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Brickell Biotech, Inc. (BBI)

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0.5189-0.2012 (-27.94%)
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Previous Close0.7201
Open0.5622
Bid0.0000 x 1200
Ask0.0000 x 1200
Day's Range0.5010 - 0.5900
52 Week Range0.5000 - 3.9800
Volume15,540,752
Avg. Volume2,213,737
Market Cap14.419M
Beta (5Y Monthly)N/A
PE Ratio (TTM)N/A
EPS (TTM)-3.1670
Earnings DateAug 12, 2020
Forward Dividend & YieldN/A (N/A)
Ex-Dividend DateN/A
1y Target Est5.50
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  • Brickell Biotech Announces Pricing of $15.0 Million Underwritten Public Offering
    GlobeNewswire

    Brickell Biotech Announces Pricing of $15.0 Million Underwritten Public Offering

    BOULDER, Colo., Oct. 22, 2020 (GLOBE NEWSWIRE) -- Brickell Biotech, Inc. (“Brickell”) (Nasdaq: BBI), a clinical-stage pharmaceutical company focused on developing innovative and differentiated prescription therapeutics for the treatment of debilitating skin diseases, today announced the pricing of an underwritten public offering of 20,833,322 shares of common stock or common stock equivalents (which includes pre-funded warrants to purchase shares of common stock in lieu of shares of common stock) and investor warrants to purchase up to an aggregate of 20,833,322 shares of common stock. Each share of common stock (or pre-funded warrant in lieu thereof) is being sold together with one, immediately exercisable investor warrant with a five year term to purchase one share of common stock at an exercise price of $0.72 per share. The shares and warrants are being sold at a combined offering price of $0.72, for total gross proceeds of approximately $15.0 million, before underwriting discounts and commissions and offering expenses payable by Brickell. The offering is expected to close on or about October 27, 2020, subject to the satisfaction or waiver of customary closing conditions. Brickell anticipates using the net proceeds from the offering for research and development, including clinical trials, working capital and general corporate purposes.Oppenheimer & Co. Inc. is acting as the sole book-running manager in connection with the offering and Lake Street Capital Markets, LLC is acting as lead manager.The securities will be offered pursuant to a registration statement on Form S-1, as amended (File No. 333-249441), which was declared effective by the Securities and Exchange Commission (the “SEC”) on October 22, 2020. The offering is being made solely by means of a prospectus. A preliminary prospectus relating to and describing the terms of the offering has been filed with the SEC and is available on the SEC’s website at www.sec.gov. Copies of the preliminary prospectus and, when available, copies of the final prospectus relating to this offering can be obtained at the SEC’s website at www.sec.gov or from Oppenheimer & Co. Inc., Attention: Syndicate Prospectus Department, 85 Broad St., 26th Floor, New York, NY 10004, by telephone at (212) 667-8055 or by email at EquityProspectus@opco.com.This press release does not constitute an offer to sell or the solicitation of an offer to buy, nor will there be any sales of these securities in any jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of such jurisdiction.About BrickellBrickell Biotech, Inc. is a clinical-stage pharmaceutical company focused on developing innovative and differentiated prescription therapeutics for the treatment of debilitating skin diseases. Brickell’s pipeline consists of potential novel therapeutics for hyperhidrosis and other prevalent dermatological conditions. Brickell’s executive management team and board of directors bring extensive experience in product development and global commercialization, having served in leadership roles at large global pharmaceutical companies and biotechs that have developed and/or launched successful products, including several that were first-in-class and/or achieved iconic status, such as Cialis®, Taltz®, Gemzar®, Prozac®, Cymbalta® and Juvederm®. Brickell’s strategy is to leverage this experience to in-license, acquire, develop and commercialize innovative products that Brickell believes can be successful in the currently underserved dermatology global marketplace. For more information, visit https://www.brickellbio.com.Cautionary Note Regarding Forward-Looking StatementsAny statements made in this press release relating to our expectations regarding the completion, timing and size of the offering and the anticipated use of net proceeds are forward-looking statements within the meaning of the U.S. Private Securities Litigation Reform Act of 1995. In addition, when or if used in this press release, the words “may,” “could,” “should,” “anticipate,” “believe,” “estimate,” “expect,” “intend,” “plan,” “predict” and similar expressions and their variants, as they relate to Brickell, may identify forward-looking statements. Brickell cautions that these forward-looking statements are subject to numerous assumptions, risks, and uncertainties, which change over time, often quickly and in unanticipated ways. Important factors that may cause actual results to differ materially from the results discussed in the forward-looking statements or historical experience include risks and uncertainties, including without limitation, market conditions and the satisfaction of customary closing conditions related to the offering, ability to obtain adequate financing to advance product development, ability to maintain and enforce intellectual property rights, potential delays for any reason in product development, regulatory changes, unsuccessful clinical trials, unanticipated demands on cash resources, any disruption to our business caused by the current COVID-19 pandemic, interruptions, disruption or inability to launch and commercialize the product by Kaken in Japan, or obtain adequate pricing, and other risks associated with developing and obtaining regulatory approval for and commercializing product candidates.Further information on the factors and risks that could cause actual results to differ from any forward-looking statements are contained in Brickell’s filings with the United States Securities and Exchange Commission (SEC), which are available at https://www.sec.gov (or at https://www.brickellbio.com). The forward-looking statements represent the estimates of Brickell as of the date hereof only, and Brickell specifically disclaims any duty or obligation to update forward-looking statements.Brickell Investor Contact: Dan Ferry LifeSci Advisors (617) 430-7576 daniel@lifesciadvisors.com

  • Oppenheimer: These 2 Stocks Are Poised to Surge by Over 100%
    TipRanks

    Oppenheimer: These 2 Stocks Are Poised to Surge by Over 100%

    When it comes to the market’s wild swings, is the glass half empty or half full? Oppenheimer’s chief investment strategist John Stoltzfus is taking the latter view.Despite the volatility that has ruled the market over the last few weeks, Stoltzfus actually likes what he’s witnessing in both the market and the economy. In particular, he points to U.S. companies that have been outperforming most other markets around the world as exciting plays, with the innovation in the U.S. reflecting a key component of his bullish thesis.“The U.S. is outperforming most of the markets around the world — whether it’s developed markets or emerging markets... We’ve taken out the froth that had come into the market in certain [mega cap] names. It may be a good opportunity to pick up some really good, high quality growth stories that are on sale right now,” Stoltzfus noted.Additionally, the strategist believes the S&P 500 could climb back to its September 2 high point, based on improving economic data. The approval of a COVID-19 vaccine as well as an election outcome that is “friendly to the domestic economy, business, job growth and the taxpayer” could also push the index higher.Turning Stoltzfus’ outlook into tangible recommendations, Oppenheimer analysts are pounding the table on two stocks, with these pros seeing over 100% upside potential in store. Running the tickers through TipRanks’ database, we wanted to find out exactly what makes them so compelling.Brickell Biotech (BBI)Focused on the development of innovative and differentiated therapeutics for the treatment of skin diseases, Brickell Biotech wants to improve the lives of patients everywhere. Given the potential of the company's lead candidate and its $0.82 share price, Oppenheimer thinks that now is the time to pull the trigger.Sofpironium bromide (SB), a prescription treatment for axillary hyperhidrosis (AH, or excessive underarm sweating), is entering U.S. Phase 3 trials. This program will consist of two identical six-week studies, and will evaluate its ability to improve the condition per the objective (gravimetric sweat production) and subjective (HDSM-Ax) co-primary endpoints. Each is expected to last 12 months, and the first will kick off next quarter.Roughly 10 million people in the U.S. suffer from AH, with this condition interfering with daily social and professional activities. Currently, only 2.3 million receive prescription treatment, and some resort to invasive or permanent interventions like Botox, MiraDry or surgery.Oppenheimer’s Leland Gershell argues that more conservative approaches could be used to meet these medical needs. He also believes the recent entry of Eli Lilly’s competing product, Qbrexza, represents a significant step forward. That said, there’s “room for improvement” with this anti-cholinergic approach.Looking at a U.S. Phase 2b trial, the highest dose of BBI's SB gel (15%) demonstrated 46% greater sweat reduction per gravimetric analysis compared to the placebo, with significant reductions in a validated patient-reported outcome instrument seen at all doses. Based on the trial data, efficacy is over 50% better than Qbrexza per label, despite higher baseline severity. In addition, their safety profiles were relatively similar.It should be noted that BBI will market the drug to U.S. dermatologists through a specialty salesforce of 120 representatives. According to Gershell’s estimates, uptake by 110,000 patients per year (just 5% of the currently treated AH population) translates to $200 million in gross sales. The analyst adds that patent issuance could extend market exclusivity to 2040.Adding to the good news, on September 25, BBI announced that Kaken Pharmaceutical, its development partner, got the green light to manufacture SB in Japan for the treatment of AH. Japan is the first country to approve the candidate, with the launch expected later this year.To sum it all up, Gershell stated, “By virtue of its efficacy, tolerability, and antiperspirant-like application, we believe SB offers an attractive profile in a market that offers much room for improved solutions. We encourage risk-tolerant investors to build a position ahead of upcoming newsflow.”To this end, Gershell rates BBI an Outperform (i.e. Buy) along with a $5 price target. This target conveys the analyst’s confidence in BBI's ability to surge 502% from current levels. (To watch Gershell’s track record, click here)Looking at the consensus breakdown, 2 Buys and no Holds or Sells have been published in the last three months. As a result, BBI gets a Moderate Buy consensus rating. The $5 average price target is identical to Gershell’s. (See BBI stock analysis on TipRanks)Aldeyra Therapeutics (ALDX)As for Oppenheimer’s other pick, Aldeyra Therapeutics works to bring new treatment options for immune-related diseases to market. Based on the solid progress of its pipeline, the firm has high hopes for this healthcare name.Representing Oppenheimer, analyst Justin Kim points out that he came away from a recent conversation with the CEO even more confident in ALDX’s long-term growth prospects. Pivotal studies on reactive aldehyde species (RASP) are slated for Q4 2020, evaluating the action of reproxalap, Aldeyra's lead therapy designed to clamp down on overactive inflammation, on tear levels of RASP over a period ranging from 1-2 days to 28 days. “Based on Phase 2a results, we are confident in the ability to replicate results in Q4 2020,” Kim stated.Given the potential of dry eye disease (DED) in the near-term, the analyst expects significant investor focus to land on clinical trial execution (Phase 3 RASP studies and safety study), which would support a potential NDA filing by the end of 2021, in Kim’s opinion. “Despite some volatility in the shares, we see a solid setup emerging as the company initiates its Phase 3 RASP studies in dry eye disease (DED),” he said.Speaking to the potential of RASP as an accepted dry eye endpoint, ALDX has experienced “a watershed moment,” with it facilitating an expedited path to registration (from traditional sign endpoints) and greater likelihood of clinical trial success, based on reproxalap's mechanism of action (MoA) as a RASP-trap, according to Kim.He added, “Moreover, agreement on RASP could have broader implications for a commercial launch in dry eye, a market that we believe will see segmentation as more therapies with targeted MoAs become incorporated into the armamentarium.”“We continue to be impressed by the progress in achieving a potential concurrent filing for dry eye and allergic conjunctivitis (AC), appreciating the importance of a differentiated dry eye agent with action also in AC. As the dry eye therapeutic landscape increases its options, we expect greater segmentation of the heterogeneous patient population potentially beginning with reproxalap's positioning in ‘allergic dry eye’,” the analyst concluded. For the rest of 2020, focus is likely to stay on Phase 3 study designs (assay work/development), execution and the potential readout in DED, which could set the stage for a commercial launch in DED and AC in 2022.If that wasn’t enough, based on the broader pipeline of candidates targeting PVR, inflammatory conditions and COVID-19, Kim sees “a rich environment of catalysts for the shares over the coming 12-18 months.”It should come as no surprise, then, that Kim stayed with the bulls. To this end, he kept an Outperform rating and $15 price target on the stock. Investors could be pocketing a gain of 110%, should this target be met in the twelve months ahead. (To watch Kim’s track record, click here)What does the rest of the Street have to say? Only Buy ratings, 2 to be exact, have been issued in the last three months. So, the consensus rating is a Moderate Buy. In addition, the $23.50 average price target suggests 227% upside potential from current levels. (See ALDX stock analysis on TipRanks)To find good ideas for stocks trading at attractive valuations, visit TipRanks’ Best Stocks to Buy, a newly launched tool that unites all of TipRanks’ equity insights.Disclaimer: The opinions expressed in this article are solely those of the featured analysts. The content is intended to be used for informational purposes only. It is very important to do your own analysis before making any investment.

  • GlobeNewswire

    Brickell Biotech Announces Approval of Sofpironium Bromide Gel, 5% in Japan for Treatment of Primary Axillary Hyperhidrosis Received by its Development Partner, Kaken Pharmaceutical

    Japan is the first country to approve sofpironium bromide with commercial launch expected later this yearBrickell is on track to initiate its U.S. pivotal Phase 3 program for sofpironium bromide in Q4 2020BOULDER, Colo., Sept. 25, 2020 (GLOBE NEWSWIRE) -- Brickell Biotech, Inc. (“Brickell”) (Nasdaq: BBI), a clinical-stage pharmaceutical company focused on developing innovative and differentiated prescription therapeutics for the treatment of debilitating skin diseases, announced today that its Japanese development partner, Kaken Pharmaceutical Co., Ltd. (“Kaken”), received approval to manufacture and market sofpironium bromide gel, 5% under the brand name ECCLOCK® in Japan for the treatment of primary axillary (underarm) hyperhidrosis.“We are thrilled with the Japanese approval of sofpironium bromide, which is the first topical prescription product to be approved in Japan for the treatment of primary axillary hyperhidrosis,” commented Robert Brown, Chief Executive Officer of Brickell. “This is a significant milestone for Brickell and Kaken, as Kaken can now focus its efforts on the commercial launch of sofpironium bromide gel in Japan, which is expected to occur later this year. Most importantly, this novel, first-in-class therapy will soon be available to help improve the quality of life for Japanese patients suffering from this debilitating condition.”This regulatory approval is based on the results of the Japanese Phase 3 pivotal registration study of sofpironium bromide gel, 5% in 281 patients with primary axillary hyperhidrosis, in which all primary and secondary efficacy endpoints demonstrated statistically significant differences between sofpironium bromide gel and vehicle (placebo). In addition, sofpironium bromide gel was deemed to be safe and generally well tolerated in this study, as well as in the accompanying 52-week long-term safety extension study in Japan.Under the sublicense agreement with Kaken, Brickell is entitled to receive sales-based milestone payments, as well as tiered royalties based on a percentage of net sales of sofpironium bromide gel in Japan. Importantly, Kaken has rights to develop and commercialize sofpironium bromide in Korea, China and certain other Asian countries, and will now turn its attention to these markets.Sofpironium bromide is currently being developed by Brickell in the U.S. for the treatment of primary axillary hyperhidrosis. Brickell is on track to initiate its pivotal Phase 3 program in the U.S. for sofpironium bromide gel, 15% during the fourth quarter of 2020, which will ultimately be comprised of two pivotal Phase 3 trials to evaluate sofpironium bromide gel compared to vehicle in approximately 350 subjects (per trial) with primary axillary hyperhidrosis.About Sofpironium BromideSofpironium bromide is a proprietary new chemical entity that belongs to a class of medications called anticholinergics. Anticholinergics block the action of acetylcholine, a chemical that transmits signals within the nervous system that are responsible for a range of bodily functions, including activation of the sweat glands. Sofpironium bromide was retrometabolically designed. Retrometabolic drugs are designed to exert their action topically and are potentially rapidly metabolized into a less active metabolite once absorbed into the blood. This proposed mechanism of action may allow for highly effective doses to be used while limiting systemic side effects. Sofpironium bromide was discovered at Bodor Laboratories, Inc. by Dr. Nicholas Bodor D.Sc., d.h.c. (multi), HoF, Graduate Research Professor Emeritus, University of Florida. Sofpironium bromide is not approved for use in any country at this time.About HyperhidrosisHyperhidrosis is a life-altering medical condition where a person sweats more than the body requires to regulate its temperature. More than 15 million people, or 4.8% of the population of the United States, and 12.7% of the population in Japan, are believed to suffer from hyperhidrosis1,2. Primary axillary (underarm) hyperhidrosis is the targeted first indication for sofpironium bromide and is the most common site of occurrence of hyperhidrosis, affecting an estimated 65% of patients with hyperhidrosis in the United States or 10 million individuals and an estimated 45% of patients with hyperhidrosis in Japan1,2. Additional information can be found on the International Hyperhidrosis Society website: https://www.sweathelp.org/.About BrickellBrickell Biotech, Inc. is a clinical-stage pharmaceutical company focused on developing innovative and differentiated prescription therapeutics for the treatment of debilitating skin diseases. Brickell’s pipeline consists of potential novel therapeutics for hyperhidrosis and other prevalent dermatological conditions. Brickell’s executive management team and board of directors bring extensive experience in product development and global commercialization, having served in leadership roles at large global pharmaceutical companies and biotechs that have developed and/or launched successful products, including several that were first-in-class and/or achieved iconic status, such as Cialis®, Taltz®, Gemzar®, Prozac®, Cymbalta® and Juvederm®. Brickell’s strategy is to leverage this experience to in-license, acquire, develop and commercialize innovative products that Brickell believes can be successful in the currently underserved dermatology global marketplace. For more information, visit https://www.brickellbio.com.Cautionary Note Regarding Forward-Looking StatementsAny statements made in this press release relating to future financial, legal, business and/or research and clinical performance, conditions, plans, prospects, trends, or strategies and other such matters, including without limitation, the anticipated timing, scope, design and/or results of future clinical trials, intellectual property rights, including the validity, term and enforceability of such, the expected timing and/or results of regulatory approvals and prospects for commercializing any of Brickell’s product candidates, or research collaborations with its partners, including in Japan, the United States or any other country, are forward-looking statements within the meaning of the U.S. Private Securities Litigation Reform Act of 1995. In addition, when or if used in this press release, the words “may,” “could,” “should,” “anticipate,” “believe,” “estimate,” “expect,” “intend,” “plan,” “predict” and similar expressions and their variants, as they relate to Brickell, may identify forward-looking statements. Brickell cautions that these forward-looking statements are subject to numerous assumptions, risks, and uncertainties, which change over time, often quickly and in unanticipated ways. Important factors that may cause actual results to differ materially from the results discussed in the forward-looking statements or historical experience include risks and uncertainties, including without limitation, ability to obtain adequate financing to advance product development, ability to maintain and enforce intellectual property rights, potential delays for any reason in product development, regulatory changes, unsuccessful clinical trials, unanticipated demands on cash resources, any disruption to our business caused by the current COVID-19 pandemic, interruptions, disruption or inability to launch and commercialize the product by Kaken in Japan, or obtain adequate pricing approval, and other risks associated with developing and obtaining regulatory approval for and commercializing product candidates.Further information on the factors and risks that could cause actual results to differ from any forward-looking statements are contained in Brickell’s filings with the United States Securities and Exchange Commission (SEC), which are available at http://www.sec.gov (or at https://www.brickellbio.com). The forward-looking statements represent the estimates of Brickell as of the date hereof only, and Brickell specifically disclaims any duty or obligation to update forward-looking statements. 1Doolittle et al. Hyperhidrosis: an update on prevalence and severity in the United States. Arch Dermatol Res 2016; 308: 743-749. 2 Fujimoto et al. Epidemiological study and considerations of focal hyperhidrosis in Japan. J Dermatol 2013; 40: 886-90. Brickell Investor Contact: Dan Ferry LifeSci Advisors (617) 430-7576 daniel@lifesciadvisors.com