Biofrontera Inc. (BFRI) has experienced a decline of 1.14% in the aftermarket. However, the last trading session closed at $7.9 with an increase of 51.34%.
BFRI to report Third Quarter Results 2021 – What’s the schedule?
BFRI announced on 23rd November 2021 that the company will report the third quarter 2021 results on 30th November 2021 before the market opens. Moreover, BFRI will also hold a conference that will begin at 4.30 p.m. ET on the same day. The team will discuss the quarter results in the meeting.
US Clinical Study Program for Ameluz – What’s going on?
On 16th November 2021, BFRI announced the launch of a clinical trial program in the United States to optimize and increase the market positioning of its in-licensed FDA-approved prescription medication Ameluz for photodynamic treatment (PDT). Patient enrollment will begin before the end of the year, and site initiations for two subsequent trials are now underway. Moreover, BFRI buys Ameluz from the Licensor in exchange for a transfer fee under the provisions of the LSA.
The Licensor secures the manufacturing and distribution of the in-licensed goods, as well as accountability for certain other factors such as regulatory clearances and quality assurance. Furthermore, the LSA requires the Licensor to conduct and fund a large-scale clinical research program. This will broaden AmeluzFDA’s clearance in the US market.
What’s next?
The phase IIb trial for the therapy of modest acne in adults is presently recruiting sites. A maximal-usage pharmacokinetics clinical investigation was finished in early 2021. Along with the Licensor’s ongoing phase III research in the United States to test Ameluz® in conjunction with PDT for the treatment of superficial basal cell carcinoma, the recent site initiations signal the start of the LSA’s extended study program.
About BFRI
Biofrontera Inc. (BFRI) is a biopharmaceutical firm established in the United States. It develops and markets pharmaceuticals for the treatment of dermatological disorders, with a focus on photodynamic therapy (PDT) and topical antibiotics. Lastly, BFRI’s approved medications treat the actinic keratoses and impetigo.
