Core Viewpoint - A shareholder class action lawsuit has been filed against Capricor Therapeutics, Inc. alleging that the company made materially false and misleading statements regarding the safety and efficacy data from its Phase 2 HOPE-2 trial study of deramiocel [1] Group 1 - The lawsuit claims that Capricor failed to disclose material adverse information concerning its four-year safety and efficacy data [1] - The lawsuit specifically targets shareholders who purchased shares between October 9, 2024, and July 10, 2025, and experienced significant losses [2] - The deadline for shareholders to request to be appointed as lead plaintiff in the case is September 15, 2025 [3] Group 2 - Holzer & Holzer, LLC is representing the shareholders in this litigation and has a history of recovering hundreds of millions of dollars for shareholders affected by corporate misconduct [3] - The firm has been recognized as an ISS top-rated securities litigation law firm for the years 2021, 2022, and 2023 [3] - Contact information for the law firm is provided for shareholders seeking to discuss their legal rights [4]

Core Insights - Viking Therapeutics (VKTX) shares have declined over 20% in the past month, underperforming the industry growth of 1% and also lagging behind the sector and S&P 500 [1][9] - The decline followed mixed results from a mid-stage study of VK2735, an experimental obesity drug, raising concerns about its safety and tolerability despite achieving weight loss results [4][5][9] Company Pipeline and Development - VKTX is developing VK2735, a dual GLP-1 and GIP receptor agonist, showing potential in the obesity treatment space with both oral and subcutaneous formulations [6] - The phase II VENTURE study for the subcutaneous version of VK2735 met all primary and secondary endpoints, leading to the initiation of two late-stage studies expected to report results by late 2026 or early 2027 [7][8] - VKTX is also pursuing drugs for non-alcoholic steatohepatitis (NASH) and X-linked adrenoleukodystrophy (X-ALD), with promising clinical study results [10] Competitive Landscape - The obesity market is projected to reach $100 billion in the U.S. by 2030, with Eli Lilly and Novo Nordisk currently leading with their injectable drugs [11] - VKTX, along with its competitors, is racing to introduce oral weight-loss pills, with Novo's oral Wegovy under FDA review and Lilly's orforglipron showing positive late-stage study results [12][13] Financial Position and Valuation - VKTX lacks a stable revenue stream and faces significant cash burn due to ongoing clinical studies, which could impact its stock if setbacks occur [14] - The company is trading at a premium valuation, with a price/book ratio of 3.82 compared to the industry average of 3.09 [15] - Estimates for VKTX's loss per share for 2025 and 2026 have widened significantly in the past 60 days, indicating potential financial challenges ahead [17] Investment Outlook - Despite a strong cash position of $808 million and no debt, the lack of revenue and competition from larger pharmaceutical companies raises concerns for VKTX's stock [18] - The stock is currently rated Zacks Rank 4 (Sell), reflecting the challenges in justifying further investment at this stage [18]

Core Points - Editas Medicine is unveiling its lead development candidate, EDIT-401, during a webinar presentation [1] - The presentation includes forward-looking statements regarding the company's future expectations and plans [2] Company Overview - Editas Medicine is focused on developing gene editing therapies, with EDIT-401 being a significant candidate in their pipeline [1] - The company emphasizes the importance of understanding the risks associated with forward-looking statements as outlined in their annual report [2]

IPO Market Overview - In August, the A-share IPO market saw 11 companies pass the initial review, marking the highest monthly number since February 2024 [1][2] - A total of 6 companies had their IPOs terminated in August, maintaining a relatively low level [1][4] - Among the 11 companies that passed the review, 9 were approved, while one was deferred and another canceled [2] Company-Specific Insights - Tai Jin New Energy, which focuses on high-end green electrolysis equipment, faced inquiries regarding potential performance declines and extended product acceptance periods [2][3] - The average acceptance period for Tai Jin's products increased from 7-12 months in 2022-2023 to over 1 year in 2024 due to industry changes [3] - Longjin Photon and Lianxun Instruments were newly accepted for IPO, with projected revenues showing growth from 2022 to 2025 [6] Market Trends - The Hong Kong IPO market was highlighted in August, with 40 companies submitting applications, a significant increase from 21 in July [1][7] - A total of 25 A-share companies announced plans to list in Hong Kong, setting a new monthly record for 2025 [8] - In the Hong Kong market, 6 companies successfully listed in August, with notable first-day gains for several, indicating a strong "new share" market performance [8]

Management Decision Further Reinforces Commitment to Responsible Capital ManagementNEW HAVEN, Conn., Sept. 02, 2025 (GLOBE NEWSWIRE) -- Specialty cancer diagnostics company Precipio, Inc. (NASDAQ: PRPO), has terminated its ATM (At-The-Market) instrument with investment bank Alliance Global Partners (AGP). “Our Company is in a much stronger position today than it was when we entered into this structure. With our elimination of negative cash flow from operations, and our recent increases of our cash balance, ...

Core Viewpoint - Capricor Therapeutics, Inc. is facing a securities fraud class action lawsuit, with a deadline for investors to join the lawsuit approaching on September 15, 2025 [1][5]. Group 1: Lawsuit Details - The lawsuit was filed in the United States District Court for the Southern District of California on behalf of investors who purchased or acquired Capricor securities between October 9, 2024, and July 10, 2025, alleging violations of the Securities Exchange Act of 1934 [3]. - The allegations include misrepresentations regarding Capricor's four-year safety and efficacy data from the Phase 2 HOPE-2 trial study of deramiocel, the company's lead cell therapy candidate for treating cardiomyopathy associated with Duchenne muscular dystrophy [4]. Group 2: Investor Participation - Investors wishing to serve as lead plaintiffs must file necessary documents by September 15, 2025, although participation as a lead plaintiff is not required to share in any potential recovery [5]. - All legal representation in this matter is on a contingency fee basis, meaning shareholders will not incur any fees or expenses [5]. Group 3: Law Firm Background - Bernstein Liebhard LLP has recovered over $3.5 billion for clients since its establishment in 1993 and has represented both individual investors and large public and private pension funds [6]. - The firm has been recognized multiple times for its success in litigating class actions, being named to The National Law Journal's "Plaintiffs' Hot List" thirteen times and listed in The Legal 500 for sixteen consecutive years [6].

NEW YORK, Sept. 02, 2025 (GLOBE NEWSWIRE) -- Bernstein Liebhard LLP, a nationally acclaimed investor rights law firm, reminds Replimune Group, Inc. (“Replimune” or the “Company”) (NASDAQ: REPL) investors of an upcoming deadline involving a securities fraud class action lawsuit commenced against the Company. Should You Join This Class Action Lawsuit? Do you, or did you, own shares of Replimune Group, Inc. (NASDAQ: REPL)?Did you purchase your shares between November 22, 2024, and July 21, 2025, inclusive?Did ...

Summary of Ionis Pharmaceuticals Conference Call on Olicerzine Results Company Overview - **Company**: Ionis Pharmaceuticals (IONS) - **Focus**: Development of olicerzine for severe hypertriglyceridemia (SHTG) and other lipid-related conditions Key Industry Insights - **SHTG**: Severe hypertriglyceridemia is characterized by fasting serum triglyceride levels ≥ 500 mg/dL, leading to increased risk of acute pancreatitis (AP) and associated complications - **Market Need**: Over 3 million people in the U.S. are affected by SHTG, with more than 1 million at high risk for AP due to triglyceride levels above 880 mg/dL or a history of pancreatitis [12][13] Core Study Results - **Olicerzine (Olazarsen)**: Demonstrated significant efficacy in reducing triglyceride levels and AP events - **Primary Endpoint**: - CORE study: 63% reduction in fasting triglycerides with 50 mg dose, 73% with 80 mg dose (placebo-adjusted) [19] - CORE II study: 63% reduction with 50 mg, 88% with 80 mg (placebo-adjusted) [20] - **Acute Pancreatitis Events**: Achieved an 85% reduction in adjudicated AP events across both studies [21] Safety and Tolerability - **Safety Profile**: Favorable safety and tolerability observed, with adverse events balanced across treatment groups; injection site reactions were the most common [22] Commercial Strategy - **Launch Plans**: - Anticipated launch in the U.S. in the second half of next year, with preparations already underway [30] - Focus on high-risk SHTG patients, particularly those with triglycerides > 880 mg/dL or a history of pancreatitis [29] - **Sales Force Expansion**: Plans to scale the sales organization to reach approximately 20,000 healthcare providers (HCPs) specializing in cardiology, endocrinology, and lipidology [94] Regulatory and Market Potential - **Regulatory Filings**: Supplemental NDA submission planned by year-end for SHTG indication, with additional global filings expected next year [30] - **Market Opportunity**: Potential for olazarsen to become a blockbuster drug, addressing a significant unmet need in the SHTG patient population [83] Financial Considerations - **Pricing Strategy**: Pricing to be announced upon approval, reflecting the value of olazarsen in reducing triglycerides and AP events [39] - **Comparison to Competitors**: Olazarsen is expected to outperform existing treatments like Vascepa, which has shown modest triglyceride reduction and no proven benefit in reducing AP [84] Additional Insights - **Patient Population**: Approximately 60,000 patients in the U.S. have triglyceride levels > 500 mg/dL with a history of AP, representing a critical target market [102] - **Future Studies**: Full data from CORE and CORE II studies to be presented at a medical congress later this year, including detailed analysis of secondary endpoints [30][101] This summary encapsulates the key points discussed during the conference call regarding Ionis Pharmaceuticals' advancements with olicerzine, its market potential, and the strategic direction for addressing the needs of patients with severe hypertriglyceridemia.

Summary of Upstream Bio Phase Two Vibrant Top-Line Results Conference Call Company Overview - **Company**: Upstream Bio - **Lead Asset**: Virecotag, an antagonist of the TSLP receptor - **Focus**: Severe respiratory diseases, including chronic rhinosinusitis with nasal polyps (CRS with NP), severe asthma, and COPD [7][24] Industry Context - **Market Size**: Sales of therapies for CRS with NP exceed $1 billion annually and are projected to grow due to new agents and expanded use [9] - **Current Treatments**: Comparison with existing treatments like Tezepelumab and Dupilumab, highlighting the need for more frequent dosing in other agents [6][20][21] Key Clinical Trial Results - **Trial Design**: Phase Two, randomized, double-blind, placebo-controlled trial with 81 participants [11][12] - **Primary Endpoint**: Significant reduction in endoscopic nasal polyp score (NPS) by 1.8 points and nasal congestion score (NCS) by 0.8 points at 24 weeks [16][17] - **Secondary Endpoints**: Improvements in sinus opacification, total symptom score, and a 76% reduction in the need for steroids or surgery [17][22] - **Safety Profile**: Virecotag was well tolerated with no serious adverse events reported; common treatment emergent adverse events included upper respiratory infections and sinusitis [15][16] Mechanism of Action - **Potency**: Virecotag is approximately 300-fold more potent than Tezepelumab due to its unique mechanism targeting the TSLP receptor [8] - **Dosing Interval**: Administered every 12 weeks, significantly less frequent than other biologics [6][20] Future Development Plans - **Upcoming Trials**: - Valiant trial in severe asthma expected to report top-line data in Q1 2026 [7][25] - Ongoing Venture trial in COPD [7] - **Potential Expansion**: Plans to explore Virecotag's efficacy in other therapeutic areas, including dermatology and gastrointestinal diseases [7] Market Opportunity - **Unmet Need**: High interest among allergists and ENT specialists for biologics targeting TSLP in CRS with NP [9] - **Commercial Strategy**: Focus on maximizing the value of Virecotag across multiple indications with substantial unmet needs [7][24] Additional Insights - **Subgroup Analysis**: Preliminary data suggests consistent efficacy across various patient subgroups, including those with comorbid asthma [19][40] - **Long-term Efficacy**: Anticipation of greater treatment effects with longer studies, as seen with other agents [38][46] Conclusion - **Overall Sentiment**: Positive trial results reinforce the potential of Virecotag as a differentiated treatment option for CRS with NP and other respiratory diseases, with a favorable safety profile and significant clinical benefits [22][24]

Core Viewpoint - Amgen plans to invest over $600 million in a new center for science and innovation at its headquarters in Thousand Oaks, California, which is expected to create hundreds of jobs in the U.S. [1][5] Investment and Economic Impact - The new center aims to enhance collaboration among researchers, engineers, and scientists to accelerate the discovery of next-generation therapeutics [2] - Amgen has invested more than $40 billion in manufacturing and R&D in the U.S. since the Tax Cuts and Jobs Act (TCJA) of 2017, including over $5 billion in direct capital expenditures [3] - The enactment of pro-growth tax policies has facilitated Amgen's ability to invest domestically in cutting-edge science and manufacturing [3] Company Commitment and Future Plans - The new center will empower scientists with advanced tools and a collaborative environment to drive scientific excellence [4] - Construction is expected to begin in Q3 2025, further building on Amgen's recent investments, including a $900 million expansion in Central Ohio and a $1 billion investment for a second manufacturing plant in North Carolina [5] Company Background and Recognition - Amgen has been a pioneer in the biotechnology industry for over 40 years, focusing on innovative medicines for serious diseases [6] - The company has received accolades such as being named one of the "World's Most Innovative Companies" and "America's Best Large Employers" [7]