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 Bicycle Therapeutics plc (NASDAQ: BCYC), a pharmaceutical company pioneering a new and differentiated class of therapeutics based on its proprietary bicyclic peptide (Bicycle) technology, reported financial results for the second quarter ended June 30, 2026, and provided recent corporate updates.

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"We are pleased with the progress we made during the second quarter. Our financial discipline with refined focus on nuzefatide pevedotin and our next-generation Bicycle conjugate pipeline, including Bicycle Radioconjugates (BRC), leaves us well capitalized to pursue our mission to help patients to not only live longer, but also live well," said Bicycle CEO Kevin Lee, Ph.D. "The encouraging data we presented during the quarter continue to deepen our belief in the potential of our technology to deliver oncology therapeutics with a superior benefit/risk profile against high-value targets like EphA2 and Nectin-4, the former being historically considered undruggable using antibody-based approaches. We believe this profile provides a strong rationale for developing nuzefatide in recurrent pancreatic cancer, where we successfully dosed our first patient in the ongoing Phase 2 trial in April. We remain on track to begin the Phase 1 trial for BT1702, our MT1-MMP targeting BRC, in 2027, backed by compelling human imaging data validating the targeting precision and translatability of our Bicycle technology."

Dr Lee added: "It is an honor to welcome world-renowned oncologist Professor Thomas Powles to our Clinical Advisory Board. His deep clinical insights and distinguished leadership in urothelial cancers will be instrumental as we accelerate our efforts to deliver precision-targeted therapies for patients."

Second Quarter 2026 and Recent Events

· Data presented at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting 2026 highlights significant opportunities for nuzefatide pevedotin (nuzefatide), a potentially first-in-class EphA2 targeting Bicycle Drug Conjugate (BDC), in EphA2 expressing cancers.

o As of the February 9, 2026 data cutoff, results from the Phase 1/2 trial evaluating nuzefatide 6.5mg/m2 once every two weeks (Q2W) plus nivolumab 480mg once every four weeks (Q4W) in 14 patients with metastatic urothelial cancer (mUC) who had previously progressed on a checkpoint inhibitor (10 while on enfortumab vedotin) showed a differentiated safety profile as well as promising anti-tumor activity.

o Preclinical assessment of nuzefatide anti-tumor activity in patient-derived xenograft (PDX) models of pancreatic ductal adenocarcinoma (PDAC). Expression of EphA2 was found in all 16 PDAC PDX models. Of the 14 PDAC PDX models assessed for anti-tumor activity, 10 models were sensitive to nuzefatide, six of which showed high sensitivity.

o Nuzefatide demonstrated potent preclinical anti-tumor activity in EphA2-expressing cell-line-derived xenograft models of head and neck squamous cell carcinoma.

Altogether, Bicycle Therapeutics believes that these data underscore the therapeutic potential for nuzefatide in EphA2-expressing cancers, including pancreatic cancer.

Bicycle Therapeutics is actively enrolling patients in a Phase 2 clinical trial to evaluate efficacy, safety, and pharmacokinetics of nuzefatide in adult patients with recurrent PDAC. The first patient was successfully dosed in April 2026 at the 8mg/m2 Q2W preferred dose for the trial.

· Additional human imaging data of a Bicycle Imaging Agent (BIA) targeting EphA2 in patients with PDAC presented at AACR (Free AACR Whitepaper) Annual Meeting 2026. The German Cancer Consortium (DKTK), part of a cooperative network with the German Cancer Research Center (DKFZ), presented human imaging data conducted with a Bicycle molecule targeting EphA2 labelled with gallium-68 (EphA2 BIA) in seven patients with histologically confirmed PDAC. Bicycle Therapeutics believes these data validate the potential of EphA2 as a novel target in the treatment of cancer, demonstrate the translatability of preclinical data and highlight the potential of Bicycle molecules for targeted radioligand therapies and radiopharmaceutical imaging.

Bicycle Therapeutics continues to advance its emerging radioligand pipeline, with the initiation of the first company-sponsored radioligand clinical trial for BT1702, an MT1-MMP targeting BRC, expected in 2027.

· Initial Duravelo-2 data presented at 2026 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting demonstrates encouraging response rates comparable to published data for standard of care (SOC) and a potentially differentiated safety profile in previously untreated patients with mUC. Zelenectide pevedotin (zelenectide) is a BDC targeting Nectin-4, a well-validated tumor antigen. The dose optimization stage of the randomized Phase 2 Duravelo-2 trial evaluated two doses of zelenectide – 5mg/m2 weekly (5mg dose) and 6mg/m2 (6mg dose) two weeks on, one week off – in combination with 200mg of pembrolizumab once every three weeks in previously untreated patients with mUC (Cohort 1). Bicycle Therapeutics reached regulatory alignment on the zelenectide 6mg dose as optimal both in combination with pembrolizumab and as a monotherapy. Cohort 1 data were extracted for the interim analysis at Week 27, on July 23, 2025. At the time of the data cut, the median progression-free survival (PFS) was not mature, and the results at the optimal dose showed:

o 65% (17/26) overall response rate (ORR) regardless of confirmation and blinded independent central review (BICR) confirmed ORR of 58% (15/26) at the 27-week cutoff. Subsequent to the 27-week cutoff, an additional confirmed BICR response was observed, which would result in an ORR of 62% (16/26).

o Low rates of zelenectide-related adverse events (AEs) of clinical interest were observed, including peripheral neuropathy, sensory (33%); skin reactions (17%); eye disorders (10%).

o There were no reported instances of zelenectide-related hyperglycemia and no zelenectide-related severe skin reactions of any grade.

· Updated Duravelo-1 data presented at 2026 ASCO (Free ASCO Whitepaper) Annual Meeting demonstrates encouraging median PFS comparable to published data for SOC in previously untreated, cisplatin-ineligible mUC patients. Updated Phase 1 Duravelo-1 results as of the August 1, 2025 data cutoff evaluating zelenectide at the 5mg dose in combination with pembrolizumab in previously untreated cisplatin-ineligible patients, 45% of whom were classified as Eastern Cooperative Oncology Group (ECOG) performance status of 2, showed:

o 59% (13/22) ORR regardless of confirmation, 50% confirmed ORR (11/22), and a disease control rate (DCR) of 82%. Of the confirmed responses, 5 (23%) were complete responses and 6 (27%) were partial responses.

o Median PFS was 13.0 months and median duration of response (mDOR) was not mature at the time of the data cutoff.

Across all patients, the safety and tolerability profile was consistent with other zelenectide data to date. No new safety signals were observed and there were no Grade 4 or Grade 5 zelenectide-related AEs of clinical interest reported.

· Expanded Clinical Advisory Board with the addition of Thomas Powles, MBBS, MRCP, M.D. Dr. Powles is a Professor of Genitourinary Oncology and Director of Barts Cancer Centre at St Bartholomew’s Hospital, and Lead for Solid Tumor Research at Barts Cancer Institute, London. Dr. Powles is an international leader in the treatment of urothelial cancers, with a research focus spanning from Phase 1 to randomized Phase 3 clinical trials, particularly in translational Phase 2 studies investigating novel targeted and immune therapies. He has played a critical role in leading over twenty randomized clinical trials, resulting in multiple U.S. Food and Drug Administration (FDA) and European Medicines Agency approvals.

Second Quarter 2026 Financial Results

· Cash and cash equivalents were $510.1 million as of June 30, 2026, compared to $628.1 million as of December 31, 2025. The decrease in cash and cash equivalents is primarily due to cash used in operations, including cash payments for clinical program activities.

· Research and development (R&D) expenses were $41.2 million for the three months ended June 30, 2026, compared to $71.0 million for the three months ended June 30, 2025. The decrease in expense of $29.8 million was primarily due to decreased clinical program expenses for zelenectide, decreased personnel-related costs and share-based compensation due to our recent workforce reduction announced in March 2026, as well as decreased discovery, platform and other expenses, offset by lower U.K. R&D tax credits period over period.

· General and administrative (G&A) expenses were $14.0 million for the three months ended June 30, 2026, compared to $18.5 million for the three months ended June 30, 2025. The decrease in expense of $4.5 million was primarily due to decreased professional and consulting fees and decreased personnel-related costs and share-based compensation due to our recent workforce reduction announced in March 2026.

· Net loss was $50.3 million, or $(0.72) basic and diluted net loss per share, for the three months ended June 30, 2026, compared to net loss of $79.0 million, or $(1.14) basic and diluted net loss per share, for the three months ended June 30, 2025.

(Press release, Bicycle Therapeutics, JUL 30, 2026, View Source [SID1234669526])

On July 30, 2026 Agios Pharmaceuticals, Inc. (Nasdaq: AGIO), a commercial-stage biopharmaceutical company focused on delivering innovative medicines for patients with rare diseases, reported financial results and updates for the second quarter ended June 30, 2026.

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"Our second-quarter performance reflects continued execution across the key priorities that will drive sustainable growth for Agios: strong commercial momentum, pipeline diversification, and strategic portfolio discipline," said Brian Goff, Chief Executive Officer, Agios. "We are encouraged by the ongoing U.S. commercial launch of AQVESME in thalassemia, which continues to see robust engagement from both physicians and patients. We also progressed mitapivat toward a potential new indication in sickle cell disease, highlighted by the FDA granting Priority Review for our sNDA. Beyond these milestones, we strengthened our hematology pipeline with the licensing of cevidoplenib and advancement of AG-236 into Phase 2/3 development, while maintaining disciplined capital allocation. Together, these achievements underscore our ability to deliver meaningful innovation for patients and long-term shareholder value."

Second Quarter 2026 and Recent Corporate Highlights
•Mitapivat (PYRUKYND and AQVESME) Commercial Performance and Update –
o$40.9 million in U.S. net revenue and $3.8 million in ex-U.S. net revenue in the second quarter of 2026.
▪U.S. net revenue was driven by the U.S. commercial launch of AQVESME (mitapivat) in thalassemia in late January 2026.
▪Ex-U.S. net revenue reflected anticipated demand for PYRUKYND (mitapivat) in Europe following approval for thalassemia in May 2026, as well as continued, consistent early demand in Gulf Cooperation Council (GCC) countries.
oAs of June 30, 2026, 442 cumulative AQVESME prescriptions for thalassemia have been written by Risk Evaluation and Mitigation Strategy (REMS)-certified U.S. physicians.

•Business Development –
oAgios announced an agreement with Oscotec to license the exclusive global rights to cevidoplenib, a highly-selective, next-generation, oral spleen tyrosine kinase (SYK) inhibitor for immune thrombocytopenia (ITP). The addition of cevidoplenib diversifies Agios’ rare hematology portfolio and represents an opportunity to unlock up to $1.0 billion in peak U.S. sales potential in this indication.
oAgios expects to advance cevidoplenib into Phase 3 development for ITP in the first half of 2028, following completion of additional chemistry, manufacturing, and controls (CMC) development work.

Research and Development (R&D) Highlights
•Mitapivat (pyruvate kinase [PK] activator)
oThalassemia –
▪The European Commission (EC) granted marketing authorization for PYRUKYND in adults for the treatment of anemia associated with transfusion-dependent and non-transfusion-dependent alpha- or beta-thalassemia, with an orphan medicinal product designation. With this decision, PYRUKYND is the only medicine approved in all European Union (EU) member states for this broad patient population.
▪Mitapivat is now approved for adults with thalassemia in the U.S., Saudi Arabia, United Arab Emirates, and EU.

oSickle Cell Disease –
▪The U.S. Food and Drug Administration (FDA) accepted Agios’ supplemental New Drug Application (sNDA) for mitapivat in sickle cell disease with a Priority Review. The Prescription Drug User Fee Act (PDUFA) goal date for this sNDA, submitted under the FDA’s accelerated approval pathway, is November 1, 2026.
▪Additionally, Agios dosed the first patient in the REIGNITE Phase 3 trial, the confirmatory clinical trial required to be conducted under the accelerated approval pathway. This global trial is designed to demonstrate the clinical benefit of mitapivat on reducing transfusion burden in patients with sickle cell disease aged 12 years or older.
▪Agios also filed for regulatory approval of mitapivat for sickle cell disease in Saudi Arabia.

•AG-236 (siRNA targeting TMPRSS6)
oPolycythemia Vera –
▪Results from Agios’ Phase 1 trial of AG-236 in healthy volunteers demonstrated sustained hepcidin control and effects on iron regulation biomarkers without the need for titration, supporting iron pathway modulation that can potentially address excess red blood cell production in polycythemia vera.
▪The data also indicate the potential for an up to every-six-month dosing schedule.
▪Based on these results, Agios will advance AG-236 into a Phase 2/3 development program in polycythemia vera, with initiation of the Phase 2 portion expected in the second half of 2026.

•AG-181 (phenylalanine hydroxylase [PAH] stabilizer)
oPhenylketonuria (PKU) –
▪Agios dosed the first patient in the Phase 1b trial evaluating the safety and tolerability of AG-181 in adults with PKU. Data from this trial are expected in the second half of 2026.
•Tebapivat (PK activator)
oLower-Risk Myelodysplastic Syndromes (LR-MDS) –
▪Agios announced that it will not advance tebapivat in LR-MDS following results from the company’s Phase 2b trial. While tebapivat demonstrated evidence of biological activity, it did not demonstrate clinical benefit in a sufficient proportion of patients or any patient subgroup to meet the company’s predefined threshold for advancement in LR-MDS.

oSickle Cell Disease –
▪Agios announced that it will not advance tebapivat in sickle cell disease following results from the company’s Phase 2 trial. The data further reinforced PK activation as a clinically validated mechanism in sickle cell disease; however, they did not demonstrate a sufficiently differentiated profile relative to other PK activators to justify continued development of tebapivat in this indication.

Second Quarter 2026 Financial Results
For the quarter ended June 30, 2026, net loss was $100.7 million, compared to net loss of $112.0 million for the quarter ended June 30, 2025.
•Net product revenue from U.S. sales of mitapivat (PYRUKYND and AQVESME) for the second quarter of 2026 was $40.9 million, compared to $12.2 million for the second quarter of 2025.

•Net product revenue from ex-U.S. sales of mitapivat (PYRUKYND) for the second quarter of 2026 was $3.8 million, compared to $0.3 million for the second quarter of 2025.
•Cost of sales for the second quarter of 2026 was $3.0 million.

•Research and Development (R&D) expenses were $100.8 million for the second quarter of 2026, compared to $91.9 million for the second quarter of 2025, driven primarily by the $25.0 million up-front payment associated with the agreement with Oscotec to license cevidoplenib.

•Selling, General and Administrative (SG&A) expenses were $51.5 million for the second quarter of 2026, compared to $45.9 million for the second quarter of 2025, due to an increase in activities related to the U.S. commercial launch of AQVESME in thalassemia.

•Cash, cash equivalents and marketable securities were $964.8 million as of June 30, 2026, compared to $1.2 billion as of December 31, 2025. Agios expects that its cash, cash equivalents and marketable securities, together with anticipated product revenue and interest income, will provide the financial independence to execute the U.S. commercial launch of AQVESME in thalassemia, prepare for the potential U.S. commercial launch of mitapivat in sickle cell disease, advance the company’s existing clinical programs, and opportunistically expand its pipeline through both internally- and externally-discovered assets.

Second Quarter 2026 Conference Call Information
Agios will host a conference call and live webcast today, July 30, 2026, at 8:00 a.m. ET to discuss the company’s second quarter 2026 financial results and recent business highlights. The live webcast will be accessible on the Investors section of the company’s website (www.agios.com) under the "Events & Presentations" tab. A replay of the webcast will be available on the company’s website approximately two hours after the event.

(Press release, Agios Pharmaceuticals, JUL 30, 2026, View Source [SID1234669525])

On July 29, 2026 Boston Scientific reported second quarter 2026 results.

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(Presentation, Boston Scientific, JUL 29, 2026, View Source [SID1234670607])

On July 29, 2026, Northwest Biotherapeutics (OTCQB:NWBO) (the "Company" or "NW Bio"), a biotechnology company developing DCVax personalized immune therapies for solid tumor cancers, reported to have entered into a $4.9 million convertible Promissory Note financing with YA II PN, Ltd., an investment fund managed by Yorkville Advisors Global, LP ("Yorkville"). The term of the Note is 12 months. No payments by the Company are due until maturity. The Note carries an Original Issue Discount of five percent but no interest. Repayment of all outstanding amounts is due at maturity. The Note includes customary default provisions. During the term of the Note, it is convertible at the option of the holder, at a small discount to the then prevailing market price. The Company plans to use the proceeds for general corporate purposes, including both its lead product and its in-licensed portfolios.

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The Company and Yorkville also entered into a standby equity subscription agreement (the "Subscription Agreement") which the Company may use after the Note is repaid or converted. The prior standby equity subscription agreement was cancelled. Under this Subscription Agreement, NW Bio has the option, in its discretion, to require Yorkville to subscribe for up to $50 million of common shares in the Company at any time during the 24-month term of the Subscription Agreement at a small discount to the then prevailing market price, after the Note is repaid or converted. The Company has no obligation to make any such use of this arrangement, and the Company can cancel the arrangement at any time after the Note is repaid or converted. The Company has no current plans to draw upon this standby facility; however, the Company believes it will be useful to have this facility available for special funding needs in connection with certain key potential upcoming milestones.

Yorkville also acquired a warrant to purchase up to $2 million of shares at $0.205 per share pursuant to the above transaction.

(Filing, Northwest Biotherapeutics, JUL 29, 2026, View Source [SID1234669577])