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Regeneron Reports Third Quarter 2025 Financial and Operating Results
Globenewswire· 2025-10-28 10:30
Third quarter 2025 revenues increased 1% to $3.75 billion versus third quarter 2024Dupixent® global net sales (recorded by Sanofi) increased 27% to $4.86 billion EYLEA HD® U.S. net sales increased 10% to $431 million; total EYLEA HD and EYLEA® U.S. net sales decreased 28% to $1.11 billion GAAP EPS of $13.62 and non-GAAP EPS(a) of $11.83; third quarter 2025 includes unfavorable $0.68 impact from acquired IPR&D chargeFDA approved Libtayo® as the first and only immunotherapy for high-risk adjuvant cutaneous sq ...
Karolinska Development invests SEK 7.5 million to support BOOST Pharma's continued development of BT-101 towards Phase 3
Globenewswire· 2025-10-28 10:06
Core Insights - Karolinska Development AB has invested SEK 7.5 million in BOOST Pharma's financing round, which totals SEK 15 million, aimed at advancing the clinical development of BT-101 for osteogenesis imperfecta [1][3][4] Company Overview - BOOST Pharma is a clinical-stage biopharmaceutical company focused on developing BT-101, a mesenchymal stem cell therapy for infants with osteogenesis imperfecta, a condition that leads to fragile bones and frequent fractures [2][3] - The financing will help BOOST Pharma accelerate its clinical program and work towards providing the first disease-modifying therapy for osteogenesis imperfecta [2] Clinical Development - Following positive results from the Phase 2 BOOSTB4 study, which showed a reduction in fracture rate of over 75% in children treated with BT-101, BOOST Pharma is preparing for a pivotal Phase 3 trial [3] - The BOOSTB4 trial demonstrated that BT-101 was safe and well-tolerated [3] Investment and Ownership - Karolinska Development holds a 14% ownership stake in BOOST Pharma, reflecting its commitment to supporting the development of innovative therapies [4]
Karolinska Development invests SEK 7.5 million to support BOOST Pharma’s continued development of BT-101 towards Phase 3
Globenewswire· 2025-10-28 10:06
Core Insights - Karolinska Development AB has invested SEK 7.5 million in BOOST Pharma's financing round, which totals SEK 15 million, aimed at advancing the clinical development of BT-101 for osteogenesis imperfecta [1][3][4] Company Overview - BOOST Pharma is a clinical-stage biopharmaceutical company focused on developing BT-101, a mesenchymal stem cell therapy for infants with osteogenesis imperfecta, a condition that leads to fragile bones and frequent fractures [2][3] - The financing will help BOOST Pharma accelerate its clinical program and work towards providing the first disease-modifying therapy for osteogenesis imperfecta [2] Clinical Development - Following positive results from the Phase 2 BOOSTB4 study, which demonstrated a reduction in fracture rate of over 75% in children with osteogenesis imperfecta, BOOST Pharma is preparing for a pivotal Phase 3 trial of BT-101 [3] - The BOOSTB4 trial indicated that BT-101 was safe and well-tolerated [3] Investment and Ownership - Karolinska Development's ownership stake in BOOST Pharma is 14% [4] - The financing round included equal participation from Industrifonden and Karolinska Development, highlighting collaborative investment efforts in the biopharmaceutical sector [3]
CSL Limited (CSLLY) Shareholder/Analyst Call Transcript
Seeking Alpha· 2025-10-28 08:57
Core Points - The meeting is the 2025 Annual General Meeting of CSL, emphasizing the company's commitment to starting on time [2] - A video presentation features a patient, Melissa, who has hereditary angioedema (HAE), highlighting the effectiveness of CSL's products in managing her condition [2] - CSL's annual report is available for further insights into the company's purpose and its impact on patients' lives [3]
Press release: Sanofi successfully prices USD 3 billion of bond issue
Globenewswire· 2025-10-28 06:00
Sanofi successfully prices USD 3 billion of bond issue Paris, France – October 28, 2025 - Sanofi announces that it has successfully priced its offering of $3 billion of notes across 5 tranches: $400 million fixed rate notes, due November 2027, bearing interest at a rate of 3.75%. $500 million floating rate notes, due November 2027, bearing interest at compounded SOFR plus 0.46%. $400 million fixed rate notes, due November 2028, bearing interest at a rate of 3.80%. $500 million floating rate notes, due No ...
CSL tumbles -15% as it points to reduced vaccination rates in US; lower Chinese demand
The Market Online· 2025-10-28 00:42
CSL Limited (ASX:CSL) has tumbled nearly -15% in the first hour of Tuesday trades after the market balked at its latest AGM, particularly news that the Australian company expects the influenza vaccination rate in the U.S. to decline -12%.Listen to the HotCopper podcast for in-depth discussions and insights on all the biggest headlines from throughout the week. On Spotify, Apple, and more. That decline will see revenues from that segment decline by a number ‘in the mid-teens,’ CSL confirmed on Tuesday, a wor ...
SHAREHOLDER ALERT: DiCello Levitt LLP Announces That A Shareholder Class Action Has Been Filed Against MoonLake Immunotherapeutics (NASDAQ: MLTX)
Globenewswire· 2025-10-28 00:04
Core Viewpoint - A class action lawsuit has been filed against MoonLake Immunotherapeutics, alleging violations of federal securities laws due to false and misleading statements regarding the company's business and prospects [1][6]. Company Overview - MoonLake Immunotherapeutics is a Swiss clinical-stage biotechnology company focused on inflammatory diseases driven by interleukin-17 (IL-17), particularly in dermatology and rheumatology [4]. - The company's sole drug candidate, sonelokimab (SLK), is primarily developed for hidradenitis suppurativa (HS) and also targets psoriatic arthritis, psoriasis, and axial spondyloarthritis [4]. Clinical Development - MoonLake began its Phase 2b MIRA trial of sonelokimab in May 2022, reporting positive top-line results in June 2023, achieving its primary HiSCR75 endpoint [5]. - Follow-up data in October 2023 indicated further improvement with continued treatment, and both the FDA and EMA endorsed the proposed Phase 3 program, which began patient screening in May 2024 [5]. Allegations and Stock Impact - The lawsuit claims that throughout the class period, the defendants made false statements regarding the efficacy of SLK compared to traditional monoclonal antibodies, including claims about molecular targets and clinical benefits [6]. - On September 28, 2025, MoonLake announced that SLK failed to demonstrate competitive efficacy relative to the traditional monoclonal structure BIMZELX, leading to a significant stock price drop of $55.75 per share, or 89.9%, closing at $6.24 on September 29, 2025 [7].
Roivant to Report Financial Results for the Second Quarter Ended September 30, 2025, and Provide Business Update on Monday, November 10, 2025
Globenewswire· 2025-10-27 20:10
BASEL, Switzerland and LONDON and NEW YORK, Oct. 27, 2025 (GLOBE NEWSWIRE) -- Roivant (Nasdaq: ROIV) today announced that it will host a live conference call and webcast at 8:00 a.m. ET on Monday, November 10, 2025, to report its financial results for the second quarter ended September 30, 2025, and provide a business update. To access the conference call by phone, please register online using this registration link. The presentation and webcast details will also be available under “Events & Presentations” ...
Avidity Biosciences Soars After $72 Per Share Novartis Takeover
Benzinga· 2025-10-27 18:52
Avidity Biosciences, Inc. (NASDAQ:RNA) stock surged after announcing a $12 billion all-cash acquisition by Novartis AG (NYSE:NVS), marking one of the largest biotech buyouts of the year.Analyst Downgrade Matches $72 Per Share OfferH.C. Wainwright analysts led by Ananda Ghosh downgraded Avidity Biosciences to Neutral from Buy and set a $72 price forecast, matching the cash offer from Novartis AG.The analysts’ move follows Avidity’s announcement that it will be acquired by Novartis for $72 per share, valuing ...
Is Halozyme Stock a Portfolio Must-Have Ahead of Q3 Earnings?
ZACKS· 2025-10-27 17:45
Core Insights - Halozyme Therapeutics (HALO) is set to report its third-quarter 2025 results on November 3, with sales and earnings estimates at $336.9 million and $1.62 per share respectively [1][7] - Earnings estimates for 2025 have risen from $6.01 to $6.18 per share over the past 60 days [1] Earnings Performance - Halozyme has a strong history of earnings surprises, having exceeded earnings expectations in the last four quarters with an average surprise of 19.74% [2][3] - The most recent quarter saw an earnings surprise of 25.20% [2] Earnings Prediction Model - The company's earnings prediction model indicates a likely earnings beat, supported by a positive Earnings ESP of +2.53% and a Zacks Rank of 3 (Hold) [4][5] Revenue Drivers - The anticipated revenue for Q3 2025 is expected to be bolstered by royalty gains from partnerships with Roche, J&J, and argenx [7][9] - Halozyme's collaboration agreements with large pharmaceutical companies utilizing its ENHANZE technology are key revenue contributors, generating royalties, milestone payments, and annual license fees [8] Recent Developments - Halozyme has entered into an agreement to acquire Elektrofi for $750 million, which is expected to enhance its drug delivery technology and support long-term revenue growth [11][12] - The company reaffirmed its 2025 revenue guidance, expecting total revenues between $1.28 billion and $1.36 billion, with royalty revenues projected at $825-$860 million [13] Stock Performance and Valuation - Year-to-date, Halozyme's shares have increased by 38.4%, outperforming the industry and the S&P 500 [14] - The stock is currently trading at a price-to-sales ratio of 6.97, which is above the industry average of 2.26 but below its five-year mean of 8.41 [16] Financial Position - Halozyme maintains a strong financial position with $548 million in cash and no near-term debt, providing sufficient liquidity for operations [17] Growth Potential - The company is expected to benefit from higher royalties and incremental contributions from proprietary products, alongside the diversification from the Elektrofi acquisition [18] - Analysts have a positive outlook on the stock, reflected in rising earnings estimates [20]