ADC THERAP. CL.C SF-,064

ADC Therapeutics (ADCT) doesn't possess the right combination of the two key ingredients for a likely earnings beat in its upcoming report. Get prepared with the key expectations.» Mehr auf zacks.com

Oral presentation shows ADCT-242 targeting Claudin-6 was well-tolerated and demonstrated potent antitumor activity in ovarian and non-small lung cancer Poster presentations highlight antitumor activity and safety of novel PSMA-targeted and ASCT2-targeted ADCs LAUSANNE, Switzerland , April 28, 2025 /PRNewswire/ -- ADC Therapeutics SA (NYSE: ADCT), a commercial-stage global leader and pioneer in the field of antibody drug conjugates (ADCs), today announced data from preclinical studies of three exatecan-based antibody drug conjugates (ADCs) targeting Claudin-6 (CLDN6), prostate-specific membrane antigen (PSMA), and Alanine, Serine, Cysteine Transporter 2 (ACST2) as presented at the American Association for Cancer Research (AACR) Annual Meeting 2025. "We believe these presentations demonstrate the strong potential of our exatecan-based ADCs to treat a wide range of solid and hematologic cancers beyond lymphoma.» Mehr auf prnewswire.com

The global oncology drug market, valued at over $200 billion today, is on pace to reach $532 billion by 2031-a growth story driven not just by rising demand but by genuine innovation. After years of incremental progress, new therapies like antibody-drug conjugates (ADCs) and immunotherapies are making strides against some of oncology's toughest challenges: rare pediatric cancers, relapsed tumors, and diseases like osteosarcoma, where survival rates have barely improved in decades. Regulators are helping accelerate this progress with tools like accelerated approvals and breakthrough designations that are shortening development timelines. At the same time, approaches like comparative oncology-using naturally occurring canine cancers as research models-are providing faster, more clinically relevant data than traditional preclinical studies. This convergence of scientific advancement and commercial opportunity is creating a market that's evolving faster than ever before. aAdsList.push('Article'); aAdsListSize.push([300, 250]); aAdsListCA.push(null); Within this expanding landscape, several companies are at the forefront of pioneering new treatments. Let's take a closer look at how some of the most innovative players in this space are tackling these pressing challenges.OS Therapies (NYSE-A: OSTX) is focused on transforming the treatment landscape for osteosarcoma, a rare and aggressive bone cancer that primarily affects children and young adults. The company's lead drug, OST-HER2, is a novel off-the-shelf immunotherapy that uses a modified form of Listeria bacteria to stimulate the immune system to target and destroy cancer cells that express the HER2 protein. Recent data has further validated the potential of OST-HER2 in treating osteosarcoma. New unpublished research shows that when combined with palliative radiation, OST-HER2 has had a significant impact on dogs with unresected, primary osteosarcoma. Out of 15 dogs treated, 5 experienced survival times exceeding 500 days, with clinical and radiographic arrest of the primary tumor and delayed pulmonary metastases. These findings could have profound implications for the potential use of OST-HER2 as a frontline therapy in humans, potentially before chemotherapy is even considered. This approach could reduce or even eliminate the need for surgery and chemotherapy, offering a more effective and less invasive treatment alternative for patients. This data complements previous research published in the journal Molecular Therapy, which demonstrated how OST-HER2 induces strong immune responses from the very first dose. These responses were shown to correlate with both the prevention of metastasis and long-term survival in dogs that had undergone surgery to remove their primary osteosarcoma. Additionally, the study showed that dogs who initially had weaker immune responses showed significant improvement after the second and third doses, supporting the use of repeated dosing as a potential strategy for treating the disease. The combination of these results marks a critical milestone in OS Therapies' development of OST-HER2. The company is now preparing to submit this new data to the USDA, along with information on their improved manufacturing process, aiming for conditional approval in the United States by 2025. Following this, OS Therapies plans to conduct a pivotal clinical study with the goal of gaining full approval for the treatment by 2026. The company is also on track to secure FDA Accelerated Approval for OST-HER2 in human osteosarcoma, with plans to submit an application by the end of 2025. If approved, OST-HER2 could be one of the first treatments to offer a meaningful improvement in survival for patients with this rare and difficult-to-treat cancer. Moreover, a successful approval would make OS Therapies eligible for a Priority Review Voucher (PRV), which could be sold for a significant financial gain, providing the company with the resources needed to fund future projects. As OS Therapies continues to advance in both human and veterinary applications, its approach to Comparative Oncology is proving to be a game-changer. With a 96% genetic similarity between human and canine osteosarcoma, research in dogs with osteosarcoma offers valuable insights that could accelerate the development of new therapies for humans. OS Therapies is leveraging this unique advantage to not only improve treatments for dogs but also to push the boundaries of cancer treatment in humans. Financially, OS Therapies remains well-positioned for the future. The company raised $12 million in 2024 through an IPO and private placement, and it expects its cash reserves to last through mid-2026. With clinical costs now tapering off as the company moves forward in its regulatory journey, OS Therapies is in a solid position to continue advancing its pipeline without needing to raise additional capital in the near term. The company's growth isn't limited to just one drug. Beyond OST-HER2, OS Therapies is also working on an innovative antibody-drug conjugate (ADC) platform, which could allow for custom-designed cancer treatments tailored to various cancers. This growing pipeline positions OS Therapies as a company to watch in the biotech space, offering not only a potential breakthrough in osteosarcoma treatment but also future opportunities in oncology. As the company works toward Accelerated Approval for OST-HER2 by the end of 2025, the potential for significant regulatory milestones, a potential PRV sale, and an expanding clinical pipeline make OS Therapies a standout in the emerging biotech field. Investors, clinicians, and patients alike should keep a close eye on this company as it continues to push forward in the fight against osteosarcoma and other forms of cancer.Day One Biopharmaceuticals (Nasdaq: DAWN) is gaining traction in the pediatric oncology world with OJEMDA (tovorafenib), its lead treatment for children with low-grade glioma (pLGG), a rare brain cancer. OJEMDA is a Type II RAF kinase inhibitor that targets BRAF alterations, which are often found in pLGG patients. It received FDA approval under the accelerated approval pathway, and the early numbers suggest strong adoption-more than 1,600 prescriptions were written in the eight months following its April 2024 launch. Full-year net product revenue came in at $57.2 million, with $29 million in the fourth quarter alone. In late 2024, OJEMDA also earned the "Exclusively Pediatric" designation from CMS, lowering its Medicaid and 340B rebate obligations, which could help margins moving forward. The drug is currently at the center of Day One's pipeline, with the Phase 3 FIREFLY-2 study ongoing. The company expects to complete enrollment by mid-2026. Beyond OJEMDA, Day One is working to expand its reach in pediatric cancer. DAY301, an antibody-drug conjugate (ADC) targeting PTK7, has cleared its first dosing cohort in a Phase 1a/b trial. If development goes well, it could become a valuable second asset alongside OJEMDA. From a financial standpoint, Day One ended 2024 with $531.7 million in cash and equivalents, giving the company plenty of runway. While the full-year net loss totaled $95.5 million-largely due to R&D and launch costs-the company continues to invest in growth. R&D expenses jumped to $227.7 million in 2024, up from $130.5 million in 2023, driven by the advancement of DAY301 and other pipeline efforts. Even with the losses, Day One is in a strong position: OJEMDA is gaining traction, the pipeline is moving, and the balance sheet is healthy. For anyone watching the space, Day One stands out as a biotech laser-focused on filling a serious treatment gap in pediatric cancer.GSK plc (NYSE: GSK) is making real moves in oncology, especially in tough-to-treat cancers like osteosarcoma. In January, the FDA gave Breakthrough Therapy Designation to one of GSK's experimental antibody-drug conjugates (ADCs) that targets B7-H3-a protein linked to tumor growth. The drug showed early promise in a mid-stage trial for patients with relapsed or refractory osteosarcoma who've already gone through two lines of treatment. That's a big deal in a space with no currently approved therapies for patients at that stage. Osteosarcoma mostly affects children and young adults, and once it comes back after initial treatment, the outlook gets bleak. GSK's drug could help fill that gap. The company is now running a global trial aimed at eventually getting the treatment approved more broadly. On the business side, GSK is firing on all cylinders. In February the company launched a $2.5 billion stock buyback after a strong Q4 and raised its long-term revenue forecast. Oncology is now a major focus for GSK's pipeline, along with respiratory diseases, HIV, and other specialty areas. With five product approvals expected this year-including a relaunch of its blood cancer drug Blenrep-the company looks well-positioned to keep growing in high-need treatment areas.ADC Therapeutics (NYSE: ADCT) stands out as a promising player in the antibody drug conjugate (ADC) space, focusing on the treatment of hematologic malignancies and solid tumors. With a proprietary ADC technology platform, the company is positioning itself to make a significant impact in oncology. Investors looking for growth potential in this innovative field should take note of ADC Therapeutics, particularly with its lead product, ZYNLONTA (loncastuximab tesirine). Recent clinical trial results further solidify the company's growth trajectory. In December 2024, ADC Therapeutics published updated data from a Phase 2 clinical trial evaluating ZYNLONTA in combination with rituximab for treating relapsed or refractory follicular lymphoma (FL). The results showed a robust 97.4% overall response rate and 76.9% complete response rate, positioning ZYNLONTA as a strong treatment option for high-risk FL patients. These results were published in The Lancet Haematology and presented at the prestigious American Society of Hematology (ASH) Annual Meeting, raising the company's profile in the oncology field. With progression-free survival remaining strong at 94.6% at 12 months, the long-term potential for ZYNLONTA in treating indolent B-cell lymphomas is clear. Additionally, ADC Therapeutics is making strides with the LOTIS-7 trial, which is evaluating ZYNLONTA in combination with glofitamab for relapsed or refractory diffuse large B-cell lymphoma (DLBCL). The initial data showed impressive results, with a 94% overall response rate and 72% complete response rate, alongside a manageable safety profile. This combination therapy could provide a competitive edge in the highly saturated DLBCL market, demonstrating the potential for ZYNLONTA beyond its initial indication. From a financial perspective, ADC Therapeutics reported stable revenues in Q4 2024, generating $16.4 million in product sales. Despite the flat revenue growth, the company is focused on reducing operating expenses, achieving a 13% year-over-year reduction. With $251 million in cash reserves at the end of 2024, the company is well-positioned to fund operations into the second half of 2026, allowing for continued investment in its clinical pipeline and commercial efforts. Disclaimers: RazorPitch Inc. "RazorPitch" is not operated by a licensed broker, a dealer, or a registered investment adviser. This content is for informational purposes only and is not intended to be investment advice. The Private Securities Litigation Reform Act of 1995 provides investors a safe harbor in regard to forward-looking statements. Any statements that express or involve discussions with respect to predictions, expectations, beliefs, plans, projections, objectives, goals, assumptions, or future events or performances are not statements of historical fact and may be forward-looking statements. Forward-looking statements are based on expectations, estimates, and projections at the time the statements are made that involve a number of risks and uncertainties that could cause actual results or events to differ materially from those presently anticipated. Forward-looking statements in this action may be identified through the use of words such as projects, foresee, expects, will, anticipates, estimates, believes, understands, or that by statements indicating certain actions & quote; may, could, or might occur. Understand there is no guarantee past performance will be indicative of future results. Investing in micro-cap and growth securities is highly speculative and carries an extremely high degree of risk. It is possible that an investor's investment may be lost or impaired due to the speculative nature of the companies profiled. RazorPitch has been retained and compensated by O S Therapies Inc to assist in the production and distribution of content related to OSTX. 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RazorPitch is not a fiduciary by virtue of any persons use of or access to this content. Media Contact Company Name: RazorPitch Contact Person: Mark McKelvie Email: markrmckelvie@gmail.com City: NAPLES State: Florida Country: United States Website: https://razorpitch.com/ Source: www.abnewswire.com .(C) 2025 M2 COMMUNICATIONS, source M2 PressWIRE» Mehr auf marketscreener.com