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Brickell Biotech, Inc. (BBI) is a clinical-stage pharmaceutical company dedicated to developing innovative and differentiated prescription therapeutics for debilitating skin diseases. With a primary focus on its lead asset, sofpironium bromide, Brickell is targeting the treatment of hyperhidrosis, a condition characterized by excessive sweating.

Brickell's executive management team and board of directors are seasoned professionals with significant experience in product development and global commercialization. They have previously held leadership roles at major pharmaceutical companies, contributing to the development and launch of successful products such as Cialis®, Taltz®, Gemzar®, Prozac®, Cymbalta®, and Juvederm®.

Brickell's strategic approach involves leveraging its team's vast experience to in-license, acquire, develop, and commercialize distinctive pharmaceutical products. The company aims to address unmet patient needs and bring transformative solutions to the market.

Recent updates indicate that Brickell is strengthening its cash position while exploring strategic options to maximize shareholder value. Additionally, the company plans to make cash distributions to shareholders, estimated to range between $5 million and $7 million, or $0.84 to $1.17 per share, pending shareholder approval and the filing of the certificate of dissolution.

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Brickell Biotech, Inc. (Nasdaq: BBI) announced its plans to report financial results for the third quarter ended September 30, 2021, on November 9, 2021. The conference call will be held at 4:30 PM ET, where management will discuss financial highlights and recent developments. Brickell focuses on developing innovative therapeutics for dermatologic and autoimmune diseases, boasting a late-stage program for hyperhidrosis. The company leverages its experienced executive team to advance its product pipeline aimed at underserved chronic diseases.

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Brickell Biotech, Inc. (Nasdaq: BBI) announced a public offering of 26,316,000 shares of common stock priced at $0.38 per share, expected to raise approximately $10.0 million in gross proceeds. The offering includes a 30-day option for underwriters to purchase an additional 3,947,400 shares. The funds will be allocated for research and development, clinical trials, and general corporate purposes. The offering is set to close on November 1, 2021, subject to customary conditions.

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Brickell Biotech, Inc. (Nasdaq: BBI) has initiated an underwritten public offering of its common stock, aiming to grant underwriters a 30-day option to purchase an additional 15% of shares at the offering price. The net proceeds will be allocated towards research, clinical trials, and general corporate purposes. The offering is contingent on market conditions and is conducted under an effective registration statement with the SEC. William Blair & Company and Oppenheimer & Co. are the joint book-running managers for this offering.

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Brickell Biotech (BBI) announced positive results from its Phase 3 studies for sofpironium bromide gel, 15%, demonstrating significant efficacy in patients with primary axillary hyperhidrosis. The studies, Cardigan I and II, involved over 700 participants and showed that the gel led to a meaningful improvement in sweating symptoms. Looking ahead, Brickell plans to submit a New Drug Application (NDA) to the FDA by mid-2022. The treatment was well-tolerated with a majority of participants completing the study, showing promise as a first-line therapy for hyperhidrosis.

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Brickell Biotech (Nasdaq: BBI) announced a KOL webinar on September 24, 2021, at 10:00 a.m. EDT to discuss DYRK1A's role in autoimmune diseases. Dr. Bernard Khor from Benaroya Research Institute will present the latest findings on this target and its therapeutic potential. Brickell's management will offer updates on their investigational DYRK1A inhibitor platform, particularly the Phase 1-ready BBI-02, aimed at treating autoimmune diseases like atopic dermatitis and rheumatoid arthritis. The webinar will be available on their website, with a replay accessible post-event.

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Brickell Biotech, Inc. (Nasdaq: BBI), a clinical-stage pharmaceutical company, will participate in two virtual investment conferences: the H.C. Wainwright 23rd Annual Global Investment Conference from September 13-15 and Lake Street Partners 5th Annual Best Ideas Growth Conference from September 14-15. CEO Robert Brown will present at the H.C. Wainwright conference starting at 7:00 a.m. ET on September 13. Management will also conduct virtual 1-on-1 meetings throughout the events. Brickell focuses on innovative therapeutics for dermatologic and autoimmune diseases.

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Brickell Biotech has appointed Dr. Monica Luchi as Chief Medical Officer, bringing over 20 years of experience in drug development.

Dr. Luchi's role will focus on clinical strategy and medical affairs, particularly in the company's pipeline expansion for autoimmune diseases.

CEO Robert Brown emphasized her expertise as critical for accelerating the development of their DYRK1A inhibitor platform and upcoming clinical trials, including the Phase 3 data for sofpironium bromide gel, 15%.

Dr. Luchi previously held significant roles in various biopharmaceutical companies, enhancing Brickell's position in the market.

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Brickell Biotech has entered a definitive agreement with Voronoi Inc. to acquire exclusive rights to develop a novel DYRK1A inhibitor platform targeting autoimmune and inflammatory diseases. The lead program, BBI-02, is set to enter Phase 1 clinical trials in 2022, promising a new, effective treatment option. The agreement involves a total payment of $5 million, with additional milestone payments up to $318.5 million. This move is anticipated to enhance Brickell's portfolio and patient impact significantly.

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Brickell Biotech (Nasdaq: BBI) announces the completion of patient visits in the Phase 3 Cardigan studies evaluating sofpironium bromide gel, 15% for primary axillary hyperhidrosis. Topline results are expected in Q4 2021, with a New Drug Application (NDA) submission anticipated in mid-2022, subject to study outcomes. The Cardigan studies involve approximately 700 participants, assessing efficacy and safety through various endpoints, including sweat production and patient-reported outcomes. Sofpironium bromide gel, 5% is already approved in Japan.

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Brickell Biotech (Nasdaq: BBI) announced significant progress in its clinical programs for sofpironium bromide gel, with the final patient completing the Phase 3 Cardigan I study and enrollment finished for Cardigan II. Topline results from both studies are expected in Q4 2021. A recent capital raise of $8.1 million will fund operations beyond a potential NDA submission in mid-2022. Financially, Brickell reported a net loss of $11.1 million for Q2 2021 and $0.2 million in revenue, driven mainly by royalty revenue from Japan.

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FAQ

What is the market cap of BBI (BBI)?

The market cap of BBI (BBI) is approximately 6.8M.

What does Brickell Biotech, Inc. specialize in?

Brickell Biotech, Inc. specializes in developing innovative prescription therapeutics for debilitating skin diseases, with a focus on hyperhidrosis.

What is Brickell Biotech, Inc.'s lead asset?

Brickell's lead asset is sofpironium bromide, aimed at treating hyperhidrosis.

Who are the key members of Brickell Biotech's leadership team?

Brickell's executive management team and board of directors consist of experienced professionals who have held leadership roles at major pharmaceutical companies.

What is the company's strategy for growth?

Brickell aims to leverage its team's experience to in-license, acquire, develop, and commercialize innovative pharmaceutical products to meet unmet patient needs.

Has Brickell Biotech recently made any significant financial moves?

Yes, Brickell has strengthened its cash position and is evaluating strategic options to maximize shareholder value.

What are the planned cash distributions to shareholders?

The company intends to distribute between $5 million and $7 million, approximately $0.84 to $1.17 per share, pending shareholder approval and the filing of the certificate of dissolution.

What notable products have Brickell's leadership previously worked on?

They have contributed to products like Cialis®, Taltz®, Gemzar®, Prozac®, Cymbalta®, and Juvederm®.

What are Brickell Biotech's recent achievements?

Recent achievements include strengthening their cash position and planning cash distributions to shareholders.

What are the focus areas for Brickell's R&D efforts?

Brickell focuses on developing therapeutics for debilitating skin diseases, particularly targeting hyperhidrosis.

How does Brickell Biotech plan to transform patient care?

By developing innovative and differentiated pharmaceutical products that address currently unmet patient needs.

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6.75M
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