On July 31, 2025 AbbVie (NYSE:ABBV) reported financial results for the second quarter ended June 30, 2025 (Press release, AbbVie, JUL 31, 2025, View Source [SID1234654664]).

"AbbVie delivered another outstanding quarter with strong performance from our diversified growth platform. We also made meaningful pipeline progress with several regulatory approvals, encouraging clinical data and strategic investments in promising external innovation," said Robert A. Michael, chairman and chief executive officer, AbbVie. "We’re entering the second half of the year with substantial momentum and are once again raising our full-year outlook."

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Second-Quarter Results

•Worldwide net revenues were $15.423 billion, an increase of 6.6 percent on a reported basis, or 6.5 percent on an operational basis.

•Global net revenues from the immunology portfolio were $7.631 billion, an increase of 9.5 percent on a reported basis, or 9.2 percent on an operational basis.
◦Global Skyrizi net revenues were $4.423 billion, an increase of 62.2 percent on a reported basis, or 61.8 percent on an operational basis.
◦Global Rinvoq net revenues were $2.028 billion, an increase of 41.8 percent on a reported basis, or 41.2 percent on an operational basis.
◦Global Humira net revenues were $1.180 billion, a decrease of 58.1 percent on a reported basis, or 58.2 percent on an operational basis.

•Global net revenues from the neuroscience portfolio were $2.683 billion, an increase of 24.2 percent on a reported basis, or 24.0 percent on an operational basis.
◦Global Vraylar net revenues were $900 million, an increase of 16.3 percent.
◦Global Botox Therapeutic net revenues were $928 million, an increase of 14.1 percent on a reported basis, or 14.2 percent on an operational basis.
◦Global Ubrelvy net revenues were $338 million, an increase of 47.1 percent on a reported basis, or 47.2 percent on an operational basis.
◦Global Qulipta net revenues were $267 million, an increase of 77.5 percent on a reported basis, or 76.9 percent on an operational basis.

•Global net revenues from the oncology portfolio were $1.676 billion, an increase of 2.6 percent on a reported basis, or 2.4 percent on an operational basis.
◦Global Imbruvica net revenues were $754 million, a decrease of 9.5 percent.
◦Global Venclexta net revenues were $691 million, an increase of 8.5 percent on a reported basis, or 8.3 percent on an operational basis.
◦Global Elahere net revenues were $159 million, an increase of 24.2 percent on a reported basis, or 23.7 percent on an operational basis.

•Global net revenues from the aesthetics portfolio were $1.279 billion, a decrease of 8.1 percent on a reported basis, or 8.0 percent on an operational basis.
◦Global Botox Cosmetic net revenues were $692 million, a decrease of 5.0 percent on a reported basis, or 4.9 percent on an operational basis.
◦Global Juvederm net revenues were $260 million, a decrease of 24.0 percent.

•On a GAAP basis, gross margin in the second quarter was 71.8 percent. The adjusted gross margin was 84.4 percent.

•On a GAAP basis, selling, general and administrative (SG&A) expense was 21.1 percent of net revenues. The adjusted SG&A expense was 21.0 percent of net revenues.

•On a GAAP basis, research and development (R&D) expense was 13.8 percent of net revenues. The adjusted R&D expense was 13.7 percent of net revenues.

•Acquired IPR&D and milestones expense was 5.3 percent of net revenues.

•On a GAAP basis, operating margin in the second quarter was 31.7 percent. The adjusted operating margin was 44.3 percent.

•Net interest expense was $678 million.

•On a GAAP basis, the tax rate in the quarter was 39.4 percent. The adjusted tax rate was 16.2 percent.

•Diluted EPS in the second quarter was $0.52 on a GAAP basis. Adjusted diluted EPS, excluding specified items, was $2.97. These results include an unfavorable impact of $0.42 per share related to acquired IPR&D and milestones expense.

Recent Events

•AbbVie announced the U.S. Food and Drug Administration (FDA) approved Rinvoq (upadacitinib) as the first oral Janus Kinase (JAK) inhibitor approved for the treatment of adults with giant cell arteritis (GCA). The approval was supported by data from the pivotal Phase 3 SELECT-GCA trial, which met the primary endpoint of sustained remission and key secondary endpoints. This marks the ninth approved indication for Rinvoq in the U.S., across rheumatology, gastroenterology and dermatology.

•AbbVie announced positive topline results from the first of two pivotal studies in the Phase 3 UP-AA clinical program evaluating the safety and efficacy of Rinvoq in adult and adolescent patients with severe alopecia areata (AA). In the study, Rinvoq achieved the primary endpoint, demonstrating that 44.6% and 54.3% of patients with severe AA treated with Rinvoq 15mg and 30mg, respectively, reached 80% or more scalp hair coverage at week 24 as defined by the severity of alopecia tool (SALT) score ≤20. Key secondary endpoints, including improvements in eyebrows and eyelashes, as well as the percentage of subjects with 90% or more scalp coverage (SALT ≤10) and complete scalp hair coverage (SALT=0) at Week 24, were also met. Rinvoq’s safety profile in AA was generally consistent with that in approved indications, and no new safety signals were identified in this study.

•AbbVie and Capstan Therapeutics, a clinical-stage biotechnology company dedicated to advancing in vivo engineering of cells through RNA delivery using targeted lipid nanoparticles (tLNPs), announced a definitive agreement under which AbbVie will acquire Capstan. The transaction includes CPTX2309, a potential first-in-class in vivo tLNP anti-CD19 CAR-T therapy candidate, currently in Phase 1 development for the treatment of B cell-mediated autoimmune diseases. Additionally, AbbVie will acquire Capstan’s proprietary tLNP platform technology designed to deliver RNA payloads, such as mRNA, capable of engineering specific cell types in vivo.

•AbbVie announced new data from its Phase 3 TEMPLE head-to-head study evaluating the tolerability, safety and efficacy of Qulipta (atogepant) compared to topiramate for the preventive treatment of migraine in adult patients with a history of four or more migraine days per month. In the study, Qulipta met the primary endpoint of fewer treatment discontinuations attributed to adverse events versus topiramate, and all six secondary endpoints achieved statistical significance for superiority versus topiramate, demonstrating clinical efficacy. Full results from the TEMPLE study will be presented at an upcoming medical meeting.

•AbbVie announced that Emrelis (telisotuzumab vedotin-tllv) was granted accelerated approval by the FDA for the treatment of adult patients with locally advanced or metastatic, non-squamous non-small cell lung cancer (NSCLC) with high c-Met protein overexpression who have received a prior systemic therapy. Emrelis is the first treatment approved for previously treated advanced NSCLC patients with high c-Met protein overexpression, a population that often faces poor prognosis and has limited treatment options.

•AbbVie announced the submission of a supplemental New Drug Application (sNDA) to the FDA for Venclexta (venetoclax) and acalabrutinib combination therapy for the treatment of chronic lymphocytic leukemia (CLL). This combination therapy has potential to be the first all oral, fixed-duration regimen for previously untreated patients with CLL. The submission is supported by data from the Phase 3 AMPLIFY trial which demonstrated that the combination regimen of Venclexta and acalabrutinib improved progression-free survival (PFS) compared to standard chemoimmunotherapy in previously untreated patients with CLL.

•At the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting, AbbVie presented key data that showcased significant progress across AbbVie’s robust oncology pipeline, in a range of difficult-to-treat solid tumors and blood cancers. Highlights included new data from AbbVie’s novel investigational antibody-drug conjugates (ADCs) telisotuzumab adizutecan (ABBV-400, Temab-A) in advanced NSCLC, ABBV-706 in high-grade neuroendocrine neoplasms (NENs) and pivekimab sunirine (PVEK) in blastic plasmacytoid dendritic cell neoplasm (BPDCN).

•AbbVie announced the global Phase 3 VERONA trial evaluating Venclexta (venetoclax) in combination with azacitidine in the treatment of newly diagnosed higher-risk myelodysplastic syndrome (MDS) did not meet the primary endpoint of overall survival. No new safety signals were observed and results from the trial will be available in a future medical congress and/or publication.

•AbbVie and Ichnos Glenmark Innovation (IGI) announced an exclusive licensing agreement for IGI’s lead investigational asset, ISB 2001, which is being investigated for the treatment of oncology and autoimmune diseases. ISB 2001 is a first-in-class trispecific T-cell engager currently in Phase 1 development for relapsed/refractory (r/r) multiple myeloma (MM).

•AbbVie announced the FDA approved a label expansion for Mavyret (glecaprevir/pibrentasvir), an oral pangenotypic direct acting antiviral (DAA) therapy. Mavyret is the first oral eight-week pangenotypic treatment option approved for people with acute or chronic hepatitis C virus (HCV). With this approval, providers can now treat HCV patients immediately at the time of diagnosis.

•AbbVie and ADARx Pharmaceuticals, a late clinical-stage biotechnology company developing next-generation RNA therapeutics, announced a collaboration and license option agreement to develop small interfering RNA (siRNA) therapeutics across multiple disease areas. The collaboration will leverage AbbVie’s expertise in biotherapeutic drug development and commercialization with ADARx’s proprietary RNA technology to advance next-generation siRNA therapies across neuroscience, immunology and oncology.

Full-Year 2025 Outlook

AbbVie is raising its adjusted diluted EPS guidance for the full year 2025 from $11.67 – $11.87 to $11.88 – $12.08, which includes an unfavorable impact of $0.55 per share related to acquired IPR&D and milestones expense incurred year-to-date through the second quarter 2025. The company’s 2025 adjusted diluted EPS guidance excludes any impact from acquired IPR&D and milestones that may be incurred beyond the second quarter of 2025, as both cannot be reliably forecasted.

On July 31, 2025 BeOne Medicines Ltd. (NASDAQ: ONC; HKEX: 06160; SSE: 688235), a global oncology company, reported that the European Medicines Agency (EMA) has granted PRIority MEdicines (PRIME) designation to the Company’s investigational Bruton’s tyrosine kinase (BTK) degrader, BGB-16673, for the treatment of patients with Waldenstrom’s macroglobulinemia (WM) previously treated with a BTK inhibitor (Press release, BeOne Medicines, JUL 31, 2025, View Source [SID1234654690]).

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"This is the Company’s first PRIME designation, marking a milestone for BeOne and providing early and enhanced interaction with the EMA as we advance BGB-16673," said Julie Lepin, Senior Vice President, Chief Regulatory Affairs Officer at BeOne. "PRIME allows us to align early with the EMA on key evidence requirements and potentially accelerate our path to marketing authorization of BGB-16673 for patients with relapsed or refractory Waldenstrom’s macroglobulinemia."

In addition to the PRIME designation, the EMA’s Committee for Medicinal Products for Human Use (CHMP) issued a positive opinion on the EU Orphan Drug Designation (ODD) application for BGB-16673 in WM. A final decision is anticipated in the coming weeks. The U.S. Food and Drug Administration (FDA) also granted Fast Track Designation to BGB-16673 for the treatment of adult patients with relapsed or refractory (R/R) chronic lymphocytic leukemia or small lymphocytic lymphoma (CLL/SLL), and adult patients with R/R mantle cell lymphoma (MCL).

The EMA’s CHMP granted PRIME designation to BGB-16673 based on data demonstrating its novel mechanism and anti-tumor activity in B-cell malignancies. The CHMP recognized the limited treatment options available for WM patients post-BTK inhibitor therapy and acknowledged the strong biological rationale and promising clinical data for BGB-16673 in this setting, thereby demonstrating the potential to address the unmet medical need.

The PRIME initiative, launched by the EMA in 2016, provides early, proactive, and enhanced regulatory support to developers of promising medicines. It is designed to optimize development plans and accelerate evaluation, helping innovative therapies reach patients with unmet medical needs faster.

About BGB-16673

BGB-16673 is an orally available Bruton’s tyrosine kinase (BTK) targeting protein degrader from BeOne’s chimeric degradation activation compound (CDAC) platform. BGB-16673 is designed to promote the degradation, or breakdown, of both wild-type and mutant forms of BTK, including those that commonly result in resistance to BTK inhibitors in patients who experience progressive disease. BGB-16673 is the most advanced BTK protein degrader in the clinic, with an extensive global clinical development program.

On July 31, 2025 Sumitomo Dainippon Pharma reported Conference on Q1 FY2025 (April 1, 2025 to June 30, 2025) Financial Results.

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(Presentation, Sumitomo Dainippon Pharma, JUL 31, 2025, View Source [SID1234661679])

On July 31, 2025 Imugene Limited (ASX:IMU), a clinical-stage immuno- oncology company, reported its Quarterly Cash Flow report (Appendix 4C) for the quarter ended 30 June 2025 (Press release, Imugene, JUL 31, 2025, https://mcusercontent.com/e38c43331936a9627acb6427c/files/0d0ee6a1-bf9b-f0a7-5414-bc82a36b02ed/IMU_Quarterly_ActivitiesAppendix_4C_Cash_Flow_Report.pdf [SID1234654647]).

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CLINICAL UPDATES

Two Additional Complete Responses and Three Partial Responses in azer-cel CAR T Phase 1b trial

Subsequent to the end of the quarter, Imugene reported further encouraging clinical results from its Phase 1b trial of azer-cel (azercabtagene zapreleucel), an allogeneic "off- the-shelf" CD19-targeting CAR T therapy for patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL).

Since the Company’s last update in February 2025, five additional patients have been treated in the trial. Of these, two achieved complete responses (CRs), defined as the disappearance of all signs of cancer, and three achieved partial responses (PRs), where tumours reduced in size by at least 50%. This brings the trial’s total best response rate to six complete responses and three partial responses bringing the overall response rate (ORR) to nine out of twelve patients, corresponding to a 75% ORR and a 55% CR rate.

The first patient treated remains cancer-free 15 months after dosing, while others have sustained responses for periods of greater than 2, 5, and 11+ months. The response durability continues to mature as more data accumulates. These patients had previously failed at least three, and in some cases up to six, prior lines of therapy, including autologous CAR T-cell therapies highlighting the potential of azer-cel in a high unmet- need population that has exhausted conventional treatment options.

Unlike currently approved autologous CD19 CAR T cell products, which require patient- specific manufacturing and face logistical limitations, azer-cel is designed as an allogeneic (donor-derived), off-the-shelf therapy that could significantly improve access and treatment timelines. Patients in this study are treated with a combination of lymphodepletion, azer-cel, and interleukin-2 (IL-2), a cytokine known to enhance CAR T- cell function and longevity.

Given the strength of the data and the FDA Fast Track Designation already granted for DLBCL, Imugene intends to meet with the US Food and Drug Administration in Q4 CY25 for a Type B (End of Phase 1) meeting. This interaction will focus on discussing the design of a pivotal or registrational trial that could lead to market approval.

In parallel with these developments, the azer-cel trial will now expand its scope to include other B-cell lymphomas in CAR T-naïve patients (those who have not previously received CAR T therapy). These include rare and underserved cancers such as primary central nervous system lymphoma (PCNSL), chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL), marginal zone lymphoma (MZL), follicular lymphoma (FL), and Waldenström macroglobulinemia (WM). Each of these indications currently suffers from limited treatment options in the relapsed/refractory setting, especially in patients who are ineligible for or unresponsive to existing therapies.

The trial is ongoing across ten sites in the United States, with up to six Australian sites planned.

First dose level cleared in IV combination arm of Phase 1 onCARlytics trial

In April, the Company announced the clearance of the first dose level in the intravenous (IV) combination arm of its Phase 1 onCARlytics clinical trial, known as OASIS. This milestone followed the successful completion of the initial safety observation period and allows the study to progress to the next dose level.

The OASIS trial is a first-in-human study targeting adult patients with advanced or metastatic solid tumours. Its aim is to evaluate both the safety and efficacy of two administration routes; intratumoural (IT) and intravenous (IV), for delivering the onCARlytics therapy. This therapy uses an engineered oncolytic virus (CF33-CD19) to make solid tumours express the CD19 protein, a well-validated target in blood cancers. By enabling CD19 expression in solid tumours, the trial seeks to make them susceptible to treatment with existing CD19-targeted therapies, such as the bispecific monoclonal antibody blinatumomab (Blincyto), which is used in combination with onCARlytics in this trial.

MAST Phase 1 Trial for VAXINIA in Bile Tract Cancer

The Metastatic Advanced Solid Tumours (MAST) trial evaluating CF33-hNIS (VAXINIA) continues to support the potential clinical benefit of our oncolytic virotherapy.

The expansion cohort has completed its first group of three patients without any dose- limiting toxicities, and the cohort remains open. The FDA has granted Orphan Drug Designation (ODD) for VAXINIA in biliary tract cancer, providing a range of regulatory and financial incentives to support ongoing development and potential partnering opportunities.

First Patient Dosed in Australia for PD1-Vaxx Neo-POLEM Phase II trial

In June, the first patient was dosed in Australia at the Queen Elizabeth Hospital in Adelaide as part of the Phase II Neo-POLEM clinical trial investigating its PD1-Vaxx immunotherapy. This investigator-sponsored trial is focused on patients with mismatch repair-deficient or microsatellite instability-high (dMMR/MSI-high) colorectal cancer, a subtype representing approximately 15% of all colorectal cancer cases.

Neo-POLEM is a neoadjuvant study, meaning treatment is administered prior to surgery. The trial is evaluating the potential of PD1-Vaxx, a therapeutic cancer vaccine designed to elicit an immune response against the PD-1 checkpoint protein to improve treatment outcomes in patients with early-stage, resectable disease. The vaccine aims to activate the patient’s immune system to target and reduce tumours before surgery is performed.

The trial is being conducted in collaboration with the Cancer Research UK Southampton Clinical Trials Unit, Royal Surrey Hospital NHS Foundation Trust, and the Australasian Gastro-Intestinal Trial Group (AGITG). Recruitment will span both Australia and the United Kingdom.

The study’s primary objective is to assess major pathological response, specifically tumour reduction post-treatment. Secondary objectives include evaluating safety, identifying biomarkers of immune response, and measuring overall response and survival outcomes.

PATENT PROTECTIONS

US patent issued for onCARlytics

Imugene received a Notice of Allowance from the United States Patent and Trademark Office for its patent application covering the onCARlytics platform. The patent, titled "Oncolytic Virus Expressing a CAR T Cell Target and Uses Thereof," protects both the composition and method of use of the Company’s CD19-expressing oncolytic virus technology. Subsequent to the end of the quarter, Imugene received notice of issue from the USPTO with a patent term extension of 110 days resulting in protection until November 28, 2038.

PD1-Vaxx patent portfolio further strengthened

In June 2025, the PD1-Vaxx cancer vaccine patent portfolio was further strengthened after receiving a Notice of Grant from the US Patent and Trademark Office (USPTO) confirming that US patent application no. 16/966442 has now issued as a patent. The official patent number is 12311019. The patent entitled "Vaccine Composition and Uses Thereof" received a 1110 day patent term extension from the USPTO meaning the patent is in force until February 2042.

On July 31, 2025 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, 2025 (Press release, Agios Pharmaceuticals, JUL 31, 2025, View Source [SID1234654665]).

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"With fewer than 40 days to our PDUFA goal date, our commercial team is prepared for the potential U.S. approval of PYRUKYND for thalassemia," said Brian Goff, Chief Executive Officer, Agios. "In the second quarter, we made progress advancing our early- and mid-stage pipeline and remain on track to deliver topline results of the RISE UP Phase 3 trial for PYRUKYND in sickle cell disease by the end of the year. Collectively, our progress reflects our continued focus on delivering innovative medicines with the potential to transform the lives of those affected by rare diseases and deliver long-term shareholder value."

Second Quarter 2025 and Recent Corporate Highlights

Commercial Performance – PYRUKYND (mitapivat)

Generated $12.5 million in net revenue for the second quarter of 2025, compared to $8.6 million in the second quarter of 2024.
248 unique patients completed prescription enrollment forms, representing an increase of 6 percent over the first quarter of 2025.
142 patients are on PYRUKYND therapy, inclusive of new starts and continued therapy, representing an increase of 4 percent over the first quarter of 2025.
Entered into a distribution agreement with Avanzanite Bioscience B.V., a rapidly growing European specialty pharmaceutical company focused on rare diseases, to distribute and commercialize PYRUKYND across the European Economic Area, the United Kingdom and Switzerland.
R&D Highlights

PYRUKYND (mitapivat)
Thalassemia –
Launch preparations underway ahead of U.S. PDUFA goal date of September 7, 2025. The sNDA for PYRUKYND for the treatment of adult patients with non-transfusion-dependent and transfusion-dependent alpha- or beta-thalassemia remains under active review by the U.S. Food and Drug Administration (FDA).
Other regulatory applications remain under review by health authorities in Saudi Arabia, United Arab Emirates, and the European Union.
Sickle Cell Disease –
Topline results from RISE UP Phase 3 trial of mitapivat in sickle cell disease on track by year-end with potential U.S. commercial launch in 2026.
Tebapivat
Sickle Cell Disease –
Dosed the first patient in the Phase 2 trial investigating tebapivat in sickle cell disease. The trial is enrolling across three dose cohorts (2.5mg, 5mg, 7.5mg) and placebo and the primary endpoint will measure hemoglobin response, defined as a ≥1g/dL increase in hemoglobin concentration from week 10 to week 12, compared to baseline.
Lower-risk Myelodysplastic Syndromes (LR-MDS) –
Continue to progress patient enrollment in the Phase 2b trial for tebapivat in LR-MDS with target enrollment completion by the end of 2025.
Early Pipeline
Investigational New Drug (IND) clearance received for AG-236, an siRNA targeting TMPRSS6 intended for the treatment of polycythemia vera (PV).
Presented new data on mitapivat and tebapivat at the 30th European Hematology Association (EHA) (Free EHA Whitepaper) Congress. A total of 14 presentations and publications, led by Agios and external collaborators, were shared, covering sickle cell disease, thalassemia, PK deficiency, and MDS.
Second Quarter 2025 Financial Results

For the quarter ended June 30, 2025, net loss was $112.0 million dollars, compared to a net loss of $96.1 million dollars for the second quarter ended June 30, 2024.

Net product revenue from sales of PYRUKYND for the second quarter of 2025 was $12.5 million, compared to $8.6 million for the second quarter of 2024.
Cost of sales for the second quarter of 2025 was $1.7 million.
Research and Development (R&D) Expenses were $91.9 million for the second quarter of 2025, compared to $77.4 million for the second quarter of 2024. The year-over-year increase was primarily attributed to a $10.0 million regulatory milestone payment to Alnylam associated with our agreement to develop and commercialize AG-236, an siRNA targeting TMPRSS6, intended for the treatment of polycythemia vera.
Selling, General and Administrative (SG&A) Expenses were $45.9 million for the second quarter of 2025 compared to $35.5 million for the second quarter of 2024. The year-over-year increase was primarily attributable to an increase in commercial-related activities, including headcount, as the company prepares for the potential approval of PYRUKYND in thalassemia.
Cash, cash equivalents and marketable securities as of June 30, 2025, were $1.3 billion compared to $1.5 billion as of December 31, 2024. Agios expects that its cash, cash equivalents and marketable securities, together with anticipated product revenue and interest income, will provide the financial independence to prepare for potential PYRUKYND launches in thalassemia and sickle cell disease, advance existing programs, and opportunistically expand its pipeline through both internally and externally discovered assets.
Conference Call Information

Agios will host a conference call and live webcast today at 8:00 a.m. ET to discuss the company’s second quarter 2025 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.