Core Viewpoint - Outset Medical, Inc. has appointed Renee Gaeta as the new Chief Financial Officer, effective immediately, as the company aims to drive growth and achieve near-term profitability [1][2]. Company Overview - Outset Medical is a medical technology company focused on reducing the cost and complexity of dialysis through its innovative Tablo® Hemodialysis System, which is FDA cleared for use in various settings [4]. - The Tablo system integrates water purification and on-demand dialysate production, allowing for flexible dialysis delivery and operational simplification for providers [4]. Leadership Appointment - Renee Gaeta brings extensive financial and leadership experience from her previous roles as CFO at Shockwave Medical and Eko Health, among others [2][3]. - Gaeta's appointment is seen as a strategic move to support Outset's next phase of growth and profitability goals [2]. Financial Guidance - Outset has reiterated its financial guidance for 2025, projecting revenues between $115 million and $125 million, with a non-GAAP gross margin expected to be in the high-30% range [2].

Shares of Candel Therapeutics, Inc. (CADL) have gained 3.2% over the past four weeks to close the last trading session at $5.45, but there could still be a solid upside left in the stock if short-term price targets of Wall Street analysts are any indication. Going by the price targets, the mean estimate of $21 indicates a potential upside of 285.3%.The average comprises four short-term price targets ranging from a low of $15 to a high of $25, with a standard deviation of $4.90. While the lowest estimate ind ...

Core Insights - Candel Therapeutics has received FDA's Regenerative Medicine Advanced Therapy (RMAT) designation for its investigational adenovirus immunotherapy candidate, CAN-2409, aimed at treating newly diagnosed localized prostate cancer in patients with intermediate-to-high risk [1][3] - The RMAT designation was based on positive results from a phase III study that demonstrated the safety and efficacy of CAN-2409 in combination with a prodrug and standard of care radiation therapy [2][6] - Following the announcement, Candel's shares increased by 6.1%, although the stock has seen a year-to-date decline of 31.6%, contrasting with the industry's decline of 4.9% [3][4] Company Developments - The phase III study met its primary endpoint, showing statistically significant improvement in disease-free survival for patients receiving the combination therapy compared to standard of care alone [6] - Treatment with CAN-2409 was well tolerated, with no new safety signals identified, leading the company to plan a Biologics License Application (BLA) submission by the end of 2026 [7] - Candel is also exploring CAN-2409 in mid-stage studies for pancreatic and non-small cell lung cancer indications, in addition to its focus on prostate cancer [8] Market Position - Candel currently holds a Zacks Rank of 2 (Buy), indicating a favorable outlook within the biotech sector [9] - Other biotech stocks with a similar ranking include Lexicon Pharmaceuticals, Chemomab Therapeutics, and Amarin, each also carrying a Zacks Rank of 2 [9]

Company Overview - Proactive is a financial news publisher that provides fast, accessible, informative, and actionable business and finance news content to a global investment audience [2] - The company has a team of experienced news journalists who produce independent content across various financial markets [2] Market Focus - Proactive specializes in medium and small-cap markets while also covering blue-chip companies, commodities, and broader investment stories [3] - The content includes insights into sectors such as biotech and pharma, mining and natural resources, battery metals, oil and gas, crypto, and emerging digital and EV technologies [3] Technology Adoption - Proactive is committed to adopting technology to enhance its content creation and workflow processes [4] - The company utilizes automation and software tools, including generative AI, while ensuring that all published content is edited and authored by humans [5]

Core Viewpoint - Candel Therapeutics has received FDA's Regenerative Medicine Advanced Therapy (RMAT) designation for its lead candidate CAN-2409, aimed at treating newly diagnosed localized prostate cancer in patients with intermediate-to-high-risk disease, highlighting the potential of this therapy to address significant unmet medical needs [1][5][9] Group 1: FDA Designation and Implications - The RMAT designation is designed to expedite the development and review of regenerative medicine therapies for serious or life-threatening diseases, providing opportunities for intensive FDA guidance and support [2] - This designation allows for mechanisms that can speed up the Biologics License Application (BLA) review and approval process, including rolling review and priority review [2] Group 2: Clinical Trial Results - Positive data from a phase 3 randomized, placebo-controlled trial showed that CAN-2409 plus valacyclovir, combined with standard of care external beam radiation therapy, met its primary endpoint, demonstrating a statistically significant improvement in disease-free survival (DFS) [3][4] - The trial indicated a 30% reduction in the risk of prostate cancer recurrence or death (HR 0.70; p=0.0155) for patients receiving CAN-2409 compared to placebo, with a 38% risk reduction in prostate-specific DFS (HR 0.62; p=0.0046) [4] - The treatment also resulted in a significant increase in patients achieving a prostate-specific antigen (PSA) nadir of <0.2 ng/ml (67.1% vs. 58.6%; p=0.0164) and an 80.4% pathological complete response in post-treatment biopsies [4] Group 3: Future Plans and Expectations - The company anticipates submitting the BLA for CAN-2409 by the end of 2026, aiming to introduce a new treatment option for early-stage prostate cancer, a field that has seen minimal innovation in the past two decades [6] - The RMAT designation is expected to facilitate the BLA filing process, bringing the company closer to achieving its objective of providing a new treatment option [6] Group 4: About CAN-2409 - CAN-2409 is an investigational, off-the-shelf, replication-defective adenovirus designed to deliver the herpes simplex virus thymidine kinase (HSV-tk) gene to tumors, inducing a CD8+ T cell-mediated immune response against cancer cells [7][8] - The therapy has shown encouraging activity in combination with standard treatments and has been dosed in over 1,000 patients with a favorable tolerability profile [8][9]

Core Insights - Candel Therapeutics announced positive phase 3 clinical results for CAN-2409 in localized, intermediate-to-high risk prostate cancer, showing a statistically significant 30% reduction in disease recurrence compared to placebo when combined with standard-of-care radiation therapy [1][10] Company Overview - Candel Therapeutics is a clinical-stage biopharmaceutical company focused on developing multimodal biological immunotherapies to combat cancer [11] - The company has established two clinical-stage platforms based on genetically modified adenovirus and HSV gene constructs, with CAN-2409 being the lead candidate from the adenovirus platform [11] Clinical Development - CAN-2409 (aglatimagene besadenovec) is designed to deliver the herpes simplex virus thymidine kinase (HSV-tk) gene to tumors, inducing a systemic immune response against cancer [8] - The investigational therapy has shown encouraging results in monotherapy and combination settings with standard treatments, with over 1,000 patients dosed and a favorable tolerability profile [9][10] - Candel is also evaluating CAN-2409 in non-small cell lung cancer (NSCLC) and borderline resectable pancreatic adenocarcinoma (PDAC) [10] Regulatory Status - CAN-2409 has received Fast Track Designation from the FDA for multiple indications, including PDAC and stage III/IV NSCLC, and has been granted Orphan Drug Designation for PDAC [10] Upcoming Events - Candel will host a webcast and conference call on June 3, 2025, to discuss the phase 3 clinical results and insights from leading prostate cancer specialists [1][5]

About this content About Emily Jarvie Emily began her career as a political journalist for Australian Community Media in Hobart, Tasmania. After she relocated to Toronto, Canada, she reported on business, legal, and scientific developments in the emerging psychedelics sector before joining Proactive in 2022. She brings a strong journalism background with her work featured in newspapers, magazines, and digital publications across Australia, Europe, and North America, including The Examiner, The Advocate, ...

Core Insights - Candel Therapeutics announced positive results from its phase 3 clinical trial of CAN-2409 for localized prostate cancer, which will be presented at the 2025 ASCO Annual Meeting [1][2][4] Clinical Trial Results - The phase 3 trial met its primary endpoint, showing a statistically significant improvement in disease-free survival (DFS) with a p-value of 0.0155 and a 30% reduction in the risk of recurrence or death (HR 0.7) for patients receiving CAN-2409 compared to placebo [2][4] - The trial included 496 patients receiving CAN-2409 and 249 patients receiving placebo, marking the first multicenter, randomized phase 3 trial in over 20 years to meet both primary and secondary endpoints in localized prostate cancer [2][3] Clinical Significance - The improvement in DFS is considered clinically meaningful, with tissue analysis indicating a higher rate of pathological clinical response in patients treated with CAN-2409 [3] - Approximately 30% of patients with intermediate-to-high-risk localized prostate cancer experience disease recurrence after standard treatments, highlighting the unmet need for effective therapies [3][10] Safety and Tolerability - CAN-2409 was generally well tolerated, with a low incidence of treatment-related serious adverse events (1.7% for CAN-2409 plus standard care vs. 2.2% for placebo plus standard care) [10] - Common adverse events included flu-like symptoms, fever, and chills, which were mostly mild to moderate [10] Future Developments - Candel plans to submit a Biologics License Application (BLA) for CAN-2409 in the fourth quarter of 2026, aiming to provide better treatment options for patients [3][10] - The company is also evaluating CAN-2409 in other cancers, including non-small cell lung cancer and pancreatic adenocarcinoma, and has received Fast Track Designation from the FDA for its use in pancreatic cancer [10][11]

Here are three stocks with buy rank and strong momentum characteristics for investors to consider today, May 19th:Candel Therapeutics, Inc. (CADL) : This clinical stage biopharmaceutical company has a Zacks Rank #1 and witnessed the Zacks Consensus Estimate for its current year earnings increasing 17.9% over the last 60 days.Candel’s shares gained 34.4% over the last six months compared with the S&P 500’s advance of 0.7%. The company possesses a Momentum Score  of B.Horace Mann Educators Corporation (HMN) : ...

Group 1 - Subsea 7 S.A. (SUBCY) has seen a nearly 17% increase in the Zacks Consensus Estimate for its current year earnings over the last 60 days [1] - MAG Silver Corp. (MAG) has experienced an 18.3% increase in the Zacks Consensus Estimate for its current year earnings over the last 60 days [1] - Karooooo Ltd. (KARO) has seen a nearly 7% increase in the Zacks Consensus Estimate for its current year earnings over the last 60 days [2] - Candel Therapeutics, Inc. (CADL) has experienced a 17.9% increase in the Zacks Consensus Estimate for its current year earnings over the last 60 days [2] - Popular, Inc. (BPOP) has seen a 4.8% increase in the Zacks Consensus Estimate for its current year earnings over the last 60 days [3]