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Bristol Myers Squibb's Breyanzi Approved by the U.S. FDA as the First and Only CAR T Cell Therapy for Adults with Relapsed or Refractory Marginal Zone Lymphoma (MZL)
Businesswire· 2025-12-05 01:15
Core Points - BMS's Breyanzi has been approved by the U.S. FDA as the first and only CAR T cell therapy specifically for adults with relapsed or refractory marginal zone lymphoma (MZL) [1] Company Summary - The approval of Breyanzi represents a significant advancement in the treatment options available for patients suffering from MZL, a type of non-Hodgkin lymphoma [1] - This approval may enhance BMS's position in the oncology market, particularly in the CAR T cell therapy segment [1] Industry Summary - The approval of Breyanzi could lead to increased competition in the CAR T cell therapy market, as it sets a precedent for future therapies targeting specific lymphoma types [1] - The development of targeted therapies like Breyanzi reflects a growing trend in the pharmaceutical industry towards personalized medicine [1]
Why Is Avis Budget (CAR) Down 8% Since Last Earnings Report?
ZACKS· 2025-11-26 17:31
Core Insights - Avis Budget Group reported strong Q3 2025 earnings, with adjusted earnings per share of $10.11, exceeding estimates by 24.7% and increasing 52% year-over-year [2] - Revenues reached $3.5 billion, surpassing the consensus estimate by 1.1% and showing a 1.1% year-over-year growth [2] Segment Performance - Revenues from the Americas were $2.6 billion, reflecting a 1% decline from the previous year, but met estimates [3] - International revenues increased to $898 million, up 7% year-over-year, exceeding the estimate of $863.6 million [3] Profitability Metrics - Adjusted EBITDA for the company was $559 million, an 11% increase from the year-ago quarter [4] - The Americas segment reported adjusted EBITDA of $398 million, a 4% year-over-year increase, while international adjusted EBITDA was $190 million, up 37% [4] Financial Position - At the end of Q3 2025, Avis Budget had cash and cash equivalents of $564 million, up from $541 million at the end of Q2 2025 [5] - Corporate debt remained stable at $6.1 billion, and the company generated $1.4 billion in net cash from operating activities [5] Estimate Trends - Consensus estimates for the stock have trended downward, with a significant shift of -112.21% noted [6] - Avis Budget currently holds a Zacks Rank 3 (Hold), indicating expectations for an in-line return in the coming months [9] VGM Scores - The company has a strong Growth Score of A, but a lower Momentum Score of D, while maintaining an overall aggregate VGM Score of A [7]
Will the Dow Transports Give Traders Something to Be Thankful For?
Investing· 2025-11-25 08:01
Group 1 - The article provides a market analysis focusing on key companies including FedEx Corporation, CH Robinson Worldwide Inc, and Union Pacific Corporation, as well as the Dow Jones Industrial Average [1] Group 2 - FedEx Corporation's performance is analyzed in the context of its operational efficiency and market positioning [1] - CH Robinson Worldwide Inc is discussed regarding its logistics services and market trends affecting its growth [1] - Union Pacific Corporation's operational metrics and impact on the transportation sector are highlighted [1]
Bristol Myers Squibb Receives Approval from the European Commission to Expand Use of CAR T Cell Therapy Breyanzi for Relapsed or Refractory Mantle Cell Lymphoma
Businesswire· 2025-11-24 22:00
Core Insights - Bristol Myers Squibb has received approval from the European Commission to expand the use of its CAR T cell therapy, Breyanzi, for adult patients with relapsed or refractory mantle cell lymphoma (MCL) after at least two lines of systemic therapy, including a Bruton's tyrosine kinase (BTK) inhibitor [1][2][4] Group 1: Clinical Efficacy - In the TRANSCEND MCL trial, Breyanzi demonstrated an overall response rate of 82.7% and a complete response rate of 71.6% among patients treated in the third-line plus setting [2][3] - The therapy showed sustained clinical benefit, with 50.8% of patients still in response at 24 months [1][2] - The median time to first response was 0.95 months, indicating rapid efficacy [2] Group 2: Safety Profile - The safety results for Breyanzi were consistent with its established profile, with cytokine release syndrome (CRS) occurring in 61% of patients, and only 1% experiencing grade three or four CRS [3][19] - Neurologic toxicities were reported in 31% of patients, with grade three or four cases in 9% [3][19] - The majority of adverse events occurred within the first 14 days post-infusion, allowing for early resolution and adjustments to monitoring requirements [3] Group 3: Regulatory and Market Implications - This approval is applicable across all EU member states and EEA countries, marking the fourth approval for Breyanzi in Europe [4][5] - Breyanzi is also approved for other indications, including relapsed or refractory diffuse large B-cell lymphoma (DLBCL) and follicular lymphoma [4][9] - Bristol Myers Squibb is positioned as a leader in cell therapy, with a focus on expanding treatment options for aggressive forms of non-Hodgkin lymphoma [34][36]
BROAD ARROW ANNOUNCES, “GLOBAL ICONS,” AN ONLINE COLLECTOR CAR AND MEMORABILIA SALE SCHEDULED FOR JANUARY 2026
Globenewswire· 2025-11-20 09:30
Core Insights - Broad Arrow Auctions, a Hagerty company, is launching a new online auction series called Global Icons in January 2026, featuring collector cars and motorsport memorabilia [1][2] Auction Format and Offerings - Global Icons will consist of three parts: two online collector car auctions (Global Icons: Europe Online and Global Icons: UK Online) and an online memorabilia auction (Global Icons: Memorabilia Online) [1][2] - The auctions will feature a diverse selection of high-quality pre-war, post-war, and modern collector cars, with a focus on 'iconic' vehicles that hold historical significance [2][3] Featured Lots - A notable early consignment for the auctions includes a 1971 Lamborghini Miura P400 S, estimated between €1.600 million and €1.800 million, which has a rich history and has been carefully restored [3][4] Memorabilia Offerings - The memorabilia auction will include approximately 100 lots, featuring items associated with legendary drivers such as Ayrton Senna and Michael Schumacher [5] Auction Timeline - Bidding for the auctions will open on January 23, 2026, with the Europe and UK Online auctions closing on January 30, and the Memorabilia Online auction closing on February 1 [6] In-Person Previews - Broad Arrow will host in-person previews of many auction lots at various locations across Europe and at its UK headquarters, enhancing the auction experience for bidders [7] Consignment Information - Interested consignors are invited to connect with Broad Arrow for consignment opportunities, with buyer's premiums set at 10% for collector vehicles and 25% for memorabilia [8]
Anixa Biosciences Announces World Health Organization (WHO) Approval of International Non-Proprietary Name for its CAR-T Therapy, Marking a Key Milestone Toward Global Recognition and Future Commercialization
Prnewswire· 2025-11-17 13:15
Core Insights - Anixa Biosciences has received approval from the WHO for the non-proprietary name "liraltagene autoleucel" for its CAR-T therapy targeting recurrent ovarian cancer, marking a significant milestone in its development and potential commercialization [1][2][3] Company Overview - Anixa Biosciences is a clinical-stage biotechnology company focused on cancer treatment and prevention, with a therapeutic portfolio that includes an ovarian cancer immunotherapy program developed in collaboration with Moffitt Cancer Center [4] - The company utilizes a novel CAR-T technology known as chimeric endocrine receptor-T cell (CER-T) therapy, which targets the follicle stimulating hormone receptor (FSHR) expressed on ovarian cells and certain cancer cells [3][4] Clinical Development - The ongoing Phase 1 trial of liraltagene autoleucel is designed to evaluate safety, identify the maximum tolerated dose, and monitor clinical activity in adult women with recurrent ovarian cancer who have progressed after at least two prior therapies [3][4] - The trial is being conducted in partnership with Moffitt Cancer Center, a leader in cancer immunotherapy [2][4] Future Directions - The approval of the non-proprietary name allows Anixa to establish a universally recognized name for its CAR-T therapy, facilitating clearer identification and safe prescription of the drug [2][3] - The company plans to transition to using the name liraltagene autoleucel, or lira-cel, in future communications [2]
Vehicle recalls weigh on US rental operators’ earnings outlook: Fitch
Yahoo Finance· 2025-11-17 08:00
Core Insights - Significant vehicle recalls in the U.S. are creating near-term earnings and operational challenges for car rental operators, potentially delaying margin recovery due to fleet modernization strategies being undermined [1][3] Vehicle Recalls - The U.S. Department of Transportation reported approximately 9.8 million vehicle recalls in Q3 2025, the highest level since early 2024 [2] - Ford accounted for around 55% of the affected units during the quarter, with increased vehicle complexity and supply chain interdependencies contributing to the challenges faced by rental operators [3] Operational Impact - Rental operators are disproportionately affected due to reliance on recently manufactured vehicles, with Avis reporting 5% of its Americas fleet under recall compared to Hertz's 2% [5] - Two-thirds of Avis's recalled vehicles were awaiting parts, which reduced utilization and increased fleet costs, while Hertz achieved a utilization rate of 84% in the quarter [5] Financial Guidance and Market Conditions - Both Hertz and Avis have lowered guidance due to recall uncertainty, government shutdown impacts, and system outages [6] - Fitch suggested that recall-driven supply constraints may support pricing discipline, potentially offsetting revenue pressures, with expectations for EBITDA margins to return to single-digit levels in 2026 [6] Liquidity Position - Hertz reported $2.2 billion in corporate liquidity at the end of Q3, while Avis held $1 billion, both supported by vehicle borrowing capacity [7] - Avis faces no corporate refinancing until July 2027, while Hertz has $500 million in senior unsecured notes maturing in December 2026, partially addressed through a $375 million exchangeable notes issuance in September 2025 [7]
Looking For A Squeeze? Here Are The Top 10 Most Shorted Stocks
Benzinga· 2025-11-13 20:05
Core Insights - Short interest data provides insights into investor sentiment and potential risks in the stock market, helping gauge market confidence in a company's future [1] - A stock is deemed heavily shorted when a significant percentage of its available shares are borrowed and sold by investors anticipating a price drop [2] - Short squeezes can occur when short-sellers rush to cover their positions, leading to rapid price increases, as seen in recent meme stock manias [3] Short Interest Overview - The most heavily shorted stocks as of November 13 include Lucid Group, Inc. (48.99%), Choice Hotels International, Inc. (46.71%), and Avis Budget Group, Inc. (46.13%) [5] - Stocks are ranked by short interest, which is the total number of shares sold short and not yet covered, expressed as a percentage of shares available for public trading [4] Market Dynamics - Highly shorted stocks represent a battleground where negative fundamentals meet speculative trading [7] - Monitoring short interest can help identify potential short squeeze candidates, although timing such trades is challenging due to high volatility [7]
Avis Budget Stock Declines 11% Despite Reporting Q3 Earnings Beat
ZACKS· 2025-11-05 19:31
Core Insights - Avis Budget Group, Inc. (CAR) reported strong third-quarter 2025 results, with earnings and revenues exceeding the Zacks Consensus Estimate [1][8] - Adjusted earnings per share reached $10.11, surpassing estimates by 24.7% and increasing 52% year-over-year [1][8] - Revenues totaled $3.5 billion, beating the consensus estimate by 1.1% and reflecting a 1.1% year-over-year growth [1][8] Financial Performance - The stock experienced an 11.1% decline since the earnings release on October 27, despite the positive earnings and revenue results [2] - Over the past year, CAR shares have increased by 43.1%, contrasting with a 13.9% decline in the industry and a 17.8% growth in the Zacks S&P 500 composite [2] Segment Performance - Revenues from the Americas were $2.6 billion, showing a 1% decline from the previous year, but meeting estimates [3] - International revenues reached $898 million, up 7% year-over-year, exceeding the estimate of $863.6 million [3] Profitability Metrics - Adjusted EBITDA was $559 million, an 11% increase from the year-ago quarter [4] - The Americas segment reported adjusted EBITDA of $398 million, a 4% year-over-year increase, while the international segment saw a significant 37% increase to $190 million [4] Balance Sheet and Cash Flow - At the end of Q3 2025, Avis Budget had cash and cash equivalents of $564 million, up from $541 million at the end of Q2 2025 [5] - Corporate debt remained stable at $6.1 billion [5] - The company generated $1.4 billion in net cash from operating activities, with adjusted free cash flow utilized at $42 million and capital expenditure at $51 million [5]
Caribou Biosciences to Host Webcast to Report New Data Updates from Two Allogeneic CAR-T Cell Therapy Programs in Lymphoma and Multiple Myeloma
Globenewswire· 2025-11-02 21:00
Core Insights - Caribou Biosciences, Inc. will present new data from the ANTLER phase 1 clinical trial for vispacabtagene regedleucel (vispa-cel) and the CaMMouflage Phase 1 trial for CB-011 on November 3, 2025 [1] - The company is focused on developing allogeneic CAR-T cell therapies for hematologic malignancies, specifically targeting relapsed or refractory B cell non-Hodgkin lymphoma and multiple myeloma [1][5] Summary of vispacabtagene regedleucel (vispa-cel) - Vispacabtagene regedleucel is an allogeneic anti-CD19 CAR-T cell therapy designed for patients with relapsed or refractory B cell non-Hodgkin lymphoma [3] - It is the first allogeneic CAR-T cell therapy in the clinic with a PD-1 knockout, aimed at enhancing CAR-T cell activity by reducing premature exhaustion [3] - The therapy has received FDA designations including Regenerative Medicine Advanced Therapy (RMAT), Orphan Drug, and Fast Track for B-NHL [3] Summary of CB-011 - CB-011 is an allogeneic anti-BCMA CAR-T cell therapy being evaluated for relapsed or refractory multiple myeloma in the CaMMouflage Phase 1 trial [4] - It is the first allogeneic CAR-T cell therapy engineered with an immune cloaking strategy, featuring a B2M knockout and a B2M–HLA-E fusion protein to mitigate immune rejection [4] - CB-011 has also been granted Fast Track and Orphan Drug designations by the FDA [4] Company Overview - Caribou Biosciences is a clinical-stage CRISPR genome-editing biopharmaceutical company focused on transformative therapies for severe diseases [5] - The company's genome-editing platform utilizes Cas12a chRDNA technology for precise development of cell therapies [5] - Caribou aims to provide broad access and rapid treatment options through its off-the-shelf CAR-T cell therapies, vispacabtagene regedleucel and CB-011 [5]