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Arcellx initiated, Cummins upgraded: Wall Street's top analyst calls
Yahoo Finance· 2025-12-22 14:47
Upgrades - Bradesco BBI upgraded Volaris (VLRS) to Outperform from Neutral with a price target of $12 [2] - Loop Capital upgraded Ollie's Bargain Outlet (OLLI) to Buy from Hold with a price target of $135, increased from $130, citing underestimated comp potential in fiscal 2026 [2] - Raymond James upgraded Cummins (CMI) to Outperform from Market Perform with a price target of $585, noting a change in sentiment for the second half of 2026 despite a cautious near-term outlook [3] Downgrades - Janney Montgomery Scott downgraded Heritage Commerce (HTBK) to Neutral from Buy with a fair value estimate of $14 following an acquisition agreement with CVB Financial (CVBF) [4] - William Blair downgraded Clearwater Analytics (CWAN) to Market Perform from Outperform without a price target after a take-private deal at $24.55 per share [5] - Raymond James double downgraded Sealed Air (SEE) to Market Perform from Strong Buy without a price target, indicating reduced odds for a topping bid after the conclusion of the "go-shop" period [6] - Citi downgraded Amicus (FOLD) to Neutral from Buy with a price target of $14.50, down from $17, after BioMarin announced an acquisition for $4.8 billion or $14.50 per share [6] Initiations - Wells Fargo initiated coverage of Arcellx (ACLX) with an Overweight rating and a price target of $100, viewing its anti-cel as a future pillar in multiple myeloma treatment [7] - Jefferies initiated coverage of BlackSky (BKSY) with a Buy rating and a price target of $23, projecting sales to double to $211 million by 2028 [7] - BTIG initiated coverage of Invivyd (IVVD) with a Buy rating and a price target of $10, highlighting its effective antibody production [7] - Jefferies initiated coverage of Relmada Therapeutics (RLMD) with a Buy rating and a price target of $9, noting a transformation towards oncology and neuro pipeline [7] - Seaport Research initiated coverage of MasterCraft Boat (MCFT) with a Neutral rating and no price target, expressing caution due to competitive pressures in the marine industry [7]
Invivyd, Inc. (IVVD): Advancing RSV Antibody VBY329 Amid Analyst Downgrade
Yahoo Finance· 2025-12-18 08:17
Group 1 - Invivyd Inc. has selected VBY329 as a monoclonal antibody candidate for the prevention of Respiratory Syncytial Virus (RSV) in neonates, infants, and children [1] - VBY329 has demonstrated 1.5-fold greater antiviral potency than clesrovimab in in vitro testing, and the company aims for IND readiness in the second half of 2026 [2][4] - The RSV prophylaxis market for babies and children under 24 months is identified as a rapidly growing pharmaceutical market, providing significant opportunities for the company [3] Group 2 - D. Boral Capital downgraded Invivyd to a Hold from a Buy, reflecting concerns about the pipeline and balance sheet expectations [4] - Invivyd utilizes a proprietary technology platform to create medicines that are more potent and resistant to virus evolution than the human immune system [5]
Invivyd (NasdaqGM:IVVD) FY Conference Transcript
2025-12-02 20:37
Summary of Invivyd Conference Call Company Overview - **Company**: Invivyd - **Industry**: Monoclonal Antibody Therapeutics - **Key Product**: PEMGARDA, a monoclonal antibody for COVID prevention in immunocompromised individuals, currently under Emergency Use Authorization (EUA) [3][6] Core Points and Arguments Product Development - **Next-Generation Asset**: VYD2311 is set to enter pivotal trials for Biologics License Application (BLA), aiming for a transition from intravenous infusion (PEMGARDA) to intramuscular injection, which is expected to enhance patient access and ease of administration [3][4][18] - **RSV Candidate**: Invivyd is also developing a candidate for Respiratory Syncytial Virus (RSV), with plans for an Investigational New Drug (IND) application by late 2026 [4] Regulatory Pathway - **BLA Pathway**: Invivyd is working closely with the FDA to design a BLA-enabling trial, with plans to start patient enrollment by the end of 2023 or early 2024 [8][18] - **Primary Efficacy Endpoint**: The primary endpoint for the pivotal trial will be the number of PCR positive COVID cases in treatment versus placebo groups [19] Commercial Strategy - **Cost of Goods Sold (COGS)**: Invivyd targets pharmaceutical-like margins of over 80%, with expectations for VYD2311 pricing in the hundreds of dollars, significantly lower than PEMGARDA's current price of approximately $6,500 [16][17] - **Market Positioning**: The company believes VYD2311 could serve as a compelling alternative to vaccines, addressing vaccine hesitancy and safety concerns [22] Clinical Insights - **Potency and Dosage**: VYD2311 is expected to have a potency increase of 15-17 times compared to PEMGARDA, allowing for a lower dose of under 300 mg [15][36] - **Half-Life**: The half-life of VYD2311 is projected to be between 60 to 70 days, providing sufficient protection with a single dose [36] Additional Important Content - **Administration Setting**: VYD2311 could be administered in pharmacies or doctor's offices, similar to flu shots, enhancing accessibility [29] - **Future Developments**: Invivyd is considering multipurpose antibodies that could target multiple pathogens, although regulatory pathways would require initial products to be approved first [31][32] - **Patient Experience**: The administration of VYD2311 is expected to have fewer side effects compared to vaccines, with typical injection site reactions being the primary concern [24][25] Timeline and Expectations - **Data Package Submission**: Invivyd aims to submit a data package to the FDA by mid-2026, with potential market entry within a year following approval [39]
Invivyd to Participate at the 8th Annual Evercore Healthcare Conference
Globenewswire· 2025-11-25 12:01
Company Overview - Invivyd, Inc. is a biopharmaceutical company focused on providing protection against serious viral infectious diseases, starting with SARS-CoV-2 [2] - The company utilizes a proprietary integrated technology platform that is unique in the industry for assessing, monitoring, developing, and adapting to create best-in-class antibodies [2] - In March 2024, Invivyd received emergency use authorization (EUA) from the U.S. FDA for a monoclonal antibody in its pipeline of innovative antibody candidates [2] Upcoming Events - Management will participate in a fireside chat at the 8th Annual Evercore Healthcare Conference on December 2, 2025, at 2:35 p.m. ET in Miami, FL [1] - A live webcast of the fireside chat will be available on the investor section of the company's website and will be archived for approximately 90 days following the presentation [1]
Invivyd Announces Selection of Potential Best-In-Class RSV Antibody Candidate VBY329; Targeting 2H 2026 IND Readiness
Globenewswire· 2025-11-24 12:01
Core Viewpoint - Invivyd, Inc. has identified a potentially best-in-class monoclonal antibody candidate, VBY329, for the prevention of Respiratory Syncytial Virus (RSV) in neonates, infants, and children, leveraging its proprietary antibody discovery technology [1][5][6] Group 1: Product Development - VBY329 demonstrates in vitro properties that indicate higher potency and improved resistance compared to existing treatments like nirsevimab and clesrovimab, with an antiviral potency 1.5-fold greater than nirsevimab and 1.2-fold greater than clesrovimab [2][6] - The antibody candidate shows up to approximately 500-fold enhanced neutralization activity against RSV F protein variants resistant to nirsevimab, indicating a strong resistance profile [6] - Invivyd aims to achieve IND readiness for VBY329 in the second half of 2026, with plans to present in vitro data at a future medical congress [3][6] Group 2: Market Potential - The market for RSV prophylaxis among children under 24 months is projected to grow significantly, with expectations of reaching $3-$4 billion in annual revenues globally by 2030 [3][6] - Monoclonal antibodies have been a critical treatment option for vulnerable populations for nearly 30 years, suggesting a robust market opportunity for VBY329 [3] Group 3: Company Overview - Invivyd, Inc. is focused on developing innovative monoclonal antibodies for serious viral infectious diseases, with a unique integrated technology platform for antibody assessment and development [7] - The company has previously received emergency use authorization from the U.S. FDA for another monoclonal antibody, highlighting its capability in the biopharmaceutical sector [7]
Invivyd: Maintaining Hold Rating With VYD2311 Alternative To Covid-19 Vaccination
Seeking Alpha· 2025-11-18 20:49
Core Insights - The article discusses the investment analysis service provided by Biotech Analysis Central, focusing on pharmaceutical companies and their potential for long-term value generation [1][2]. Company Overview - Invivyd, Inc. (IVVD) is highlighted as a company of interest, particularly in the context of its development of monoclonal antibodies (mAb) for COVID-19 and respiratory syncytial virus (RSV) [2]. Service Features - Biotech Analysis Central offers a comprehensive library of over 600 biotech investing articles, a model portfolio featuring more than 10 small and mid-cap stocks, and various analysis and news reports aimed at assisting healthcare investors [2]. - The subscription service is priced at $49 per month, with a discounted annual plan available at $399, representing a 33.50% savings [1].
Helmerich and Payne, Invivyd, Home Depot And Other Big Stocks Moving Lower In Tuesday's Pre-Market Session - Alpha Technology Group (NASDAQ:ATGL), Fulcrum Therapeutics (NASDAQ:FULC)
Benzinga· 2025-11-18 13:23
Core Points - U.S. stock futures are lower, with Dow futures down approximately 200 points [1] - Helmerich and Payne Inc reported a fourth-quarter loss of 1 cent per share, with quarterly sales of $1.012 billion, exceeding analyst expectations of $973.678 million [1] - Helmerich and Payne shares fell 7% to $25.69 in pre-market trading [1] Company Movements - Alpha Technology Group Ltd shares decreased by 19% to $17.50 after a significant surge of 132% on Monday [4] - Invivyd Inc shares fell 13.4% to $2.46 following the announcement of a $125 million public offering [4] - Nice Ltd shares dropped 7.3% to $112.00 after a 9% decline on the previous day [4] - H World Group Ltd shares fell 6.7% to $41.95 despite reporting better-than-expected third-quarter results [4] - Fulcrum Therapeutics Inc shares decreased by 6.6% to $9.01 after a 12% gain on Monday [4] - Rocket Pharmaceuticals Inc shares declined 6% to $2.86 [4] - OBOOK Holdings Inc shares fell 5.6% to $7.53 [4] - Iperionx Ltd shares decreased by 5% to $33.00 [4] - Home Depot Inc shares slipped 2% to $351.01 after reporting worse-than-expected third-quarter adjusted EPS and lowering FY25 adjusted EPS outlook [4]
Morning Market Movers: OLMA, LFMD, ATGL, INLX See Big Swings
RTTNews· 2025-11-18 13:20
Core Insights - Premarket trading is showing notable activity with significant price movements indicating potential trading opportunities before the market opens [1] Premarket Gainers - Olema Pharmaceuticals, Inc. (OLMA) has seen a substantial increase of 213%, trading at $26.68 - Diginex Limited (DGNX) is up 12%, currently priced at $15.25 - Gorilla Technology Group Inc. (GRRR) has risen by 11%, trading at $14.05 - Amer Sports, Inc. (AS) is up 9%, priced at $33.47 - Click Holdings Limited (CLIK) has increased by 9%, trading at $7.38 - Beamr Imaging Ltd. (BMR) is up 9%, currently at $2.14 - James Hardie Industries plc (JHX) has risen by 8%, trading at $18.22 - Arvinas, Inc. (ARVN) is up 8%, priced at $12.00 - Axalta Coating Systems Ltd. (AXTA) has increased by 7%, trading at $30.28 - Genprex, Inc. (GNPX) is up 6%, currently at $4.31 [3] Premarket Losers - LifeMD, Inc. (LFMD) has decreased by 22%, trading at $3.65 - Alpha Technology Group Limited (ATGL) is down 21%, currently priced at $17.00 - Intellinetics, Inc. (INLX) has fallen by 19%, trading at $7.25 - Energizer Holdings, Inc. (ENR) is down 16%, priced at $20.00 - Invivyd, Inc. (IVVD) has decreased by 14%, currently at $2.42 - BellRing Brands, Inc. (BRBR) is down 12%, trading at $22.30 - Sadot Group Inc. (SDOT) has fallen by 9%, currently priced at $3.99 - CEVA, Inc. (CEVA) is down 8%, trading at $21.60 - Helmerich & Payne, Inc. (HP) has decreased by 7%, currently at $25.44 - Opendoor Technologies Inc. (OPEN) is down 5%, trading at $7.39 [4]
Invivyd Announces Pricing of $125 Million Public Offering of Common Stock and Pre-Funded Warrants
Globenewswire· 2025-11-18 03:40
Core Viewpoint - Invivyd, Inc. has announced a public offering of 44 million shares of common stock at $2.50 per share, aiming to raise approximately $125 million before expenses [1][3]. Group 1: Offering Details - The offering includes 44,000,000 shares of common stock priced at $2.50 each and pre-funded warrants for 6,000,000 shares at $2.4999 each [1]. - Underwriters have a 30-day option to purchase an additional 7,500,000 shares at the public offering price [1]. - The offering is expected to close on or about November 19, 2025, pending customary closing conditions [1]. Group 2: Use of Proceeds - Invivyd plans to use the net proceeds for commercial preparedness for the potential launch of VYD2311, ongoing research and development for pipeline programs including RSV and measles, and efforts related to monoclonal antibody therapy for Long COVID and COVID-19 Post-Vaccination Syndrome [3]. Group 3: Company Background - Invivyd, Inc. is a biopharmaceutical company focused on providing protection against serious viral infectious diseases, starting with SARS-CoV-2, utilizing a proprietary technology platform for developing antibodies [7].
Morning Market Movers: CDTX, BCG, IVVD, TSSI See Big Swings
RTTNews· 2025-11-14 12:04
Core Insights - Premarket trading is showing notable activity with significant price movements indicating potential opportunities for traders before the market opens [1] Premarket Gainers - Cidara Therapeutics, Inc. (CDTX) is up 91% at $203.18 - Binah Capital Group, Inc. (BCG) is up 45% at $2.07 - Invivyd, Inc. (IVVD) is up 42% at $2.52 - Omeros Corporation (OMER) is up 15% at $7.25 - The Oncology Institute, Inc. (TOI) is up 12% at $3.47 - AlphaVest Acquisition Corp (ATMV) is up 11% at $7.99 - ARB IOT Group Limited (ARBB) is up 7% at $7.31 - Hyperion DeFi, Inc. (HYPD) is up 6% at $5.27 - TruGolf Holdings, Inc. (TRUG) is up 6% at $2.02 - Boqii Holding Limited (BQ) is up 5% at $2.24 [3] Premarket Losers - TSS, Inc. (TSSI) is down 40% at $9.12 - StubHub Holdings, Inc. (STUB) is down 20% at $15.02 - ESS Tech, Inc. (GWH) is down 20% at $3.38 - Red Cat Holdings, Inc. (RCAT) is down 17% at $6.38 - WhiteFiber, Inc. (WYFI) is down 15% at $16.81 - New Era Energy & Digital, Inc. (NUAI) is down 13% at $3.66 - NET Power Inc. (NPWR) is down 11% at $2.62 - Korro Bio, Inc. (KRRO) is down 9% at $5.90 - Anavex Life Sciences Corp. (AVXL) is down 8% at $5.20 - Interactive Strength Inc. (TRNR) is down 5% at $2.47 [4]