Biofrontera Inc (BFRI)

Biofrontera Reports Positive Phase 3 Data for Ameluz in Actinic KeratosisFebruary 9, 2026 9:39 AM
IH Market News
Biofrontera Inc. (NASDAQ:BFRI) said on Monday that its Phase 3 clinical study of Ameluz photodynamic therapy (PDT) successfully achieved its primary endpoint in the treatment of actinic keratoses affecting the extremities, neck and trunk. Despite the encouraging trial outcome, shares of the micro-cap company—currently trading around $0.82 and valued at roughly $9.56 million—have fallen 8.37% over the past week.The multicenter, randomized, double-blind trial enrolled 172 patients and showed complete clearance in 45.6% of those treated with Ameluz PDT, compared with 16.7% in the vehicle PDT group, a difference that was statistically significant (p

BFRI news ... Biofrontera Announces Positive Results in Phase 3 Study of Ameluz® PDT for Actinic Keratoses on the Extremities, Neck, and Trunk, Meeting Primary Endpoint
https://finance.yahoo.com/news/biofrontera-announces-positive-results-phase-141500130.html

Anyone know the share structure 

Buys 104k/sells 43k ,looks like loading going on
https://investorshub.advfn.com/stock-market/NASDAQ/biofrontera-BFRI/trades

Watching close for breakout and golden cross,had a restructuring and future looking better,fda/and trials news coming(any news could see a nice up move )

BFRI...........................https://stockcharts.com/h-sc/ui?s=BFRI&p=W&b=5&g=0&id=p86431144783

BFRI, new 52 WEEK LOW

BFRI under $2

BFRI.............https://stockcharts.com/h-sc/ui?s=BFRI&p=W&b=5&g=0&id=p86431144783

Not bad $1.46 +
22%

BFRI....................................https://stockcharts.com/h-sc/ui?s=BFRI&p=W&b=5&g=0&id=p86431144783

BFRI..................https://stockcharts.com/h-sc/ui?s=BFRI&p=W&b=5&g=0&id=p86431144783

$1.21 02:22 PM EST, 11/22/2024 (MT Newswires) -- Biofrontera (BFRI) shares jumped nearly 13% in recent Friday trading after the company raised $4.2 million from a private placement of a senior secured convertible note with its principal shareholders.

Running it good results phase 3 in October 

OK, I picked up the 94s, now going after some 87s. It looks like the earnings report changed from November 11 to November 13 OK either way we only have a few days to bottom feed 

With a lack of volume, and the technical is getting weaker, I am going to put in a buy at $.94. Also with BFRI going over a dollar yesterday And closing over a dollar. We are no longer in our 30 day window for NASDAQ compliance of being under a dollar. 💵 yay remember earnings is scheduled for 11 seven aftermarket closes. So trade accordingly I believe they're going to beat the street

Defending that 1.11 beautifully!

$BFRI

Hold 1.11 please could see a stop loss raid happen to steal shares from the weak minded a juke move to the dollar sub $1.00 area is possible lets hope not. Either way you have some relentless bears trying to the pin the stock down. Patience and Long term perspective =success. Great product dismal management team.


$BFRI

The lawsuit is in process I don't know much about it. Honestly not that concerned about it. It might tweak their earnings a little bit with the $5 million spend between BFRI and their subsidiary. They have about some cash not much would like to see a private placement and not offering at this time. Holding 225k shares not one of my core positions but it's free would like to see it hold 1.11 area for now.

I have called the company and told them to put up a Business Presentation if anyone else would like to call and suggest them to create one that would be great.
phone 781-245-1325 Not that impressed with the executive team but that's OK they have a product that works! I also don't understand the guy from Bench mark on their Board of Directors seems un ethical John J Borer what a dweeb. Company needs to do some house cleaning.

Hermann Lübbert | Biofrontera LOL



$BFRI

What's nice is this is old news it is from July and with over $150 million being traded today I don't believe any of the smart money is worried.

Biofrontera AG has been sued by a USA competitor with the argument that Biofrontera infringes some competitors' lamps patents.

https://www.biofrontera.com/en/investors/financial-announcements/ad-hoc-news/pta-adhoc-biofrontera-ag-legal-dispute-on-import-in-the-usa-and-resulting-revised-outlook

Need to get this lawsuit Resolved a competitor is suing Biofronteria just stumbled across this from a friend of mine. I'm riding free shares houses money significant amount but I believe a Buyout or Merger happens soon. Not that concerned about this will hold until buyout or Merger.

Biofrontera AG: Legal dispute on import in the USA and resulting revised outlook



Public disclosure of inside information according to article.

Leverkusen, Germany (pta008/21.07.2024/14:45) - Biofrontera AG has been sued by a USA competitor with the argument that Biofrontera infringes some competitors' lamps patents.

The competitor has filed two different processes, one for two patent infringements in front of the district court, and a second one before the ITC (International Trade Commission), aiming to prohibit the import in the USA of Biofrontera XL Lamp.

Biofrontera has requested initial legal advice and is currently in the process of evaluating its legal position. Biofrontera AG and its subsidiaries have signed a jointly defense agreement with Biofrontera Inc, to share legal expenses.

Costs for the ITC legal proceedings are expected to amount to US$5 million, to be shared between to two companies. The outlook for the business year 2024 needs to be revised as a result. ?Currently the company is about to establish the effects and will inform about a new outlook once there is more clarity about the situation.

(end)

emitter: Biofrontera AG
address: Hemmelrather Weg 201, 51377 Leverkusen
country: Germany
contact person: Investor Relations
phone: +49 (0) 214 87 63 20
e-mail: ir@biofrontera.com
website: www.biofrontera.com

Still expecting new 52 week highs!

$BFRI

1.44s 

1.51s what a dump 118mil volume 

BFRI..........................https://stockcharts.com/h-sc/ui?s=BFRI&p=W&b=5&g=0&id=p86431144783

dont think we will see a offering this week but next week i give it 80% it coming 

watch out for a offering 

problem is they need cash 

Very nice congrats TechandBio! Gave you a follow/member mark)! ➕️
This stock just came to my attention today, but I've already made some 💲 and if it dips, I'm ready to add some more!
That's how its done don't question the authority! Got to see the angles BEFORE they are Played! another jackpot hit when the clown market makers where playing games I loaded 450k shares the last 3 weeks before the Boom!

Wait for $2.22+ for continuation to the upside could see new 52 week highs 5.23 if that resistance level breaks in the 2.20+ area to the upside. Holding 225k shares houses money I school these clown MM all day . Call me Daddy Buy out in the works IMO!

$BFRI

That's how its done don't question the authority! Got to see the angles BEFORE they are Played! another jackpot hit when the clown market makers where playing games I loaded 450k shares the last 3 weeks before the Boom!

Wait for $2.22+ for continuation to the upside could see new 52 week highs 5.23 if that resistance level breaks in the 2.20+ area to the upside. Holding 225k shares houses money I school these clown MM all day . Call me Daddy Buy out in the works IMO!

$BFRI

Sold some for $1.80 - $2.00 and bought some more back at $1.61 and $1.65 😃
Let's see what happens in the coming weeks and months etc.
Holding long!

$BFRI 🚀

Wow! Bought some this morning ($0.90 on average). Look at that!😃
Over $2 already!

Biofrontera Inc. Announces Highly Significant Results In Phase 3 Study Of Ameluz®-Photodynamic Therapy (PDT) Regarding The Treatment Of Superficial Basal Cell Carcinoma (sBCC)

https://ih.advfn.com/stock-market/NASDAQ/biofrontera-BFRI/stock-news/94815772/biofrontera-inc-announces-highly-significant-resu

$BFRI 🚀

great call 

dont they need $$$$$ 
offering could come 

The company achieving profitability in first half 2025. This will be further supported by the label change of Ameluz for the use of up to three tubes per treatment from one Tube approved by the FDA with a user fee goal of October 4, 2024.”
Approved for Actinic Keratosis. 13 million patients population.
Approvals coming for Basil Cell & Basal Cell Carcinoma Phase 3
Acne coming
1.3 Million Floating shares 67% owned by Insiders and institutions 5 Million market cap
Wildly undervalued
https://www.healio.com/news/dermatology/20241007/fda-approves-increase-of-ameluz-dosing-from-one-to-three-tubes-for-actinic-keratosis
Ameluz topical gel 10% (aminolevulinic acid hydrochloride, Biofrontera Inc.) is currently the only FDA-approved AK medication for both lesion-directed and field-directed treatment of actinic keratosis. Since AK may affect many areas of both the face and scalp, this approval allows for patients with AK who are undergoing the use Ameluz on larger surface areas and multiple sites.

Typical movement and manipulation before a buyout takes place shaking the tree. I added a lot of shares last 2 weeks and have many friends buying shares one of them wants to buy the company he is a British financier and investor who has bought dozens of companies in Europe and the USA..

$BFRI

Buyout Merger in the works! You can make Book on That!


https://us.ameluz.com/

https://www.biofrontera-us.com/research/product-pipeline

Basil Cell & Squamous cell carcinoma indication coming soon and Acne not that far behind.

$BFRI

I hope you are right

This is gonna move like $DRUG. 

Big $ is going to send this soon! Book it!
Multiple Skin cancer FDA approved drugs and deep late stage pipeline.
Cash flow positive near term with big drug indications coming to market!
Parabolic move is on the horizon.
2.5 Million floating shares nearly 70% owned by insiders and institutions 4 million dollar market

$BFRI

New 52 week high of $9.00= fair value for just the pipeline today 1100% ROI=45 million dollar market cap

Cash flow positive in the coming months Roth $16.00 Target last week.

They have one of 2 drugs on the market for a patient population of 13 million for pre cancerous legions the 3 tube = $1200 from $400 for 1 tube in one session approval accelerates revenue BFRI has the superior efficacy and safety record.. @ Xepi 2nd FDA approved drug. Never understood the ones who buy stocks after a parabolic move trend is changing.

Phase 3 Squamous cell carcinoma & basal cell carcinoma updates coming soon.

$20.00 price tag is in the cards the revenue next year should climb hence the 1-3 Tubes + in the coming quarters. + Late stage Phase 3's Skin cancer drugs that are safe and effective. Key Cash flow positive soon unheard of for a biotech under 5 million with a deep pipeline and nearing positive cash flow. Send it!

$BFRI

4 & half Million market cap 2.5 million floating the pipeline is worth 10x current price.

Institutions own 35%+
Insiders own 32%

The two FDA approved skin cancer drugs will make the company cash flow positive Q1 next year.

Reminds me of PLSE non revenue co a stock that can go from a $1.00-$20.00 in a blink of an eye.

Roth gave $16.00 PT last week.

Ameluz®

Ameluz® i approved for AK is the second most common diagnosis made by dermatologists in the United States

An estimated 13 million treatments given each year for AK in the US. Only one other drug is approved for this indication and is less effective and has side effects. Revenue should climb substantially after FDA approved 3 tubes in a single patient session instead of 1 tube $1200 instead of $400 not not all patients will need 3 tubes but figure at least half of them will.



Clinical trials must be conducted for further indications to be approved. Which trials are conducted for which new indications is a matter determined in close coordination with the FDA.

In the near future, Biofrontera is aiming for the US approval of Ameluz® for superficial basal cell carcinoma, acne, as well as new indications for actinic keratosis for areas beyond the face and scalp.

https://www.biofrontera-us.com/research/product-pipeline

BF-200 ALA AK: Pharmacokinetics study Completed
BF-200 ALA AK: Safety study for use of 3 tubes ♦ Completed Approved by FDA
BF-200 ALA Superficial basal cell carcinoma ♦ Last patient in
BF-200 ALA Moderate to severe acne ♦ Phase II ongoing
BF-200 ALA AK: Face and scalp with pain-reducing illumination protocol Phase III in preparation
BF-200 ALA AK: Trunk & extremities ♦ Phase III ongoing
BF-200 ALA Squamous cell carcinoma in situ Phase III in preparation

2nd FDA approved drug XEPI® (ozenoxacin) Cream, 1% also approved by the FDA for the Treatment of Impetigo.

Multiple Clinical data updates coming Q4 2024 and Q1 2025

4.4 Million cap potential for 10-20x ROI from this level Cash flow positive early 2025 all outstanding debt has been paid off. The company is turning the corner timing is everything!

$BFRI

Revenue 35.24 Million

Quarterly Revenue Growth 34.00%

The Approval for 3 tubes from 1 tube per patient session will increase revenue drastically by 50%+.
https://finance.yahoo.com/news/fda-approves-three-tubes-biofrontera-124500388.html

Shares Outstanding 5.54M
Market Cap: 4.4 Million
Float 2.62M
% Held by Insiders 32.06%
% Held by Institutions 35.64%
Biofrontera raised an additional $8.0M in May 2024 from the exercise of warrants and has since paid down all outstanding debt

Pipeline Late stage Data updates in Q4 2024

https://www.biofrontera-us.com/research/product-pipeline

BF-200 ALA AK: Pharmacokinetics study Completed
BF-200 ALA AK: Safety study for use of 3 tubes ♦ Completed
BF-200 ALA Superficial basal cell carcinoma ♦ Last patient in
BF-200 ALA Moderate to severe acne ♦ Phase II ongoing
BF-200 ALA AK: Face and scalp with pain-reducing illumination Phase 3
BF-200 ALA AK: Trunk & extremities ♦ Phase III ongoing
BF-200 ALA Squamous cell carcinoma in situ Phase III in preparation

Cash Flow Positive Q1 2025 Tremendous upside potential from these levels at 4.4 Million market cap

$BFRI

2 FDA Approved Skin Cancer drugs.

Cash flow positive in 2025

All outstanding debt paid off.

Deep/Late stage Pipeline .

https://www.biofrontera-us.com/research/product-pipeline

Multiple data updates on the Superficial basal cell carcinoma & Squamous cell carcinoma by year end 2024.

Acne clinical data Q1 2025

$BFRI

$1.80-$2.00 Target 1 could happen in a blink of an eye.

Passes that 10-20x ROI seen these types of move happen dozens of time in 2024

Cash Flow positive in the coming quarters all outstanding debt paid off with a 13 million patient market they have 1 of 2 drugs approved by the FDA for this indication BFRI is more effective and saferr. Revenue 3x with the latest approval this week from 1 to 3 tubes being used in a single treatment each tube is roughly $400 now that translates into $1200 per patient late stage Pipeline alone is worth 10x the current market cap of 4 million! This company could get bought out by a big player pipeline is invaluable Acne and Skin Cancer markets are growing tremendously most drugs in late stage 3. Acne phase 2 70% of the shares are owned by Insiders and institutions



$BFRI

4 hour RSI Relative Strength Index 22.85. Market cap 3.9 Million


FDA approved drug with 13 Million patient market place and best in class RX for Ameluz®-PDT is indicated for the treatment of actinic keratoses (AK), one of the most common precancerous skin conditions. Biofrontera also commercializes the drug Xepi® (ozenoxacin cream, 1%), FDA-approved for the treatment of impetigo.

News on the approval for 3 Tubes instead of 1 for a treatment is a big deal!


WOBURN, Mass., Oct. 07, 2024 (GLOBE NEWSWIRE) -- Biofrontera Inc. (Nasdaq: BFRI) (“Biofrontera” or the “Company”) , a biopharmaceutical company specializing in the commercialization of dermatologic products, today announced that the U.S. Food and Drug Administration (FDA) has approved the Company’s sNDA to increase the maximally approved dosage from one to three tubes of Ameluz ® per treatment.

BFRI Pipeline
https://www.biofrontera-us.com/research/product-pipeline

BF-200 ALA AK: Pharmacokinetics study Completed
BF-200 ALA AK: Safety study for use of 3 tubes ♦ Completed & Approved
BF-200 ALA Superficial basal cell carcinoma ♦ Last patient in Phase 3 (HUGE)
BF-200 ALA Moderate to severe acne ♦ Phase II ongoing. (massive market)
BF-200 ALA AK: Face and scalp with pain-reducing illumination protocol Phase III in preparation. (Niche Market)
BF-200 ALA AK: Trunk & extremities ♦ Phase III ongoing (key segment in skin disorders)
BF-200 ALA Squamous cell carcinoma in situ Phase III in preparation. (Billion dollar market)

This company can move a 1000% a still be undervalued. Roth analyst gave a $16.00 Target this week. Cash flow positive in 2025

Almost 60% shares locked up by insiders and Institutions 35 million in sales 34% YOY growth and 3 Tubes approval this week.


$BFRI

Sponging up shares RSI is extremely oversold!

Buy the fear and make the big $

$ 4 Million Micro cap with FDA approved skin cancer drugs with a deep late stage pipeline!


$BFRI

13 million patients for Ameluz® (aminolevulinic acid hydrochloride)
Topical gel, $1200 for 3 tubes 1st Line Best in class topical only one other drug on the market that has side effects and less effective.

“Up to 60% of squamous cell carcinomas begin as untreated AK lesions, so it’s important for us to be able to treat the entire affected field. I have used Ameluz ® now for more than 7 years for the management of AK because of the demonstrated efficacy and safety it delivers. With the approval of the sNDA, I look forward to being able to use up to three tubes for those patients that need them,” said Dr. Jonathan Weiss, investigator and co-managing partner at Georgia Dermatology Partners in Atlanta.

https://www.biofrontera-us.com/research/product-pipeline

Nearly 60% of the shares held by insiders and institutions revenues should drastically increase from the $1200 cost of 3 tubes the FDA has approved in a singles use compared to 1 tube which ran about $400.00

ROTH gave a $16.00 price target a few days ago Cash flow positive coming quarters!
3 days ago — Roth/MKM analyst Jonathan Aschoff reiterated a Buy rating and $16.00 price target on Biofrontera (NASDAQ: BFRI).

$5.00 gap fill then $10.00+ Way Oversold on the RSI

$50 Million market is in line with their sales and massive growth + pipeline that will be seen in the coming quarters cash flow positive near team. 5 million market cap today.

$BFRI

Ameluz Skin Cancer Prevention prescription +PDT (Photodynamic Therapy)


Micro Float of 2.5 Million I own a decent chunk of the floating shares and will keep adding.

5 Million market cap.

Cash flow positive in the coming quarters deep late stage pipeline with multiple approved FDA drugs.

https://www.biofrontera-us.com/research/product-pipeline

Roth/MKM analyst Jonathan Aschoff reiterated a Buy rating and $16.00 price target on Biofrontera (NASDAQ: BFRI)
https://www.streetinsider.com/Analyst+Comments/RothMKM+Reiterates+Buy+Rating+on+Biofrontera+%28BFRI%29/23809849.html

$BFRI

Multiple suitors looking to acquire This is going to be funny when the buyout is announced!

The late stage pipeline has some very spectacular molecules for skin disease. Profitable Next Year!

Added 71k today on the fake red candle. Going to get aggressive here. Bears are going to get a sharp stick in the eye!


$BFRI

10x is possible here debt scrubbed profitable next year New Board member who is the largest shareholder

2 Million share float insiders and Tutues are up to 57% now



BFRI drug that just got approved for 3 tubes instead of 1 tube for their drug Ameluz

Estimated 13 million treatments given each year.

Each dose of Ameluz 10% topical gel is around $392.

Maximum dosage units is approximately $1,176.

That's a potential of 10 million additional units per treatment.


BF-200 ALA AK: Pharmacokinetics study Completed
BF-200 ALA AK: Safety study for use of 3 tubes ♦ Completed
BF-200 ALA Superficial basal cell carcinoma ♦ Last patient in
BF-200 ALA Moderate to severe acne ♦ Phase II ongoing
BF-200 ALA AK: Face and scalp with pain-reducing illumination protocol Phase III in preparation
BF-200 ALA AK: Trunk & extremities ♦ Phase III ongoing
BF-200 ALA Squamous cell carcinoma in situ Phase III in preparation