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Yahoo
10 hours ago
- Yahoo
Sharp Therapeutics Corp. Engages Rho Inc. to Help Advance Compounds into Clinical Trials for Gaucher Disease
Pittsburgh, Pennsylvania and Toronto, Ontario--(Newsfile Corp. - July 29, 2025) - Sharp Therapeutics Corp. (TSXV: SHRX) ("Sharp" or the "Company"), a preclinical-stage biotechnology company developing small molecule therapies to treat genetic diseases, today announced that it has engaged Rho, Inc. ("Rho"), a global contract research organization (CRO), to support Sharp's preparation and planned submission of its Investigational New Drug Application ("IND") to the U.S. Food and Drug Administration (the "FDA") for the evaluation of its clinical candidate compound ("'901") for the treatment of Gaucher disease. Gaucher disease is a genetic disorder caused by a deficiency in the enzyme glucocerebrosidase (also called beta-glucosidase or GBA1). Sharp's small molecule compound is a potential new orally available CNS-penetrant therapy for the treatment of Gaucher disease. "We are excited by the preclinical data from our Gaucher candidate, '901, and look forward to Rho's support in preparing our IND and other filings," said Scott Sneddon, PhD, JD and Chief Executive Officer of Sharp. "We intend to meet with FDA on our Phase I clinical plan, and to file for orphan drug designation this year. IND-enabling studies are also planned to commence before end of 2025. This is a key milestone for Sharp as we transition from a preclinical-stage to a clinical-stage company," he added. About '901 The '901 compound increases GBA1 activity for numerous mutations in Gaucher patient-derived cells, as well as increasing substrate turnover in a rodent model of Gaucher. Preclinical studies show the compound to be orally available and CNS-penetrant with good safety and preclinical pharmacology profiles. The compound is being targeted to all types of Gaucher with an application to GBA-associated Parkinson's disease also possible. The scientific data supporting the '901 series of compounds was presented at the GBA1 Conference in Montreal on June 5, 2025. That presentation is available on the Company's website at About Gaucher Disease Gaucher disease is a lysosomal storage disease caused by a deficiency in the GBA1 enzyme. Gaucher is the most common lysosomal storage disorder. Without this enzyme, the glucocerebroside lipid accumulates within the lysosomes of certain cells, particularly macrophages (immune cells). These overloaded cells, called "Gaucher cells," become enlarged and dysfunctional. The buildup primarily affects the spleen, liver, bone marrow, and sometimes the nervous system, leading to organ enlargement and the characteristic symptoms of the disease. This is the classic pattern of lysosomal storage diseases: enzyme deficiency → substrate accumulation → cellular dysfunction → organ pathology. About Rho, Inc. Rho is a global, privately held contract research organization (CRO) headquartered in Research Triangle Park, a biotech hub in North Carolina, US. Rho provides a full range of drug development services, from program strategy through to clinical trials and marketing applications. Since 1984, Rho has been a trusted partner to some of the most innovative pharmaceutical, biotechnology and medical device companies as well as academic and government organizations. Dedicated to service excellence and cross-functional collaboration, Rho's therapeutic expertise, employee focus and commitment to strong site relationships change what it means to work with a CRO – accelerating time to market, maximizing ROI, and delivering consistent, smarter and more efficient programs. Experience Rho by following the company on LinkedIn. About Sharp Therapeutics Corp. - First-Choice Therapies for Genetic Diseases Sharp Therapeutics is a preclinical-stage company developing small-molecule therapeutics for genetic diseases. The Company's discovery platform combines novel high throughput screening technologies, with compound libraries computational optimized based on the physics and biology of cellular trafficking defects and allosteric activation of proteins. The platform produces small molecule compounds that restore activity in mutated proteins giving the potential to treat genetic disorders with conventional pill-based medicines. For additional information on Sharp, please visit: Sharp Therapeutics Sneddon, PhD, JDCEO/CSOEmail: scott@ Caution Regarding Forward-Looking Information Certain statements contained in this press release constitute "forward-looking information" as such term is defined in applicable Canadian securities legislation. The words "may", "would", "could", "should", "potential", "will", "seek", "intend", "plan", "anticipate", "believe", "estimate", "expect" and similar expressions are intended to identify forward-looking information. All statements other than statements of historical fact may be forward-looking information. Such statements reflect Sharp's current views and intentions with respect to future events, and current information available to Sharp, and are subject to certain risks, uncertainties and assumptions. Many factors could cause the actual results, performance or achievements that may be expressed or implied by such forward-looking information to vary from those described herein should one or more of these risks or uncertainties materialize. Should any factor affect Sharp in an unexpected manner, or should assumptions underlying the forward-looking information prove incorrect, the actual results or events may differ materially from the results or events predicted. Any such forward-looking information is expressly qualified in its entirety by this cautionary statement. Moreover, Sharp does not assume responsibility for the accuracy or completeness of such forward-looking information. The forward-looking information included in this press release is made as of the date of this press release and Sharp undertakes no obligation to publicly update or revise any forward-looking information, other than as required by applicable law. Neither TSX Venture Exchange nor its Regulation Services Provider (as that term is defined in the policies of the TSX Venture Exchange) accepts responsibility for the adequacy or accuracy of this release. To view the source version of this press release, please visit 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
10 hours ago
- Yahoo
Cardiff Oncology Announces Positive Data from Ongoing Randomized Phase 2 First-line RAS-mutated mCRC Clinical Trial (CRDF-004)
– Trial demonstrates 49% confirmed ORR in the 30mg onvansertib dose arm versus 30% confirmed ORR in the control arm in intent-to-treat population (N=110) – – Early PFS data show a trend favoring 30mg onvansertib dose arm vs. control arm – – Onvansertib continues to be well-tolerated and demonstrates a dose dependent response for all endpoints including ORR, early tumor shrinkage and depth of response – – Company will hold a conference call today at 4:30 p.m. ET / 1:30 p.m. PT – SAN DIEGO, July 29, 2025 (GLOBE NEWSWIRE) -- Cardiff Oncology, Inc. (Nasdaq: CRDF), a clinical-stage biotechnology company leveraging PLK1 inhibition to develop novel therapies across a range of cancers, today announced positive data from the ongoing CRDF-004, a randomized, Phase 2 clinical trial evaluating onvansertib in combination with standard-of-care (SoC) in patients with first-line RAS-mutated metastatic colorectal cancer (mCRC). Efficacy data represents intent-to-treat patients as of a July 8, 2025 data cut-off, and is determined by blinded, independent central review (BICR) of each patient's tumor scans. 'We are highly encouraged by the 19% improvement in confirmed ORR as well as the shorter time to response and deeper tumor regression observed in our trial with onvansertib combined with SoC compared to SoC alone. Furthermore, early PFS data shows a trend favoring the 30mg dose of onvansertib vs. control,' said Roger Sidhu, MD, Chief Medical Officer of Cardiff Oncology. 'The totality of the data we are releasing today strengthens the initial findings from our December 2024 data release in a significantly larger patient population, compares favorably to previous practice-changing Phase 3 trials, and demonstrates that onvansertib could be a novel therapy for the treatment of first-line RAS-mutated mCRC.' Trial Design The CRDF-004 phase 2 trial enrolled patients with mCRC who have a documented KRAS or NRAS mutation. Onvansertib is added to SoC consisting of FOLFIRI plus bevacizumab or FOLFOX plus bevacizumab. Patients were randomized to one of six arms including 20mg of onvansertib plus SoC, 30mg of onvansertib plus SoC, or SoC alone. The primary endpoint is objective response rate (ORR), and the secondary endpoints include progression-free survival (PFS), duration of response (DOR) and safety. Additional prespecified endpoints include early tumor shrinkage (ETS), defined as a ≥20% reduction in tumor size at the 2-month scan, and depth of response (DpR), defined as the greatest reduction in tumor size achieved while on therapy during the trial. ETS and DpR are well-established predictors for PFS in first-line mCRC as demonstrated in multiple peer-reviewed publications.1-3 Efficacy Data Efficacy data in the intent-to-treat population (ITT) from the CRDF-004 clinical trial, as of the July 8, 2025 data cut-off, are shown below. Control Arm(SoC alone)(n=37) 20mg dose of onvansertib + SoC (n=36) 30mg dose of onvansertib + SoC (n=37) Confirmed ORRa 30%(11 of 37) 42%(15 of 36) 49%(18 of 37) Confirmed ORR at 6-monthsa 22%(8 of 37) 33%(12 of 36) 46%(17 of 37) ORRb 43%(16 of 37) 50%(18 of 36) 59%(22 of 37) aConfirmed Objective Response Rate (ORR) per RECIST v1.1 includes those patients who had a complete response (CR) or partial response (PR) confirmed by repeat imaging ≥4 weeks after response criteria first met. bORR per RECIST v1.1 includes confirmed CRs/PRs and unconfirmed PRs who were still on treatment and may yet be confirmed Spider Plots, displaying the change in tumor size from baseline for each patient over time, demonstrate deeper responses in patients receiving the 30mg dose of onvansertib in combination with the SoC compared to both the control arm and 20mg dose of onvansertib Radiographic response was determined per RECIST 1.1 by blinded independent central review. Spider plot reflects data as of July 8, 2025 from an ongoing trial and unlocked database. Progression-free Survival (PFS) Data Both the 20mg and 30mg onvansertib arms demonstrated an early separation of the PFS curves compared to the control arm at a median follow up time of 6 months. While the median PFS has not been reached, there was a dose dependent effect in favor of the 30mg onvansertib dose. Safety and Tolerability The safety analysis was conducted for the 104 patients who were dosed in the trial. Onvansertib in combination with chemo/bevacizumab was well-tolerated and there were no major or unexpected toxicities observed. Grade 3 or higher adverse events were infrequent, with neutropenia being the most common treatment-emergent adverse event associated with onvansertib. 'We are highly encouraged by the strength of our data which achieves the key objectives we set for the trial, and positions us to engage in discussions with the FDA as we advance toward our registrational CRDF-005 trial,' said Mark Erlander, Chief Executive Officer of Cardiff Oncology. 'Looking ahead, we are optimistic about onvansertib's potential to redefine the first-line treatment for RAS-mutated mCRC and will provide an update on our first-line mCRC program by Q1 2026.' Upcoming expected milestones Update on first-line mCRC program expected by 1Q 2026 Conference Call and Webcast Cardiff Oncology will host a conference call and live webcast at 4:30 p.m. ET / 1:30 p.m. PT on July 29, 2025. Individuals interested in listening to the live conference call may do so by using the webcast link in the "Events" section of the company's website. A webcast replay will be available in the investor relations section on the company's website following the completion of the call. About Cardiff Oncology, Inc. Cardiff Oncology is a clinical-stage biotechnology company leveraging PLK1 inhibition, a well-validated oncology drug target, to develop novel therapies across a range of cancers. The Company's lead asset is onvansertib, a PLK1 inhibitor being evaluated in combination with standard of care (SoC) therapeutics in clinical programs targeting indications such as RAS-mutated metastatic colorectal cancer (mCRC), as well as in ongoing and planned investigator-initiated trials in metastatic pancreatic ductal adenocarcinoma (mPDAC), small cell lung cancer (SCLC) and triple negative breast cancer (TNBC). These programs and the Company's broader development strategy are designed to target tumor vulnerabilities in order to overcome treatment resistance and deliver superior clinical benefit compared to the SoC alone. For more information, please visit References Cremolini, et al. Early tumor shrinkage and depth of response predict long-term outcome in metastatic colorectal cancer patients treated with first-line chemotherapy plus bevacizumab: results from phase III TRIBE trial by the Gruppo Oncologico del Nord Ovest. Ann Oncol. 2015;26(6):1188–1194. doi: 10.1093/annonc/mdv112 Piessevaux, et al. Use of early tumor shrinkage to predict long-term outcome in metastatic colorectal cancer treated with cetuximab. J Clin Oncol. 2013 Oct 20;31(30):3764-75. doi: 10.1200/JCO.2012.42.8532 Bando H, et al. Associations between early tumor shrinkage/depth of response and survival from the ARCAD database. JNCI Cancer Spectr. 2025 Apr 30;9(3):pkaf042. doi: 10.1093/jncics/pkaf042 Forward-Looking Statements Certain statements in this press release are forward-looking within the meaning of the Private Securities Litigation Reform Act of 1995. These statements may be identified using words such as "anticipate," "believe," "forecast," "estimated" and "intend" or other similar terms or expressions that concern Cardiff Oncology's expectations, strategy, plans or intentions. These forward-looking statements are based on Cardiff Oncology's current expectations and actual results could differ materially. There are several factors that could cause actual events to differ materially from those indicated by such forward-looking statements. These factors include, but are not limited to, clinical trials involve a lengthy and expensive process with an uncertain outcome, and results of earlier studies and trials may not be predictive of future trial results; our clinical trials may be suspended or discontinued due to unexpected side effects or other safety risks that could preclude approval of our product candidate; results of preclinical studies or clinical trials for our product candidate could be unfavorable or delayed; our need for additional financing; risks related to business interruptions, including the outbreak of COVID-19 coronavirus and cyber-attacks on our information technology infrastructure, which could seriously harm our financial condition and increase our costs and expenses; uncertainties of government or third party payer reimbursement; dependence on key personnel; limited experience in marketing and sales; substantial competition; uncertainties of patent protection and litigation; dependence upon third parties; and risks related to failure to obtain FDA clearances or approvals and noncompliance with FDA regulations. There are no guarantees that our product candidate will be utilized or prove to be commercially successful. Additionally, there are no guarantees that future clinical trials will be completed or successful or that our product candidate will receive regulatory approval for any indication or prove to be commercially successful. Investors should read the risk factors set forth in Cardiff Oncology's Form 10-K for the year ended December 31, 2024, and other periodic reports filed with the Securities and Exchange Commission. While the list of factors presented here is considered representative, no such list should be considered to be a complete statement of all potential risks and uncertainties. Unlisted factors may present significant additional obstacles to the realization of forward-looking statements. Forward-looking statements included herein are made as of the date hereof, and Cardiff Oncology does not undertake any obligation to update publicly such statements to reflect subsequent events or circumstances. Cardiff Oncology Contact: James Levine Chief Financial Officer 858-952-7670jlevine@ Investor Contact: Kiki Patel, PharmD Gilmartin Group 332-895-3225Kiki@ Media Contact: Meghan Bianco Taft Communications, a division of RF|Binder 609-544-5446 A photo accompanying this announcement is available at while retrieving data Sign in to access your portfolio Error while retrieving data Error while retrieving data Error while retrieving data Error while retrieving data
Yahoo
12 hours ago
- Yahoo
Myriad Genetics to Release Second Quarter 2025 Financial Results on August 5, 2025
SALT LAKE CITY, July 29, 2025 (GLOBE NEWSWIRE) -- Myriad Genetics, Inc. (NASDAQ: MYGN), a leader in molecular diagnostic testing and precision medicine, will hold its second quarter 2025 earnings conference call at 4:30pm ET on Tuesday, Aug. 5, 2025. The company's quarterly earnings will be released the same day after the market closes. During the call, Myriad management will provide a financial overview and business update of the company's performance for the second quarter 2025. A live webcast of the conference call can be accessed on Myriad's Investor Relations website at To participate in the live conference call via telephone, please register here. Upon registering, a dial-in number and unique PIN will be provided to join the conference call. An archived webcast of the call will be available at following the call. About Myriad GeneticsMyriad Genetics is a leading molecular diagnostic testing and precision medicine company dedicated to advancing health and well-being for all. Myriad Genetics develops and offers molecular tests that help assess the risk of developing disease or disease progression and guide treatment decisions across medical specialties where molecular insights can significantly improve patient care and lower healthcare costs. For more information, visit Investor Contact Matt Scalo (801) 584-3532 IR@ Media Contact Kate Schraml(224) 875-4493PR@ 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
