Novavax Reports First Quarter 2026 Financial Results and Operational Highlights

On May 6, 2026 Novavax, Inc. (Nasdaq: NVAX) reported its financial results and operational highlights for the first quarter ended March 31, 2026.

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"Novavax continued to make significant progress executing our corporate strategy which is comprised of partnering our technology, capital-efficient R&D innovation and a lean operating platform. In 2026, we signed a new, Matrix-M license with Pfizer for up to two vaccine candidates and secured four additional MTAs with a growing list of large pharmaceutical and innovative biotech companies," said John C. Jacobs, President and Chief Executive Officer, Novavax. "With these agreements in place, our partners have the right to evaluate Matrix in over 30 unique fields of experimentation targeting more than 50% of the projected over $100B market for infectious disease and oncology vaccines and immuno-therapeutics. In addition, Novavax continued to advance our own R&D efforts with the selection of our C. difficile vaccine candidate as our next potential asset to advance to the clinic as early as 2027."

First Quarter 2026 and Recent Highlights

Key Business Highlights

•In January 2026, Novavax entered into a license agreement with Pfizer for use of Novavax’s Matrix-M adjuvant in vaccine development. Under the terms of the agreement, Pfizer was granted a non-exclusive license for Matrix-M use in two infectious disease areas.

◦Novavax received an upfront payment of $30 million in the first quarter of 2026 and has the potential for up to $500 million in additional development and sales milestones. In addition, Novavax is eligible to receive high-mid-single digit percentage royalties on sales from products incorporating Matrix-M.
◦Pfizer will be solely responsible for the development and commercialization of its products utilizing Matrix-M, and Novavax will be responsible for the supply of Matrix-M.
◦This partnership has the potential to generate billions of dollars of revenue for Novavax over the life of the agreement.

•In 2026, Novavax continued to expand its Matrix-M partnering efforts with global pharmaceutical companies and innovative biopharma companies.
◦In April, Novavax signed a new material transfer agreement (MTA) with a top ten global pharmaceutical company who is also a global leader in oncology to explore Matrix-M in a broad array of oncology targets, as well as antibiotic resistant bacterial infections and other infectious diseases.
◦In April, Novavax signed a new MTA with an existing pharmaceutical partner for evaluation of Matrix-M in nine additional, identified disease areas.
◦In February, Novavax expanded an existing MTA with a major global pharmaceutical company to explore an additional field and signed a new MTA with an innovative oncology company.

•In total, Novavax now has MTA collaborations and/or license agreements with four of the top ten global pharmaceutical companies and a number of innovative biotech companies who, collectively, have the right to explore Matrix-M in over 30 unique fields of experimentation across both infectious diseases and oncology.
◦The goal of our MTA collaborations is to enable exploration of Matrix-M with the intent of entering into deeper partnership via formal license agreements, that in turn results in the advancement of partner’s R&D clinical work toward the potential commercialization of innovative vaccines.
▪The broad utility of our technology has resulted in several companies exploring Matrix-M for application in the same high-potential markets, including infectious disease areas such as cytomegalovirus, Epstein-Barr Virus, pneumococcal, and RSV; and also includes overlap in oncology areas such as colorectal cancer, head and neck cancer and pancreatic cancer.
▪Existing partners under license and MTA agreements, have the right to address fields of experimentation that cover over 50% of the global market opportunity for infectious disease and oncology vaccines and immunotherapeutics, which is projected to grow to over $100 billion by the early 2030s.

•In April, Sanofi announced positive Phase 4 results from the COMPARE study, a head-to-head study showing that Nuvaxovid demonstrated statistically significant lower side effects compared to Moderna’s mNEXSPIKE across all pre-specified endpoints, reinforcing Nuvaxovid’s well-established and differentiated reactogenicity profile ahead of the fall season.

•Continued to progress Novavax R&D innovation in support of our growth strategy
◦Clostridioides difficile colitis (C. difficile) vaccine candidate prioritized as potential next asset to enter the clinic as early as 2027.
◦Preliminary preclinical data generated by Novavax on its varicella-zoster virus (shingles) and respiratory syncytial virus early-stage assets were positive and provide path forward for informing the Company’s future antigen design and adjuvant work.
•Ongoing adjuvant research is intended to expand the utility of our technology by creating new adjuvants tailored to foster specific differentiated immune properties for certain diseases that may require unique immune responses.

•Novavax continued to progress its cost reduction program to create a more lean and agile organization.
◦Targeting full year Non-GAAP combined R&D and Selling, General and Administrative (SG&A) expenses of $325 million for full year 2026 and $225 million for full year 2027, each period at the midpoint of the guidance range.
◦Improving the 2028 target for full year Non-GAAP combined R&D and SG&A expenses to between $150 million and $200 million. This reflects an anticipated expense reduction of over $200 million and over 50% when compared to full year 2025.

First Quarter 2026 Total Revenue

First quarter 2025 Nuvaxovid sales included $603 million of non-cash sales related to the close-out of two APA agreements.

First Quarter
$ in millions Q1 2026 Q1 2025 Change %
NuvaxovidTM Sales1
$10 $608 ($598) (98%)
Supply Sales2
33 14 19 139%
Product Sales 42 622 ($579) (93%)
Sanofi3
49 40 9 21%
Pfizer 30 0 30 NM
Serum 7 4 3 65%
Other Partners4
11 0 11 NM
Licensing, Royalties and Other Revenue 97 45 52 116%
Total Revenue $140 $667 ($527) (79%)

Notes
1.Nuvaxovid Sales reflects product sales where Novavax is the commercial market lead and records revenue related to the sales and distribution of its COVID-19 vaccine.
2.Supply Sales includes sales of finished product, adjuvant and other supplies from Novavax to its license partners.
3.Sanofi includes revenue recognized under the license agreement including upfront payments, milestones, royalties and transition services reimbursement.
4.Other Partners include upfront payments, royalties and milestone revenue under licensing agreements including Takeda and SK bioscience.

First Quarter 2026 Financial Results

•Total revenue for the first quarter of 2026 was $140 million, a 79% decrease compared to $667 million in the same period in 2025. Higher Nuvaxovid product sales for the first quarter of 2025 were primarily due to $603 million of non-cash sales revenue recognized with the close-out of two Advance Purchase Agreements (APA). Licensing Royalty and Other revenue of $97 million in the first quarter of 2026 included $30 million related to the Pfizer Matrix-M agreement signed in January 2026.

•Cost of sales for the first quarter of 2026 was $31 million, compared to $14 million in the same period in 2025.

•Research and development (R&D) expenses for the first quarter of 2026 were $95 million, compared to $89 million in the same period in 2025. The higher R&D costs were primarily associated with COVID-19 postmarketing commitment studies and annual strain change activities. R&D expenses reimbursed by partners in the first quarter of 2026 were $28 million. Non-GAAP R&D expenses, net of partner reimbursement, were $68 million in the first quarter of 2026, a 13% decrease when compared to $78 million in the same period in 2025. The lower Non-GAAP R&D expenses were driven by the ongoing Novavax cost reduction program as it streamlines operations to make targeted R&D investments.

•Selling, General and Administrative (SG&A) expenses for the first quarter of 2026 were $29 million, a 40% decrease compared to $48 million for the same period in 2025. The decrease was primarily due to the transition of lead commercial activities to Sanofi and the elimination of commercial infrastructure plus the ongoing general administrative cost reduction program.

•Net Loss for the first quarter of 2026 was $9 million, compared to net income of $519 million in the same period in 2025. First quarter of 2025 net income benefited from $603 million of non-cash sales related to the close-out of two APA agreements.

•Cash, cash equivalents, marketable securities and restricted cash (Cash) were $795 million as of March 31, 2026, compared to $751 million as of December 31, 2025. In February 2026, Novavax announced a $330 million credit facility with MidCap Financial, including an initial capital draw of $50 million. The credit facility was put in place to further strengthen Novavax’s balance sheet and provide access to non-dilutive capital as Novavax advances its growth strategy.

Financial Framework

Reiterates Full Year 2026 Financial Guidance

Novavax reiterates its Full Year 2026 Financial Guidance for Combined R&D and SG&A Expenses and Non-GAAP Combined R&D and SG&A Expenses and expects to achieve the following results:
$ in millions
Full Year 2026
(as of May 6, 2026)
Combined R&D and SG&A Expenses
$380 – $420
Less: R&D Reimbursements
($70 – $80)
Non-GAAP Combined R&D and SG&A Expenses
$310 – $340

Non-GAAP Combined R&D and SG&A Expenses exclude R&D Reimbursements, which are amounts reimbursed by Novavax’s license partners. See "Non-GAAP Financial Measures" below. R&D Reimbursements are recorded as revenue under Licensing, Royalties and Other Revenue.

Reiterates Full Year 2026 Revenue Framework

For 2026, Novavax reiterates its 2026 Revenue Framework and expects to achieve Adjusted Total Revenue4 of between $230 million and $270 million. Novavax transitioned lead commercial responsibility of Nuvaxovid beginning with the 2025-2026 COVID-19 vaccination season to Sanofi for select markets. Since Novavax is reliant on Sanofi’s sales forecasts for certain revenue components, these are not included in the Full Year 2026 Revenue Framework.

$ in millions
Full Year 2026
(as of May 6, 2026)
Nuvaxovid Product Sales1
$35 – $45
Adjusted Supply Sales2
$40 – $50
Adjusted Licensing, Royalties and Other Revenue3
$155 – $175
Adjusted Total Revenue4
$230 – $270
Sanofi Supply Sales, Sanofi Royalties and Sanofi Milestones
No guidance

Revenue Category
Revenue Framework Footnotes
Nuvaxovid Product Sales1
$35 million to $45 million in Nuvaxovid Product Sales by Novavax under existing APA and commercial agreements.
Adjusted Supply Sales2
$40 million to $50 million in Adjusted Supply Sales associated with collaborations with the Serum Institute on R21/Matrix-M and collaboration partners for COVID-19 vaccine, including Serum and Takeda.
Adjusted Licensing, Royalties and Other Revenue3
◦$70 million to $80 million in R&D Reimbursement. Under the Sanofi co-exclusive licensing agreement (CLA), Novavax is eligible to receive reimbursement for costs incurred related to select R&D and technology transfer activities during the transition performance period.
◦$50 million to $60 million in Other Partner related revenue including royalties and milestones from Pfizer, Serum on R21/Matrix-M and collaboration partners for COVID-19 vaccine, including Serum and Takeda. Includes a $30 million upfront payment under the Pfizer agreement received in the first quarter of 2026
◦$35 million amortization related to the $500 million Upfront Payment and the $50 million Database Lock Milestone. Revenue recognition will occur over the transition performance period.
Adjusted Total Revenue4
◦Adjusted Total Revenue is a Non-GAAP Financial Measure. Adjusted Total Revenue is total revenue excluding Sanofi Supply Sales, Sanofi Royalties and Sanofi. See "Non-GAAP Financial Measures."

Components of Revenue excluded from the Full Year 2026 Revenue Framework are described below.

Sanofi Supply Sales

•Novavax will sell Nuvaxovid commercial supply to Sanofi for the 2026-2027 COVID-19 vaccination season and the reimbursement for this supply will be recorded as product sales.

Sanofi Royalties
•Sanofi will lead commercial activities for the 2026-2027 COVID-19 vaccination season in select markets, including the U.S. Novavax is eligible to receive royalties in the high teens to low twenties percent on Sanofi sales.

Sanofi Milestones
•Novavax is eligible to receive a $75 million milestone payment related to the completion of the technology transfer of the Nuvaxovid manufacturing process to Sanofi.
•Novavax is eligible to receive up to $350 million in Phase 3 development and commercial launch milestone payments associated with Sanofi influenza-COVID-19 combination products.
•For each new vaccine using Matrix-M, Novavax is eligible to receive up to $200 million in launch and sales milestones and mid-single digit sales royalties for 20 years.

Conference Call
Novavax will host its quarterly conference call today at 8:30 a.m. Eastern Time (ET). To join the call without operator assistance, you may register and enter your phone number at View Source to receive an instant automated call back. You may also dial direct to be entered into the call by an operator. The dial-in numbers for the conference call are (888) 880-3330 (Domestic) or (+1) (646) 357-8766 (International). Participants will be prompted to request to join the Novavax, Inc. call. A replay of the conference call will be available starting at 11:30 a.m. ET on May 6, 2026, until 11:59 p.m. ET on May 13, 2026. To access the replay by telephone, dial (800) 770-2030 (Domestic) or (+1) (609) 800-9909 (International) and use passcode 1309751#.

A webcast of the conference call can also be accessed on the Novavax website at ir.novavax.com/events. A replay of the webcast will be available on the Novavax website until June 6, 2026.

(Press release, Novavax, MAY 6, 2026, View Source [SID1234665192])

Xencor Reports First Quarter 2026 Financial Results

On May 6, 2026 Xencor, Inc. (NASDAQ:XNCR), a clinical-stage biopharmaceutical company developing engineered antibodies for the treatment of cancer and autoimmune diseases, reported financial results for the first quarter ended March 31, 2026.

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"Xencor continues to execute across our wholly owned clinical pipeline, with significant progress in both oncology and autoimmune disease. We look forward to presenting expansion cohort data from our Phase 1 study of XmAb819 for the treatment of advanced clear cell renal cell carcinoma at a medical meeting in the second half of 2026, which will help support the initiation of our first pivotal study planned for 2027," said Bassil Dahiyat, Ph.D., president and chief executive officer at Xencor.

"Our TL1A pipeline continues to advance with strong enrollment in the global Phase 2b XENITH-UC Study of XmAb942 in ulcerative colitis supported by investigator enthusiasm for its potential best-in-class profile in moderately to severely active ulcerative colitis. We expect to complete a blinded interim analysis around year-end 2026 and complete the primary endpoint analysis for the study’s 12-week induction period during the second half of 2027. We also look forward to initiating the first-in-human study of XmAb412, our novel TL1A x IL23p19 bispecific antibody, in the third quarter of 2026. XmAb412 utilizes our novel XenLock Fab domain platform, which enables multi-specific biologics designed to address the very stringent requirements for high potency, long half-life and low immunogenicity in the treatment of autoimmune and inflammatory disease."

Wholly Owned Pipeline Overview

XmAb819 (ENPP3 x CD3), a first-in-class, tumor-targeted T-cell engaging XmAb 2+1 bispecific antibody in development for patients with advanced clear cell renal cell carcinoma (ccRCC).

Xencor plans to present expansion cohort data from the ongoing Phase 1 study to define a recommended Phase 3 target dose at a medical conference in 2H26 and support initiation of a pivotal study of XmAb819 in ccRCC planned for 2027.
Tumor expansion cohorts in ENPP3+ colorectal cancer (CRC), non-small cell lung cancer (NSCLC) and papillary renal cell carcinoma (pRCC) are open to enrollment.
Xencor plans to initiate a sub-study in patients with advanced ccRCC who have not previously received treatment with a tyrosine kinase inhibitor (TKI) in 3Q26.
XmAb541 (CLDN6 x CD3), a first-in-class, tumor-targeted T-cell engaging XmAb 2+1 bispecific antibody in Phase 1 clinical development for patients with advanced gynecologic and germ cell tumors.

Xencor plans to present Phase 1 dose-escalation data to define a recommended Phase 3 target dose in 2H26 and evaluate plans for a pivotal study of XmAb541 during 2027.
Additionally, Xencor is initiating a new clinical study to evaluate the combination of XmAb541 and XmAb808 (B7H3 x CD28) for patients with CLDN6+ high-grade serous ovarian cancer. XmAb808 is a bispecific antibody designed to provide conditional co-stimulation of T cells. Xencor presented a poster characterizing preclinical combinations of XmAb808 with multiple CD3 T cell engaging bispecific antibodies, including XmAb541, at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting in April 2026.
XmAb942 (Xtend anti-TL1A), a potential best-in-class, high-potency, extended half-life antibody in development for patients with inflammatory bowel disease.

Xencor is conducting the XENITH-UC Study, a global Phase 2b study of XmAb942 in ulcerative colitis (UC). XENITH-UC is a randomized, double-blind, placebo-controlled trial in patients with moderately to severely active UC, whose disease has progressed after at least one conventional or advanced therapy.
Xencor presented final results from the Phase 1 dose-escalation study of XmAb942 in healthy participants at Digestive Disease Week (DDW) in May 2026. All dose levels and routes of administration were well tolerated. XmAb942’s immunogenicity profile supports best-in-class drug exposure, and no impacts of anti-drug antibodies on safety or tolerability or on the population pharmacokinetic model were observed. The estimated terminal half-life of 74 days supports the single subcutaneous injection 12-week dosing interval used during the maintenance treatment period in XENITH-UC.
Enrollment expectations support a XENITH-UC blinded interim analysis around year-end 2026 and reaching the primary endpoint of the 12-week induction period during the second half of 2027. The primary endpoint is percentage of patients achieving clinical remission defined by the modified Mayo score at week 12.
XmAb412 (TL1A x IL23p19), a novel bispecific antibody format using the XenLock platform for dual targeting of inflammatory pathways in autoimmune and inflammatory disease.

Xencor presented preclinical characterization of XmAb412 at DDW in May 2026. XmAb412 robustly suppresses both TL1A and IL-23 inflammatory pathways and is predicted to have a human half-life between 60 and 70 days. XmAb412 supports high-concentration, low viscosity and citrate-free formulation suitable for subcutaneous dosing.
Xencor plans to initiate a first-in-human study of XmAb412 in 3Q26.
Plamotamab (CD20 x CD3), a clinical-stage, B-cell depleting bispecific T-cell engager in Phase 1 development for patients with rheumatoid arthritis (RA), who have progressed through prior standard-of-care treatment.

Xencor plans to provide an update on progress achieved in the Phase 1b study of plamotamab in RA in 2H26.
XmAb657 (CD19 x CD3), a clinical-stage, potent, extended half-life B-cell depleting bispecific T-cell engager in Phase 1 dose escalation, enrolling healthy participants and patients with idiopathic inflammatory myopathies (IIM).

Xencor plans to provide an update on progress achieved in the Phase 1 study of XmAb657 in 2H26.
Financial Guidance: Based on current operating plans, Xencor expects to end 2026 with between $380 million and $400 million in cash, cash equivalents and marketable debt securities, and to have sufficient cash resources to fund research and development programs and operations into mid-2028.

Financial Results for the First Quarter Ended March 31, 2026

Cash, cash equivalents and marketable debt securities totaled $541.8 million as of March 31, 2026, compared to $610.8 million as of December 31, 2025.

Revenue for the first quarter ended March 31, 2026 was $4.5 million, compared to $32.7 million for the same period in 2025. Revenue earned in the first quarter of 2026 was primarily non-cash royalty revenue from Incyte and Alexion, compared to the same period in 2025, which was primarily non-cash royalty revenue from Alexion and Incyte and milestone revenue from Incyte and Vir. Revenue for the first quarter ended March 31, 2026 includes a one-time $6.6 million reduction due to royalties on disputed U.S. sales due from Alexion.

Research and development (R&D) expenses for the first quarter ended March 31, 2026 were $64.7 million, compared to $58.6 million for the same period in 2025. Increased R&D spending for the first quarter of 2026 compared to 2025 is primarily due to increased spending on pipeline programs, partially offset by reduced lower stock-based compensation expense.

General and administrative (G&A) expenses for the first quarter ended March 31, 2026 were $17.7 million, compared to $17.3 million for the same period in 2025. G&A spending for the first quarter 2026 compared to 2025 remained relatively consistent.

Other expense, net, for the first quarter ended March 31, 2026 was $50.8 million, compared to $5.1 million for the same period in 2025. Increased other expense, net, for the first quarter of 2026, compared to 2025, is primarily due to unrealized losses on an equity security.

Net loss attributable to Xencor for the first quarter ended March 31, 2026 was $128.9 million, or $(1.71) on a fully diluted per share basis, compared to net loss of $48.4 million, or $(0.66) on a fully diluted per share basis, for the same period in 2025.

Upcoming Investor Conference

Company management will present at the BofA Securities Health Care Conference on Tuesday, May 12, 2026 at 3:00 p.m. PDT. A live webcast of the presentation will be available under "Events & Presentations" in the Investors section of the Company’s website located at www.xencor.com. A replay of the event will be available on the Xencor website for at least 30 days following the presentation.

(Press release, Xencor, MAY 6, 2026, View Source [SID1234665211])

Signadori Bio Raises €11 Million Seed Round to Advance Next-Generation Solid Tumour Platform

On May 6, 2026 Signadori Bio SAS ("Signadori" or the "Company"), a preclinical-stage biopharmaceutical company developing a next generation, off-the-shelf, in vivo engineered, monocyte immunotherapy platform to treat solid tumours, reported the successful completion of its seed extension financing round, bringing the total raised to €11.1 million. This latest investment was through participation from Taiho Ventures, and existing investors Sofinnova Partners and Invivo Partners.

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The proceeds from the financing will support the advancement of Signadori Bio’s lead programme SiB-2101 towards lead candidate nomination, further development of its proprietary in vivo monocyte engineering platform, and expansion of its scientific and operational teams.

Signadori Bio is developing a novel immunotherapy approach based on engineering monocytes in vivo to regulate and enhance myeloid anti-tumour activity. By harnessing the innate immune system, the company aims to overcome the immunosuppressive tumour microenvironment and address key limitations of existing immunotherapies and autologous cell therapies, particularly in solid tumours.

"This financing represents an important milestone for Signadori Bio as we continue to build on our promising preclinical data and advance our platform toward the clinic," said Dr. Selwyn Ho, Chief Executive Officer of Signadori Bio. "Our approach to in vivo engineering of monocytes has the potential to unlock a new class of immunotherapies that are more accessible, scalable, and effective for patients with solid tumours. We are delighted to welcome Taiho Ventures alongside our existing investors, Sofinnova Partners and Invivo Partners."

"Signadori Bio is advancing a highly differentiated strategy in immuno-oncology by targeting monocytes and leveraging in vivo engineering," said Seiji Miyahara, Partner & Senior Investment Director at Taiho Ventures, LLC. "The company’s compelling preclinical data and strong scientific foundation position it well to address significant unmet needs in solid tumours. We are excited to support the team in this next phase of development."

"Since inception, Signadori Bio has made strong progress in validating its platform and demonstrating the therapeutic potential of p21-driven monocyte reprogramming," said Matthieu Coutet, Chair of the Board at Signadori Bio and Partner at Sofinnova Partners. "This financing will enable the company to accelerate its development strategy and move closer to clinical translation."

Founded by Dr Jean-Luc Perfettini and Professor Nathalie Chaput, and based on research conducted at Gustave Roussy, Signadori Bio is focused on developing off-the-shelf immunotherapies that reprogram innate immune cells directly in the patient.

(Press release, Signadori Bio, MAY 6, 2026, View Source [SID1234665227])

Q1 2026 results

On May 6, 2026 BeOne Medicines reported first quarter 2026 financial results.

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(Presentation, BeOne Medicines, MAY 6, 2026, View Source [SID1234666034])

Financial report for the period 1 January 2026 to 31 March 2026

On May 6, 2026 Novo Nordisk reported financial report for the period 1 January 2026 to 31 March 2026.

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(Press release, Novo Nordisk, MAY 6, 2026, View Source [SID1234669137])