On August 5, 2025 Cerus Corporation (Nasdaq:CERS) reported financial results for the second quarter ended June 30, 2025, and provided a business update (Press release, Cerus, AUG 5, 2025, View Source [SID1234654780]).

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"With our singular focus to advance blood safety and availability around the globe by establishing INTERCEPT as the standard of care, this quarter’s commercial results are evidence of the progress we are making in multiple geographies and across our INTERCEPT product portfolio. The early launch and adoption of our next generation, LED-based INT200 illumination device continues to surpass our expectations around performance and customer experience, and advancements in our product development pipeline are encouraging, including the early resubmission for RBC CE Mark and the recent DoD award for the CRYO-First study," said William "Obi" Greenman, Cerus’ president and chief executive officer.

"In addition, the continued strong commercial and financial execution in Q2 resulted in record product sales, a year-over-year narrowing of net loss attributable to Cerus, and another quarter of positive non-GAAP adjusted EBITDA," continued Greenman. "Given the anticipated sales trajectory, we are raising our full-year 2025 product revenue guidance today."

Additional highlights include:

Second-quarter 2025 total revenue comprised of (in millions, except percentages):
Three Months Ended

Six Months Ended

June 30,

Change

June 30,

Change

2025

2024

$

%

2025

2024

$

%

Product Revenue

$

52.4

$

45.1

$

7.4

16

%

$

95.7

$

83.4

$

12.2

15

%

Government Contract Revenue

7.7

5.4

2.2

41

%

13.3

10.5

2.8

27

%

Total Revenue

$

60.1

$

50.5

$

9.6

19

%

$

109.0

$

93.9

$

15.1

16

%

Numbers may not sum due to rounding. Percentages calculated from unrounded figures.

Customer demand for Pathogen Reduced, Cryoprecipitated Fibrinogen Complex (commonly referred to as INTERCEPT Fibrinogen Complex, or IFC) continues to increase with second quarter IFC revenue of $5.6 million compared to $2.0 million in the prior year period.
The European regulatory review of our CE Mark application for the INTERCEPT Blood System for Red Blood Cells (RBCs) continues. TÜV-SÜD, the Notified Body, has completed their review of several modules of the submission, including the clinical module, and transferred the dossier to the State Institute for Drug Control (SÚKL), our Competent Authority, in the Czech Republic, for consultation.
Awarded an additional $7.2 million in funding from the U.S. Department of Defense Industrial Base Analysis and Sustainment (IBAS) program for the development of lyophilized IFC.
Second-quarter net loss attributable to Cerus Corporation was $5.7 million. Second-quarter non-GAAP adjusted EBITDA of $0.9 million, marking another quarter of positive non-GAAP adjusted EBITDA.
Cash, cash equivalents, and short-term investments were $78.0 million at June 30, 2025.
Revenue

Product revenue during the second quarter of 2025 was $52.4 million, compared to $45.1 million during the prior year period. This year-over-year increase of 16% was led by growth in IFC and global platelet sales. Second-quarter product revenue included U.S. sales of IFC, which were $5.6 million, up from $2.0 million during the prior year period.

Second-quarter 2025 government contract revenue was $7.7 million, compared to $5.4 million during the prior year period. Our government contract revenue was comprised of funding associated with research and development (R&D) activities related to the INTERCEPT RBC program as well as efforts related to the development of next-generation pathogen reduction technology to treat whole-blood and development of lyophilized IFC. The year-over-year increase was primarily driven by increasing enrollment in the Phase 3 RedeS trial for the INTERCEPT RBC system covered under the Company’s 2016 agreement with BARDA and the activities for the advancement of the INTERCEPT RBC system covered under the Company’s 2024 BARDA contract.

Product Gross Profit and Margin

Product gross profit for the second quarter of 2025 was $29.0 million, increasing by 17% over the prior year period. Product gross margin for the second quarter of 2025 was 55.2% compared to 54.7% for the second quarter of 2024. A number of offsetting factors resulted in relatively stable product gross margin in the second quarter of 2025.

Operating Expenses

Total operating expenses for the second quarter of 2025 were $40.1 million, compared to $33.9 million for the same period of the prior year, reflecting a year-over-year increase of 18%. Both R&D and selling, general, and administrative (SG&A) expenses increased year-over-year, reflecting investments in our business to drive future revenue growth.

R&D expenses for the second quarter of 2025 were $18.9 million, compared to $15.0 million for the second quarter of 2024. The primary drivers for the increase in R&D expenses were related to development costs on INT200, the new LED-based illumination device, higher government contract costs incurred to support the higher government contract revenue and higher employee compensation expenses tied to cost-of-living adjustments which became effective earlier in the year.

SG&A expenses totaled $21.2 million for the second quarter of 2025, compared to $19.0 million for the second quarter of 2024. The primary driver for the increase in SG&A expenses was higher employee compensation expenses tied to cost-of-living adjustments which became effective earlier in the year.

Net Loss Attributable to Cerus Corporation

Net loss attributable to Cerus Corporation for the second quarter of 2025 was $5.7 million, or $0.03 per basic and diluted share, compared to a net loss attributable to Cerus Corporation of $5.8 million, or $0.03 per basic and diluted share, for the same period of the prior year. Net loss attributable to Cerus Corporation for the first half of 2025 was $13.4 million compared to net loss attributable to Cerus Corporation of $15.5 million for the first half of 2024.

Non-GAAP Adjusted EBITDA

Non-GAAP adjusted EBITDA for the second quarter of 2025 was positive $0.9 million, compared to non-GAAP adjusted EBITDA of positive $0.8 million for the same period of the prior year. Non-GAAP adjusted EBITDA for the first half of 2025 was a positive $1.1 million compared to non-GAAP adjusted EBITDA of negative $1.9 million for the first half of 2024.

The Company remains committed to its goal of achieving positive, full-year 2025 non-GAAP adjusted EBITDA. For additional information, please see definitions and the reconciliation of this non-GAAP measure to net loss attributable to Cerus Corporation accompanying this release.

Balance Sheet and Cash Flows

At June 30, 2025, the Company had cash, cash equivalents, and short-term investments of $78.0 million, compared to $80.5 million at December 31, 2024. The Company’s revolving line of credit allows for an additional $15.0 million as of June 30, 2025, which is dependent on eligible assets supporting the borrowing base.

For the second quarter of 2025, cash used from operations totaled $2.4 million compared to $0.4 million generated during the same period of the prior year. Cash use from operations in the second quarter of 2025 was tied to an increase in working capital, namely inventory in support of the expected growth.

Increasing Full-Year 2025 Product Revenue Guidance

Given the strong performance during the first half of 2025, coupled with increasing conviction about expected second half growth, the Company now expects full-year 2025 product revenue will be in the range of $200 million to $203 million. These revisions include increased IFC guidance, which the Company now expects to be between $16 million to $18 million for 2025. Previously, the Company’s 2025 product revenue guidance range was $194 million to $200 million, including 2025 IFC revenue guidance between $12 million and $15 million.

Quarterly conference Call

The Company will host a conference call at 4:30 P.M. ET this afternoon, during which management will discuss the Company’s financial results and provide a general business overview and outlook. To listen to the live webcast, please visit the Investor Relations page of the Cerus website at View Source

A replay will be available on Cerus’ website approximately three hours after the call through August 26, 2025.

On August 5, 2025 BridgeBio Pharma, Inc. (Nasdaq: BBIO) ("BridgeBio" or the "Company"), a new type of biopharmaceutical company focused on genetic diseases, reported its financial results for the second quarter ended June 30, 2025, and provided business updates (Press release, BridgeBio, AUG 5, 2025, View Source [SID1234654779]).

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Commercial Progress:
As of August 1, 2025, 3,751 unique patient prescriptions for Attruby have been written by 1,074 unique healthcare providers since FDA approval in November 2024. The second quarter revenue totaled $110.6 million, comprised of $71.5 million of U.S. Attruby net product revenue, $1.6 million from royalty revenue, and $37.5 million in license and services revenue.

"Attruby’s latest results showcase the power of pairing breakthrough scientific excellence with disciplined commercial execution," said Matt Outten, Chief Commercial Officer of BridgeBio. "Product revenue nearly doubled this quarter, driven by growing adoption across centers of excellence and community physicians. With increasing demand and best-in-class patient access programs, we are confident Attruby will become the standard of care for ATTR-CM, setting the foundation for three additional rare disease launches in 2026 and 2027."

Pipeline Overview:

Program

Status

Next expected milestone

Acoramidis for ATTR-CM

Approved in U.S., EU, Japan, and UK

New rapidity of response data at ESC Congress in August 2025

BBP-418 for LGMD2I/R9

FORTIFY, Phase 3 study enrollment completed

Topline results in fall 2025

Encaleret for ADH1

CALIBRATE, Phase 3 study enrollment completed

Topline results in fall 2025

Infigratinib for achondroplasia

PROPEL 3, Phase 3 study enrollment completed

Topline results in early 2026

Encaleret for chronic hypoparathyroidism

Phase 2 proof-of-principle study ongoing

Late-stage clinical study to be initiated in 2026

Infigratinib for hypochondroplasia

ACCEL 2/3, Phase 2 study first participant dosed

Enrollment completion for Phase 2 portion in 2H 2025

Key Program Updates:

"The launch of Attruby continues to accelerate, increasing the number of patients’ lives we are able to touch. We remain grateful for the physicians and patients who are partnering with us on both treatment and on new clinical research," said Neil Kumar, Ph.D., CEO and Founder of BridgeBio. "The next six months will be transformative with Phase 3 readouts across ADH1, LGMD2I/R9, and achondroplasia. We hope these programs will build on Attruby’s success to allow us to become a leading diversified genetic disease company."

Attruby (acoramidis) – First near-complete (≥90%) transthyretin (TTR) stabilizer for treatment of transthyretin amyloid cardiomyopathy (ATTR-CM):

•
At this year’s Annual Congress of the Heart Failure Association of the European Society of Cardiology, BridgeBio shared a post-hoc analysis of ATTRibute-CM, showing acoramidis reduced the annual frequency of cardiovascular hospitalization due to atrial fibrillation (AF)/atrial flutter (AFL) by 43% compared to placebo and reduced the incidence of new-onset AF/AFL by 17% in the subgroup with no prior history of AF compared to placebo in the overall ATTR-CM population.
•
Findings were published in the Journal of the American College of Cardiology (JACC), showing for each 5-mg/dL increase in serum TTR level within 28 days of starting treatment, the relative risk reduction of mortality was up to 31.6% through Month 30, confirming the hypothesis that ever better levels of stabilization achieved by treatment with acoramidis lead to ever better clinical outcomes.

ATTRibute-CM is the only study to demonstrate a direct association between a prompt, sustained increase in serum TTR and survival in patients with ATTR-CM.
•
In May 2025, the first asymptomatic participant with a known pathogenic TTR variant, that may lead to transthyretin amyloid disease (either cardiomyopathy, ATTR-CM, polyneuropathy, ATTR-PN, or both) was dosed in ACT-EARLY with acoramidis. ACT-EARLY is the first ever primary prevention study for ATTR, testing the hypothesis that prophylactic treatment of asymptomatic carriers of a pathogenic TTR variant with the near-complete TTR stabilizer, acoramidis, could delay the onset or prevent the development of variant ATTR (ATTRv), also known as hereditary ATTR (hATTR).
•
More data on Attruby will be shared at the European Society of Cardiology (ESC) Congress in August 2025 and at additional medical meetings in the second half of 2025.

BBP-418 – Glycosylation substrate for limb-girdle muscular dystrophy type 2I/R9 (LGMD2I/R9):

•
FORTIFY, the Phase 3 clinical trial of BBP-418 in LGMD2I/R9, a rare genetic disorder caused by variants in the fukutin‑related protein (FKRP) gene that results in progressive muscle degeneration and damage, and eventual loss of functional independence, is fully enrolled with 112 participants. The trial is the largest prospective interventional study to ever be conducted in LGMD2I/R9.
•
The study includes a planned interim analysis at 12 months focused on assessing a surrogate endpoint biomarker (glycosylated alpha-dystroglycan) to support a potential Accelerated Approval in the U.S.
•
Last participant last visit has been achieved, and the topline results of the interim analysis cohort are expected in fall 2025.
•
An open-label Phase 2 clinical trial of BBP-418 in LGMD2I/R9 resulted in an approximate doubling of glycosylated alpha-dystroglycan (αDG) levels, a sustained decrease of ≥70% in serum creatine kinase (CK), and stabilization of ambulatory measures, in contrast to the progressive decline observed in natural history.
•
If successful, BBP-418 would be the first approved therapy for individuals living with LGMD2I/R9.

Encaleret – Calcium-sensing receptor (CaSR) antagonist for autosomal dominant hypocalcemia type 1 (ADH1) and chronic hypoparathyroidism:

•
CALIBRATE, the Phase 3 clinical trial of oral encaleret in ADH1, a genetic form of hypoparathyroidism, is fully enrolled with 71 participants. The registrational study is the largest prospective interventional study to ever be conducted in ADH1.
•
BridgeBio expects topline results of CALIBRATE in the fall 2025.
•
If successful, encaleret would be the first approved therapy for individuals living with ADH1.
•
Dosing completed in a Phase 2 proof-of-principle clinical trial of encaleret in participants with hypoparathyroidism, which resulted in 80% of N=10 study participants achieving concomitant normal blood and urine calcium within 5 days. The Company intends to advance development of encaleret to enable registration in chronic hypoparathyroidism.
•
Newly published findings from analyses of academic biobanks confirm previously cited estimates of ADH1 prevalence to be approximately 1 in 25,000. (source: American Journal of Human Genetics)

Infigratinib – FGFR1-3 inhibitor for achondroplasia and hypochondroplasia:

•
PROPEL 3, the Phase 3 clinical trial of infigratinib in achondroplasia, the most common form of disproportionate short stature, is fully enrolled with 114 participants randomized.
•
BridgeBio expects topline results of PROPEL 3 in early 2026.
•
BridgeBio has reached regulatory alignment with the FDA on the clinical development plan for infigratinib in children with achondroplasia from birth to less than 3 years old. Based on the discussion, the Company expects to initiate clinical development in this important age range by the end of the year.
•
The first participant in the Phase 2 portion of ACCEL 2/3 in hypochondroplasia was dosed in April 2025 and the Company expects to fully enroll the study for the Phase 2 portion in the second half of 2025.
•
In achondroplasia, infigratinib has received Breakthrough Designation from the U.S. Food and Drug Administration, Orphan Drug Designation, Fast Track Designation, and Rare Pediatric Disease Designation. To date, in hypochondroplasia, infigratinib has received Orphan Drug Designation from the U.S. Food and Drug Administration and Fast Track Designation.
•
If successful, infigratinib would be the first approved oral therapy option for children living with achondroplasia and hypochondroplasia.

Corporate Updates:

•
BridgeBio received $300 million from the partial and capped sale of a portion of royalties due to the Company on sales of BEYONTTRA in Europe to HealthCare Royalty (HCRx) and funds managed by Blue Owl Capital (Blue Owl).
•
BridgeBio received a regulatory-related milestone cash payment of $30 million from Alexion for the Japan approval of BEYONTTRA.

Financial Updates:

Cash, Cash Equivalents and Marketable Securities

Cash, cash equivalents and marketable securities totaled $756.9 million as of June 30, 2025, compared to cash and cash equivalents of $681.1 million as of December 31, 2024. The $75.8 million net increase is primarily attributable to net proceeds of $563.0 million received from the issuance of the 2031 Notes in February 2025 and net proceeds of $297.0 million received from the execution of the Royalty Interest Purchase and Sale Agreement with HCRx and Blue Owl in June 2025. These increases were partially offset by net cash used in operating activities of $279.9 million for the first half of 2025, repayment of the Company’s previous term loan under the credit facility (including prepayment fees) of $459.0 million in February 2025, and the repurchase of common stock of $48.3 million using proceeds from the 2031 Notes in February 2025.

On August 5, 2025 Boundless Bio (Nasdaq: BOLD), a clinical-stage oncology company interrogating extrachromosomal DNA (ecDNA) biology to deliver transformative therapies to patients with previously intractable oncogene amplified cancers, reported financial results and business highlights for the fiscal quarter ended June 30, 2025 (Press release, Boundless Bio, AUG 5, 2025, View Source [SID1234654778]).

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"We are executing with sharpened focus on programs that we believe have the strongest scientific rationale and greatest potential to impact patients with oncogene-amplified cancers," said Zachary Hornby, President and CEO of Boundless Bio. "We are excited to advance our BBI-355/BBI-825 combination in the clinic and to progress BBI-940, our development candidate in our novel kinesin program, toward IND submission, as we work to make a meaningful impact for both patients and shareholders."

Research and Development Highlights and Upcoming Milestones

POTENTIATE clinical trial

•
The Company believes recent preclinical data provide a strong mechanistic rationale to combine BBI-355, its novel, selective, oral CHK1 inhibitor, with BBI-825, its novel, selective, oral RNR inhibitor, for synergistic anti-tumor activity without overlapping toxicity, and with a dosing regimen that does not require continuous administration.
•
The BBI-355/BBI-825 combination arm of the POTENTIATE trial is open for enrollment. The Company expects to deliver initial proof-of-concept clinical data within its existing cash runway timeline.

Novel Kinesin program targeting ecDNA segregation and inheritance

•
Boundless selected BBI-940 as its development candidate for its novel program targeting a previously undrugged kinesin.
•
Boundless expects to submit an investigational new drug (IND) application for BBI-940 in the first half of 2026 and to deliver initial proof-of-concept clinical data within its existing cash runway timeline.

Second Quarter 2025 Financial Results

•
Cash Position: Cash, cash equivalents, and short-term investments totaled $127.1 million as of June 30, 2025.
•
Research and Development (R&D) Expenses: R&D expenses were $12.2 million for the second quarter of 2025, compared to $14.7 million for the same period in 2024.
•
General and Administrative (G&A) Expenses: G&A expenses were $4.8 million for the second quarter of 2025, compared to $4.7 million for the same period in 2024.
•
Net Loss: Net loss totaled $15.7 million for the second quarter of 2025, compared to $17.0 for the same period in 2024.

On August 5, 2025 Biomea Fusion, Inc. ("Biomea" or "Biomea Fusion" or "the Company") (Nasdaq: BMEA), a clinical-stage diabetes and obesity company, reported its financial results for the second quarter ended June 30, 2025, and provided a business update (Press release, Biomea Fusion, AUG 5, 2025, View Source [SID1234654777]).

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"In the second quarter, we presented clinical and preclinical results with icovamenib that support its unique role as a novel, potentially first-in-class investigational agent for the treatment of type 2 diabetes as well as in obesity, while further strengthening our BMF-650 program with robust data in non-human primates," said Mick Hitchcock, Ph.D., Interim Chief Executive Officer and Board Member of Biomea Fusion. "At ADA 2025, we showed in preclinical models that our menin inhibitor, icovamenib, in combination with low-dose semaglutide not only drove superior glycemic control but also considerably boosted weight reduction, while fully preserving lean mass and outperforming semaglutide alone. Furthermore, icovamenib promoted myotube health and reduced drug-induced atrophy in a human cell model, highlighting its potential to support muscle health. We look forward to engaging with FDA and further evaluating icovamenib in this patient setting. Our next-generation investigational GLP-1 RA, BMF-650, showed encouraging results in a 28-day study in obese cynomolgus monkeys, achieving up to 15% weight reduction and robust dose-dependent appetite suppression. These findings reinforce BMF-650’s potential as an oral GLP-1 RA. With these clinical advances and the completion of our $42.8 million equity financing, we now have the necessary resources to advance these high-priority diabetes and obesity programs."

Second Quarter Highlights:

Icovamenib (Oral Small Molecule Menin Inhibitor for T2D and Type 1 Diabetes (T1D))

Three presentations at ADA 2025 highlighted the therapeutic potential of icovamenib across multiple aspects of metabolic health:
In patients with T2D not achieving glycemic targets, icovamenib demonstrated durable HbA1c reduction and enhanced beta-cell function three months subsequent to the dosing period, particularly in severe insulin deficient patients enrolled in its Phase II trial; icovamenib was well tolerated across the dosing arms.
In a Zucker Diabetic Fatty (ZDF) rat model of T2D, treatment of icovamenib in combination with low-dose semaglutide delivered superior metabolic benefits compared to low-dose semaglutide alone:
60% lower fasting blood glucose and 50% lower glucose OGTT AUC
Greater HbA1c decline of >1% by Day 28 and >2% by Day 39
Greater improvement in insulin sensitivity with a 75% lower HOMA-IR (marker of insulin resistance)
2-fold increase in C-peptide to glucose ratio indicating enhanced beta cell function
Superior appetite suppression with a 10% greater body weight reduction than low-dose semaglutide alone
The observed body weight loss was primarily due to fat mass reduction with complete preservation of lean mass
Icovamenib also promoted healthy myotube morphology and diminished drug-induced atrophy in ex vivo human myotube cultures.
BMF-650 (Next-generation Oral Small Molecule GLP-1 RA for Obesity)

In a 28-day study in obese cynomolgus monkeys, BMF-650 achieved rapid, dose-dependent reductions in food intake and significant weight loss, with average weight reductions of 15% at the higher dose of 30 mg/kg/day.
BMF-650 was generally well tolerated across all dose levels and showed no aminotransferase elevations.
These preclinical results compare favorably to published preclinical data from other leading oral GLP-1 RA candidates in development and support BMF-650’s potential as a best-in-class oral small-molecule GLP-1 RA.
BMF-500 (Oral Small Molecule FLT3 Inhibitor in Acute Myeloid Leukemia (AML))

Presented updated Phase I data at EHA (Free EHA Whitepaper) 2025, showing sustained antileukemic responses, deep bone marrow blast reductions, and survival benefit in relapsed/refractory FLT3-mutant AML patients, all of whom had failed FLT3 inhibitor gilteritinib.
The Company concluded its oncology efforts and is now exploring strategic partnerships for BMF-500.
Financing & Operations

In June 2025, Biomea closed its previously announced underwritten public offering and in July 2025 the underwriters partially exercised their over-allotment option to purchase additional shares of common stock. The aggregate gross proceeds from the offering, including the over-allotment option, were approximately $42.8 million, before deducting underwriting discounts and commissions and offering expenses payable by Biomea.

During the first half of 2025 Biomea also reduced its workforce and operational expenses and anticipates future quarterly operational expenses to be approximately 40% lower than the most recent quarter, depending on study enrollments and expansion.

Key Anticipated 2025 Milestones:

Icovamenib (Oral Small Molecule Menin Inhibitor for T2D and T1D)

52-week data from the Phase II COVALENT-111 study in T2D expected in the second half of 2025.
Initiation of Phase II study of icovamenib in T2D patients currently uncontrolled on a GLP-1 based therapy in the second half of 2025.
Preliminary data from the Phase II COVALENT-112 study in T1D anticipated in the second half of 2025.
BMF-650 (Next-generation Oral Small Molecule GLP-1 RA for Obesity)

Submission of the IND application for BMF-650 is planned for the second half of 2025.
Phase I study initiation in obese, otherwise healthy volunteers anticipated by late 2025, pending regulatory clearance.
Second Quarter 2025 Financial Results

Cash, Cash Equivalents, and Restricted Cash: As of June 30, 2025, the Company had cash, cash equivalents and restricted cash of $56.6 million. The Company expects its cash, cash equivalents, and restricted cash to be sufficient to fund planned operating activities into the second half of 2026.

Net Loss: The Company reported a net loss attributable to common stockholders of $20.7 million for the three months ended June 30, 2025, which included $2.6 million of stock-based compensation, compared to a net loss of $37.3 million for the same period in 2024, which included $4.8 million of stock-based compensation. Net loss attributable to common stockholders was $50.0 million for the six months ended June 30, 2025, which included $5.7 million of stock-based compensation, compared to a net loss of $76.3 million for the same period in 2024, which included $9.9 million of stock-based compensation.

Research and Development (R&D) Expenses: R&D expenses were $16.6 million for the three months ended June 30, 2025, compared to $31.8 million for the same period in 2024. The decrease of approximately $15.3 million was primarily driven by a decrease of $9.1 million related to clinical activities, a decrease of $2.0 million related to preclinical and exploratory programs, a decrease of $0.1 million of manufacturing costs and a decrease of $0.2 million in other external costs related to consultants, advisors and other professional services to support our clinical studies. Personnel-related expenses decreased by $3.8 million, including stock-based compensation, due to a decrease in headcount. R&D expenses were $39.5 million for the six months ended June 30, 2025, compared to $65.6 million for the same period in 2024. The decrease of $26.1 million was primarily driven by a decrease of $16.4 million related to clinical activities, a decrease of $3.0 million related to preclinical and exploratory programs and a decrease of $1.9 million of manufacturing costs. This decrease in external costs was partially offset by an increase of $0.7 million in other external costs related to consultants, advisors and other professional services to support our clinical studies. Personnel-related expenses decreased by $5.5 million, including stock-based compensation, due to a decrease in headcount.

General and Administrative (G&A) Expenses: G&A expenses were $4.7 million for the three months ended June 30, 2025, compared to $7.1 million for the same period in 2024. The decrease of $2.4 million is primarily driven by a decrease of $1.9 million related to personnel-related expenses, including stock-based compensation, due to a decrease in headcount and a decrease of $0.4 million related to professional and legal services. G&A expenses were $11.5 million for the six months ended June 30, 2025, compared to $14.4 million for the same period in 2024. The decrease of $2.8 million is primarily driven by a decrease of $2.9 million related to personnel-related expenses, including stock-based compensation, due to a decrease in headcount.

On August 5, 2025 Amgen (NASDAQ:AMGN) reported financial results for the second quarter of 2025 (Press release, Amgen, AUG 5, 2025, View Source [SID1234654776]).

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"We’re delivering strong performance and reaching more patients with innovative medicines and biosimilars that address serious diseases. We continue to invest in science that enables longer, healthier lives and supports sustainable, long-term growth," said Robert A. Bradway, chairman and chief executive officer.

Key results include:

For the second quarter, total revenues increased 9% to $9.2 billion in comparison to the second quarter of 2024.
Product sales grew 9%, driven by 13% volume growth, partially offset by 3% lower net selling price.
Fifteen products delivered at least double-digit sales growth in the second quarter, including Repatha (evolocumab), EVENITY (romosozumab-aqqg), IMDELLTRA (tarlatamab-dlle)/IMDYLLTRA (tarlatamab), BLINCYTO (blinatumomab), TEZSPIRE (tezepelumab-ekko), UPLIZNA (inebilizumab-cdon) and TAVNEOS (avacopan).
GAAP earnings per share (EPS) increased 92% from $1.38 to $2.65, primarily driven by higher revenues.
GAAP operating income increased from $1.9 billion to $2.7 billion, and GAAP operating margin increased 6.6 percentage points to 30.3%.
Non-GAAP EPS increased 21% from $4.97 to $6.02, primarily driven by higher revenues, partially offset by higher operating expenses.
Non-GAAP operating income increased from $3.9 billion to $4.3 billion, and non-GAAP operating margin increased 0.7 percentage points to 48.9%.
The Company generated $1.9 billion of free cash flow in the second quarter of 2025 versus $2.2 billion in the second quarter of 2024, driven by 2024 tax payments deferred to 2025 and higher capital expenditures, partially offset by business performance.
References in this release to "non-GAAP" measures, measures presented "on a non-GAAP basis," and "free cash flow" (computed by subtracting capital expenditures from operating cash flow) refer to non-GAAP financial measures. Adjustments to the most directly comparable GAAP financial measures and other items are presented in the attached reconciliations. Refer to Non-GAAP Financial Measures below for further discussion.

Product Sales Performance

General Medicine

Repatha (evolocumab) sales increased 31% year-over-year to $696 million in the second quarter, driven by 36% volume growth, partially offset by unfavorable changes to estimated sales deductions.
EVENITY (romosozumab-aqqg) sales increased 32% year-over-year to $518 million in the second quarter, primarily driven by volume growth.
Prolia (denosumab) sales decreased 4% year-over-year to $1.1 billion in the second quarter, driven by lower net selling price. For 2025, we expect sales erosion driven by biosimilar competition in the second half of the year, as biosimilars have now launched in the U.S. market.
Rare Disease

TEPEZZA (teprotumumab-trbw) sales increased 5% year-over-year to $505 million in the second quarter, primarily driven by higher inventory levels.
KRYSTEXXA (pegloticase) sales increased 19% year-over-year to $349 million in the second quarter, of which 12% was derived from higher inventory levels and 6% from volume growth.
UPLIZNA (inebilizumab-cdon) sales increased 91% year-over-year to $176 million in the second quarter, driven by 79% volume growth, with 16% derived from higher inventory levels. Year-over-year sales benefited from the timing of shipments to our ex-U.S. partner that occurred in the third quarter of 2024. Excluding these shipments, sales grew by 56% year-over-year in the second quarter.
TAVNEOS (avacopan) sales increased 55% year-over-year to $110 million in the second quarter, driven by volume growth.
Ultra-Rare products, which consist of RAVICTI (glycerol phenylbutyrate), PROCYSBI (cysteamine bitartrate), ACTIMMUNE (interferon gamma-1b), QUINSAIR (levofloxacin) and BUPHENYL (sodium phenylbutyrate), generated $183 million of sales in the second quarter. Sales decreased 2% year-over-year for the second quarter, driven by lower net selling price.
Inflammation

TEZSPIRE (tezepelumab-ekko) sales increased 46% year-over-year to $342 million in the second quarter, driven by volume growth.
Otezla (apremilast) sales increased 14% year-over-year to $618 million in the second quarter, driven by 12% favorable changes to estimated sales deductions and 4% volume growth.
Enbrel (etanercept) sales decreased 34% year-over-year to $604 million in the second quarter, driven by 20% unfavorable changes to estimated sales deductions and 19% lower net selling price resulting from increased 340B Program mix and the impact of the U.S. Medicare Part D redesign, partially offset by 3% volume growth.
AMJEVITA (adalimumab-atto)/AMGEVITA (adalimumab) sales were flat year-over-year at $133 million in the second quarter.
PAVBLU (aflibercept-ayyh) generated $130 million of sales in the second quarter.
WEZLANA (ustekinumab-auub)/WEZENLA (ustekinumab) generated $35 million of sales in the second quarter.
Oncology

BLINCYTO (blinatumomab) sales increased 45% year-over-year to $384 million in the second quarter, driven by volume growth.
Vectibix (panitumumab) sales increased 13% year-over-year to $305 million in the second quarter, driven by volume growth.
KYPROLIS (carfilzomib) sales were flat year-over-year at $378 million in the second quarter.
LUMAKRAS/LUMYKRAS (sotorasib) sales increased 6% year-over-year to $90 million in the second quarter, driven by 16% volume growth, partially offset by 10% lower net selling price.
XGEVA (denosumab) sales decreased 5% year-over-year to $532 million in the second quarter, driven by 2% unfavorable changes to estimated sales deductions and volume decline. For 2025, we expect sales erosion driven by biosimilar competition in the second half of the year, as biosimilars have now launched in the U.S. market.
Nplate (romiplostim) sales increased 7% year-over-year to $369 million in the second quarter, driven by volume growth.
IMDELLTRA (tarlatamab-dlle)/IMDYLLTRA (tarlatamab) generated $134 million of sales in the second quarter. Sales increased 65% quarter-over-quarter, driven by volume growth.
MVASI (bevacizumab-awwb) sales increased 22% year-over-year to $191 million in the second quarter, driven by 16% favorable changes to estimated sales deductions, 6% volume growth and 5% higher net selling price, partially offset by lower inventory levels. In the quarter, MVASI benefited from competitor bevacizumab product shortages, and going forward, we expect to return to continued sales erosion driven by competition.
Established Products

Our established products, which consist of Aranesp (darbepoetin alfa), Parsabiv (etelcalcetide) and Neulasta (pegfilgrastim), generated $533 million of sales in the second quarter. Sales decreased 5% year-over-year for the second quarter, driven by 14% lower net selling price and 4% lower volume, partially offset by favorable changes to estimated sales deductions.
Product Sales Detail by Product and Geographic Region

$Millions, except percentages

Q2 ’25

Q2 ’24

YOY Δ

U.S

ROW

TOTAL

TOTAL

TOTAL

Repatha

$ 361

$ 335

$ 696

$ 532

31 %

EVENITY

395

123

518

391

32 %

Prolia

745

377

1,122

1,165

(4 %)

TEPEZZA

466

39

505

479

5 %

KRYSTEXXA

349

—

349

294

19 %

UPLIZNA

132

44

176

92

91 %

TAVNEOS

103

7

110

71

55 %

Ultra-Rare products(1)

175

8

183

187

(2 %)

TEZSPIRE

342

—

342

234

46 %

Otezla

512

106

618

544

14 %

Enbrel

597

7

604

909

(34 %)

AMJEVITA/AMGEVITA

—

133

133

133

— %

PAVBLU

126

4

130

—

N/A

WEZLANA/WEZENLA

—

35

35

—

N/A

BLINCYTO

270

114

384

264

45 %

Vectibix

144

161

305

270

13 %

KYPROLIS

232

146

378

377

0 %

LUMAKRAS/LUMYKRAS

52

38

90

85

6 %

XGEVA

347

185

532

562

(5 %)

Nplate

228

141

369

346

7 %

IMDELLTRA/IMDYLLTRA

107

27

134

12

*

MVASI

142

49

191

157

22 %

Aranesp

107

252

359

348

3 %

Parsabiv

51

41

92

106

(13 %)

Neulasta

63

19

82

105

(22 %)

Other products(2)

278

56

334

378

(12 %)

Total product sales

$ 6,324

$ 2,447

$ 8,771

$ 8,041

9 %

N/A = not applicable

* Change in excess of 100%

(1) Ultra-Rare products consist of RAVICTI, PROCYSBI, ACTIMMUNE, QUINSAIR and BUPHENYL

(2) Consists of Aimovig, KANJINTI, AVSOLA, EPOGEN, RIABNI, BKEMV/BEKEMV, IMLYGIC, NEUPOGEN, Corlanor, RAYOS, DUEXIS, PENNSAID and Sensipar/Mimpara, where Biosimilars total $172 million in Q2 ’25 and $183 million in Q2 ’24

Operating Expense, Operating Margin and Tax Rate Analysis

On a GAAP basis:

Total Operating Expenses increased 1% year-over-year for the second quarter. Cost of Sales as a percentage of product sales decreased 5.9 percentage points driven by lower amortization expense from the fair value step-up of inventory acquired from Horizon and lower manufacturing costs, partially offset by higher profit share expense and changes in our sales mix. Research & Development (R&D) expenses increased 21% driven by investments in later-stage clinical programs, including those related to MariTide, for which four Phase 3 studies are underway. Selling, General & Administrative (SG&A) expenses decreased 5% driven by lower commercial product-related expenses and lower Horizon acquisition-related expenses. Other operating expenses include litigation expenses.
Operating Margin as a percentage of product sales increased 6.6 percentage points in the second quarter to 30.3%.
Tax Rate increased 2.7 percentage points in the second quarter due to the change in earnings mix, including lower amortization expense from the fair value step-up of inventory acquired from Horizon and current year net unfavorable items, as compared to the prior year.
On a non-GAAP basis:

Total Operating Expenses increased 8% year-over-year for the second quarter. Cost of Sales as a percentage of product sales increased 0.2 percentage points driven by higher profit share expense and changes in our sales mix, partially offset by lower manufacturing costs. R&D expenses increased 18% driven by investments in later-stage clinical programs, including those related to MariTide, for which four Phase 3 studies are underway. SG&A expenses decreased 2% primarily driven by lower commercial product-related expenses.
Operating Margin as a percentage of product sales increased 0.7 percentage points in the second quarter to 48.9%.
Tax Rate decreased 0.7 percentage points in the second quarter due to the change in earnings mix.
$Millions, except percentages

GAAP

Non-GAAP

Q2 ’25

Q2 ’24

YOY Δ

Q2 ’25

Q2 ’24

YOY Δ

Cost of Sales

$ 3,011

$ 3,236

(7 %)

$ 1,551

$ 1,406

10 %

% of product sales

34.3 %

40.2 %

(5.9) pts

17.7 %

17.5 %

0.2 pts

Research & Development

$ 1,744

$ 1,447

21 %

$ 1,685

$ 1,423

18 %

% of product sales

19.9 %

18.0 %

1.9 pts

19.2 %

17.7 %

1.5 pts

Selling, General & Administrative

$ 1,691

$ 1,785

(5 %)

$ 1,650

$ 1,686

(2 %)

% of product sales

19.3 %

22.2 %

(2.9) pts

18.8 %

21.0 %

(2.2) pts

Other

$ 77

$ 11

*

$ —

$ —

N/A

Total Operating Expenses

$ 6,523

$ 6,479

1 %

$ 4,886

$ 4,515

8 %

Operating Margin

Operating income as % of product sales

30.3 %

23.7 %

6.6 pts

48.9 %

48.2 %

0.7 pts

Tax Rate

8.7 %

6.0 %

2.7 pts

14.2 %

14.9 %

(0.7) pts

pts: percentage points

* = Change in excess of 100%

N/A = not applicable

Cash Flow and Balance Sheet

The Company generated $1.9 billion of free cash flow in the second quarter of 2025 versus $2.2 billion in the second quarter of 2024, driven by timing of 2024 tax payments deferred to 2025 and higher capital expenditures, partially offset by business performance.
The Company declared a second quarter 2025 dividend on March 4, 2025 of $2.38 per share that was paid on June 6, 2025 to all stockholders of record as of May 16, 2025, representing a 6% increase from the same period in 2024.
The Company retired $1.4 billion of debt during the second quarter of 2025, and $4.3 billion year to date.
During the second quarter of 2025, there were no repurchases of shares of common stock.
Cash and cash equivalents totaled $8.0 billion and debt outstanding totaled $56.2 billion as of June 30, 2025.
$Billions, except shares

Q2 ’25

Q2 ’24

YOY Δ

Operating Cash Flow

$ 2.3

$ 2.5

$ (0.2)

Capital Expenditures

$ 0.4

$ 0.2

$ 0.1

Free Cash Flow

$ 1.9

$ 2.2

$ (0.3)

Dividends Paid

$ 1.3

$ 1.2

$ 0.1

Share Repurchases

$ 0.0

$ 0.0

$ 0.0

Average Diluted Shares (millions)

541

541

0

Note: Numbers may not add due to rounding

$Billions

6/30/25

12/31/24

YTD Δ

Cash and Cash Equivalents

$ 8.0

$ 12.0

$ (3.9)

Debt Outstanding

$ 56.2

$ 60.1

$ (3.9)

Note: Numbers may not add due to rounding

For the full year 2025, the Company expects:

Total revenues in the range of $35.0 billion to $36.0 billion.
On a GAAP basis, EPS in the range of $10.97 to $12.11, and a tax rate in the range of 11.0% to 12.5%.
On a non-GAAP basis, EPS in the range of $20.20 to $21.30, and a tax rate in the range of 14.5% to 16.0%.
Capital expenditures to be approximately $2.3 billion.
Share repurchases not to exceed $500 million.
This guidance includes the estimated impact of implemented tariffs, but does not account for any tariffs or potential pricing actions announced or described but not implemented as well as any tariffs, sector specific tariffs, or pricing actions that could be implemented in the future.

Second Quarter Product and Pipeline Update

The Company provided the following updates on selected product and pipeline programs:

General Medicine

MariTide (maridebart cafraglutide, AMG 133)

MariTide is a differentiated peptide-antibody conjugate that activates the glucagon like peptide 1 (GLP-1) receptor and antagonizes the glucose-dependent insulinotropic polypeptide receptor (GIPR).
In June, the underlying details from Part 1 of the Phase 2 study of MariTide and complete results from the primary analysis of the Phase 1 pharmacokinetics low dose initiation (PK-LDI) study evaluating lower starting doses of MariTide were presented at the American Diabetes Association 85th Scientific Sessions and simultaneously published in the New England Journal of Medicine.
In the Phase 2 study per the efficacy estimand1, MariTide demonstrated:
up to ~20% average weight loss in people living with obesity without Type 2 diabetes (T2D).
up to ~17% average weight loss in people living with obesity with T2D.
no weight loss plateau by 52 weeks, indicating the potential for further weight reduction.
robust and sustained reduction in hemoglobin A1c (HbA1c) of up to 2.2% in people living with obesity and T2D.
improvements across pre-specified cardiometabolic measures, including waist circumference, blood pressure, high-sensitivity C-reactive protein (hs-CRP) and select lipid parameters.
No new safety signals were identified in the Phase 2 study and tolerability was consistent with the GLP-1 class. The most frequently reported adverse events (AEs) were gastrointestinal (GI) related, and most were mild to moderate, were predominantly limited to initial dosing and less frequent when dose escalation was used without compromising efficacy.
Discontinuation rates of MariTide due to GI AEs in the dose escalation arms (up to 7.8%) were lower than non-dose escalation arms.
The Phase 1 PK-LDI study showed participants that received 21 mg/70 mg/350 mg had an overall incidence of vomiting of 24.4% and participants that received 35 mg/70 mg/350 mg had an overall incidence of vomiting of 22.5%. There were no discontinuations due to GI AEs at any time during the study.
Part 2 of the Phase 2 chronic weight management study is ongoing in adults living with obesity or overweight, with or without T2D. Data readout is anticipated in Q4 2025.
A Phase 2 study investigating MariTide for the treatment of T2D is ongoing in adults living with and without obesity. Data readout is anticipated in Q4 2025.
MARITIME-1, a Phase 3 study of MariTide is enrolling adults living with obesity or overweight, without T2D.
MARITIME-2, a Phase 3 study of MariTide is enrolling adults living with obesity or overweight, with T2D.
MARITIME-CV, a Phase 3 study of MariTide on cardiovascular (CV) outcomes was initiated and is enrolling adults living with established atherosclerotic cardiovascular disease and obesity or overweight.
MARITIME-HF, a Phase 3 study of MariTide on reduction of heart failure events and cardiovascular risk, was initiated and is enrolling adults living with heart failure with preserved or mildly reduced ejection fraction and obesity.
The Company is planning to initiate Phase 3 study of obstructive sleep apnea in H2 2025.
AMG 513

A Phase 1 study of AMG 513 is enrolling adults living with obesity.
Repatha

VESALIUS-CV, a Phase 3 CV outcomes study of Repatha, is ongoing in patients at high CV risk without prior myocardial infarction or stroke. Data readout is event driven and anticipated in H2 2025.
EVOLVE-MI, a Phase 4 study of Repatha administered within 10 days of an acute myocardial infarction to reduce the risk of CV events, is ongoing.
Olpasiran (AMG 890)

Olpasiran is a potentially best-in-class small interfering ribonucleic acid (siRNA) molecule that reduces lipoprotein(a) (Lp(a)) synthesis in the liver.
The OCEAN(a)-outcomes trial, a Phase 3 secondary prevention CV outcomes study, is ongoing in patients with atherosclerotic CV disease and elevated Lp(a).
A Phase 3 CV outcomes study in patients with elevated Lp(a) and at high risk for a first CV event is expected to be initiated in H2 2025/H1 2026.
Rare Disease

UPLIZNA

U.S. Food and Drug Administration (FDA) review of the MINT Phase 3 data in patients with generalized myasthenia gravis is ongoing, with a PDUFA date of December 14, 2025.
TEPEZZA

In June, the European Commission granted marketing authorization approval of TEPEZZA for the treatment of adults with moderate to severe thyroid eye disease (TED). Regulatory review is underway in multiple additional geographies.
A Phase 3 study of TEPEZZA in Japan is enrolling patients with chronic/low clinical activity score TED.
A Phase 3 study evaluating the subcutaneous route of administration of teprotumumab has completed enrollment of patients with TED.
TAVNEOS

A Phase 3, open-label study of TAVNEOS in combination with rituximab or a cyclophosphamide-containing regimen, is enrolling patients from 6 years to < 18 years of age with active ANCA-associated vasculitis (Granulomatosis with Polyangiitis (GPA)/Microscopic Polyangiitis (MPA)).
Dazodalibep

Dazodalibep is a fusion protein that inhibits CD40L.
Two Phase 3 studies of dazodalibep in Sjögren’s disease are underway. The first study has completed enrollment of patients with moderate-to-severe systemic disease activity. The second study is enrolling patients with moderate-to-severe symptomatic burden and low systemic disease activity.
Daxdilimab

Daxdilimab is a fully human monoclonal antibody targeting immunoglobulin-like transcript 7 (ILT7).
A Phase 2 study of daxdilimab is ongoing in patients with moderate-to-severe active primary discoid lupus erythematosus refractory to standard of care.
A Phase 2 study of daxdilimab is ongoing in patients with dermatomyositis and antisynthetase inflammatory myositis.
AMG 329

AMG 329 is a fully human monoclonal antibody targeting FMS-like tyrosine kinase 3 (FLT3) ligand.
A Phase 2 study of AMG 329 is ongoing in patients with Sjögren’s disease.
AMG 732

AMG 732 is an insulin-like growth factor-1 receptor (IGF-1R) targeting monoclonal antibody.
A Phase 2 study of AMG 732 is enrolling patients with moderate-to-severe active TED.
Inflammation

TEZSPIRE

Two Phase 3 studies of TEZSPIRE are enrolling adults with moderate to very severe chronic obstructive pulmonary disease (COPD) and a BEC ≥ 150 cells/µl.
In May, primary results from the Phase 3b WAYFINDER study were presented, showing that TEZSPIRE reduces or eliminates oral cortical steroid (OCS) use in OCS-dependent patients with severe uncontrolled asthma.
FDA review of the WAYPOINT Phase 3 data in patients with chronic rhinosinusitis with nasal polyps is ongoing with a PDUFA date of October 19, 2025.
A Phase 3 study of TEZSPIRE has completed enrollment of patients with eosinophilic esophagitis.
Rocatinlimab (AMG 451/KHK4083)

Rocatinlimab is a first-in-class T-cell rebalancing monoclonal antibody that inhibits and reduces OX40-positive pathogenic T-cells.
The eight study ROCKET Phase 3 program evaluating rocatinlimab in patients with moderate-to-severe atopic dermatitis (AD) has enrolled over 3,300 patients. Enrollment is now complete in seven studies.
Key upcoming milestones from the ROCKET Phase 3 program:
ROCKET ASCEND is a study evaluating rocatinlimab maintenance therapy in adult and adolescent patients with moderate-to-severe AD. Data readout is anticipated in H2 2025.
ROCKET ASTRO is a 52-week study of rocatinlimab in adolescent patients with moderate-to-severe AD. Data readout is anticipated in H2 2025.
A Phase 2 study of rocatinlimab is enrolling patients with moderate-to-severe asthma.
A Phase 3 study of rocatinlimab is enrolling patients with prurigo nodularis.
Blinatumomab

Blinatumomab is a bispecific T-cell engager (BiTE) molecule targeting CD19.
A Phase 2 study of blinatumomab in autoimmune disease was initiated in adults with systemic lupus erythematosus (SLE) and in adults with refractory rheumatoid arthritis.
Inebilizumab

Inebilizumab is a B-cell depleting monoclonal antibody targeting CD19.
A Phase 2 study of inebilizumab in autoimmune disease is enrolling adults with SLE with nephritis.
AMG 104 (AZD8630)

AMG 104 is an inhaled anti-thymic stromal lymphopoietin (TSLP) fragment antigen-binding (Fab).
A Phase 2 study is enrolling patients with asthma.
Oncology

BLINCYTO / blinatumomab

In June, Phase 1b/2 subcutaneous blinatumomab data were presented at the European Hematology Association (EHA) (Free EHA Whitepaper) Congress and simultaneously published in The Lancet Haematology demonstrating 89–92% remission rates (complete remission/complete remission with partial hematological recovery rates/complete remission with incomplete count recovery) and manageable safety in adults with relapsed/refractory CD19-positive Philadelphia chromosome (Ph)-negative B-cell precursor acute lymphoblastic leukemia (B-ALL).
The dose-expansion and optimization phase of a Phase 1/2 study of subcutaneous blinatumomab is ongoing in adult patients with relapsed or refractory CD19-positive Ph-negative B-ALL. The Company is planning to initiate a potentially registration-enabling Phase 2 portion of this study in both adults and adolescents in H2 2025.
Golden Gate, a Phase 3 study of BLINCYTO alternating with low-intensity chemotherapy, is enrolling older adult patients with newly diagnosed CD19-positive Ph-negative B-ALL.
IMDELLTRA / tarlatamab

IMDELLTRA is the first and only FDA-approved delta-like ligand 3 (DLL3) targeting BiTE molecule.
In June, interim results from the global Phase 3 DeLLphi-304 trial were presented at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) annual meeting (ASCO) (Free ASCO Whitepaper) and simultaneously published in the New England Journal of Medicine. The data showed that IMDELLTRA reduced the risk of death by 40% and significantly extended median overall survival (OS) by more than five months compared to standard-of-care (SOC) chemotherapy in patients with small cell lung cancer (SCLC) who progressed on or after one line of platinum-based chemotherapy. Imdelltra significantly improved patient-reported outcomes of dyspnea and cough compared to SOC chemotherapy. The safety profile of IMDELLTRA was consistent with its known profile. Regulatory filing activities are underway.
The Company is advancing a comprehensive, global clinical development program across extensive-stage (ES) and limited-stage (LS) SCLC:
DeLLphi-303, a Phase 1b study of IMDELLTRA in combination with a programmed cell death protein ligand-1 (PD-L1) inhibitor, carboplatin and etoposide or separately in combination with a PD-L1 inhibitor alone, is ongoing in patients with first-line ES-SCLC.
DeLLphi-305, a Phase 3 study of IMDELLTRA and durvalumab, is enrolling patients with first-line ES-SCLC in the maintenance setting.
DeLLphi-306, a Phase 3 study of IMDELLTRA following concurrent chemoradiation therapy, is enrolling patients with LS-SCLC.
DeLLphi-308, a Phase 1b study evaluating subcutaneous tarlatamab, is enrolling patients with second line or later ES-SCLC.
DeLLphi-309, a Phase 2 study evaluating alternative intravenous dosing regimens of IMDELLTRA in second-line ES-SCLC, is enrolling patients.
DeLLphi-310, a Phase 1b study of IMDELLTRA in combination with YL201, a B7-H3 targeting antibody-drug conjugate, with or without a PD-L1 inhibitor, is enrolling patients with ES-SCLC.
DeLLphi-311, a Phase 1b study of IMDELLTRA in combination with etakafusp alfa (AB248), a novel CD8+ T-cell selective interleukin-2 (IL-2), was initiated in patients with ES-SCLC.
DeLLphi-312, a Phase 3 study of first-line IMDELLTRA in combination with carboplatin, etoposide and durvalumab, was initiated in patients with ES-SCLC.
Xaluritamig (AMG 509)

Xaluritamig is a first-in-class BiTE targeting six-transmembrane epithelial antigen of prostate 1 (STEAP1).
XALute, a Phase 3 study of xaluritamig, is enrolling patients with metastatic castrate resistant prostate cancer (mCRPC) who have previously been treated with taxane-based chemotherapy.
A Phase 1 study of xaluritamig monotherapy is ongoing in patients with mCRPC who have not yet received taxane-based chemotherapy and is ongoing in patients with mCPRC who have previously received taxane-based chemotherapy in a fully outpatient treatment setting to further improve administration convenience. This study continues to enroll mCRPC patients into a combination treatment of xaluritamig and abiraterone.
A Phase 1b study of neoadjuvant xaluritamig therapy prior to radical prostatectomy is enrolling patients with newly diagnosed localized intermediate or high‐risk prostate cancer.
A Phase 1b study of xaluritamig is enrolling patients with high-risk biochemically recurrent prostate cancer after definitive therapy.
Bemarituzumab

Bemarituzumab is a first-in-class fibroblast growth factor receptor 2b (FGFR2b) targeting monoclonal antibody.
In June, the Company announced the Phase 3 FORTITUDE-101 clinical trial of first-line bemarituzumab plus chemotherapy (mFOLFOX6) met its primary endpoint of OS at a pre-specified interim analysis:
Bemarituzumab plus chemotherapy demonstrated a statistically significant and clinically meaningful improvement in OS as compared to placebo plus chemotherapy in patients with unresectable locally advanced or metastatic gastric or gastroesophageal junction cancer with FGFR2b overexpression and who are non-HER2 positive. FGFR2b overexpression was defined as 2+/3+ staining in ≥10% of tumor cells by centrally performed immunohistochemistry testing.
The most common treatment-emergent adverse events (>25%) in patients treated with bemarituzumab plus chemotherapy were reduced visual acuity, punctate keratitis, anemia, neutropenia, nausea, corneal epithelium defect and dry eye. While ocular events were consistent with the Phase 2 experience and observed in both arms, they occurred with greater frequency and severity in the Phase 3 bemarituzumab arm.
Detailed results from FORTITUDE 101 will be shared at a future medical meeting.
FORTITUDE-102, a Phase 1b/3 study of bemarituzumab plus chemotherapy and nivolumab, is ongoing in patients with first-line gastric cancer. Phase 3 data readout is anticipated in H2 2025/H1 2026.
FORTITUDE-103, a Phase 1b/2 study of bemarituzumab plus oral chemotherapy regimens with or without nivolumab, is enrolling patients with first-line gastric cancer.
FORTITUDE-301, a Phase 1b/2 basket study of bemarituzumab monotherapy, is ongoing in patients with solid tumors with FGFR2b overexpression.
AMG 193

AMG 193 is a first-in-class small molecule methylthioadenosine (MTA)-cooperative protein arginine methyltransferase 5 (PRMT5) inhibitor.
A Phase 2 study of AMG 193 is enrolling patients with methylthioadenosine phosphorylase (MTAP)-null previously treated advanced non-small cell lung cancer (NSCLC).
A Phase 1/1b/2 study of AMG 193 is enrolling patients with advanced MTAP-null solid tumors in the dose-expansion portion of the study.
A Phase 1b study of AMG 193 alone or in combination with other therapies is enrolling patients with advanced MTAP-null thoracic malignancies.
A Phase 1b study of AMG 193 in combination with other therapies is enrolling patients with advanced MTAP-null gastrointestinal, biliary tract or pancreatic cancers.
Kyprolis

In May, the FDA granted pediatric exclusivity to Kyprolis for studies conducted under a Written Request and approved updates to the "Pediatric Use" subsection of the Kyprolis prescribing information.
LUMAKRAS/LUMYKRAS

In May, the FDA granted Breakthrough Therapy Designation to LUMAKRAS in combination with Vectibix and FOLFIRI for the first-line treatment of patients with KRAS G12C-mutated metastatic colorectal cancer (CRC), as determined by an FDA-approved test. This is the third Breakthrough Therapy Designation granted by the FDA for LUMAKRAS.
CodeBreaK 301, a Phase 3 study of LUMAKRAS in combination with Vectibix and FOLFIRI vs. FOLFIRI with or without bevacizumab-awwb, is enrolling patients with first-line KRAS G12C–mutated metastatic CRC.
CodeBreaK 202, a Phase 3 study of LUMAKRAS plus chemotherapy vs. pembrolizumab plus chemotherapy, is enrolling patients with first-line KRAS G12C–mutated and PD-L1 negative advanced NSCLC.
Nplate

In June, data were presented at ASCO (Free ASCO Whitepaper) from the final analysis of RECITE, a Phase 3 study of Nplate as supportive care for chemotherapy-induced thrombocytopenia (CIT) in gastrointestinal cancers:
the study met its primary endpoint; more patients on Nplate had no chemotherapy dose modifications due to CIT compared to placebo (84.4% vs. 35.7%, Odds Ratio 10.2; P<0.001).
Nplate was well tolerated in a highly comorbid population, with no treatment-related serious adverse events or treatment-related adverse events leading to death or discontinuation of Nplate or chemotherapy.
PROCLAIM, a Phase 3 study of Nplate for the treatment of CIT, is enrolling patients with NSCLC, ovarian cancer, or breast cancer.
Biosimilars

A randomized, double-blind pharmacokinetic similarity study of ABP 206 compared with OPDIVO (nivolumab) is ongoing in patients with resected stage III or stage IV melanoma in the adjuvant setting. Data readout is anticipated in H2 2025.
A randomized, double-blind comparative clinical study of ABP 206 compared with OPDIVO is enrolling patients with treatment-naïve unresectable or metastatic melanoma.
A randomized, double-blind pharmacokinetic similarity study of ABP 234 compared with KEYTRUDA (pembrolizumab) is enrolling patients with early-stage non-squamous NSCLC as adjuvant treatment.
A randomized, double-blind combined pharmacokinetic/comparative clinical study of ABP 234 compared to KEYTRUDA is enrolling patients with advanced or metastatic non-squamous NSCLC.
A randomized, double-blind pharmacokinetic similarity/comparative clinical study of ABP 692 compared to OCREVUS (ocrelizumab) is enrolling patients with relapsing-remitting multiple sclerosis.
TEZSPIRE is being developed in collaboration with AstraZeneca.
AMG 104 is being developed in collaboration with AstraZeneca.
Rocatinlimab, formerly AMG 451/KHK4083, is being developed in collaboration with Kyowa Kirin.
Xaluritamig, formerly AMG 509, is being developed pursuant to a research collaboration with Xencor, Inc.
YL201 is an investigational B7-H3 targeting antibody-drug conjugate being developed by MediLink.
Etakafusp alfa (AB248) is a novel CD8+ T cell selective interleukin-2 (IL-2) being developed by Asher Biotherapeutics.
OPDIVO is a registered trademark of Bristol-Myers Squibb Company.
KEYTRUDA is a registered trademark of Merck & Co., Inc.
OCREVUS is a registered trademark of Genentech, Inc.

1 The efficacy estimand represents the efficacy as if treated participants had adhered to MariTide for the entire 52-week study period. The efficacy estimand includes endpoint data so long as study drug is taken. Where endpoint data is missing with early discontinuation, the endpoint results for the patient are estimated using individual patient response and predicted performance after drug discontinuation.