On March 30, 2026 UroGen Pharma Ltd. (Nasdaq: URGN), a biotech company dedicated to developing and commercializing innovative solutions that treat urothelial and specialty cancers, reported the publication of results from the pivotal Phase 3 ENVISION trial of ZUSDURI (mitomycin) for intravesical solution in The Journal of Urology. ZUSDURI is indicated for the treatment of adults with recurrent low-grade intermediate-risk non-muscle invasive bladder cancer (LG-IR-NMIBC). The publication reports a 72.2% probability of remaining event-free at 24 months after complete response (CR) (95% CI: 64%, 79%) as determined by Kaplan-Meier analysis. The CR rate at three months was 79.6%. The median follow-up time after three-month CR was 23.7 months, and the median DOR was not reached.

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"The publication of these long-term data in The Journal of Urology provides important peer-reviewed validation of the durability of ZUSDURI treatment observed in the ENVISION trial," said Sandip Prasad, M.D., M.Phil., Director of Genitourinary Surgical Oncology and Vice Chair of Urology at Morristown Medical Center/Atlantic Health System, New Jersey, and Principal Investigator of the ENVISION trial. "For patients who achieved a complete response, the likelihood of remaining event-free through two years was substantial, underscoring the potential of ZUSDURI to change the long-term management of this highly recurrent disease with a six-week induction treatment alone without maintenance. For the first time, adult patients with recurrent LG-IR-NMIBC have an FDA-approved therapy."

The existing standard of care for LG-IR-NMIBC is transurethral resection of bladder tumor (TURBT), a surgical procedure typically performed under general anesthesia. Due to high recurrence rates, patients, who are often elderly with multiple comorbidities, may require repeated TURBT procedures over their lifetime, which can negatively impact quality of life and may be associated with increased health risks. An estimated 59,000 patients with LG-IR-NMIBC experience recurrence annually in the United States.

"Now that the 24-month duration of response data from ENVISION are published in a leading urology journal, we’re seeing even stronger validation of ZUSDURI’s clinical impact," said Mark Schoenberg, Chief Medical Officer, UroGen. "As the first and only approved treatment for recurrent LG-IR-NMIBC, ZUSDURI gives patients a real chance at meaningful, recurrence-free periods. These results suggest we may finally be able to break the long-standing cycle of repeated recurrences and surgeries that has defined care for patients with recurrent LG-IR-NMIBC."

The most common (≥10%) adverse reactions, including laboratory abnormalities, observed in patients treated with ZUSDURI were dysuria, hematuria, urinary tract infection, increased creatinine, increased potassium, decreased hemoglobin, decreased lymphocytes, decreased neutrophils, increased eosinophils, and increased liver enzymes (AST and ALT). Adverse reactions were primarily mild to moderate in severity. Serious adverse reactions occurred in 12% of patients and included urinary retention (0.8%) and urethral stenosis (0.4%).

About ZUSDURI

ZUSDURI (mitomycin) for intravesical solution is an innovative drug formulation of mitomycin approved for the treatment of adults with recurrent LG-IR-NMIBC. Utilizing UroGen’s proprietary RTGel technology (a sustained release, hydrogel-based formulation), ZUSDURI is delivered directly into the bladder by a trained healthcare professional using a urinary catheter in an outpatient setting, thereby enabling the treatment of tumors by non-surgical means.

About Non-Muscle Invasive Bladder Cancer (NMIBC)
LG-IR-NMIBC affects around 82,000 people in the U.S. every year and of those, an estimated 59,000 are recurrent. Bladder cancer primarily affects older populations with increased risk of comorbidities, with the median age of diagnosis being 73 years. Guideline recommendations for the management of NMIBC include transurethral resection of bladder tumor (TURBT) as the standard of care. Up to 70 percent of NMIBC patients experience at least one recurrence, and LG-IR-NMIBC patients are even more likely to recur and face repeated TURBT procedures. Learn more about non-muscle invasive bladder cancer at www.BladderCancerAnswers.com.

(Press release, UroGen Pharma, MAR 30, 2026, View Source [SID1234664030])

On March 30, 2026 INmune Bio Inc. (NASDAQ: INMB) (the "Company"), a late-stage biotechnology company focused on inflammation and immunology, reported its financial results for the year ended December 31, 2025 and provides a business update.

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Recent Corporate Highlights

CORDStrom Platform:

The CORDStrom program in recessive dystrophic epidermolysis bullosa (RDEB) is on target to file an MAA submission in the UK mid-summer, followed shortly thereafter by anticipated EMA and FDA regulatory submissions.
Hosted KOL led webinar focused on the latest results from the MissionEB Phase III clinical trial highlighting the systemic disease-modifying capabilities of CORDStrom in patients with RDEB.
Announced the publishing of an overview of future applications and research areas for mesenchymal stromal cell (MSC) therapies in the peer-reviewed journal Cytotherapy.
XPro Platform:

Reported new Phase 2 imaging data at the 18th Clinical Trials on Alzheimer’s Disease conference (CTAD), in San Diego, CA. Additional brain imaging analyses are ongoing and expected to be reported in the near future.
Announced FDA alignment to advance to an adaptive Phase 2b/3 registrational pathway with XPro in early Alzheimer’s Disease.
Hosted expert-led webinar on XPro registrational study strategy for early Alzheimer’s Disease, with the discussion focused on results of the Phase 2 MINDFuL trial and alignment with the FDA following the End-of-Phase 2 meeting.
INmune’s MINDFuL trial was featured in a plenary presentation at the AD/PD 2026 conference as a successful example of how aligning patient selection with mechanism of action identifies the patients most likely to respond.
INKmune Platform:

Met primary and two of three secondary endpoints in CARE-PC trial
Continued evaluation of clinical data from the INKmune CARE-PC trial in metastatic castration-resistant prostate cancer.
Ongoing analysis of immune activation and tumor response endpoints to inform future development strategy.
Corporate:

Received Australian R&D rebate of $5.2m AUD ($3.6 million USD) during January 2026.
Company estimates that cash on hand provides runway through Q1 of 2027.
During 2025, the Company sold 4,304,707 shares of common stock in exchange for net cash proceeds of $27.5 million.
Continued alignment of capital allocation with clinical development priorities.
Upcoming Events and Milestones:

The Marketing Authorization Application (MAA) for CORDStrom is scheduled for submission to the UK’s MHRA in mid-summer, followed directly by an EMA filing.
CORDStrom Biologics License Application (BLA) submission to the FDA expected in Q4 2026.
"Reflecting on the progress of 2025 and the momentum of early 2026, it is clear that INmune Bio has reached a defining inflection point," said David Moss, CEO of INmune Bio. "We have transitioned from a mid-stage clinical company into a late-stage, registration-directed organization. Our mission to harness the innate immune system to treat diseases of inflammation has never been more tangible or more urgent. Looking ahead through 2026 and 2027, our strategy is anchored by two late-stage assets that represent significant value for both patients and shareholders: CORDStrom and XPro."

CORDStrom: A Clear Path to Commercialization

CORDStrom, our mesenchymal stromal cell platform for Recessive Dystrophic Epidermolysis Bullosa, is our most immediate commercial catalyst.

2026 Regulatory Milestones: In February, we formally submitted our pre-submission package to the UK’s MHRA. A face-to-face meeting with the MHRA is scheduled for mid-May. We remain on track to file our first Marketing Authorization Application (MAA) in the UK by mid-summer 2026, followed by EU and U.S. (BLA) filings in Q4.
Operational Readiness: We have successfully completed three commercial pilot-scale manufacturing runs at our Stevenage facility, meeting all release criteria. This ensures we are ready to supply the market upon approval.
Financial Strategy: With the recent reauthorization of the Rare Pediatric Disease Priority Review Voucher (PRV) program through 2029, CORDStrom offers a dual-value proposition: a life-changing therapy for "butterfly children" and a high-value PRV that can be monetized to non-dilutively fund our long-term operations.
XPro: Redefining the Alzheimer’s Paradigm

The landscape of Alzheimer’s disease (AD) is shifting toward precision medicine, and INmune Bio is at the forefront.

2026 Focus: Following our successful End-of-Phase 2 meeting with the FDA in February, we have achieved alignment on an integrated Phase 2b/3 registrational pathway. Unlike traditional "all-comer" trials, our program uses a biomarker-enriched design, targeting patients with neuroinflammation. This "precision" approach, validated by our MINDFuL trial data featured at the AD/PD 2026 Plenary, significantly de-risks our path forward.
2027 Horizon: Our Phase 2b/3 program is built to bridge the gap between early cognitive signals (EMACC) and late-stage functional outcomes (CDR-SB). The Phase 2b stage evaluates co-primary endpoints at nine months and serves as a clearly powered go or no-go before we commit to the full Phase 3 registrational portion of the trial. If EMACC and/or pTau-217 readout successfully in the Phase 2b portion of the trial, it advances seamlessly into the registrational stage Phase 3 with CDR-SB at eighteen months (the same primary endpoint used to approve lecanemab and donanemab). The scientific basis for this design is well established: cognitive changes (EMACC) precede and predict functional decline (CDR-SB), which means early cognitive signals at nine months support confidence in functional outcomes at eighteen. We believe this program represents a compelling partnership opportunity, while remaining a viable path for independent development following CORDStrom approval, assuming favorable capital conditions.
Notably, XPro has reported zero cases of ARIA across all clinical studies to date, a critical differentiator in a treatment landscape where ARIA remains a significant limitation of approved therapies.

"From a capital perspective, we remain committed to capital efficiency," said Mr. Moss. "Our strategy is built on hitting clear, data-driven milestones that allow us to maximize shareholder value while minimizing unnecessary burn. We are focused on maintaining the lean, execution-oriented culture that has brought us to this stage."

"2026 is the year of filings and preparation; 2027 will be the year of pivotal execution and potential launch. We thank you for your continued trust and partnership as we work to transform the treatment of inflammatory disease."

Financial Results for the Year Ended December 31, 2025

Net loss attributable to common stockholders for the year ending December 31, 2025 was approximately $45.9 million, compared to approximately $42.1 million during the year ended December 31, 2024.
Research and development expenses totaled approximately $20.7 million for the year ended December 31, 2025, compared to approximately $33.2 million during the year ended December 31, 2024.
General and administrative expenses were approximately $10.3 million for the year ended December 31, 2025, compared to approximately $9.5 million during the year ended December 31, 2024.
Impairment of acquired in-process research and development intangibles assets was $16.5 million during the year ended December 31, 2025, compared to $0 during the year ended December 31, 2024.
As of December 31, 2025, the Company had cash and cash equivalents of approximately $24.8 million.
As of December 31, 2025, the Company had approximately 26.6 million common shares outstanding.
Earnings Call Information

To participate in this event, dial approximately 5 to 10 minutes before the beginning of the call. Please ask for the INmune Bio Fourth Quarter and Full Year Ended December 31, 2025 Conference Call when reaching an operator.

Date: March 30th, 2026

Time: 4:30 PM Eastern Time

Participant Dial-in: 1-800-343-4136
Participant Dial-in (international): +1-203-518-9843

Conference ID: INMUNE

A live audio webcast of the call can be accessed using this link or clicking here:
View Source;tp_key=96ca7c85d7

A replay will be available approximately 3 hours after the call through April 13, 2026 by dialing 1-844-512-2921 or 1-412-317-6671 (international) and entering PIN no. 11160807.

About CORDStrom

CORDStrom is a patent-pending cell medicine comprising aseptic, allogeneic, pooled human umbilical cord-derived mesenchymal stromal cells (hucMSCs) in suspension for injection or infusion. The CORDStrom platform leverages, among other things, proprietary screening, pooling and expansion techniques to create off-the-shelf, allogeneic, pooled hucMSCs as medicines to treat complex inflammatory and autoimmune diseases. CORDStrom products are designed to provide high-quality, off-the-shelf, batch-to-batch consistent, scalable, cGMP manufactured, potent cellular medicines that can be produced affordably and with repeatable specification. Pooling allows tuning of different CORDStrom products with different effector functions dependent upon selected donor characteristics. While the first generation CORDStrom product is agnostic to disease indication, the platform enables creation of indication-specific products, which can be tuned for optimization of anti-inflammatory, immunomodulatory, wound healing, and other characteristics.

About XPro

XPro is a next-generation inhibitor of tumor necrosis factor (TNF) that is currently in clinical trial and acts differently than currently available TNF inhibitors in that it neutralizes soluble TNF (sTNF), without affecting trans-membrane TNF (tmTNF) or TNF receptors. XPro could have potential substantial beneficial effects in patients with neurologic disease by decreasing neuroinflammation. For more information about the importance of targeting neuroinflammation in the brain to improve cognitive function and restore neuronal communication, visit our website at www.inmunebio.com.

(Press release, INmune Bio, MAR 30, 2026, View Source [SID1234664051])

On March 29, 2026 Insilico Medicine ("Insilico", HKEX: 3696), a clinical-stage biotechnology company powered by generative artificial intelligence (AI) and automation, reported a drug discovery collaboration with Eli Lilly and Company ("Lilly") that uses Insilico’s AI engine to accelerate the discovery and development of novel therapeutics across multiple therapeutic areas.

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The agreement grants Lilly an exclusive worldwide license for the development, manufacturing, and commercialization of potentially best-in-class, novel oral therapeutics in preclinical development for certain indications. In addition, Insilico and Lilly will collaborate on multiple R&D programs focused on targets selected by Lilly, by combining Insilico’s state-of-the-art Pharma.AI platforms with Lilly’s development capabilities and deep disease-area expertise.

"From its inception, Insilico Medicine has been developing deep learning for end-to-end drug discovery. By deploying frontier AI technologies that scale from biomarkers to life models, world models of human and animal life, we can identify multi-purpose targets driving multiple diseases at the same time," said Alex Zhavoronkov, PhD, founder and CEO of Insilico Medicine. "Working with Lilly, we aim to deliver transformative therapies that treat diseases with high unmet need. This collaboration is a testament to the power of AI in tackling the most complex challenges in human health."

Under the terms of the agreement, Insilico is eligible to receive an $115 million upfront payment, followed by development, regulatory, and commercial milestones that could bring the total deal value to approximately $2.75 billion, plus tiered royalties on future sales.

"Insilico’s AI-enabled discovery capabilities represent a powerful complement to Lilly’s deep expertise in clinical development across multiple therapeutic areas," said Andrew Adams, Group Vice President of Molecule Discovery at Lilly. "This collaboration allows us to explore novel mechanisms and accelerate the identification of promising therapeutic candidates across multiple disease areas."

(Press release, Insilico Medicine, MAR 29, 2026, View Source [SID1234664001])

On March 27, 2026 Eisai Co., Ltd. (Headquarters: Tokyo, CEO: Haruo Naito, "Eisai"), a human-centered global leading research-based pharmaceutical company working in the neurology and oncology therapeutic areas, and Nuvation Bio Inc. (NYSE: NUVB, Corporate Headquarters: New York, NY, CEO: David Hung, M.D., "Nuvation Bio"), a global oncology company focused on tackling some of the toughest challenges in cancer treatment, reported that the European Medicines Agency (EMA) has validated the Marketing Authorisation Application (MAA) for taletrectinib for the treatment of advanced ROS1-positive (ROS1+) non-small cell lung cancer (NSCLC). The filing will follow a standard review timeline.

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Taletrectinib (marketed as IBTROZI in the U.S. and Japan) is a highly selective, next-generation oral treatment for patients living with advanced ROS1+ NSCLC. In January 2026, Eisai and Nuvation Bio announced they had entered into an exclusive licensing and collaboration agreement in Europe and additional countries* outside the U.S., China and Japan to extend the global reach of taletrectinib. Following this filing to the EMA, additional filings are planned for the U.K., Canada and other regions included in Eisai’s licensed territories.

Across Europe, nearly 400,000 people are diagnosed with lung cancer each year, with NSCLC accounting for 80% of cases. It is estimated that approximately 2% of patients with NSCLC have ROS1+ disease.

"The validation of the MAA is a significant moment for patients in Europe with ROS1+ NSCLC," said Terushige Iike, Chief Business Officer of Eisai Co., Ltd. "With its efficacy and safety profile, we believe taletrectinib has the potential to become a standard of care therapy for the thousands of patients living with this aggressive disease in Europe. We look forward to working closely with the EMA during the review process with the goal of making this treatment available to appropriate patients who urgently need targeted options."

The application is based on data from the two pivotal Phase 2 clinical studies, TRUST-I and TRUST-II, evaluating taletrectinib in patients globally. Results from a pooled analysis of the TRUST clinical program were published in the Journal of Clinical Oncology in April 2025, and Nuvation Bio anticipates near-term disclosure of updated data reflecting even longer patient follow-up, further building on the depth and durability of responses observed to date. Additionally, given the comprehensive nature of the taletrectinib clinical dataset and based on favorable feedback received at a pre-submission meeting with the CHMP Rapporteur and Co-Rapporteur, the accepted MAA will be considered to support full approval.

"Having seen the meaningful impact taletrectinib has already made for patients with ROS1+ NSCLC in the U.S., China and Japan, we are thrilled to partner with Eisai and have an accepted MAA for review in Europe," said David Hung, M.D., Founder, President and Chief Executive Officer of Nuvation Bio. "This accepted filing represents an important milestone in our global development strategy and brings us one step closer to delivering this highly selective, next-generation oral therapy to more patients who need it in Europe and around the world."

In June 2025, the U.S. Food and Drug Administration (FDA) granted full approval to taletrectinib for the treatment of locally advanced or metastatic ROS1+ NSCLC across lines of therapy, following a Priority Review and double Breakthrough Therapy designations. Taletrectinib is also approved for patients with advanced ROS1+ NSCLC in Japan, where it is marketed by Nippon Kayaku, and in China, where it is marketed by Innovent Biologics under the brand name DOVBLERON.

* Eisai’s licensed territories: Europe, the Middle East, North Africa, Russia, Turkey, Canada, Australia, New Zealand, Singapore, the Philippines, Indonesia, Thailand, Malaysia, Vietnam and India.

About ROS1+ NSCLC
Each year, more than one million people globally are diagnosed with non-small cell lung cancer (NSCLC), the most common form of lung cancer. It is estimated that approximately 2% of patients with NSCLC have ROS1+ disease. About 35% of patients newly diagnosed with metastatic ROS1+ NSCLC have tumors that have spread to their brain. The brain is also the most common site of disease progression, with about 50% of previously treated patients developing central nervous system (CNS) metastases.

About Taletrectinib
Taletrectinib is an oral, potent, CNS-active, selective, next-generation ROS1 inhibitor therapy. On June 11, 2025, following Priority Review and Breakthrough Therapy designations for both TKI-naive and TKI-pretreated disease, the U.S. Food and Drug Administration (FDA) approved taletrectinib for the treatment of adult patients with locally advanced or metastatic ROS1+ NSCLC. Learn more about taletrectinib in the U.S. at IBTROZI.com.

About the TRUST Clinical Program
The TRUST clinical program comprises three registrational studies evaluating the safety and efficacy of taletrectinib. TRUST-I (NCT04395677) and TRUST-II (NCT04919811) are Phase 2 single-arm studies evaluating taletrectinib for the treatment of adults with advanced ROS1+ NSCLC in China (N=173) and globally (N=189), respectively. The primary endpoint of both studies is confirmed objective response rate (cORR) as assessed by an independent review committee. TRUST-IV (NCT07154706) is a Phase 3 placebo-controlled study evaluating taletrectinib for the adjuvant treatment of adults with resected early-stage ROS1+ NSCLC. The study will enroll approximately 180 patients in the U.S., Canada, Europe, Japan and China. The primary endpoint is disease-free survival as determined by investigator, and the primary completion date is estimated to be in 2030. Nuvation Bio is also sponsoring TRUST-III (NCT06564324), a confirmatory randomized Phase 3 study evaluating taletrectinib versus crizotinib in 138 patients in China with advanced ROS1+ NSCLC who have not previously received ROS1 TKIs.

(Press release, Eisai, MAR 27, 2026, View Source [SID1234663939])

On March 27, 2026 Agenus Inc. ("Agenus") (Nasdaq: AGEN), a leader in immuno-oncology, reported it will host its March Stakeholder Webcast focused on continued progress of its botensilimab and balstilimab (BOT+BAL) immunotherapy program and will provide an update on the Company’s patient access programs, development across tumor types, and key priorities for 2026.

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The session will be moderated by Garo H. Armen, PhD, Founder, Chairman, and Chief Executive Officer of Agenus, and will conclude with a live Q&A.

Featured Topics and Speakers

Strategic Direction: Advancing BOT+BAL
Garo Armen, PhD
Founder, Chairman, and Chief Executive Officer, Agenus
Dr. Armen will open the session by discussing Agenus’ mission to harness the immune system across tumor types and the urgency of advancing new options for patients with historically treatment-resistant cancers. He will also outline key priorities for 2026 as momentum continues to build across the BOT+BAL program.

Clinical Progress: Durability and Consistency Across Tumors
Steven J. O’Day, MD
Chief Medical Officer, Agenus
Dr. O’Day will provide a clinical perspective on the durability and consistency of BOT+BAL across tumor types, including in historically immunotherapy-resistant cancers. He will also highlight how these data are informing ongoing development and later-stage trials.

Access and Execution: Expanding Patient Through Available Global Programs
Kamel Djazouli, MD
Head, Medical Affairs, Agenus
Dr. Djazouli will provide an update on Agenus’ global access programs, including the France AAC and Named Patient Programs, and how they are enabling treatment for patients with limited options.
Stakeholder Briefing Details:

Registration Link: View Source
Live webcast link will be provided once registration is completed.

Submit questions in advance at: View Source

This session marks the second event in Agenus’ 2026 Stakeholder Briefing Series, building on prior discussions regarding BOT+BAL’s clinical progress, patient access pathways, and Agenus corporate milestones.

(Press release, Agenus, MAR 27, 2026, View Source;BAL-Across-Tumor-Types-and-Expand-Patient-Access/default.aspx [SID1234663984])