-induced damage. Combining these two payloads into one pre|CISION PDC that delivers them directly to the tumor has tremendous potential to improve outcomes in TOP1i-resistant cancers, a growing area of unmet need in oncology.

Details of the poster presentation

Title: AVA6207 is a novel pre|CISION technology compound delivering complementary TOP1i and ATRi payloads to the tumor microenvironment following FAP cleavage

Authors: Victoria Juskaite, Tom Clough, Ellen Watts, et al. and David Jones

Session Title: DNA Repair Modulation (e.g. PARP, CHK, ATR, ATM)

Session Date and Time: Thursday, November 19, 09:00-17:30

Location: Exhibition Hall, Poster Area

Abstract Number: 161

(Press release, Avacta Life Sciences, NOV 3, 2026, View Source [SID1234674119])

Pfizer Reports Strong Third-Quarter 2026 Results And Raises 2026 Guidance

On November 3, 2026 Pfizer Inc. (NYSE: PFE) reported financial results for the third quarter of 2026 and raised its full-year 2026 guidance(2) for both Revenues and Adjusted(3) diluted EPS.

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EXECUTIVE COMMENTARY

Dr. Albert Bourla, Chairman and CEO of Pfizer:

"Pfizer had another strong quarter with commercial momentum and disciplined execution while advancing our strategy for creating long-term shareholder value. Our obesity program continued to advance and recent milestones in oncology, immunology and vaccines further demonstrate the potential of our pipeline. With a robust slate of expected catalysts ahead, I believe we’re well positioned to deliver meaningful new medicines for patients and lasting value in the years ahead."

Cecile Guegan, CFO and EVP of Pfizer:

"Our third-quarter results reflect strong commercial performance globally and continued operational discipline. This quarter, our non-COVID products delivered strong 7% operational revenue growth, and I’m particularly pleased with the 32% year-over-year operational revenue growth from our launched and acquired products(1). Today, we are raising our full-year 2026 Revenue and Adjusted diluted EPS guidance, reflecting our strong year-to-date performance and confidence in our business."

OVERALL RESULTS

Third-Quarter 2026 Revenues of $16.6 Billion, Relatively Flat Year-over-Year Operationally
Excluding Contributions from Comirnaty and Paxlovid, Revenues Grew 7% Operationally
Revenues of Launched and Acquired Products(1) Grew 32% Operationally
Third-Quarter 2026 Reported(4) Diluted EPS of $0.56, and Adjusted(3) Diluted EPS of $0.87
Raises Full-Year 2026 Revenue Guidance(2) by $1.5 billion at the Midpoint to a Range of $62.0 to $64.0 billion
Raises and Narrows Full-Year 2026 Adjusted(3) Diluted EPS Guidance to a Range of $2.95 to $3.05
Recent Late-Stage Pipeline Progress Includes Eight Key Pivotal Study Starts, One Pivotal Readout and Two Regulatory Decisions
Some amounts in this press release may not add due to rounding. All percentages have been calculated using unrounded amounts. References to operational variances pertain to period-over-period changes that exclude the impact of foreign exchange rates(5).

Results for the third quarter and first nine months of 2026 and 2025(6) are summarized below.

($ in millions, except per share amounts)

Third-Quarter

Nine Months

2026

2025

% Change

2026

2025

% Change

Revenues

$

16,583

$

16,654

—

$

46,067

$

45,022

2%

Reported(4) Net Income

3,242

3,541

(8%)

5,681

9,419

(40%)

Reported(4) Diluted EPS

0.56

0.62

(9%)

0.99

1.65

(40%)

Adjusted(3) Income

4,985

4,949

1%

13,715

14,620

(6%)

Adjusted(3) Diluted EPS

0.87

0.87

—

2.39

2.56

(7%)

REVENUES

($ in millions)

Third-Quarter

Nine Months

2026

2025

% Change

2026

2025

% Change

Total

Oper.

Total

Oper.

Global Biopharmaceuticals Business (Biopharma)

$

16,283

$

16,310

—

—

$

45,105

$

44,056

2%

1%

Pfizer CentreOne

300

344

(13%)

(12%)

962

966

—

(2%)

TOTAL REVENUES

$

16,583

$

16,654

—

—

$

46,067

$

45,022

2%

1%

2026 FINANCIAL GUIDANCE(2)

Raises full-year 2026 Revenue guidance(2) by $1.5 billion at the midpoint to a range of $62.0 to $64.0 billion from $60.5 to $62.5 billion previously.
Raises and narrows full-year 2026 Adjusted(3) diluted EPS guidance(2) to a range of $2.95 to $3.05 from $2.80 to $3.00 previously.
Includes a one-time $650 million Acquired In-Process R&D charge related to the in-licensing and collaboration agreement with Innovent Biologics, Inc. recorded in the third quarter of 2026 with an unfavorable impact of approximately $0.10.
The company’s guidance takes into consideration our strong year-to-date performance, continued confidence in our business and progress with ongoing cost improvement initiatives.
Revenues

$62.0 to $64.0 billion

(previously $60.5 to $62.5 billion)

Adjusted(3) SI&A Expenses

$12.5 to $13.5 billion

Adjusted(3) R&D Expenses

$10.8 to $11.8 billion

(previously $10.5 to $11.5 billion)

Effective Tax Rate on Adjusted(3) Income

Approximately 15.0%

Adjusted(3) Diluted EPS

$2.95 to $3.05

(previously $2.80 to $3.00)

CAPITAL ALLOCATION

During the first nine months of 2026, Pfizer deployed its capital in a variety of ways, which primarily included:

Reinvesting capital into initiatives intended to enhance the future growth prospects of the company, including:
$8.3 billion invested in internal research and development projects, and
Approximately $850 million invested in business development transactions, primarily reflecting the Innovent Biologics, Inc. in-licensing deal.
Returning capital directly to shareholders through $7.3 billion of cash dividends, or $1.29 per share of common stock.
Our capital allocation framework is designed to enhance long-term shareholder value, and is based on three core pillars: (i) reinvesting in the business, including maintaining the flexibility to deploy capital towards potential value-creating business development transactions, (ii) maintaining and, over the long term, growing our dividend, and (iii) in the future, the potential to resume the return of capital to shareholders through value-enhancing share repurchases after de-levering our balance sheet. The company expects to continue to de-lever over the longer term in a prudent manner in order to maintain a balanced capital allocation strategy.

No share repurchases have been completed to date in 2026. As of November 3, 2026, Pfizer’s remaining share repurchase authorization is $3.3 billion. Current financial guidance does not anticipate any share repurchases in 2026.

Diluted weighted-average shares outstanding of 5,751 million and 5,714 million were used to calculate Reported(4) and Adjusted(3) diluted EPS for third-quarter 2026 and 2025, respectively.

QUARTERLY FINANCIAL HIGHLIGHTS (Third-Quarter 2026 vs. Third-Quarter 2025)

Third-quarter 2026 revenues totaled $16.6 billion, a decrease of $71 million, or relatively flat on a percentage basis compared to the prior-year quarter, reflecting an operational decrease of $57 million and an unfavorable impact of foreign exchange of $15 million. The operational decrease was driven by a decline in revenues from COVID-19 products, the Prevnar family and several other products across categories, largely offset by an increase in revenues for Eliquis, Padcev, the Vyndaqel family, Nurtec, Lorbrena and several other products across categories. Excluding contributions from Comirnaty and Paxlovid, revenues for the third quarter grew 7% operationally. Additionally, third-quarter revenues of our Launched and Acquired Products(1) grew 32% operationally.

Third-quarter 2026 operational revenue reflected higher revenues primarily for:

Eliquis globally, up $513 million, or 25%, operationally, driven primarily by higher net price in the U.S. primarily due to pricing dynamics, including lower rebates and channel mix favorability, as well as higher demand globally; partially offset by declines due to generic entry and price erosion in certain international markets;
Padcev globally, up $255 million, or 55%, operationally, driven primarily by increased market share in first-line locally advanced or metastatic urothelial cancer (la/mUC), as well as launch uptake in the cisplatin-ineligible indication for muscle-invasive bladder cancer;
Vyndaqel family (Vyndaqel, Vyndamax, Vynmac) globally, up $193 million, or 12%, operationally, driven primarily by continued market expansion in the U.S., as well as strong demand with continuing uptake in patient diagnosis across international markets and improved access in certain international markets;
Nurtec ODT/Vydura globally, up $135 million, or 33%, operationally, driven primarily by strong demand in the U.S., as well as launch uptake in certain international markets; and
Lorbrena globally, up $114 million, or 43%, operationally, driven primarily by increased patient share in the first-line ALK-positive metastatic non-small cell lung cancer (ALK+ mNSCLC) treatment setting in the U.S., China, and certain other international markets;
offset primarily by lower revenues for:

Paxlovid globally, down $771 million, or 63%, operationally, driven primarily by lower COVID-19 infections across the U.S. and international markets, partially offset by timing of government purchases in certain emerging markets;
Comirnaty globally, down $339 million, or 29%, operationally, driven primarily by a lower favorable adjustment to the U.S. returns provision, lower utilization in the U.S. primarily resulting from narrower vaccine recommendations, as well as lower contractual deliveries in certain international markets; and
Prevnar family globally, down $180 million, or 10%, operationally, driven primarily in the U.S. by lower vaccination rates in the adult and pediatric indications, as well as market share erosion for the adult indication; and by lower demand in the pediatric indication in certain international markets.
GAAP Reported(4) Statement of Operations Highlights

SELECTED REPORTED(4) COSTS AND EXPENSES

($ in millions)

Third-Quarter

Nine Months

2026

2025

% Change

2026

2025

% Change

Total

Oper.

Total

Oper.

Cost of Sales(4)

$

4,028

$

4,172

(3%)

1%

$

11,668

$

10,795

8%

6%

Percent of Revenues

24.3

%

25.0

%

N/A

N/A

25.3

%

24.0

%

N/A

N/A

SI&A Expenses(4)

3,279

3,186

3%

3%

9,651

9,632

—

(1%)

R&D Expenses(4)

3,016

2,546

18%

18%

8,315

7,231

15%

15%

Acquired IPR&D Expenses(4)

669

1,390

(52%)

(52%)

822

1,401

(41%)

(41%)

Other (Income)/Deductions—net(4)

288

517

(44%)

(42%)

4,866

2,210

*

*

Effective Tax Rate on Reported(4) Income

3.9

%

(6.5

%)

3.2

%

(2.9

%)

* Indicates calculation not meaningful or results are greater than 100%.

Third-quarter 2026 Cost of Sales(4) as a percentage of revenues decreased by 0.8 percentage points compared to the prior-year quarter, primarily driven by a favorable change in sales mix and a favorable impact from foreign exchange, partially offset by the non-recurrence of a favorable revision to our estimate of accrued royalties in the third quarter of 2025.

Third-quarter 2026 SI&A Expenses(4) increased 3% operationally compared to the prior-year quarter, primarily reflecting an increase in compensation-related expenses in the quarter, a lower favorable adjustment of U.S. healthcare reform fees recorded in the third quarter of 2026 compared to the third quarter of 2025, and an increase in implementation costs associated with our cost realignment program; partially offset by a decrease in marketing and promotional spend on various products from more targeted investments and ongoing productivity improvements.

Third-quarter 2026 R&D Expenses(4) increased 18% operationally compared to the prior-year quarter, driven primarily by an anticipated net increase in spending in certain oncology and obesity product candidates, as well as an increase in compensation-related expenses in the quarter.

Third-quarter 2026 Acquired In-Process R&D Expenses(4) decreased $722 million compared to the prior-year quarter, primarily reflecting a $650 million charge in the third quarter of 2026 related to an in-licensing and collaboration agreement with Innovent Biologics, Inc., compared to a $1.35 billion charge in the prior-year quarter related to an in-licensing agreement with 3SBio, Inc.

Pfizer’s higher effective tax rate on Reported(4) income for the third quarter of 2026 compared to the prior-year quarter reflects the non-recurrence of the remeasurement of certain deferred tax liabilities and agreements with tax authorities, partially offset by favorable changes in the jurisdictional mix of earnings.

Adjusted(3) Statement of Operations Highlights

SELECTED ADJUSTED(3) COSTS AND EXPENSES

($ in millions)

Third-Quarter

Nine Months

2026

2025

% Change

2026

2025

% Change

Total

Oper.

Total

Oper.

Adjusted(3) Cost of Sales

$

3,843

$

3,979

(3%)

—

$

10,905

$

10,075

8%

6%

Percent of Revenues

23.2

%

23.9

%

N/A

N/A

23.7

%

22.4

%

N/A

N/A

Adjusted(3) SI&A Expenses

3,221

3,158

2%

2%

9,481

9,562

(1%)

(2%)

Adjusted(3) R&D Expenses

2,942

2,486

18%

18%

8,107

7,096

14%

14%

Acquired IPR&D Expenses(3)

669

1,390

(52%)

(52%)

822

1,401

(41%)

(41%)

Adjusted(3) Other (Income)/Deductions—net

102

257

(60%)

(56%)

598

688

(13%)

(14%)

Effective Tax Rate on Adjusted(3) Income

14.0

%

7.9

%

14.9

%

9.5

%

See the reconciliations of certain Reported(4) to non-GAAP Adjusted(3) financial measures and associated footnotes in the financial tables section of this press release located at the hyperlink below.

RECENT NOTABLE DEVELOPMENTS (Since August 4, 2026)

Product Developments

Product/Project

Milestone

Recent Development

Link

Comirnaty
(COVID-19 Vaccine, mRNA)

Regulatory

August 2026. Pfizer and BioNTech announced U.S. Food and Drug Administration (FDA) approval for the companies’ 2026-2027 COVID-19 vaccine formula targeting the XFG variant for use in adults ages 65 years and older, as well as in individuals ages 5 through 64 years with at least one underlying condition that puts them at high risk for severe outcomes from COVID-19.

Full Release

Elrexfio
(elranatamab)

Phase 3 Results

October 2026. Announced topline results from the investigational Phase 3 MagnetisMM-32 study evaluating Elrexfio as monotherapy in adults with relapsed or refractory multiple myeloma (RRMM) who received at least one prior line of treatment with anti-CD38 therapy and lenalidomide. At the pre-specified interim analysis for efficacy, the study met its primary endpoint of progression-free survival (PFS) as assessed by blinded independent central review (BICR). Elrexfio demonstrated a statistically significant and clinically meaningful reduction in the risk of disease progression or death versus investigator’s choice of elotuzumab, pomalidomide and dexamethasone (EloPd); pomalidomide, bortezomib and dexamethasone (PVd); or carfilzomib and dexamethasone (Kd). The safety profile of Elrexfio in MagnetisMM-32 was consistent with its known profile and no new safety signals were identified.

Full Release

Litfulo
(ritlecitinib)

Phase 3 Results

October 2026. Presented results from two investigational Phase 3 trials — TRANQUILLO 2 and TRANQUILLO – in which once-daily oral Litfulo significantly improved facial and total body repigmentation at Week 52 compared to placebo in patients with nonsegmental vitiligo (NSV). The safety profile of Litfulo in NSV was consistent with the established safety profile in alopecia areata. Pfizer intends to submit these data to regulatory authorities globally.

Full Release

Talzenna
(talazoparib)

Regulatory

October 2026. Announced FDA expanded approval of Talzenna in combination with Xtandi expanding use to the treatment of men with metastatic androgen pathway modulation-naïve or -sensitive (mAPMN/S) prostate cancer with homologous recombination repair (HRR) gene mutations, including both BRCA and non-BRCA mutations. Approval was based on the pivotal TALAPRO-3 data, offering a potential new standard of care earlier in the course of disease.

Full Release

Tukysa
(tucatinib)

Regulatory

October 2026. Announced FDA approval of Tukysa in combination with trastuzumab and pertuzumab for the maintenance treatment of adults with unresectable locally advanced or metastatic human epidermal growth factor receptor 2-positive (HER2+) breast cancer following induction treatment. The approval expands the use of Tukysa to frontline, an earlier stage of metastatic disease, offering a new chemotherapy-free maintenance treatment option that may help further delay disease progression.

Full Release

Pipeline Developments

A comprehensive update of Pfizer’s development pipeline was published today and is now available at www.pfizer.com/science/drug-product-pipeline. It includes an overview of Pfizer’s research and a list of compounds in development with targeted indication and phase of development, as well as mechanism of action for some candidates in Phase 1 and all candidates from Phase 2 through registration.

Product/Project

Milestone

Recent Development

Link

25-valent pneumococcal conjugate vaccine candidate

(PF-07872412)

Phase 2 Results

October 2026. Announced detailed results across serotypes from a Phase 2 study (NCT06524414) investigating 25-valent pneumococcal conjugate vaccine candidate (25vPnC) in infants. In the study, a four-dose series of 25vPnC elicited robust immune responses against all 25 serotypes and showed safety and tolerability comparable to four doses of Prevnar 20. These data support the ongoing Phase 3 development program for 25vPnC.

Full Release

Lyme disease vaccine candidate

(PF-07307405)

Regulatory

August 2026. Pfizer and Valneva SE announced the European Medicines Agency (EMA) validated the Marketing Authorization Application (MAA) for the companies’ 6-valent outer surface protein A (OspA)-based Lyme disease vaccine candidate and will begin its assessment of the application. The submission was based on favorable efficacy and safety results from the Phase 3 VALOR "Vaccine Against Lyme for Outdoor Recreationists" trial.

Full Release

Tilrekimig

(PF-07275315)

Phase 2 Results

October 2026. Presented detailed results from an ongoing Phase 2 study investigating the potentially first-in-class trispecific antibody tilrekimig in adults with moderate-to-severe atopic dermatitis (AD). The study met its primary endpoint, demonstrating a statistically significant increase in the percentage of participants achieving EASI-75 (≥75% reduction in the Eczema Area and Severity Index) at Week 16 across all evaluated doses compared to placebo. Tilrekimig was well-tolerated, with no dose-dependent safety signals, with treatment-emergent adverse event rates comparable between treatment and placebo groups. The Phase 3 pivotal program is underway with ongoing studies in AD and asthma. Tilrekimig is also being studied in an ongoing Phase 2b/3 study in chronic obstructive pulmonary disease (COPD).

Full Release

Corporate Developments

Topic

Recent Development

Link

Finance Leadership

November 2026. Cecile Guegan appointed Chief Financial Officer, Executive Vice President effective November 1, 2026.

(Press release, Pfizer, NOV 3, 2026, View Source [SID1234674118])

Strand Therapeutics to Present Updated STX-001 Clinical Data Highlighting Durable, Systemic Anti-Tumor Activity, and Showcase STX-003 Trial Design at SITC 2026

On November 3, 2026 Strand Therapeutics, a clinical-stage biotechnology company pioneering programmable mRNA therapeutics, reported two presentations at the 2026 Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) Annual Meeting, taking place November 4-8 in Phoenix: an oral presentation featuring updated clinical data from its STX-001 program and a trial-in-progress poster on the design of ASCENT-1, the company’s Phase I trial of its flagship clinical program STX-003.

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STX-001: Durable, systemic responses in advanced melanoma

Georgina Long, AO, PhD, MBBS (Hons), FRACP, FAHMS, FAA, FASCO, Medical Director of Melanoma Institute Australia (MIA), and Chair of Melanoma Medical Oncology and Translational Research at MIA and Royal North Shore Hospital, The University of Sydney, will present updated results from the Phase I study of STX-001, Strand’s intratumorally delivered, self-replicating mRNA therapy expressing IL-12. The STX-001 abstract was recognized among the Top 150 highest-scoring abstracts at SITC (Free SITC Whitepaper) 2026.

Abstract Title: Durable, Interferon-Associated Systemic Responses with STX-001, an LNP-Encapsulated IL-12-Expressing Self-Replicating mRNA, Used as Monotherapy in Advanced Solid Tumors in a Phase I/II Study
Abstract #: 823
Presentation Type: Oral presentation
Date and Time: Friday, November 6, 2026, 4:55-5:05 pm MT
Location: Phoenix Convention Center, West Building-300 Level, 301BC

STX-003: ASCENT-1 trial design

Trial principal investigator Melissa Johnson, MD, Chief Scientific Officer and Director of Lung Cancer Research at Sarah Cannon Research Institute, will present the trial-in-progress poster, which outlines the rationale and design for evaluating STX-003 – a systemically delivered, programmable self-replicating mRNA expressing IL-12 – initially as a monotherapy in patients with solid tumors, with potential subsequent evaluation in combination with pembrolizumab. Dosing of the first patients was announced on October 28, 2026.

Abstract Title: Phase I/II trial of STX-003, a systemically delivered programmable self-replicating mRNA expressing IL-12 ± pembrolizumab in solid tumors
Abstract #: 537
Presentation Type: Poster presentation
Date and Time: Friday, November 6, 2026, Poster Sessions
Location: Phoenix Convention Center, North Building-Lower Level, Exhibition Halls 4-6

Both abstracts will be published in the Journal for ImmunoTherapy of Cancer (JITC). Full details are available on the SITC (Free SITC Whitepaper) website.

(Press release, Strand Therapeutics, NOV 3, 2026, View Source [SID1234674117])