Latest news with #biotechnology
Yahoo
9 hours ago
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Harbinger Health Showcases Multi-Cancer Early Detection Performance in High-Risk Populations at ASCO 2025
Reflex blood-based multi-cancer early detection (MCED) test demonstrated clinically meaningful per-cancer Positive Predictive Value (PPV) and early-stage sensitivity for multiple cancers with elevated incidence and mortality in a high-risk population Data to be presented at ASCO's Clinical Science Symposium on the future of cancer detection CAMBRIDGE, Mass., May 31, 2025 (GLOBE NEWSWIRE) -- Harbinger Health, a biotechnology company pioneering the detection of early cancer, today announced clinical data demonstrating the performance of its blood-based MCED test across multiple high-incidence, high-mortality cancers, including those disproportionately affecting individuals with obesity, at the American Society of Clinical Oncology (ASCO) Annual Meeting in Chicago, Illinois. Results highlight the potential of Harbinger's ctDNA-methylation-based assay and reflex testing paradigm to address gaps in population-level early cancer detection, particularly for cancers without established screening programs, and in high-risk patient populations with limited clinical guidelines. 'The results from our study demonstrate the robust early-stage performance of our test across multiple cancer types. While the obesity-associated subset demonstrates our ability to target high-risk groups, the broader results underscore the platform's potential across a wide range of deadly cancers that lack mechanisms for effective, large-scale early detection via routine screening,' said Hutan Ashrafian, M.D., Ph.D., M.B.A., Chief Medical Officer of Harbinger Health. 'The analysis that we are presenting at ASCO validates the alignment between our test performance and disease burden and reflects our commitment to designing a test for those who need it most, when it matters most.' Harbinger's test uses specific proprietary methylation patterns of cell-free ctDNA in blood to detect the presence of cancer. The company has developed a platform that combines unique insights into the biology of cancer's origin with artificial intelligence and analytical and methodological innovations to create novel diagnostic and screening products in multiple clinical settings and cancer indications. Harbinger's reflex test system uses a two-step approach. The primary methylome profiling test is optimized for high sensitivity to rule out disease. This is followed by a confirmatory reflex test with an expanded methylation panel designed to improve PPV, rule in the presence of cancer, and identify tissue of origin (TOO). Harbinger conducted the Cancer ORigin Epigenetics-Harbinger Health (CORE-HH) study (NCT05435066) with Sarah Cannon Research Institute to validate and further develop Harbinger's platform. The multi-center, case-controlled study enrolled approximately 8,095 subjects from 126 sites across the U.S. and included two groups: a cancer group of treatment-naïve patients with confirmed diagnoses across 20+ solid and hematologic tumor types, and a non-cancer (control) group of individuals without suspected cancer at enrollment. All participants provided a single blood sample, and controls were followed for one year to confirm their cancer-free status. Dax Kurbegov, M.D., Senior Vice President at HCA Healthcare Sarah Cannon Cancer Network, will present the findings from the obesity cohort of the CORE-HH study at a Clinical Science Symposium entitled 'The Future of Cancer Detection is Coming' from 8:00-9:30 a.m. CDT on Saturday, May 31, 2025, in Hall D1 of the McCormick Place Chicago Convention Center. Key highlights from the presentation include: The test cohort, consisting of 762 individuals with obesity, was assembled from the CORE-HH study and had a mean age of 57.1 ± 13.4 years and were 63.3% female, 22.4% Black or African American, and 67.8% White. The distribution of cancer types evaluated in this study was breast, uterine, lung, lymphoid-line, prostate, colorectal, pancreas, upper GI (includes esophageal, esophagogastric junction, and gastric), head and neck, liver, biliary tract, and others. Cancer types grouped under 'Others' were not used to train the TOO model due to low sample counts. These include ovarian, renal, anal, neuroendocrine, cervical, melanoma, bladder, myeloid, soft tissue, sarcoma, among others. At 98.3% specificity, the reflex test achieved conventional sensitivities of 25.8% for early-stage (I-II) cancer and 80.3% for late-stage (III-IV) cancer. At 98.3% specificity, the reflex test achieved a conventional sensitivity of 50.9% for cancers without a screening program in the U.S. general population. Cancers with screening programs in the U.S. general population that were excluded are breast, colorectal, lung, prostate, and cervix. Overall intrinsic accuracy - the proportion of correct TOO readouts among cases with a corresponding readout category - was 36%. TOO-specific performance as measured by PPV for the following cancers was hepatobiliary (15%), upper GI (22%), colorectal (33%), and lung cancer (25%). In a modeled 100,000-person cohort, the test identified 51 of 86 pancreaticobiliary cancers, including 8 of 31 at early-stage. Dr. Kurbegov commented: 'These data introduce for the first time a metric for intrinsic accuracy to measure a test's ability to correctly identify both a cancer signal and its tissue of origin. This is a more stringent and clinically relevant result as compared to conventional sensitivity, which has been the current industry standard and does not provide information on the location of cancer within an individual. Measuring per-cancer PPV, combined with the reflex test design, are novel aspects of Harbinger's approach that may support stratified diagnostic and follow-up strategies that could help physicians tailor downstream evaluation and management according to the likely tissue of origin and associated benefit-risk considerations. These advances solve some of the most confounding challenges we currently face in our ability to make the most of blood-based tools for early cancer detection. Given these technological advances and study results, I am optimistic that the future of cancer detection is bright and close at hand.' Obesity is estimated to contribute to ~84,000 new cancer cases in the U.S. annually1,2, and the incidence of obesity-related cancers has increased substantially over the past two decades3. Thirteen obesity-associated cancers represent ~40% of cancer diagnoses in the U.S.4, and most of these cancers, such as pancreatic, liver, and endometrial, do not have screening programs available. About Harbinger Health Harbinger Health is leading a transformation in early cancer detection, introducing fundamentally new approaches to screening, diagnosis, and management. The company combines advances in artificial intelligence with proprietary insights into the biology of the beginnings of cancer to identify cancer before it is visible or symptomatic with the aim of developing a low-cost, multi-cancer blood test. Harbinger envisions a future where, instead of keeping cancer from spreading, it could be kept from forming, making a cancer diagnosis a routine health problem to be addressed rather than a life-altering event to be feared with profound implications for people, healthcare systems and societies. Harbinger was founded by Flagship Pioneering after three years of foundational research in its Labs unit and launched in 2020. Learn more about Harbinger by visiting or following us on LinkedIn. Media Contactpress@ ______________________________________ American Association for Cancer Research. Cancer Progress Report 2024 Ligibel JA, Alfano CM, Courneya KS, et al. American Society of Clinical Oncology position statement on obesity and cancer. J Clin Oncol. 2014 Shiels MS, Haque AT, González AB et al. Trends in Cancer Incidence and Mortality Rates in Early-Onset and Older-Onset Age Groups in the United States, 2010–2019. Cancer Discovery. 2025 National Cancer Institute. Obesity and Cancer Fact Sheet. Updated 2022Error 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
Yahoo
11 hours ago
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Fulcrum Therapeutics, Inc. (FULC): A Bull Case Theory
We came across a bullish thesis on Fulcrum Therapeutics, Inc. (FULC) on Stock Pursuit's Substack. In this article, we will summarize the bulls' thesis on FULC. Fulcrum Therapeutics, Inc. (FULC)'s share was trading at $6.44 as of 23rd May. FULC's trailing P/E was 312.50 according to Yahoo Finance. A scientist in a lab conducting research on cell-based therapeutics and biotechnology. Fulcrum Therapeutics (FULC) recently surged over 110% from around $3.30 to $7.00, reflecting growing optimism but also presenting a prime opportunity to take profits. The company's lead candidate, Pociredir (FTX-6058), is an oral small molecule in Phase 1b trials aimed at treating Sickle Cell Disease (SCD) by increasing fetal hemoglobin expression. While early data are encouraging, larger trials are needed to confirm efficacy and safety, especially following a prior clinical hold related to concerns over EED inhibitors. Analysts have raised their peak sales forecasts to roughly $600 million with a 50% probability of success, and Fulcrum's cash runway extends into 2027. Market dynamics favor Pociredir due to Pfizer's withdrawal of Oxbryta and slow adoption of gene therapies, creating scarcity value for new oral treatments. Beyond SCD, Fulcrum is developing programs for inherited aplastic anemias, with an Investigational New Drug application for Diamond-Blackfan anemia expected in late 2025. Despite this promise, history shows that small-cap pharma stocks can experience volatile reversals after big gains, so locking in profits while retaining a small position for potential upside on drug results seems prudent. The broader biotech sector, historically avoided by the author, has recently become more attractive due to technological advances and compelling net cash positions, as demonstrated by previous successes like Somalogic. Overall, Fulcrum represents a high-risk, high-reward opportunity in a niche with growing unmet medical needs, but caution and disciplined profit-taking remain essential given the sector's volatility. Fulcrum Therapeutics, Inc. (FULC) is not on our list of the 30 Most Popular Stocks Among Hedge Funds. As per our database, 21 hedge fund portfolios held FULC at the end of the first quarter which was 23 in the previous quarter. While we acknowledge the risk and potential of FULC as an investment, our conviction lies in the belief that some AI stocks hold greater promise for delivering higher returns, and doing so within a shorter timeframe. If you are looking for an AI stock that is more promising than FULC but that trades at less than 5 times its earnings, check out our report about the cheapest AI stock. READ NEXT: 8 Best Wide Moat Stocks to Buy Now and 30 Most Important AI Stocks According to BlackRock. Disclosure: None. This article was originally published at Insider Monkey. 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
Yahoo
12 hours ago
- Business
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Bio-Techne Corporation (TECH): A Bull Case Theory
We came across a bullish thesis on Bio-Techne Corporation (TECH) on scuttleblurb's Substack. In this article, we will summarize the bulls' thesis on TECH. Bio-Techne Corporation (TECH)'s share was trading at $47.93 as of 28th May. TECH's trailing and forward P/E were 57.75 and 22.03 respectively according to Yahoo Finance. A close-up of a biotechnology machine working on an oncology therapy. Bio-Techne has built a diverse and complex business centered on its strong legacy in recombinant proteins, expanding downstream into antibodies, assays, and instrument platforms, while also moving into cell and gene therapy (CGT) solutions. Its revenue is split roughly between Protein Sciences and Diagnostics, which are closely linked—diagnostics identify disease biomarkers that then become therapeutic targets developed using Bio-Techne's proteins and antibodies. Despite about 20 acquisitions over the past decade, its core legacy products still contribute 56% of total revenue, with the remainder coming from faster-growing, less penetrated markets. Around half of Bio-Techne's revenue comes from commercial R&D, now dominated by smaller, venture-funded biotechs rather than big pharma, making this segment more cyclical. Academia accounts for another 20%, a price-sensitive group vulnerable to budget swings. The company is gaining ground in GMP protein production for clinical and commercial use, a highly regulated and lucrative niche, though it trails established leaders like Miltenyi and Cellgenix. Bio-Techne has also expanded into proteomics and spatial biology through acquisitions. While the company once forecasted nearly $2 billion in revenue by 2026, growth slowed due to several factors: COVID-related demand spikes followed by inventory destocking, a 20-30% revenue decline in China, fading COVID testing tailwinds, and cautious FDA oversight of CGTs that hurt growth expectations. Despite these setbacks causing a nearly 50% stock price decline, recent signs point to recovery with organic growth rebounding to 9% and instrument sales improving. Bio-Techne's broad strategy reflects its efforts to protect core franchises while expanding into new growth areas, including becoming an instrument provider to capture more downstream value. Bio-Techne Corporation (TECH) is not on our list of the 30 Most Popular Stocks Among Hedge Funds. As per our database, 34 hedge fund portfolios held TECH at the end of the first quarter which was 24 in the previous quarter. While we acknowledge the risk and potential of TECH as an investment, our conviction lies in the belief that some AI stocks hold greater promise for delivering higher returns, and doing so within a shorter timeframe. If you are looking for an AI stock that is more promising than TECH but that trades at less than 5 times its earnings, check out our report about the cheapest AI stock. READ NEXT: 8 Best Wide Moat Stocks to Buy Now and 30 Most Important AI Stocks According to BlackRock. Disclosure: None. This article was originally published at Insider Monkey.
Yahoo
14 hours ago
- Business
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Revelation Biosciences, Inc. (REVB) Raises $4M in Public Offering
Revelation Biosciences, Inc. (NASDAQ:REVB), a clinical-stage life sciences company dedicated to rebalancing inflammation for improved health outcomes, has successfully closed a public offering, raising approximately $4 million in gross proceeds. The offering included 3,640,000 shares of common stock (or equivalents) and warrants to purchase up to 14,560,000 shares, all priced at $1.10 per share and warrant. The warrants, exercisable upon shareholder approval, will remain valid for five years from their initial exercise date. Roth Capital Partners served as the sole placement agent for the transaction. A female doctor using the latest healthcare IT technology in her medical practice. Revelation Biosciences, Inc. (NASDAQ:REVB) plans to use the net proceeds to advance its clinical and preclinical programs. Key initiatives include completing its ongoing Phase 1b clinical trial, manufacturing clinical drug supplies, conducting additional preclinical studies for multiple indications, developing new products and therapies, and supporting general corporate operations. While we acknowledge the potential of REVB to grow, our conviction lies in the belief that some AI stocks hold greater promise for delivering higher returns and have limited downside risk. If you are looking for an AI stock that is more promising than AMZN and that has 100x upside potential, check out our report about this READ NEXT: and Disclosure: None.
Yahoo
17 hours ago
- Business
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bluebird bio, Inc. (BLUE) Nears Acquisition by Carlyle and SK Capital
Investment firms The Carlyle Group Inc. (NASDAQ:CG) and SK Capital Partners, together with Beacon Parent Holdings, L.P., have successfully completed the tender offer for bluebird bio, Inc. (NASDAQ:BLUE) to acquire all outstanding common stock. With a value of either $3.00 per share plus a contingent value right or $5.00 per share in cash, the transaction is set to be finalized through a merger on June 2, 2025. A medical researcher inspecting a petri-dish filled with bacteria in a laboratory setting. We have previously seen how bluebird bio, Inc. (NASDAQ:BLUE), a biotechnology company engaging in gene therapies for serious genetic diseases, was both out of time and out of money. Among the challenges faced by the company were financial burdens, a high debt-to-capital ratio of 0.82, and a low current ratio of 0.55. In February, the management reported a deal with Carlyle and SK Capital Partners for $3 in cash and a $6.84 contingent value. Soon after, the entities secured approvals from the EU, China, and Turkey, meeting all the regulatory requirements. Under the terms of the agreement, the transaction is anticipated to advance without a vote from the bluebird bio, Inc. (NASDAQ:BLUE) stockholders, complying with Delaware's General Corporation Law. By offering a choice to the shareholders through an amended buyout agreement, the company provides immediate cash to those who desire it instead of potential future payments. READ NEXT: 20 Best AI Stocks To Buy Now and 30 Best Stocks to Buy Now According to Billionaires. Disclosure. None. Sign in to access your portfolio
