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 Tempest Therapeutics, Inc. (Nasdaq: TPST) ("Tempest"), a clinical-stage biotechnology company developing a pipeline of advanced CAR-T cell therapy product candidates to treat cancer, reported financial results for the year ended December 31, 2025, and provided a corporate update.

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"2025 was a transformative year for Tempest as we strengthened our pipeline with the strategic acquisition of a portfolio of next-generation CAR-T assets," said Matt Angel, Ph.D., President and Chief Executive Officer of Tempest. "The portfolio is already proving potentially fruitful as we reported encouraging early clinical data from our lead CAR-T program, TPST-2003, which is being tested in a Phase 1/2a trial in patients with relapsed or refractory multiple myeloma. The data, which suggests a favorable safety and efficacy profile for TPST-2003, reinforced our belief that this therapy has the potential to differentiate itself from currently approved CAR-T treatments and provide a meaningful option for patients who continue to face limited durable treatment options. We look forward to the potential initiation of a U.S. registrational study of TPST-2003 in patients with rrMM later this year, while we continue our strategy of leveraging partner-funded and externally supported development where possible to advance our pipeline."

2025 & Recent Accomplishments

TPST-2003
Announced positive interim results from the ongoing REDEEM-1 Phase 1/2a trial of TPST-2003 in patients with rrMM, which is being sponsored and conducted by Tempest’s partner, Novatim Immune Therapeutics:
100% complete response (CR) rate among all six efficacy evaluable patients as of the January 31, 2026 data cutoff
Favorable safety profile with no Grade >3 cytokine release syndrome ("CRS") or immune effector cell-associated neurotoxicity syndrome ("ICANS") appears to be emerging as a potentially differentiating attribute in its class
Prior investigator-initiated trial ("IIT") reached median progression free survival (PFS) of 23.1 months, including in patients with extramedullary disease
36 patients with rrMM treated to date across two studies
Corporate:
Announced closing of strategic acquisition of new dual-targeting CAR-T assets from Factor Bioscience Inc. and its affiliates
All-stock transaction brought Tempest a portfolio of next-generation CAR-T assets, including TPST-2003, a clinical-stage dual-targeting CD-19/BCMA CAR-T with strategic partner-funded biologics license application (BLA) filing in China planned for 2027
In November 2025, announced up to $8.35 million registered direct offering (an "RDO" and, such offering, the "November Offering") of common stock and concurrent private placement of warrants priced at-the-market under Nasdaq
In March 2026, announced up to $6 million private placement (the "2026 Offering") of common stock and warrants, with $2 million upfront and up to $4 million of potential aggregate gross proceeds upon the exercise in full of warrants
Amezalpat (TPST-1120) (clinical PPARα antagonist):
Received clearance to proceed with pivotal trial of amezalpat combination therapy for first-line hepatocellular carcinoma ("HCC") in China
Granted orphan drug designation from the European Medicines Agency for amezalpat for the treatment of patients with HCC
Reported new data at the 2025 American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting supporting the immune component of amezalpat’s dual mechanism of action and reinforcing its potential as a novel cancer treatment
Granted both Orphan Drug and Fast Track designations by the U.S. Food and Drug Administration ("FDA") for amezalpat for the treatment of patients with HCC
TPST-1495 (clinical dual EP2/4 prostaglandin receptor antagonist)
Granted Orphan Drug designation by the FDA to treat patients with Familial Adenomatous Polyposis ("FAP")
Received a "Study May Proceed" letter from the FDA to evaluate TPST-1495 in a Phase 2 Trial for the treatment of FAP
Potential Future Milestones

TPST-2003
Present results from the ongoing Phase 1/2a REDEEM-1 study, as well as updated data from the Phase 1/2 IIT, in 2026
Submit a U.S. IND application and, subject to clearance, initiate a Phase 2b U.S. registrational study of TPST-2003 in patients with rrMM in 2026
TPST-1495
Initiate a Phase 2 study of TPST-1495 in FAP, with first patient enrollment expected in 2026. The study is expected to be funded by the National Cancer Institute and conducted through the Cancer Prevention Clinical Trials Network, enabling advancement without internal capital deployment.
Financial Results

Year End 2025

Tempest ended the year with $7.7 million in cash and cash equivalents, compared to $30.3 million on December 31, 2024. The decrease was primarily due to cash used in operating activities, offset by net proceeds from the issuance of common stock of $4.1 million from the RDO in June, $3.8 million from the November Offering and $2.8 million from Tempest’s at-the-market offering program.
Net loss and net loss per share for the year were $26.3 million and $6.33, respectively, compared to $41.8 million and $19.50, respectively, for the same period in 2024.
Research and development expenses for the year were $12.6 million compared to $28.5 million for the same period in 2024. The $15.9 million decrease was primarily due to a decrease in costs incurred as a result of re-prioritizing efforts towards exploring strategic alternatives.
General and administrative expenses for the year were $14.0 million compared to $13.6 million for the same period in 2024. The $0.4 million increase was primarily due to one-time separation costs for employees terminated during the period.

(Press release, Tempest Therapeutics, MAR 30, 2026, View Source [SID1234664029])

On March 30, 2026 Sensei Biotherapeutics, Inc. (Nasdaq: SNSE) reported financial results for the full year ended December 31, 2025, following its previously announced acquisition of Faeth Therapeutics and concurrent $200 million private placement. The financing, together with the Company’s cash on hand, is expected to support advancement of PIKTOR through key clinical milestones, including topline data readouts from both the ongoing Phase 2 trial in advanced endometrial cancer (Study FTH-PIK-201) and the planned Phase 1b trial in HR+/HER2- advanced breast cancer (Study FTH-PIK-101).

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Acquired through the Faeth transaction, PIKTOR is now Sensei’s lead program. The investigational, proprietary, all-oral combination of serabelisib and sapanisertib is designed to inhibit multiple nodes of the PI3K/AKT/mTOR pathway through PI3K-alpha and dual mTORC1/2 targeting.

"2025 was a year of focus and discipline for Sensei, and with the addition of Faeth and injection of new capital, we are entering 2026 with a clear path forward," said Christopher Gerry, President & General Counsel of Sensei Biotherapeutics. "We are now focused on advancing PIKTOR through key clinical milestones, including topline data from the ongoing Phase 2 trial in advanced endometrial cancer and initiation of the planned Phase 1b trial in HR+/HER2- advanced breast cancer, both expected by year-end 2026."

"The data to date suggest PIKTOR may achieve more comprehensive pathway suppression than single-node approaches, with an emerging tolerability profile that compares favorably to existing therapies, highlighting its potential to address significant unmet need in multiple solid tumor indications," said Anand Parikh, Chief Operating Officer of Sensei Biotherapeutics. "We are focused on disciplined execution as we advance PIKTOR through clinical trials in endometrial and breast cancer, with additional opportunities in ovarian and lung cancer."

Full Year 2025 Financial Results

Cash Position: Cash, cash equivalents and marketable securities were $21.2 million as of December 31, 2025 as compared to $41.3 million as of December 31, 2024.

Research and Development (R&D) Expenses: R&D expenses were $11.0 million for the year ended December 31, 2025, compared with $18.6 million for the year ended December 31, 2024. The decrease in R&D expenses was primarily attributable to reduced costs across personnel, facilities, lab supplies, clinical trials, and manufacturing.

General and Administrative (G&A) Expenses: G&A expenses were $11.3 million for the year ended December 31, 2025, compared to $13.0 million for the year ended December 31, 2024. The decrease in G&A expense was primarily attributable to lower personnel costs, partially offset by higher restructuring costs in 2025 and higher consulting costs.

Net Loss: Net loss was $21.1 million, or $(16.72) per basic and diluted share, for the year ended December 31, 2025, compared with a net loss of $30.2 million, or $(24.01) per basic and diluted share, for the year ended December 31, 2024.

Weighted-average common shares outstanding, basic and diluted, were 1,260,772 for the year ended December 31, 2025, compared with 1,255,776 for the year ended December 31, 2024.

Condensed Statements of Operations

(Unaudited, in thousands except share and per share data)

Year Ended 2025

Year Ended 2024

Operating expenses:

Research and development

$

10,960

$

18,627

General and administrative

11,328

13,036

Long-lived asset impairment

—

951

Total operating expenses

22,288

32,614

Loss from operations

(22,288

)

(32,614

)

Total other income

1,203

2,457

Net loss

$

(21,085

)

(30,157

)

Net loss attributable to common stockholders

(21,085

)

(30,157

)

Net loss per share, basic and diluted

$

(16.72

)

$

(24.01

)

Weighted-average common shares outstanding, basic and diluted

1,260,772

1,255,776

Selected Condensed Balance Sheet Data

(Unaudited, in thousands)

December 31, 2025

December 31, 2024

Cash and cash equivalents

$

8,668

$

9,994

Marketable securities

12,516

31,341

Total assets

22,902

45,361

Total liabilities

4,310

6,975

Total stockholders’ equity

18,592

38,386

(Press release, Sensei Biotherapeutics, MAR 30, 2026, View Source [SID1234664028])

On March 30, 2026, Protara Therapeutics, Inc. (the "Company" or "Protara") reported that the Company has received confirmation on the six-month complete response ("CR") rate of the 25th Bacillus Calmette-Guérin ("BCG")-Unresponsive patient in its ongoing Phase 2 open-label ADVANCED-2 trial of TARA-002 in patients with carcinoma in situ or CIS (± Ta/T1) non-muscle invasive bladder cancer ("NMIBC"). The average six-month CR rate in the 25 BCG-Unresponsive patients is 68.0%, which is consistent with the 68.2% CR rate at six months that was announced by the Company on February 24, 2026, and is meaningfully above 41.9%.

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As a result, the Company has determined that it has satisfied the condition set forth in its common stock purchase warrants issued in April 2024 (the "April 2024 Common Warrants") for fixing the termination date for exercise of the April 2024 Common Warrants. Specifically, the April 2024 Common Warrants are exercisable at an exercise price of $5.25 per share and may be exercised at any time on or prior to June 29, 2026.

The information contained in Item 7.01 of this Current Report on Form 8-K is being furnished and shall not be deemed to be "filed" for the purposes of Section 18 of the Exchange Act of 1934, as amended (the "Exchange Act"), or otherwise subject to the liabilities of that section and shall not be incorporated by reference in any filing under the Securities Act of 1933, as amended, or the Exchange Act, except as shall be expressly set forth by specific reference in such filing.

(Press release, Protara Therapeutics, MAR 30, 2026, View Source [SID1234664027])

On March 30, 2026 Phio Pharmaceuticals Corp. (NASDAQ: PHIO) is a clinical-stage siRNA biopharmaceutical company developing therapeutics using its proprietary INTASYL gene silencing technology to eliminate cancer, reported that it has entered into a cGMP drug product manufacturing services agreement with a U.S. manufacturer for clinical supply for future clinical trial. The company will manufacture Phio’s lead compound PH-762 for both clinical and commercial supply.

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"It is a pleasure to partner with an organization known for its quality and expertise in drug product manufacturing services," said Mr. Robert Bitterman, Phio’s President and CEO. "Further, we value the strategic advantages of working with a U.S. based organization."

Recent Company Highlights

Phio’s lead clinical candidate, PH-762, is being evaluated as an intratumoral therapy for cutaneous carcinomas. In its Phase 1b trial, Phio has reported that 22 patients completed treatment across five dose-escalation cohorts, with no dose-limiting toxicities or serious adverse events. The Company has also reported a pathological response rate in cSCC across all dosing cohorts of approximately 65%, including an 85% pathological response (6 of 7 patients) in the highest-dose cohort.

Phio has indicated that FDA engagement regarding next-stage clinical development is targeted for the second quarter of 2026 and has reported cash and cash equivalents projected to sustain operations into the first half of 2027.

(Press release, Phio Pharmaceuticals, MAR 30, 2026, View Source [SID1234664026])