Latest news with #Phase1b
Yahoo
11 hours ago
- Business
- Yahoo
Apogee Therapeutics (APGE) Is Up 5.9% After Strong APG777 Phase 2 Data and Accelerated Plans
Apogee Therapeutics recently reported positive 16-week results from its APEX Phase 2 Part A trial, with APG777 meeting all primary and key secondary endpoints in moderate-to-severe atopic dermatitis and showing potential for significantly reduced injection frequency. This progress has led the company to accelerate its clinical timeline, planning Phase 3 studies for APG777 in 2026 and initiating a head-to-head Phase 1b trial comparing APG279 to an established competitor. We'll examine how the accelerated advancement of APG777 in atopic dermatitis could influence Apogee's broader investment story. Explore 24 top quantum computing companies leading the revolution in next-gen technology and shaping the future with breakthroughs in quantum algorithms, superconducting qubits, and cutting-edge research. What Is Apogee Therapeutics' Investment Narrative? For Apogee Therapeutics, the core investment case hinges on belief in its pipeline's potential, particularly APG777 for atopic dermatitis after strong Phase 2 data. The company's accelerated timeline into Phase 3 and an upcoming head-to-head trial signal critical short-term catalysts that could shift perception, especially considering the market's muted reaction so far. However, the expanded losses reported this quarter, coupled with no revenue and extended unprofitability forecasts, reinforce ongoing risks, especially reliance on clinical milestones for future value and eventual commercial success. Recent clinical wins offer momentum, but investors still face the uncertainty of transitioning from promising trial data to real-world uptake and regulatory approval. This news is material to the story, making near- and medium-term trial readouts the main events to watch, but financial pressure has not eased. But, despite recent positive trial results, the absence of meaningful revenue remains a risk investors need to watch. Our valuation report unveils the possibility Apogee Therapeutics' shares may be trading at a premium. Exploring Other Perspectives Across three community fair value estimates, retail investors in the Simply Wall St Community see US$10 to US$100 per share, with one outlier at the upper end. This striking variation shows how much opinions can diverge, and it puts the focus on whether Apogee's cash position can bridge the gap to its next big trial deliverables. Consider these viewpoints as you weigh what might come next for the company. Explore 3 other fair value estimates on Apogee Therapeutics - why the stock might be worth over 2x more than the current price! Build Your Own Apogee Therapeutics Narrative Disagree with this assessment? Create your own narrative in under 3 minutes - extraordinary investment returns rarely come from following the herd. A great starting point for your Apogee Therapeutics research is our analysis highlighting 1 key reward and 3 important warning signs that could impact your investment decision. Our free Apogee Therapeutics research report provides a comprehensive fundamental analysis summarized in a single visual - the Snowflake - making it easy to evaluate Apogee Therapeutics' overall financial health at a glance. Ready For A Different Approach? Right now could be the best entry point. These picks are fresh from our daily scans. Don't delay: The best AI stocks today may lie beyond giants like Nvidia and Microsoft. Find the next big opportunity with these 18 smaller AI-focused companies with strong growth potential through early-stage innovation in machine learning, automation, and data intelligence that could fund your retirement. AI is about to change healthcare. These 27 stocks are working on everything from early diagnostics to drug discovery. The best part - they are all under $10b in market cap - there's still time to get in early. Trump has pledged to "unleash" American oil and gas and these 22 US stocks have developments that are poised to benefit. This article by Simply Wall St is general in nature. We provide commentary based on historical data and analyst forecasts only using an unbiased methodology and our articles are not intended to be financial advice. It does not constitute a recommendation to buy or sell any stock, and does not take account of your objectives, or your financial situation. We aim to bring you long-term focused analysis driven by fundamental data. Note that our analysis may not factor in the latest price-sensitive company announcements or qualitative material. Simply Wall St has no position in any stocks mentioned. Companies discussed in this article include APGE. Have feedback on this article? Concerned about the content? with us directly. Alternatively, email editorial-team@ Sign in to access your portfolio
National Post
2 days ago
- Business
- National Post
Satellos Reports Second Quarter 2025 Results and Highlights Upcoming Clinical Milestones
Article content Reported positive Phase 1b data in five adults with Duchenne muscular dystrophy (DMD) after 28 days of treatment Demonstrated safety, tolerability and an approximate doubling in grip strength On track to initiate a follow-up of the Phase 1b study in adults with DMD in Q3 2025 Expected to report 3-month interim data this year Preparing submissions to enable initiation of a global Phase 2 randomized, placebo-controlled clinical trial in children with DMD Appointed Dr. Wildon Farwell as chief medical officer (CMO) Ended the second quarter of 2025 with cash balance of $52.1 million ($38.2 million in $U.S.) Article content TORONTO — Satellos Bioscience Inc. (TSX: MSCL, OTCQB: MSCLF) ('Satellos' or the 'Company'), a clinical-stage biotechnology company developing life-improving medicines to treat degenerative muscle diseases, today announced its financial results and corporate highlights for the second quarter ended June 30, 2025. Article content 'We are excited by the clean safety profile and promising functional improvements with SAT-3247 in our Phase 1a/1b study,' said Satellos Co-Founder and Chief Executive Officer Frank Gleeson. 'The consistency between our clinical and preclinical findings continues to point to the transformative potential of SAT-3247 as a novel treatment for degenerative muscle conditions broadly. In Duchenne, current therapies are making important progress in slowing disease progression and preserving muscle. We designed SAT-3247 to do something different — help rebuild muscle and improve strength. We look forward to our imminent Phase 1b long-term follow-up trial in adults and planned Phase 2 study with children, where we aim to demonstrate how SAT-3247 may contribute to that most important goal of improving functional outcomes for people living with Duchenne through a potentially safe, disease modifying, oral treatment.' Article content On May 22, 2025, Satellos announced positive Phase 1b results from a 28-day open-label study in five adult male patients with DMD (ages 20–27). SAT-3247 was safe and well tolerated in all participants Grip strength, measured using the standardized MyoGrip device, showed an approximate doubling across the 5 participants from ~ 2 kg to 4 kg. In addition, patients demonstrated an approximate average increase in force-vital capacity of 5%. Study participants appeared to remain stable in other exploratory measurement areas. The expected pharmacokinetic of SAT-3247 was met — an important result with these patients who were all on steroids. Building on these positive outcomes, Satellos received approval and plans to initiate SAT-3247-LT-001 in Q3 2025. This will offer an additional 11 months of treatment for adult participants from the initial 28-day Phase 1b trial. The study will assess the durability of functional responses, longer-term safety, and changes in muscle composition as measured by MRI. Interim 3-month results are expected prior to year-end. Satellos also plans to expand the protocol to include additional patients. Global Phase 2 trial for pediatric patients with DMD: Satellos is on track to submit an IND application to the FDA and CTAs in other countries in Q3 2025 to enable initiation — subject to regulatory approval — of a global Phase 2 randomized, placebo-controlled, proof-of-concept trial in pediatric patients with DMD. The planned trial is designed to assess safety, pediatric pharmacokinetics, optimal dose, biologic effects, and measures of functional efficacy. Article content FINANCIAL RESULTS (in $U.S.) Article content Satellos had cash and cash equivalents and short-term investments of $38.2 million as of June 30, 2025, compared with $48.5 million at Dec. 31, 2024. The decrease in funds available is due to the net loss in the current year period, as well as increased deposits related to the planned Phase 2 clinical trial. Article content For the three-months ended June 30, 2025, Satellos reported a net loss of $5.6 million ($0.03 loss per share), compared to a net loss of $4.4 million ($0.04 loss per share) for the three-months ended June 30, 2024. The increase in net loss for the three-months ended June 30, 2025, compared with the same period in 2024, was a result of increased research and development (R&D) expenses, as well as increased general and administrative (G&A) expenses. Article content R&D expenses increased to $4.4 million for the three-months ended June 30, 2025, compared to $3.6 million for the three-months ended June 30, 2024. The increase in R&D expenses was the result of increased clinical costs associated with ongoing and planned clinical trials, partially offset by decreased CMC activities related to the process development and manufacturing of SAT-3247 for clinical use in the prior year period and preclinical costs due to IND enabling studies conducted to support the clinical regulatory filings for SAT-3247 as we prepared to initiate Phase 1 clinical development in Q3 2024. Article content G&A expenses increased to $1.9 million for the three-months ended June 30, 2025, as compared to $1.3 million for the three-months ended June 30, 2024. The increase in general and administrative expenses in the current year period is primarily the result of increased salary and professional fees related to changes in headcount to support expanded operations and non-cash stock-based compensation expense due to new grants issued in the current period. Article content The Satellos consolidated interim financial statements for the three- and six-months ended June 30, 2025, and the related management discussion and analysis will be available on SEDAR+ at Article content ABOUT SAT-3247 Article content SAT-3247 is a proprietary, oral, small molecule drug being developed by Satellos as a novel treatment to regenerate skeletal muscle that is lost in Duchenne muscular dystrophy and other degenerative or injury conditions. Satellos is advancing SAT-3247 as a potential treatment for DMD, independent of dystrophin and regardless of exon mutation status. Article content ABOUT SATELLOS BIOSCIENCE INC. Article content Satellos is a clinical-stage drug development company focused on restoring natural muscle repair and regeneration in degenerative muscle diseases. Through its research, Satellos has developed SAT-3247, a first-of-its-kind, orally administered small molecule drug designed to address deficits in muscle repair and regeneration. SAT-3247 targets AAK1, a key protein that Satellos has identified as capable of replacing the signal normally provided by dystrophin in muscle stem cells to effect repair and regeneration. By restoring this missing dystrophin signal in DMD, SAT-3247 enables muscle stem cells to divide properly and more efficiently, promoting natural muscle repair and regeneration. SAT-3247 is currently in clinical development as a potential disease-modifying treatment initially for DMD. Satellos also is leveraging its proprietary discovery platform MyoReGenX™ to identify additional muscle diseases or injury conditions where restoring muscle repair and regeneration may have therapeutic benefit and represent future clinical development opportunities. For more information, visit Article content This press release includes forward-looking information or forward-looking statements within the meaning of applicable securities laws regarding Satellos and its business, which may include, but are not limited to, expected timing for Phase 2 regulatory filings, the timing of initiating the Phase 1b long term follow up study and when three month interim data will be available, estimated runway based on cash on hand; statements regarding the potential for SAT-3247 to represent a disease modifying approach to the therapeutic treatment of people living with Duchenne; anticipated benefits to patients from a small molecule treatment for Duchenne; the advancement SAT-3247 through clinical trials; the pharmacodynamic properties and mechanism-of-action of SAT-3247; the potential of our approach in other degenerative muscle diseases; its/their prospective impact on Duchenne patients, patients with other degenerative muscle disease or muscle injury or trauma, and on muscle regeneration generally; and Satellos' technologies and drug development plans. All statements that are, or information which is, not historical facts, including without limitation, statements regarding future estimates, plans, programs, forecasts, projections, objectives, assumptions, expectations or beliefs of future performance, occurrences or developments, are 'forward-looking information or statements.' Often but not always, forward-looking information or statements can be identified by the use of words such as 'shall', 'intends', 'believe', 'plan', 'expect', 'intend', 'estimate', 'anticipate', 'potential', 'prospective' , 'assert' or any variations (including negative or plural variations) of such words and phrases, or state that certain actions, events or results 'may', 'might', 'can', 'could', 'would' or 'will' be taken, occur, lead to, result in, or, be achieved. Such statements are based on the current expectations and views of future events of the management of the Company. They are based on assumptions and subject to risks and uncertainties. Although management believes that the assumptions underlying these statements are reasonable, they may prove to be incorrect. The forward-looking events and circumstances discussed in this release, may not occur and could differ materially as a result of known and unknown risk factors and uncertainties affecting the Company, including, without limitation, risks relating to the pharmaceutical and bioscience industry (including the risks associated with preclinical and clinical trials and regulatory approvals), and the research and development of therapeutics, the results of preclinical and clinical trials, general market conditions and equity markets, economic factors and management's ability to manage and to operate the business of the Company generally, including inflation and the costs of operating a biopharma business, and those risks listed in the 'Risk Factors' section of Satellos' Annual Information Form dated March 26, 2025 (which is located on Satellos' profile at Although Satellos has attempted to identify important factors that could cause actual actions, events or results to differ materially from those described in forward-looking statements, there may be other factors that cause actions, events or results to differ from those anticipated, estimated or intended. Accordingly, readers should not place undue reliance on any forward-looking statements or information. No forward-looking statement can be guaranteed. Except as required by applicable securities laws, forward-looking statements speak only as of the date on which they are made and Satellos does not undertake any obligation to publicly update or revise any forward-looking statement, whether resulting from new information, future events, or otherwise. Article content Article content Article content Article content Article content Contacts Article content Investors: Article content Liz Williams, CFO, Article content ir@ Article content Article content Media: Article content Emily Williams, Senior Director of Communications, Article content Article content
Yahoo
4 days ago
- Business
- Yahoo
Nuvectis Pharma Announces the Initiation of the Phase 1b Program for NXP900
The Phase 1b program is designed to evaluate the clinical activity of NXP900 as a single agent in patients with advanced solid tumors whose cancers harbor specific genetic alterations, and in combination with EGFR and ALK inhibitors in patients with NSCLC whose cancers developed resistance to these treatments Nuvectis will hold a conference call tomorrow, Tuesday, August 12 at 8:30 AM ET to discuss the elements of the Phase 1b program and the overall market opportunity for NXP900 Fort Lee, NJ, Aug. 11, 2025 (GLOBE NEWSWIRE) -- Nuvectis Pharma, Inc. (NASDAQ: NVCT), a clinical stage biopharmaceutical company focused on the development of innovative precision medicines for the treatment of serious conditions of unmet medical need in oncology, today announced the initiation of the Phase 1b program for NXP900. NXP900 Phase 1b clinical program The Phase 1b program was initiated following the successful completion of a dose escalation study in patients with advanced solid tumors and a clinical drug-drug interaction study in healthy volunteer, and is intended to include a single agent component, which is now underway, and a combination component that is expected to commence later this year. Single agent: We will evaluate patients with specific genetic alterations selected based on their characteristics as either direct (YES1 amplification), or dependent (Hippo Pathway alterations) targets of NXP900, and the tumor types were selected based on the prevalence of the relevant genetic alterations and supporting scientific data. These include: YES1 amplified or FAT1 mutated non-small cell lung cancer (NSCLC) NF2 mutated mesothelioma and renal cancer Other advanced solid tumors with any of the genetic alterations mentioned above or other relevant Hippo Pathway alterations Combination: We plan to evaluate NXP900 in combination with market-leading epidermal growth factor receptor (EGFR) and anaplastic lymphoma kinase (ALK) inhibitors for the treatment of non-small cell lung cancer, in patients who have initially responded to treatment and subsequently developed acquired resistance and experienced disease progression. Ron Bentsur, Chairman and Chief Executive Officer of Nuvectis commented, "We are very excited to announce the initiation of the NXP900 Phase 1b program, starting with the single agent segment. We believe that NXP900 represents a unique 'pipeline in a pill' opportunity with the potential to address several substantial areas of unmet medical need in oncology. The Phase 1b protocol was designed to showcase the potential of NXP900 as an important treatment option for various types of cancer and increase the likelihood of observing a therapeutic effect, building on an extensive scientific program to understand the underlying biology of specific cancers that may confer sensitivity to treatment with NXP900. We have high expectations for the Phase 1b program for NXP900 based on a robust dataset comprised of early mechanistic studies, preclinical proof of concept results and the emerging clinical profile from the completed Phase 1a and drug-drug interaction clinical studies,' added Mr. Bentsur. 'Additionally, we believe that the recent acquisition of shares by a highly regarded healthcare-specialized institutional investor is a vote of confidence in this Phase 1b program, and that we are well funded to execute on our ambitious plans for NXP900.' Conference Call and Webcast Information Date: Tuesday, August 12, 2025, at 8:30 AM ET Participant Dial-in (U.S.): 1-877-407-0784 Participant Dial-in (International): 1-201-689-8560 Webcast Access: Click Here A replay of the webcast will be available on the Investors section of the Nuvectis website at About Nuvectis Pharma, Inc. Nuvectis Pharma, Inc. is a biopharmaceutical company focused on the development of innovative precision medicines for the treatment of serious conditions of unmet medical need in oncology. The Company's assets include two clinical-stage drug candidates, NXP900 and NXP800. NXP900 is an oral small molecule inhibitor of the SRC Family of Kinases (SFK), including SRC and YES1. Its unique mechanism of action enables inhibition of both the catalytic and scaffolding functions of the SRC kinase, providing comprehensive shutdown of the signaling pathway. NXP900 has completed a Phase 1a dose escalation study and the Phase 1b program has been initiated. NXP800 is an oral small molecule GCN2 activator that has demonstrated anti-cancer activity in recurrent, platinum-resistant, ARID1a-mutated ovarian cancer, and may be explored in the future in other cancer types. For additional information about Nuvectis Pharma please visit: Forward Looking Statements This press release contains "forward-looking statements" within the meaning of the U.S. federal securities laws, which are subject to substantial risks and uncertainties. All statements, other than statements of historical fact, contained in this press release are forward-looking statements. Forward-looking statements contained in this press release may be identified by the use of words such as "anticipate', "believe', "contemplate', "could', "estimate', "expect', "intend', "seek', "may', "might', "plan', "potential', "predict', "project', "target', "aim', "should', "will', "would', or the negative of these words or other similar expressions, although not all forward-looking statements contain these words. Forward-looking statements are based on Nuvectis Pharma, Inc.'s current expectations and interpretations of data and information available, including preclinical and clinical safety, pharmacokinetics, pharmacodynamics, and efficacy data generated to date for NXP900 and the timing and data expectations for the NXP900 Phase 1b study and estimates and projections regarding our financial condition. The outcomes of the events described in these forward-looking statements are subject to inherent uncertainties, risks, assumptions, market and other conditions, and other factors that are difficult to predict. Further, certain forward-looking statements are based on assumptions as to future events that may not prove to be accurate. These and other risks and uncertainties may also be subject to market and other conditions and described more fully in the section titled "Risk Factors" in our Q2 2025 Form 10-Q and our other public filings with the U.S. Securities and Exchange Commission ("SEC"). However, these risks are not exhaustive and new risks and uncertainties emerge from time to time, and it is not possible for us to predict all risks and uncertainties that could have an impact on the forward-looking statements contained in this press release or other filings with the SEC. Any forward-looking statements contained in this press release speak only as of the date of this press release. We expressly disclaim any obligation or undertaking to release publicly any updates or revisions to any forward-looking statements contained herein to reflect any change in our expectations or any changes in events, conditions or circumstances on which any such statement is based, except as may be required by law, and we claim the protection of the safe harbor for forward-looking statements contained in the Private Securities Litigation Reform Act of 1995. Company ContactRon BentsurChairman, Chief Executive Officer and Presidentrbentsur@ Media Relations ContactKevin GardnerLifeSci Advisorskgardner@ Sign in to access your portfolio
Yahoo
14-07-2025
- Business
- Yahoo
Imugene Announces Outstanding Response Rates from the Phase 1b Trial of the Azer-cel Allogeneic CAR T in 3L+ DLBCL
Since the February update, an additional 5 patients have been dosed, resulting in 2 Complete Responses (CR) and 3 Partial Responses (PR) 75% Overall Response rate (ORR): 6 total CR and 3 PR in Phase 1b trial of azer-cel, an allogeneic off-the-shelf CD19 CAR T therapy in relapsed diffuse large B-cell lymphoma (DLBCL), an aggressive type of blood cancer First patient remains cancer free at 15 months and ongoing with additional patients having durable responses at 2, 5, and 11 months+ and durability data continuing to mature Patients in the trial have previously failed at least 3 lines of therapy with many patients failing 4-6 lines of therapy, including autologous CAR-T, reinforcing the potential of azer-cel in this high-unmet-need population Based on these positive results, Imugene expects to meet with the US FDA in Q4 2025 regarding a pivotal / registrational study for azer-cel Trial now open to enrol into CAR T naïve niche indications in other lymphomas Additional update expected in coming months SYDNEY, July 14, 2025 /PRNewswire/ -- Imugene Limited (ASX: IMU), a clinical-stage immuno-oncology company, is pleased to announce exciting new data from its Phase 1b clinical trial evaluating azer-cel (azercabtagene zapreleucel) in patients with relapsed/refractory diffuse large B-cell lymphoma (DLBCL). In February 2025, Imugene announced that a total of four out of seven patients had achieved a Complete Response (CR), defined as the disappearance of all signs of cancer in response to treatment. Since then, two additional patients have also achieved a Complete Response, and three patients have achieved Partial Response (cancer reduction by at least 50%) bringing the best overall response rate to 75% and the CR rate to 55%. The duration of response continues to mature. These patients are being treated with azer-cel and interleukin 2 (IL -2). Evaluable patients Treatment N Overall Response Rate (ORR) Complete Response (CR) At Day 60 Best Durability (Time of response) DLBCL Lymphodepletion (LD)1 +azer-cel +Interleukin-2 (IL-2) 12 9/12 (75%) 6/11 (55%) >450 days on going For approved, autologous CD19 CART products, the average time to best response is 2-3 months with some patients taking up to 6 months to achieve their best response. Azer-cel is being developed as a potential allogeneic, off-the-shelf, CAR T-cell therapy, addressing key limitations of approved autologous CAR T drugs, including geographical access to treatment centres, manufacturing complexity and time to receive treatment (on-demand). Based on the updated response rate and maturing durability data, as well as having been awarded FDA Fast Track Designation for DLBCL in March 2025, Imugene will request a Type B (End of Phase 1) Meeting in Q4 2025, with the US FDA to present the data and to discuss designs for a pivotal / registrational trial for azer-cel. Leslie Chong, Managing Director and CEO of Imugene, said: "We are very pleased with the continued positive data coming from the azer-cel trial, which further reinforces its potential as a treatment for DLBCL patients who have failed several previous lines of therapy. The data also significantly improves our position from both a regulatory and commercial standpoint, and we look forward to expanding on these discussions with the FDA. Additionally, given the positive results, we are opening the trial to other niche blood cancer indications, such as PCNSL and other subtypes of B Cell Lymphoma, for CAR T naïve patients. This is a high unmet need with potential to expedite and expand the scope of azer-cel." Dr John Byon, Chief Medical Officer of Imugene, said: "DLBCL remains one of the most aggressive forms of lymphoma, and despite the existing therapies, there are a large number of patients that still face relapse or resistance. We are seeing significant potential from azer-cel to date in its ability to provide a critical step forward for these patients who have relapsed on multiple therapies, offering deep and durable responses with a one-time treatment. We remain deeply committed to transforming the standard of care in difficult-to-treat blood cancers, where significant unmet medical need still exists." The FDA Fast Track Designation for DLBCL received for azer-cel is designed to facilitate the development and expedite the review of drugs that address serious or life-threatening conditions and meet an unmet medical need. Benefits of the designation include more frequent meetings with the FDA to discuss development plans, the option for rolling review of regulatory submissions, and potential eligibility for Accelerated Approval and Priority Review upon meeting relevant criteria. Imugene continues to actively enrol patients into the Phase 1b azer-cel trial at ten US sites with up to six sites in Australia planned, after the first Australian patient was dosed in January 2025 at Royal Prince Alfred Hospital in Sydney, resulting in a Complete Response. About the Phase 1b azer-cel trial The azer-cel allogeneic CAR T trial is an ongoing, open-label, multi-centre Phase 1b clinical trial in the U.S. and Australia, for CAR T relapsed patients with DLBCL. The study has recently expanded to include and treat CAR T naïve patients diagnosed with a broad range of Non-Hodgkins lymphomas including primary central nervous system lymphoma (PCNSL), chronic lymphocytic leukemia (CLL)/ small lymphocytic lymphoma (SLL), marginal zone lymphoma (MZL), Waldenstrom macroglobulinemia (WM) and follicular lymphoma (FL). Treatment with azer-cel, lymphodepletion (LD) and IL-2 is showing promising results with evidence of meaningful clinical activity, and durability of response. Additionally, the safety profile is manageable and generally well tolerated. About diffuse large B cell lymphoma (DLBCL) DLBCL is an aggressive and fast-growing type of non-Hodgkin's lymphoma (NHL), a type of blood cancer. DLBCL is the most common type of NHL, with approximately 160,000[1] global cases per year and approximately 30,000 new cases per year in the U.S. Relapsed/refractory DLBCL has a high unmet medical need; ~60% of patients treated with approved autologous CD19 CAR T relapse. [1]Science Direct Volume 60, Issue 5, November 2023 About primary central nervous system lymphoma (PCNSL) PCNSL is a rare and aggressive form of non-Hodgkin lymphoma (NHL), a type of blood cancer that originates in the brain, spinal cord, leptomeninges, or eyes, usually without evidence of systemic disease. In the U.S., there are approximately 1,500 to 1,800 new cases per year with limited approved treatment options and is a high unmet need. Currently, there are no CAR T-cell products approved for the treatment of PCNSL providing a unique opportunity for azer-cel to treat CART naïve patients. About other types of B Cell Lymphoma Other subtypes of non-Hodgkin lymphoma (NHL) include chronic lymphocytic leukemia (CLL)/small lymphocytic lymphoma (SLL), the most common slow growing leukemia that can become resistant to therapy; marginal zone lymphoma (MZL), a slow-growing B-cell lymphoma that arises in lymphoid tissues associated with mucosal sites like the stomach and lung; Waldenström macroglobulinemia (WM), a rare slow-growing lymphoma characterized by excess IgM production, which can cause multiple complications ; and follicular lymphoma (FL), a common slow-growing NHL that can become more aggressive. While several targeted therapies and monoclonal antibodies are available for these types of B Cell Lymphoma, relapsed or refractory disease remains an ongoing challenge, highlighting the ongoing need for continued innovation and new and better treatments. About Interleukin 2 (IL-2) IL-2 is a cytokine (a protein that affects what happens between cells in the immune system) that helps T-cells (which are part of the immune system that help fight cancer) grow and survive. IL-2 has been shown to help T cells live longer and to enhance the cancer killing functions of CAR T cells, making them more effective at targeting and killing cancer cells. For more information please contact: Leslie ChongManaging Director and Chief Executive Officerinfo@ General Investor Enquiriesshareholderenquiries@ Media EnquiriesMatt Wrightmatt@ Connect with us on LinkedIn @Imugene LimitedFollow us on Twitter @TeamImugene Watch us on YouTube @ImugeneLimited About Imugene (ASX:IMU) Imugene is a clinical stage immuno-oncology company developing a range of new and novel immunotherapies that seek to activate the immune system of cancer patients to treat and eradicate tumours. Our unique platform technologies seek to harness the body's immune system against tumours, potentially achieving a similar or greater effect than synthetically manufactured monoclonal antibody and other immunotherapies. Our pipeline includes an off-the-shelf (allogeneic) cell therapy CAR T drug azer-cel (azercabtagene zapreleucel) which targets CD19 to treat blood cancers. Our pipeline also includes oncolytic virotherapy (CF33) aimed at treating a variety of cancers in combination with standard of care drugs and emerging immunotherapies such as CAR T's for solid tumours and B-cell vaccine candidates. We are supported by a leading team of international cancer experts with extensive experience in developing novel cancer therapies that are currently marketed globally. Our vision is to help transform and improve the treatment of cancer and the lives of the millions of patients who need effective treatments. This vision is backed by a growing body of clinical evidence and peer-reviewed research. Together with leading specialists and medical professionals, we believe Imugene's immuno-oncology therapies will become foundation treatments for cancer. Our goal is to ensure that Imugene and its shareholders are at the forefront of this rapidly growing global market. Release authorised by the Managing Director and Chief Executive Officer Imugene Limited. View original content to download multimedia: SOURCE Imugene Ltd Error in retrieving data Sign in to access your portfolio Error in retrieving data Error in retrieving data Error in retrieving data Error in retrieving data
Globe and Mail
15-04-2025
- Business
- Globe and Mail
Why Verve Therapeutics Is Skyrocketing Today
Verve Therapeutics (NASDAQ: VERV) stock is seeing explosive gains Tuesday. The biotech company's share price was up 24.5% as of 12:30 p.m. ET and had been up as much as 41% earlier in the session. Yesterday, Verve published promising data from its Heart-2 Phase 1b clinical trial of its VERVE-102 treatment for heterozygous familial hypercholesterolemia (HeFH) and premature coronary artery disease. Several analysts have now raised their price targets on the stock, and investors are buying up shares in response. Verve Therapeutics stock sees a swell of bullish coverage In coverage published this morning, Cantor Fitzgerald raised its rating on Verve Therapeutics stock from neutral to overweight -- indicating that the firm thinks the stock is a good buy. The firm's analysts said that results for VERVE-102 had come in better than expected in terms of both safety and efficacy. Guggenheim also published new coverage on Verve this morning -- maintaining a buy rating on the stock and raising its one-year price target from $18 per share to $24 per share. The firm's analysts cheered on the results for the Heart-2 Phase 1b trial and now sees a 75% chance that the treatment will be successfully marketed -- up from its previous estimate of 60%. Canaccord was even more bullish. The firm reiterated a buy rating on the stock and increased its one-year price target from $32 per share to $39 per share, saying that safety and efficacy results for the treatment in the trial had knocked it out of the park. What's next for Verve Therapeutics? Verve is scheduled to share more information about VERVE-102 at a medical conference this quarter, including trial data from the treatment at a higher dosage level. With the treatment potentially delivering best-in-class results, Verve stock could have room to run above current levels. Should you invest $1,000 in Verve Therapeutics right now? Before you buy stock in Verve Therapeutics, consider this: The Motley Fool Stock Advisor analyst team just identified what they believe are the 10 best stocks for investors to buy now… and Verve Therapeutics wasn't one of them. The 10 stocks that made the cut could produce monster returns in the coming years. Consider when Netflix made this list on December 17, 2004... if you invested $1,000 at the time of our recommendation, you'd have $502,231!* Or when Nvidia made this list on April 15, 2005... if you invested $1,000 at the time of our recommendation, you'd have $678,552!* Now, it's worth noting Stock Advisor 's total average return is800% — a market-crushing outperformance compared to156%for the S&P 500. Don't miss out on the latest top 10 list, available when you join Stock Advisor. See the 10 stocks » *Stock Advisor returns as of April 14, 2025
