Biofrontera Inc. (BFRI)
eröffnet am 29.12.21 23:35:38 von
neuester Beitrag 02.02.24 16:38:08 von
neuester Beitrag 02.02.24 16:38:08 von
Beiträge: 30
ID: 1.355.960
ID: 1.355.960
Aufrufe heute: 1
Gesamt: 4.440
Gesamt: 4.440
Aktive User: 0
ISIN: US09077D1000 · WKN: A3C6YA · Symbol: BFRI
0,5400
USD
+3,85 %
+0,0200 USD
Letzter Kurs 03.07.23 Nasdaq
Neuigkeiten
Werte aus der Branche Biotechnologie
| Wertpapier | Kurs | Perf. % |
|---|---|---|
| 1,9000 | +59,66 | |
| 4,7450 | +35,57 | |
| 23,050 | +19,74 | |
| 0,5250 | +19,08 | |
| 1,9700 | +15,20 |
| Wertpapier | Kurs | Perf. % |
|---|---|---|
| 11,820 | -12,18 | |
| 8,0100 | -12,85 | |
| 1,9500 | -25,14 | |
| 1,6052 | -30,21 | |
| 0,5121 | -30,80 |
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Biofrontera Inc. Announces $4.5 Million Registered Direct Offering Priced At-the-market Under NASDAQ Rules
https://investors.biofrontera-us.com/full-news/?qm-storyId=4…
WOBURN, MA / ACCESSWIRE / October 31, 2023 / Biofrontera Inc. (NASDAQ:BFRI) ("Biofrontera" or the "Company"), a biopharmaceutical company specializing in the commercialization of dermatologic products, entered into a securities purchase agreement with a certain institutional investor, pursuant to which the Company agreed to issue and sell to the investor an aggregate of 1,205,000 shares of its common stock (or common stock equivalents in lieu thereof) and warrants to purchase an aggregate of up to 1,807,000 shares of Common Stock, at an exercise price of $3.55 per share of Common Stock.
The warrants are exercisable immediately upon issuance and will expire five years following the date of issuance. The Company also agreed to adjust the strike price of 385,236 outstanding warrants held by the investor to $3.55. The offering is expected to close on or about November 2, 2023, subject to customary closing conditions.
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Biofrontera Inc. Announces Positive Results from Phase 1 Safety Study Evaluating Photodynamic Therapy with Three Tubes of Ameluz(R)
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WOBURN, MA / ACCESSWIRE / August 28, 2023 / Biofrontera Inc. (NASDAQ:BFRI) (the "Company"), a biopharmaceutical company specializing in the commercialization of dermatological products, announces positive topline results from its non-randomized, open-label, multicenter Phase 1 study evaluating the safety and tolerability of 3 entire tubes of BF-200 ALA (Ameluz®) in the treatment of actinic keratosis (AK) on the face and scalp with photodynamic therapy (PDT) using the RhodoLED® XL lamp.
Of the 100 patients treated in 9 participating clinical centers, the incidences of Treatment Emergent Adverse Events (TEAEs) were consistent with the TEAEs listed in the US prescribing information (US PI) that are based on studies with 1 tube. The treatment was generally well tolerated and TEAEs were as expected due to the therapeutic principle of photodynamic therapy. All TEAEs were transient. In most cases, they resolved within 1 to 4 days after PDT, but occasionally persisted for 1 to 2 weeks or in a few cases even longer, similar to the TEAEs observed after single-tube PDT. No Serious Adverse Events (SAEs), deaths or other clinically relevant AEs were reported during the study and no subject discontinued the study due to a TEAE.
With results demonstrating no additional safety or tolerability issues with 3 tubes, Biofrontera Inc. intends to present these findings to the U.S. Food and Drug Administration (FDA) during the fourth quarter of this year.
This Phase 1 study, conducted by Biofrontera Bioscience GmbH, follows a maximal-usage pharmacokinetics study presented to the FDA in 2021, upon which the FDA requested another safety study focusing on transient side effects before amending the product information, which currently limits use to one tube of Ameluz® per treatment.
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WOBURN, MA / ACCESSWIRE / August 28, 2023 / Biofrontera Inc. (NASDAQ:BFRI) (the "Company"), a biopharmaceutical company specializing in the commercialization of dermatological products, announces positive topline results from its non-randomized, open-label, multicenter Phase 1 study evaluating the safety and tolerability of 3 entire tubes of BF-200 ALA (Ameluz®) in the treatment of actinic keratosis (AK) on the face and scalp with photodynamic therapy (PDT) using the RhodoLED® XL lamp.
Of the 100 patients treated in 9 participating clinical centers, the incidences of Treatment Emergent Adverse Events (TEAEs) were consistent with the TEAEs listed in the US prescribing information (US PI) that are based on studies with 1 tube. The treatment was generally well tolerated and TEAEs were as expected due to the therapeutic principle of photodynamic therapy. All TEAEs were transient. In most cases, they resolved within 1 to 4 days after PDT, but occasionally persisted for 1 to 2 weeks or in a few cases even longer, similar to the TEAEs observed after single-tube PDT. No Serious Adverse Events (SAEs), deaths or other clinically relevant AEs were reported during the study and no subject discontinued the study due to a TEAE.
With results demonstrating no additional safety or tolerability issues with 3 tubes, Biofrontera Inc. intends to present these findings to the U.S. Food and Drug Administration (FDA) during the fourth quarter of this year.
This Phase 1 study, conducted by Biofrontera Bioscience GmbH, follows a maximal-usage pharmacokinetics study presented to the FDA in 2021, upon which the FDA requested another safety study focusing on transient side effects before amending the product information, which currently limits use to one tube of Ameluz® per treatment.
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Trading Spotlight
13.7.
Biofrontera Inc. Announces Preliminary Second Quarter Revenues are Up 26% to 31%
Management Reaffirms Full-Year 2023 Revenue Growth of at least 25% over Prior Year
https://api.quotemedia.com/supplement/news-story/?webmasterI…
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Biofrontera Inc. (Nasdaq:BFRI) ("Biofrontera" or the "Company"), a biopharmaceutical company specializing in the commercialization of dermatologic products, today announced preliminary unaudited revenues for the three months ended June 30, 2023.
Revenues for the second quarter of 2023 are anticipated to be in the range of approximately $5.7 million to $5.9 million, an increase of approximately 26% to 31% compared with the second quarter of 2022. As a result, revenues for the first half of 2023 are anticipated to be in the range of approximately $14.4 million to $14.6 million, representing growth of approximately 1% to 3% compared with the first half of 2022.
"We are proud of the hard work of our commercial teams, which resulted in year-over-year revenue growth without the benefit of a price increase for Ameluz® as we had in 2022. The revenue trends and record-high second quarter results reflect increasing adoption among dermatologists of photodynamic therapy for the field treatment of actinic keratosis. Of note, our sales force has been successful in securing larger contracts, which will help make our quarterly financial results more predictable. New hires have performed admirably well while the balance of our maturing salesforce is executing to plan," said Hermann Luebbert, Chief Executive Officer and Chairman of Biofrontera Inc.
Biofrontera Inc. affirms its previously announced expectations for full-year 2023 growth in revenue to be at least 25% compared with 2022.
The preliminary unaudited revenues described in this press release are estimates only and are based on currently available information. Final results may vary from the preliminary revenue estimates. Biofrontera Inc. expects to report financial results for the second quarter of 2023 in August 2023. Details concerning that announcement and conference call will be provided in the coming weeks.
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Biofrontera Inc. Announces Preliminary Second Quarter Revenues are Up 26% to 31%
Management Reaffirms Full-Year 2023 Revenue Growth of at least 25% over Prior Year
https://api.quotemedia.com/supplement/news-story/?webmasterI…
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Biofrontera Inc. (Nasdaq:BFRI) ("Biofrontera" or the "Company"), a biopharmaceutical company specializing in the commercialization of dermatologic products, today announced preliminary unaudited revenues for the three months ended June 30, 2023.
Revenues for the second quarter of 2023 are anticipated to be in the range of approximately $5.7 million to $5.9 million, an increase of approximately 26% to 31% compared with the second quarter of 2022. As a result, revenues for the first half of 2023 are anticipated to be in the range of approximately $14.4 million to $14.6 million, representing growth of approximately 1% to 3% compared with the first half of 2022.
"We are proud of the hard work of our commercial teams, which resulted in year-over-year revenue growth without the benefit of a price increase for Ameluz® as we had in 2022. The revenue trends and record-high second quarter results reflect increasing adoption among dermatologists of photodynamic therapy for the field treatment of actinic keratosis. Of note, our sales force has been successful in securing larger contracts, which will help make our quarterly financial results more predictable. New hires have performed admirably well while the balance of our maturing salesforce is executing to plan," said Hermann Luebbert, Chief Executive Officer and Chairman of Biofrontera Inc.
Biofrontera Inc. affirms its previously announced expectations for full-year 2023 growth in revenue to be at least 25% compared with 2022.
The preliminary unaudited revenues described in this press release are estimates only and are based on currently available information. Final results may vary from the preliminary revenue estimates. Biofrontera Inc. expects to report financial results for the second quarter of 2023 in August 2023. Details concerning that announcement and conference call will be provided in the coming weeks.
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Biofrontera Inc. Announces 1-for-20 Reverse Stock Split
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WOBURN, MA / ACCESSWIRE / July 3, 2023 / Biofrontera Inc. (Nasdaq:BFRI) ("Biofrontera" or the "Company"), a biopharmaceutical company specializing in the commercialization of dermatologic products, announces that it will effect a reverse stock split of its outstanding shares of common stock at a ratio of 1-for-20 that will become effective after the close of trading at 11:59 p.m. today.
Biofrontera Inc. common stock will begin trading on Nasdaq on a split-adjusted basis when the market opens on Wednesday, July 5, 2023 under the existing symbol, BFRI, and under a new CUSIP number, 09077D 209.
Upon effectiveness of the reverse stock split, every 20 shares of Biofrontera Inc. common stock issued and outstanding will be automatically combined into one share of common stock. Outstanding equity-based awards and other equity rights will be proportionately adjusted. No fractional shares will be issued as a result of the reverse stock split. Stockholders otherwise entitled to receive a fractional share as a result of the reverse stock split will automatically receive an additional fraction of a share of common stock to round up to the next whole share.
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This reverse stock split is primarily intended to bring the Company into compliance with Nasdaq's minimum bid price requirement for continued listing.
"This reverse stock split, which was approved by our shareholders and authorized by our Board of Directors, should allow Biofrontera to regain compliance with Nasdaq's continued-listing requirements. Additionally, we believe the post-split stock price may make an investment in Biofrontera more attractive to a broader group of investors," commented Hermann Luebbert, Chief Executive Officer and Chairman of Biofrontera Inc.
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WOBURN, MA / ACCESSWIRE / July 3, 2023 / Biofrontera Inc. (Nasdaq:BFRI) ("Biofrontera" or the "Company"), a biopharmaceutical company specializing in the commercialization of dermatologic products, announces that it will effect a reverse stock split of its outstanding shares of common stock at a ratio of 1-for-20 that will become effective after the close of trading at 11:59 p.m. today.
Biofrontera Inc. common stock will begin trading on Nasdaq on a split-adjusted basis when the market opens on Wednesday, July 5, 2023 under the existing symbol, BFRI, and under a new CUSIP number, 09077D 209.
Upon effectiveness of the reverse stock split, every 20 shares of Biofrontera Inc. common stock issued and outstanding will be automatically combined into one share of common stock. Outstanding equity-based awards and other equity rights will be proportionately adjusted. No fractional shares will be issued as a result of the reverse stock split. Stockholders otherwise entitled to receive a fractional share as a result of the reverse stock split will automatically receive an additional fraction of a share of common stock to round up to the next whole share.
...
This reverse stock split is primarily intended to bring the Company into compliance with Nasdaq's minimum bid price requirement for continued listing.
"This reverse stock split, which was approved by our shareholders and authorized by our Board of Directors, should allow Biofrontera to regain compliance with Nasdaq's continued-listing requirements. Additionally, we believe the post-split stock price may make an investment in Biofrontera more attractive to a broader group of investors," commented Hermann Luebbert, Chief Executive Officer and Chairman of Biofrontera Inc.
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12.6.
Biofrontera Inc. Sponsors The Sun Bus, Delivering Free Mobile Skin Cancer Screenings Across the U.S.
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Biofrontera Inc. (Nasdaq:BFRI) ("Biofrontera" or the "Company"), a biopharmaceutical company specializing in the commercialization of dermatologic products, announces its sponsorship of The Sun Bus, a mobile classroom and clinic bringing free skin cancer screenings and public education to communities across the U.S.
The 2023 tour kicked off in March in Colorado and continues through November with stops in Texas, Missouri, Iowa, Wyoming and Arizona. The Sun Bus works with local volunteer dermatology providers and educators at each stop - which includes workplaces, community events and festivals - to provide skin cancer screenings, sun safety education and free sunscreen samples.
"We are proud to partner with Biofrontera as their financial support enables us to bring crucial medical services to those who need it most," said Tamara Terzian, PhD, Executive Director at The Sun Bus. "With their sponsorship, we are driving forward towards a brighter future, ensuring that The Sun Bus continues to be a beacon of hope and health for communities in need."
"Although skin cancer is the most common cancer in the U.S., it also is one of the most preventable with regular screening. At Biofrontera, we're committed to improving the treatment of actinic keratosis (AK) lesions, which are premalignant but may lead to squamous cell carcinoma if left untreated. We're proud to partner with The Sun Bus as we strive to increase awareness of our trusted brand among more dermatologists and patients, and underscore the importance of early screening and preventive actions," said Hermann Luebbert, Chief Executive Officer and Chairman of Biofrontera.
"We have provided free screenings to more than 5,000 people over the past three years and found more than 700 AKs, 130 suspected squamous cell carcinomas and 300 other suspected skin cancers. It is clear that The Sun Bus is providing a vital service to those in our community who are concerned about something growing on their skin," added Karen Nern, MD, MBA, a board-certified dermatologist and Medical Director of The Sun Bus.
About The Sun Bus
The Sun Bus is a mobile clinic that offers a sun safety education experience that hyper-targets select audiences at varying times throughout the year. The program was launched in 2019, attending major community events throughout Colorado with over 700,000 people. Dr. Karen Nern, Medical Director of The Sun Bus, reported that 854 skin cancer screens were performed, and 26,000 people visited the bus to interact with the educational displays, take free sunscreen samples or check out the hats. The 2021 tour expanded to four additional states, adding Arizona, Colorado, New Mexico and Texas, and 2,142 free skin cancer screens were performed. In 2022, over 3,000 skin cancer screens were performed in nine states.
About Actinic Keratosis
Actinic keratosis (AK) is the most common pre-cancerous skin lesion caused by chronic sun exposure that may, if left untreated, develop into life-threatening skin cancer called squamous cell carcinoma. AKs typically appear on sun-exposed areas such as the face, bald scalp, arms or the back of the hands. According to the Skin Cancer Foundation, in the U.S. AK affected approximately 58 million people in 2020 and an estimated 13 million AK treatments were performed.
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Biofrontera Inc. Sponsors The Sun Bus, Delivering Free Mobile Skin Cancer Screenings Across the U.S.
https://api.quotemedia.com/supplement/news-story/?webmasterI…
...
Biofrontera Inc. (Nasdaq:BFRI) ("Biofrontera" or the "Company"), a biopharmaceutical company specializing in the commercialization of dermatologic products, announces its sponsorship of The Sun Bus, a mobile classroom and clinic bringing free skin cancer screenings and public education to communities across the U.S.
The 2023 tour kicked off in March in Colorado and continues through November with stops in Texas, Missouri, Iowa, Wyoming and Arizona. The Sun Bus works with local volunteer dermatology providers and educators at each stop - which includes workplaces, community events and festivals - to provide skin cancer screenings, sun safety education and free sunscreen samples.
"We are proud to partner with Biofrontera as their financial support enables us to bring crucial medical services to those who need it most," said Tamara Terzian, PhD, Executive Director at The Sun Bus. "With their sponsorship, we are driving forward towards a brighter future, ensuring that The Sun Bus continues to be a beacon of hope and health for communities in need."
"Although skin cancer is the most common cancer in the U.S., it also is one of the most preventable with regular screening. At Biofrontera, we're committed to improving the treatment of actinic keratosis (AK) lesions, which are premalignant but may lead to squamous cell carcinoma if left untreated. We're proud to partner with The Sun Bus as we strive to increase awareness of our trusted brand among more dermatologists and patients, and underscore the importance of early screening and preventive actions," said Hermann Luebbert, Chief Executive Officer and Chairman of Biofrontera.
"We have provided free screenings to more than 5,000 people over the past three years and found more than 700 AKs, 130 suspected squamous cell carcinomas and 300 other suspected skin cancers. It is clear that The Sun Bus is providing a vital service to those in our community who are concerned about something growing on their skin," added Karen Nern, MD, MBA, a board-certified dermatologist and Medical Director of The Sun Bus.
About The Sun Bus
The Sun Bus is a mobile clinic that offers a sun safety education experience that hyper-targets select audiences at varying times throughout the year. The program was launched in 2019, attending major community events throughout Colorado with over 700,000 people. Dr. Karen Nern, Medical Director of The Sun Bus, reported that 854 skin cancer screens were performed, and 26,000 people visited the bus to interact with the educational displays, take free sunscreen samples or check out the hats. The 2021 tour expanded to four additional states, adding Arizona, Colorado, New Mexico and Texas, and 2,142 free skin cancer screens were performed. In 2022, over 3,000 skin cancer screens were performed in nine states.
About Actinic Keratosis
Actinic keratosis (AK) is the most common pre-cancerous skin lesion caused by chronic sun exposure that may, if left untreated, develop into life-threatening skin cancer called squamous cell carcinoma. AKs typically appear on sun-exposed areas such as the face, bald scalp, arms or the back of the hands. According to the Skin Cancer Foundation, in the U.S. AK affected approximately 58 million people in 2020 and an estimated 13 million AK treatments were performed.
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Antwort auf Beitrag Nr.: 73.434.465 von faultcode am 08.03.23 22:14:17ominös:
12.5.
Biofrontera Inc. Announces Resignation of CEO -- Executive Chairman Hermann Luebbert to Assume CEO Responsibilities, Reaffirms the Company's Strategic Plan and 2023 Commercial Goals
https://api.quotemedia.com/supplement/news-story/?webmasterI…
12.5.
Biofrontera Inc. Announces Resignation of CEO -- Executive Chairman Hermann Luebbert to Assume CEO Responsibilities, Reaffirms the Company's Strategic Plan and 2023 Commercial Goals
https://api.quotemedia.com/supplement/news-story/?webmasterI…
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