On March 9, 2026 Calidi Biotherapeutics, Inc. (NYSE AMERICAN: CLDI) ("Calidi" or the "Company"), a biotechnology company pioneering the development of targeted genetic medicines, reported the closing of its previously announced underwritten public offering and the exercise in full of the underwriters’ over-allotment option for gross proceeds of approximately $6.0 million, prior to deducting underwriting commissions and offering expenses.

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In connection with the offering, the Company sold 12,094,631 shares of common stock (or pre-funded warrants in lieu thereof) Series J warrants to purchase 12,094,631 shares of common stock, Series K warrants to purchase 12,094,631 shares of common stock, and Series L warrants to purchase 12,094,631 shares of common stock, including the full exercise of the underwriter’s option to purchase 1,575,000 shares of common stock and accompanying warrants..

Ladenburg Thalmann & Co. Inc. acted as sole book-running manager for the offering.

The securities described above were offered pursuant to a shelf registration statement on Form S-3 (File No. 333-284229), which was declared effective by the United States Securities and Exchange Commission ("SEC") on February 7, 2025 and the related registration statement filed under Rule 462(b) of the Securities Act of 1933, as amended, which became automatically effective upon filing. A final prospectus supplement was filed with the SEC and is available on the SEC’s website at View Source Electronic copies of the final prospectus may also be obtained by contacting Ladenburg Thalmann & Co. Inc., Prospectus Department, 640 Fifth Avenue, 4th Floor, New York, New York 10019 or by email at [email protected].

The Series J warrant has an initial exercise price of $0.50 per share, is exercisable upon issuance, and has a term expiring five years from issuance. The Series K warrant has an initial exercise price of $0.50 per share, is exercisable upon issuance, and has a term expiring one year from issuance. The Series L warrant has an initial exercise price of $0.50 per share, is exercisable upon issuance, and has a term expiring six months from issuance. The warrants issued in this offering each include a reset of the exercise price on two separate occasions: (i) on the forty-fifth (45th) calendar day following the date of issuance and (ii) the sixth (6th) trading day immediately following the date on which a reverse stock split is approved and deemed effective during the fiscal year ended December 31, 2026.

This press release does not constitute an offer to sell or the solicitation of an offer to buy, nor will there be any sales of these securities in any jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of such jurisdiction.

(Press release, Calidi Biotherapeutics, MAR 9, 2026, View Source [SID1234663387])

On March 9, 2026 Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), reported results from the Phase III persevERA Breast Cancer study evaluating investigational giredestrant in combination with palbociclib for people with estrogen receptor (ER)-positive, human epidermal growth factor receptor 2 (HER2)-negative, locally advanced or metastatic breast cancer. The study did not meet its primary objective of a statistically significant improvement in progression-free survival in the intent-to-treat population versus letrozole plus palbociclib, but a numerical improvement was observed. The adverse events for the giredestrant combination were manageable and consistent with the known safety profiles of each individual treatment.

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"While persevERA didn’t meet its primary objective, we are confident in the potential of giredestrant to become a new standard-of-care endocrine therapy in early and advanced ER-positive breast cancer," said Levi Garraway, M.D., Ph.D., chief medical officer and head of Global Product Development. "We believe there is a path forward for combining giredestrant with a CDK4/6 inhibitor in the adjuvant setting and we are conducting further studies. The efficacy demonstrated in evERA and lidERA provides clear validation of the clinical activity of giredestrant and reinforces the strength of our expanding clinical development program."

The giredestrant clinical development program is made up of distinct studies designed to reflect the specific disease biology of each stage of breast cancer. Genentech will continue to advance the clinical development program to identify the people with ER-positive breast cancer who can derive the greatest benefit from giredestrant.

Giredestrant Phase III clinical development program

Trial

Indication

Regimen

lidERA

Breast Cancer

Adjuvant ER+/HER2- breast cancer

Giredestrant vs. standard-of-care endocrine therapy (SoC ET)

persevERA Breast Cancer

1L ER+/HER2- metastatic breast cancer

(endocrine-sensitive)

Giredestrant + palbociclib vs. letrozole plus palbociclib

pionERA Breast Cancer

1L ER+/HER2- metastatic breast cancer

(endocrine-resistant)

Giredestrant + physician’s choice of CDK4/6 inhibitor vs. fulvestrant + physician’s choice of CDK4/6 inhibitor

evERA

Breast Cancer

2L+ ER+/HER2- metastatic breast cancer

Giredestrant + everolimus vs. SoC ET + everolimus

heredERA Breast Cancer

1L maintenance ER+/HER2+ metastatic breast cancer

Giredestrant + dual HER2 blockade vs. HER2 blockade

evERA was the first positive Phase III readout for giredestrant, followed by lidERA in the early-stage setting. The scientific rationale for lidERA was supported by prior results in the neoadjuvant setting, including the Phase II coopERA trial showing that giredestrant was superior to an aromatase inhibitor in reducing malignant cell division (Ki67 levels). This growing body of evidence underscores the potential of giredestrant to become a new standard-of-care endocrine therapy across ER-positive early-stage and advanced breast cancer.

persevERA is the first of two distinct Phase III studies in the first-line setting; the pionERA study of giredestrant in combination with physician’s choice of cyclin-dependent kinase (CDK)4/6 inhibitor in endocrine-resistant ER-positive, HER2-negative breast cancer is expected to readout in 2027.

The United States Food and Drug Administration (FDA) recently accepted the New Drug Application based on the evERA data. In the coming weeks, Genentech will submit the giredestrant Phase III lidERA data in early-stage breast cancer to the FDA.

The full results from persevERA will be presented at an upcoming medical meeting.

About the persevERA Breast Cancer study

persevERA Breast Cancer [NCT04546009] is a Phase III, randomized, double-blind, placebo-controlled, multicenter study evaluating the efficacy and safety of giredestrant plus palbociclib versus letrozole plus palbociclib as first-line treatment for people with estrogen receptor-positive, human epidermal growth factor receptor 2-negative, locally advanced or metastatic breast cancer. The study enrolled 992 patients globally.

The primary endpoint is investigator-assessed progression-free survival. Key secondary endpoints include overall survival, objective response rate, duration of response and safety.

About giredestrant

Giredestrant is an investigational, oral, potent next-generation selective estrogen receptor degrader and full antagonist.

Giredestrant is designed to block estrogen from binding to the estrogen receptor (ER), triggering its breakdown (known as degradation) and stopping or slowing down the growth of cancer cells.

Giredestrant has an extensive clinical development program and is being investigated in five company-sponsored Phase III clinical trials that span multiple treatment settings and lines of therapy to benefit as many people as possible:

Giredestrant versus standard-of-care endocrine therapy (SoC ET) as adjuvant treatment in ER-positive, human epidermal growth factor receptor 2 (HER2)-negative early-stage breast cancer (lidERA Breast Cancer; NCT04961996)
Giredestrant plus everolimus versus SoC ET plus everolimus in ER-positive, HER2-negative, locally advanced or metastatic breast cancer (evERA Breast Cancer; NCT05306340)
Giredestrant plus palbociclib versus letrozole plus palbociclib in ER-positive, HER2-negative, endocrine-sensitive, recurrent locally advanced or metastatic breast cancer (persevERA Breast Cancer; NCT04546009)
Giredestrant plus investigator’s choice of a cyclin-dependent kinase (CDK)4/6 inhibitor versus fulvestrant plus a CDK4/6 inhibitor in ER-positive, HER2-negative advanced breast cancer resistant to adjuvant endocrine therapy (pionERA Breast Cancer; NCT06065748)
Giredestrant plus dual HER2 blockade versus dual HER2 blockade in ER-positive, HER2-positive locally advanced or metastatic breast cancer (heredERA Breast Cancer; NCT05296798)
About estrogen receptor (ER)-positive breast cancer

Globally, the burden of breast cancer continues to grow, with 2.3 million women diagnosed and 670,000 dying from the disease every year. Breast cancer remains the number one cause of cancer-related deaths amongst women, and the second most common cancer type.

ER-positive breast cancer accounts for approximately 70% of breast cancer cases. In the U.S. and EU5, an estimated 273,000 people are diagnosed in the early-stage setting, 88,000 people are diagnosed in first-line and 106,000 in the second and third-line setting combined.

A defining feature of ER-positive breast cancer is that its tumor cells have receptors that attach to estrogen, which can contribute to tumor growth.

Despite treatment advances, ER-positive breast cancer remains particularly challenging to treat due to its biological complexity. In the early-stage setting, up to a third of people eventually experience disease recurrence on or after adjuvant endocrine therapy treatment. Additionally, many have to interrupt or stop treatment early due to safety or tolerability issues, thereby increasing the risk of death. In advanced settings, resistance to endocrine therapy – particularly following treatment with cyclin-dependent kinase inhibitors – increases the risk of disease progression and is associated with poor outcomes.

There is an urgent need for more effective treatments that can delay clinical progression and reduce the burden of treatment on people’s lives.

(Press release, Genentech, MAR 9, 2026, View Source [SID1234663385])

On March 9, 2026 enGene Holdings Inc. (Nasdaq: ENGN, "enGene" or the "Company"), a clinical-stage, non-viral genetic medicines company, reported its financial results for the first quarter ended January 31, 2026, and provided a business update.

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"As data from LEGEND’s pivotal cohort in high-risk, BCG-unresponsive NMIBC continues to mature, we look forward to providing an update at a spring medical conference," said Ron Cooper, President and Chief Executive Officer, enGene. "On the heels of our successful November follow-on offering, we entered 2026 in a position of financial strength and ready to execute. With RMAT and CDRP designations for detalimogene, we are in active dialogue with the FDA to ensure regulatory and manufacturing readiness as we plan for a BLA submission in the second half of this year and potential launch in 2027."

Recent Corporate Updates

Expanded debt facility: In January 2026, the Company expanded its existing loan and security agreement with Hercules Capital, Inc. (NYSE: HTGC) ("Hercules"), for up to $125 million. Access to the additional non-dilutive capital strengthens enGene’s balance sheet in preparation for its planned Biologics License Application ("BLA") to the U.S. Food and Drug Administration ("FDA") for detalimogene voraplasmid as a treatment for high-risk, Bacillus Calmette-Guérin ("BCG")-unresponsive non-muscle invasive bladder cancer ("NMIBC") with carcinoma in situ ("CIS") in the second half of 2026, and the potential commercial launch of detalimogene should it receive FDA approval.

Successful completion of public offering: In November 2025, the Company successfully closed an underwritten public offering of its common shares and pre-funded warrants at an offering price of $8.50 per share and $8.4999 per pre-funded warrant. The offering totaled $140.1 million in net proceeds, following the full exercise of the underwriters’ option to purchase additional shares.

LEGEND pivotal cohort update: In November 2025, enGene reported preliminary data from LEGEND’s pivotal cohort for patients enrolled following a protocol amendment implemented in the fourth quarter of 2024. The preliminary analysis of the post-amendment patients with at least one post-baseline disease assessment included 62 patients at 3 months and 37 patients at 6 months and demonstrated:

63% complete response (CR) rate at any time (n=62);
56% CR rate at 3 months (n=62);
62% CR rate at 6 months (n=37), including 4 patients who successfully converted to CR post reinduction; and
All 5 patients who completed the 9-month assessment had a CR.
The Company completed enrollment of 125 patients in total. Data from these patients demonstrated a generally favorable tolerability profile:

42% of patients experienced a treatment-related adverse event (TRAE);
1.6% of patients experienced dose interruptions due to TRAEs; and
0.8% of patients experienced dose discontinuations due to TRAEs.
enGene continues to believe that detalimogene’s emerging profile supports its potential first-line use in patients with high-risk, BCG-unresponsive non-muscle invasive bladder cancer with CIS.

CMC Development and Readiness Pilot (CDRP) Program: In November 2025, the Company was selected as one of nine companies to participate in the FDA’s Chemistry, Manufacturing, and Controls (CMC) Development and Readiness Pilot (CDRP) program. The FDA created the CDRP Program to facilitate CMC development for therapies with compressed clinical development timeframes based on the anticipated clinical benefits of earlier patient access to the therapy. Acceptance into the program further supports enGene’s confidence in detalimogene’s potential and aligns with enGene’s commitment to strong manufacturing practices as clinical development advances.

Anticipated Milestones

Update from LEGEND pivotal cohort planned for a spring 2026 medical conference.
12-month complete response data from LEGEND pivotal cohort expected in 2H 2026.
Planned BLA filing for LEGEND’s pivotal cohort in the second half of 2026.
First Quarter 2026 Financial Results

As of January 31, 2026, cash, cash equivalents and marketable securities were $312.5 million. The Company expects that its cash, cash equivalents and marketable securities will fund operating expenses, debt obligations and capital expenditures into the second half of 2028.

Total operating expenses were $31.2 million for the three months ended January 31, 2026, compared to $26.6 million for 2025. Research and development expenses increased by $2.3 million, primarily driven by increased personnel and clinical costs related to our LEGEND trial and in preparation for our planned Biologics License Application submission in the second half of 2026. General and administrative expenses increased by $2.3 million, primarily driven by personnel and facilities costs as the Company scales its general and administrative function to support the operation of a public company.

For the three months ended January 31, 2026, net loss attributable to common shareholders was approximately $29.8 million, or $0.44 per share, compared to approximately $24.6 million, or $0.48 per share, for the three months ended January 31, 2025. The increase in net loss is mainly attributed to the increase in operating expenses, partially offset by net interest income earned during the period.

About Non-Muscle Invasive Bladder Cancer (NMIBC)

Non-muscle invasive bladder cancer (NMIBC) is a disease that poses a significant burden on both patients and clinics and has a massive economic impact on our healthcare system. NMIBC occurs when cancer cells grow in the tissues that line the interior of the bladder, but the cancer has not yet penetrated the muscle of the bladder wall. NMIBC can present as papillary outgrowths from the bladder wall, which are typically resected, or as carcinoma in situ (CIS), which consists of flat, multifocal lesions that cannot be resected. The two forms can also co-occur. About 75-80% of new bladder cancer diagnoses are NMIBC. Patients suffering from high-risk NMIBC who are unresponsive to the standard of care, Bacillus Calmette-Guérin (BCG), face high rates of disease recurrence (50-70%) and are potentially subject to full removal of the bladder (cystectomy) as a curative but life-altering next step.

About Detalimogene Voraplasmid

Detalimogene is a novel, investigational, non-viral gene therapy for patients with high-risk, non-muscle invasive bladder cancer (NMIBC), including Bacillus Calmette-Guérin (BCG)-unresponsive disease. It is designed to be instilled in the bladder and elicit a powerful yet localized anti-tumor immune response.

Detalimogene was developed using the Company’s Dually Derivatized Oligochitosan (DDX) platform, a technology designed to transform how gene therapies are accessed by patients and utilized by clinicians. Medicines developed with the DDX platform can potentially overcome the limitations of viral-based gene therapies, reduce complexities related to safe handling and cold storage, and streamline both manufacturing processes and administration paradigms.

Detalimogene has received Regenerative Medicine Advanced Therapy (RMAT) and Fast Track designations from the U.S. Food and Drug Administration (FDA) based on its potential to address the high unmet medical need for patients with BCG-unresponsive carcinoma in situ (CIS) NMIBC with or without resected papillary tumors who are unable to undergo cystectomy. The RMAT program is intended to expedite the development and review of regenerative medicine therapies for serious or life-threatening conditions, where preliminary clinical evidence suggests potential to address unmet medical needs. Similarly, Fast Track designation is a process designed to facilitate the development and expedite the review of drugs to treat serious conditions and fill an unmet medical need. Detalimogene has also been selected to participate in the FDA’s Chemistry, Manufacturing, and Controls (CMC) Development and Readiness Pilot (CDRP) program. The FDA created the CDRP Program to facilitate CMC development for therapies with compressed clinical development timeframes based on the anticipated clinical benefits of earlier patient access to the therapy.

About the LEGEND Trial

Detalimogene is being evaluated in the ongoing, open-label, multi-cohort, Phase 2 LEGEND trial to establish its safety and efficacy in high-risk NMIBC. LEGEND’s pivotal cohort (Cohort 1) consists of 125 patients with high-risk, BCG-unresponsive NMIBC with CIS (with or without papillary disease) and is designed to serve as the basis of the Company’s planned Biologics License Application (BLA) filing. In addition to this pivotal cohort, LEGEND includes three additional cohorts, including NMIBC patients with CIS who are naïve to treatment with BCG (Cohort 2a); NMIBC patients with CIS who have been exposed to BCG but have not received adequate BCG treatment (Cohort 2b); and BCG-unresponsive high-risk NMIBC patients with papillary-only disease (Cohort 3). The LEGEND trial is actively enrolling patients with sites participating in the USA, Canada, Europe, and the Asia-Pacific region.

(Press release, enGene, MAR 9, 2026, View Source [SID1234663384])

On March 9, 2026 Daiichi Sankyo (TSE: 4568) and AstraZeneca (LSE/STO/NYSE: AZN) reported that its supplemental Biologics License Application (sBLA) for ENHERTU (fam-trastuzumab deruxtecan-nxki) has been accepted and granted Priority Review in the U.S. for the treatment of adult patients with HER2 positive (immunohistochemistry [IHC] 3+ or in-situ hybridization (ISH)+) breast cancer who have residual invasive disease after neoadjuvant HER2 targeted treatment.

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ENHERTU is a specifically engineered HER2 directed DXd antibody drug conjugate (ADC) discovered by Daiichi Sankyo and being jointly developed and commercialized by Daiichi Sankyo and AstraZeneca.

The U.S. Food and Drug Administration (FDA) grants Priority Review to applications for medicines that, if approved, would offer significant benefit over available treatment options by demonstrating safety or efficacy improvements, preventing serious conditions or enhancing patient compliance. The Priority Review follows receipt of Breakthrough Therapy Designation granted by the FDA in December 2025 for ENHERTU based on data from the DESTINY-Breast05 phase 3 trial presented at the 2025 European Society of Medical Oncology (ESMO) (Free ESMO Whitepaper) (#ESMO25) Congress and subsequently published in The New England Journal of Medicine. The Prescription Drug User Fee Act (PDUFA) date, the FDA target action date for their regulatory decision, is July 7, 2026.

Results from DESTINY-Breast05 showed ENHERTU significantly reduced the risk of invasive disease recurrence or death (invasive disease-free survival [IDFS]) by 53% (hazard ratio [HR]=0.47; 95% confidence interval [CI]: 0.34-0.66; p<0.0001) compared to trastuzumab emtansine (T-DM1) as a post-neoadjuvant treatment for patients with HER2 positive breast cancer with residual invasive disease following neoadjuvant therapy. Trial results demonstrated a three-year IDFS rate of 92.4% (95% CI: 89.7-94.4) in the ENHERTU arm compared to 83.7% with T-DM1 (95% CI: 80.2-86.7). IDFS findings were consistent across all prespecified subgroups.

Data also showed that ENHERTU significantly reduced the risk of disease recurrence or death by 53% (HR=0.47; 95% CI: 0.34-0.66; p<0.0001) compared to T-DM1. Treatment with ENHERTU in DESTINY-Breast05 also reduced the risk of distant disease recurrence (distant recurrence-free interval [DRFI]) by 51% (HR=0.49; 95% CI: 0.34-0.71) and the risk of brain metastases (brain metastasis-free interval [BMFI]) by 36% (HR=0.64; 95% CI: 0.35-1.17) versus T-DM1.

The sBLA is being reviewed under Project Orbis, which provides a framework for the concurrent submission and review of oncology medicines among participating international partners. This initiative is designed to bring effective cancer treatments to patients as early as possible.

"For patients with residual invasive disease after neoadjuvant therapy, identifying additional treatments following surgery is critical to help further reduce the risk of recurrence and help prevent progression to metastatic disease," said Ken Takeshita, MD, Global Head, R&D, Daiichi Sankyo. "This Priority Review reinforces the potential of ENHERTU to become a new standard of care for HER2 positive early breast cancer based on the results of DESTINY-Breast05."

"While there has been significant progress in treating HER2 positive early breast cancer, managing patients at a higher risk of recurrence remains challenging," said Susan Galbraith, MBBChir, PhD, Executive Vice President, Oncology Hematology R&D, AstraZeneca. "With this Priority Review, we move closer to bringing ENHERTU to the post-neoadjuvant setting, offering more patients the opportunity for sustained long-term outcomes and a potential path to cure."

The safety profile of ENHERTU observed in DESTINY-Breast05 was consistent with its known profile with no new safety concerns identified. Grade 3 or higher treatment emergent adverse event (TEAE) rates were comparable between ENHERTU (50.6%) and T-DM1 (51.9%). The most common grade 3 or higher TEAEs occurring in 5% or more of patients treated with ENHERTU were decreased neutrophil count (15.5%), decreased white blood cell count (10.1%), decreased platelet count (6.7%) and neutropenia (8.1%). Rates of interstitial lung disease (ILD) or pneumonitis were low in both arms with ILD events occurring in 9.6% of the ENHERTU arm and 1.6% of the T-DM1 arm. The majority of ILD or pneumonitis events were low grade (grade 1 [ENHERTU=16; 2.0%; T-DM1=8; 1.0%] or grade 2 [ENHERTU=52; 6.5%; T-DM1=5; 0.6%]). There were no grade 3 or higher ILD or pneumonitis events for T-DM1. In the ENHERTU arm, there were seven grade 3 events (0.9%) and two grade 5 events (0.2%) as determined by an independent adjudication committee.

Regulatory submissions for ENHERTU based on DESTINY-Breast05 are under review in the EU and Japan. In addition, an sBLA for ENHERTU followed by paclitaxel, trastuzumab and pertuzumab (THP) currently is under review in the U.S. for the neoadjuvant treatment of adult patients with HER2 positive (IHC 3+ or ISH+) stage 2 or stage 3 breast cancer based on results from the DESTINY-Breast11 trial with a PDUFA date of May 18, 2026.

About DESTINY-Breast05

DESTINY-Breast05 is a global, multicenter, randomized, open-label, phase 3 trial evaluating the efficacy and safety of ENHERTU (5.4 mg/kg) versus T-DM1 in patients with HER2 positive early breast cancer with residual invasive disease in breast or axillary lymph nodes following neoadjuvant therapy and a high risk of recurrence. High risk of recurrence was defined as presentation with inoperable cancer (prior to neoadjuvant therapy) or pathologically positive axillary lymph nodes following neoadjuvant therapy.

The primary endpoint of DESTINY-Breast05 is investigator-assessed IDFS, which is defined as the time from randomization until first invasive local, axillary or distant recurrence or death from any cause. The key secondary endpoint is investigator-assessed DFS. Other secondary endpoints include overall survival, DRFI, BMFI, interval and safety.

DESTINY-Breast05 enrolled 1,635 patients in Asia, Europe, North America, Oceania and South America. For more information about the trial, visit ClinicalTrials.gov.

About Post-Neoadjuvant Treatment for HER2 Positive Early Breast Cancer

Breast cancer is the second most common cancer and one of the leading causes of cancer-related deaths worldwide.1 More than two million breast cancer cases were diagnosed in 2022, with more than 665,000 deaths globally.1 In the U.S., more than 320,000 cases of breast cancer are diagnosed annually with more than 42,000 deaths.2

HER2 is a tyrosine kinase receptor growth-promoting protein expressed on the surface of many types of tumors including breast cancer.3 HER2 protein overexpression may occur as a result of HER2 gene amplification and is often associated with aggressive disease and poor prognosis in breast cancer.3 Approximately one in five cases of breast cancer is considered HER2 positive.4

For patients with HER2 positive early breast cancer, achieving pathologic complete response (pCR) with neoadjuvant treatment is the earliest indicator of improved long-term survival.5 However, approximately half of patients who receive neoadjuvant treatment do not experience pCR, putting them at increased risk of disease recurrence.6,7,8,9,10

Despite receiving additional treatment for residual disease in the post-neoadjuvant setting, some patients still experience invasive disease or death and current treatment options have shown limited impact on central nervous system recurrence.11 Once patients are diagnosed with metastatic disease, the five-year survival rate drops from nearly 90% to approximately 30%.12

Post-neoadjuvant therapy represents a key opportunity to minimize the risk of recurrence and prevent progression to metastatic disease for patients with residual disease. New treatment options are needed in the early breast cancer setting to help reduce the likelihood of disease progression and improve long-term outcomes for more patients.13,14

About ENHERTU

ENHERTU (trastuzumab deruxtecan; fam-trastuzumab deruxtecan-nxki in the U.S. only) is a HER2 directed ADC. Designed using Daiichi Sankyo’s proprietary DXd ADC Technology, ENHERTU is the lead ADC in the oncology portfolio of Daiichi Sankyo and the most advanced program in AstraZeneca’s ADC scientific platform. ENHERTU consists of a HER2 monoclonal antibody attached to a number of topoisomerase I inhibitor payloads (an exatecan derivative, DXd) via tetrapeptide-based cleavable linkers.

ENHERTU (5.4 mg/kg) in combination with pertuzumab is approved in the U.S. as a first-line treatment for adult patients with unresectable or metastatic HER2 positive (IHC 3+ or ISH+) breast cancer, as determined by an FDA-approved test, based on the results from the DESTINY-Breast09 trial.

ENHERTU (5.4 mg/kg) is approved in more than 90 countries/regions worldwide for the treatment of adult patients with unresectable or metastatic HER2 positive (IHC 3+ or ISH+) breast cancer who have received a prior anti-HER2-based regimen, either in the metastatic setting or in the neoadjuvant or adjuvant setting, and have developed disease recurrence during or within six months of completing therapy based on the results from the DESTINY-Breast03 trial.

ENHERTU (5.4 mg/kg) is approved in more than 90 countries/regions worldwide for the treatment of adult patients with unresectable or metastatic HER2 low (IHC 1+ or IHC 2+/ISH-) breast cancer who have received a prior systemic therapy in the metastatic setting or developed disease recurrence during or within six months of completing adjuvant chemotherapy based on the results from the DESTINY-Breast04 trial.

ENHERTU (5.4 mg/kg) is approved in more than 60 countries/regions worldwide for the treatment of adult patients with unresectable or metastatic hormone receptor (HR) positive, HER2 low (IHC 1+ or IHC 2+/ ISH-) or HER2 ultralow (IHC 0 with membrane staining) breast cancer, as determined by a locally or regionally approved test, that have progressed on one or more endocrine therapies in the metastatic setting based on the results from the DESTINY-Breast06 trial.

ENHERTU (5.4 mg/kg) is approved in more than 70 countries/regions worldwide for the treatment of adult patients with unresectable or metastatic NSCLC whose tumors have activating HER2 (ERBB2) mutations, as detected by a locally or regionally approved test, and who have received a prior systemic therapy based on the results from the DESTINY-Lung02 and/or DESTINY-Lung05 trials. Continued approval in China and the U.S. for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial.

ENHERTU (6.4 mg/kg) is approved in more than 80 countries/regions worldwide for the treatment of adult patients with locally advanced or metastatic HER2 positive (IHC 3+ or IHC 2+/ISH+) gastric or gastroesophageal junction (GEJ) adenocarcinoma who have received a prior trastuzumab-based regimen based on the results from the DESTINY-Gastric01, DESTINY-Gastric02 and/or DESTINY-Gastric04 trials.

ENHERTU (5.4 mg/kg) is approved in more than 10 countries/regions worldwide for the treatment of adult patients with unresectable or metastatic HER2 positive (IHC 3+) solid tumors who have received prior systemic treatment and have no satisfactory alternative treatment options based on efficacy results from the DESTINY-PanTumor02, DESTINY-Lung01 and DESTINY-CRC02 trials. Continued approval in the U.S. for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial.

About the ENHERTU Clinical Development Program

A comprehensive global clinical development program is underway evaluating the efficacy and safety of ENHERTU as a monotherapy or in combination or sequentially with other cancer medicines across multiple HER2 targetable cancers.

(Press release, Daiichi Sankyo, MAR 9, 2026, View Source [SID1234663383])

On March 9, 2026 Caris Life Sciences (NASDAQ: CAI), a leading patient-centric, next-generation AI TechBio company and precision medicine pioneer, reported the launch of a novel, proprietary Caris AI Insights signature for pancreatic cancer included in the Caris Molecular Tumor Board Report. The Caris Molecular Tumor Board Report is an innovative tumor profiling report that provides an additional tumor biology resource and is available upon request with no additional tissue sampling required when ordering MI Cancer Seek.

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Caris Life Sciences continues to advance precision oncology by integrating multimodal real-world datasets, available with its proprietary CodeAI platform, enabling the creation of Caris AI Insights, an engine that utilizes Whole Exome Sequencing (WES), Whole Transcriptome Sequencing (WTS), and clinical data to generate deeper biological understanding and more actionable insights for clinicians and researchers.

By harnessing AI across its comprehensive real-world datasets, comprised of over 550,000 patients, Caris researchers are building next-generation multimodal models that accelerate biomarker discovery, enhance therapeutic decision-making, and support the development of more personalized cancer treatments.

This signature, designed to support first-line treatment selection for patients with pancreatic ductal adenocarcinoma (PDAC), leverages Caris’ WES and WTS to provide biologically informed insights that may help clinicians personalize therapy decisions in one of the deadliest and most treatment-challenging cancers.

FOLFIRINOX and gemcitabine/nab-paclitaxel (gem/nab-p) are the most commonly used first-line regimens for advanced PDAC, yet limited actionable biomarker guidance exists for therapy selection. As a result, treatment selection often relies on clinical factors rather than tumor biology, exposing patients to potentially unnecessary toxicity with limited benefit.

"Caris AI Insights for PDAC represents a meaningful step forward in bringing molecular intelligence to a disease where clinicians have historically had to make difficult treatment decisions with limited biological guidance," said David Spetzler, MS, PhD, MBA, President of Caris Life Sciences. "By harnessing the power of WES and WTS, this Caris AI Insights signature identifies complex molecular patterns that may predict differential benefit between standard first-line regimens. This is exactly the type of advancement to improve patient care that our comprehensive platform was built to deliver."

The PDAC signature provides clinicians with risk categorization (standard or high risk) and treatment recommendations between FOLFIRINOX and gem/nab-p, based on molecular patterns associated with differential benefit. The report includes a Kaplan-Meier plot for patients treated with either regimen, matching the predictions to the clinicians’ patients to advise likely responses.

Caris received FDA approval in November 2024 for MI Cancer Seek, a tissue-based assay that is the first and only simultaneous Whole Exome Sequencing (WES) and Whole Transcriptome Sequencing (WTS)-based assay with FDA-approved companion diagnostic (CDx) indications for molecular profiling of solid tumors.

A future publication is expected this year, highlighting how Caris AI Insights for pancreatic cancer identified a significant subset of patients who may be candidates for treatment de-escalation, as well as those more likely to benefit from a more intensive regimen and those who likely need the more intensive therapy.

(Press release, Caris Life Sciences, MAR 9, 2026, View Source [SID1234663382])