Forte Biosciences, Inc. (FBRX - Free Report) announced that the mid-stage study of its lead product candidate FB-401, which is being evaluated for the treatment of atopic dermatitis, was not successful. Consequently, the company will not advance the study any further.
Shares of this clinical-stage biopharmaceutical company have plunged significantly following the above-mentioned announcement.
FB-401 is a topical live biotherapeutic, which was being developed to treat inflammatory skin diseases
Top-line data from the phase II study of FB-401 failed to meet statistical significance for the primary endpoint of EASI-50 (the proportion of patients with at least 50% improvement in atopic dermatitis disease severity as measured by EASI).
It is important to note that the main goal of EASI-50 was achieved by 58% of the subjects who were administered FB-401 compared with 60% of the enrollees on placebo (p=0.7567).
Nevertheless, positive trends were observed in respect of the key secondary endpoints including EASI-90 with 27.6% of volunteers in the active arm achieving the goal while 20.5% experienced the same in the control arm (p=0.3075).
FB401 was developed in collaboration with the National Institutes of Health (NIH) and the National Institute of Allergy and Infectious Diseases (NIAID). The FDA granted a Fast Track Designation to FB-401 for the treatment of atopic dermatitis.
The company previously reported that it had cash and cash equivalents of $50.8 million as of Jun 30, 2021. It expects to provide investors with an update on its future plans over the next few months.
We note that Sanofi (SNY - Free Report) and Regeneron’s (REGN - Free Report) Dupixent is approved for atopic dermatitis. Incyte (INCY - Free Report) is also evaluating the ruxolitinib cream for the treatment of atopic dermatitis. Ruxolitinib cream is a proprietary formulation of Incyte’s selective JAK1/JAK2 inhibitor ruxolitinib that was designed for a topical application. However, the company announced that the FDA extended the review period for the cream’s New Drug Application (NDA) by three months.
Forte currently has a Zacks Rank #4 (Sell).
You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
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Forte Biosciences, Inc. (FBRX - Free Report) announced that the mid-stage study of its lead product candidate FB-401, which is being evaluated for the treatment of atopic dermatitis, was not successful. Consequently, the company will not advance the study any further.
Shares of this clinical-stage biopharmaceutical company have plunged significantly following the above-mentioned announcement.
FB-401 is a topical live biotherapeutic, which was being developed to treat inflammatory skin diseases
Top-line data from the phase II study of FB-401 failed to meet statistical significance for the primary endpoint of EASI-50 (the proportion of patients with at least 50% improvement in atopic dermatitis disease severity as measured by EASI).
It is important to note that the main goal of EASI-50 was achieved by 58% of the subjects who were administered FB-401 compared with 60% of the enrollees on placebo (p=0.7567).
Nevertheless, positive trends were observed in respect of the key secondary endpoints including EASI-90 with 27.6% of volunteers in the active arm achieving the goal while 20.5% experienced the same in the control arm (p=0.3075).
FB401 was developed in collaboration with the National Institutes of Health (NIH) and the National Institute of Allergy and Infectious Diseases (NIAID). The FDA granted a Fast Track Designation to FB-401 for the treatment of atopic dermatitis.
The company previously reported that it had cash and cash equivalents of $50.8 million as of Jun 30, 2021. It expects to provide investors with an update on its future plans over the next few months.
We note that Sanofi (SNY - Free Report) and Regeneron’s (REGN - Free Report) Dupixent is approved for atopic dermatitis. Incyte (INCY - Free Report) is also evaluating the ruxolitinib cream for the treatment of atopic dermatitis. Ruxolitinib cream is a proprietary formulation of Incyte’s selective JAK1/JAK2 inhibitor ruxolitinib that was designed for a topical application. However, the company announced that the FDA extended the review period for the cream’s New Drug Application (NDA) by three months.
Forte currently has a Zacks Rank #4 (Sell).
You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
Zacks Naming Top 10 Stocks for 2024
Want to be tipped off early to our 10 top picks for the entirety of 2024?
History suggests their performance could be sensational.
From 2012 (when our Director of Research, Sheraz Mian assumed responsibility for the portfolio) through November, 2023, the Zacks Top 10 Stocks gained +974.1%, nearly TRIPLING the S&P 500’s +340.1%. Now Sheraz is combing through 4,400 companies to handpick the best 10 tickers to buy and hold in 2024. Don’t miss your chance to get in on these stocks when they’re released on January 2.
Be First to New Top 10 Stocks >>
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