We use cookies to improve user experience, and analyze website traffic.
For these reasons, we may share your site usage data with our analytics partners. By clicking "Accept Cookies" you consent to store on your device all the technologies described in our Cookie Policy.
Guardant Health has announced support for an investigator initiated study led and conducted by The Ohio State University Comprehensive Cancer Center - Arthur G. James Cancer Hospital and Richard J. Solove Research Institute to evaluate patient compliance with a blood-based test for colorectal cancer, CRC, screening. In this study, The Ohio State University Guardant Shield Colorectal Cancer Screening Project, individuals from minority and underserved populations aged 45 and older who are in need of CRC screening will have the option to receive the Shield blood test, administered by a mobile phlebotomist, as part of their engagement with a community health van. Integrating Shield into mobile health services will allow health care providers to bring blood-based screening directly to communities making it accessible for eligible individuals who are not compliant with CRC screening. "We learned early on in the COVID-19 pandemic that we need to be innovative in how we deliver care to our communities. By deploying a mobile phlebotomist as part of a mobile health clinic, we are further able to understand the potential and ease of a blood test to reach rural and underserved communities," said AmirAli Talasaz, Guardant Health co-CEO. "The Ohio State University Comprehensive Cancer Center research team has a long legacy of community leadership in Ohio and Appalachia, so we know we are meeting patients where they are, helping to further reduce barriers to access, and improve CRC screening rates to pre-pandemic levels."
In a regulatory filing, Guardant Health disclosed that its co-CEO Amirali Talasaz bought 97K shares of common stock on March 13th in a total transaction size of $2.5M.
Guardant Health announced that it has submitted to the FDA the final module of its premarket approval, or PMA, application for Shield, Guardant Health's blood test to screen for colorectal cancer, or CRC. The submission is comprised of data from the company's positive ECLIPSE study, an over 20,000 patient registrational study evaluating the performance of its blood test for detecting colorectal cancer in average-risk adults. Preliminary results from the study showed that the Shield test achieved 83% sensitivity for the detection of colorectal cancer with specificity of 90%.
Sermonix Pharmaceuticals and Guardant Health (GH) announced the initiation of a registrational Phase 3 clinical study comparing targeted lasofoxifene, which Sermonix licensed globally from Ligan (LGND) in combination with the CDK 4/6 inhibitor abemaciclib versus fulvestrant plus abemaciclib in pre- and post-menopausal subjects with locally advanced or metastatic ER+/HER2- breast cancer with an ESR1 mutation. This global randomized study will enroll 400 subjects with locally advanced or metastatic ER+/HER2- breast cancer with an ESR1 mutation, who have progressed on palbociclib or ribociclib plus an aromatase inhibitor and up to one line of chemotherapy. Subjects will be randomized 1:1 to receive either lasofoxifene or fulvestrant, and both groups will also receive 150 mg of abemaciclib twice daily. Study subjects will be prospectively screened for an ESR1 mutation using the Guardant360 CDx liquid biopsy, a next generation sequencing-based test that detects genomic alterations using circulating tumor DNA from blood. Eli Lilly and Company - which provided abemaciclib for the ELAINE-2 study - has entered into a new clinical trial collaboration and drug supply agreement with Sermonix and will provide abemaciclib for the ELAINE-3 study. The primary efficacy endpoint is progression-free survival. Key secondary endpoints include overall response rate and overall survival. Additional secondary endpoints to be assessed include clinical benefit rate, duration of response, time to disease recurrence, time to chemotherapy, quality of life, patient reported outcomes on vaginal and sexual health, and safety. Sermonix anticipates dosing the first subject in the first half of 2023.
Citi analyst Patrick Donnelly downgraded Guardant Health to Neutral from Buy with a price target of $33, down from $60. The analyst cut its target multiple for the shares, saying Guardant deserves to trade inline with the peer group given its slowing growth and "longer line of sight" to profitability.
Piper Sandler lowered the firm's price target on Guardant Health to $35 from $50 and keeps a Neutral rating on the shares. The analyst updated estimates post the earnings report.
Morgan Stanley lowered the firm's price target on Guardant Health to $66 from $73 and keeps an Overweight rating on the shares, arguing there were "no surprises" in the company's quarterly report following a January pre-announcement. Though the mid-point of guidance was modestly below recently lowered estimates, soft guidance was anticipated and the firm argues that "now isn't the time to throw in the towel" as it sees a compelling risk/reward given its view of "multiple areas of conservatism" in the outlook and an attractive valuation.
BTIG lowered the firm's price target on Guardant Health to $50 from $60 but keeps a Buy rating on the shares. The company's Q4 results topped estimates but its FY23 guidance was worse than expected as its biopharma services business was impacted by a more difficult funding environment for smaller biopharmaceutical companies, the analyst tells investors in a research note. The firm maintains however that shares of Guardant Health are oversold and believes that its major levers will come in 2024 when the company should obtain both FDA approval and Medicare reimbursement of its Guardant Shield blood-based screening test.
Canaccord lowered the firm's price target on Guardant Health to $60 from $65 and keeps a Buy rating on the shares. The analyst believes the shares are undervalued and the initial outlook is entirely achievable, with potential upside from reimbursement later in 2023.
Cowen analyst Max Masucci lowered the firm's price target on Guardant Health to $53 from $70 and keeps an Outperform rating on the shares. The analyst said with out-year estimates likely coming down and the company's ultra-premium valuation back to earth, we believe long-term investors are well-positioned to initiate and/or add to existing GH positions following its Q4 print.
