Biotech

Robbins Geller Rudman & Dowd LLP announces that a class action lawsuit has been filed in the Southern District of New York on behalf of purchasers of BELLUS Health Inc. (NASDAQ:BLU) securities between September 5, 2019 and July 5, 2020, inclusive (the "Class Period"). The case is captioned Cachia v. BELLUS Health Inc. , No. 21-cv-02278, and is assigned to Judge George B. Daniels. The BELLUS Health class action lawsuit charges BELLUS Health and certain of its executives with violations of the Securities Exchange Act of 1934.

The Private Securities Litigation Reform Act of 1995 permits any investor who purchased BELLUS Health securities during the Class Period to seek appointment as lead plaintiff in the BELLUS Health class action lawsuit. A lead plaintiff is generally the movant with the greatest financial interest in the relief sought by the putative class who is also typical and adequate of the putative class. A lead plaintiff acts on behalf of all other class members in directing the BELLUS Health class action lawsuit. The lead plaintiff can select a law firm of its choice to litigate the BELLUS Health class action lawsuit. An investor's ability to share in any potential future recovery of the BELLUS Health class action lawsuit is not dependent upon serving as lead plaintiff. If you wish to serve as lead plaintiff of the BELLUS Health class action lawsuit or have questions concerning your rights regarding the BELLUS Health class action lawsuit, please provide your information here or contact counsel, Jennifer Caringal of Robbins Geller, at 800/449-4900 or 619/231-1058 or via e-mail at jcaringal@rgrdlaw.com . Lead plaintiff motions for the BELLUS Health class action lawsuit must be filed with the court no later than May 17, 2021.

BELLUS Health is a clinical-stage biopharmaceutical company whose lead product is BLU-5937, which is being developed for the treatment of chronic cough (one that lasts over eight weeks) and other afferent hypersensitization-related disorders. Merck & Co. has been leading the race to develop the first U.S. Food and Drug Administration ("FDA") approved treatment for chronic cough. In March 2020, Merck announced that its experimental drug, Gefapixant, had met its primary endpoint in two Phase 2 studies. However, side effects of taste alteration or loss of taste were reported in 80% of the patients on Gefapixant.

The BELLUS Health class action lawsuit alleges that, throughout the Class Period, defendants touted that because BLU-5937 was more selective than Gefapixant, it would come with a better safety profile and would not have the side effects of taste alteration or loss of taste. As a result, the BELLUS Health class action lawsuit alleges that defendants misled investors into believing that the Phase 2 study for BELLUS Health's BLU-5937 would demonstrate the same level of efficacy as, but a higher level of safety than, Merck's Gefapixant. However, the BELLUS Health class action lawsuit alleges that defendants knew, but failed to disclose, that BLU-5937 had a much higher risk of failing to demonstrate efficacy for chronic cough. Accordingly, the BELLUS Health class action lawsuit alleges that despite Merck's successful Phase 2 study, BLU-5937 had a high risk of failing its Phase 2 study.

The BELLUS Health class action lawsuit further alleges that defendants' scheme: (i) deceived the investing public regarding BELLUS Health's business, operations, drug products, drug product development, competition, and present and future business prospects; (ii) facilitated BELLUS Health's September 2019 public offering ("Offering"); (iii) created artificial demand for the BELLUS Health common shares sold in the Offering; (iv) enabled BELLUS Health to receive approximately $70 million in net proceeds from the sale of BELLUS Health common stock in the Offering; and (v) caused investors to purchase BELLUS Health publicly traded common stock at artificially inflated prices.

Then, on July 6, 2020, defendants announced that BLU-5937 had failed a Phase 2 study of chronic cough patients for whom other treatments had not worked. Specifically, defendants revealed that BLU-5937 was not significantly better than a placebo at reducing the frequency at which patients coughed. The Phase 2 trial showed a "clinically meaningful and highly statistically significant" effect only on a subset of patients who had high cough counts (around 32 per day), so BELLUS Health was planning a Phase 2b trial focused on those patients. On this news, BELLUS Health's stock price fell approximately 75%, damaging investors.

Robbins Geller Rudman & Dowd LLP is one of the world's leading law firms representing investors in securities class action litigation. With 200 lawyers in 9 offices, Robbins Geller has obtained many of the largest securities class action recoveries in history. For seven consecutive years, ISS Securities Class Action Services has ranked the Firm in its annual SCAS Top 50 Report as one of the top law firms in the world in both amount recovered for shareholders and total number of class action settlements. Robbins Geller attorneys have helped shape the securities laws and have recovered tens of billions of dollars on behalf of aggrieved victims. Beyond securing financial recoveries for defrauded investors, Robbins Geller also specializes in implementing corporate governance reforms, helping to improve the financial markets for investors worldwide. Robbins Geller attorneys are consistently recognized by courts, professional organizations, and the media as leading lawyers in the industry. Please visit http://www.rgrdlaw.com for more information.

Robbins Geller Rudman & Dowd LLP
Jennifer Caringal, 800-449-4900
jcaringal@rgrdlaw.com

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AbbVie Reports Second-Quarter 2022 Financial Results

  • Reports Second-Quarter Diluted EPS of $0.51 on a GAAP Basis, an Increase of 21.4 Percent; Adjusted Diluted EPS of $3.37 , an Increase of 11.2 Percent; These Results Include an Unfavorable Impact of $0.14 Per Share related to Acquired IPR&D and Milestones Expense 1
  • Delivers Second-Quarter Net Revenues of $14.583 Billion , an Increase of 4.5 Percent on a Reported Basis and 6.1 Percent Operationally
  • Second-Quarter Global Net Revenues from the Immunology Portfolio Were $7.207 Billion , an Increase of 17.8 Percent on a Reported Basis, or 19.2 Percent on an Operational Basis; U.S. Humira Net Revenues Were $4.664 Billion , an Increase of 9.6 Percent; Internationally, Humira Net Revenues Were $699 Million , a Decrease of 13.8 Percent on a Reported Basis, or 7.3 Percent on an Operational Basis, Due to Biosimilar Competition; Global Skyrizi Net Revenues Were $1.252 Billion ; Global Rinvoq Net Revenues Were $592 Million ; Combined Global Skyrizi and Rinvoq Net Revenues Were $1.844 Billion
  • Second-Quarter Global Net Revenues from the Hematologic Oncology Portfolio Were $1.650 Billion , a Decrease of 9.1 Percent on a Reported Basis, or 7.9 Percent on an Operational Basis; Global Imbruvica Net Revenues Were $1.145 Billion , a Decrease of 17.1 Percent , with U.S. Net Revenues of $862 Million and International Profit Sharing of $283 Million ; Global Venclexta Net Revenues Were $505 Million
  • Second-Quarter Global Net Revenues from the Neuroscience Portfolio Were $1.658 Billion , an Increase of 13.7 Percent on a Reported Basis, or 15.2 Percent on an Operational Basis; Global Botox Therapeutic Net Revenues Were $678 Million ; Vraylar Net Revenues Were $492 Million
  • Second-Quarter Global Net Revenues from the Aesthetics Portfolio Were $1.371 Billion , a Decrease of 4.4 Percent on a Reported Basis, or 2.1 Percent on an Operational Basis; Global Botox Cosmetic Net Revenues Were $695 Million ; Global Juvederm Net Revenues Were $344 Million , Unfavorably Impacted by COVID-19 Restrictions in China and Suspension of Aesthetics Operations in Russia
  • Confirms 2022 Adjusted Diluted EPS Guidance Range of $13.78 - $13.98 , which Includes an Unfavorable Impact of $0.23 Per Share Related to Acquired IPR&D and Milestones Expense Incurred Year-To-Date Through the Second Quarter 2022

ABBVie (NYSE:ABBV) announced financial results for the second quarter ended June 30, 2022 .

"We delivered another strong quarter with substantial progress for our new products and indications. Importantly, Skyrizi and Rinvoq continued their impressive ramps and are on pace to deliver approximately $7.5 billion in combined annual sales, underscoring their significant potential," said Richard A. Gonzalez , chairman and chief executive officer, AbbVie. "The momentum of our business, combined with advances across our pipeline continue to support AbbVie's promising long-term outlook."

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Bristol Myers Squibb Provides Update on CheckMate -914 Trial Evaluating Opdivo Plus Yervoy as Adjuvant Treatment of Localized Renal Cell Carcinoma

Bristol Myers Squibb (NYSE: BMY) today announced that Part A of the Phase 3 CheckMate -914 trial, evaluating Opdivo (nivolumab) plus Yervoy (ipilimumab) as an adjuvant treatment for patients with localized renal cell carcinoma (RCC) who have undergone full or partial removal of the kidney and who are at moderate or high risk of relapse, did not meet the primary endpoint of disease-free survival (DFS) as assessed by Blinded Independent Central Review (BICR). The safety profile was consistent with previously reported studies of the Opdivo plus Yervoy combination in solid tumors.

"Even with notable progress in the treatment of metastatic renal cell carcinoma, there are still limited treatment options available for patients with localized disease," said Dana Walker, M.D., M.S.C.E., vice president, development program lead, genitourinary cancers, Bristol Myers Squibb. " Opdivo and Opdivo -based combinations have shown survival benefits in several earlier-stage and advanced cancers, including genitourinary tumors, and we are disappointed that the final analysis of CheckMate -914 Part A did not show this same benefit for the post-surgical treatment of patients with localized RCC. Nonetheless, we are dedicated to continuing research and advancing cancer care for all patients with RCC."

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RINVOQ® Approved by European Commission as an Oral Treatment for Adults with Active Non-Radiographic Axial Spondyloarthritis

  • With this approval, RINVOQ ® (upadacitinib 15 mg, once daily) is the first and only Janus Kinase (JAK) inhibitor approved to treat patients across the spectrum of axial spondyloarthritis (nr-axSpA and ankylosing spondylitis) in the European Union (EU) 1
  • Approval is supported by data from the Phase 3 SELECT-AXIS 2 pivotal clinical trial in which RINVOQ delivered meaningful disease control with nearly half of nr-axSpA patients achieving ASAS40 at week 14 (45 percent versus 23 percent; p 2

ABBVie (NYSE: ABBV) today announced that the European Commission (EC) has approved RINVOQ ® (upadacitinib 15 mg, once daily), an oral therapy, for the treatment of active non-radiographic axial spondyloarthritis (nr-axSpA) in adult patients with objective signs of inflammation, as indicated by elevated C-reactive protein (CRP) andor magnetic resonance imaging (MRI), who have responded inadequately to nonsteroidal anti-inflammatory drugs (NSAIDs). *1

"For years, healthcare providers and patients have had limited treatment options to manage axial spondyloarthritis, which can cause back pain, stiffness, and irreversible damage to the spine," said Thomas Hudson , M.D., senior vice president of research and development, chief scientific officer, AbbVie. "AbbVie is proud to offer RINVOQ as a first-in-class treatment option now approved in the European Union for adults living with nr-axSpA with objective signs of inflammation and inadequate response to NSAIDs. RINVOQ is the first and only JAK inhibitor approved to treat patients across the spectrum of axial spondyloarthritis, which includes nr-axSpA and ankylosing spondylitis."

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Biktarvy® Demonstrates High Efficacy for a Broad Range of People Initiating Treatment for HIV, Including Those With HBV Coinfection

ALLIANCE Trial Highlights Potential of Biktarvy for Adults with HIV and HBV Coinfection –

– No Cases of Treatment Failure Due to Resistance to Biktarvy was Detected in a Pooled Analysis of Five-Year Data from Two Phase 3 Studies –

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AbbVie Submits Regulatory Applications to FDA and EMA for Upadacitinib in Crohn's Disease

  • Submissions are supported by three Phase 3 clinical trials demonstrating upadacitinib achieved the co-primary endpoints of clinical remission and endoscopic response as induction and maintenance treatment 1-4
  • Safety results were generally consistent with the known safety profile of upadacitinib, with no new safety risks observed 1-8
  • Crohn's disease is a chronic, systemic disease that manifests as inflammation within the gastrointestinal tract, causing persistent diarrhea and abdominal pain 9,10

ABBVie (NYSE: ABBV) today announced that it has submitted applications for a new indication to the U.S. Food and Drug Administration (FDA) and European Medicines Agency (EMA) for upadacitinib (RINVOQ ® 45 mg [induction dose] and 15 mg and 30 mg [maintenance dose]) for the treatment of adult patients with moderately to severely active Crohn's disease. 4,11

"Crohn's disease can be debilitating and have a significant impact on a person's daily life," said Neil Gallagher , M.D., Ph.D., vice president, development, chief medical officer, AbbVie. "Those patients who are still suffering fuel our continued commitment to innovation in care for patients with IBD, and we look forward to potentially introducing a new treatment option for this disruptive condition."

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Aptose to Present at the Canaccord Genuity 42nd Annual Growth Conference

Aptose Biosciences Inc. ("Aptose" or the "Company") (NASDAQ: APTO, TSX: APS), a clinical-stage precision oncology company developing highly differentiated oral kinase inhibitors to treat hematologic malignancies, today announced that Dr. William G. Rice, Chairman, President and CEO of Aptose, and Mr. Fletcher Payne, CFO of Aptose, will attend the Canaccord Genuity 42nd Annual Growth Conference, and Dr. Rice will present at the Conference:

Canaccord Genuity 42 nd Annual Growth Conference

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