On February 18, 2026 Charles River Laboratories International, Inc. (NYSE: CRL) reported its results for the fourth quarter and full-year 2025 and provided guidance for 2026. For the quarter, revenue was $994.2 million, a decrease of 0.8% from $1,002.5 million in the fourth quarter of 2024.

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The impact of foreign currency translation increased reported revenue by 1.9%, and the divestiture of a small Safety Assessment site in 2024 reduced reported revenue by 0.1%. Excluding the effect of these items, revenue declined 2.6% on an organic basis, driven primarily by the Discovery and Safety Assessment (DSA) and Manufacturing Solutions (Manufacturing) segments.

In the fourth quarter of 2025, the GAAP operating margin was (28.5)%, compared to (16.7)% in the fourth quarter of 2024. The GAAP net loss available to common shareholders for the fourth quarter of 2025 was $(276.6) million, or $(5.62) per diluted share, compared to a net loss of $(215.7) million, or $(4.22) per diluted share for the same period in 2024. GAAP net income and earnings per share included non-cash intangible asset impairments of $211.0 million, or $3.22 per share, for the Biologics Solutions reporting unit (Manufacturing segment) and the Cell Solutions business (RMS segment) and a non-cash goodwill impairment totaling $165.0 million, or $3.35 per share, in the Biologics Solutions reporting unit in the fourth quarter of 2025, compared to a non-cash goodwill impairment of $215.0 million, or $4.20 per share, in the Biologics Solutions reporting unit in the fourth quarter of 2024. In the fourth quarter of 2025, the Company reported a gain of $0.10 per share on certain venture capital and other strategic investments, compared to a loss of $0.32 per share in the fourth quarter of 2024.

On a non-GAAP basis, the fourth-quarter operating margin decreased to 18.1% from 19.9% in the fourth quarter of 2024, primarily as a result of lower revenue, higher study-related direct costs in the DSA segment, and an unfavorable revenue mix in the RMS segment. Non-GAAP net income was $118.8 million for the fourth quarter of 2025, a decrease of 13.0% from $136.6 million for the same period in 2024. Fourth-quarter diluted earnings per share on a non-GAAP basis were $2.39, a decrease of 10.2% from $2.66 per share for the fourth quarter of 2024. The non-GAAP net income and earnings per share decreases were driven primarily by lower revenue and operating margin, as well as a higher tax rate.

James C. Foster, Chair, President and Chief Executive Officer, said, "We were pleased with our 2025 financial results, including substantial improvement in DSA net bookings in the fourth quarter that demonstrates the stabilization of the biopharmaceutical demand environment. We are making significant progress on several strategic initiatives that will enable the Company to better capitalize on future growth opportunities, and we remain intently focused on scientific innovation that will reinforce our position as the leader in preclinical drug development."
"As we look ahead, we are cautiously optimistic that positive demand trends will continue in 2026. We remain committed to driving our strategy forward, including through selective and strategic acquisitions that align with our core competencies; taking decisive actions to drive efficiency and process improvements that will deliver continued benefits; and by strengthening and refining our organization to enhance our speed and responsiveness. This approach ensures Charles River remains the partner of choice for our clients as the biopharmaceutical demand environment continues to improve," Mr. Foster concluded.

Fourth-Quarter Segment Results

Research Models and Services (RMS)
Revenue for the RMS segment was $206.3 million in the fourth quarter of 2025, an increase of 1.0% from $204.3 million in the fourth quarter of 2024. The impact of foreign currency translation increased revenue by 1.9%. Organic revenue decreased by 0.9%, due primarily to lower revenue for large research models and for small research models in North America. The decline was partially offset by higher revenue for research model services, including in the Insourcing Solutions business, and small research models in China and Europe.
In the fourth quarter of 2025, the RMS segment’s GAAP operating margin decreased to (33.6)% from 6.7% in the fourth quarter of 2024 primarily due to the intangible asset impairment related to the Cell Solutions business. On a non-GAAP basis, the operating margin decreased to 21.9% from 22.8%. The non-GAAP operating margin decrease was primarily driven by the unfavorable revenue mix related to large research models and lower revenue for small research models in North America.

Discovery and Safety Assessment (DSA)

Revenue for the DSA segment was $591.6 million in the fourth quarter of 2025, a decrease of 2.0% from $603.3 million in the fourth quarter of 2024. The impact of foreign currency translation increased DSA revenue by 1.5% and the divestiture of a small DSA site reduced reported revenue by 0.2%. Organic revenue decreased by 3.3%, driven primarily by lower sales volume for discovery services, and also for regulated safety assessment services.
In the fourth quarter of 2025, the DSA segment’s GAAP operating margin increased to 14.3% from 10.4% in the fourth quarter of 2024. The increase was primarily driven by a favorable comparison to the prior year’s large model (NHP) inventory write down. On a non-GAAP basis, the operating margin decreased to 20.1% from 24.7% in the fourth quarter of 2024. The non-GAAP operating margin decrease was primarily driven by lower revenue, as well as higher study-related direct costs related to large-model sourcing and staffing.
Manufacturing Solutions (Manufacturing)
Revenue for the Manufacturing segment was $196.4 million in the fourth quarter of 2025, an increase of 0.7% from $194.9 million in the fourth quarter of 2024. The impact of foreign currency translation increased Manufacturing revenue by 2.8%. Organic revenue decreased 2.1%, driven by lower revenue in the CDMO business, partially offset by higher revenue in the Microbial Solutions and Biologics Testing businesses.
The Manufacturing segment’s GAAP operating margin was (115.9)%, compared to (93.6)% in the fourth quarter of 2024. The decrease was primarily the result of larger impairments in the fourth quarter of 2025 related to the Biologics Solutions reporting unit, which includes both the CDMO and Biologics Testing businesses. On a non-GAAP basis, the operating margin increased to 32.1% from 28.7% in the fourth quarter of 2024, driven primarily by the benefit of cost savings resulting from the Company’s restructuring initiatives.
Full-Year Results
For 2025, revenue decreased by 0.9% to $4.02 billion from $4.05 billion in 2024. Revenue declined by 1.6% on an organic basis.
The GAAP operating margin decreased to 0.6% from 5.6% in 2024, and on a non-GAAP basis, the operating margin decreased to 19.8% from 19.9%.
On a GAAP basis, the net loss available to common shareholders was $(144.3) million in 2025, a decrease from net income available to common shareholders of $10.3 million in 2024. The diluted loss per share on a GAAP basis in 2025 was $(2.91), a decrease from diluted earnings per share of $0.20 in 2024.
On a non-GAAP basis, net income was $512.3 million in 2025, a decrease of 3.9% from $532.9 million in 2024. Diluted earnings per share on a non-GAAP basis in 2025 were $10.28, a decrease of 0.4% from $10.32 in 2024.
Research Models and Services (RMS)
For 2025, RMS revenue was $846.1 million, an increase of 2.0% from $829.4 million in 2024. Revenue increased by 1.2% on an organic basis.

On a GAAP basis, the RMS segment operating margin decreased to 5.3% in 2025 from 13.8% in 2024. On a non-GAAP basis, the operating margin increased to 24.8% in 2025 from 23.7% in 2024.
Discovery and Safety Assessment (DSA)
For 2025, DSA revenue was $2.40 billion, a decrease of 2.0% from $2.45 billion in 2024. Revenue declined by 2.6% on an organic basis.
On a GAAP basis, the DSA segment operating margin decreased to 17.7% in 2025 from 18.1% in 2024. On a non-GAAP basis, the operating margin decreased to 24.2% in 2025 from 25.7% in 2024.
Manufacturing Solutions (Manufacturing)
For 2025, Manufacturing revenue was $766.4 million, a decrease of 0.4% from $769.3 million in 2024. Revenue declined by 1.6% on an organic basis.
On a GAAP basis, the Manufacturing segment operating margin decreased to (24.0)% in 2025 from (9.3)% in 2024. On a non-GAAP basis, the operating margin increased to 28.8% in 2025 from 27.4% in 2024.
2026 Guidance
The Company is providing financial guidance for 2026, which does not include the impact of planned divestitures that represent approximately 7% of annual revenue for 2025 and estimated 2026. On an organic basis, this outlook assumes that the robust DSA booking trends in the fourth quarter of 2025, combined with an expectation that favorable booking activity will continue in 2026, will result in a return to organic revenue growth in the second half of 2026 on both a consolidated basis and for the DSA segment. In addition, the Company also expects revenue will increase organically in the Manufacturing segment, as a result of the anniversary of the loss of a large, commercial CDMO client in 2025 and a continuation of solid demand trends in the Microbial Solutions business. The revenue increase is expected to be partially offset by lower revenue in the RMS segment due to lower large model revenue, as well as lower revenue in its Insourcing Solutions business, principally related to its CRADLTM operations.
Non-GAAP earnings per share are expected to increase by approximately 4% to 9% in 2026, as a result of the benefit from incremental cost savings related to restructuring and efficiency initiatives, as well as the earnings accretion from the completed acquisition of the assets of K.F. (Cambodia) Ltd. A lower tax rate will also contribute to non-GAAP earnings per share growth in 2026.
The Company’s 2026 guidance for revenue and earnings per share is as follows:

2026 GUIDANCE (1)
Revenue growth/(decrease), reported
At Least Flat to +1.5%
Impact of divestitures/(acquisitions), net
0.0% – (0.5)%
(Favorable)/unfavorable impact of foreign exchange
(1.0)% – (1.5)%
Revenue growth/(decrease), organic (2)
(1.0)% to At Least Flat
GAAP EPS estimate
$6.30 – $6.80
Acquisition-related amortization and other acquisition- and integration-related costs (3)
$3.50 – $3.60
Costs associated with restructuring actions (4)
$0.80 – $0.85
Non-GAAP EPS estimate
$10.70 – $11.20

Footnotes to Guidance Table:
(1) Revenue and earnings per share of the planned divested businesses remain embedded in the Company’s guidance for the full-year 2026.
(2) Organic revenue growth is defined as reported revenue growth adjusted for completed acquisitions and divestitures (as well as the planned acquisition of PathoQuest SAS), 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. In addition, these adjustments include some costs related to the evaluation and integration of acquisitions and divestitures.
(4) These adjustments primarily include site consolidation (including site transition costs), severance, impairment, and other costs related to the Company’s restructuring actions.

Webcast
Charles River has scheduled a live webcast on Wednesday, February 18th, 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.
Non-GAAP Reconciliations
The Company reports non-GAAP results in this press release, which exclude often-one-time charges and other items that are outside of normal operations. A reconciliation of GAAP to non-GAAP results is provided in the schedules at the end of this press release.

On February 18, 2026 Aprea Therapeutics, Inc. (Nasdaq: APRE) ("Aprea" or the "Company"), a clinical-stage biopharmaceutical company developing innovative therapies that exploit cancer-specific vulnerabilities while minimizing damage to healthy cells, reported additional preliminary data from the ongoing Phase 1 ACESOT-1051 trial evaluating its investigational WEE1 kinase inhibitor APR-1051.

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The Company reported a second unconfirmed partial response at first on-treatment scan in a patient with advanced endometrial cancer being treated at the 220 mg dose level (Cohort 8).

At the first on-treatment imaging assessment of single dose daily APR-1051, the responding patient achieved a 50% reduction from baseline in target lesion measurements, consistent with partial response per RECIST v1.1 criteria. In addition, there was a notable decline in the tumor biomarker CA-125, with levels dropping from 362 U/mL at baseline to 47 U/mL (-87%), further supporting the anti-tumor activity of APR-1051. The patient’s tumor harbors a PPP2R1A mutation. To date, the patient had only Grade 1 treatment-emergent adverse effects and continues treatment.

The observed unconfirmed partial responses for both patients with PPP2R1A mutations require confirmation at subsequent imaging assessments to be designated as confirmed responses under standard criteria.

A further update from the trial is expected in the second quarter of 2026.

"We are encouraged to see a second patient in the ongoing ACESOT trial achieve an unconfirmed partial response," said Eugene Kennedy, MD, Chief Medical Advisor at Aprea. "We believe the magnitude of tumor reduction and the substantial drop in CA-125 in this patient provides further evidence of APR-1051’s biologic activity and potential therapeutic impact. Importantly, this patient was refractory to her most recent two prior therapies. The response in a tumor with a PPP2R1A alteration underscores the potential of genomically guided patient selection in our DDR program."

Oren Gilad, Ph.D., President and Chief Executive Officer of Aprea, commented, "We believe the emergence of a second unconfirmed partial response strengthens the clinical trend we are observing as dose escalation progresses. These results reinforce our confidence in the therapeutic potential of WEE1 inhibition in genetically defined difficult-to-treat cancers. In addition, the good safety profile of APR-1051 to date supports our development strategy of a differentiated WEE1 inhibition through a potentially improved therapeutic index (TI), as low TI has been a major hurdle in the development of WEE1 inhibitors. We remain focused on advancing APR-1051 and look forward to providing further updates from this trial."

ACESOT-1051 Trial Key Findings to Date

The ongoing Phase 1 trial is designed to evaluate the safety, tolerability, pharmacokinetics, and preliminary anti-tumor activity of APR-1051 in patients with advanced solid tumors. A total of 22 patients have been treated to date, at doses ranging from 10 mg to 220 mg.

Partial Responses: Two patients have achieved partial responses (unconfirmed) at their first scan, both with endometrial cancer, and with tumors harboring PPP2R1A mutations. These responses were observed at the 150 mg and 220 mg dose levels of APR-1051. Both patients remain on therapy.
Stable Disease: A total of five patients in the trial have had stable disease:
70 mg cohort: HPV-positive head and neck squamous cell carcinoma (HNSCC)
100 mg cohort: FBXW7-mutated colon cancer; KRAS & p53-mutated colon cancer; CCNE1 & TP53 mutated uterine cancer
150 mg cohort: FBXW7-mutated colon cancer
Favorable tolerability: APR-1051 has been generally well tolerated

Taken together, these data support the potential activity of APR-1051 in genomically defined cancers across multiple solid tumor types.

Enrollment in the 220 mg dose cohort continues, and the Company plans to further expand enrollment of PPP2R1A endometrial and HPV-positive HNSCC patients within the study.

About the ACESOT-1051 Trial

ACESOT-1051 is a first-in-human, open-label Phase 1 study evaluating the safety, pharmacokinetics, pharmacodynamics, and preliminary efficacy of single-agent APR-1051 in patients with advanced solid tumors harboring cancer-associated genetic alterations. The dose-escalation portion of the study is expected to enroll up to 50 patients. APR-1051 is administered orally once daily in continuous 28-day cycles. To date, enrollment has evaluated doses up to 150 mg, with the 220 mg cohort currently enrolling. For more information, visit ClinicalTrials.gov (NCT06260514).

(Press release, Aprea, FEB 18, 2026, View Source [SID1234662747])

On February 18, 2026 Akari Therapeutics, Plc (Nasdaq: AKTX), an oncology biotechnology company developing antibody drug conjugates (ADCs) with novel immuno-oncology payloads, reported that Abizer Gaslightwala, President and Chief Executive Officer of Akari Therapeutics, will present at the 2026 Biocom Global Partnering & Investor Conference, being held February 24–26, 2026, at The Lodge at Torrey Pines in San Diego, CA.

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Presentation details are as follows:

Date/Time: Wednesday, February 25, 2026, at 11:00 AM PST

Location: Track B

In addition to the presentation, management will be available to participate in in-person one-on-one meetings with qualified members of the investor community who are registered to attend the conference. For more information about the conference, please visit the conference website.

(Press release, Akari Therapeutics, FEB 18, 2026, View Source [SID1234662746])

On February 17, 2026 HCW Biologics Inc. (the "Company"), (NASDAQ: HCWB), a U.S.-based clinical-stage biopharmaceutical company focused on discovering and developing innovative immunotherapies to extend health span by targeting the link between chronic inflammation and disease, reported the pricing of its follow-on offering of an aggregate of 2,477,292 units at a purchase price of $0.6055 per unit priced at-the-market under Nasdaq rules. Each unit consists of one share of common stock (or pre-funded warrant in lieu thereof) and one warrant, each to purchase one share of common stock. The warrant will have an exercise price of $0.6055 per share, will be exercisable upon shareholder approval, and will expire on the five-year anniversary from such date of shareholder approval. The shares of common stock (or pre-funded warrants) and the warrant comprising the units are immediately separable and will be issued separately in this offering. The closing of the offering is expected to occur on or about February 19, 2026, subject to the satisfaction of customary closing conditions.

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Maxim Group LLC is acting as the sole placement agent for the offering.

The gross proceeds from the offering, before deducting the placement agent’s fees and other offering expenses, are expected to be approximately $1.5 million. The Company intends to use the net proceeds from this offering for funding preclinical and clinical development, including the clinical trials for HCW9302, and general corporate purposes.

In addition, the Company has entered into a privately negotiated agreement with the holder of certain existing outstanding warrants to purchase up to 3,020,410 shares of common stock (the "Existing Warrants") to reduce the exercise price of such Existing Warrants from $2.41 per share to $0.6055 per share. The reduction of the exercise price of the Existing Warrants is subject to shareholder approval.

The securities described above are being offered pursuant to a registration statement on Form S-1, as amended (File No. 333-293396), which was declared effective by the Securities and Exchange Commission (the "SEC") on February 17, 2026. The offering is being made only by means of a prospectus which forms a part of the effective registration statement. A preliminary prospectus relating to the offering has been filed with the SEC. Electronic copies of the final prospectus, when available, may be obtained on the SEC’s website at www.sec.gov and may also be obtained by
contacting Maxim Group LLC at 300 Park Avenue, 16th Floor, New York, NY 10022, Attention: Prospectus Department, or by telephone at (212) 895-3745 or by email at [email protected].

This press release shall not constitute an offer to sell or a solicitation of an offer to buy any of the securities described herein, nor shall there be any sale of these securities in any state or other jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of any such state or other jurisdiction.

(Press release, HCW Biologics, FEB 17, 2026, View Source [SID1234662783])

On February 17, 2026, Amgen Inc. (the "Company") issued and sold $1,000,000,000 aggregate principal amount of the Company’s 4.200% Senior Notes due 2031 (the "2031 Notes"), $1,750,000,000 aggregate principal amount of the Company’s 4.850% Senior Notes due 2036 (the "2036 Notes"), $500,000,000 aggregate principal amount of the Company’s 5.500% Senior Notes due 2046 (the "2046 Notes") and $750,000,000 aggregate principal amount of the Company’s 5.650% Senior Notes due 2056 (the "2056 Notes" and, together with the 2031 Notes, the 2036 Notes and the 2046 Notes, the "Notes"). The Notes are registered under an effective Registration Statement on Form S-3 (Registration No. 333-293477) (the "Registration Statement"), filed on February 13, 2026, and were issued pursuant to an indenture, dated as of May 22, 2014 (the "Indenture"), between the Company and The Bank of New York Mellon Trust Company, N.A., as trustee, and an officer’s certificate, dated as of February 19, 2026 (the "Officer’s Certificate"), setting forth the terms of the Notes. Net proceeds to the Company from the offering were approximately $3,961,495,000, after deducting underwriters’ discounts and estimated offering expenses payable by the Company.

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The relevant terms of the Notes are set forth in the Indenture, included as Exhibit 4.1 of the Company’s Current Report on Form 8-K, filed on May 22, 2014, and incorporated herein by reference, and the Officer’s Certificate (including the forms of the Notes) attached hereto as Exhibit 4.2 and incorporated herein by reference.

The 2031 Notes will pay interest at the rate of 4.200% per annum, the 2036 Notes will pay interest at the rate of 4.850% per annum, the 2046 Notes will pay interest at the rate of 5.500% per annum and the 2056 Notes will pay interest at the rate of 5.650% per annum, which shall be payable in cash semi-annually in arrears on February 19 and August 19 of each year, beginning on August 19, 2026. The 2031 Notes will mature on February 19, 2031, the 2036 Notes will mature on February 19, 2036, the 2046 Notes will mature on February 19, 2046 and the 2056 Notes will mature on February 19, 2056.

In the event of a change in control triggering event, as defined in the Officer’s Certificate, the holders of the Notes may require the Company to purchase for cash all or a portion of their Notes at a purchase price equal to 101% of the principal amount of Notes, plus accrued and unpaid interest, if any. The descriptions of the Indenture, the Officer’s Certificate and the Notes in this report are summaries and are qualified in their entirety by the terms of the Indenture, the Officer’s Certificate and the Notes, respectively.

The Notes will rank equal in right of payment to all of the Company’s other existing and future senior unsecured indebtedness, senior in right of payment to all of the Company’s existing and future subordinated indebtedness, effectively subordinated in right of payment to all of the Company’s subsidiaries’ obligations (including secured and unsecured obligations) and subordinated in right of payment to the Company’s secured obligations, to the extent of the assets securing such obligations.

(Filing, Amgen, FEB 17, 2026, View Source [SID1234662780])