On February 23, 2026 MacroGenics, Inc. (NASDAQ: MGNX), a clinical-stage biopharmaceutical company focused on developing innovative antibody-based therapeutics for the treatment of cancer, reported that the U. S. Food and Drug Administration (FDA) has placed a partial clinical hold on its Phase 2 LINNET study of lorigerlimab, an investigational, bispecific DART molecule that targets PD-1 and CTLA-4, in patients with gynecologic cancers. Under the partial clinical hold, no new patients will be enrolled in the LINNET study until the partial hold is lifted by the FDA. Current study participants may continue to receive study drug.

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The FDA’s partial clinical hold was initiated following the Company’s recent notification to the FDA of a temporary pause in enrollment of new participants in the LINNET trial due to the occurrence of recent safety events. The safety events that prompted the enrollment pause occurred across four patients and included Grade 4 thrombocytopenia (N=2), Grade 4 myocarditis (N=1), and Grade 4 neutropenia and concurrent septic shock (N=1) which led to a Grade 5 event. To date, 41 study participants have been dosed at 6 mg/kg every 3 weeks across the platinum-resistant ovarian cancer (PROC) and clear cell gynecologic cancer (CCGC) cohorts.

"At MacroGenics, our top priority is patient safety," said Eric Risser, President and CEO. "MacroGenics is fully committed to working closely with the FDA to resolve the partial clinical hold and we intend to resume study enrollment as soon as possible."

About the LINNET Study

The LINNET study is evaluating lorigerlimab, an investigational, bispecific DART molecule that targets PD-1 and CTLA-4, as monotherapy in a Simon two-stage trial in eligible patients with PROC who have received up to three prior lines of therapy. If a predefined activity threshold is met in the first stage — based on approximately 20 patients — the study may expand to enroll an additional 20 patients. The study was also designed to enroll up to 20 patients with CCGC who have received at least one prior line of therapy. The primary endpoint is objective response rate (ORR), with multiple secondary endpoints.

(Press release, MacroGenics, FEB 23, 2026, View Source [SID1234662855])

On February 23, 2026 Biogen Inc. (Nasdaq: BIIB) reported that Christopher A. Viehbacher, President and Chief Executive Officer, will participate in a fireside chat during the TD Cowen 46th Annual Health Care Conference. The webcast will be live on Monday, March 2, 2026, at 9:10 a.m. ET. To access the live webcast, please visit the Investors section of Biogen’s website at investors.biogen.com. An archived version of the webcast will be available for at least 30 days following the presentation.

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(Press release, Biogen, FEB 23, 2026, View Source [SID1234662872])

On February 23, 2026 Artios Pharma Limited ("Artios"), a clinical-stage biopharmaceutical company pioneering the development of new classes of DNA Damage Response (DDR) medicines to deliver meaningful survival benefits for patients with cancer, reported that the U.S. Food and Drug Administration (FDA) granted Fast Track designation to its potentially first-in-class DNA polymerase theta (Polθ) inhibitor, ART6043, in combination with the PARP inhibitor, olaparib, for the treatment of adult patients with germline BRCA-mutated (gBRCAm) HER2-negative locally advanced or metastatic breast cancer who have received no prior treatment with a PARP inhibitor.

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"Breast cancer remains the second leading cause of cancer death in women in the United States. Granting of U.S. Fast Track designation is an important recognition of ART6043’s clinical profile to treat gBRCAm HER2-negative breast cancer and supports our mission to rapidly deliver potential first-in-class therapies to patients who have limited treatment options," said Mike Andriole, Chief Executive Officer of Artios. "Importantly, breast cancer patients with a BRCA mutation often develop resistance to treatment with a PARP inhibitor alone. There remains a significant need to improve clinical outcomes and rates of survival through inhibition of Polθ."

The designation was granted based on data from the ongoing, first-in-human, Phase 1/2a study (NCT05898399), evaluating ART6043 in combination with olaparib in patients with advanced solid tumors harboring mutations in DDR pathways, including gBRCAm HER2-negative breast cancer. In data presented at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Congress 2025, ART6043 demonstrated an attractive tolerability profile, expected PK/PD activity, and promising clinical signals.

"gBRCA-mutated HER2-negative breast cancer presents significant treatment challenges due to its frequently aggressive nature and high risk of recurrence, often due to BRCA reversions, with patients requiring intensive therapy," said Ian Smith, Chief Medical Officer of Artios. "In our ongoing Phase 1/2a study, ART6043, in combination with olaparib, has shown encouraging clinical activity in the relevant genetic background, together with a favorable tolerability and pharmacology profile. These early results support ART6043 as a potential new targeted therapy capable of removing a cancer cell’s reliance on Polθ as a DNA repair mechanism to enhance anti-tumor activity in a well-defined patient population."

"Our experiments to date with ART6043 have been rationally designed following our team’s pioneering work with the industry’s first PARP inhibitor and recognizing that inhibition of Polθ may enhance the cancer cell killing effects of PARP inhibition and overcome key mechanisms of resistance to improve survival in these patients," added Graeme Smith, Chief Scientific Officer of Artios.

The FDA’s Fast Track program is designed to facilitate the development and expedite the review of investigational drugs that demonstrate the potential to address unmet medical needs in serious or life-threatening conditions. Product candidates with Fast Track designation are eligible for priority review and accelerated approval if relevant criteria are met. This designation will enable Artios to interact more frequently and earlier with the FDA to discuss ART6043’s development path.

About ART6043

ART6043 is a potential first-in-class, selective, orally bioavailable, small‑molecule inhibitor of the polymerase domain of DNA polymerase theta (Polθ), a DNA repair enzyme that is preferentially expressed in cancer cells but is virtually absent in most healthy tissues. By inhibiting Polθ, ART6043 targets microhomology-mediated end joining (MMEJ) to exploit tumor dependence on error-prone DNA repair, with broad rationale for use as monotherapy and in combination with PARP inhibition and other DNA‑damaging modalities. Artios’ differentiated approach is to evaluate ART6043 with olaparib in molecularly defined solid tumors, including settings with BRCA variants and PARP inhibitor resistance, to enhance target engagement and anti-tumor activity while maintaining tolerability.

(Press release, Artios Pharma, FEB 23, 2026, View Source [SID1234662840])

On February 23, 2026 Myriad Genetics, Inc. (NASDAQ: MYGN), a leader in molecular diagnostic testing and precision medicine, reported financial results for its fourth quarter ended December 31, 2025, and reaffirmed its financial guidance on business performance for the full-year 2026.

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"We ended 2025 with positive momentum in a number of key areas, including within the Cancer Care Continuum where we drove another quarter of high single-digit volume growth in Hereditary cancer testing year-over-year and recognized improving volume growth for our Prolaris prostate cancer test. I’m also pleased to report improving volume growth in our GeneSight mental health test. We attribute this momentum to strengthened execution across the commercial team and the enterprise overall. Prenatal testing has been uneven through 2025 but we continue to make progress and expect growth to reaccelerate in the coming quarters," said Sam Raha, President and CEO, of Myriad Genetics. "2026 is a milestone year for Myriad Genetics, with three significant new test launches, including Precise MRD, starting with a targeted alpha launch for breast cancer expected in March 2026, and full commercial launches of our AI-enabled Prolaris prostate cancer test in partnership with PATHOMIQ expected in the second quarter of 2026, and the multiple prenatal screen test, FirstGene, expected in the second half of 2026. We are looking forward to these tests supporting clinical decisions starting in 2026 and being important components of our growth in 2027 and beyond."
Financial and Operational Highlights
•Test volumes of 382,000 in the fourth quarter of 2025 increased 2% year-over-year.
•The following table summarizes year-over-year testing volume changes in the company’s core product categories:
Three months ended December 31, Twelve Months Ended December 31,
(in thousands) 2025 2024 % Change 2025 2024 % Change
Product volumes:
Hereditary cancer
82 75 9 % 315 294 7 %
Tumor profiling(1)
12 12 — % 48 53 (9) %
Prenatal 150 160 (6) % 637 666 (4) %
Mental Health 138 127 9 % 537 507 6 %
Total 382 374 2 % 1,537 1,520 1 %
(1) Tumor Profiling decreased for the twelve months ended December 31, 2025 compared to the same period in the prior year due primarily to a decrease in testing volume for EndoPredict due to the sale of the company’s international EndoPredict business in August 2024.

•The following table summarizes year-over-year revenue changes in the company’s core product categories:
Three months ended December 31, Twelve Months Ended December 31,
(in millions)
2025 2024 % Change 2025 2024 % Change
Product revenues:
Hereditary cancer
$ 96.8 $ 94.3 3 % $ 372.4 $ 364.5 2 %
Tumor profiling(1)
31.5 30.8 2 % 121.7 125.8 (3) %
Prenatal 44.9 44.9 — % 186.3 177.1 5 %
Mental Health 36.6 40.6 (10) % 144.1 170.2 (15) %
Total $ 209.8 $ 210.6 — % $ 824.5 $ 837.6 (2) %

•Operating expenses in the fourth quarter of 2025 were $152.5 million, decreasing $37.4 million year-over-year. Adjusted operating expenses in the fourth quarter of 2025 decreased $7.0 million year-over-year to $139.0 million, reflecting the company’s commitment to disciplined cost management while maintaining investments in key strategic areas.
•Operating loss in the fourth quarter of 2025 was $5.7 million.

Cash Flow and Liquidity
Fourth quarter 2025 cash flow provided by operations was $10.6 million; adjusted operating cash flow in the fourth quarter of 2025 was $17.9 million. Capital expenditures and capitalization of internal use software costs totaled $6.0 million in the fourth quarter 2025 resulting in adjusted free cash flow of $11.9 million in the fourth quarter of 2025.

As of the end of the fourth quarter of 2025, the company had cash and cash equivalents of $149.6 million.

Business Performance and Highlights
Oncology
The Oncology business delivered revenue of $84.7 million in the fourth quarter of 2025.
•Fourth quarter 2025 hereditary cancer testing revenue in Oncology increased 2% year-over-year driven by a 9% year-over-year increase in volume.
•Fourth quarter 2025 Prolaris testing revenue grew 16% year-over-year. The company continues to make progress and intends to commercially launch its first AI-enabled prostate cancer test, in partnership with PATHOMIQ, in the first half of 2026.
•The company advanced personalized breast cancer risk assessment through the launch of the first integrated AI and genetic risk platform, developed in partnership with Clairity and MagView. The company believes this solution enhances its leadership in precision breast health.
•The company showcased nine new oncology and Molecular Residual Disease (MRD) research abstracts at the 2025 San Antonio Breast Cancer Symposium, highlighting continued progress in its precision oncology pipeline. The company believes these data reinforce the scientific strength behind the company’s MRD and hereditary cancer programs and underscore Myriad Genetics’ commitment to advancing clinically meaningful innovations for patients and providers.
•In January 2026, at the 2026 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Gastrointestinal Cancers Symposium, collaborators from the National Cancer Center Hospital East in Japan reported positive interim key outcomes from MONSTAR-SCREEN-3, a multi-center, prospective study of patients with resectable Stage I-IV colorectal cancer that incorporates Precise MRD. These outcomes include 100% baseline sensitivity and highly sensitive detection of residual disease post-surgery.

Women’s Health
The Women’s Health business delivered revenue of $88.5 million in the fourth quarter of 2025.
•Fourth quarter 2025 hereditary cancer testing revenue and volume for the unaffected population increased 3% and 11% year-over-year, respectively, demonstrating progress with implementing the company’s electronic medical records (EMR) solutions and breast cancer risk assessment programs.
•Prenatal testing revenue in the fourth quarter of 2025 was stable year-over-year, while volume decreased 6% year-over-year reflecting transition dynamics following the second quarter 2025 implementation of the company’s new order management system.
•The multi-site CONNECTOR study, using the company’s FirstGene Multiple Prenatal Screen, continues to see meaningful progress in enrollment and the Company expects this study to support future commercial launch activities and expand capabilities in prenatal testing.

Mental Health
GeneSight test revenue was $36.6 million in the fourth quarter of 2025.
•Fourth quarter 2025 revenue continues to reflect the impact of UnitedHealthcare’s discontinuation of coverage of multi-gene panel pharmacogenetic testing, including GeneSight, effective in the first quarter of 2025.
•GeneSight test volume in the fourth quarter of 2025 grew 9% year-over-year, reflecting ongoing improvement in the year-over-year volume growth through 2025.

Financial Guidance
Myriad Genetics does not provide forward-looking guidance in accordance with accounting principles generally accepted in the United States (GAAP) for the measures on which it provides forward-looking non-GAAP guidance as the company is unable to provide a quantitative reconciliation of forward-looking non-GAAP measures to the most directly comparable forward-looking GAAP measure, without unreasonable effort, because of the inherent difficulty in accurately forecasting the occurrence and financial impact of the various adjusting items necessary for such reconciliations that have not yet occurred, are dependent on various factors, are out of the company’s control, or cannot be reasonably predicted. Such adjustments include, but are not limited to, strategic realignment, certain litigation charges and loss contingencies, costs related to acquisitions/divestitures and the related amortization, impairment and related charges, depreciation, equity compensation, tax benefits, and other adjustments. For example, stock-based compensation may fluctuate based on the timing of employee stock transactions and unpredictable fluctuations in the company’s stock price. Any associated estimate of these items and their impact on GAAP performance could vary materially.

Below is a table summarizing Myriad Genetics’ full-year 2026 financial guidance*:
(in millions, except percentages)
2026 Guidance
FY 2026 Comments
Revenue $860 – $880
Reiterate the full year 2026 revenue range. Q1’26 revenue is expected to be between $200 and $203 million, or 2% to 4% growth over Q1’25. This reflects current business trends offset by an unfavorable YOY comparison for Prenatal testing.

Expect 2H’26 revenue to be greater than 1H’26
Adjusted Gross Margin %**
68% – 69% Gross margins expected to fluctuate quarter to quarter given product mix and pricing trends.
Adjusted EBITDA***
$37 – $49
Q1’26 adjusted EBITDA is expected to be near breakeven
*
Assumes currency rates as of February 23, 2026.
**
Adjusted Gross Margin is defined as Gross Margin plus non-cash cost of sales, such as amortization of intangible assets and share-based compensation expense, and non-recurring one-time expenses.
***
Adjusted EBITDA is defined as Net income (loss) plus income tax expense (benefit), total other income (expense), non-cash operating expenses, such as amortization of intangible assets, depreciation, impairment of long-lived assets, and share-based compensation expense, and one-time expenses such as expenses from strategic realignment, legal settlements, and divestitures and acquisitions.

These projections are forward-looking statements and are subject to the risks summarized in the safe harbor statement at the end of this press release.

Conference Call and Webcast

A conference call will be held today, Monday, February 23, 2026, at 4:30 p.m. ET to discuss Myriad Genetics’ financial results and business developments for the fourth quarter of 2025. A live webcast of the conference call can be accessed on Myriad Genetics’ Investor Relations website at investor.myriad.com. To participate in the live conference call via telephone, please register at View Source Upon registering, a dial-in number and unique PIN will be provided to join the conference call. Following the conference call, an archived webcast of the call will be available at investor.myriad.com.

(Press release, Myriad Genetics, FEB 23, 2026, View Source [SID1234662856])

On February 23, 2026 Tyra Biosciences, Inc. (Nasdaq: TYRA), a clinical-stage biotechnology company focused on developing next-generation precision medicines that target large opportunities in Fibroblast Growth Factor Receptor (FGFR) biology, reported that two abstracts have been accepted for presentation at the 2026 ASCO (Free ASCO Whitepaper) Genitourinary (GU) Cancers Symposium (ASCO GU). The meeting is being held February 26-28, 2026, in San Francisco, California.

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Details of the poster presentations are below:

Title: "ctDNA monitoring of FGFR3-altered metastatic urothelial cancer treated with dabogratinib (formerly TYRA-300) in the SURF301 trial"

Abstract Number: 809
Session: Poster Session B: Prostate Cancer and Urothelial Carcinoma
Date and Time: February 27, 2026, 11:30 AM–12:45 PM PST
Presenting Author: Andrew J. Murtha, BSc, University of British Columbia, Vancouver, BC, Canada
Title: "A phase 2 multicenter, open-label study evaluating the efficacy and safety of dabogratinib (formerly TYRA-300) in participants with FGFR3-altered low-grade, intermediate risk non-muscle invasive bladder cancer (SURF302)"

Abstract Number: TPS886
Session: Trials in Progress Poster Session B: Urothelial Carcinoma
Date and Time: February 27, 2026, 11:30 AM–12:45 PM PST
Presenting Author: Gautam Jayram, MD, Urology Associates, Nashville, TN
More information can be found at the ASCO (Free ASCO Whitepaper) GU website. The posters will be available on the IR page of TYRA’s website following presentation at ASCO (Free ASCO Whitepaper) GU: View Source

(Press release, Tyra Biosciences, FEB 23, 2026, View Source [SID1234662873])