On July 31, 2026 Amplia Therapeutics Limited (ASX:ATX; OTCQB:INNMF), ("Amplia" or the "Company"), reported that a scientific manuscript detailing extensive preclinical studies of narmafotinib in pancreatic cancer has been made publicly available on the biology preprint server bioRxiv and can be accessed via this link.

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The manuscript describes research conducted by Professor Paul Timpson and colleagues at the Garvan Institute of Medical Research, Sydney, and provides further insight into the multiple mechanisms through which narmafotinib may act to improve outcomes in pancreatic cancer.

Key findings reported in the manuscript include:

*Reduction of tumour fibrosis, a hallmark of pancreatic cancer that contributes to treatment resistance and impaired drug delivery;

*Enhanced anti-tumour activity when combined with chemotherapy across multiple preclinical pancreatic cancer models;

*Reduced cancer dissemination and metastatic spread in a model of metastatic pancreatic cancer; and

*Downregulation of multiple genes associated with chemotherapy resistance, further supporting the biological rationale for combining narmafotinib with chemotherapy and other drugs

Dr Chris Burns, CEO and Managing Director of Amplia commented: "We are delighted that the extensive research conducted by Professor Timpson’s team at the Garvan Institute over recent years is now being shared with the broader scientific community. Importantly, these studies strengthen the scientific rationale for the clinical development of narmafotinib, and provides further insight into the multifaceted mechanisms through which narmafotinib can act in the treatment of this devastating disease."

The publication represents one of the most comprehensive preclinical evaluations of narmafotinib undertaken to date and further supports Amplia’s ongoing clinical development program in pancreatic cancer.

This ASX announcement was approved and authorised for release by the Board of Amplia Therapeutics.

(Press release, Amplia Therapeutics, JUL 31, 2026, View Source [SID1234669584])

On July 31, 2026 FibroBiologics, Inc. (Nasdaq: FBLG) ("FibroBiologics"), a clinical-stage biotechnology company with 270+ patents issued and pending with a focus on the development of therapeutics and potential cures for chronic diseases using fibroblasts and fibroblast-derived materials, reported financial results for the second quarter ended June 30, 2026, and provided a corporate update.

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Recent Highlights:

Clinical Updates:

Initiation of patient dosing in the Company’s Phase 1/2 clinical trial evaluating CYWC628 for the treatment of diabetic foot ulcers (DFUs).
Completed manufacturing of three batches of the CYWC628 drug product in accordance with FDA’s Good Manufacturing Practices (cGMP). Two of these batches have been released and the third batch will be released after it successfully passes all required safety and quality testing.
Financing:

Strengthened financial position through completion of a $9.0 million private placement with $3.0 million upfront and up to approximately $6.0 million of potential additional gross proceeds upon the exercise in full of warrants. Additionally, closed a $3.0 million public offering.
Preclinical Progress:

Reported preclinical results suggesting that topical treatment with human dermal fibroblast (HDF) spheroids may reprogram the burn wound environment by dampening harmful inflammation, reshaping immune cell behavior, and reducing markers of scar-forming activity, within just eight days of injury.
Patent Portfolio:

Received a notice of an allowance for a patent with the U.S. Patent and Trademark Office (USPTO) covering methods of treating and accelerating the healing of wounds by topically administering a composition comprising 3D spheroid fibroblasts together or with one or more fibroblast-derived materials.
Filed a provisional patent application with the USPTO covering oral delivery systems designed to protect fibroblast-based therapeutics through the stomach and enable targeted release in the gastrointestinal tract.
Conference Presentations:

Presented poster presentations on the novel thymus organoid platform at the Keystone Symposia on Aging and Immunity; and preclinical data from its CYPS317 program for psoriasis at the Society for Investigative Dermatology 2026 Annual Meeting.
Presented its proprietary thymus organoid technology to reboot the immune system and extend human life at the Alliance for Longevity Initiatives H-Span Summit in Washington DC.
Upcoming Milestones

Wound Healing:

Phase 1/2 clinical trial evaluating fibroblast-based spheroids product candidate, CYWC628, in DFU patients:
Expects to report interim results in the second half of 2026.
Anticipates completion and disclosure of primary safety and efficacy results by the end of 2026.
Psoriasis:

Anticipates IND clearance for the treatment of psoriasis with CYPS317, the Company’s fibroblast spheroid product candidate, in the fourth quarter of 2026.
Multiple Sclerosis:

Plans to submit an IND application with the U.S. Food & Drug Administration (FDA) for the treatment of multiple sclerosis with FibroBiologics’ fibroblast spheroid product candidate, CYMS101, in the fourth quarter of 2026.
Degenerative Disc Disease:

Plans to amend the IND clearance with the FDA to replace single-cell fibroblasts with fibroblast-derived chondrocyte spheroids derived from the CYWC628 master cell bank.
Pete O’Heeron, CEO and Founder of FibroBiologics, said, "With the first patient dosed in our CYWC628 trial, FibroBiologics has entered an important stretch as a clinical-stage company. Every milestone ahead builds on this one, and every data point will speak to what fibroblasts can do for patients. We are positioned for the catalysts ahead and eager to share our initial findings this year."

Financial Highlights for the Quarter Ended June 30, 2026

Research and development expenses were approximately $1.7 million for the three months ended June 30, 2026, compared to approximately $2.0 million for the same period in 2025. The decrease was primarily due to decreased CRO costs of $0.3 million as clinical validation changed to manufacturing, and certain costs were capitalized to research and development supplies.
General and administrative expenses were approximately $2.4 million for both the three months ended June 30, 2026 and 2025. The primary areas of net change are decreased personnel expenses of $0.2 million; increased professional fees of $0.1 million for accounting, legal and marketing expenses; decreased facilities expenses of $0.1 million; and increased listing expenses of $0.1 million.
For the three months ended June 30, 2026, FibroBiologics reported a net loss of approximately $4.1 million. The net loss for the three months ended June 30, 2026, was primarily due to research and development expenses and general and administrative expenses discussed above.

Cash and cash equivalents totaled approximately $3.5 million at June 30, 2026.

(Press release, FibroBiologics, JUL 31, 2026, View Source [SID1234669585])

On July 30, 2026 Bristol Myers Squibb (NYSE: BMY) reported results for the second quarter of 2026.

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"The Growth Portfolio continues to deliver, achieving 15% growth in the quarter, and represents an expanding share of our overall business," said Christopher Boerner, Ph.D., board chair and chief executive officer, Bristol Myers Squibb. "We are building from a position of strength and progressing a differentiated pipeline designed to generate long-term value. As a result of our consistent execution and continued momentum, we are raising our 2026 full-year outlook."

Second Quarter Results
$ in millions, except per share amounts 2026 2025 Change
Change Excl. FX**
Total Revenues $12,973 $12,269 6 % 5 %
Earnings/(Loss) Per Share – GAAP* 1.62 0.64 153 % N/A
Earnings/(Loss) Per Share – Non-GAAP* 2.04 1.46 40 % N/A
Acquired IPRD Charges and Licensing Income Net Impact on Earnings/(Loss) Per Share 0.01 (0.57) N/A N/A

*GAAP and Non-GAAP earnings/(loss) per share include the net impact of Acquired IPRD charges and licensing income.
**See "Use of Non-GAAP Financial Information".

1

SECOND QUARTER RESULTS*
•Growth Portfolio revenues of $7.6 billion increased 15%, or 14% Ex-FX. Revenue growth was primarily driven by Opdivo Qvantig, Reblozyl, Camzyos, Breyanzi and Opdualag.
•Legacy Portfolio revenues of $5.4 billion decreased 4%, or 5% Ex-FX. Demand increased for Eliquis, which was more than offset by expected continued generic impacts across the remainder of the Legacy Portfolio.
•Total revenues of $13.0 billion increased 6%, or 5% Ex-FX.
◦U.S. revenues of $9.0 billion increased 6%.
◦International revenues of $4.0 billion increased 6%, or 5% Ex-FX.
*All comparisons are made versus the same period in 2025 unless otherwise stated.

SECOND QUARTER PRODUCT REVENUE HIGHLIGHTS(e)

($ amounts in millions) Quarter Ended June 30, 2026
% Change from Quarter Ended June 30, 2025
% Change from Quarter Ended June 30, 2025 Ex-FX**

U.S.
Int’l
WW(d)
U.S.
Int’l
WW(d)
Int’l
WW(d)
Growth Portfolio
Opdivo $ 1,417 $ 1,068 $ 2,485 (6) % 1 % (3) % (1) % (4) %
Opdivo Qvantig 206 55 261 >200% >200% >200% >200% >200%
Orencia 801 233 1,034 13 % (8) % 7 % (8) % 7 %
Yervoy 481 288 769 7 % 4 % 6 % 2 % 5 %
Reblozyl 593 142 735 31 % 24 % 29 % 24 % 29 %
Breyanzi 354 131 484 39 % 48 % 41 % 47 % 41 %
Opdualag 294 55 349 17 % 72 % 23 % 65 % 22 %
Camzyos 310 105 416 45 % 129 % 60 % 124 % 59 %
Zeposia 116 53 169 11 % 17 % 12 % 14 % 12 %
Sotyktu 51 36 87 19 % 30 % 23 % 27 % 23 %
Krazati 47 8 55 1 % >200% 14 % >200% 14 %
Cobenfy 60 3 63 73 % >200% 81 % >200% 81 %
Other Growth Products(a)
244 409 653 (1) % 32 % 17 % 32 % 17 %
Total Growth Portfolio
4,974 2,585 7,560 14 % 15 % 15 % 13 % 14 %
Legacy Portfolio
Eliquis 3,357 1,124 4,481 27 % 9 % 22 % 7 % 21 %
Revlimid 352 72 425 (52) % (32) % (49) % (30) % (49) %
Pomalyst/Imnovid 131 73 204 (78) % (41) % (71) % (38) % (71) %
Sprycel 52 35 88 (23) % (32) % (27) % (30) % (26) %
Abraxane 12 43 55 (62) % (40) % (47) % (40) % (47) %
Other Legacy Products(b)
112 58 170 12 % (53) % (24) % (53) % (24) %
Total Legacy Portfolio 4,017 1,405 5,422 (4) % (7) % (4) % (7) % (5) %
Other Revenue(c)
— (9) (9) N/A N/A N/A N/A N/A
Total Revenues $ 8,991 $ 3,982 $ 12,973 6 % 6 % 6 % 5 % 5 %

** See "Use of Non-GAAP Financial Information".
(a) Includes Abecma, Augtyro, Onureg, Inrebic, Nulojix, Empliciti and royalty revenues, including royalties received from Merck on Winrevair.
(b) Includes other mature brands.
(c) Includes revenue hedging activities in 2026.
(d) Worldwide (WW) includes U.S. and International (Int’l).
(e) For the above table and all subsequent tables, certain totals may not sum due to rounding. Percentages have been calculated using unrounded amounts.
2

SECOND QUARTER COST & EXPENSES
The table below presents selected line-item information.

GAAP Non-GAAP**
Three months ended June 30, Three months ended June 30,
($ amounts in millions)
2026
2025
Change
2026
2025
Change
Cost of products sold
$ 3,726 $ 3,372 11% $ 3,711 $ 3,356 11%
Gross margin
71.3 % 72.5 % (120) bps 71.4 % 72.6 % (120) bps
Selling, general and administrative
1,826 1,713 7% 1,826 1,691 8%
Research and development
2,959 2,580 15% 2,316 2,263 2%
Acquired IPRD(a)
— 1,508 (100)% — 1,508 (100)%
Amortization of acquired intangible assets
437 830 (47)% — — N/A
Other (income)/expense, net
(61) 494 NM 126 (108) NM
Effective tax rate
18.8 % 25.9 % (710) bps 16.5 % 16.1 % 40 bps

** See "Use of Non-GAAP Financial Information" and refer to the Specified Items schedule below for further detail.
NM Not meaningful.
(a) Non-GAAP Acquired IPRD does not include adjustments to GAAP Acquired IPRD.

•Gross margin decreased from 72.5% to 71.3% on a GAAP basis, and from 72.6% to 71.4% on a non-GAAP basis, primarily reflecting a change in product mix.
•Selling, general and administrative expenses of $1.8 billion increased 7% on a GAAP basis and 8% on a non-GAAP basis, primarily driven by investments in new product launches.
•Research and development expenses of $3.0 billion increased 15% on a GAAP basis, primarily driven by the purchase of a priority review voucher and higher IPRD impairment charges in 2026. Non-GAAP research and development expenses of $2.3 billion increased 2%.
•Amortization of acquired intangible assets of $437 million decreased 47% on a GAAP basis, primarily driven by lower amortization expense related to Pomalyst.
•Other (income)/expense, net of $(61) million and $126 million on a GAAP and non-GAAP basis, respectively, reflects the expiry of royalty income on diabetes products at the end of 2025.
•Effective tax rate decreased from 25.9% to 18.8% on a GAAP basis and increased from 16.1% to 16.5% on a non-GAAP basis, primarily driven by jurisdictional earnings mix.
•Net income attributable to Bristol Myers Squibb of $3.3 billion, or $1.62 per share, increased from $1.3 billion, or $0.64 per share, on a GAAP basis. On a non-GAAP basis, net income attributable to Bristol Myers Squibb of $4.2 billion, or $2.04 per share, increased from $3.0 billion, or $1.46 per share. GAAP and non-GAAP EPS include the impacts of Acquired IPRD charges and licensing income.

PRODUCT AND PIPELINE UPDATES
Entries organized by date and inclusive of second quarter and recent updates.
Asset(s)
Date Announced
Milestone
Reblozyl (luspatercept)
July 30
The U.S. Food and Drug Administration (FDA) accepted the supplemental Biologics License Application for Reblozyl with concomitant janus kinase inhibitor therapy in adult patients with myelofibrosis-associated anemia receiving red blood cell transfusions. The acceptance was supported by results from the Phase 3 INDEPENDENCE study. The FDA granted a Prescription Drug User Fee Act (PDUFA) date of March 11, 2027.
mezigdomide July 13
The FDA accepted a New Drug Application for mezigdomide in combination with carfilzomib and dexamethasone (MeziKd) in patients with relapsed or refractory multiple myeloma (RRMM), granting a PDUFA date of May 13, 2027. The filing was based on the positive results from the Phase 3 SUCCESSOR-2 trial.

Mezigdomide is the second BMS CELMoD to be granted a PDUFA date this year for an RRMM indication, joining iberdomide, which has a PDUFA date of August 17, 2026.
izalontamab brengitecan
(iza-bren) June 2
Announced with SystImmune that SystImmune’s parent company, Sichuan Biokin Pharmaceutical Co., Ltd., reported positive results from prespecified interim analyses of two Phase 3 studies evaluating iza-bren. In the studies, iza-bren achieved statistically significant and clinically meaningful improvements in overall survival and progression-free survival (PFS) in heavily pretreated, unresectable, locally advanced or metastatic triple-negative breast cancer and recurrent or metastatic esophageal squamous cell carcinoma.
Camzyos (mavacamten)
June 1
The FDA accepted for priority review a supplemental New Drug Application (sNDA) for Camzyos as a potential treatment for adolescents ages 12 to <18 years with symptomatic obstructive hypertrophic cardiomyopathy. The sNDA submission was based on data from the Phase 3 SCOUT-HCM trial.
Opdivo (nivolumab)
June 1
The European Commission (EC) approved Opdivo in combination with doxorubicin, vinblastine and dacarbazine for the treatment of adult and adolescent patients 12 years of age and older with previously untreated Stage III or IV classical Hodgkin Lymphoma. The EC approval is based on data from the Phase 3 SWOG 1826 (Study CA2098UT).
pumitamig May 30
Interim Phase 2 data, announced with BioNTech SE, from the global Phase 2/3 ROSETTA Lung-02 trial evaluating pumitamig plus chemotherapy in patients with previously untreated advanced non-small cell lung cancer (NSCLC) demonstrated robust anti-tumor activity with high response rates observed in both non-squamous and squamous NSCLC and at each PD-L1 expression level.
mezigdomide May 29
Announced positive results from the Phase 3 SUCCESSOR-2 trial of MeziKd versus carfilzomib and dexamethasone alone (Kd) in patients with RRMM. MeziKd demonstrated a clinically meaningful and statistically significant improvement in PFS, representing a 52% reduction in the risk of disease progression or death compared with Kd.
Sotyktu (deucravacitinib)
May 8
The EC approved Sotyktu, alone or in combination with methotrexate, for the treatment of psoriatic arthritis (PsA) in adults who have had an inadequate response or who have been intolerant to a prior disease-modifying antirheumatic therapy. The EC approval is based on positive results from the pivotal POETYK PsA-1 and POETYK PsA-2 Phase 3 clinical trials.

Our Strategy
At Bristol Myers Squibb, our goal is to build a company that is financially strong and delivers industry-leading, sustainable growth into the 2030s and beyond.
As we advance our multi-year strategy to position the company for long-term growth, we are guided by the following priorities:
•Focusing R&D on high-impact, transformational medicines to treat life-threatening diseases;
•Embedding rigorous operational execution across the organization to build momentum in our Growth Portfolio comprised primarily of medicines early in their lifecycles; and
•Maintaining disciplined capital allocation to drive sustainable cash flow generation, balance sheet strength and long-term shareholder returns.

Business Development
The company recently entered into multiple transactions that strengthen its pipeline and operational capabilities.

In July 2026, the company announced an expansion of its existing collaboration with NVIDIA to deploy NVIDIA’s newest AI infrastructure, Vera Rubin NVL72, for running predictive models at scale and training large AI models on BMS’s own data. Through this latest agreement, BMS scientists have the potential to understand disease biology more deeply, design and test candidate molecules faster, and gain deeper insights from clinical outcomes sooner. We expect this to ensure the company can continue pursuing the right targets and advancing stronger candidates, ultimately working toward smarter, more targeted clinical trial design and earlier, better-informed decisions about which programs to move forward.

In May 2026, the company announced a strategic agreement with Anthropic to deploy Claude across Bristol Myers Squibb’s research, clinical development, manufacturing, commercial and corporate functions. Claude will serve as the shared intelligence platform between enterprise functions, enabling the company to unlock its data and accelerate innovation.

Also in May 2026, the company entered into global strategic collaboration and licensing agreements with Hengrui Pharma to advance a portfolio of 13 early-stage programs in oncology, hematology and immunology. The collaboration furthers Bristol Myers Squibb’s efforts to accelerate early-stage clinical development and make informed, responsible decisions that contribute to the company’s growth potential.

Financial Guidance
Bristol Myers Squibb is increasing its full-year, non-GAAP revenue guidance from a range of approximately $46.0 billion to $47.5 billion to a range of approximately $49.0 billion to $50.0 billion. This update primarily reflects broad-based and continuing momentum across the portfolio.
Full-year operating expenses in 2026 are now expected to be approximately $16.5 billion, due to increased investment behind key pipeline programs and new product launches.
As a result of these guidance updates, non-GAAP EPS is increasing to an anticipated range of $6.75 – $7.00.
2026 Non-GAAP1,2 Line-Item Guidance
April
(Prior) July
(Updated)
Total Revenues
(Reported & Ex-FX)
~$46.0 – $47.5 billion
~$49.0 – $50.0 billion
Gross Margin % ~69% – 70% No change
Operating Expenses3
~$16.3 billion ~$16.5 billion
Other income/(expense) ~($700 million) No change
Effective tax rate
~18%
No change
Diluted EPS
$6.05 – $6.35
$6.75 – $7.00

1 See "Use of Non-GAAP Financial Information."
2 April was calculated based on mid-April 2026 foreign exchange rates, and July was calculated based on mid-July exchange rates.
3 Operating Expenses = SG&A and R&D.

The company continues to expect total Worldwide Eliquis revenues to increase in 2026 when compared to 2025, and is raising its projected range as shown in the table below.

2026 Eliquis Revenue Guidance
April
(Prior) July
(Updated)
2026 WW Revenue Growth* 10% – 15% 20% – 25%

* Compared to 2025 Worldwide Eliquis revenues.

The 2026 financial guidance provided excludes the impact of any potential future strategic acquisitions, divestitures, specified items that have not yet been identified and quantified, and the impact of Acquired IPRD charges and licensing income incurred after June 30, 2026. To the extent we have quantified the impact of significant R&D charges or other income resulting from upfront or contingent milestone payments in connection with asset acquisitions or licensing of third-party intellectual property rights, we may update this information from time to time on our website, www.bms.com, in the "Investors" section. Non-GAAP guidance assumes exchange rates as of the date noted. The financial guidance is subject to risks and uncertainties applicable to all forward-looking statements as described elsewhere in this press release.

A reconciliation of forward-looking non-GAAP measures, including non-GAAP EPS, to the most directly comparable GAAP measures is not provided because comparable GAAP measures for such measures are not reasonably accessible or reliable due to the inherent difficulty in forecasting and quantifying measures that would be necessary for such reconciliation. Namely, we are not, without unreasonable effort, able to reliably predict the impact of accelerated depreciation and impairment charges, legal and other settlements, gains and losses from equity investments and other adjustments. In addition, the company believes such a reconciliation would imply a degree of precision and certainty that could be confusing to investors. These items are uncertain, depend on various factors and may have a material impact on our future GAAP results. See "Cautionary Statement Regarding Forward-Looking Statements" and "Use of Non-GAAP Financial Information."

Conference Call Information
Bristol Myers Squibb will host a conference call today, Thursday, July 30, 2026, at 8:15 a.m. ET, during which company executives will review financial results with the investment community.
Investors and the general public are invited to listen to a live webcast of the call at View Source." target="_blank" title="View Source." rel="nofollow">View Source Materials related to the call will be available at View Source prior to the start of the conference call.
A replay of the webcast will be available at View Source approximately three hours after the conference call concludes.

(Press release, Bristol-Myers Squibb, JUL 30, 2026, View Source [SID1234669527])

On July 30, 2026 Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) reported financial results for the second quarter of 2026 and provided a business update.

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"Regeneron delivered another quarter of strong financial performance, with double-digit top- and bottom-line growth reflecting the continued strength of our commercial portfolio and the potential of our pipeline," said Leonard S. Schleifer, M.D., Ph.D., Board co-Chair, President and Chief Executive Officer of Regeneron. "Of note, global Dupixent, global Libtayo, and U.S. EYLEA HD net product sales increased by 38%, 30%, and 52%, respectively, compared to the second quarter of 2025. With approximately 50 clinical assets, we remain focused on translating our science into even more successful new medicines across a broad array of diseases."
Financial Highlights

($ in millions, except per share data) Q2 2026 Q2 2025 % Change
Total revenues $ 4,291 $ 3,676 17 %
GAAP net income $ 1,297 $ 1,392 (7 %)
GAAP net income per share – diluted $ 12.23 $ 12.81 (5 %)
Non-GAAP net income(a)
$ 1,543 $ 1,424 8 %
Non-GAAP net income per share – diluted(a)
$ 14.29 $ 12.89 11 %

"Second quarter revenues grew 17% and non-GAAP net income per share grew 11%, marking our second consecutive quarter of double-digit growth on both measures," said Christopher Fenimore, Executive Vice President, Finance and Chief Financial Officer of Regeneron. "By the end of the second quarter, we had fully repaid the Sanofi Development Balance, which represented the outstanding amount due to Sanofi for their funding of prior collaboration development activities. The repayment of this obligation will drive a meaningful step-up in collaboration profits beginning in the third quarter. Given our strong financial position, we continue to invest confidently in our pipeline, U.S. manufacturing, and external innovation, while returning capital to shareholders, reflected by the nearly $3.0 billion deployed in the first half of the year to share repurchases, dividends, capital expenditures, and business development."
Business Highlights
Key Pipeline Progress
Regeneron has approximately 50 product candidates in clinical development, including a number of marketed products for which it is investigating additional indications. Updates from the clinical pipeline include:
Dupixent (dupilumab)
•In April 2026, the U.S. Food and Drug Administration (FDA) and European Commission approved Dupixent for the treatment of chronic spontaneous urticaria (CSU), expanding the eligible population to include children aged 2 to 11 years who remain symptomatic despite antihistamine treatment.
EYLEA HD (aflibercept) 8 mg
•In April 2026, the FDA approved the extension of dosing intervals for EYLEA HD up to every 20 weeks (5 months) for patients with wet age-related macular degeneration (wAMD) and diabetic macular edema (DME) following one year of successful response based on visual and anatomic outcomes.
Otarmeni (lunsotogene parvec, formerly known as DB-OTO)
•In May 2026, the European Medicines Agency (EMA) accepted for review, under accelerated assessment, the Marketing Authorization Application (MAA) for Otarmeni for the treatment of biallelic OTOF variant-associated hearing loss.
Fianlimab (LAG-3 antibody)
•In May 2026, the Company announced results from the Phase 3 trial evaluating two dose levels of fianlimab in combination with cemiplimab as a first-line treatment for patients with unresectable locally advanced or metastatic melanoma. The trial did not reach statistical significance for the primary endpoint of improvement in progression-free survival (PFS) compared to pembrolizumab monotherapy.
Other Programs
•In June 2026, the Company announced that both the FDA and EMA have accepted the regulatory applications for cemdisiran (C5 RNAi therapy) to treat adult patients with gMG. The FDA will review the New Drug Application (NDA) under priority review with a target action date in November 2026, following use of a Priority Review Voucher. A decision from the European Commission is anticipated in the second half of 2027.
•The Company announced positive results from the Phase 1/2 LINKER-AL2 trial for Lynozyfic (linvoseltamab) in adults with second-line-plus systemic amyloid light chain amyloidosis. The results were presented at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper)

(ASCO) 2026 Annual Meeting. The Phase 2 portion of the trial with registrational intent, part of a broad clinical development program investigating Lynozyfic, is underway.
•A Phase 3 study was initiated in peripheral artery disease (PAD) for cenvacibart (REGN7508, an antibody to Factor XI (catalytic domain)), and amrecibart (REGN9933, an antibody to Factor XI (A2 domain)), to evaluate each antibody individually compared to standard of care.
Corporate Updates
•The FDA selected the Company’s manufacturing facility in Saratoga Springs, New York, which is currently under construction, to participate in the FDA PreCheck Pilot Program. The FDA PreCheck Pilot Program is intended to support the development of new U.S. pharmaceutical manufacturing facilities by encouraging earlier FDA engagement and providing a more predictable regulatory pathway.
•In May 2026, the Company entered into a collaboration with Parabilis Medicines to discover and develop multiple therapeutic candidates based on Parabilis’ Helicon peptide platform.
•The Company announced that it had been named to the Dow Jones Best-in-Class World Index, one of the world’s most recognized benchmarks for corporate sustainability performance, for the seventh consecutive year.
Second Quarter 2026 Financial Results
Revenues
($ in millions) Q2 2026 Q2 2025 % Change
Net product sales:
EYLEA HD – U.S. $ 596 $ 393 52 %
EYLEA – U.S.
412 754 (45 %)
Total EYLEA HD and EYLEA – U.S. 1,008 1,147 (12 %)
Libtayo – U.S. 343 248 38 %
Libtayo – ROW* 146 129 13 %
Total Libtayo – Global
489 377 30 %
Praluent – U.S.
75 66 14 %
Evkeeza – U.S.
53 41 29 %
Lynozyfic – Global
17 — **
Total net product sales 1,642 1,631 1 %
Collaboration revenue:
Sanofi 2,174 1,444 51 %
Bayer 276 415 (33 %)
Other 6 2 **
Other revenue 193 184 5 %
Total revenues $ 4,291 $ 3,676 17 %

Net product sales of EYLEA HD increased in the second quarter of 2026, compared to the second quarter of 2025, primarily due to higher sales volumes driven by increased demand, partly offset by a lower net selling price.
Net product sales of EYLEA in the second quarter of 2026, compared to the second quarter of 2025, were negatively impacted by (i) lower sales volumes, driven by decreased demand, as a result of continued competitive pressures and the continued transition of patients to EYLEA HD, and (ii) a lower net selling price.
Global net product sales of Libtayo increased in the second quarter of 2026, compared to the second quarter of 2025, primarily due to higher sales volumes driven by increased demand.
Sanofi collaboration revenue increased in the second quarter of 2026, compared to the second quarter of 2025, due to an increase in the Company’s share of profits from the commercialization of antibodies, which were $2.033 billion and $1.282 billion in the second quarter of 2026 and 2025, respectively. The change in the Company’s share of profits from the commercialization of antibodies was driven by higher profits primarily associated with an increase in Dupixent sales. In addition, the Sanofi Development Balance was fully repaid as of the end of the second quarter of 2026 and will no longer reduce Sanofi collaboration revenue beginning in the third quarter of 2026.
Refer to Table 4 for a summary of collaboration revenue.
Operating Expenses
GAAP % Change
Non-GAAP(a)
% Change
($ in millions)
Q2 2026 Q2 2025 Q2 2026 Q2 2025
Research and development (R&D) $ 1,632 $ 1,422 15 % $ 1,500 $ 1,283 17 %
Acquired in-process research and development (IPR&D) $ 127 $ 10 ** * * *
Selling, general, and administrative (SG&A) $ 662 $ 634 4 % $ 574 $ 542 6 %
Cost of goods sold (COGS) $ 361 $ 276 31 % $ 221 $ 222 — %
Gross margin on net product sales(b)
78% 83% 87% 86%
Cost of collaboration and contract manufacturing (COCM)(c)
$ 216 $ 255 (15 %) * * *
* GAAP and non-GAAP amounts are equivalent as no non-GAAP adjustments have been recorded
** Percentage not meaningful or greater than 100%

•GAAP and non-GAAP R&D expenses increased in the second quarter of 2026, compared to the second quarter of 2025, driven by the Company’s mid- and late-stage clinical pipeline.
•Acquired IPR&D expenses for the second quarter of 2026 included up-front and opt-in payments in connection with collaboration and licensing agreements.
•GAAP gross margin on net product sales decreased in the second quarter of 2026, compared to the second quarter of 2025, primarily due to unabsorbed manufacturing costs as a result of the previously disclosed temporary interruption of bulk manufacturing production at the Company’s facility in Limerick, Ireland. As of the end of the second quarter of 2026, bulk manufacturing production returned to normal levels. The interruption did not impact the availability of any of the Company’s products.
Other Financial Information
GAAP other income (expense), net decreased in the second quarter of 2026, compared to the second quarter of 2025, primarily due to lower net gains on marketable and other securities.
In the second quarter of 2026, the Company’s GAAP effective tax rate (ETR) was 15.1%, compared to 8.4% in the second quarter of 2025. The GAAP ETR increased in the second quarter of 2026, compared to the second quarter of 2025, primarily due to the net change in unrecognized tax benefits, as during the second quarter of 2025 the Company released liabilities associated with unrecognized tax benefits upon the settlement of an IRS audit. In the second quarter of 2026, the non-GAAP ETR was 15.5%, compared to 8.3% in the second quarter of 2025.
A reconciliation of the Company’s GAAP to non-GAAP results is included in Table 3 of this press release.
Capital Allocation
During the three and six months ended June 30, 2026, the Company repurchased $1.2 billion and $2.0 billion, respectively, of its common stock. As of June 30, 2026, $2.5 billion remained available for share repurchases under the Company’s share repurchase programs.
In July 2026, the Company’s board of directors declared a cash dividend of $0.94 per share on the Company’s common stock and Class A stock, payable on August 31, 2026 to shareholders of record as of August 18, 2026.
2026 Financial Guidance*
The Company’s full year 2026 financial guidance consists of the following components:
2026 Guidance
Prior
Updated
GAAP R&D $6.450–$6.680 billion $6.500–$6.635 billion
Non-GAAP R&D(a)
$5.900–$6.100 billion $5.950–$6.050 billion
GAAP SG&A
$2.860–$3.040 billion $2.830–$2.960 billion
Non-GAAP SG&A(a)
$2.500–$2.650 billion $2.500–$2.600 billion
GAAP gross margin on net product sales
77%–78% 78%–79%
Non-GAAP gross margin on net product sales(a)
83%–84% 84%–85%
GAAP COCM
$955 million–$1.035 billion
$985 million–$1.035 billion
Non-GAAP COCM(a)
$940 million–$1.020 billion $970 million–$1.020 billion
Capital expenditures
$1.100–$1.200 billion
$1.030–$1.100 billion
GAAP effective tax rate 12%–14% 13%–14%
Non-GAAP effective tax rate(a)
13%–15% 14%–15%
* The Company’s 2026 financial guidance does not assume the completion of any business development transactions not completed as of the date of this press release

(Press release, Regeneron, JUL 30, 2026, View Source [SID1234669546])

On July 30, 2026 Nanjing Leads Biolabs Co., Ltd. ("Leads Biolabs" or the "Company," Stock Code: 9887.HK) reported that the Phase II clinical study of its core product Opamtistomig (LBL-024, a PD-L1/4-1BB bispecific antibody) for the treatment of first-line advanced biliary tract cancer (BTC) has completed enrollment of all 70 patients. In April 2026, the study successfully entered the expansion phase based on a favorable safety profile and robust efficacy that exceeded expectations, and rapidly completed full patient enrollment, fully demonstrating the efficient clinical advancement and continuously validated significant efficacy of Opamtistomig.

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Despite the recent adoption of PD-(L)1 immunotherapy combined with chemotherapy as a first-line standard of care for advanced BTC, clinical benefits remain limited. Current standard regimens, including pembrolizumab plus chemotherapy and durvalumab plus chemotherapy, have demonstrated objective response rates (ORR) below 30% and median overall survival (OS) of only approximately 12–13 months, leaving a substantial unmet medical need in this aggressive malignancy.

The potential of Opamtistomig as an IO 2.0 pan-tumor cornerstone therapy has been continuously validated across three dimensions: broad-spectrum anti-tumor activity, long-term survival benefit trends, and a safety profile comparable to PD-(L)1 monoclonal antibodies. Existing data show that, following extrapulmonary neuroendocrine carcinoma (EP-NEC) and small cell lung cancer (SCLC), Opamtistomig has once again demonstrated highly competitive efficacy in BTC, a typical immune-cold tumor, with the potential to elevate the efficacy of immunotherapy in BTC to new heights. Given that the predominant pathological type of BTC is adenocarcinoma, combined with the positive data previously observed in squamous cell carcinoma subtypes of major cancer types such as non-small cell lung cancer (NSCLC), Opamtistomig has shown clear efficacy in both adenocarcinoma and squamous cell carcinoma types, with its broad-spectrum anti-cancer potential being continuously validated.

The multicenter study is led by Academician Zhou Jian of Zhongshan Hospital, Fudan University and is being conducted across multiple hospitals in China. Results from safety run-in data showed that Opamtistomig in combination with chemotherapy demonstrated a favorable overall safety profile and good tolerability, with no new safety signals identified. Preliminary efficacy assessments showed an encouraging tumor shrinkage. Detailed clinical data will be presented at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Annual Meeting to be held in Madrid, Spain from October 23 to 27, 2026.

Executive Commentary
Dr. Charles Cai, Chief Medical Officer of Leads Biolabs, said: "The rapid progress of our Phase II BTC study reflects the strong confidence investigators and patients have placed in the encouraging efficacy signals generated by Opamtistomig to date. Immune-cold tumors remain among the greatest challenges in oncology and represent one of the most important frontiers for next generation immunotherapy. Across multiple immune-cold tumor types, Opamtistomig has consistently demonstrated promising clinical activity, further validating its potential as an IO 2.0 pan-tumor cornerstone therapy. We are committed to accelerating the clinical development of Opamtistomig in BTC and look forward to bringing a more effective and durable treatment option to patients with this devastating disease as early as possible."

About Biliary Tract Cancer
Biliary tract malignancies primarily include gallbladder cancer and intrahepatic/extrahepatic cholangiocarcinoma, with approximately 419,100 new cases globally in 2024. These malignancies are predominantly ‌adenocarcinomas‌ with high invasiveness, and most cases are diagnosed at advanced stages, leading to ‌poor prognosis‌ (5-year survival rate <5%)‌. Currently, global incidence of biliary tract malignancies is rising, with the highest prevalence observed in Asian countries.

Although ‌PD-1/L1 inhibitors combined with chemotherapy‌ have been approved as first-line treatment for advanced biliary tract malignancies, clinical benefits remain limited: ‌Modest improvement in median overall survival (OS)‌ (from ~11.5 to 12.8 months)‌ and ‌Low objective response rate (ORR)‌ (<30%)‌. These gaps highlight ‌unmet medical needs‌ for more effective therapies‌.

About Opamtistomig
Opamtistomig (LBL-024) is emerging as a next-generation pan-cancer backbone therapy with potential overall survival (OS) benefit that simultaneously targets PD-L1 and the co-stimulatory receptor 4-1BB. Developed using Leads Biolabs’ proprietary X-Body bispecific platform, Opamtistomig is designed to simultaneously block PD-1/L1 immune suppression and conditionally activate 4-1BB, an agonist pathway, resulting in a potent and synergistic anti-tumor immune response. It has a safety profile comparable to PD-1/PD-L1 inhibitors and demonstrates broader-spectrum anti-cancer potential. To date, Opamtistomig has demonstrated first- or best-in-class potential in Phase II or registrational clinical trials across four indications: non-small cell lung cancer (NSCLC), small cell lung cancer (SCLC), biliary tract cancer (BTC), and extrapulmonary neuroendocrine carcinoma (EP-NEC).

As the first 4-1BB–targeting bispecific antibody globally to advance to a single-arm pivotal trial as monotherapy, Opamtistomig has been evaluated in 13 solid tumor indications in China, including 1 pivotal registration trial and 8 proof-of-concept studies. These cover EP-NEC, NSCLC, SCLC, BTC, ovarian cancer (OC), esophageal squamous cell carcinoma (ESCC), hepatocellular carcinoma (HCC), gastric cancer (GC), triple-negative breast cancer (TNBC), malignant melanoma, and other areas with high unmet medical needs.

Mechanistically, 4-1BB agonism can reactivate exhausted T cells and promote robust T-cell proliferation, offering significant promise for PD-1/PD-L1–resistant or immunologically "cold" tumors. Recognizing its clinical potential, Opamtistomig received Breakthrough Therapy Designation (BTD) from China’s National Medical Products Administration (NMPA) in October 2024, and Orphan Drug Designation (ODD) from the U.S. Food and Drug Administration (FDA) for the treatment of neuroendocrine carcinoma in November 2024. Additionally, in January 2026, Opamtistomig was granted Fast Track Designation (FTD) by the FDA and ODD by the European Commission for the treatment of EP-NEC, further underscoring its potential to address unmet medical needs in this patient population.

(Press release, Nanjing Leads Biolabs, JUL 30, 2026, View Source [SID1234669563])