On March 26, 2026 Agilent Technologies Inc. (NYSE: A) reported that it has received U.S. Food and Drug Administration (FDA) approval for PD-L1 IHC 22C3 pharmDx, Code SK006, as a companion diagnostic to aid in identifying patients with esophageal or gastroesophageal junction (GEJ) carcinoma who may be eligible for treatment with KEYTRUDA (pembrolizumab), Merck’s anti-PD-1 therapy.

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PD-L1 IHC 22C3 pharmDx, Code SK006, is the only FDA-approved companion diagnostic indicated to identify patients with esophageal or GEJ carcinoma whose tumors express PD-L1 (Combined Positive Score (CPS) ≥ 1) who may be eligible for treatment with KEYTRUDA. This approval marks the eighth FDA approved companion diagnostic indication currently available for PD-L1 IHC 22C3 pharmDx, Code SK006, for use with KEYTRUDA.

"With the expanded FDA approval of PD-L1 IHC 22C3 pharmDx in esophageal or GEJ carcinoma, Agilent is proud to support clinicians in identifying patients eligible for treatment with KEYTRUDA," said Nina Green, vice-president and general manager of Agilent’s Clinical Diagnostics Division. "This milestone reinforces Agilent’s commitment to advancing precision medicine and underscores its leadership in delivering trusted companion diagnostics that help enable treatment with anti-PD-1 therapies."

In addition to esophageal or GEJ carcinoma, PD-L1 IHC 22C3 pharmDx, Code SK006, is also indicated to help physicians identify patients with non-small cell lung cancer (NSCLC), esophageal squamous cell carcinoma (ESCC), cervical cancer, head and neck squamous cell carcinoma (HNSCC), triple-negative breast cancer (TNBC), gastric or GEJ adenocarcinoma, and epithelial ovarian, fallopian tube, or primary peritoneal carcinoma (EOC) who may benefit from treatment with KEYTRUDA.

KEYTRUDA is indicated for the treatment of patients with locally advanced or metastatic esophageal or gastroesophageal junction (GEJ) (tumors with epicenter 1 to 5 centimeters above the GEJ) carcinoma that is not amenable to surgical resection or definitive chemoradiation in combination with platinum- and fluoropyrimidine-based chemotherapy for patients with tumors that express PD-L1 (CPS ≥ 1).

In 2025, esophageal cancer caused approximately 16,250 deaths in the United States, with a 5-year relative survival rate of 21.9 percent.3

PD-L1 IHC 22C3 pharmDx, Code SK006, was developed by Agilent in partnership with Merck (known as MSD outside the United States and Canada) as a companion diagnostic for KEYTRUDA.

KEYTRUDA (pembrolizumab) is a registered trademark of Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc., Rahway, NJ, USA.

(Press release, Agilent, MAR 26, 2026, View Source [SID1234663960])

On March 26, 2026 ImmunityBio, Inc. (NASDAQ: IBRX), a vertically integrated, commercial-stage immunotherapy company, reported that based on the Independent Data Monitoring Committee (IDMC) review of the interim data, the committee recommended that the study is adequately powered to detect the pre-specified clinically meaningful difference in complete response (CR) rate between the experimental arm (ANKTIVA + BCG) and the control arm (BCG alone) at the protocol-specified power, in the randomized QUILT-2.005 (NCT02138734) study. The QUILT-2.005 study was designed to detect the pre-specified difference in CR rate between ANKTIVA (nogapendekin alfa inbakicept-pmln) plus Bacillus Calmette-Guérin (BCG) and BCG alone in patients with BCG-naïve non-muscle invasive bladder cancer (NMIBC) with carcinoma in situ (CIS) with or without papillary disease, based on its review of the planned interim analysis.

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On February 26, 2026, ImmunityBio announced enrollment was complete in the pivotal randomized trial. By March 2026, 50% of enrolled patients were evaluable (N=183) for the primary efficacy endpoint. Upon reaching this pre-specified 50% evaluable threshold, a planned interim analysis by an IDMC was initiated per protocol to verify that the 366 patients enrolled to date provides sufficient statistical power to detect the pre-specified clinically meaningful difference in CR rate between the two arms.

Based on the IDMC review of the interim data, the committee recommended that no additional enrollment beyond N=366 is required and that the study is adequately powered to detect the pre-specified clinically meaningful difference in CR rate at the protocol-specified power.

"Over the past decade, our scientific thesis has been that activating natural killer cells and CD8+ cytotoxic T cells through IL-15 receptor agonism would generate durable immunological memory against bladder cancer. The NCI identified IL-15 as the number one ranked immunostimulatory cytokine nearly two decades ago, and this program has been the clinical validation of that thesis. The IDMC’s confirmation that QUILT-2.005 is adequately powered to detect clinically meaningful differences when ANKTIVA is combined with BCG. Among participants from the QUILT 2.005 Phase 1b study which began in 2014, those patients who enrolled in long-term follow-up (6 of 9 evaluable), all (6 out of 6, 100%) demonstrated a prolonged duration of complete remission with a median survival of 8.8 years with ongoing bladder preservation to date. In addition, the initial interim analysis of QUILT-2.005 performed in the first 43 patients in 2023, further demonstrated a difference in durable complete response when ANKTIVA is combined with BCG in the BCG-naïve setting. The consistency of durable response from the first 9 patients in 2014, to the next 43 patients in 2023 is encouraging and I am pleased that statistical power of the randomized trial requires no further enrollment," said Patrick Soon-Shiong, M.D., Founder, Executive Chairman and Global Chief Medical and Scientific Officer of ImmunityBio. "The combination of ANKTIVA with BCG is approved for adult patients with BCG-unresponsive NMIBC with CIS with or without papillary disease, and the enrollment of QUILT-2.005 is now complete. ImmunityBio is on track to submit a supplemental Biologics License Application based on the final data analysis in 2026."

"The regulatory and commercial development of ANKTIVA in urologic oncology and across solid tumor indications continues to advance. We are grateful to the patients who participated in this trial and to the ImmunityBio team whose work made this milestone possible," said Richard Adcock, President and CEO of ImmunityBio. "With ANKTIVA approved with BCG for adult patients with BCG-unresponsive NMIBC CIS with or without papillary disease in 34 countries and territories, the opportunity to extend its use earlier in the disease course in the BCG-naïve setting represents a substantial expansion of the addressable patient population."

About QUILT-2.005

QUILT-2.005 (NCT02138734) is a randomized, controlled Phase 2b clinical trial evaluating ANKTIVA (nogapendekin alfa inbakicept-pmln) in combination with Bacillus Calmette-Guérin (BCG) versus BCG alone in patients with BCG-naïve non-muscle invasive bladder cancer (NMIBC). BCG-naïve patients are those receiving BCG-based therapy for the first time, representing an earlier stage of treatment than the BCG-unresponsive population for whom ANKTIVA is currently FDA approved. The trial is designed to assess whether the addition of ANKTIVA to standard induction BCG improves the complete response (CR) rate in patients with carcinoma in situ (CIS) with or without papillary disease. QUILT-2.005 completed enrollment in February 2026. In March 2026, the Independent Data Monitoring Committee determined that the study was adequately powered to detect a clinically meaningful difference between the control and experimental arms. Supplemental BLA submission is anticipated Q4 2026.

About ANKTIVA (nogapendekin alfa inbakicept-pmln)

The cytokine interleukin-15 (IL-15) plays a crucial role in the immune system by affecting the development, maintenance, and function of key immune cells—NK and CD8+ killer T cells—that are involved in killing cancer cells. By activating NK cells, ANKTIVA overcomes the tumor escape phase of clones resistant to T cells and restores memory T cell activity with resultant prolonged duration of complete response. ANKTIVA is a first-in-class IL-15 receptor agonist IgG1 fusion complex, consisting of an IL-15 mutant (IL-15N72D) fused with an IL-15 receptor alpha, which binds with high affinity to IL-15 receptors on NK, CD4+, and CD8+ T cells. This fusion complex of ANKTIVA mimics the natural biological properties of the dendritic cell membrane-bound IL-15 receptor alpha driving the activation and proliferation of NK cells with the generation of memory killer T cells that have retained immune memory against these tumor clones.

IMPORTANT SAFETY INFORMATION

INDICATION AND USAGE: ANKTIVA is an interleukin-15 (IL-15) receptor agonist indicated with Bacillus Calmette-Guérin (BCG) for the treatment of adult patients with BCG-unresponsive non-muscle invasive bladder cancer (NMIBC) with carcinoma in situ (CIS) with or without papillary tumors.

WARNINGS AND PRECAUTIONS: Risk of Metastatic Bladder Cancer with Delayed Cystectomy. Delaying cystectomy can lead to the development of muscle-invasive or metastatic bladder cancer, which can be lethal. If patients with CIS do not have a complete response to treatment after a second induction course of ANKTIVA with BCG, reconsider cystectomy.

DOSAGE AND ADMINISTRATION: For Intravesical Use Only. Do not administer by subcutaneous or intravenous routes.

Please see the complete Indication and Important Safety Information and Prescribing Information for ANKTIVA at Anktiva.com.

(Press release, ImmunityBio, MAR 26, 2026, View Source [SID1234663942])

On March 26, 2026 LeonaBio, Inc. (NASDAQ: LONA), a clinical-stage biopharmaceutical company dedicated to the development of novel therapeutics for diseases with high unmet medical needs, reported financial results for the year ended December 31, 2025, and provided recent pipeline and business updates.

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"2025 was a truly transformational year for LeonaBio. With our license for lasofoxifene, we added a late-stage drug candidate that has the potential to become the endocrine therapy of choice in the multi-billion-dollar second line metastatic breast cancer setting" stated Mark Litton, Ph.D., President and Chief Executive Officer of LeonaBio. "Coupled with our successful $90 million fundraise with the potential for $146 million in additional capital available through warrant exercises, we enter 2026 with the financial resources needed to advance both our oncology and neurodegeneration programs with confidence."

"Our transition from Athira Pharma to LeonaBio reflects far more than a name change; it represents our evolution into a more focused, diversified, and opportunity-driven biopharmaceutical company. We now have two clinical-stage programs and an experienced team aligned around focused execution. As we look ahead to meaningful clinical milestones in 2026 — including the anticipated completion of enrollment of the Phase 3 ELAINE-3 clinical trial and initiation of patient dosing in our ATH-1105 ALS program — we are energized by what lies ahead. We are building a company that we believe has the potential to change the treatment landscape for patients who urgently need better options, and I couldn’t be more optimistic about the momentum we carry into 2026 and beyond," concluded Dr. Litton.

Clinical Development & Pipeline Programs

Lasofoxifene – A novel, nonsteroidal selective estrogen receptor modulator (SERM) with a unique binding profile, designed to confer potent activity against both wild-type and mutant estrogen receptors, including the clinically significant ESR1 mutations commonly associated with resistance to endocrine therapy in metastatic breast cancer.

In December 2025, LeonaBio acquired an exclusive global license (excluding Asia and certain countries in the Middle East) from Sermonix Pharmaceuticals, Inc. for rights to develop and commercialize lasofoxifene.

Lasofoxifene is being advanced in a Phase 3 clinical trial (NCT05696626) in combination with abemaciclib, a CDK4/6 inhibitor, as a targeted therapy for estrogen receptor-positive (ER+), HER2-negative, ESR1-mutated metastatic breast cancer, a population with limited treatment options following progression on aromatase inhibitors and CDK4/6 inhibitors. The primary endpoint of the study is statistically significant improvement in progression free survival (PFS) as determined by blinded, independent central review (BICR). The ongoing Phase 3 trial aims to establish a new standard of care for this genetically defined patient group.
LeonaBio is amending the ELAINE-3 trial protocol to increase the sample size from 500 participants to up to 600 participants. The primary goal of the amendment is to help ensure that the trial will have the appropriate number of disease progression events. The Company expects to complete enrollment of the Phase 3 ELAINE-3 clinical trial in the fourth quarter of 2026 and to have topline data in the second half of 2027.
Lasofoxifene was previously evaluated in two Phase 2 studies in patients with ER+, HER2-negative locally advanced or metastatic breast cancer expressing an ESR1 mutation, ELAINE-1 and ELAINE-2
ELAINE-1, an open-label, randomized trial comparing lasofoxifene to fulvestrant, showed improved outcomes for lasofoxifene as a potential monotherapy. Although the trial was not powered, results included longer median progression-free survival (5.6 vs. 3.7 months), higher objective response rates (13.3% vs. 2.9%) and a durable complete response lasting more than 2.5 years. The treatment was well-tolerated with patients reporting quality-of-life benefits.
ELAINE-2, an open-label study evaluating lasofoxifene in combination with abemaciclib, demonstrated clinical benefits in heavily pretreated patients, with a median progression-free survival of approximately 13 months, an objective response rate of 56% and a clinical benefit rate of 65.5%. The combination was generally well-tolerated with most adverse events being low grade.
ATH-1105 – A novel, orally available, brain-penetrant, next-generation small molecule drug candidate designed to positively modulate the neurotrophic HGF system for potential treatment of neurodegenerative diseases, including amyotrophic lateral sclerosis (ALS), Alzheimer’s disease, and Parkinson’s disease. ATH-1105 is currently being developed for the potential treatment of ALS.

In August 2025, LeonaBio presented results from the first-in-human Phase 1 clinical trial (NCT 06432647) of ATH-1105 in healthy volunteers at the ALS Nexus 2025 conference.
Results from the Phase 1 trial demonstrated a favorable safety and tolerability profile as well as dose-proportional pharmacokinetics and CNS penetration.
Previously, the Company presented data from the Phase 1 clinical trial of ATH-1105 at the 4th Annual ALS Drug Development Summit. Key highlights from the presentation included:
ATH-1105 showed a favorable safety profile and was well tolerated in both single and multiple ascending dose studies in healthy volunteers
ATH-1105 showed dose proportional pharmacokinetics and central nervous system (CNS) penetration
ATH-1105 demonstrated consistent and robust beneficial effects in preclinical models of ALS
LeonaBio conducted the first-in-human Phase 1 double-blind, placebo-controlled clinical trial that enrolled 80 healthy volunteers to evaluate single and multiple oral ascending doses of ATH-1105. The study was completed in November 2024 and evaluated the safety and tolerability of ATH-1105 and included measurements of pharmacokinetic outcomes.
ATH-1105’s potential is supported by a body of preclinical evidence demonstrating statistically significant improvements in nerve and motor function, biomarkers of inflammation and neurodegeneration, including neurofilament light chain and survival in various models of ALS.
LeonaBio is on track to dose ALS patients in a Phase 2 proof-of-concept clinical trial in the second half of 2026.
Corporate Updates

In February 2026, Mark F. Kubik was appointed as Chief Business Officer of LeonaBio, with responsibility for licensing, partnership strategy and corporate development initiatives.
In January 2026, LeonaBio changed its name from Athira Pharma to align with the Company’s transformative acquisition of rights to develop and commercialize lasofoxifene as a treatment for metastatic breast cancer and better reflect its commitment to continued leadership, resilience and innovation.
In December 2026, the Company acquired an exclusive global license (excluding Asia and certain countries in the Middle East) from Sermonix Pharmaceuticals, Inc. for rights to develop and commercialize lasofoxifene, a selective estrogen receptor modulator (SERM) for the potential treatment of metastatic breast cancer.
In conjunction with the Sermonix license agreement, LeonaBio announced a $90 million private placement financing of common stock and warrants, with the warrants providing, if exercised, up to an additional $146 million to support development through key clinical and regulatory milestones.
Financial Results

Cash Position. Cash, cash equivalents and investments were $88.3 million as of December 31, 2025, compared to $51.3 million as of December 31, 2024. Net cash used in operations was $45.7 million for the year ended December 31, 2025, compared to $97.2 million for the year ended December 31, 2024.
Research and Development (R&D) Expenses. R&D expenses were $85.6 million for the year ended December 31, 2025, compared to $70.7 million for the year ended December 31, 2024. The increase was driven primarily by acquired in-process research and development costs related to our license of lasofoxifene.
General and Administrative (G&A) Expenses. G&A expenses were $16.7 million for the year ended December 31, 2025, compared to $26.1 million for the year ended December 31, 2024. The decrease was driven primarily by a realization of cost efficiencies in 2025 as we pursued our strategic alternatives.
Net Loss. Net loss was $105.6 million, or $24.70 per share, for the year ended December 31, 2025, compared to a net loss of $96.9 million, or $25.19 per share, for the year ended December 31, 2024.

(Press release, LeonaBio, MAR 26, 2026, View Source [SID1234663961])

On March 26, 2026 Inhibikase Therapeutics, Inc. (Nasdaq: IKT) ("Inhibikase" or "Company"), a clinical-stage pharmaceutical company developing therapeutics to modify the course of cardiopulmonary diseases namely, Pulmonary Arterial Hypertension ("PAH"), reported financial results for the year ended December 31, 2025 and highlighted recent developments.

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"The fourth quarter of 2025 was a transformational quarter for the Company as we transitioned to a global pivotal Phase 3 clinical study in Pulmonary Arterial Hypertension following receipt of a Written Response from a Type C interaction from the United States Food and Drug Administration," said Mark Iwicki, Chief Executive Officer of Inhibikase. "With regulatory submissions in over 20 countries already filed and our first sites initiated, we are well-placed to advance enrollment in our global pivotal study, called IMPROVE-PAH, in PAH."

Recent Developments:

The Company is advancing IKT-001 into a global pivotal Phase 3 study in PAH:
The Phase 3 study, named IMPROVE-PAH (IKT-001 for Measuring Pulmonary Vascular Resistance and Outcome Variables in a Phase 3 Evaluation of PAH; NCT07365332), has been initiated with regulatory approval and the recent activation of our first clinical sites in the United States.
Following receipt from the United States Food and Drug Administration (the "FDA") of the Written Response from the Company’s Type C meeting interaction with the agency, the Company is initiating a two-part adaptive Phase 3 study.
Part A of IMPROVE-PAH is a double blind, placebo-controlled study in approximately 140 patients with a primary endpoint of Pulmonary Vascular Resistance ("PVR") at Week 24.
Part B of IMPROVE-PAH, which shall immediately commence enrollment following enrollment of the last patient in Part A, adopts an identical format to Part A, except the primary endpoint will be 6-minute walk distance ("6MWD") at Week 24 in approximately 346 patients.
The Company believes this adaptive Phase 3 study design has important advantages including: (1) permitting a 12-week dose-titration phase designed to get patients to the highest tolerable dose of IKT-001; (2) uninterrupted enrollment between Part A and Part B; and (3) the ability to, if necessary, undertake a sample size re-estimation for Part B based on Part A findings.
IMPROVE-PAH is expected to be conducted in up to approximately 180 sites around the world.
The Company is progressing regulatory approvals with submissions in over 20 countries together with receiving confirmation of acceptance under "Facilitating and Accelerating Strategic Trials in the European Union", called FAST-EU, which is a pilot initiative that commenced on January 30, 2026 to accelerate the approval of multinational clinical trials. FAST-EU offers a potential maximum 10-week (70-day) timeline for authorization, integrating Ethics Committee opinions and improving efficiency within the European Union Clinical Trials Information System.
Inhibikase successfully completed various required pre-clinical studies that are necessary to support an application to the FDA for Orphan Drug Designation for delivery of IKT-001 for PAH. Various information from these studies is expected to be presented at the American Thoracic Society International Conference to be held in Orlando, Florida on May 17th and 20th, 2026.
In November 2025, the Company completed a $115 million underwritten public offering of its common stock and pre-funded warrants.
Aggregate gross proceeds from this offering were approximately $115 million, before deducting underwriting discounts and commissions and other offering expenses, excluding the exercise of any pre-funded warrants.
Financial Results

Cash Position: As of December 31, 2025, cash, cash equivalents and marketable securities were $178.8 million as compared to $97.5 million as of December 31, 2024.

Net Loss: Net loss for the year ended December 31, 2025, was $48.3 million, or $0.49 per share, compared to a net loss of $27.5 million, or $1.16 per share in the year ended December 31, 2024.

R&D Expenses: Research and development expenses were $29.8 million for the year ended December 31, 2025, which includes a non-cash write-off of in-process research and development of $7.4 million and $2.5 million of stock-based compensation expense, both associated with the Company’s acquisition of CorHepta in February 2025, compared to $17.2 million for the year ended December 31, 2024.

SG&A Expenses: Selling, general and administrative expenses for the year ended December 31, 2025 were $23.6 million, which includes $1.0 million of severance expenses resulting from the transition of senior executives in the Company during the year, compared to $11.4 million for the year ended December 31, 2024.

(Press release, Inhibikase Therapeutics, MAR 26, 2026, View Source [SID1234663943])

On March 26, 2026 RenovoRx, Inc. ("RenovoRx" or "the Company") (Nasdaq: RNXT), a life-sciences company developing innovative targeted oncology therapies and commercializing RenovoCath, a patented, FDA-cleared drug-delivery device, reported the Company has achieved a key milestone in its ongoing Phase III TIGeR‑PaC clinical trial by surpassing 100 randomized patients and remains on track for enrollment completion in the first half of 2026, with final data expected in 2027.

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"Reaching over 100 randomized patients marks an important milestone in our Phase III trial as we maintain strong momentum toward enrollment completion. We remain committed to completing the TIGeR-PaC trial and delivering final data in 2027," said Leesa Gentry, Chief Clinical Officer of RenovoRx. "In parallel, select TIGeR-PaC cancer centers have begun using the TAMP therapy platform, enabled by the RenovoCath device, for targeted drug-delivery in the treatment of patients diagnosed with solid tumors."

RenovoRx’s novel drug-device combination oncology product candidate (intra-arterial gemcitabine delivered via RenovoCath, known as IAG) is being evaluated in the TIGeR-PaC trial. IAG is being evaluated by the Center for Drug Evaluation and Research (the drug division of the FDA) under a U.S. investigational new drug application that is regulated by the FDA’s 21 CFR 312 pathway. IAG utilizes RenovoCath, the Company’s patented, FDA-cleared drug-delivery device, indicated for temporary vessel occlusion in applications including arteriography, preoperative occlusion, and chemotherapeutic drug infusion. TIGeR-PaC is evaluating IAG in locally advanced pancreatic cancer, and its potential to minimize a therapy’s toxicities versus systemic intravenous therapy.

The current protocol and statistical analysis plan for the TIGeR-PaC trial requires 114 randomized patients, with 86 events (deaths) necessary to complete the final analysis. As of March 24, 2026, 104 patients have been randomized and 72 events have occurred. RenovoRx anticipates completion of enrollment by the end of the first half of 2026, ensuring a minimum of 114 patients will be randomized.

The first and second pre-planned interim analyses were conducted per protocol specifications and triggered upon the 26th event (2023) and the 52nd event (2025), respectively. In both the first and second interim analyses, the independent data monitoring committee (DMC) for the trial recommended that RenovoRx continue with the trial, based on its review of the data.

About RenovoCath

Based on its FDA clearance, RenovoCath is intended for the isolation of blood flow and delivery of fluids, including diagnostic and/or therapeutic agents, to select sites in the peripheral vascular system. RenovoCath is also indicated for temporary vessel occlusion in applications including arteriography, preoperative occlusion, and chemotherapeutic drug infusion. For further information regarding our RenovoCath Instructions for Use ("IFU"), please see: IFU-10004-Rev.-G-Universal-IFU.pdf.

(Press release, Renovorx, MAR 26, 2026, View Source [SID1234663962])