Last updated
Revenue
R&D Expenses
Operating CF
Total Assets
Total Liabilities
Equity
Shares Out.
D/E Ratio
Dilution Watch
Financials
52W LOW $0.5552W HIGH $1.66
Volume
231.65 K
Value Traded
550.67 K
Short % Float
3.62%
-9.48%Week
-40.34%1 Month
-16.47%3 Month
-10.8%6 Month
-99.01%5 Year
-99.01%All Time
Cash Data
- Monthly Burn
- Burn Trend
- Dilution Risk
- SEC Filing
Key Stats
Market Cap
13.65 M
EPS (TTM)
-0.43
P/E Ratio
-
Ent. Value
13.61 M
Total Shares
14.85 M
Float Shares
12.84 M
Insiders
13.53%
Institutions
19.63%
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.
BFRI Catalyst Timeline
Dated clinical, regulatory and corporate events for Biofrontera Inc.
Catalyst Timeline
Dated clinical, regulatory & corporate events for Biofrontera Inc.
478Total events
6Upcoming
109Tier-1 (high impact)
2017 to 2027Coverage
Upcoming catalysts 2
Event history 50
●sNDA SubmissionAmeluzApprovedRegulatory Filing
Biofrontera submits sNDA to FDA to expand Ameluz PDT to AKs on extremities, neck and trunk
mild-to-moderate actinic keratoses (AKs) on the extremities, neck and trunksource ↗
▲Supplemental ApprovalAmeluzApprovedFDA Decision
FDA approves supplemental NDA for Ameluz with RhodoLED PDT for superficial basal cell carcinoma
superficial Basal Cell Carcinoma (sBCC)source ↗
▲FDA ApprovalAmeluzApprovedFDA Decision
FDA approved Ameluz with RhodoLED red light for superficial basal cell carcinoma
superficial basal cell carcinoma (sBCC)source ↗
◆Oral PresentationPresentation
Biofrontera webcast presentation at Lytham Partners Spring 2026 Investor Conference
◆Quarterly UpdateCorporate
Biofrontera Inc. First Quarter 2026 Financial Results and Business Update Conference Call
▲Topline ReadoutAmeluzApprovedClinical Data
Positive top-line results from Phase 3 trial of Ameluz PDT for AK on extremities, neck, and trunk
mild to moderate actinic keratoses (AKs) on extremities, neck, and trunksource ↗
▲Primary Endpoint MetAmeluzApprovedClinical Data
Primary endpoint met in Phase 3 trial of Ameluz PDT for AK on extremities, neck, and trunk
mild to moderate actinic keratoses (AKs) on extremities, neck, and trunksource ↗
◆Timing GuidanceAmeluzApprovedPresentation
Planned sNDA submission to FDA for AK on extremities, neck and trunk
actinic keratoses on extremities, neck and trunksource ↗
◆Trial CompletionAmeluzApprovedTrial
12-month follow-up phase expected to conclude
actinic keratoses on extremities, neck and trunksource ↗
◆Quarterly UpdateCorporate
Biofrontera Inc. to report Q4 and full year 2025 financial results and host conference call
▲Topline ReadoutAmeluzApprovedClinical Data
Positive Phase 3 topline results for Ameluz PDT in AK on extremities, neck, trunk
actinic keratoses on extremities, neck, trunksource ↗
▲FDA Filing AcceptedAmeluzApprovedRegulatory Filing
FDA accepted sNDA for Ameluz PDT in sBCC
superficial basal cell carcinoma (sBCC)source ↗
●Enrollment CompleteAmeluzApprovedTrial
Database lock of Phase 1 PK study for FDA filing on treatment field up to 240 cm2
actinic keratoses on extremities, neck, trunksource ↗
▲Topline ReadoutAmeluzApprovedClinical Data
Phase 2b topline results for Ameluz PDT in acne vulgaris
moderate to severe acne vulgarissource ↗
▲IP Litigation RulingIP / Competition
PTAB Final Written Decision finds all challenged claims of Sun Pharma's '028 patent unpatentable
▲Primary CompletionAmeluzApprovedTrial
Database lock of Phase 1 PK study of Ameluz for AK on trunk and extremities
actinic keratoses on trunk and extremitiessource ↗
▲FDA Filing AcceptedAmeluzApprovedRegulatory Filing
FDA accepts sNDA filing for Ameluz PDT in sBCC
superficial basal cell carcinomasource ↗
▲Topline ReadoutAmeluzApprovedClinical Data
Positive top-line results from Phase 3 study of Ameluz PDT for AK on extremities, neck, and trunk
actinic keratoses on the extremities, neck, and trunksource ↗
▲Primary Endpoint MetAmeluzApprovedClinical Data
Primary endpoint met: complete clearance rate superiority over vehicle
actinic keratoses on the extremities, neck, and trunksource ↗
◆Topline ReadoutAmeluzApprovedClinical Data
Topline data expected for Phase 3 AK study
actinic keratosis (AK) on the extremities, neck and trunksource ↗
◆Oral PresentationPresentation
Biofrontera management to present at Lytham Partners Healthcare Investor Summit
▲Enrollment CompleteAmeluzApprovedTrial
Database lock for Phase 3 AK study
actinic keratosis (AK) on the extremities, neck and trunksource ↗
◆Topline ReadoutAmeluzApprovedClinical Data
Top-line data expected from Phase 2b trial of Ameluz for acne vulgaris
moderate to severe acne vulgarissource ↗
●Partnership / LicenseAmeluzApprovedCorporate
Step-wise transfer price increase from 25% to 35% for AK, BCC, SCC from 2026 to 2032
actinic keratosissource ↗
▲Patent GrantedAmeluzApprovedIP / Competition
Transfer of 10 pending US patent applications for Ameluz and RhodoLED to Biofrontera Inc.
▲Patent GrantedRhodoLEDIP / Competition
Transfer of 19 international patent applications/registered designs for RhodoLED lamps to Biofrontera Inc.
▲NDA SubmissionAmeluzApprovedRegulatory Filing
Transfer of Ameluz NDA to Biofrontera Inc. completed
Actinic Keratosissource ↗
▲IND SubmissionAmeluzApprovedIND
Transfer of Ameluz IND to Biofrontera Inc. completed
Actinic Keratosissource ↗
●sNDA SubmissionAmeluzApprovedRegulatory Filing
sNDA submission to FDA for Ameluz-PDT for sBCC
superficial basal cell carcinomasource ↗
●sNDA SubmissionAmeluzApprovedRegulatory Filing
sNDA submitted for sBCC in December 2025
superficial Basal Cell Carcinoma (sBCC)source ↗
▲Partnership / LicenseAmeluzApprovedCorporate
Completed agreement with Biofrontera AG acquiring all U.S. rights, approvals, and patents for Ameluz and RhodoLED lamps
actinic keratosissource ↗
▼Equity OfferingCorporate
Secured $11 million investment from healthcare-focused institutional investors
▲Enrollment CompleteAmeluzApprovedTrial
Clinical studies for AK on entire body almost completed
actinic keratosis (full body)source ↗
▲Partnership / LicenseXepi™ApprovedCorporate
Sale of US license for Xepi to Pelthos Therapeutics
impetigosource ↗
●Program DiscontinuationXepi™ApprovedCorporate
Divestiture of Xepi antibiotic cream to Pelthos Pharmaceuticals
▲AcquisitionCorporate
Biofrontera Inc. closes purchase of all Ameluz and RhodoLED US assets from Biofrontera AG
▼Equity OfferingCorporate
$11 million investment led by Rosalind Advisors and AIGH Capital Management
▲Quarterly UpdateCorporate
New earnout structure replaces prior transfer-pricing model; expected to drive gross margin expansion starting Q4 2025
●Manufacturing MilestoneCMC / Inspection
Full transfer of assets and personnel expected to be completed
◆Oral PresentationPresentation
Biofrontera Inc. webcast presentation at Lytham Partners Fall 2025 Investor Conference
●Timing GuidancePresentation
Finalization of detailed asset transfer agreement expected by September 30, 2025
▲Last Patient Last VisitAmeluzApprovedTrial
Last patient completed active treatment phase in Phase 3 study of Ameluz PDT for AK on extremities, neck and trunk
actinic keratoses on extremities, neck and trunksource ↗
◆Trial CompletionAmeluzApprovedTrial
Treatment phase completion expected
actinic keratoses on the extremities, neck and trunksource ↗
Past FDA Catalysts and PDUFA Decisions
How BFRI actually traded into and out of each decision
| Date | Drug | Catalyst | Stage | Reaction | Event Move % | Best Trade % |
|---|---|---|---|---|---|---|
| 2026-09-30 | Ameluz® (aminolevulinic acid HCL) topical gel, 10% PDT | Phase 2b data readout | Phase 2b |
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
D39 / 100
Pipeline Score
$5M
Pipeline Value
$46M
Commercial Value
Undervalued
Valuation Signal
2
Drugs Scored
1.2x
rNPV / MCap
Top 41%
Micro Cap(rank 270 of 658)
Percentile Rank
Biofrontera Inc. faces pipeline headwinds (39/100), with $515M risk-adjusted pipeline value, led by Ameluz in Cutaneous Squamous Cell Carcinoma (Phase 2).
Commercial products (revenue basis: trailing 4 quarters of total revenue (10-K and 10-Q), to Jun 2026) Revenue $46.2M x 1.0 = $46M
| Drug | Indication | Phase | PTRS | rNPV | Status | Enroll | Velocity | Design | Est. Completion | ML Signal | Last Change |
|---|---|---|---|---|---|---|---|---|---|---|---|
| Ameluz Small moleculeMarketedNCT03573401 | Superficial Basal Cell Carcinoma | Phase 3 | ACTIVE NOT_RECRUITING | 187 | Feb 1, 2029 |
Clinical Trial Results
Readouts, endpoints and source filings for every BFRI program
| Drug Name | Indication | Phase | Date | Trial Results Summary | Title | Source |
|---|---|---|---|---|---|---|
| Ameluz® | moderate to severe acne vulgaris | Phase 2b | 2026-03-09 | inflammatory lesion reduction: 57.97%; vehicle inflammatory lesion reduction: 36.51%; m IGA success rate: 25%; vehicle m IGA success rate: 21.4%; lesion reductions: inflammatory 19.7, non inflammatory 23.1, total 42.7; vehicle lesion reductions: inflammatory 15.4, non inflammatory 16.5, total 31.9; patient satisfaction: would choose again 85.7%, rated outcome good or very good 71.4%Read More | Biofrontera Inc. Reports Positive Phase 2b Results Supporting Further Development of Ameluz® Photodynamic Therapy for moderate to severe Acne VulgarisRead More |
Inside Trades
| Insider | Side | Shares | Price | Value | Date |
|---|---|---|---|---|---|
| Luebbert HermannDirector, Officer (CEO & Chairman) | Option | 62,500 352,711 held | $0.00 | 07/28/2026 |
Hedge Fund 13F Activity
Hedge Funds invested in BFRI
| Fund | % of Portfolio | Current MV | Shares Owned | Activity |
|---|---|---|---|---|
| No hedge fund reported a 13F position in BFRI for Q2 2026. | ||||
BFRI 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 |
|---|
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 BFRI ranks across every disease it competes in
Competitive Position is a premium feature
See how BFRI ranks against every competitor across each disease it develops in: phase, best drug, trials and likelihood of approval.
Start free trialBFRI News
BFRI▼ -1.8%today
Biofrontera Submits Supplemental New Drug Application to FDA to Expand Ameluz® Red Light PDT to Actinic Keratoses on the Full Body
Biofrontera Inc. has submitted a supplemental New Drug Application to the FDA to expand the use of Ameluz® PDT for treating actinic keratoses on the full body. Currently approved for the face and scalp, this expansion would allow dermatologists to treat a broader range of patients. The submission is backed by a Phase 3 trial demonstrating significant efficacy and patient satisfaction. If approved, Ameluz® would be the only PDT in the U.S. for full-body AK treatment.
Read more →BFRI▼ -12.3%on this news· ran to -23% by day 1
Biofrontera Announces FDA Approval of Ameluz® Red Light PDT for the Treatment of Superficial Basal Cell Carcinoma
Biofrontera Inc. has received FDA approval for Ameluz®, a topical gel used with the RhodoLED lamp for treating superficial basal cell carcinoma (sBCC). This marks Ameluz as the first photodynamic therapy approved for skin cancer in the U.S., enhancing its market position. The approval is supported by positive results from a Phase 3 trial, indicating significant efficacy in treating sBCC.
Read more →BFRIBiofrontera Inc. Reports Strong Second Quarter 2026 Financial Results Driven by 33% Revenue Growth
Biofrontera Inc. reported strong financial results for Q2 2026, with a 32.9% increase in net product revenue to $12 million. The company achieved a gross margin of 80%, up from 71% in the prior year, and reduced its net loss to $0.6 million. The positive performance is attributed to a restructured cost base and increased demand for Ameluz. Additionally, Biofrontera is advancing its clinical pipeline, including a potential approval for superficial basal cell carcinoma.
Read more →BFRIBiofrontera Inc. to Report Second Quarter 2026 Financial Results on August 13, 2026
Biofrontera Inc. has announced it will report its financial results for the second quarter of 2026 on August 13, 2026. The company specializes in dermatology and markets Ameluz for photodynamic therapy. A conference call will be held on the same day to discuss the results and provide a business update.
Read more →BFRIBiofrontera Inc. to Participate in the Lytham Partners Spring 2026 Investor Conference on May 28, 2026
Biofrontera Inc. will participate in the Lytham Partners Spring 2026 Investor Conference on May 28, 2026. The event will feature a webcast presentation at 11:00 a.m. ET and virtual one-on-one meetings with investors. This engagement highlights Biofrontera's focus on investor relations and its commitment to the biopharmaceutical sector.
Read more →BFRIBiofrontera Inc. Reports First Quarter 2026 Financial Results and Provides a Business Update
Biofrontera Inc. reported a 17% increase in revenues for Q1 2026, reaching $10.1 million. The company also saw improvements in gross margins, which rose to approximately 80%. Despite an operating loss of $4.3 million, Biofrontera announced positive results from its Phase 3 and Phase 2b clinical trials, and regained compliance with Nasdaq listing requirements. The company is focused on achieving sustained profitability and growth.
Read more →BFRIBiofrontera Launches Second Annual “Hats On” Campaign to Raise Awareness of Actinic Keratosis
Biofrontera has launched its second annual 'Hats On' campaign to raise awareness of actinic keratosis (AK) from May 18-24, 2026. This social media initiative encourages participants to wear hats and share photos to highlight the importance of sun protection. With over 58 million Americans affected by AK, the campaign aims to promote preventive measures against skin cancer.
Read more →BFRIBiofrontera Inc. to Report First Quarter 2026 Financial Results and Host a Conference Call on May 14, 2026
Biofrontera Inc. will announce its financial results for Q1 2026 on May 14, 2026, after market close. The company will also conduct a conference call at 11:00 a.m. ET to discuss these results and provide a business update. Biofrontera specializes in photodynamic therapy for dermatological conditions.
Read more →BFRIBiofrontera Inc. Reports Record Fourth Quarter and Full Year 2025 Financial Results and Provides a Business Update
Biofrontera Inc. reported record financial results for the fourth quarter and full year of 2025, reflecting significant revenue growth and improved operating metrics. The company achieved revenues of $17.1 million in Q4 2025, a 36% increase from the previous year, and transitioned to a more favorable cost structure with gross margins rising to 82.4%. Additionally, Biofrontera showcased positive results from its Phase 2b clinical trial for acne treatment and a supportive FDA review of its supplemental new drug application. Despite some continued losses, the company expressed optimism about sustained profitability in the upcoming years.
Read more →BFRIBiofrontera Inc. Reports Positive Phase 2b Results Supporting Further Development of Ameluz® Photodynamic Therapy for moderate to severe Acne Vulgaris
Biofrontera Inc. announced positive results from its Phase 2b trial of Ameluz® PDT for moderate to severe acne vulgaris. The study demonstrated greater reductions in inflammatory lesions compared to a vehicle gel, with a 3-hour incubation regimen showing the most promise. The company plans to present these findings to the FDA in Q3 2026 to discuss further development.
Read more →BFRIBiofrontera Inc. to Report Fourth Quarter and Full Year 2025 Financial Results and Host a Conference Call on March 19, 2026
Biofrontera Inc. announced that it will report its financial results for the fourth quarter and full year of 2025 on March 19, 2026, after the market closure. A conference call is scheduled for the same day at 10:00 a.m. ET, where the company will discuss the results and provide a business update. The announcement emphasizes the company's focus on photodynamic therapy (PDT) and its products for treating dermatological conditions.
Read more →BFRIU.S. Patent Office Issues Final Written Decision Finding All Challenged Claims of Sun Pharma’s Patent 11,697,028 To Be Unpatentable
Biofrontera Inc. announced that the U.S. Patent Trial and Appeal Board ruled all challenged claims of Sun Pharma's U.S. Patent No. 11,697,028 as unpatentable. This decision follows Sun Pharma's infringement claims against Biofrontera. The ruling allows Biofrontera to continue its focus on photodynamic therapy development without the burden of this patent. Sun Pharma may appeal the decision.
Read more →BFRI▲ +6.6%on this news· ran to +19% by day 1
Biofrontera Inc. Announces Database Lock of Phase 1 Pharmacokinetics Study of Ameluz® for Actinic Keratoses on Trunk and Extremities
Biofrontera Inc. has announced the database lock of its Phase 1 pharmacokinetics study for Ameluz®, aimed at treating actinic keratoses on the trunk and extremities. The study's data, alongside positive Phase 3 results, will support a supplemental New Drug Application to the FDA for expanding treatment indications. This could allow for broader treatment areas, enhancing Ameluz®'s market potential.
Read more →BFRIBiofrontera Announces FDA Filing Acceptance of Supplemental New Drug Application for Ameluz® PDT in Superficial Basal Cell Carcinoma
Biofrontera Inc. announced that the FDA has accepted its supplemental New Drug Application for Ameluz® in treating superficial basal cell carcinoma (sBCC). The FDA identified no deficiencies in the filing and set a PDUFA target action date of September 28, 2026. If approved, this will expand Ameluz®'s use beyond actinic keratosis, addressing a significant unmet medical need.
Read more →BFRIBiofrontera Announces Positive Results in Phase 3 Study of Ameluz® PDT for Actinic Keratoses on the Extremities, Neck, and Trunk, Meeting Primary Endpoint
Biofrontera Inc. announced positive results from its Phase 3 clinical trial of Ameluz® PDT for treating actinic keratoses on the extremities, neck, and trunk. The study showed a significant complete clearance rate of 45.6% for Ameluz® compared to 16.7% for the vehicle. The company plans to submit a supplemental New Drug Application to the FDA in Q3 2026.
Read more →BFRIBiofrontera Inc. Announces Record Preliminary Fourth Quarter 2025 Revenues between $17.0 Million and $17.5 Million, Representing Approximately 35% Year-Over-Year Growth
Biofrontera Inc. announced preliminary revenue results for Q4 2025, projecting revenues between $17.0 million and $17.5 million, marking a record high for the company. The anticipated year-over-year growth for Q4 is approximately 35%. The full year revenue is expected to be between $41.5 million and $42.0 million, reflecting an 11% to 13% increase. The company attributes its success to strong execution and customer engagement.
Read more →BFRIBiofrontera Inc. Announces Data Base Locks for Two Clinical Studies Supporting Key Data and Regulatory Milestones
Biofrontera Inc. has successfully locked the databases for two clinical studies evaluating Ameluz® PDT, marking a significant milestone ahead of expected data and regulatory events in 2026. The studies focus on treating actinic keratosis and moderate to severe acne vulgaris. Data is anticipated in February 2026, with plans for regulatory submissions based on positive outcomes.
Read more →BFRI▲ +5.6%on this news
Biofrontera Inc. Completes Transfer of Ameluz and RhodoLED FDA approval and Associated Intellectual Property Portfolio
Biofrontera Inc. has successfully completed the transfer of FDA approvals for Ameluz and the RhodoLED Lamp Series, including associated intellectual property rights. The move includes the assignment of 11 granted US patents and 10 pending patent applications, enhancing the company's regulatory control. Furthermore, Biofrontera has initiated applications for 19 international patents. This strategic transfer, which follows a recent $11.0 million investment, positions the company to independently manage clinical development and marketing operations for their products in the US.
Read more →BFRILast Patient Completes Biofrontera’s Phase 1 Pharmacokinetics Study of Ameluz® for Treatment of Actinic Keratoses on the Trunk and Extremities
Biofrontera Inc. has completed its Phase 1 pharmacokinetics study of Ameluz® for treating actinic keratoses on non-facial areas. The study's completion is a crucial step towards a supplemental New Drug Application to the FDA, aimed at expanding the drug's label. If approved, this could significantly benefit patients suffering from actinic keratoses.
Read more →About Biofrontera Inc.
Headquarters120 PRESIDENTIAL WAY,, WOBURN, MA, 01801
Founded2015
BIOPHARMAWATCH ELITE PLUS
Trade the next BFRI catalyst before the market reprices
Every FDA decision, PoA score, 13F move and dilution flag on this page, for 1,100+ biotech tickers. From $19/mo billed annually.
Cancel anytime