BLU BELLUS Health Inc.

2.58
-0.01  -1%
Previous Close 2.59
Open 2.59
52 Week Low 2.3
52 Week High 12.03
Market Cap $155,138,582
Shares 60,439,583
Float 60,247,993
Enterprise Value $70,982,901
Volume 691,761
Av. Daily Volume 5,105,983
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Upcoming Catalysts

Drug Stage Catalyst Date
BLU-5937
Chronic pruritus associated with atopic dermatitis
Phase 2
Phase 2
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Drug Pipeline

Drug Stage Notes
BLU-5937
Chronic cough
Phase 2
Phase 2
Phase 2 trial did not meet primary endpoint - July 6, 2020.

Latest News

  1. BOSTON, July 19, 2020 (GLOBE NEWSWIRE) -- Block & Leviton LLP (www.blockesq.com), a national securities litigation firm, reminds investors that it is investigating the following companies and certain of their officers for potential violations of the federal securities laws: Commercial Vehicle Group, Inc. (NASDAQ:CVGI); Tactile Systems Technology, Inc. (NASDAQ:TCMD), and BELLUS Health, Inc. (NASDAQ:BLU). Further details about the investigations are described below.

    CVGI Shareholders – Click Here: https://www.blockleviton.com/cases/cvgi

    TCMD Shareholders – Click Here: https://www.blockleviton.com/cases/tcmd

    BLU Shareholders – Click Here: https://www.blockleviton.com/cases/bellus

    Commercial Vehicle Group, Inc. (NASDAQ:CVGI)

    CVGI, through…

    BOSTON, July 19, 2020 (GLOBE NEWSWIRE) -- Block & Leviton LLP (www.blockesq.com), a national securities litigation firm, reminds investors that it is investigating the following companies and certain of their officers for potential violations of the federal securities laws: Commercial Vehicle Group, Inc. (NASDAQ:CVGI); Tactile Systems Technology, Inc. (NASDAQ:TCMD), and BELLUS Health, Inc. (NASDAQ:BLU). Further details about the investigations are described below.

    CVGI Shareholders – Click Here: https://www.blockleviton.com/cases/cvgi

    TCMD Shareholders – Click Here: https://www.blockleviton.com/cases/tcmd

    BLU Shareholders – Click Here: https://www.blockleviton.com/cases/bellus

    Commercial Vehicle Group, Inc. (NASDAQ:CVGI)

    CVGI, through its subsidiaries, is a supplier of electrical wire harnesses, seating systems, and a full range of other cab related products for global commercial vehicle markets. On March 16, 2020, after the market closed, CVGI issued a press release announcing its fourth quarter and full year 2017 financial results. The Company disclosed that certain financial statements for fiscal 2018 and 2019 periods should no longer be relied upon due to misstatements. CVGI's Audit Committee had determined that, among other things, for the nine months ended September 30, 2019, cost of revenues were understated by $4.6 million, net income was overstated by $3.5 million, and diluted earnings per share was overstated by $0.11. On this news, CVGI's share price fell over 38% over the next two trading days, to close at just $1.56 per share on March 18, 2020.

    Tactile Systems Technology, Inc. (NASDAQ:TCMD)

    On June 8, 2020, OSS Research published a report entitled "Strong Sell on Tactile Systems: Bloated Stock Needs Compression Therapy," regarding Tactile Systems. In this report, OSS Research asserted, among other things, that "the likely true source of Tactile's growth" is "a kickback arrangement . . . resulting in rampant over-prescribing" and that "Medicare has launched an audit, and data reveals Tactile has been found non-compliant on 71% of its claims." The OSS Research report further noted that "[s]ince 2017, Tactile has seen multiple key departures" among its executive leadership. On this news, TCMD's stock price fell $5.28 per share, or approximately 10%, to close at just $47.26 per share on June 8, 2020.

    BELLUS Health, Inc. (NASDAQ:BLU)

    The Firm's investigation is centered on BELLUS' statements concerning the efficacy of its lead drug candidate, BLU-5937, which is BELLUS' only drug in a clinical trial. BLU-5937 is designed to treat refractory chronic cough, which impacts millions of patients. Although competing treatments exist, other drugs have an associated side effect of taste loss. BELLUS has promoted BLU-5937 as also targeting refractory chronic cough, but with the specific design of reducing the likelihood of taste loss. On July 6, 2020, BELLUS announced the topline results for its Phase 2 RELIEF trial for BLU-5937. The trial failed to achieve its primary endpoint of a statistically significant reduction from baseline in awake coughs per hour at eight time points in the four doses tested. The drug was unable to outperform placebo. On this news, shares of BELLUS common stock plummeted over 70%, closing at just $3.40 per share on July 6, 2020.

    If you purchased or acquired shares of CVGI, TCMD, or BLU and have questions about your legal rights or possess information relevant to these matters, please contact Block & Leviton attorneys at (617) 398-5600, via email at , or via the links provided above.

    Block & Leviton LLP is a firm dedicated to representing investors and maintaining the integrity of the country's financial markets.  The firm represents many of the nation's largest institutional investors as well as individual investors in securities litigation throughout the United States.  The firm's lawyers have recovered billions of dollars for its clients.

    This notice may constitute attorney advertising.

    CONTACT:

    BLOCK & LEVITON LLP

    260 Franklin St., Suite 1860

    Boston, MA 02110

    Phone: (617) 398-5600

    Email:

    SOURCE: Block & Leviton LLP

    www.blockesq.com 

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  2. - Primary endpoint of placebo-adjusted reduction in awake cough frequency did not reach statistical significance -

    - Highly statistically significant and clinically meaningful reductions in placebo adjusted awake cough frequency achieved in pre-specified analysis of high cough count patients (baseline cough frequency at or above the median) -

    - BLU-5937 was well tolerated with low impact on taste perception; safety profile comparable to placebo -

    - Patient enrichment strategy with higher cough count patients to be pursued in adaptive Phase 2b trial expected to start in Q4 2020 -

    - Company to host conference call and webcast at 8:00 a.m. ET -

    BELLUS Health Inc. (NASDAQ:BLU, TSX:BLU) ("BELLUS Health" or the "Company"), a clinical-stage…

    - Primary endpoint of placebo-adjusted reduction in awake cough frequency did not reach statistical significance -

    - Highly statistically significant and clinically meaningful reductions in placebo adjusted awake cough frequency achieved in pre-specified analysis of high cough count patients (baseline cough frequency at or above the median) -

    - BLU-5937 was well tolerated with low impact on taste perception; safety profile comparable to placebo -

    - Patient enrichment strategy with higher cough count patients to be pursued in adaptive Phase 2b trial expected to start in Q4 2020 -

    - Company to host conference call and webcast at 8:00 a.m. ET -

    BELLUS Health Inc. (NASDAQ:BLU, TSX:BLU) ("BELLUS Health" or the "Company"), a clinical-stage biopharmaceutical company developing novel therapeutics for the treatment of chronic cough and other hypersensitization-related disorders, today announced topline results from its Phase 2 RELIEF trial of BLU-5937 in patients with refractory chronic cough.

    The Phase 2 RELIEF trial of BLU-5937 did not achieve statistical significance for the primary endpoint of reduction in placebo-adjusted cough frequency at any dose tested. A clinically meaningful and highly statistically significant placebo-adjusted reduction in cough frequency was achieved in a pre-specified sub-group of high cough count patients (all patients at or above the baseline median average of 32.4 coughs per hour).

    All patients (n=62)

    Dose

    Placebo-adjusted

    reduction in awake

    cough frequency

    P-value

    25mg BID

    -11%

    p=0.14

    50mg BID

    -6%

    p=0.46

    100mg BID

    -8%

    p=0.41

    200mg BID

    -17%

    p=0.09

    Patients with awake cough frequency at or above baseline median (≥32.4 cough/hr; n=31)

    Dose

    Placebo-adjusted

    reduction in awake

    cough frequency

    P-value

    25mg BID

    -28%

    p=0.0005

    50mg BID

    -28%

    p=0.0003

    100mg BID

    -30%

    p=0.0014

    200mg BID

    -32%

    p=0.0006

    BLU-5937 was also observed to be well tolerated with no serious adverse events reported and no withdrawals due to treatment-related adverse events at any dose. Taste effects, including taste alteration and partial taste loss, were infrequent at all dose levels (6.5%, 9.8%, 10% and 8.6% at 25mg BID, 50mg BID, 100mg BID and 200mg BID, respectively, versus 4.9% on placebo) and mostly mild in nature. No patients reported complete taste loss. There were no clinically meaningful changes in vital signs, electrocardiogram or clinical laboratory values.

    "In the RELIEF trial, we observed data that we believe is competitive within the P2X3 class, including the reduction in cough frequency shown in patients with higher cough counts and a low taste effect. While we had hoped to see more response in the lower cough patients, BLU-5937 and other P2X3 antagonists may have the most benefit in patients with a greater disease burden," said Roberto Bellini, President and Chief Executive Officer of BELLUS Health. "We believe the Phase 2 data support moving BLU-5937 forward into an adaptive Phase 2b trial enriched for higher cough count patients. We expect to begin this trial in the fourth quarter of 2020."

    "Currently, there are no approved treatments for refractory chronic cough, a condition that affects the quality of life of millions of patients globally. BELLUS Health was able to show clinically and statistically meaningful reductions in cough count in patients with higher baseline cough count, which may be the best available clinical indicator of cough hypersensitization via the P2X3 pathway. In addition, BLU-5937's high selectivity resulted in a favorable tolerability profile with little reported taste disturbance," said Dr. Jaclyn Smith, Professor of Respiratory Medicine at the University of Manchester in the United Kingdom and an Honorary Consultant at the University Hospital of South Manchester NHS Foundation Trust, and Chair of BELLUS Health's Clinical Advisory Board. "The RELIEF Phase 2 data set the stage for the further development of BLU-5937 and I look forward to continuing to work on the program."

    About the Clinical Phase 2 RELIEF Trial

    The RELIEF trial is a dose-escalation, placebo-controlled, and crossover design to assess the efficacy, safety and tolerability of BLU-5937, a highly selective P2X3 antagonist, at four doses: 25, 50, 100 and 200mg, administered orally, twice-daily. RELIEF enrolled a total of 68 refractory chronic cough patients from 16 sites in the United Kingdom and United States, with 52 completing both treatment periods. Sixteen patients dropped out in total, including 13 as a result of difficulties with conducting follow-up visits related to the COVID-19 pandemic or early termination of the trial. There were three additional non-drug related discontinuations. Further details on the RELIEF trial can be found at https://clinicaltrials.gov/ct2/show/NCT03979638.

    Conference Call & Webcast Information:

    The Company will host a conference call and webcast to discuss the topline results from the RELIEF Phase 2 trial on July 6th, 2020 at 8:00 a.m. ET.

    Individuals can participate in the conference call by dialing 877-407-9041 (domestic) or 201-389-0937 (international) and referring to the "BELLUS RELIEF Phase 2 Trial Topline Results." The live webcast of the event may be accessed through the Events and Presentations page of BELLUS Health's website, under the Investors & News section.

    The archived webcast will be available for replay on the BELLUS Health website after the event.

    About BLU-5937

    BLU-5937, a highly selective P2X3 antagonist - (>1500 fold) - is in development for chronic cough, chronic pruritus and other hypersensitization-related disorders.

    The P2X3 receptor in the cough reflex pathway, which is implicated in chronic cough, is a rational target for treating chronic cough, and it has been evaluated in multiple clinical trials with different P2X3 antagonists. The Company believes that its highly selective P2X3 antagonist has the potential to reduce coughing in patients with chronic cough while maintaining taste function by not inhibiting P2X2/3 receptors, which play a major role in taste.

    In addition to chronic cough and chronic pruritus, BLU-5937 may also have broad applicability across other afferent hypersensitization-related disorders, enabling the Company to consider developing a pipeline of therapies using its P2X3 platform. BELLUS Health is exploring how P2X3 activation can contribute to irritation and pain, and whether inhibition of P2X3 receptors can help treat these afferent hypersensitization-related disorders.

    About BELLUS Health (www.bellushealth.com)

    BELLUS Health is a clinical-stage biopharmaceutical company developing novel therapeutics for the treatment of chronic cough and other hypersensitization-related disorders. The Company's product candidate, BLU-5937, is being developed for the treatment of chronic cough and chronic pruritus.

    Chronic cough, the lead indication for BLU-5937, is a cough lasting more than eight weeks and is associated with significant adverse physical, social and psychosocial effects on health and quality of life. It is estimated that approximately 26 million adults in the United States suffer from chronic cough with approximately 3 million having refractory chronic cough lasting for more than a year and approximately 6 million having refractory chronic cough lasting more than 8 weeks and under one year. There is no specific therapy approved for refractory chronic cough and current treatment options are limited.

    Chronic pruritus, commonly known as chronic itch, is an irritating sensation that leads to scratching, and persists for longer than six weeks, which can be debilitating and has a significant impact on quality-of-life. It is a hallmark of many conditions, including atopic dermatitis (AD). It is estimated that chronic pruritus associated with AD affects more than 16.9 million adults in the United States.

    Forward-Looking Statements

    Certain statements contained in this news release, other than statements of fact that are independently verifiable at the date hereof, may constitute "forward-looking statements" within the meaning of Canadian securities legislation and regulations, the U.S. Private Securities Litigation Reform Act of 1995, as amended, and other applicable securities laws. Forward-looking statements are frequently, but not always, identified by words such as "expects," "anticipates," "believes," "intends," "estimates," "potential," "possible," "projects," "plans," and similar expressions. Such statements, based as they are on the current expectations of management, inherently involve numerous important risks, uncertainties and assumptions, known and unknown, many of which are beyond BELLUS Health's control. Such statements include, but are not limited to, the potential of BLU-5937 to successfully treat chronic cough, chronic pruritus and other hypersensitization-related disorders, BELLUS Health's expectations related to its preclinical studies and clinical trials, including its clinical development plan and timing and design of future trials for its chronic cough program, the potential tolerability profile, selectivity and other characteristics of BLU-5937 as compared to other competitor candidates and the potential applicability of BLU-5937 and BELLUS Health's P2X3 platform to treat other disorders. Risk factors that may affect BELLUS Health's future results include but are not limited to: the ability to expand and develop its project pipeline, the ability to obtain adequate financing, the ability of BELLUS Health to maintain its rights to intellectual property and obtain adequate protection of future products through such intellectual property, the impact of general economic conditions, general conditions in the pharmaceutical industry, the impact of the COVID-19 pandemic on BELLUS Health's operations, plans and prospects, including to the initiation and completion of clinical trials in a timely manner or at all, changes in the regulatory environment in the jurisdictions in which BELLUS Health does business, stock market volatility, fluctuations in costs, changes to the competitive environment, achievement of forecasted burn rate, potential payments/outcomes in relation to indemnity agreements and contingent value rights, achievement of forecasted preclinical study and clinical trial milestones, reliance on third parties to conduct preclinical studies and clinical trials for BLU-5937 and that actual results may vary once the final and quality-controlled verification of data and analyses has been completed. In addition, the length of BELLUS Health's product candidate's development process and its market size and commercial value are dependent upon a number of factors. Moreover, BELLUS Health's growth and future prospects are mainly dependent on the successful development, patient tolerability, regulatory approval, commercialization and market acceptance of its product candidate BLU-5937 and other products. Consequently, actual future results and events may differ materially from the anticipated results and events expressed in the forward-looking statements. BELLUS Health believes that expectations represented by forward-looking statements are reasonable, yet there can be no assurance that such expectations will prove to be correct. The reader should not place undue reliance, if any, on any forward-looking statements included in this news release. These forward-looking statements speak only as of the date made, and BELLUS Health is under no obligation and disavows any intention to update publicly or revise such statements as a result of any new information, future event, circumstances or otherwise, unless required by applicable legislation or regulation. Please see BELLUS Health's public filings with the Canadian securities regulatory authorities, including, but not limited to, its Annual Information Form, and the United States Securities and Exchange Commission, including, but not limited to, its Annual Report on Form 40-F, for further risk factors that might affect BELLUS Health and its business.

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  3. BELLUS Health Inc. (NASDAQ:BLU, TSX:BLU) ("BELLUS Health" or the "Company"), a clinical-stage biopharmaceutical company developing novel therapeutics for the treatment of chronic cough and other hypersensitization-related disorders, today announced that Roberto Bellini, BELLUS Health's President and Chief Executive Officer, will participate in a fireside chat at the Jefferies Virtual Healthcare Conference.

    Presentation Details:

    Event: Jefferies Virtual Healthcare Conference

    Date: Tuesday, June 2, 2020

    Time: 1:30 p.m. EDT

    A live webcast of the fireside chat may be accessed on the Events and Presentations page under the Investors & News section of BELLUS Health's website at www.bellushealth.com. Following the event, an archived webcast will…

    BELLUS Health Inc. (NASDAQ:BLU, TSX:BLU) ("BELLUS Health" or the "Company"), a clinical-stage biopharmaceutical company developing novel therapeutics for the treatment of chronic cough and other hypersensitization-related disorders, today announced that Roberto Bellini, BELLUS Health's President and Chief Executive Officer, will participate in a fireside chat at the Jefferies Virtual Healthcare Conference.

    Presentation Details:

    Event: Jefferies Virtual Healthcare Conference

    Date: Tuesday, June 2, 2020

    Time: 1:30 p.m. EDT

    A live webcast of the fireside chat may be accessed on the Events and Presentations page under the Investors & News section of BELLUS Health's website at www.bellushealth.com. Following the event, an archived webcast will be available on the Company's website.

    About BELLUS Health

    BELLUS Health is a clinical-stage biopharmaceutical company developing novel therapeutics for the treatment of chronic cough and other hypersensitization-related disorders. The Company's product candidate, BLU-5937, is being developed for the treatment of chronic cough and chronic pruritus.

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