Last updated
Revenue
R&D Expenses
Operating CF
Total Assets
Total Liabilities
Equity
Shares Out.
D/E Ratio
Dilution Watch
Financials
52W LOW $0.6952W HIGH $1.57
Volume
24.70 K
Value Traded
135.40 K
Short % Float
1.82%
-4.42%Week
-11.48%1 Month
-26.03%3 Month
+41.99%6 Month
-96.91%5 Year
-99.18%All Time
Cash Data
- Monthly Burn
- Burn Trend
- Dilution Risk
- SEC Filing
Key Stats
Market Cap
56.06 M
EPS (TTM)
-0.29
P/E Ratio
-
Ent. Value
38.98 M
Total Shares
51.88 M
Float Shares
38.57 M
Insiders
25.69%
Institutions
46.07%
Upcoming Catalysts
FDA decisions, readouts and PDUFA dates · scored by probability of approval
| Catalyst | Drug / Treatment | Stage | Prob. of Approval | Description | Drug Type | Therapeutic Area | Source |
|---|---|---|---|---|---|---|---|
PDUFA 2026 | Example Drug Treatment for example condition requiring FDA review | Phase 3 | Small Molecule | Oncology | - |
PoA blends historical approval base rates, trial design score and FDA review track record.
TLPH Catalyst Timeline
Dated clinical, regulatory and corporate events for Talphera, Inc.
Catalyst Timeline
Dated clinical, regulatory & corporate events for Talphera, Inc.
342Total events
5Upcoming
85Tier-1 (high impact)
2010 to 2026Coverage
Upcoming catalysts 2
Event history 50
▲Enrollment MilestoneNiyadFiledTrial
NEPHRO CRRT study reached 75% enrollment
anticoagulant for CRRTsource ↗
▲Other Regulator MilestonenafamostatFiledEx-US Regulatory
KDIGO 2026 guideline cites nafamostat as acceptable CRRT anticoagulant
CRRT anticoagulationsource ↗
▲FDA Filing AcceptednafamostatFiledRegulatory Filing
KDIGO 2026 guideline cites nafamostat as acceptable CRRT anticoagulant
CRRT anticoagulationsource ↗
◆Quarterly UpdateCorporate
First quarter 2026 financial results release and corporate update call
▲FDA Filing AcceptednafamostatFiledRegulatory Filing
KDIGO 2026 guideline cites nafamostat as acceptable CRRT anticoagulant
CRRT anticoagulationsource ↗
◆Poster PresentationnafamostatFiledPresentation
Poster presentation on in vivo assessment of nafamostat in porcine model at AKI & CRRT 2026
anticoagulation during CRRT in a porcine model of AKIsource ↗
◆Poster PresentationNiyadFiledPresentation
Poster presentation on NEPHRO-CRRT study design at AKI & CRRT 2026
anticoagulation during continuous renal replacement therapy (CRRT)source ↗
◆Enrollment UpdateNiyadFiledTrial
Enrolling patients in NEPHRO-CRRT registrational study
anticoagulation during CRRTsource ↗
◆R&D DayNiyadFiledPresentation
Virtual investor and analyst event on Niyad for CRRT
continuous renal replacement therapy (CRRT)source ↗
▲Enrollment MilestoneNiyadFiledTrial
50% enrollment milestone achieved (35 of 70 patients)
anticoagulant for continuous renal replacement therapy (CRRT)source ↗
▲Enrollment MilestoneNiyadFiledTrial
35-patient enrollment milestone (50% enrollment) in NEPHRO CRRT study
anticoagulant for continuous renal replacement therapy (CRRT)source ↗
●Poster PresentationNiyadFiledPresentation
Two posters presented at AKI & CRRT 2026 conference
anticoagulant for CRRTsource ↗
◆Timing GuidanceNiyadFiledPresentation
PMA submission expected early 2026
anticoagulant for extracorporeal circuit in continuous renal replacement therapysource ↗
▲FDA Filing AcceptednafamostatFiledRegulatory Filing
KDIGO 2026 guideline cites nafamostat as acceptable CRRT anticoagulant
CRRT anticoagulationsource ↗
◆Trial CompletionNiyadFiledTrial
Planned study completion by end of 2025
anticoagulation for continuous renal replacement therapysource ↗
◆Primary Endpoint MetNiyadFiledClinical Data
Achievement of primary endpoint in NEPHRO CRRT study triggers $12 million second closing
anticoagulation for continuous renal replacement therapy (CRRT)source ↗
▲Enrollment CompleteNiyadFiledTrial
Enrollment completion in NEPHRO CRRT study expected by end of 2025
anticoagulation for CRRTsource ↗
▲Enrollment MilestoneNiyadFiledTrial
5 of 9 target profile clinical sites activated
anticoagulant for extracorporeal circuit in CRRTsource ↗
◆Enrollment CompleteNiyadFiledTrial
Target completion of NEPHRO CRRT study by end of 2025
anticoagulant for extracorporeal circuit in continuous renal replacement therapysource ↗
▼Equity OfferingCorporate
Private placement financing of up to $29 million priced at-the-market
▼Equity OfferingCorporate
CorMedix strategic investment in Talphera private placement financing
▲Enrollment MilestoneNiyadFiledTrial
Enrolled 17 patients in NEPHRO CRRT pivotal trial (25% enrollment)
anticoagulation for continuous renal replacement therapysource ↗
◆Quarterly UpdateCorporate
Second quarter 2025 financial results release and corporate update call
▲Enrollment UpdateNiyadFiledTrial
15 patients enrolled in NEPHRO study
anticoagulation for CRRTsource ↗
◆Enrollment UpdateNiyadFiledTrial
Six new sites expected to begin enrolling in Q3 2025
anticoagulation for continuous renal replacement therapysource ↗
▲Enrollment MilestoneNiyadFiledTrial
Expect to add six new clinical sites by end of Q3 2025
anticoagulation for CRRTsource ↗
◆Enrollment UpdateNiyadFiledTrial
Five additional sites expected by mid-year 2025
anticoagulation for continuous renal replacement therapy (CRRT)source ↗
◆Quarterly UpdateCorporate
First quarter 2025 financial results release and corporate update call
▼Equity OfferingCorporate
First tranche of private placement closed on April 2, 2025, net proceeds $4.4 million
◆FDA ApprovalNiyadFiledFDA Decision
Potential FDA approval targeted for Q2 2025
anticoagulant for continuous renal replacement therapy (CRRT)source ↗
▲Enrollment CompleteNiyadFiledTrial
FDA agreed to reduce NEPHRO CRRT study size to 70 patients from 166
anticoagulant for extracorporeal circuit in continuous renal replacement therapysource ↗
▲FDA Feedback ReceivedNiyadFiledFDA Meeting
FDA approved Prior Approval Supplement reducing patient number from 166 to 70
anticoagulation for continuous renal replacement therapy (CRRT)source ↗
●Timing GuidanceNiyadFiledPresentation
Submission of Prior Approval Supplement to reduce patient number expected within coming week
anticoagulant for continuous renal replacement therapysource ↗
▲FDA Feedback ReceivedNiyadFiledFDA Meeting
FDA agrees to review Prior Approval Supplement to reduce patient number and to two protocol changes
anticoagulant for continuous renal replacement therapysource ↗
●Enrollment CompleteNiyadFiledTrial
NEPHRO CRRT study completion expected by end of 2025
anticoagulant for continuous renal replacement therapysource ↗
▲FDA Feedback ReceivedNiyadFiledFDA Meeting
FDA agreed to broaden inclusion criteria in January 2025
anticoagulation for continuous renal replacement therapy (CRRT)source ↗
●Trial CompletionNiyadFiledTrial
NEPHRO CRRT study anticipated to be completed in 2025
anticoagulation for continuous renal replacement therapy (CRRT)source ↗
▲Enrollment UpdateNiyadFiledTrial
Three new clinical study sites activated and screening patients in 2025
anticoagulation for continuous renal replacement therapy (CRRT)source ↗
◆Enrollment MilestoneNiyadFiledTrial
Next enrollment update expected when 17 patients enrolled (milestone for second tranche)
anticoagulation for continuous renal replacement therapy (CRRT)source ↗
Past FDA Catalysts and PDUFA Decisions
How TLPH actually traded into and out of each decision
| Date | Drug | Catalyst | Stage | Reaction | Event Move % | Best Trade % |
|---|---|---|---|---|---|---|
| 2014-07-25 | Zalviso (sufentanil sublingual) | PDUFA Date CRL | PDUFA |
Reaction: 30 trading days around the event · Event Move: close to close on decision day · Best Trade: peak run-up from entry 10 days before the decision
Drug Pipeline Intelligence
D20 / 100
Pipeline Score
$0M
Pipeline Value
Not rated
Valuation Signal
14
Drugs Scored
-
rNPV / MCap
Top 95%
Micro Cap(rank 625 of 658)
Percentile Rank
Talphera, Inc. faces pipeline headwinds (20/100), with 14 assets in development.
| Drug | Indication | Phase | PTRS | rNPV | Status | Enroll | Velocity | Design | Est. Completion | ML Signal | Last Change |
|---|---|---|---|---|---|---|---|---|---|---|---|
| Sufentanil/Triazolam NanoTab Small moleculeMarketedNCT02447848 | Acute Moderate-to-severe Pain | Phase 3 | COMPLETED | 216 | Jul 1, 2016 |
Clinical Trial Results
Readouts, endpoints and source filings for every TLPH program
| Drug Name | Indication | Phase | Date | Trial Results Summary | Title | Source |
|---|---|---|---|---|---|---|
| ARX-04 | moderate-to-severe acute pain | Phase 3 | 2016-09-15 | 63% of all patients had no adverse events; 90% of healthcare professionals and 87% of patients responded 'good' or 'excellent'; mean pain score of 6.2 at baseline; 27%, 49%, and 57% reductions in mean pain intensity at 1 hour, 2 hours, and 12 hours, respectivelyRead More | AcelRx Reports Positive Results for ARX-04 (sufentanil sublingual tablet, 30 mcg), Including in Elderly Patients and Patients with Organ Impairment, in Third Phase 3 Registration Trial, SAP303 Majority of Patients Had NoRead More |
Inside Trades
| Insider | Side | Shares | Price | Value | Date |
|---|---|---|---|---|---|
| Aslam ShakilOfficer (Chief Medical Officer) | Disposition | -4,518 76,542 held | $0.82 | 05/20/2026 |
Hedge Fund 13F Activity
Hedge Funds invested in TLPH
| Fund | % of Portfolio | Current MV | Shares Owned | Activity |
|---|---|---|---|---|
| No hedge fund reported a 13F position in TLPH for Q2 2026. | ||||
TLPH Institutional Ownership Trends
Options Data
Option Volume
Open Interest
Call OI
Put OI
Put-Call Ratio
OI 30-day avg
Today vs avg
Option Volume
Call Vol
Put Vol
Put-Call Ratio
Vol 30-day avg
Today vs avg
Option Chain Statistics
| Expiry | Call Vol | Put Vol | Vol P/C | Call OI | Put OI | OI P/C | IV Call | IV Call OI-Wtd | IV Call Vol-Wtd | IV Put | IV Put OI-Wtd | IV Put Vol-Wtd |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 2026-10-16 | ||||||||||||
Real-Time Option Chain
| Calls | Strike | Puts | ||||
|---|---|---|---|---|---|---|
| Last | Vol | OI | Last | Vol | OI | |
| No data available | ||||||
Calls vs Puts by Expiry
CallsPutsLog scale
Competitive positioning
How TLPH ranks across every disease it competes in
Competitive Position is a premium feature
See how TLPH ranks against every competitor across each disease it develops in: phase, best drug, trials and likelihood of approval.
Start free trialTLPH News
TLPHTalphera to Participate in the H.C. Wainwright 28th Annual Global Investment Conference
Talphera, Inc. will present at the H.C. Wainwright 28th Annual Global Investment Conference on September 14, 2026. CEO Vince Angotti and CMO Shakil Aslam will engage in a fireside chat and hold one-on-one meetings. The company is known for its innovative therapies, particularly its lead product candidate, Niyad®, which has received Breakthrough Device Designation from the FDA.
Read more →TLPH▼ -13.6%on this news
Talphera Announces Second Quarter 2026 Financial Results and Provides Corporate Update
Talphera, Inc. reported a 75% enrollment in its NEPHRO CRRT clinical study, expected to complete by year-end. The KDIGO 2026 guidelines have positively recognized nafamostat as an acceptable anticoagulant. Market research indicates a significant increase in CRRT procedures, with an estimated 200,000 expected in the U.S. in 2027. However, the company reported a net loss of $4.3 million for Q2 2026.
Read more →TLPH▲ +5.9%on this news
Talphera to Report Second Quarter 2026 Financial Results on Wednesday, August 12, 2026
Talphera, Inc. will hold a conference call on August 12, 2026, to discuss its second quarter financial results and recent business developments. The call will take place at 4:30 PM ET. Talphera is known for its innovative therapies, with its lead candidate, Niyad, currently under investigation as an anticoagulant. The company has received FDA Breakthrough Device Designation for nafamostat.
Read more →TLPH▲ +5.1%on this news
Talphera Announces First Quarter 2026 Financial Results and Provides Corporate Update
Talphera, Inc. announced its first quarter 2026 financial results, highlighting significant progress in its NEPHRO CRRT clinical study, which is expected to complete later this year. The company reported a cash balance of $21.1 million and discussed the potential of nafamostat as an alternative anticoagulant for Continuous Renal Replacement Therapy. Despite a net loss of $2.6 million, the company remains optimistic about its product's market potential.
Read more →TLPHTalphera to Host First Quarter Financial Results and Corporate Update Call and Webcast on Wednesday, May 13, 2026
Talphera, Inc. will announce its first quarter 2026 financial results on May 13, 2026, followed by a live webcast and conference call. Investors can dial in to participate in the discussion of the results and business updates. Talphera's lead product, Niyad®, is recognized for its potential as an anticoagulant and has received Breakthrough Device Designation from the FDA, highlighting the company's focus on innovative therapies.
Read more →TLPH▲ +9.1%on this news
Talphera Announces Two Abstracts Accepted for Presentation at AKI & CRRT 2026
Talphera, Inc. announced the acceptance of two abstracts for presentation at the AKI & CRRT 2026 conference. The studies focus on the safety and efficacy of nafamostat, a novel regional anticoagulant, in patients undergoing continuous renal replacement therapy. The NEPHRO-CRRT study aims to address unmet medical needs in this area, with promising early results.
Read more →TLPHTalphera Announces Fourth Quarter and Full Year 2025 Financial Results and Provides Corporate Update
Talphera, Inc. reported its fourth quarter and full year 2025 financial results, highlighting a significant milestone with 50% enrollment in the NEPHRO CRRT clinical study. The company has a strong cash position of $20.4 million and is hosting a virtual investor day to discuss the study's progress and the potential of nafamostat. The study aims to evaluate nafamostat's efficacy as an anticoagulant in renal replacement therapy.
Read more →TLPH▼ -8.2%on this newsshared move
Talphera to Host Virtual Investor & Analyst Event to Discuss Niyad® for Use in Continuous Renal Replacement Therapy (CRRT), on March 23, 2026
Talphera, Inc. will host a virtual investor and analyst event on March 23, 2026, to discuss its product candidate Niyad for continuous renal replacement therapy (CRRT). The event will feature principal investigators from the NEPHRO CRRT study, which evaluates Niyad's efficacy as an anticoagulant. The study aims to address limitations of current anticoagulants like heparin and citrate, particularly for patients at risk of bleeding.
Read more →TLPHTalphera Announces 50% Enrollment Milestone in Ongoing NEPHRO-CRRT Registrational Trial
Talphera, Inc. has announced that it has reached a 50% enrollment milestone in its NEPHRO-CRRT clinical trial, enrolling 35 out of 70 patients. The company has made significant changes to the trial, including a reduction in the total number of patients and updated enrollment criteria. Talphera plans to file for PMA this year, aiming to be the first FDA-approved regional anticoagulant for CRRT. A virtual investor event is scheduled for March 23, 2026, featuring expert nephrologists.
Read more →TLPH▼ -18.6%on this news
Talphera Announces Third Quarter 2025 Financial Results and Provides Corporate Update
Talphera, Inc. announced its third quarter 2025 financial results, highlighting a $17 million financing led by CorMedix. The company expects sufficient cash to support its Niyad PMA approval anticipated in late 2026. Five out of nine clinical sites for the NEPHRO study are now activated, with completion expected in the first half of 2026. The company will hold a conference call on November 12, 2025, to discuss these results further.
Read more →TLPH▼ -8.7%on this news
Talphera to Host Third Quarter Financial Results and Corporate Update Call and Webcast on Wednesday, November 12, 2025
Talphera, Inc. will announce its third quarter 2025 financial results on November 12, 2025. Following the release, the company will host a live webcast and conference call to discuss the results and provide a business update. The webcast will include a slide presentation and be available for replay for 90 days. Talphera's lead product candidate has received Breakthrough Device Designation from the FDA.
Read more →TLPHTalphera Announces the Appointment of Joe Todisco to Board of Directors
Talphera, Inc. has appointed Joe Todisco, CEO of CorMedix, to its Board of Directors. This move follows CorMedix's strategic investment in Talphera, providing them the right to nominate a board member. Todisco expressed optimism about Talphera's lead product, Niyad, which aims to become a new standard of care for anticoagulation in CRRT.
Read more →TLPH▲ +45%on this news· ran to +76% by day 3
Talphera Announces Private Placement Financing of up to $29 Million Priced At-the Market
Talphera, Inc. has announced a private placement financing of up to $29 million, led by CorMedix and supported by existing stockholders and new institutional investors. The first closing is expected to raise $17 million, with an additional $12 million contingent on achieving a primary endpoint in the NEPHRO clinical study. This funding aims to support Talphera through the anticipated approval of its Niyad PMA in late 2026.
Read more →TLPH▲ +17.3%on this news
Talphera Announces Achievement of 17 Patient Enrollment Milestone in NEPHRO CRRT Pivotal Trial
Talphera, Inc. has announced the enrollment of 17 patients in its pivotal NEPHRO CRRT clinical trial, marking a significant milestone. The trial is on track for completion by the end of 2025, aided by an accelerated recruitment rate from new clinical sites. The study aims to evaluate the efficacy of Niyad, a formulation of nafamostat, in patients undergoing renal replacement therapy.
Read more →TLPHTalphera Announces Second Quarter 2025 Financial Results and Provides Corporate Update
Talphera, Inc. announced its second quarter 2025 financial results and provided an update on its NEPHRO clinical study, reporting that 15 patients have been enrolled. The company is on track for study completion by year-end 2025 and anticipates increasing the number of clinical sites to 13 to enhance enrollment. Financial results show a net loss of $3.5 million for the quarter, an improvement compared to $3.8 million in the same period last year. Talphera also provided guidance for 2025 operating expenses, estimating between $16 million to $17 million.
Read more →TLPHTalphera to Host Second Quarter Financial Results and Corporate Update Call and Webcast on Thursday, August 14, 2025
Talphera, Inc. will release its second quarter financial results on August 14, 2025, after market close. Following the release, the company will conduct a live webcast and conference call to discuss the results and provide business updates. The event can be accessed via the company's website, and a replay will be available for 90 days. Talphera focuses on innovative therapies with its lead product candidate, Niyad™, currently under investigation as an anticoagulant and designated as a Breakthrough Device by the FDA.
Read more →TLPHTalphera Announces First Quarter 2025 Financial Results and Provides Corporate Update
Talphera, Inc. has reported its first quarter 2025 financial results and provided updates on its ongoing clinical initiatives. The company has activated three new clinical study sites in its NEPHRO CRRT study and anticipates five additional sites by mid-year. They received FDA approval to amend their study protocol, reducing the target patient enrollment to 70. Financially, Talphera closed a $4.4 million financing tranche, but reported a net loss of $2.6 million for the quarter, highlighting the ongoing challenges they face in terms of operational costs.
Read more →TLPHTalphera to Host First Quarter Financial Results and Corporate Update Call and Webcast on Wednesday, May 14, 2025
Talphera, Inc. will announce its first quarter 2025 financial results on May 14, 2025, followed by a live webcast and conference call. This event aims to provide investors with insights into the company’s performance and updates on its business operations. The conference will also cover details about their lead product candidate, Niyad™, which is under investigation for anticoagulant use and has received Breakthrough Device Designation from the FDA.
Read more →TLPH▼ -15.5%on this news
Talphera Announces Fourth Quarter and Full Year 2024 Financial Results and Provides Corporate Update
Talphera, Inc. announced its fourth-quarter and full-year 2024 financial results, highlighting several key developments. Significant news included the FDA's approval to reduce the patient count in the NEPHRO CRRT study and a new financing agreement for $14.8 million. Talphera aims to complete the NEPHRO study by the end of 2025, supported by new clinical sites. However, the company reported a net loss of $1.9 million for Q4 2024, marking a decrease from the previous year's loss.
Read more →TLPH▼ -15.5%on this news
Talphera Announces Agreement with the FDA to Reduce the NEPHRO CRRT Study Size to 70 Patients From 166 and a Private Placement Financing Priced At-the Market of up to $14.8 Million
Talphera, Inc. has announced an agreement with the FDA to reduce the patient size for its NEPHRO CRRT study from 166 to 70, with 6 patients already enrolled. The company expects to complete the study by the end of 2025 and has initiated a private placement financing aiming to raise up to $14.8 million, with initial gross proceeds of $4.925 million expected. The financing is contingent on achieving certain milestones in patient enrollment and stock price performance. CEO Vince Angotti expressed optimism regarding the study's potential and the support from existing investors.
Read more →About Talphera, Inc.
Headquarters1850 GATEWAY DRIVE, SAN MATEO, CA, 94404
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