On May 7, 2026 Altasciences, a fully integrated drug development solution company, and Certara (Nasdaq: CERT), a global leader in model-informed drug development (MIDD), reported a strategic partnership to accelerate early-phase development programs.

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Fewer than half of preclinical drug candidates successfully reach in-human trials. Failures are driven by toxicity, poor pharmacokinetics, lack of efficacy, and challenges translating results from animals to humans. Many of these risks can be mitigated through a fully integrated model-informed drug development approach.

Building on Altasciences’ Acceleration Platform, the integration of Certara’s strategic drug development services and biosimulation technology enables sponsors to establish proof of mechanism earlier, design more efficient studies, and make informed go/no-go decisions with greater confidence. By embedding modeling insights and digital workflows directly into development execution, study designs are optimized, dosing strategies are refined, and programs are more seamlessly integrated across nonclinical, clinical, bioanalytical, and manufacturing services.

"At Altasciences, we already help sponsors move from first safety assessment to proof of concept with speed and precision," said Marie-Hélène Raigneau, CEO of Altasciences. "By embedding Certara’s modeling capabilities into our platform, we can further inform critical decisions earlier and with greater confidence. This collaboration is about reducing uncertainty at the moments that matter most."

The partnership comes at an opportune time as the FDA continues to advance new guidance supporting more adaptive, data-driven, and real-time drug development approaches, capabilities that integrated MIDD execution models are well positioned to deliver.

"This partnership unlocks new opportunities to improve early development decisions for biotech sponsors and their investors," said Jon Resnick, CEO of Certara. "By embedding modeling and simulation directly into execution, we enable faster, more informed decision-making that ultimately benefits patients."

Together, Altasciences and Certara are advancing a model-first, fully integrated, and resource-efficient approach to early drug development that accelerates the path to proof of concept for biotech innovators, investors and pharmaceutical companies across the globe.

(Press release, Certara, MAY 7, 2026, View Source [SID1234665314])

On May 7, 2026 Intensity Therapeutics, Inc. ("Intensity" or "the Company") (Nasdaq: INTS), a late-stage clinical biotechnology company focused on the discovery and development of novel intratumoral cancer therapies that are designed to kill tumors and increase immune system recognition of cancers using its proprietary non-covalent conjugation technology, reported first quarter 2026 financial results and provides a corporate update.

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Corporate Update

INVINCIBLE-4 Study: Phase 2 randomized open-label, multicenter study to analyze the clinical activity, safety, and tolerability of INT230-6 given before administration of the SOC treatment in patients with early-stage, operable triple negative breast cancer and SOC alone.
In March 2026, the Company reported the following:
•Preliminary observations of the INVINCIBLE-4 Study showed that five (5) out of seven (7) patients (71.4%) who received INT230-6 prior to SOC ("Cohort A") achieved a pathological complete response ("pCR") whereas two (2) out of six (6) (33%) patients in the SOC arm alone ("Cohort B") achieved a pCR, with one patient still to be evaluated.
•Forty-four percent (44%) fewer grade 3 or higher adverse events were observed in Cohort A compared to Cohort B.
•A protocol amendment was submitted to Swissmedic, Switzerland’s regulatory authority, and the Switzerland Ethics Committee to resume enrollment. Full approval to resume enrollment was granted on March 26, 2026. The Company plans to resume enrollment in the second quarter of 2026.
The Company expects presentation of more detailed results for the seven (7) Cohort A patients at a future oncology conference.

INVINCIBLE-3 Study: Phase 3 open-label, randomized study testing INT230-6 as monotherapy compared to the SOC drugs in second- and third-line treatment for specific soft tissue sarcoma subtypes.
In March 2025, the Company paused new site activations and patient enrollments due to funding constraints. Before this pause, the trial had enrolled 21 patients. The Company has continued to treat patients enrolled in this study, maintain the database, conduct pharmacovigilance, and conduct other study-related activities in cooperation with its third-party contract research organizations at significantly reduced ongoing costs during this pause. In April 2026, the Company decided to resume enrollment in the INVINCIBLE-3 Study in a limited number of U.S. sites by the third quarter of 2026, and has prioritized commencing full patient enrollment and site activations in this study once sufficient incremental funding is obtained.

Lewis H. Bender, Founder, President, and CEO, stated, "The Company made excellent progress in the first quarter. We announced early data from the INVINCIBLE-4 Study, our randomized controlled study in TNBC, showing the possibilities for INT230-6 to increase efficacy while also potentially improving safety. We are now seeking additional patients in our INVINCIBLE-4 Study in Switzerland and expect to initiate enrollment in France in the second or third quarter of 2026. Further, after a successful funding campaign in 2025 and the establishment of a $60 million ATM facility in March 2026, we have made the decision to reinitiate enrollment of our INVINCIBLE-3 Study and plan to manage our cash burn judiciously. Both of our clinical trials focus on indications with high unmet medical need."

First Quarter 2026 Financial Results

Research and development expenses were $1.2 million for the three months ended March 31, 2026, compared to $2.2 million for the same period in 2025. The decrease was primarily due to lower INVINCIBLE-3 Study costs. In March 2025, the Company paused new site activations and patient enrollments in the INVINCIBLE-3 Study due to funding constraints. Prior to this pause, the trial had enrolled 21 patients. The Company has continued to treat all patients enrolled in this study in cooperation with our third-party contract research organizations during this pause. The Company plans to resume enrollment in the INVINCIBLE-3 Study in a limited number of U.S. sites by the third quarter of 2026, and has prioritized commencing full patient enrollment and site activations once sufficient funding is obtained. In addition, lower headcount-related costs in 2026 were entirely offset by an estimated bonus accrual during the three months ended March 31, 2026 compared to no bonus accrual during the three months ended March 31, 2025.

General and administrative expenses were $1.3 million for the three months ended March 31, 2026, compared to $1.2 million for the same period in 2025. The increase was due to an estimated bonus accrual during the three months ended March 31, 2026 compared to no bonus accrual during the three months ended March 31, 2025. This increase was partially offset by lower stock-based compensation and one-time expenses related to our reverse stock split in February 2026.

Overall, net loss was $2.4 million for the three months ended March 31, 2026, compared to a net loss of $3.3 million for the three months ended March 31, 2025.

As of March 31, 2026, cash and cash equivalents totaled $10.2 million.

About Triple Negative Breast Cancer in the Presurgical Setting
Women with aggressive forms of breast cancer, such as Triple Negative Breast Cancer ("TNBC"), are often counseled to undergo pre-surgical (neoadjuvant) systemic therapy in advance to reduce the risk of the disease returning. Having a pathological complete response, meaning the absence of live cancer at the time of surgery, has been shown to result in a lower risk of disease recurrence from 50% to 16% at 5 years. Approximately 11 to 17% of breast cancers test negative for estrogen receptors ("ER"), progesterone receptors (PR), and overexpression of human epidermal growth factor receptor 2 ("HER2") protein, qualifying them as triple negative. There are approximately 56,000 new cases of TNBC in the US and 420,000 worldwide diagnosed each year, 85% of which are local to the breast. TNBC is considered to be more aggressive and has a poorer prognosis than other types of breast cancer, because there are fewer available targeted medicines. Most patients with local TNBC typically receive immunochemotherapy before surgery. Since the publication of Keynote-522, the standard neoadjuvant treatment for TNBC includes systemic chemotherapy (anthracyclines, cyclophosphamide, paclitaxel, carboplatin) and the anti-PD-1 monoclonal antibody pembrolizumab. pCR rates range from 50 to 65%, depending on tumor size. Rates are generally lower in the larger-sized tumors or with lymph node metastasis. The toxicity of the Keynote-522 regimen is high, with 77% of patients experiencing grade 3 or higher treatment-related AEs, including treatment-related adverse events that lead to death in 0.5% of patients.

About Sarcoma

Soft tissue sarcoma is a rare type of cancer that starts with the growth of cells in the body’s soft tissue, such as muscle, fat, blood vessels, nerves, tendons, and linings of the joints. The disease mostly occurs in the arms, legs and belly. There are 197,000 patients in the US living with sarcoma and more than 100 types of soft tissue sarcoma, the treatment of which first involves surgery. Other treatments might include radiation therapy and then chemotherapy. Using the U.S. SEER database, the Company estimated that 14,400 patients have regional or distal (metastatic) leiomyosarcoma, liposarcoma, and undifferentiated pleomorphic sarcoma.

About INT230-6

INT230-6, Intensity’s lead proprietary investigational product candidate, is designed for direct intratumoral injection. INT230-6 was discovered using Intensity’s proprietary DfuseRx℠ technology platform. The drug consists of two proven, potent anti-cancer agents, cisplatin and vinblastine sulfate, and a diffusion and cell penetration enhancer molecule ("SHAO") that non-covalently conjugates to the two payload drugs, facilitating the dispersion of potent cytotoxic drugs throughout tumors and allowing the active agents to diffuse into cancer cells. These agents remain in the tumor, resulting in a favorable safety profile. In addition to local disease control and direct tumor killing, INT230-6 causes a release of a bolus of neoantigens specific to the malignancy, leading to immune system engagement and systemic anti-tumor effects. Importantly, these effects are mediated without immunosuppression, which often occurs with systemic chemotherapy.

(Press release, Intensity Therapeutics, MAY 7, 2026, View Source [SID1234665330])

On May 7, 2026 Werewolf Therapeutics, Inc. (the "Company" or "Werewolf") (Nasdaq: HOWL), an innovative biopharmaceutical company pioneering the development of conditionally activated therapeutics engineered to stimulate the body’s immune system for the treatment of cancer and other immune-mediated conditions, reported a business update and announced financial results for the first quarter ended March 31, 2026.

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"Werewolf, assisted by its exclusive financial advisor, Piper Sandler & Co. ("Piper Sandler"), continues to explore a range of alternatives available to the Company to maximize shareholder value," said Daniel J. Hicklin, Ph.D., President and Chief Executive Officer of Werewolf. "As will be disclosed in more detail in our Quarterly Report on Form 10-Q that will be filed today, we have entered into an asset purchase agreement with Jazz Pharmaceuticals Ireland Limited ("Jazz") by which Jazz has acquired exclusive global development and commercialization rights to JZP898, an IFNα program, which was previously exclusively licensed by Jazz pursuant to a collaboration and license agreement entered into in 2022. Additionally, we have repaid all amounts owed under the loan and security agreement dated May 2, 2024, with K2 HealthVentures LLC ("K2") as of May 6, 2026. We continue to explore options for our INDUKINE and INDUCER platforms and programs."

Financial Results for the First Quarter of 2026:

•Cash position: As of March 31, 2026, cash and cash equivalents were $46.5 million, compared to $57.1 million as of December 31, 2025. Subsequent to the end of the first quarter of 2026, the Company entered into the asset purchase agreement with Jazz and repaid all obligations under the loan and security agreement with K2, in each case as described above. The Company plans to update cash runway guidance in the near future.
•Research and development expenses: Research and development expenses were $8.2 million for the first quarter of 2026, compared to $13.1 million for the same period in 2025.
•General and administrative expenses: General and administrative expenses were $5.1 million for the first quarter of 2026, compared to $4.9 million for the same period in 2025.
•Net loss: Net loss was $13.5 million for the first quarter of 2026, compared to $18.1 million for the same period in 2025.

(Press release, Werewolf Therapeutics, MAY 7, 2026, View Source [SID1234665346])

On May 7, 2026 ArriVent BioPharma, Inc. (Company or ArriVent) (Nasdaq: AVBP), a clinical-stage company dedicated to accelerating the global development of innovative biopharmaceutical therapeutics, reported clearance of an investigational new drug (IND) application by the United States Food and Drug Administration (FDA) for ARR-002, a potential first-in-class MUC16/NaPi2b targeting tetravalent antibody-drug conjugate (ADC) with an initial focus in ovarian and endometrial cancers and broader therapeutic potential across solid tumors.

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"We are pleased to advance ARR-002 into the clinic as the second next-generation ADC from our portfolio," said Stuart Lutzker, MD, Ph.D., President of Research and Development of ArriVent. "At AACR (Free AACR Whitepaper), compelling preclinical data was presented demonstrating ARR-002’s potential to improve safety and efficacy over conventional single-target and bivalent bispecific ADCs in ovarian and endometrial cancers. ARR-002’s dual-target approach is designed to improve delivery and reduce off-tumor toxicity to overcome key limitations of single-target ADCs, including limited internalization, suboptimal payload delivery, and heterogeneous target expression. We expect to initiate a Phase 1 trial and dose the first patient in the second half of the year."

MUC16 and NaPi2b are highly expressed on ovarian and endometrial cancers with limited expression in normal tissues, making them strong co-targets. Select preclinical data included in the IND submission of ARR-002 was presented at the 2026 American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting in a joint presentation with Aarvik Therapeutics demonstrating:

Effective binding to individual targets, simultaneous engagement of both targets, and enhanced internalization vs. single-target antibody controls
Superior in vivo efficacy vs. single-target ADCs in the OVCAR-3 xenograft model
The potential for a wider therapeutic window based on a favorable tolerability profile in cynomolgus monkeys, consisting of reversible hematologic findings at a higher maximum tolerated single dose vs. other approaches in development

(Press release, ArriVent Biopharma, MAY 7, 2026, View Source [SID1234665365])

On May 7, 2026 Charles River Laboratories International, Inc. (NYSE: CRL) reported its results for the first quarter of 2026. For the quarter, revenue was $995.8 million, an increase of 1.2% from $984.2 million in the first quarter of 2025.

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The impact of foreign currency translation increased reported revenue by 2.8%, while a divestiture reduced reported revenue by 0.1%. Excluding the effect of these items, revenue declined 1.5% on an organic basis. By segment, organic revenue growth in the Manufacturing Solutions (Manufacturing) segment was more than offset by organic revenue declines in the Research Models and Services (RMS) and Discovery and Safety Assessment (DSA) segments.
In the first quarter of 2026, the GAAP operating margin was 12.0%, compared to 7.6% in the first quarter of 2025. The increase in the GAAP operating margin was primarily driven by lower accelerated amortization expense related to certain CDMO client relationships. The GAAP net loss available to common shareholders for the first quarter of 2026 was $(14.8) million, or $(0.30) per diluted share, compared to GAAP net income of $25.5 million, or $0.50 per diluted share for the same period in 2025. The decrease was principally due to a loss on assets held for sale related to the CDMO and Cell Solutions divestiture totaling $118.0 million, or $1.53 per share.

On a non-GAAP basis, the first-quarter operating margin decreased to 16.3% from 19.1% in the first quarter of 2025, primarily as a result of higher study-related direct costs in the DSA segment, unfavorable revenue mix in the RMS segment, and higher stock-based compensation expense related largely to executive transition. Non-GAAP net income was $101.7 million for the first quarter of 2026, a decrease of 14.6% from $119.1 million for the same period in 2025. First-quarter diluted earnings per share on a non-GAAP basis were $2.06, a decrease of 12.0% from $2.34 per share in the first quarter of 2025. The non-GAAP net income and earnings per share decreases were driven primarily by the lower operating margin.
Birgit Girshick, Chief Executive Officer, said, "We are pleased to deliver on our first-quarter financial targets, and remain well positioned to generate improving results over the course of the year. Our confidence is supported by a DSA demand environment that is tracking to our expectations, resulting in solid bookings in the first quarter, as well as the successful execution of our strategy."

"As we look to the future, our focus remains on enhancing our clients’ experience, strengthening our world-class scientific portfolio, achieving our financial and operational goals, and increasing long‑term shareholder value. We have already established a solid foundation and with a refreshed strategic focus aimed at modernizing the Company and the industry, we intend to continue to evolve and lead the way. By doing so, we will enable the Company to realize its full potential and ensure future success. I am energized to lead this great company into its next chapter of growth and am confident in the path we are taking to create the future for Charles River," Ms. Girshick concluded.

First-Quarter Segment Results

Research Models and Services (RMS)

Revenue for the RMS segment was $208.4 million in the first quarter of 2026, a decrease of 2.2% from $213.1 million in the first quarter of 2025. The impact of foreign currency translation increased revenue by 3.3%. Organic revenue decreased by 5.5%, due primarily to lower revenue for small research models in North America, as well as for large research models. The decline was partially offset by higher revenue for small research models in China.
In the first quarter of 2026, the RMS segment’s GAAP operating margin increased to 23.9% from 20.5% in the first quarter of 2025, primarily due to a gain on the sale of real estate in Massachusetts. On a non-GAAP basis, the operating margin decreased to 24.7% from 27.1%. The non-GAAP operating margin decrease was primarily driven by the unfavorable revenue mix, principally related to small research models in North America and large research models.
Discovery and Safety Assessment (DSA)
Revenue for the DSA segment was $596.9 million in the first quarter of 2026, an increase of 0.7% from $592.6 million in the first quarter of 2025. The impact of foreign currency translation increased DSA revenue by 2.2%, while a divestiture reduced reported revenue by 0.1%. Organic revenue decreased by 1.4%, driven primarily by lower revenue for discovery services due in part to the impact of prior site consolidation activities.
In the first quarter of 2026, the DSA segment’s GAAP operating margin increased to 17.4% from 15.9% in the first quarter of 2025. The increase was primarily driven by lower third-party legal costs related to a non-human primate (NHP) supply matter, as well as lower costs associated with the Company’s restructuring and efficiency initiatives. On a non-GAAP basis, the operating margin decreased to 21.0% from 23.9% in the first quarter of 2025. The non-GAAP operating margin decrease was primarily driven by higher study-related direct costs associated with large-model sourcing and study starts.
Manufacturing Solutions (Manufacturing)

Revenue for the Manufacturing segment was $190.5 million in the first quarter of 2026, an increase of 6.8% from $178.5 million in the first quarter of 2025. The impact of foreign currency translation increased Manufacturing revenue by 3.9%. Organic revenue increased 2.9%, driven by higher revenue in the Microbial Solutions business, partially offset by lower revenue in the CDMO business.

The Manufacturing segment’s GAAP operating margin was 24.6%, compared to (4.8)% in the first quarter of 2025. The increase was primarily the result of lower accelerated amortization expense related to certain CDMO client relationships. On a non-GAAP basis, the operating margin increased to 25.9% from 23.1% in the first quarter of 2025, driven primarily by the benefit of cost savings resulting from the Company’s restructuring initiatives.

Divestiture Update

On May 6, 2026, the Company completed the previously announced divestiture of the CDMO and Cell Solutions businesses to GI Partners. In addition, the Company expects to complete the sale of certain European Discovery Services sites in May 2026. These strategic transactions will enable Charles River to refine and refocus its comprehensive portfolio on core competencies and drive synergistic growth in areas in which it has differentiated scientific expertise, including regulated drug development testing.

Stock Repurchase Update

During the first quarter of 2026, the Company repurchased 1.1 million shares for a total of $200.0 million. As of March 28, 2026, the Company had $800.0 million remaining under its $1.0 billion stock repurchase authorization that was approved by the Board of Directors on October 29, 2025.

2026 Guidance Update

The Company is reaffirming its 2026 organic revenue and non-GAAP earnings per share guidance, which was last updated on February 25, 2026, and previously included the expected impact of the completed divestiture of the CDMO and Cell Solutions businesses, as well as the planned divestiture of certain European Discovery Services sites in May 2026.

However, the Company is reducing its 2026 reported revenue outlook by approximately 50 basis points to reflect recent changes in assumptions for foreign exchange rates. The Company’s GAAP earnings per share guidance has now been updated to primarily reflect the impact of the divestitures.
The Company’s 2026 guidance for revenue and earnings per share is as follows:

2026 GUIDANCE (1) CURRENT PRIOR
Revenue growth/(decrease), reported
(5.5)% – (4.0)%
(5.0)% – (3.5)%
Less: Contribution from acquisitions
0.0% – (0.5)%
0.0% – (0.5)%
Add: Impact from divestitures
~5.0%
~5.0%
Less: Favorable impact of foreign exchange
(0.5)% – (1.0)%
(1.0)% – (1.5)%
Revenue growth/(decrease), organic (2)
(1.5)% – (0.5)% (1.5)% – (0.5)%
GAAP EPS estimate
$5.35 – $5.85
—
Acquisition-related amortization (3)
~$2.30
—
Acquisition- and divestiture-related costs (4)
~$2.30
Costs associated with restructuring and efficiency initiatives (5)
~$0.85
—
Other, net (6)
NM
—
Non-GAAP EPS estimate $10.80 – $11.30 $10.80 – $11.30

Footnotes to Guidance Table:
(1) Revenue and earnings per share guidance assumes the planned divestiture of certain European Discovery Services sites will be completed in May 2026, and that the CDMO and Cell Solutions divestiture was completed on May 6, 2026.
(2) Organic revenue growth is defined as reported revenue growth adjusted for completed acquisitions and both completed and previously announced divestitures (including the CDMO and Cell Solutions businesses, as well as certain European Discovery Services sites), as well as foreign currency translation.
(3) These adjustments primarily include amortization related to intangible assets, as well as the purchase accounting step-up on inventory and certain long-term biological assets.
(4) These adjustments include costs related to the evaluation and integration of acquisitions and divestitures, as well as a loss on assets held for sale related to divestitures and other transaction-related tax adjustments.
(5) These adjustments primarily include site consolidation (including site transition costs), severance, impairment, third-party consulting and professional services, and other costs related to the Company’s restructuring actions and efficiency initiatives. These adjustments also include gains and/or losses on the sale of certain assets and real estate.
(6) These adjustments primarily include immaterial items related to: (i) certain venture capital and other strategic investment losses/(gains), net. This item only includes recognized gains or losses on certain investments. The Company does not forecast the future performance of these investments; and (ii) reductions to a previous $27 million inventory charge associated with an NHP supply matter. As a result of the resolution of the U.S. government investigations during fiscal year 2025, certain NHPs were subsequently utilized.

Webcast
Charles River has scheduled a live webcast on Thursday, May 7th, at 8:30 a.m. ET to discuss matters relating to this press release. To participate, please go to ir.criver.com and select the webcast link. You can also find the associated slide presentation and reconciliations of GAAP financial measures to non-GAAP financial measures on the website.

(Press release, Charles River Laboratories, MAY 7, 2026, View Source [SID1234665315])