Key Takeaways INCY's Monjuvi gets FDA approval for use in relapsed or refractory follicular lymphoma. The approval was backed by phase III inMIND data showing improved progression-free survival. This marks the second U.S. approval for Monjuvi in a blood cancer indication.Incyte (INCY) announced that the FDA has approved its humanized Fc-modified cytolytic CD19-targeting monoclonal antibody, Monjuvi (tafasitamab-cxix), for a new cancer indication.The U.S. regulatory body approved Monjuvi in combination wit ...

Core Viewpoint - Class action lawsuits have been filed against Viatris Inc. and Canopy Growth Corporation, alleging that both companies made materially false and misleading statements regarding their business operations and financial prospects during specified class periods [2][3]. Viatris Inc. (NASDAQ: VTRS) - Class Period: August 8, 2024 – February 26, 2025 - Lead Plaintiff Deadline: June 3, 2025 - Allegations include failure to disclose the significant impact of a failed FDA inspection at the Indore facility, which affected the company's ability to manufacture and ship key products, particularly Lenalidomide [2]. - The complaint states that the positive statements made by the defendants regarding the company's business were materially misleading and lacked a reasonable basis [2]. Canopy Growth Corporation (NASDAQ: CGC) - Class Period: May 30, 2024 – February 6, 2025 - Lead Plaintiff Deadline: June 3, 2025 - Allegations include incurring significant costs related to the production of Claybourne pre-rolled joints and the Storz & Bickel vaporizer devices, which negatively impacted the company's gross margins and overall financial results [3]. - The complaint asserts that the defendants overstated the efficacy of cost reduction measures and downplayed issues affecting gross margins, leading to materially misleading statements about the company's business [3].

Core Viewpoint - Faruqi & Faruqi, LLP is investigating potential claims against Viatris, Inc. due to allegations of violations of federal securities laws related to misleading statements and undisclosed information impacting the company's revenue outlook and growth projections [2][4]. Group 1: Legal Investigation and Class Action - The firm is reminding investors of the June 3, 2025 deadline to seek the role of lead plaintiff in a federal securities class action against Viatris [2]. - The complaint alleges that Viatris and its executives made false statements and failed to disclose significant risks related to a failed FDA inspection at its Indore facility, which adversely affected the company's financial outlook [4]. - The class action lawsuit claims that Viatris downplayed the impact of the FDA inspection and the resulting remediation efforts, which significantly hindered the company's ability to manufacture and ship key products [4]. Group 2: Financial Impact and Stock Performance - On February 27, 2025, Viatris announced disappointing financial results for Q4 and full fiscal year 2024, attributing below-expectation guidance to the financial impact from the Indore facility's warning letter and import alert [5]. - Following the announcement, Viatris' stock price dropped from $11.24 per share on February 26, 2025, to $9.53 per share on February 27, 2025, marking a decline of approximately 15.21% in one day [6].

Core Viewpoint - A lawsuit has been filed against Viatris Inc. and certain senior executives for potential violations of federal securities laws, stemming from misleading statements regarding the company's operational conditions and the impact of a failed FDA inspection on its financial performance [1][2][3]. Group 1: Lawsuit Details - The lawsuit is pending in the U.S. District Court for the Western District of Pennsylvania, captioned Quinn v. Viatris Inc., et al., No. 25-cv-466, with investors having until June 3, 2025, to seek lead plaintiff status [2]. - The complaint alleges violations under Sections 10(b) and 20(a) of the Securities Exchange Act of 1934 on behalf of investors who purchased Viatris securities [2]. Group 2: Company Background and Allegations - Viatris is a global healthcare company that provides medicines to approximately 1 billion patients across over 165 countries [3]. - The complaint claims that Viatris misrepresented the condition of its facilities, stating they were in "good operating condition" and suitable for their intended purposes, while downplaying the significance of a Warning Letter from the FDA following a failed inspection at its Indore, India facility [3][4]. Group 3: Financial Impact - The failed FDA inspection has had a substantial negative impact on Viatris's financial results, preventing the company from manufacturing and distributing key products, including Lenalidomide [4]. - In its Q4 2024 results released on February 27, 2025, Viatris disclosed that the inspection's repercussions would lower 2025 revenue by approximately $500 million and earnings from operations by about $385 million [5]. - Following this announcement, Viatris's stock price fell roughly 15%, from $11.24 per share on February 26, 2025, to $9.53 per share on February 27, 2025 [5].

Core Viewpoint - A lawsuit has been filed against Viatris Inc. and certain senior executives for potential violations of federal securities laws, stemming from misleading statements regarding the company's operational conditions and the impact of a failed FDA inspection on its financial performance [1][2][3]. Group 1: Lawsuit Details - The lawsuit is pending in the U.S. District Court for the Western District of Pennsylvania, titled Quinn v. Viatris Inc., et al., No. 25-cv-466, with investors having until June 3, 2025, to seek lead plaintiff status [2]. - The complaint alleges violations under Sections 10(b) and 20(a) of the Securities Exchange Act of 1934 on behalf of investors who purchased Viatris securities [2]. Group 2: Company Background and Allegations - Viatris is a global healthcare company that provides medicines to approximately 1 billion patients across over 165 countries [3]. - The complaint claims that Viatris misrepresented the condition of its facilities, stating they were in "good operating condition" and suitable for their intended purposes, while downplaying the significance of a Warning Letter from the FDA following a failed inspection at its Indore, India facility [3][4]. Group 3: Financial Impact - The failed FDA inspection has had a substantial negative impact on Viatris's financial results, preventing the company from manufacturing and distributing key products, including Lenalidomide [4]. - In the Q4 2024 results released on February 27, 2025, Viatris disclosed that the failed inspection would lower 2025 revenue by approximately $500 million and earnings from operations by approximately $385 million [5]. - Following this announcement, Viatris's stock price fell about 15%, from $11.24 per share on February 26, 2025, to $9.53 per share on February 27, 2025 [5].

Core Viewpoint - A class action lawsuit has been filed against Viatris Inc. for allegedly misleading investors regarding the company's revenue and growth challenges, particularly related to a failed FDA inspection at its Indore facility [3][4]. Group 1: Class Action Details - The class action represents investors who purchased Viatris securities between August 8, 2024, and February 26, 2025, with a deadline of June 3, 2025, to file a lead plaintiff motion [1]. - Investors are encouraged to contact the Portnoy Law Firm for legal rights discussions and complimentary case evaluations [2]. Group 2: Allegations Against Viatris - The lawsuit claims that Viatris downplayed the seriousness of the failed FDA inspection and its consequences, leading to a false impression of the company's stability [3]. - It is alleged that Viatris underestimated the impact of the FDA inspection failure, which resulted in significant setbacks, including ongoing remediation efforts and disruptions in manufacturing and shipping key products like Lenalidomide [4]. Group 3: Financial Impact - On February 27, 2025, Viatris reported disappointing fourth-quarter and full-year 2024 financial results, along with guidance for fiscal year 2025 that reflected the expected financial effects of the FDA warning letter [5]. - Following this announcement, Viatris' stock price experienced a decline of over 15% [5].

Core Viewpoint - A lawsuit has been filed against Viatris Inc. and certain senior executives for potential violations of federal securities laws, stemming from misleading statements regarding the company's operational conditions and the impact of a failed FDA inspection on its financial performance [1][2][3]. Group 1: Lawsuit Details - The lawsuit is pending in the U.S. District Court for the Western District of Pennsylvania, titled Quinn v. Viatris Inc., et al., No. 25-cv-466, with investors having until June 3, 2025, to seek lead plaintiff status [2]. - The complaint alleges violations under Sections 10(b) and 20(a) of the Securities Exchange Act of 1934 on behalf of investors who purchased Viatris securities [2]. Group 2: Company Background and Allegations - Viatris is a global healthcare company that provides medicines to approximately 1 billion patients across over 165 countries [3]. - The complaint claims that Viatris misrepresented its facilities as being in "good operating condition" and suitable for their intended purposes, while downplaying the significance of a Warning Letter issued by the FDA following a failed inspection at its Indore, India facility [3][4]. Group 3: Financial Impact - The failed FDA inspection has had a substantial negative impact on Viatris's financial results, hindering the company from manufacturing and distributing key products, including Lenalidomide [4]. - In the Q4 2024 results released on February 27, 2025, Viatris disclosed that the inspection's repercussions would lower 2025 revenue by approximately $500 million and earnings from operations by about $385 million [5]. - Following this announcement, Viatris's stock price fell roughly 15%, from $11.24 per share on February 26, 2025, to $9.53 per share on February 27, 2025 [5].

Core Viewpoint - GSK's Blenrep combination therapy has received a positive opinion from the EMA's CHMP for treating relapsed or refractory multiple myeloma, marking a significant step towards regulatory approval in Europe and the United States [1][2][3]. Group 1: Regulatory Developments - The CHMP recommended Blenrep in combination with J&J's Velcade and dexamethasone, as well as with Bristol Myers' Pomalyst and dexamethasone for adult patients who have undergone at least one prior therapy [2]. - The European Commission will review the CHMP's opinion, with a decision expected in Q3 2025 [3]. - Blenrep combinations have already been approved in the UK and Japan in April and May 2025, respectively, and are under review in China, Canada, and Switzerland [8]. Group 2: Clinical Data - Data from the III DREAMM-7 and DREAMM-8 studies indicated that Blenrep combinations resulted in statistically significant improvements in progression-free survival (PFS) and overall survival compared to standard treatments [4]. - The safety and tolerability profiles of Blenrep combinations were consistent with the known profiles of the individual agents used in the studies [4]. Group 3: Market Performance - GSK's shares have increased by 14.3% year-to-date, contrasting with a 5.5% decline in the industry [5]. - The company is also awaiting a decision from the FDA regarding the Blenrep combination therapy, expected on July 23, 2025 [7]. Group 4: Historical Context - Blenrep was previously withdrawn from the U.S. market in November 2022 after failing to meet the primary endpoint in the DREAMM-3 study, which evaluated its efficacy as a monotherapy [9]. - The company aims to reintroduce Blenrep to the market for patients with relapsed or refractory multiple myeloma following the recent positive developments [10].

Core Viewpoint - A lawsuit has been filed against Viatris Inc. and certain senior executives for potential violations of federal securities laws, stemming from misleading statements regarding the company's operational status and the impact of a failed FDA inspection on its financial performance [1][2][3]. Group 1: Lawsuit Details - The lawsuit is pending in the U.S. District Court for the Western District of Pennsylvania, titled Quinn v. Viatris Inc., et al., No. 25-cv-466, with claims under Sections 10(b) and 20(a) of the Securities Exchange Act of 1934 [2]. - Investors have until June 3, 2025, to request to be appointed to lead the case [2]. Group 2: Company Background and Allegations - Viatris is a global healthcare company that provides medicines to approximately 1 billion patients across over 165 countries [3]. - The complaint alleges that Viatris misrepresented its facilities as being in "good operating condition" and committed to high-quality manufacturing standards, despite a Warning Letter from the FDA following a failed inspection at its Indore, India facility [3][4]. Group 3: Financial Impact - The failed FDA inspection has significantly impacted Viatris's financial results, preventing the company from manufacturing and distributing key products, including Lenalidomide [4]. - In its Q4 2024 results, Viatris disclosed that the negative impact from the Indore facility's inspection would reduce 2025 revenue by approximately $500 million and earnings from operations by about $385 million [5]. - Following this announcement, Viatris's stock price fell roughly 15%, from $11.24 per share on February 26, 2025, to $9.53 per share on February 27, 2025 [5].

NEW YORK, May 23, 2025 (GLOBE NEWSWIRE) -- Leading securities law firm Bleichmar Fonti & Auld LLP announces that a lawsuit has been filed against Viatris Inc. (NASDAQ: VTRS) and certain of the Company’s senior executives for potential violations of the federal securities laws. If you invested in Viatris, you are encouraged to obtain additional information by visiting https://www.bfalaw.com/cases-investigations/viatris-inc. Investors have until June 3, 2025, to ask the Court to be appointed to lead the case. ...