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Berger Montague Reminds Organon & Co. (NYSE: OGN) Investors With Substantial Losses to Inquire About a Securities Fraud Class Action by July 22, 2025
Prnewswire· 2025-07-14 20:06
Core Viewpoint - A securities class action lawsuit has been filed against Organon & Co. for failing to disclose risks related to Nexplanon sales growth, which impacted investor expectations and stock performance [1][3]. Summary by Sections Lawsuit Details - The lawsuit represents purchasers of Organon securities from November 3, 2022, to April 30, 2025, alleging that the company did not disclose a higher risk of loss of exclusivity and price erosion for Nexplanon [1][3]. Investor Information - Investors who acquired Organon securities during the class period have until July 22, 2025, to seek appointment as lead plaintiff [2]. Financial Impact - On May 1, 2025, Organon announced a significant reduction in its dividend payout from $0.28 to $0.02 per share, indicating a shift in capital allocation priorities towards deleveraging [4]. - Following this announcement, Organon’s stock price fell by $3.48, approximately 27%, from $12.93 to $9.45 per share [4].
60 Degrees Pharmaceuticals to Submit MUMS (Minor Use/Minor Species) Designation Request to FDA for Tafenoquine for Acute Canine Babesiosis in 2025
Globenewswire· 2025-07-14 20:01
Data from three independent clinical studies demonstrate utility of tafenoquine to treat acute canine babesiosis WASHINGTON, July 14, 2025 (GLOBE NEWSWIRE) -- 60 Degrees Pharmaceuticals, Inc. (NASDAQ: SXTP; SXTPW) (“60 Degrees” or the “Company”), a pharmaceutical company focused on developing new medicines for infectious diseases, today announced that the Company will conduct a gap analysis of its existing data prior to submitting a Minor Use Minor Species (MUMS) designation request to the United States Foo ...
New 3-Year Phase 3 Data Confirmed Sustained Response to TransCon® PTH (Palopegteriparatide) Therapy in Adults with Hypoparathyroidism, Including Improvements in Biochemistries, Kidney Function, and Quality of Life
GlobeNewswire News Room· 2025-07-14 20:01
COPENHAGEN, Denmark, July 14, 2025 (GLOBE NEWSWIRE) -- Ascendis Pharma A/S (Nasdaq: ASND) today announced new data from Week 156 of its Phase 3 PaTHway Trial confirming that long-term treatment with TransCon PTH (palopegteriparatide) continued to provide a durable response in adults with hypoparathyroidism regardless of its cause (post-surgical, autoimmune, genetic, or idiopathic), including improvements in biochemistries, kidney function, and quality of life. Results were shared over the weekend in an oral ...
HIMS Investors Have Opportunity to Lead Hims & Hers Health, Inc. Securities Fraud Lawsuit
Prnewswire· 2025-07-14 18:23
Core Viewpoint - Rosen Law Firm is reminding investors who purchased common stock of Hims & Hers Health, Inc. during the specified Class Period of the upcoming lead plaintiff deadline for a class action lawsuit [1][2] Group 1: Class Action Details - The Class Period for the lawsuit is from April 29, 2025, to June 23, 2025, and the lead plaintiff deadline is August 25, 2025 [1] - Investors who purchased Hims common stock during the Class Period may be entitled to compensation without any out-of-pocket fees through a contingency fee arrangement [1] Group 2: Legal Representation - Investors are encouraged to select qualified legal counsel with a proven track record in securities class actions, as many firms may not have the necessary experience or resources [3] - Rosen Law Firm has a history of successful settlements, including the largest securities class action settlement against a Chinese company at the time, and has recovered hundreds of millions for investors [3] Group 3: Case Allegations - The lawsuit alleges that Hims & Hers made false and misleading statements regarding its partnership with Novo Nordisk A/S, which affected investor decisions [4] - Specific claims include the failure to disclose the nature of the collaboration with Novo, the approval of Hims' compounded semaglutide products, and the availability of branded Wegovy alongside these products [4]
Amylyx Drug Slashes Sugar Spikes Post-Weight Loss Surgery
Benzinga· 2025-07-14 18:15
Core Insights - Amylyx Pharmaceuticals presented new exploratory analyses of avexitide at the Endocrine Society's annual meeting, focusing on its potential to treat post-bariatric hypoglycemia (PBH) [1] Group 1: Clinical Trials and Efficacy - The Phase 2b trial of avexitide showed a 64% reduction in moderate to severe hypoglycemic events with a 90 mg once-daily dose, and over half of participants experienced no such events during treatment [2] - The ongoing Phase 3 LUCIDITY trial is evaluating avexitide's safety and efficacy in approximately 75 patients with PBH following Roux-en-Y gastric bypass surgery, with a primary endpoint of reducing Level 2 and 3 hypoglycemic events [3] - Previous trials demonstrated consistent, dose-dependent reductions in hypoglycemic events, with the 90 mg dose showing sustained 24-hour GLP-1 receptor inhibition [4] Group 2: Safety Profile and Future Prospects - Across five clinical trials, avexitide has shown statistically and clinically meaningful efficacy with a favorable safety profile [5] - LUCIDITY is expected to complete enrollment in 2025, with top-line results anticipated in the first half of 2026 and a potential commercial launch in 2027 [5] Group 3: Market Impact - Following the presentation of these findings, AMLX stock increased by 7.55%, reaching $8.26 [5]
Is Bristol-Myers Squibb Still An Undervalued Biopharma Play?
Benzinga· 2025-07-14 17:52
Core Viewpoint - Bristol-Myers Squibb is preparing to announce its Q2 2025 earnings, with expectations of adjusted earnings of $1.585 per share and sales of $11.31 billion, despite slight downward revisions in revenue and earnings estimates for 2025 [1][2]. Financial Performance - The company anticipates a low-single-digit percentage increase in total revenue for the later 2020s, primarily due to updated assumptions for its cancer drug Yervoy [2][4]. - Bank of America Securities has revised the company's earnings model, showing a decline of more than 1% in total revenue and EPS for Q2, with similar trends for 2025 [3][4]. Product Performance and Market Dynamics - Key products such as Pomalyst, Revlimid, Camzyos, and Orencia are expected to face significant headwinds due to U.S. drug pricing reforms [5]. - The earnings call will focus on the commercial performance of products like Cobenfy, Camzyos, Reblozyl, and Breyanzi, which are crucial for immediate revenue streams [7][8]. Industry Challenges - The evolving landscape of U.S. drug pricing policies, including the 'most favored nation' rule and potential pharma-specific tariffs, poses systemic pressures on the pharmaceutical industry, affecting Bristol-Myers Squibb [6]. - The company is expected to face several challenging years ahead, with anticipated earnings declines driven by generic competition [10]. Valuation Insights - Bristol-Myers Squibb is considered one of the cheaper companies in large-cap biopharma, with a price-to-earnings ratio of 7 to 8 times expected 2025 earnings, comparable to peers like Pfizer, GSK, Biogen, and Merck [9].
Exelixis (EXEL) is an Incredible Growth Stock: 3 Reasons Why
ZACKS· 2025-07-14 17:46
Core Viewpoint - Growth stocks are appealing due to their potential for above-average financial growth, but identifying the right ones can be challenging due to associated risks and volatility [1] Group 1: Company Overview - Exelixis (EXEL) is highlighted as a promising growth stock, possessing a favorable Growth Score and a top Zacks Rank [2] - The company has a historical EPS growth rate of 28.3%, with projected EPS growth of 31.8% this year, surpassing the industry average of 19.8% [5] - Exelixis has achieved a year-over-year cash flow growth of 135.6%, significantly higher than the industry average of -4.5% [6] Group 2: Financial Metrics - Earnings growth is crucial for attracting investor attention, with double-digit growth being particularly favorable [4] - The annualized cash flow growth rate for Exelixis over the past 3-5 years is 10.8%, compared to the industry average of 3.7% [7] - There has been a positive trend in earnings estimate revisions for Exelixis, with a 1.3% increase in the current-year earnings estimates over the past month [9] Group 3: Investment Positioning - Exelixis has earned a Growth Score of A and a Zacks Rank 2 due to positive earnings estimate revisions, positioning it well for potential outperformance [11]
Andrew Hill Dumps 38,000 Johnson & Johnson Shares in Q2 2025 Exit
The Motley Fool· 2025-07-14 15:54
On July 11, 2025, Andrew Hill Investment Advisors, Inc. disclosed it sold out its entire Johnson & Johnson (JNJ -0.60%) position, totaling $6.31 million in trades.What happenedAccording to a July 10, 2025 SEC filing, the firm exited its entire position in Johnson & Johnson during Q2 2025, selling all 38,037 shares for $6,308,131 in reported transaction value. Andrew Hill Investment Advisors no longer holds JNJ shares as of June 30, 2025, based on 13F disclosures.What else to knowThe sale represents a full e ...
FDA Accepts GSK Filing for Expanded Use of RSV Shot in Younger Adults
ZACKS· 2025-07-14 15:16
Core Insights - GSK's RSV vaccine, Arexvy, has received FDA acceptance for expanded use in high-risk adults under 50, with a final decision expected in the first half of 2026 [1][2] - Arexvy is currently approved for individuals aged 60 and older, and for high-risk individuals aged 50-59, and if approved for the younger demographic, it will be the third FDA-approved RSV vaccine for this age group [2][9] - GSK's stock has performed well, gaining 13% year-to-date compared to a 1% decline in the industry [4] Regulatory Developments - A similar regulatory filing for Arexvy was accepted by the EMA, with approval anticipated early next year [3] - The filing is backed by late-stage study data demonstrating Arexvy's safety profile consistent with previous studies [2][8] Sales Performance - Arexvy's sales declined by 51% year-over-year to £590 million (approximately $755 million) in full-year 2024, primarily due to narrower vaccination recommendations from the U.S. Advisory Committee on Immunization Practices (ACIP) [6][8] - The ACIP recommended Arexvy for adults aged 75 and older, but limited vaccination for those aged 60-74 to individuals at increased risk, reducing the eligible population [7][8] Competitive Landscape - GSK's competitive position has weakened as Pfizer and Moderna have gained broader regulatory approvals for their RSV vaccines, covering high-risk individuals aged 18-74 [9] - The CDC has updated guidelines to recommend vaccination for high-risk adults aged 50-59, a group for which Arexvy is already approved, improving the outlook for the upcoming RSV season [10] - All three vaccine-makers, GSK, Pfizer, and Moderna, are on relatively equal footing due to the absence of CDC guidance for high-risk adults under 50, with pending regulatory decisions likely to influence market dynamics [11]
Best Momentum Stocks to Buy for July 14th
ZACKS· 2025-07-14 15:01
Group 1: Eledon Pharmaceuticals, Inc. (ELDN) - Eledon Pharmaceuticals is a clinical stage biotechnology company with a Zacks Rank 1 [1] - The Zacks Consensus Estimate for its current year earnings increased by 23.8% over the last 60 days [1] - Eledon's shares gained 22.2% over the past month, outperforming the S&P 500's advance of 3.8% [1] - The company has a Momentum Score of A [1] Group 2: KDDI Corporation (KDDIY) - KDDI Corporation is a Japanese telecommunications services company with a Zacks Rank 1 [2] - The Zacks Consensus Estimate for its current year earnings increased by 39.7% over the last 60 days [2] - KDDI's shares gained 5.9% over the last six months, slightly outperforming the S&P 500's advance of 5.2% [2] - The company has a Momentum Score of B [2] Group 3: Penguin Solutions, Inc. (PENG) - Penguin Solutions is a designer and developer of enterprise solutions with a Zacks Rank 1 [3] - The Zacks Consensus Estimate for its current year earnings increased by 14.2% over the last 60 days [3] - Penguin's shares gained 41.2% over the last three months, significantly outperforming the S&P 500's advance of 16% [3] - The company has a Momentum Score of A [3]