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Tag: BBI

  • Here is why Brickell Biotech Inc. (BBI) stock faced the headwinds on the first day of the week?

    Here is why Brickell Biotech Inc. (BBI) stock faced the headwinds on the first day of the week?

    Brickell Biotech Inc. (BBI) shares fell 13.14% in after-hours on Monday, July 19, 2021, and closed Monday’s trading at $0.64. Earlier in the morning session, BBI’s stock lost 1.77% to close Monday’s session at $0.74. BBI shares have fallen 18.49% over the last 12 months, and they have moved down 10.16% in the past week. Over the past three months, the stock has lost 12.31%, while over the past six months, it has shed 33.03%. Further, the company has a current market of $51.08 million and its outstanding shares stood at 67.18 million.

    Let’s see is there any recent news or development behind its negative start on Monday?

    Increasing Bought Deal Offering of Common Stock

    On July 19, 2021, Brickell Biotech, Inc announced that the underwriter has agreed to increase the size of the previously announced public offering and purchase on a firm commitment basis 11,290,323 shares of common stock of the Company at a price to the public of $0.62 per share, less underwriting discounts and commissions, due to demand. The offer will close on July 22, 2021.

    Participation in the recent investor conference

    Brickell Biotech recently participated in one-on-one investor meetings at the William Blair Biotech Focus Conference 2021, which was held virtually on July 14 – 15, 2021.

    Update about patient enrollment in Phase 3 pivotal Cardigan I &II study

    On June 29, 2021, Brickell Biotech, Inc announced that the final patient has completed the Phase 3 pivotal Cardigan I study and that all planned patients have been enrolled in the Phase 3 pivotal Cardigan II study. Both studies are evaluating sofpironium bromide gel, 15% in patients with primary axillary (underarm) hyperhidrosis.

    Brickell’s U.S. Phase 3 clinical program for sofpironium bromide gel, 15% is comprised of two pivotal clinical studies, Cardigan I and Cardigan II. Each study has enrolled approximately 350 subjects nine years of age and older with primary axillary hyperhidrosis.

    Initiation of Phase 1 clinical study of sofpironium bromide gel in Japan

    On June 24, 2021, the development partner of Brickell Biotech, Kaken Pharmaceutical Co., Ltd initiated a Phase 1 clinical study to assess the pharmacokinetics (PK) of sofpironium bromide gel in patients with primary palmoplantar hyperhidrosis (PPH) in Japan.

    Publication of Phase 3 Results for ECCLOCKin the Journal of Dermatology

    On June 01, 2021, Brickell Biotech, Inc announced that the results from the Phase 3 long-term safety and efficacy study conducted in Japan by its development partner, Kaken Pharmaceutical Co., Ltd were published in the peer-reviewed Journal of Dermatology1.

    Conclusion

    The BBI stock faced negativity on Monday after it announced to increase in the size of the previously announced public offering. BBI stock can further slide down in the coming days.

  • Brickell Biotech, Inc. (BBI) Stock Rallies Ahead of Sofpironium Bromide Clinical Trial Milestones

    Brickell Biotech, Inc. (BBI) Stock Rallies Ahead of Sofpironium Bromide Clinical Trial Milestones

    Brickell Biotech, Inc. (BBI) stock prices were down by a marginal 0.52% as of the market closing on June 29th, 2021, bringing the price per share down to USD$0.93 at the end of the trading day. Subsequent pre-market fluctuations saw the stock rally by 5.91%, bringing it up to USD$0.98.

    Sofpironium Bromide Gel, 15%, Study

    The company’s U.S Phase 3 clinical program is comprised of two pivotal studies designed to evaluate sofpironium bromide gel, 15%. Cardigan I and Cardigan II each have approximately 350 subjects enrolled, each of which is above the age of 8 and has primary axillary hyperhidrosis. The efficacy and safety of topically applied sofpironium bromide gel will be evaluated in the multicenter, randomized, double-blinded, vehicle-controlled studies, with safety and tolerability assessments being performed throughout the studies.

    Details of the Study

    The regimen consists of subjects applying the treatment or a placebo to their underarms once daily before sleeping at night for a period of six consecutive weeks, with a 2-week post-treatment follow up. The co-primary efficacy endpoints of both studies include the demographic of patients that exhibited at least a 2-point improvement on the Hyperhidrosis Disease Severity Measure-Axillary (HDSM-Ax) scale, which is a proprietary and validated patient-reported outcome measure. The studies will also evaluate changes in gravimetric sweat production (GSP) from baseline to the end of treatment.

    Scope of Clinical Study

    Topline results from each of the Cardigan clinical studies is expected for the fourth quarter of 2021. The success of these results will form the basis of a potential NDA in the U.S for sofpironium bromide gel, 15% for the treatment of primary axillary hyperhidrosis.

    Phase 1 PPH Clinical Study

    June 24th, 2021 had seen the company announce that its development partner, Kaken Pharmaceutical, had initiated a Phase 1 clinical study to assess the pharmacokinetics of sofpironium bromide gel. The Study would assess the efficacy and safety of the treatment in patients with primary palmoplantar hyperhidrosis in Japan. PPH is a medical disorder that is very common, resulting in excessive sweating from the palms and soles. Primary palmar hidrosis is estimated to affect 5.33% of the Japanese population, while primary plantar hyperhidrosis is thought to affect 2.79% of the population. With no existing approved topical prescription treatments available for PPH in Japan, the study’s scope is potentially massive.

    Future Outlook for BBI

    Armed with a solid liquidity position, BBI is poised to capitalize on the strides made in its clinical studies, with the company pushing for the commercialization and proliferation of sofpirinium bromide gel, 15%. Current and potential investors are hopeful that management will continue to leverage the resources at their disposal to facilitate significant and sustained increases in shareholder value.

  • Brickell Biotech, Inc. (BBI) stock falls in Pre-Market: Why is it so?

    Brickell Biotech, Inc. (BBI) stock falls in Pre-Market: Why is it so?

    Brickell Biotech, Inc. (BBI) announced its fourth-quarter and full-year financial results of 2020 after which the BBI stock happened to be red, and its price saw a downtrend of 2.75% in today’s pre-market to drop at $1.06 a share at the time of this writing. BBI was gaining in the previous trading session and closed with a 0.93% gain. Let’s discuss the earnings report in detail.

    Fourth Quarter Results:

    • BBI stock recorded revenue of $27 thousand in the fourth quarter of 2020 which is significantly less than the $0.7 million in the same quarter of the prior year. The reduction in the revenue was mainly due to the winding down of the safety study of sofpironium bromide gel as well as various clinical activities in the first quarter of 2020.
    • Reduction of clinical activities resulted in less research and development costs of $4.6 million in the fourth quarter of 2020 as compared to $6.6 million in the same tenure of the previous year.
    • General and administrative expenses were reduced to $2.9 million of BBI stock as compared to$4.9 million in the same period of the previous year. This reduction is due to the reduction in cost related to the merger with Vical Incorporated, reduced impairment expenses, and other reduced miscellaneous expenses.

    Full Year Financial Results:

    • BBI stock generated $1.8 million revenue in 2020, a huge decrease as compared to the $7.9 million revenue of 2020. This decrease owes to the reduced clinical activities in 2020.
    • Research and development expenses reduced to $11.2 million in 2020 as compared to $20.2 million in 2019.
    • General and administrative expenses of BBI stock reduced to $11.6 million in 2020 while these were $12.2 in the prior-year period.
    • As of December 31, 2020, BBI recorded a net loss of $20.9 million as compared to a net loss of $23.9 million as of December 31, 2019.
    • BBI stock had cash and cash equivalents and market securities of $30.1 million at the end of 2020 while these were $11.7 million at the end of 2019.

    Recent Developments of BBI stock:

    Brickell Biotech completed an equity financing in 2020 that resulted in $13.7 million net proceeds.Moreover, Brickell Biotech initiated the enrollment of U.S. Phase 3 Cardigan I and Cardigan II studies related to sofpironium bromide gel and exceeded 50% enrollment in the former. Launching of ECCLOCK in Japan, publishing of phase 3 study results by Kaken, and completion of  Phase 1/2 study of investigational COVID-19 vaccine candidate and initiation of Phase 2/3 study in Japan are some other major business developments of BBI stock.

    Conclusion:

    Investors are responding to the earnings report released by BBI stock today. Results are not much satisfactory by BBI stock in 2020 as compared to 2019 as revenue as well as operating expenses decreased significantly which points to the decline in growth over the year.

  • 20 Trending Stocks In Biotechnology Industry You Should Consider Buying

    20 Trending Stocks In Biotechnology Industry You Should Consider Buying

    Investors are always looking for safe and secure investments and as a strong and profitable industry, the biotechnology industry is considered to be an attractive area of investment. This industry has experienced massive growth in recent years and is continuously adopting new technological advancements to keep pace with the fast-growing market. Biotechnology is a set of tools that uses living organisms to create or change a product, improve plants, trees, or animals, or develop microorganisms for specific uses.

    Modern Biotechnology’s main focus is on medicine. The companies in this sector are involved in the development of new treatments for various complex diseases. Technology has always been at the heart of the biotechnology industry. As the new technologies emerged with the passage of time the efficiency of companies has also improved. Similarly, technological advancements have also changed the clinical trial process.

    There are various other trends that the companies are following. Let see the top 20 companies in the biotechnology industry to get a better view:

    Cassava Sciences Inc. (NASDAQ: SAVA)

    Cassava Sciences Inc. (NASDAQ: SAVA) last closed at $11.47, in a 52-week range of $1.05 to $11.25. Analysts have a consensus price target of $17.00. Cassava Sciences Inc. (SAVA) has earlier announced the results of the Phase 2b study with its drug candidate Sumifilam, in Alzheimer’s disease. The clinical study which has received the funding by the National Institutes of Health (NIH) has shown the improvement in Alzheimer’s disease. Cassava Sciences Inc. (SAVA) market cap has remained high, hitting $242.02 M at the time of writing.

    Inovio Pharmaceuticals Inc. (NASDAQ: INO)

    Inovio Pharmaceuticals Inc. (NASDAQ: INO) stock soar by 10.21% to $16.94. The most recent rating by ROTH Capital, on July 01, 2020, is at a Sell. Inovio Pharmaceuticals Inc. (INO) has revealed that the US Food and Drug Administration (FDA) has informed the company that it has some questions related to the Phase 2/3 trial of its COVID-19 vaccine candidate INO-4800, including its CELLECTRA 2000 delivery device to be used in the trial. the company said that it will halt the trial until it clear all the ambiguities of FDA.

    Sorrento Therapeutics Inc. (NASDAQ: SRNE)

    Sorrento Therapeutics Inc. (NASDAQ: SRNE) Shares headed rising, higher as much as 4.84%. The most recent rating by H.C. Wainwright, on July 31, 2020, is at a Buy. Sorrento Therapeutics Inc. (SRNE) has earlier revealed the results of its’ multicenter, open-label, Phase 1b Study to Evaluate Safety and MTD of Epidural Resiniferatoxin Injection for the Treatment of Intractable Cancer Pain at the 14th Annual Pain Therapeutics Summit. The company has reported the encouraging results from its Phase 1b study to evaluate Epidural Resiniferatoxin Injection.

    Vaxart Inc. (NASDAQ: VXRT)

    Vaxart Inc. (NASDAQ: VXRT) rose 7.40% after gaining more than $0.51 on Friday. Pomerantz LLP is investigating claims on behalf of investors of Vaxart, Inc. Vaxart Inc. share price went from a low point around $0.25 to briefly over $17.49 in the past 52 weeks, though shares have since pulled back to $7.40. Vaxart Inc.’s market cap has remained high, hitting $752.43 M at the time of writing.

    Novavax Inc. (NASDAQ: NVAX)

    Novavax Inc. (NASDAQ: NVAX) stock soar by 10.86% to $113.56. The most recent rating by H.C. Wainwright, on August 06, 2020, is at a Buy. Par Sterile Products, LLC (Par Sterile) has entered into a non-exclusive agreement with Novavax, Inc. to provide fill-finish manufacturing services at its plant in Rochester, Michigan for NVX-CoV2373, Novavax’ COVID-19 vaccine candidate.

    Onconova Therapeutics Inc. (NASDAQ: ONTX)

    Onconova Therapeutics Inc. (NASDAQ: ONTX) Shares headed falling, lower as much as -3.23%. The most recent rating by H.C. Wainwright, on March 01, 2018, is at a Buy. Onconova Therapeutics Inc. (ONTX) earlier revealed that it has started the Phase 1 clinical trial in China for ON 123300 by its partner, HanX Biopharmaceuticals. Onconova has partnered with HanX Biopharmaceuticals in December 2017 for the development, registration, and commercialization of ON 123300 in China.

    Jaguar Health Inc. (NASDAQ: JAGX)

    Jaguar Health Inc. (NASDAQ: JAGX) last closed at $0.31, in a 52-week range of $0.29 to $1.38. Jaguar Health Inc. (JAGX) earlier revealed itis scheduled to participate in its first “Diarrhea Dialogues” virtual event on October 20 from 3:00 PM. The event, open to the financial and business community, will discuss the importance of supportive care for cancer patients as it relates to chronic lower GI tract distress, specifically with regard to debilitating diarrhea experienced as a result of cancer therapy.

    Zogenix Inc. (NASDAQ: ZGNX)

    Zogenix Inc. (NASDAQ: ZGNX) stock drop by -1.46% to $17.50. The most recent rating by Raymond James, on August 25, 2020, is at an Mkt perform. Zogenix Inc. (ZGNX) has revealed the pricing of its offering of $200,000,000 aggregate principal amount of 2.75% convertible senior notes due 2027 in a private offering to qualified institutional buyers pursuant to Rule 144A under the Securities Act of 1933, as amended.

    Trevena Inc. (NASDAQ: TRVN)

    Trevena Inc. (NASDAQ: TRVN) Shares headed rising, higher as much as 4.04%. The most recent rating by Guggenheim, on September 14, 2020, is at a Buy. Trevena Inc. (TRVN) has earlier participated in three presentations at the virtual 2020 American College of Clinical Pharmacology (ACCP) Annual Meeting. The meetings have taken place from September 21st to 23rd, 2020.

    VBI Vaccines Inc. (NASDAQ: VBIV)

    VBI Vaccines Inc. (NASDAQ: VBIV) last closed at $3.08, in a 52-week range of $0.47 to $6.93. VBI Vaccines Inc. (VBIV) is scheduled to participate in upcoming presentations including Sci-B-Vac: Results on Ph3 Hep B vaccine, Targeting CMV for the development of effective GBM immunotherapy on September 29 and 30, 2020, respectively. It has today participated in the COVID-19 panel discussion on the topic: What existing treatments and vaccine development platforms show promise to control the rate of infection and spread?

    Brickell Biotech Inc. (NASDAQ: BBI)

    Brickell Biotech Inc. (NASDAQ: BBI) Shares headed rising, higher as much as 3.90%. The most recent rating by Lake Street, on August 28, 2020, is at a Buy. Brickell Biotech Inc. (BBI) has revealed that its Japanese development partner, Kaken Pharmaceutical Co., Ltd. has 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.

    VYNE Therapeutics Inc. (NASDAQ: VYNE)

    VYNE Therapeutics Inc. (NASDAQ: VYNE) Shares headed falling, lower as much as -6.17%. VYNE Therapeutics Inc. (VYNE) has revealed that the Company will host a physician symposium on AMZEEQ and ZILXI™ on Thursday, October 1, 2020. VYNE market cap has remained high, hitting $271.70-M at the time of writing.

    Acorda Therapeutics Inc. (NASDAQ: ACOR)

    Acorda Therapeutics Inc. (NASDAQ: ACOR) shares were trading up 30.13% at $0.62 at the time of writing on Friday. Acorda Therapeutics Inc. (NASDAQ: ACOR) share price went from a low point around $0.42 to briefly over $3.27 in the past 52 weeks, though shares have since pulled back to $0.62. ACOR market cap has remained high, hitting $22.70M at the time of writing, giving it a price-to-sales ratio of more than 0. If we look at the recent analyst rating ACOR, H.C. Wainwright downgraded coverage on ACOR shares with a Neutral rating.

    Moderna Inc. (NASDAQ: MRNA)

    Moderna Inc. (NASDAQ: MRNA) last closed at $69.47, in a 52-week range of $13.53 to $95.21. Analysts have a consensus price target of $91.90. Moderna Inc. (MRNA) has moved up 413.45% from its 52-weeks low and moved down -327.03% from its 52-weeks high. Looking at its liquidity, it has a current ratio of 17.30. This company’s market capitalization has remained high, hitting $25.72 billion at the time of writing.

    iBio Inc. (AMEX: IBIO)

    iBio Inc. (AMEX: IBIO) rose 7.77% after gaining more than $0.15 on Friday. iBio Inc. (IBIO) share price went from a low point around $0.05 to briefly over $7.45 in the past 52 weeks, though shares have since pulled back to $2.08. iBio Inc. has moved up 4060.00% from its 52-weeks low and moved down -72.08% from its 52-weeks high.  IBIO market cap has remained high, hitting $336.61 M at the time of writing.

    Akebia Therapeutics Inc. (NASDAQ: AKBA)

    Akebia Therapeutics Inc. (NASDAQ: AKBA) rose 0.81% after gaining more than $0.02 on Friday.  In the past 52-weeks of trading, this company’s stock has fluctuated between the low of $2.34 and a high of $13.71. It has moved up 5.98% from its 52-weeks low and moved down -8191% from its 52-weeks high. Looking at its liquidity, it has a current ratio of 2.30. This company’s market capitalization has remained high, hitting $347.50 million at the time of writing.

    Vaccinex Inc. (NASDAQ: VCNX)

    Vaccinex Inc. (NASDAQ: VCNX) stock drop by -1.10% to $1.79. The most recent rating by BTIG Research, on September 23, 2020, is at a Neutral. Vaccinex Inc. (VCNX) share price went from a low point around $1.70 to briefly over $12.23 in the past 52 weeks, though shares have since pulled back to $1.79. VCNX has moved up 5.29% from its 52-weeks low and moved down -85.36% from its 52-weeks high.  VCNX market cap has remained high, hitting $36.19M at the time of writing.

    Ocugen Inc. (NASDAQ: OCGN)

    Ocugen Inc. (NASDAQ: OCGN) rose 2.29% after gaining more than $0.0 on Friday. In the past 52-weeks of trading, this company’s stock has fluctuated between the low of $0.17 and a high of $16.80. It has moved up 78.53% from its 52-weeks low and moved down -98.19% from its 52-weeks high. Looking at its liquidity, it has a current ratio of 3.30. This company’s market capitalization has remained high, hitting $40.03 million at the time of writing.

    9 Meters Biopharma Inc. (NASDAQ: NMTR)

    9 Meters Biopharma Inc. (NMTR) last closed at $0.76, in a 52-week range of $0.37 to $1.22. 9 Meters Biopharma Inc. (NMTR) has moved up 106.59% from its 52-weeks low and moved down -37.33% from its 52-weeks high. Looking at its liquidity, it has a current ratio of 1.30. This company’s market capitalization has remained high, hitting $101.25 million at the time of writing.

    Clovis Oncology Inc. (NASDAQ: CLVS)

    Clovis Oncology Inc. (NASDAQ: CLVS) stock soar by 3.25% to $5.88. The most recent rating by H.C. Wainwright, on May 18, 2020, is at a Buy. Clovis Oncology Inc. (CLVS) share price went from a low point around $2.93 to briefly over $17.37 in the past 52 weeks, though shares have since pulled back to $5.88. CLVS has moved up 100.68% from its 52-weeks low and moved down -66.15% from its 52-weeks high.  CLVS market cap has remained high, hitting $502.33M at the time of writing.