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MCap 13m ,has FDA Decision in September ,take a look at their pipeline below . Thisvery cheap low float stock could run to 5dollar or more even before FDA Decision .
Announced FDA's completion of its filing review and filing acceptance of the Company's supplemental New Drug Application (sNDA) for Ameluz® PDT for the treatment of superficial basal cell carcinoma (sBCC), with a PDUFA target action date of September 28, 2026.
BFRI, new 52 WEEK LOW
BFRI under $2
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
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
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!
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 🚀
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
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
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
Ameluz Skin Cancer Prevention prescription +PDT (Photodynamic Therapy)
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
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Meta (NASDAQ:META) launched a new open-weight artificial intelligence model on Monday as CEO Mark Zuckerberg called for the United States to reduce barriers facing domestic developers in order to compete more effectively with Chinese rivals. The new model, called Muse Glimmer, is considerably smaller than the flagship AI systems developed by leading competitors. Rather than […]
