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Merck to Acquire Cidara Therapeutics, Inc., Diversifying Its Portfolio to Include Late-Phase Antiviral Agent
Businesswire· 2025-11-14 11:45
Core Insights - Merck is acquiring Cidara Therapeutics for $221.50 per share, totaling approximately $9.2 billion, to diversify its portfolio with the late-phase antiviral agent CD388 [1][2][4] Company Overview - Merck, known as MSD outside the U.S. and Canada, focuses on science-led business development and aims to enhance its pipeline with innovative therapeutics [2][12] - Cidara Therapeutics specializes in developing drug-Fc conjugate (DFC) therapeutics, with its lead candidate CD388 targeting influenza prevention [1][10] Product Details - CD388 is a long-acting, strain-agnostic antiviral agent currently in Phase 3 trials, designed to prevent influenza in high-risk individuals [1][8] - The drug has received Breakthrough Therapy Designation from the FDA, supported by positive results from the Phase 2b NAVIGATE study [2][11] Clinical Trials - The ongoing Phase 3 ANCHOR study aims to evaluate CD388's safety and efficacy among adults and adolescents at higher risk for influenza complications, with a target enrollment of 6,000 participants [9][11] - The NAVIGATE study demonstrated that CD388 met all primary and secondary endpoints for preventing symptomatic influenza in healthy adults [2][11] Strategic Importance - The acquisition is expected to enhance Merck's respiratory portfolio, addressing significant global health threats posed by influenza, which affects approximately 1 billion people annually [3][7] - Merck's global development and regulatory capabilities will support the commercialization of CD388, potentially providing a new option alongside existing vaccines and antivirals [3][4]
Pfizer Invites Public to View and Listen to Webcast of Pfizer Discussion at Healthcare Conference
Businesswire· 2025-11-12 15:00
Core Viewpoint - Pfizer is inviting the public and investors to participate in a webcast discussion at the Jefferies London Healthcare Conference, scheduled for November 19, 2025, at 9:00 a.m. GMT, featuring CFO Dave Denton [1][2]. Group 1: Webcast Details - The webcast can be accessed via Pfizer's investor website, with registration information available starting today [2]. - A transcript and replay of the discussion will be accessible on the website within 24 hours after the live event and will remain available for at least 90 days [2]. Group 2: Company Overview - Pfizer focuses on applying science and global resources to develop therapies that significantly improve patients' lives, aiming to set standards for quality, safety, and value in healthcare product development [3]. - The company collaborates with healthcare providers, governments, and communities to enhance access to affordable healthcare globally, with a history of 175 years in the biopharmaceutical industry [3]. Group 3: Legal and Financial Context - Pfizer has filed a second lawsuit against Metsera, its controlling stockholders, and Novo Nordisk, alleging anticompetitive actions by Novo Nordisk in relation to a merger proposal [8]. - The company has also responded to a Delaware Chancery Court ruling regarding a temporary restraining order related to the merger agreement with Metsera [6].
Guild: The AI trade is still in question despite the market rebound
CNBC Television· 2025-11-11 12:30
after what we saw yesterday and now this morning following Cororeweave's earnings. Again, we just mentioned uh Megga Cap Tech uh MAX7 I should say, adding over $500 billion in market cap and this morning under pressure once again following Coree. Are you starting to get concerned about some of the volatility in the tech trade.>> I I think it's actually been pretty volatile for a while. Um I I made a call uh at the end of last year saying that a VIX which is like volatility of volatility uh would be elevated ...
Assertio Reports Third Quarter 2025 Financial Results
Businesswire· 2025-11-10 21:13
Core Insights - Assertio Holdings reported strong financial results for Q3 2025, with significant growth in net product sales, particularly for Rolvedon, which saw sales increase to $38.6 million from $15.0 million year-over-year [7][2] - The company has narrowed its FY2025 net product sales guidance to a range of $110 million to $112 million and adjusted EBITDA guidance to $14 million to $16 million [5][1] - Paul Schwichtenberg has been promoted to President and COO, indicating a strategic focus on operational efficiency and commercial execution [6][8] Financial Performance - Rolvedon net product sales reached $38.6 million in Q3 2025, a 157% increase from $15.0 million in Q3 2024 [7] - Sympazan net product sales grew to $2.8 million in Q3 2025, up from $2.6 million in the prior-year quarter [7] - Indocin net product sales decreased to $4.8 million in Q3 2025 from $5.7 million in Q3 2024 due to generic competition [7] - Gross margin was reported at 72%, down from 74% in the prior-year quarter, attributed to a higher proportion of Rolvedon sales [7] - Adjusted EBITDA for Q3 2025 was $20.9 million, significantly up from $4.4 million in Q3 2024 [7] Guidance and Outlook - The updated guidance for FY2025 reflects the impact of the Rolvedon pull-forward and improved visibility into expected performance for the remainder of the year [5][2] - The company expects uninterrupted patient supply of Rolvedon, with regular sales of the newly labeled product anticipated to begin in Q2 2026 [7] Leadership Changes - Paul Schwichtenberg's promotion to President and COO is aimed at enhancing commercial strategies and driving future growth [8][6] - Schwichtenberg has a history of leadership roles within the company, focusing on operational and commercial execution [8]
Sun: NextVision jumps on TA 35 Index debut
En.Globes.Co.Il· 2025-11-09 15:05
Market Overview - The Tel Aviv Stock Exchange experienced a flat day with the Tel Aviv 35 Index decreasing by 0.03% to 3,334.88 points, while the Tel Aviv 125 Index increased by 0.07% to 3,391.87 points. The BlueTech Global Index fell by 0.44% to 591.20 points. The All Bond corporate bond index slightly decreased by 0.01% to 418.02 points. Total turnover in equities was NIS 1.41 billion and in bonds was NIS 2.09 billion [1]. Currency Exchange Rates - The shekel-dollar exchange rate was set 0.369% higher at NIS 3.265/$, and the shekel-euro rate was set 0.518% higher at NIS 3.766/€ [2]. Company Performance - Bank Leumi led the market with a decline of 0.33% on the highest trading turnover. Tower Semiconductor Ltd. experienced the largest drop on the Tel Aviv 35 Index, falling by 3.88%. Other notable declines included Teva Pharmaceutical Industries Ltd. at 1.91%, Nice at 2.97%, and Energean plc at 3.37% [3]. - NextVision had a strong debut, rising by 7.09% on its first day of trading on the Tel Aviv 35 Index, marking the largest increase for the day. Other companies that saw gains included Israel Discount Bank at 0.94%, Bank Hapoalim at 0.57%, and Phoenix Finance at 1.96% [4].
Takeda Presents New Data Showing Mezagitamab (TAK-079) Sustained Effect on Kidney Function 18 Months After Treatment in Primary IgA Nephropathy
Businesswire· 2025-11-07 16:00
Core Insights - Takeda has presented new data indicating that mezagitamab (TAK-079) shows sustained effects on kidney function in patients with primary IgA nephropathy, maintaining stable kidney function (eGFR) 18 months after the last treatment dose [1][2][4] Group 1: Clinical Study Results - In a Phase 1b open-label study, kidney function remained stable in patients with IgA nephropathy through Week 96, with a mean change in eGFR from baseline of +2.5 (95% CI: 1.8, +7.6; n=12) [4] - Patients experienced a 55.2% mean reduction in proteinuria (95% CI: 30.2, 72.6; n=13) and a 50.1% reduction in Gd-IgA1 levels by Week 96 [4][5] - Hematuria resolved in 60% of patients by Week 96, indicating significant improvements in kidney health [4] Group 2: Safety and Tolerability - Mezagitamab was generally well tolerated, with no serious adverse events, including serious hypersensitivity or injection-related reactions reported [5][6] - The study did not identify any new safety concerns, reinforcing the potential of mezagitamab as a treatment for autoimmune diseases like IgA nephropathy [5] Group 3: Future Development and Designations - Takeda is currently conducting pivotal Phase 3 clinical trials for mezagitamab in both primary IgA nephropathy and chronic immune thrombocytopenia, with patient enrollment ongoing [6] - Mezagitamab received Orphan Drug Designation from the European Medicines Agency for primary IgA nephropathy and Breakthrough Therapy Designation from the U.S. FDA for chronic immune thrombocytopenia [6]
Dr. Oz: Drugmakers' narrative that lower costs will impact innovation 'is false'
CNBC Television· 2025-11-07 15:30
there's no there's not as much innovation over there and if we import those price controls here the argument is from the pharmaceutical industry that they're not going to be able to afford innovation and testing out new drug is is that totally false or is the truth somewhere in the middle >> I think that specific narrative is false and I my evidence for that is all these drug companies Eli Liy and Novo Norris are well-run companies their CEOs were in the Oval Office they came there willingly they were not h ...
Worldwide Exchange: ETF Flows Week of November 3
CNBC Television· 2025-11-07 12:29
Welcome to CBC. com. I'm Frank Colin, anchor of Worldwide Exchange.We are taking a look at the ETF market, which as of today has $1.13% trillion in net inflows, just a tick below the record set last year. And we are on pace for another record year this year. With that, I want to bring in my guest for today.It's Anaket Ulfra, head of their ETF business. Anakette, thanks for joining us. >> Thanks for having me, Frank.Um, first off, let me talk to you about the fact that ETF inflows are going to hit a record f ...
Stocks Waver Ahead of UMich. Data; Shutdown Flight Cancellations Begin | Bloomberg Brief 11/07/2025
Bloomberg Television· 2025-11-07 12:15
>> IT IS 10:00 A.M. IN LONDON AND 5:00 A.M. IN NEW YORK CITY. LET US GET STARTED WITH WHAT YOU NEED TO KNOW. A TERRIBLE WEEK FOR TECH. VALUATION WORRIES KNOCKING GLOBAL EQUITIES. MID-CAP STOCKS SELLOFF DESPITE POCKETS OF POSITIVE EARNINGS REPORTS. THE TESLA TRILLIONAIRE. SHAREHOLDERS APPROVE A ONE TRILLION DOLLAR COMPENSATION PACKAGE TO ELON MUSK MARKING THE LARGEST PAYOFF EVER AWARDED TO A CEO. AIRLINES BEGIN CANCELING FLIGHTS AS THE GOVERNMENT SHUTDOWN DRAGS ON. WE ARE LIVE ON THE GROUND. LET US GET A QUI ...
Organon To Report Third Quarter 2025 Results and Host Conference Call on November 10, 2025
Businesswire· 2025-11-06 12:30
Nov 6, 2025 7:30 AM Eastern Standard Time Organon To Report Third Quarter 2025 Results and Host Conference Call on November 10, 2025 Share JERSEY CITY, N.J.--(BUSINESS WIRE)--Organon (NYSE: OGN), a global healthcare company with a primary focus on women's health, will release its third quarter 2025 financial results on November 10, 2025, prior to the company's webcast and conference call scheduled for 8:30 a.m. ET. The webcast and conference call will be hosted by Carrie Cox, Organon's Executive Board Chair ...