On November 4, 2025 Prelude Therapeutics Incorporated (Nasdaq:PRLD), a clinical-stage precision oncology company, reported an exclusive option agreement with Incyte (Nasdaq:INCY) focused on Prelude’s previously undisclosed mutant selective JAK2V617F JH2 inhibitor program in development for patients with myeloproliferative neoplasms (MPNs). Per the agreement, Incyte secures an exclusive option to acquire the JAK2V617F program in exchange for an upfront payment and a strategic equity investment in Prelude, plus potential downstream milestones and royalties.

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Kris Vaddi, Ph.D., Chief Executive Officer of Prelude stated, "We’re pleased to put this agreement in place with Incyte, recognized global leaders in the MPN field. Prelude and Incyte both aim to deliver transformational treatments to improve upon the standard of care established with first generation JAK2 JH1 inhibitors like Jakafi (ruxolitinib). Our research team made significant progress discovering the first known inhibitors that bind into the JAK2 JH2 ‘deep pocket’ where the V617F mutation resides. These potent and orally bioavailable compounds demonstrate mutant specific inhibition and the potential for disease modification in multiple preclinical models of MPNs. Today’s agreement with Incyte provides us with the capital needed to advance further our JAK2V617F program, while also allowing us to advance the development of our other pipeline programs."

"The agreement with Prelude provides an opportunity to enhance our robust portfolio of clinical and preclinical JAK2V617F candidates for patients with MPNs," said Bill Meury, President and Chief Executive Officer of Incyte. "This transaction aligns with our strategy to develop new and innovative therapies poised to make a meaningful difference for patients."

Terms of the Agreement
Under the terms of the Transaction Agreement, Incyte secures an exclusive option to acquire Prelude’s mutant selective JAK2V617F JH2 inhibitor program, including Prelude’s library of preclinical candidates. Prelude will receive $60 million in capital, comprised of an upfront payment of $35 million, plus a $25 million equity investment by Incyte in Prelude. Incyte will purchase 6.25 million shares of Prelude non-voting common stock at a price of $4.00 per share at deal close. Prelude intends to apply the upfront payment and net proceeds from the sale of the purchased shares to advance the JAK2V617F program and other pipeline assets, and for working capital and general corporate purposes.

Prelude expects to advance the JAK2V617F program to pre-defined milestones. Incyte may elect to exercise its exclusive option during the option period to acquire the program and associated assets from Prelude for $100 million. As the JAK2V617F program candidates advance in the clinic, Prelude would be eligible to receive up to $775 million in additional clinical and regulatory milestones, and single digit royalties on global net sales. Combined, total potential cash payments from the transaction, excluding royalties, could reach up to $910 million.

If Incyte elects to not exercise its option to acquire the program, all JAK2V617F global program rights and interests would remain in the sole ownership and control of Prelude.

Prelude Therapeutics was advised on the transaction by Morgan Lewis & Bockius LLP as legal counsel.

Mutant selective JAK2V617F JH2 inhibitor program
JAK2V617F is the primary driver mutation responsible for disease progression in the majority of patients living with myeloproliferative neoplasms (MPNs). The mutation impacts approximately 95% of patients with polycythemia vera (PV), 60% of patients with essential thrombocythemia (ET) and 55% of patients with myelofibrosis (MF). Identifying JAK2 JH2 inhibitors that selectively target V617F+ cells has long been a shared goal and challenge for industry. If successful, this approach has potential to reduce mutant allele burden, modify disease progression, and transform treatment outcomes for MPN patients. Prelude has discovered novel allosteric inhibitors that bind into the JAK2 JH2 "deep pocket" where the V617F mutation resides. These candidates demonstrate mutant specific inhibition in multiple preclinical models of MPNs. The first disclosure of program data was accepted for oral presentation at the American Society of Hematology (ASH) (Free ASH Whitepaper) 67th Annual Meeting taking place in Orlando, FL December 6-9, 2025. The abstract can be found on the ASH (Free ASH Whitepaper) 2025 website ASH (Free ASH Whitepaper) Annual Meeting & Exposition – Hematology.org.

(Press release, Prelude Therapeutics, NOV 4, 2025, View Source [SID1234659368])

On November 4, 2025 Pfizer Inc. (NYSE: PFE) reported financial results for the third quarter of 2025 and reaffirmed its 2025 Revenue guidance(1) while raising and narrowing guidance for Adjusted(2) diluted EPS.

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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 2025 and 2024(6) are summarized below.
($ in millions, except per share amounts)
Third-Quarter Nine Months
2025 2024
% Change
2025 2024
% Change
Revenues $ 16,654 $ 17,702 (6%) $ 45,022 $ 45,864 (2%)
Reported(3) Net Income
3,541 4,465 (21%) 9,419 7,621 24%
Reported(3) Diluted EPS
0.62 0.78 (21%) 1.65 1.34 23%
Adjusted(2) Income
4,949 6,050 (18%) 14,620 14,124 4%
Adjusted(2) Diluted EPS
0.87 1.06 (18%) 2.56 2.48 3%

REVENUES
($ in millions) Third-Quarter Nine Months
2025 2024 % Change 2025 2024 % Change
Total Oper. Total Oper.
Global Biopharmaceuticals Business (Biopharma) $ 16,310 $ 17,392 (6%) (7%) $ 44,056 $ 44,987 (2%) (2%)
Pfizer CentreOne (PC1) 344 285 21% 18% 929 820 13% 13%
Pfizer Ignite — 25 (99%) (99%) 37 56 (34%) (34%)
TOTAL REVENUES $ 16,654 $ 17,702 (6%) (7%) $ 45,022 $ 45,864 (2%) (2%)

2025 FINANCIAL GUIDANCE(1)
■Reaffirms full-year 2025 Revenue guidance of $61.0 to $64.0 billion.
■Raises and narrows Adjusted(2) diluted EPS guidance(1) to a range of $3.00 to $3.15 from $2.90 to $3.10 previously.
■The updated 2025 Adjusted(2) diluted EPS guidance takes into consideration our solid year-to-date performance, continued confidence in our business, progress with ongoing cost improvement initiatives, and improvement in our effective tax rate.
–Includes a one-time $1.35 billion Acquired In-Process R&D charge related to the in-licensing agreement with 3SBio, Inc. recorded in the third quarter of 2025 with an unfavorable impact of approximately $0.20.
■The company’s guidance absorbs the impact of the currently imposed tariffs from China, Canada, and Mexico.
Revenues
$61.0 to $64.0 billion
Adjusted(2) SI&A Expenses
$13.1 to $14.1 billion
Adjusted(2) R&D Expenses
$10.0 to $11.0 billion
(previously $10.4 to $11.4 billion)
Effective Tax Rate on Adjusted(2) Income
Approximately 11.0%
(previously approximately 13.0%)
Adjusted(2) Diluted EPS
$3.00 to $3.15
(previously $2.90 to $3.10)

CAPITAL ALLOCATION
During the first nine months of 2025, 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:
•$7.2 billion invested in internal research and development projects, and
•Approximately $1.6 billion invested in business development transactions, primarily reflecting the 3SBio in-licensing deal.
▪Returning capital directly to shareholders through $7.3 billion of cash dividends, or $1.29 per share of common stock.
No share repurchases have been completed to date in 2025. As of November 4, 2025, Pfizer’s remaining share repurchase authorization is $3.3 billion. Current financial guidance does not anticipate any share repurchases in 2025. The company expects to continue to de-lever in a prudent manner in order to maintain a balanced capital allocation strategy. This includes maintaining the flexibility to deploy capital towards potential value-creating business development transactions and the potential to return capital to shareholders through share repurchases.
Diluted weighted-average shares outstanding of 5,714 million and 5,705 million were used to calculate Reported(3) and Adjusted(2) diluted EPS for third-quarter 2025 and 2024, respectively.
QUARTERLY FINANCIAL HIGHLIGHTS (Third-Quarter 2025 vs. Third-Quarter 2024)
Third-quarter 2025 revenues totaled $16.7 billion, a decrease of $1.0 billion, or 6%, compared to the prior-year quarter, reflecting an operational decrease of $1.3 billion, or 7%, and a favorable impact of foreign exchange of $203 million. The operational decrease was primarily driven by a year-over-year decline in COVID-19 product revenues largely due to lower infection rates impacting Paxlovid demand as well as a narrower vaccine recommendation for COVID-19 in the U.S. that reduced the eligible population for Comirnaty.
Third-quarter 2025 operational revenue reflected higher revenues primarily for:
▪Eliquis globally, up 22% operationally, driven primarily by higher demand globally and favorable net price in the U.S. as a result of the expected favorable year-over-year impact of the elimination of the coverage gap as part of the IRA Medicare Part D Redesign, partially offset by generic entry and price erosion in certain international markets;
▪Vyndaqel family (Vyndaqel, Vyndamax, Vynmac) globally, up 7% operationally, driven largely by strong demand with continuing uptake in patient diagnosis primarily in the U.S. and certain international developed markets, as well as improved patient affordability in the U.S.; partially offset by lower net price in the U.S. mostly due to the impact of higher manufacturer discounts resulting from the IRA Medicare Part D Redesign, as well as new payer contracts; and
▪Nurtec ODT/Vydura globally, up 22% operationally, driven primarily by strong demand in the U.S. and recent launches in certain international markets, partially offset by lower net price in the U.S. mainly due to unfavorable changes in channel mix;
more than offset primarily by lower revenues for:
▪Paxlovid, down 55% operationally, driven primarily by lower COVID-19 infections across U.S. and international markets and lower international government purchases, as well as the non-recurrence of a $442 million favorable U.S. government stockpile purchase in the third quarter of 2024; partially offset by favorable adjustments of rebate accruals related to prior periods, as well as higher net price in the U.S. following transition from the U.S. government agreement; and
▪Comirnaty, down 20% operationally, mainly due to a narrower recommendation for vaccination in the U.S. as well as delayed approval of the new variant vaccine; partially offset by a lower returns provision and higher market share in the U.S., as well as higher contractual deliveries in certain international markets.
EXECUTIVE COMMENTARY
Dr. Albert Bourla, Chairman and CEO of Pfizer:
"I am proud of Pfizer’s leadership as the first in our industry to reach an agreement with the U.S. Government, which we believe provides greater clarity for our business. Additionally, our recent strategic actions have strengthened opportunities to advance innovation that could address significant medical needs in high growth markets, helping us deliver value for patients and shareholders."
David Denton, CFO and EVP of Pfizer:
"Our third-quarter performance demonstrates our continued focus on execution and financial discipline. We raised and narrowed our full-year 2025 Adjusted diluted EPS guidance, underscoring confidence in our ability to deliver strong results for our shareholders."
OVERALL RESULTS
■Third-Quarter 2025 Revenues of $16.7 Billion, Representing a 7% Year-over-Year Operational Decline
–Strengthened Commercial Execution Drives 4% Operational Revenue Growth of Non-COVID Portfolio
■Third-Quarter 2025 Reported(3) Diluted EPS of $0.62, and Adjusted(2) Diluted EPS of $0.87
■Reaffirms Full-Year 2025 Revenue Guidance(1) in a Range of $61.0 to $64.0 Billion
■Raises and narrows Full-Year 2025 Adjusted(2) Diluted EPS Guidance(1) to a Range of $3.00 to $3.15
■On Track to Deliver Approximately $7.2 Billion in Overall Anticipated Net Cost Savings from Previously Announced Cost Improvement Initiatives(4) by End of 2027, Driving Productivity Gains and Operating Margin Expansion

(Press release, Pfizer, NOV 4, 2025, View Source [SID1234659367])

On November 4, 2025 Personalis, Inc. (Nasdaq: PSNL), a leader in advanced genomics for precision oncology, reported financial results for the third quarter ended September 30, 2025. The quarter was distinguished by significant operational momentum in its "Win-in-MRD" strategy, headlined by increasing clinical tests delivered and robust clinical evidence generation.

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Third Quarter 2025 and Recent Business Highlights

●
Accelerated Clinical Adoption: Delivered 4,388 clinical tests, demonstrating robust 26% sequential increase over Q2 2025 and a 364% year-over-year growth fueled by increasing physician adoption of the NeXT Personal platform for cancer monitoring.
●
Submitted for Medicare Lung Cancer Coverage: Submitted a third dossier for Medicare coverage. The Company has three pending indications and remains confident its evidence will meet the standard for coverage.
●
Presented New Lung Cancer Data: Presented positive new data from AstraZeneca’s Phase 3 NeoADAURA trial in lung cancer. The findings show NeXT Personal is a strong predictor of patient outcomes and a more sensitive and accurate measure of MRD in the neoadjuvant setting. Data from the LAURA trial was also presented at ESMO (Free ESMO Whitepaper) that showed NeXT Personal could detect recurrence 5 months ahead of blinded expert review and NeXT Personal could be utilized for treatment response monitoring in adjuvant lung cancer.
●
Launched Prospective Breast Cancer Utility Study: Launched the CATE clinical trial in collaboration with Yale Cancer Center. The study aims to demonstrate the utility of NeXT Personal in guiding treatment decisions for patients with HR+/HER2- breast cancer to prevent metastatic relapse.
"Our third-quarter results demonstrate clear progress in our strategy to Win-in-MRD," said Chris Hall, Chief Executive Officer and President of Personalis. "The 364% year-over-year growth in our clinical test volume is a powerful indicator of physician enthusiasm for NeXT Personal. We believe the compelling data from the AstraZeneca NeoADAURA and LAURA studies and the launch of our CATE trial with Yale are helping to build an unimpeachable evidence base for our technology. With our third indication submitted for Medicare coverage, we are well positioned for success in this large market."

Third Quarter 2025 Financial Results Compared with 2024

Revenue of $14.5 million for the third quarter of 2025 compared with $25.7 million. The decrease of 44% was primarily due to the expected decline of $4.6 million in revenue from Natera, a decrease in population sequencing revenue of $4.2 million, and a decrease in revenue from pharma tests and services, and other customers of $2.5 million.

○
Pharma tests and services, and other customers of $13.2 million for the third quarter of 2025 compared with $15.7 million, a decrease of 16%.

○
Population sequencing of $0.2 million for the third quarter of 2025 compared with $4.4 million, a decrease of 95%.

●
Gross margin of 13.2% for the third quarter of 2025 compared with 34.0%. The decrease was primarily due to a reduction in fixed cost absorption from the lower revenue volume and increased unreimbursed clinical test costs demonstrating the interest in our tests as we await reimbursement.

●
Net loss of $21.7 million, and net loss per share of $0.24 based on a weighted-average basic and diluted share count of 88.7 million in the third quarter 2025, compared with a net loss of $39.1 million, and net loss per share of $0.64 based on a weighted-average basic and diluted share count of 61.1 million; the prior year net loss included a $26.0 million non-cash expense from warrants which were exercised in the third quarter of the prior year.

●
Cash, cash equivalents, and short-term investments of $150.5 million as of September 30, 2025; cash usage of $23.4 million from operations and capital equipment additions in the third quarter of 2025.

Fourth Quarter and Full Year 2025 Outlook

Personalis expects the following for the fourth quarter of 2025:

●
Total company revenue to be in the range of $15.7 to $20.7 million
●
Revenue from pharma tests and services, and all other customers to be in the range of $12.0 to $17.0 million
●
Revenue from population sequencing and enterprise sales of approximately $3.7 million

Personalis now expects the following for the full year of 2025 (updated guidance):

●
Total company revenue in the range of $68.0 to $73.0 million (reduced range from prior guidance of $70.0 to $80.0 million)
●
Revenue from pharma tests and services, and all other customers in the range of $50.0 to $54.0 million (reduced range from prior guidance of $52.0 to $58.0 million)
●
Revenue from population sequencing and enterprise sales in the range of $16.5 to $17.0 million (increased range from prior guidance of $15.0 to $16.0 million)
●
Revenue from clinical tests reimbursed in the range of $1.5 to $2.0 million (reduced range from prior guidance of $3.0 to $6.0 million to account for reimbursement milestone later in 2025)
●
Gross margin in the range of 22% to 24% (no change from prior guidance), which is lower than the 32% gross margin for the full year of 2024 as we invest to drive clinical use of NeXT Personal ahead of reimbursement
●
Net loss of approximately $85 million (no change from prior guidance)
●
Cash usage of approximately $75 million (no change from prior guidance)

Webcast and Conference Call Information

Personalis will host a conference call to discuss the third quarter financial results, as well as plans for the remainder of 2025, after market close on Tuesday, November 4, 2025, at 2:00 p.m. Pacific Time / 5:00 p.m. Eastern Time. The conference call can be accessed live by dialing 877-451-6152 for domestic callers or 201-389-0879 for international callers. The live webinar can be accessed at View Source A replay of the webinar will be available shortly after the conclusion of the call and will be archived on the company’s website.

(Press release, Personalis, NOV 4, 2025, View Source [SID1234659366])

On November 4, 2025 Pasithea Therapeutics Corp. (Nasdaq: KTTA) ("Pasithea" or the "Company"), a clinical-stage biotechnology company developing PAS-004, a next-generation macrocyclic oral MEK inhibitor, reported activation of a new U.S. clinical trial site at the University of Alabama at Birmingham ("UAB") for its ongoing Phase 1/1b open-label study evaluating PAS-004 in adult patients with neurofibromatosis type 1 (NF1) with symptomatic and inoperable, incompletely resected, or recurrent plexiform neurofibromas.

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The UAB site joins the list of clinical centers participating in the Company’s global Phase 1/1b trial, which is designed to assess the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of PAS-004 in adult NF1 patients. Enrollment at the UAB site is expected to begin immediately.

"We are pleased to activate UAB as a clinical site for our ongoing Phase 1/1b PAS-004 trial," said Dr. Tiago Reis Marques, Chief Executive Officer of Pasithea. "UAB brings deep clinical expertise in NF1 and a strong commitment to advancing care for patients with NF1 neurofibromas. Alongside our continued engagement with the NF community, including our recent platinum sponsorship of the NF Caregivers Symposium, we remain focused on advancing PAS-004 through clinical development with urgency and purpose."

In parallel with the site activation, Pasithea will serve as Platinum Sponsor of the 2025 NF Caregivers Symposium that will be hosted at UAB on November 8, 2025. The symposium gathers caregivers, clinicians, researchers, and advocates to discuss patient care, caregiver support, emerging research, and quality-of-life considerations for families affected by NF1.

"Collaborations between academia, industry, caregivers, and patient advocates improve outcomes and support for NF1 patients," said Dr. Rebecca Brown, Director of NF Clinical Programs at UAB. "We look forward to participating in this clinical trial and supporting other activities that promote resources for the NF community."

About the Phase 1/1b Study of PAS-004

The primary objective of the Phase 1/1b study (NCT06961565) is to evaluate the safety and tolerability of PAS-004 when administered for one 28-day treatment cycle in adult NF1 participants with at least one and up to two additional target plexiform neurofibromas (PNs) that are symptomatic and inoperable, incompletely resected, or recurrent. Secondary objectives are (i) to identify the recommended Part B dose ("RPBD") or Maximum Tolerated Dose (MTD) of PAS-004, (ii) to characterize the PK and PD profile of PAS-004, (iii) to evaluate the preliminary efficacy of PAS-004 on target PN volume, (iv) to evaluate the preliminary efficacy of PAS-004 on the size, appearance, and associated symptoms of cutaneous neurofibromas (CNs), and (v) to evaluate the impact of PAS-004 on quality of life ("QOL") and any physical symptoms attributed to the target PN. Experimental objectives are (i) to evaluate the impact of PAS-004 on QOL and any physical symptoms attributed to CNs, (ii) to evaluate the impact of PAS-004 on pain and function attributed to PNs, and (iii) to investigate PAS-004 effects on CN tumor cellular and molecular biology.

The trial will be conducted in two parts. In Part A (dose escalation phase), following a screening period of up to 28 days, up to 24 eligible participants will be enrolled sequentially to receive one of four planned dose levels of PAS-004 tablets (4mg, 8mg, 12mg, 18mg) in a modified 3+3 design. Part A will identify the recommended RPBD. During Part B (expansion phase), approximately 24 eligible participants will be enrolled in parallel to receive one of two planned dose levels of PAS-004 tablets. Participants will be dosed at the RPBD level and at a dose level below the RPBD for up to six continuous 28-day treatment cycles. Part B will identify the recommended phase 2 dose (RP2D).

The study is planned to be conducted at five clinical trial sites in Australia, South Korea and the U.S.

(Press release, Pasithea Therapeutics, NOV 4, 2025, View Source [SID1234659365])

On November 4, 2025 Nuvectis Pharma, Inc. (NASDAQ: NVCT) ("Nuvectis" or the "Company"), a clinical-stage biopharmaceutical company focused on the development of innovative precision medicines for the treatment of serious conditions of unmet medical need in oncology, reported its financial results for the third quarter 2025 and provided an update on recent business progress.

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Ron Bentsur, Chairman and Chief Executive Officer of Nuvectis, commented, "Our activity in the third quarter focused on advancing the clinical work required to support our ambitious Phase 1b program for NXP900, which recently commenced." Mr. Bentsur continued, "Our goal for the Phase 1b program is to showcase NXP900’s therapeutic potential, both as a single agent and in combination with certain market-leading therapies with the aim of reversing acquired resistance to these drugs. With the Phase 1b monotherapy component already underway, and the expected upcoming initiation of the combination component, we continue to make strides towards achieving this goal." Mr. Bentsur added, "To support and inform the Phase 1b program, we completed the NXP900 Phase 1a dose escalation study and the drug-drug interaction study in healthy volunteers and are pleased with NXP900’s emerging clinical profile, especially with the deep pharmacodynamic response observed at clinically relevant doses." Mr. Bentsur concluded, "We believe that our cash position and focus on efficient operations will enable us to achieve the key milestones and potential value inflection points for the NXP900 Phase 1b program."

Third Quarter 2025 Financial Results

Cash and cash equivalents were $35.4 million as of September 30, 2025, compared to $18.5 million as of December 31, 2024. The increase of $16.9 million in the cash balance as of the end of the third quarter of 2025 is a result primarily of our public offering in February 2025 and the utilization of our At-the-Market facility, partially offset by the operating expenses for the first nine months of 2025.

The Company’s net loss was $7.5 million for the three months ended September 30, 2025, compared to $4.2 million for the three months ended September 30, 2024, an increase in net loss of $3.4 million. The increase in net loss in the third quarter of 2025 was primarily due to a one-time $2.0 million milestone achievement expense for NXP900 and $0.7 million related to the clinical drug-drug interaction study. The three months ended September 30, 2025 also includes $1.5 million of non-cash stock-based compensation.

Research and development expenses, including non-cash stock-based compensation, were $5.8 million for the three months ended September 30, 2025, compared to $2.8 million for the three months ended September 30, 2024, an increase of $3.0 million.

General and administrative expenses, including non-cash stock-based compensation, were $2.0 million for the three months ended September 30, 2025, compared to $1.5 million for the three months ended September 30, 2024, an increase of $0.5 million.

Interest income was $0.3 million for the three months ended September 30, 2025, compared to $0.2 million for the three months ended September 30, 2024.

(Press release, Nuvectis Pharma, NOV 4, 2025, View Source [SID1234659364])