Talphera Announces 50% Enrollment Milestone in Ongoing NEPHRO-CRRT Registrational Trial

Rhea-AI Summary

Talphera (Nasdaq: TLPH) announced it has enrolled 35 of 70 patients (50%) in the NEPHRO-CRRT registrational trial as of March 2, 2026. The company said it reduced total enrollment by nearly 60%, refocused sites on medical ICUs with nephrologist PIs, and achieved >90% enrollment from new sites.

Talphera will host a virtual investor and analyst event on March 23, 2026 at 11:00 am ET featuring nephrologists Dr. Blaithin McMahon and Dr. Joao Teixeira; a replay will be available for 90 days.

Positive

• 50% enrollment achieved with 35 of 70 patients enrolled
• Study size reduced ~60% after FDA-agreed protocol changes
• >90% of patients enrolled at new target-profile sites (medical ICU nephrologist PIs)
• Company anticipates filing a PMA this year to seek FDA approval

Negative

• Protocol changes included a ~60% enrollment reduction, altering original trial scope
• Enrollment concentration: >90% of patients from revised sites could raise site-dependence risk

News Market Reaction – TLPH

+0.02%

1 alert

+0.02% News Effect

+$8K Valuation Impact

$42M Market Cap

0.0x Rel. Volume

On the day this news was published, TLPH gained 0.02%, reflecting a mild positive market reaction. This price movement added approximately $8K to the company's valuation, bringing the market cap to $42M at that time.

Data tracked by StockTitan Argus on the day of publication.

Key Figures

Patients enrolled: 35 of 70 patients Enrollment reduction: Nearly 60% reduction New-site enrollment share: More than 90% +5 more

8 metrics

Patients enrolled 35 of 70 patients NEPHRO-CRRT registrational study enrollment milestone

Enrollment reduction Nearly 60% reduction Reduction in total planned NEPHRO CRRT patient enrollment over 2025

New-site enrollment share More than 90% Portion of enrolled patients coming from updated target profile sites

Investor event time 11:00 a.m. ET Virtual investor and analyst event on March 23, 2026

Webcast replay period 90 days Duration replay will be available on Talphera’s website

Dr. McMahon publications Over 50 papers Peer-reviewed nephrology and AKI research output

Dr. McMahon citations More than 1000 citations Citations in acute kidney injury and CRRT research

Patients enrolled by Dr. Teixeira Approximately 300 patients Critically ill or hospitalized patients in clinical trials

Market Reality Check

Price: $0.8954 Vol: Volume 126,396 is below 2...

low vol

$0.8954 Last Close

Volume Volume 126,396 is below 20-day average 242,293 (relative volume 0.52x). low

Technical Shares at 0.9116 are trading slightly above the 200-day MA of 0.84, despite the positive trial update.

Peers on Argus

TLPH was down 1.44% pre-news while close peers showed mixed moves (e.g., AYTU +6...

1 Up 1 Down

TLPH was down 1.44% pre-news while close peers showed mixed moves (e.g., AYTU +6.2%, TXMD -1.31%, IXHL -14%). Momentum scanner names also diverged (BFRI up, SCYX down), supporting a stock-specific rather than sector-wide setup.

Historical Context

4 past events · Latest: Nov 12 (Positive)

Pattern 4 events

Date	Event	Sentiment	Move	Catalyst
Nov 12	Earnings and update	Positive	-18.6%	Q3 2025 results, reduced cash opex guidance, NEPHRO CRRT progress, financing.
Nov 5	Earnings call notice	Neutral	-8.7%	Announcement of Q3 2025 results release timing and webcast details.
Oct 21	Board appointment	Positive	-1.7%	Appointment of CorMedix CEO to board and exclusivity around NEPHRO results.
Sep 8	Private placement	Positive	+49.1%	Up to $29M financing led by CorMedix to support Niyad PMA plans.

Pattern Detected

Recent news, including financing and earnings, often saw negative price reactions, with a private placement announcement as the main positive outlier.

Recent Company History

Over the past six months, Talphera has focused on funding and advancing the NEPHRO CRRT program. A private placement of up to $29 million in Sep 2025 led by CorMedix drove a 49.13% move higher, while subsequent earnings and corporate updates in Nov 2025 saw declines of 18.6% and 8.66%. Board changes in Oct 2025 tied to CorMedix’s strategic role also drew a modest negative reaction. Today’s 50% enrollment milestone fits into this ongoing registrational trial narrative.

Regulatory & Risk Context

Active S-3 Shelf

Shelf Active

Active S-3 Shelf Registration 2025-10-28

An active S-3 from 2025-10-28 registers the resale of up to 1,023,890 existing common shares and up to 1,706,484 shares issuable upon exercise of pre-funded warrants. The company is not selling securities in this registration and will not receive proceeds from these stockholder sales.

Market Pulse Summary

This announcement highlights that Talphera’s NEPHRO-CRRT registrational trial has reached 35 of 70 p...

Analysis

This announcement highlights that Talphera’s NEPHRO-CRRT registrational trial has reached 35 of 70 patients enrolled after protocol changes agreed with the FDA. More than 90% of patients now come from optimized ICU sites, and management expects to pursue a PMA filing for nafamostat in CRRT. Investors may track remaining enrollment, timing of top-line data, and the March 23 investor event featuring trial investigators for additional detail on clinical positioning.

Key Terms

pma, fda, crrt, regional anticoagulant, +4 more

8 terms

pma regulatory

"anticipate filing our PMA this year to potentially have the only FDA approved"

PMA stands for Premarket Approval, the U.S. Food and Drug Administration’s highest-level review for high-risk medical devices. It’s a thorough evaluation to confirm a device is safe and effective before it can be sold, like a final safety inspection and license to operate. Investors care because receiving PMA can open a significant revenue stream, while delays or rejection can postpone sales and reduce a company’s value.

fda regulatory

"with agreement from the FDA, we implemented significant changes to the NEPHRO CRRT"

The FDA is the U.S. federal agency that evaluates and approves medical drugs, devices, biological therapies and certain foods; think of it as the gatekeeper that decides whether a medical product is safe and effective for patients. For investors, FDA decisions determine whether a company can sell a product, affect expected revenue and introduce regulatory risk, so approvals, rejections or safety warnings can quickly move a company's valuation and stock price.

crrt medical

"the only FDA approved regional anticoagulant for CRRT. We continue to receive feedback"

Continuous Renal Replacement Therapy (CRRT) is a hospital treatment that uses a machine to slowly and continuously filter a patient’s blood when the kidneys have failed, similar to a home water filter running all day instead of a quick rinse. For investors, CRRT signals demand for critical-care equipment, supplies and specialized staffing, and changes in its use or reimbursement can affect revenues and costs for medical-device makers, hospitals and dialysis service providers.

regional anticoagulant medical

"to potentially have the only FDA approved regional anticoagulant for CRRT."

A regional anticoagulant is a blood-thinning medicine designed to act only in a limited part of the body — for example, around a surgical site or inside a dialysis circuit — rather than circulating through the whole bloodstream. Like turning on a faucet for one plant instead of flooding the garden, it can lower bleeding risk and side effects, which matters to investors because safer, targeted options can ease regulatory approval, broaden clinical use, and create commercial advantage.

nafamostat medical

"and how they see nafamostat filling a role. They will also take questions"

Nafamostat is a short-acting prescription medication that blocks specific enzymes involved in blood clotting and inflammation, and has been studied as an antiviral in hospital settings. For investors it matters because its value depends on clinical trial results, regulatory approvals, and hospital adoption—think of it as a specialized tool whose commercial success rests on proving effectiveness and safety against competing treatments and standards of care.

acute kidney injury medical

"Dr. McMahon's key research is in the field of Acute Injury Kidney."

A sudden decline in how well the kidneys remove waste and balance fluids, often developing over hours or days; think of it like an engine that abruptly loses power and can’t filter efficiently. It matters to investors because it can drive higher medical costs, alter clinical trial results, trigger regulatory scrutiny, lead to drug label changes or recalls, and affect revenue and liability for healthcare and life sciences companies.

extracorporeal membrane oxygenation (ecmo) medical

"therapeutics for AKI, CRRT, septic shock, vasopressor therapy, extracorporeal membrane oxygenation (ECMO)"

Extracorporeal membrane oxygenation (ECMO) is a hospital life-support technique that temporarily takes over the work of the lungs and/or heart by pumping a patient’s blood through an external machine that adds oxygen and removes carbon dioxide, then returns it to the body—think of it as an artificial lung and pump outside the body. Investors watch ECMO because demand for the machines, supplies, specialized staffing, and regulatory approvals can affect revenues, clinical trial outcomes, hospital costs, and the commercial prospects of medical-device and healthcare companies.

acute respiratory distress syndrome (ards) medical

"hepatorenal syndrome (HRS), COVID-19, and acute respiratory distress syndrome (ARDS)."

Acute respiratory distress syndrome (ARDS) is a sudden, severe lung condition where fluid fills the tiny air sacs and the lungs become stiff, making it hard for oxygen to get into the blood—think of lungs like sponges that have become waterlogged and rigid. It matters to investors because ARDS drives urgent hospital care, use of ventilators and monitoring equipment, and demand for drugs and therapies, so changes in its incidence or treatment can affect healthcare costs, hospital capacity and the outlook for medical companies.

AI-generated analysis. Not financial advice.

Enrolled 35 of the 70 patients in the ongoing NEPHRO-CRRT registrational study, supported by new target profile sites

Company to host a virtual investor and analyst event on March 23 at 11:00 am ET featuring nephrologists, Dr. Blaithin McMahon and Dr. Joao Teixeira

SAN MATEO, Calif., March 2, 2026 /PRNewswire/ -- Talphera, Inc. (Nasdaq: TLPH), ("Talphera"), a specialty pharmaceutical company focused on the development and commercialization of innovative therapies for use in medically supervised settings, today announced 50% patient enrollment of the NEPHRO-CRRT clinical trial.

"Over the course of 2025, with agreement from the FDA, we implemented significant changes to the NEPHRO CRRT clinical trial, including a nearly 60% reduction in the total number of patients to be enrolled and revising other enrollment criteria. In addition, we reviewed and updated our target profile for clinical sites to focus on medical ICUs and having nephrologists as our principal investigators. These changes have yielded positive results in enrollment rates, allowing us to achieve our 50% enrollment milestone with more than 90% of the patients from our new sites," said Vince Angotti, CEO of Talphera. "We're looking forward to completing the study, and anticipate filing our PMA this year to potentially have the only FDA approved regional anticoagulant for CRRT. We continue to receive feedback from physicians— that they desperately need a better CRRT anticoagulant. In just a few weeks, we are excited to have two key experts share their deep experience with CRRT at our planned virtual investor and analyst day," continued Angotti.

Virtual Investor and Analyst Event Information and Biographies of Key Experts

Talphera will hold a conference call and webcast for investors and analysts at 11:00 am Eastern Time on March 23, 2026 with two key experts and principal investigators in the NEPHRO CRRT study. The guest physicians will discuss their experience with CRRT and the anticoagulants currently being used during CRRT today, and how they see nafamostat filling a role. They will also take questions from investors and analysts.

The webcast can be accessed here or by visiting the Investors section of the Company's website at www.talphera.com and clicking on the webcast link posted within Investors/News & Events/Upcoming Events section. The webcast will include a slide presentation, and a replay will be available on the Talphera website for 90 days following the event.

Dr. Blaithin McMahon (Medical University of South Carolina)

Dr. McMahon is an Associate Professor of Medicine at the Medical University of South Carolina. She did her medical residency and nephrology fellowship training at the Johns Hopkins Hospital, Baltimore, from 2011-2016. In July 2016, she joined the nephrology faculty at the Johns Hopkins Hospital prior to moving to MUSC in September 2018.  Dr. McMahon's key research is in the field of Acute Injury Kidney. She has published over 50 papers in leading peer reviewed international nephrology medical journals and penned numerous editorials, commentaries, case reports, expert opinions, review papers, book chapters and has more than 1000 citations in this area of interest. She is the director of nephrology clinical trials at MUSC and is involved in several prospective national and international ICU studies ongoing in the area of Acute Kidney Injury and continuous kidney replacement therapy. Dr. McMahon is also the Director of CRRT at MUSC and is responsible for managing prescription protocols related to dialysis in the intensive care unit. She has been awarded multiple teaching awards at Johns Hopkins Hospital MUSC and University College Dublin.

Dr. Joao Teixeira (University of New Mexico)

Dr. Teixeira is an Associate Professor in Divisions of Nephrology and Pulmonary, Critical Care, and Sleep Medicine in the Department of Internal Medicine (DOIM) at the University of New Mexico (UNM). He staffs the inpatient nephrology consult service and medical intensive care unit (ICU) at UNM Hospital (UNMH), works as medical co-director of a local outpatient hemodialysis unit, and serves as the director of the acute dialysis and continuous kidney replacement therapy (CRRT) programs at UNMH. He was previously the Training Program Director of UNM's Nephrology Fellowship and has served as Core Faculty in the Critical Care Medicine Fellowship and the Internal Medicine Residency.

As a critical care nephrologist, his scholarly interests lie in all areas of overlap between the two fields, centering on the realm of acute kidney injury (AKI). He developed a critical care research program focused on diagnostics and therapeutics for AKI, CRRT, septic shock, vasopressor therapy, extracorporeal membrane oxygenation (ECMO), hepatorenal syndrome (HRS), COVID-19, and acute respiratory distress syndrome (ARDS). As site principal investigator or an investigator, he has enrolled approximately 300 critically ill or hospitalized patients into more than a dozen investigator-initiated or industry-sponsored clinical trials. He has coauthored over 100 peer-reviewed publications, book chapters, and conference abstracts; he is on the editorial boards of three journals and has served as an ad hoc reviewer for several dozen other journals. He has served as invited faculty at over a dozen national and international conferences, including the National Kidney Foundation Spring Clinical Meeting, American Society of Nephrology Kidney Week, and European Society of Intensive Care Medicine.

About the NEPHRO CRRT Study

The NEPHRO CRRT Study is designed as a prospective, double-blinded trial to be conducted at up to 14 U.S. hospital intensive care units. The study will enroll and evaluate 70 adult patients undergoing renal replacement therapy, who cannot tolerate heparin or are at risk of bleeding. The primary endpoint of the study is the mean post-filter activated clotting time on Niyad versus placebo over the first 24 hours. Key secondary endpoints include the mean post-filter activated clotting time over 72 hours, filter lifespan, number of filter changes over 72 hours, number of transfusions over 72 hours and dialysis efficacy (based on urea concentration) over the first 24 hours.

About Niyad and Nafamostat

Nafamostat is a broad spectrum, synthetic serine protease inhibitor with anticoagulant, anti-inflammatory and potential anti-viral activities. Niyad™ is a lyophilized formulation of nafamostat and is currently being studied under an IDE, as an anticoagulant for the extracorporeal circuit, and has received Breakthrough Device Designation Status from the FDA. Talphera's registrational study of Niyad™ is named the NEPHRO CRRT (Nafamostat Efficacy in Phase 3 Registrational Continuous Renal Replacement Therapy) study. An ICD-10 procedural code, XY0YX37, has been issued for the extracorporeal introduction of nafamostat. The ICD-10 code is a specific/billable code that can be used to indicate a procedure. LTX-608 is a proprietary nafamostat formulation for direct IV infusion that may be investigated and developed for the treatment of acute respiratory distress syndrome (ARDS), disseminated intravascular coagulation (DIC), acute pancreatitis or anti-viral treatment, amongst other potential targets.

About Talphera, Inc.

Talphera, Inc. is a specialty pharmaceutical company focused on the development and commercialization of innovative therapies for use in medically supervised settings. Talphera's lead product candidate, Niyad™ is a lyophilized formulation of nafamostat and is currently being studied under an investigational device exemption (IDE) as an anticoagulant for the extracorporeal circuit and has received Breakthrough Device Designation status from the U.S. Food and Drug Administration (FDA).

This release is intended for investors only. For additional information about Talphera, please visit www.talphera.com

Forward-looking statements

This press release contains forward-looking statements based upon Talphera's current expectations and assumptions. These and any other forward-looking statements are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. These statements may be identified by the use of forward-looking terminology such as "believe," "expect," "anticipate," "may," "if," "intends," "plans," "potential," "projected," "will," or the negative of these words or other comparable terminology, and include: looking forward to completing the NEHPRO CRRT study and the Company's target filing of the PMA this year to potentially have the only FDA approved regional anticoagulant for CRRT. Talphera's discussion of its strategy, plans and intentions also include forward-looking statements, which are predictions, projections and other statements about future events that are based on current expectations and assumptions. These forward-looking statements involve risks and uncertainties that could cause actual results to differ materially from those projected, anticipated or implied by such statements, including: (i) risks relating to Talphera's product development activities, including that clinical studies may not be fully enrolled or completed and/or confirm any safety, efficacy or other potential developmental product characteristics described or assumed in this press release; (ii) Talphera's developmental product candidates may not be beneficial to patients or healthcare providers or be successfully commercialized; (iii) risks relating to Talphera's ability to obtain regulatory approvals for its developmental product candidates; (iv) risks related to the ability of Talphera and its business partners to implement development plans, commercial launch plans, forecasts and other business expectations; and (v) risks related to Talphera's liquidity and its ability to maintain capital resources sufficient to conduct its clinical studies. Although it is not possible to predict or identify all such risks and uncertainties, they may include, but are not limited to, those described under the caption "Risk Factors" and elsewhere in Talphera's annual, quarterly and current reports (i.e., Form 10-K, Form 10-Q and Form 8-K) as filed or furnished with the SEC and any subsequent public filings. You are cautioned not to place undue reliance on any such forward-looking statements, which speak only as of the date such statements were first made. To the degree financial information is included in this press release, it is in summary form only and must be considered in the context of the full details provided in Talphera's most recent annual, quarterly or current report as filed or furnished with the SEC. Talphera's SEC reports are available at www.talphera.com under the "Investors" tab. Except to the extent required by law, Talphera undertakes no obligation to publicly release the result of any revisions to these forward-looking statements to reflect new information, events or circumstances after the date hereof, or to reflect the occurrence of unanticipated events.

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SOURCE Talphera, Inc.

FAQ

How many patients has Talphera (TLPH) enrolled in the NEPHRO-CRRT trial as of March 2, 2026?

Talphera has enrolled 35 of 70 patients (50%) in the NEPHRO-CRRT trial. According to the company, the enrollment reflects protocol changes and site targeting implemented with FDA agreement to accelerate recruitment.

What protocol changes did Talphera announce for the NEPHRO-CRRT study and why does it matter for TLPH?

The company implemented a nearly 60% reduction in total patients and revised enrollment criteria. According to the company, these FDA-agreed changes and new site targeting improved enrollment rates and study feasibility.

When is Talphera's virtual investor and analyst event on NEPHRO-CRRT, and who will speak?

The webcast is scheduled for March 23, 2026 at 11:00 am ET featuring Dr. Blaithin McMahon and Dr. Joao Teixeira. According to the company, the session will include a slide presentation, live Q&A, and a 90-day replay.

What proportion of NEPHRO-CRRT patients came from Talphera's new targeted sites?

More than 90% of enrolled patients are from the new target-profile sites focused on medical ICUs with nephrologist PIs. According to the company, this shift materially improved enrollment velocity.

Does Talphera plan to file for FDA approval of its CRRT anticoagulant in 2026?

Talphera said it anticipates filing a PMA this year to seek FDA approval for its regional anticoagulant for CRRT. According to the company, successful trial completion would support that PMA timeline.