Latest news with #QuinceTherapeutics
Business Wire
25-06-2025
- Business
- Business Wire
Quince Therapeutics to Participate at A-T Society's 2025 A-T Clinical Research Conference
SOUTH SAN FRANCISCO, Calif.--(BUSINESS WIRE)--Quince Therapeutics, Inc. (Nasdaq: QNCX), a late-stage biotechnology company dedicated to unlocking the power of a patient's own biology for the treatment of rare diseases, today announced its participation at the upcoming 2025 A-T Clinical Research Conference organized by the A-T Society, a leading Ataxia-Telangiectasia (A-T) patient advocacy group based in the United Kingdom. Taking place June 25-27, 2025 at Loughborough University in the U.K., key opinion leaders (KOLs) will present post hoc data analyses from the company's prior Phase 3 ATTeST clinical trial of its lead asset, eDSP, for the treatment of patients with A-T. Additionally, Quince management will provide an overview of its pivotal Phase 3 NEAT clinical trial. Highlights of A-T Clinical Research Conference Presentations KOLs will present the following data and information at the upcoming A-T Clinical Research Conference: Endocrine and Metabolic Events in Patients with A-T Treated with eDSP: William Whitehouse, M.D., Honorary Clinical Associate Professor of the School of Medicine at the University of Nottingham, England, recently retired Consultant Pediatric Neurologist at Nottingham Children's Hospital, Nottingham University Hospitals NHS Trust, and current Quince Scientific Advisory Board member, will provide a presentation titled Endocrine and Metabolic Events in Children with Ataxia-Telangiectasia Treated Long-term with Erythrocyte-Delivered Encapsulated Dexamethasone Sodium Phosphate (eDSP). The objective of the data analysis was to evaluate metabolic and endocrine adverse events (AEs), growth, and safety laboratory results in patients with A-T treated with eDSP. Key findings reported in Dr. Whitehouse's presentation highlighted that there were no reports of serious metabolic or endocrine events in the 68 patients with A-T treated with eDSP for two years or longer. Growth in height of these patients was also preserved. MiniATM Family Expression in Patients with A-T Treated with eDSP: Michele Menotta, Ph.D., Associate Professor in the Department of Biomolecular Sciences at the University of Urbino in Urbino, Italy, will provide a presentation titled MiniATM Family Expression in ATTeST: Molecular Insights into Unusual ATM Variants in A-T Cells. The objective of the data analysis investigates the potential relationship between miniATM family expression in the blood of patients with A-T who participated in Quince's prior Phase 3 ATTeST clinical trial and their corresponding neurological scores. Additionally, novel functions of the miniATM family were explored in A-T cells and its molecular mechanism of action was investigated. The analysis found that miniATM genes were present in 40% of patients with A-T and were correlated with A-T disease severity at baseline. Lab tests also showed results that may variably influence cell processes, offering new insights for potential treatments. Pivotal Phase 3 NEAT Enrollment Update Quince's management will provide an overview of the company's pivotal Phase 3 NEAT (N eurologic E ffects of e DSP on Subjects with A - T; #IEDAT-04-2022 / NCT06193200) clinical trial and latest enrollment update at the A-T Society meeting. A total of 99 participants have been enrolled to date, including 78 participants in the six to nine year-old primary analysis population and 21 participants aged 10 years or older. All 42 NEAT participants to date have elected to transition to the NEAT open label extension (OLE) study (NCT06664853 / IEDAT-04-2022). Quince is currently enrolling a pivotal Phase 3 NEAT clinical trial, which is an international, multi-center, randomized, double-blind, placebo-controlled clinical trial evaluating the neurological effects of eDSP (previously referred to as EryDex) treatment in patients with A-T. The company expects to report topline results in the first quarter of 2026 with a potential New Drug Application (NDA) submission to the FDA in the second half of 2026, assuming positive study results. Quince was granted Fast Track designation by the FDA for the company's eDSP System for the treatment of patients with A-T based on the potential for eDSP to address a high unmet medical need. About Ataxia-Telangiectasia A-T is an inherited autosomal recessive neurodegenerative and immunodeficiency disorder caused by mutations in the ATM gene, which is responsible for cell homeostatic and cell division functions including but not limited to double-stranded DNA repair. Typically, A-T is first diagnosed before the age of five as children begin to develop an altered gait and fall with greater frequency. Neurological symptoms worsen and patients with A-T frequently become wheelchair-bound by adolescence. Teenage years for patients with A-T are typically marked by repeated infections, pulmonary impairment, and malignancies. The median lifespan is approximately 25 to 30 years old with mortality due to infections and malignancy. Based on IQVIA Medical Claims (Dx), PharmetricsPlus (P+), and IQVIA Analytics information, there are approximately 4,600 diagnosed patients with A-T in the U.S. Quince estimates that there are approximately 5,000 patients with A-T in the U.K. and EU4 countries. There are currently no approved therapeutic treatments in any global market for A-T. About eDSP for A-T eDSP is comprised of dexamethasone sodium phosphate (DSP) encapsulated in a patient's own red blood cells (autologous erythrocytes). DSP is a corticosteroid well known for its anti-inflammatory properties as well as its dose-limiting toxicity due to adrenal suppression. The eDSP System is designed to provide the efficacy of corticosteroids and to reduce or eliminate the significant adverse effects that accompany chronic use of corticosteroid treatment. eDSP leverages Quince's proprietary Autologous Intracellular Drug Encapsulation, or AIDE, technology platform, which is a novel drug/device combination that uses an automated process designed to encapsulate a drug into the patient's own red blood cells. Red blood cells have several characteristics that make them a potentially effective vehicle for drug delivery, including potentially better tolerability, enhanced tissue distribution, reduced immunogenicity, and prolongation of circulating half-life. Quince's AIDE technology is designed to harness these benefits to allow for the chronic administration of drugs that have limitations due to toxicity, poor biodistribution, suboptimal pharmacokinetics, or immune response. About Quince Therapeutics Quince Therapeutics, Inc. (Nasdaq: QNCX) is a late-stage biotechnology company dedicated to unlocking the power of a patient's own biology for the treatment of rare diseases. For more information on the company and its latest news, visit and follow Quince on social media platforms LinkedIn, Facebook, X, and YouTube. Forward-looking Statements Statements in this news release contain 'forward-looking statements' within the meaning of the Private Securities Litigation Reform Act of 1995 as contained in Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended, which are subject to the 'safe harbor' created by those sections. All statements, other than statements of historical facts, may be forward-looking statements. Forward-looking statements contained in this news release may be identified by the use of words such as 'believe,' 'may,' 'should,' 'expect,' 'anticipate,' 'plan,' 'believe,' 'estimated,' 'potential,' 'intend,' 'will,' 'can,' 'seek,' or other similar words. Examples of forward-looking statements include, among others, statements relating to the timing, success, and reporting of results of the clinical trials and related data, including plans and the ability to enroll participants, impact of closing enrollment, conduct, and/or complete current and additional studies; expected cash position and operating runway; ability to secure additional funding and financial support; current and future clinical development of eDSP, including for the potential treatment of Ataxia-Telangiectasia (A-T), Duchenne muscular dystrophy (DMD), and other potential indications; the strategic development path for eDSP; planned regulatory agency submissions and clinical trials and timeline, prospects, and milestone expectations; and the potential benefits of eDSP and the company's market opportunity. Forward-looking statements are based on Quince's current expectations and are subject to inherent uncertainties, risks, and assumptions that are difficult to predict and could cause actual results to differ materially from what the company expects. Further, certain forward-looking statements are based on assumptions as to future events that may not prove to be accurate. Factors that could cause actual results to differ include, but are not limited to, the risks and uncertainties described in the section titled 'Risk Factors' in the company's Quarterly Report on Form 10-Q filed with the Securities and Exchange Commission (SEC) on May 13, 2025, and other reports as filed with the SEC. Forward-looking statements contained in this news release are made as of this date, and Quince undertakes no duty to update such information except as required under applicable law.
Yahoo
25-06-2025
- Health
- Yahoo
Quince Therapeutics to Participate at A-T Society's 2025 A-T Clinical Research Conference
Phase 3 NEAT enrollment momentum continues with 99 total participants enrolled to date SOUTH SAN FRANCISCO, Calif., June 25, 2025--(BUSINESS WIRE)--Quince Therapeutics, Inc. (Nasdaq: QNCX), a late-stage biotechnology company dedicated to unlocking the power of a patient's own biology for the treatment of rare diseases, today announced its participation at the upcoming 2025 A-T Clinical Research Conference organized by the A-T Society, a leading Ataxia-Telangiectasia (A-T) patient advocacy group based in the United Kingdom. Taking place June 25-27, 2025 at Loughborough University in the U.K., key opinion leaders (KOLs) will present post hoc data analyses from the company's prior Phase 3 ATTeST clinical trial of its lead asset, eDSP, for the treatment of patients with A-T. Additionally, Quince management will provide an overview of its pivotal Phase 3 NEAT clinical trial. Highlights of A-T Clinical Research Conference Presentations KOLs will present the following data and information at the upcoming A-T Clinical Research Conference: Endocrine and Metabolic Events in Patients with A-T Treated with eDSP: William Whitehouse, M.D., Honorary Clinical Associate Professor of the School of Medicine at the University of Nottingham, England, recently retired Consultant Pediatric Neurologist at Nottingham Children's Hospital, Nottingham University Hospitals NHS Trust, and current Quince Scientific Advisory Board member, will provide a presentation titled Endocrine and Metabolic Events in Children with Ataxia-Telangiectasia Treated Long-term with Erythrocyte-Delivered Encapsulated Dexamethasone Sodium Phosphate (eDSP). The objective of the data analysis was to evaluate metabolic and endocrine adverse events (AEs), growth, and safety laboratory results in patients with A-T treated with eDSP. Key findings reported in Dr. Whitehouse's presentation highlighted that there were no reports of serious metabolic or endocrine events in the 68 patients with A-T treated with eDSP for two years or longer. Growth in height of these patients was also preserved. MiniATM Family Expression in Patients with A-T Treated with eDSP: Michele Menotta, Ph.D., Associate Professor in the Department of Biomolecular Sciences at the University of Urbino in Urbino, Italy, will provide a presentation titled MiniATM Family Expression in ATTeST: Molecular Insights into Unusual ATM Variants in A-T Cells. The objective of the data analysis investigates the potential relationship between miniATM family expression in the blood of patients with A-T who participated in Quince's prior Phase 3 ATTeST clinical trial and their corresponding neurological scores. Additionally, novel functions of the miniATM family were explored in A-T cells and its molecular mechanism of action was investigated. The analysis found that miniATM genes were present in 40% of patients with A-T and were correlated with A-T disease severity at baseline. Lab tests also showed results that may variably influence cell processes, offering new insights for potential treatments. Pivotal Phase 3 NEAT Enrollment Update Quince's management will provide an overview of the company's pivotal Phase 3 NEAT (Neurologic Effects of eDSP on Subjects with A-T; #IEDAT-04-2022/NCT06193200) clinical trial and latest enrollment update at the A-T Society meeting. A total of 99 participants have been enrolled to date, including 78 participants in the six to nine year-old primary analysis population and 21 participants aged 10 years or older. All 42 NEAT participants to date have elected to transition to the NEAT open label extension (OLE) study (NCT06664853/IEDAT-04-2022). Quince is currently enrolling a pivotal Phase 3 NEAT clinical trial, which is an international, multi-center, randomized, double-blind, placebo-controlled clinical trial evaluating the neurological effects of eDSP (previously referred to as EryDex) treatment in patients with A-T. The company expects to report topline results in the first quarter of 2026 with a potential New Drug Application (NDA) submission to the FDA in the second half of 2026, assuming positive study results. Quince was granted Fast Track designation by the FDA for the company's eDSP System for the treatment of patients with A-T based on the potential for eDSP to address a high unmet medical need. About Ataxia-Telangiectasia A-T is an inherited autosomal recessive neurodegenerative and immunodeficiency disorder caused by mutations in the ATM gene, which is responsible for cell homeostatic and cell division functions including but not limited to double-stranded DNA repair. Typically, A-T is first diagnosed before the age of five as children begin to develop an altered gait and fall with greater frequency. Neurological symptoms worsen and patients with A-T frequently become wheelchair-bound by adolescence. Teenage years for patients with A-T are typically marked by repeated infections, pulmonary impairment, and malignancies. The median lifespan is approximately 25 to 30 years old with mortality due to infections and malignancy. Based on IQVIA Medical Claims (Dx), PharmetricsPlus (P+), and IQVIA Analytics information, there are approximately 4,600 diagnosed patients with A-T in the U.S. Quince estimates that there are approximately 5,000 patients with A-T in the U.K. and EU4 countries. There are currently no approved therapeutic treatments in any global market for A-T. About eDSP for A-T eDSP is comprised of dexamethasone sodium phosphate (DSP) encapsulated in a patient's own red blood cells (autologous erythrocytes). DSP is a corticosteroid well known for its anti-inflammatory properties as well as its dose-limiting toxicity due to adrenal suppression. The eDSP System is designed to provide the efficacy of corticosteroids and to reduce or eliminate the significant adverse effects that accompany chronic use of corticosteroid treatment. eDSP leverages Quince's proprietary Autologous Intracellular Drug Encapsulation, or AIDE, technology platform, which is a novel drug/device combination that uses an automated process designed to encapsulate a drug into the patient's own red blood cells. Red blood cells have several characteristics that make them a potentially effective vehicle for drug delivery, including potentially better tolerability, enhanced tissue distribution, reduced immunogenicity, and prolongation of circulating half-life. Quince's AIDE technology is designed to harness these benefits to allow for the chronic administration of drugs that have limitations due to toxicity, poor biodistribution, suboptimal pharmacokinetics, or immune response. About Quince Therapeutics Quince Therapeutics, Inc. (Nasdaq: QNCX) is a late-stage biotechnology company dedicated to unlocking the power of a patient's own biology for the treatment of rare diseases. For more information on the company and its latest news, visit and follow Quince on social media platforms LinkedIn, Facebook, X, and YouTube. Forward-looking Statements Statements in this news release contain "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995 as contained in Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended, which are subject to the "safe harbor" created by those sections. All statements, other than statements of historical facts, may be forward-looking statements. Forward-looking statements contained in this news release may be identified by the use of words such as "believe," "may," "should," "expect," "anticipate," "plan," "believe," "estimated," "potential," "intend," "will," "can," "seek," or other similar words. Examples of forward-looking statements include, among others, statements relating to the timing, success, and reporting of results of the clinical trials and related data, including plans and the ability to enroll participants, impact of closing enrollment, conduct, and/or complete current and additional studies; expected cash position and operating runway; ability to secure additional funding and financial support; current and future clinical development of eDSP, including for the potential treatment of Ataxia-Telangiectasia (A-T), Duchenne muscular dystrophy (DMD), and other potential indications; the strategic development path for eDSP; planned regulatory agency submissions and clinical trials and timeline, prospects, and milestone expectations; and the potential benefits of eDSP and the company's market opportunity. Forward-looking statements are based on Quince's current expectations and are subject to inherent uncertainties, risks, and assumptions that are difficult to predict and could cause actual results to differ materially from what the company expects. Further, certain forward-looking statements are based on assumptions as to future events that may not prove to be accurate. Factors that could cause actual results to differ include, but are not limited to, the risks and uncertainties described in the section titled "Risk Factors" in the company's Quarterly Report on Form 10-Q filed with the Securities and Exchange Commission (SEC) on May 13, 2025, and other reports as filed with the SEC. Forward-looking statements contained in this news release are made as of this date, and Quince undertakes no duty to update such information except as required under applicable law. View source version on Contacts Media & Investor Contact: Stacy RoughanQuince Therapeutics, President, Corporate Communications & Investor Relationsir@
Business Insider
07-06-2025
- Business
- Business Insider
Analysts' Opinions Are Mixed on These Healthcare Stocks: Quince Therapeutics (QNCX) and Moderna (MRNA)
Analysts have been eager to weigh in on the Healthcare sector with new ratings on Quince Therapeutics (QNCX – Research Report) and Moderna (MRNA – Research Report). Confident Investing Starts Here: Quince Therapeutics (QNCX) In a report issued on June 4, Jason McCarthy from Maxim Group maintained a Buy rating on Quince Therapeutics, with a price target of $6.00. The company's shares closed last Friday at $1.17. According to McCarthy 's ranking currently consits of 0 on a 0-5 ranking scale, with an average return of -19.2% and a 28.3% success rate. McCarthy covers the Healthcare sector, focusing on stocks such as Reviva Pharmaceuticals Holdings, Brainstorm Cell Therapeutics, and SELLAS Life Sciences Group. The word on The Street in general, suggests a Strong Buy analyst consensus rating for Quince Therapeutics with a $6.67 average price target. Moderna (MRNA) In a report released today, Matt Phipps from William Blair reiterated a Hold rating on Moderna. The company's shares closed last Friday at $27.46. According to Phipps is currently ranked with 0 stars on a 0-5 stars ranking scale, with an average return of -8.1% and a 41.7% success rate. Phipps covers the Healthcare sector, focusing on stocks such as NewAmsterdam Pharma Company, Ultragenyx Pharmaceutical, and Janux Therapeutics Inc. Currently, the analyst consensus on Moderna is a Hold with an average price target of $49.29, an 88.1% upside from current levels. In a report issued on May 27, Barclays also maintained a Hold rating on the stock with a $40.00 price target.
Yahoo
13-05-2025
- Business
- Yahoo
Quince Therapeutics Provides Business Update and Reports First Quarter 2025 Financial Results
Plan to potentially conclude enrollment early for Phase 3 NEAT clinical trial in Ataxia-Telangiectasia (A-T) to align topline results with existing cash runway SOUTH SAN FRANCISCO, Calif., May 13, 2025--(BUSINESS WIRE)--Quince Therapeutics, Inc. (Nasdaq: QNCX), a late-stage biotechnology company dedicated to unlocking the power of a patient's own biology for the treatment of rare diseases, today provided an update on the company's development pipeline and reported financial results for the first quarter ended March 31, 2025. Dirk Thye, M.D., Quince's Chief Executive Officer and Chief Medical Officer, said, "In light of current cash runway and with the goal of maximizing a capital efficient development plan, Quince has made the strategic business decision to potentially conclude enrollment of our pivotal Phase 3 NEAT clinical trial early by the end of June 2025 absent additional funding to extend our cash runway beyond the first quarter of 2026. Several factors contributed to this shift in strategy, including slower than anticipated enrollment, uncertain macroeconomic environment, challenging academic site environment, and an operationally well-executed study with limited withdrawals and low rates of missing data and procedural deviations. The combination of these factors leads us to now consider concluding enrollment prior to reaching the pre-specified target of 86 patients in the primary analysis population. "It is important to highlight that the potential to conclude enrollment at the end of June 2025 is expected to provide an approximate 80% power to determine a statistically significant difference in the primary endpoint. Additionally, this timeline would allow the company to report topline results by early 2026 while maintaining a positive cash balance. Assuming positive results from the NEAT trial, we plan to submit applications for approval in the U.S. and Europe in the second half of 2026," said Thye. Patient Enrollment in Pivotal Phase 3 NEAT Clinical Trial Quince is contemplating an early conclusion of enrollment for its pivotal Phase 3 NEAT clinical trial by the end of June 2025 to align the reporting of topline results with the company's existing cash runway in early 2026. To date, a total of 63 participants have been enrolled, including 56 participants in the six to nine year-old primary analysis population and seven participants aged 10 years or older. All 19 study sites are now activated, including several additional sites opened in the U.K. and Europe. Slower than anticipated enrollment in recent months is primarily due to a challenging academic site environment. Quince expects an increased rate of screening and randomization activities in the near term due to the activation of new sites. Approximately seven participants are scheduled for screening over the coming week. A total of 80 NEAT participants have been screened to date and the study has a low screen failure rate of 10%. Quince's potential early enrollment conclusion by the end of June 2025 would result in approximately 80% power to determine a statistically significant difference in the primary endpoint. If additional funding is secured in the near term, Quince intends to continue enrollment as previously planned targeting 86 patients with A-T ages six to nine years old in the primary analysis population. All 30 NEAT participants to date have elected to transition to the NEAT open label extension study (NCT06664853/IEDAT-04-2022). Participants who complete the full treatment period, complete study assessments, and provide informed consent are eligible to transition to the OLE study. New Drug Application (NDA) submission to the U.S. Food and Drug Administration (FDA) and a Marketing Authorization Application (MAA) submission to the European Medicines Agency (EMA) planned in the second half of 2026, assuming positive study results. NEAT (Neurological Effects of eDSP on Subjects with A-T; NCT06193200/IEDAT-04-2022) is an international, multicenter, randomized, double-blind, placebo-controlled clinical trial to evaluate the neurological effects of Quince's lead asset, eDSP (dexamethasone sodium phosphate [DSP] encapsulated in autologous red blood cells; previously referred to as EryDex) in patients with A-T. Participants are randomized (1:1) between eDSP or placebo and treatment consists of six infusions scheduled once every 21 to 30 days. The primary efficacy endpoint will be measured by the change from baseline to last efficacy visit in the rescored modified International Cooperative Ataxia Rating Scale (RmICARS) compared to placebo. First Quarter 2025 Financial Results Reported cash, cash equivalents, and short-term investments of $31.6 million for the first quarter ended March 31, 2025. Quince expects its existing cash runway to be sufficient to fund the company's capital efficient development plan through Phase 3 NEAT topline results, which are now expected by early 2026. Reported research and development (R&D) expenses of $8.1 million for the first quarter ended March 31, 2025. R&D expenses primarily included costs related to ongoing Phase 3 NEAT clinical trial activities and related manufacturing costs. Reported general and administrative (G&A) expenses of $4.8 million for the first quarter ended March 31, 2025. G&A expenses primarily included personnel-related and stock-based compensation expenses, commercial planning and new product planning expenses, and other professional administrative costs. Reported a net loss of $15.0 million, or a net loss of $0.34 per basic and diluted share, for the first quarter ended March 31, 2025. Weighted average shares outstanding for the year were 43.9 million. Reported net cash used in operating activities of $9.6 million for the first quarter ended March 31, 2025. Cash used in operating activities was primarily due to net loss of $15.0 million for the period, adjusted for $3.4 million of non-cash items, including $1.9 million change in the fair value of contingent consideration liabilities, $1.4 million in stock-based compensation, $0.4 million change in the fair value of the European Investment Bank loan and a net decrease in operating assets of $1.1 million, offset by a net increase in accounts payable, and accrued expenses and other current liabilities of $0.9 million. About Quince Therapeutics Quince Therapeutics, Inc. (Nasdaq: QNCX) is a late-stage biotechnology company dedicated to unlocking the power of a patient's own biology for the treatment of rare diseases. For more information on the company and its latest news, visit and follow Quince on social media platforms LinkedIn, Facebook, X, and YouTube. Forward-looking Statements Statements in this news release contain "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995 as contained in Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended, which are subject to the "safe harbor" created by those sections. All statements, other than statements of historical facts, may be forward-looking statements. Forward-looking statements contained in this news release may be identified by the use of words such as "believe," "may," "should," "expect," "anticipate," "plan," "believe," "estimated," "potential," "intend," "will," "can," "seek," or other similar words. Examples of forward-looking statements include, among others, statements relating to the timing, success, and reporting of results of the clinical trials and related data, including plans and the ability to enroll participants, impact of closing enrollment, conduct, and/or complete current and additional studies; expected cash position and operating runway; ability to secure additional funding and financial support; current and future clinical development of eDSP, including for the potential treatment of Ataxia-Telangiectasia (A-T), Duchenne muscular dystrophy (DMD), and other potential indications; the strategic development path for eDSP; planned regulatory agency submissions and clinical trials and timeline, prospects, and milestone expectations; and the potential benefits of eDSP and the company's market opportunity. Forward-looking statements are based on Quince's current expectations and are subject to inherent uncertainties, risks, and assumptions that are difficult to predict and could cause actual results to differ materially from what the company expects. Further, certain forward-looking statements are based on assumptions as to future events that may not prove to be accurate. Factors that could cause actual results to differ include, but are not limited to, the risks and uncertainties described in the section titled "Risk Factors" in the company's Annual Report on Form 10-K filed with the Securities and Exchange Commission (SEC) on March 24, 2025, and other reports as filed with the SEC. Forward-looking statements contained in this news release are made as of this date, and Quince undertakes no duty to update such information except as required under applicable law. View source version on Contacts Media & Investor Contact: Stacy RoughanQuince Therapeutics, President, Corporate Communications & Investor Relationsir@ Sign in to access your portfolio
Yahoo
05-05-2025
- Business
- Yahoo
Oppenheimer Predicts Up to ~840% Surge for These 2 ‘Strong Buy' Stocks
Wall Street wrapped up the week with a bang, as a solid jobs report and a possible thaw in US-China trade tensions gave investors plenty to cheer about. Discover companies with rock-solid fundamentals in TipRanks' Smart Value Newsletter. Receive undervalued stocks, resilient to market uncertainty, delivered straight to your inbox. The S&P 500 notched its longest bull run in nearly two decades, surging for a ninth consecutive day and fully erasing the losses triggered by President Trump's early-April 'Liberation Day' tariff blitz. Watching the current situation from Oppenheimer, chief investment strategist John Stoltzfus believes that the markets are finally finding their footing after months of uncertainty. 'US equities that had been pretty much locked in worry-worry mode for much of the time since February 19 when the S&P 500 hit its most recent record high found reason to change direction not just on a lessening of the day-to-day tariff war worry, but also on better-than-expected earnings growth… We remain positive on equities with current conditions suggesting we are right about where we should be considering the changes in stateside trade policy that are underway, and the degree of uncertainty change brings,' Stoltzfus opined. Stoltzfus' colleagues among the Oppenheimer stock analysts are running with this positive outlook and advising investors to buy two stocks they believe are primed for major gains – one of which could skyrocket as much as 840%. And they're not alone. TipRanks data shows the broader analyst community is firmly behind these names, handing out 'Strong Buy' ratings and projecting massive upside potential. Let's take a closer look at what makes these stocks so compelling. Quince Therapeutics (QNCX) We'll start with Quince Therapeutics, a late-stage biotech firm taking an innovative approach to rare disease treatment by harnessing the patient's biology. Its lead program, eDSP (formerly EryDex), is a novel formulation of dexamethasone, a well-established corticosteroid valued for its anti-inflammatory power. While dexamethasone is effective, it's also known to cause serious adverse effects, such as adrenal gland suppression, especially with prolonged use. eDSP, however, leverages Quince's proprietary AIDE technology to encapsulate the drug within a patient's own red blood cells, aiming to preserve its efficacy while reducing those side effects. That delivery method – AIDE, or Autologous Intracellular Drug Encapsulation – is where Quince's innovation stands out. Instead of traditional drug delivery routes, AIDE employs red blood cells from the patient to carry therapeutic agents through the bloodstream. This method offers several built-in advantages: improved tolerability, extended circulation time, reduced immune response, and broader tissue exposure. By leveraging the body's natural carriers, AIDE enables the drug to remain active and better tolerated until it reaches its destination. On the clinical trial side, eDSP is currently undergoing a Phase 3 NEAT study in the treatment of ataxia-telangiectasia, or A-T. This is a rare, inherited pediatric disease caused by mutations in the ATM gene that controls cell homeostatic and cell division functions. The gene mutation causes a neurodegenerative and immunodeficiency disorder. Quince plans to enroll 86 A-T patients from ages 6 to 9 years, and another 20 patients aged 10 years or older. Currently, 61 patients are enrolled. Topline results are expected to be ready for release in 4Q25, and assuming a positive outcome, the company plans to make regulatory submissions to the FDA and EMA during 2026. The company is also preparing a Phase 2 clinical trial to assess eDSP as a prospective treatment for Duchenne muscular dystrophy (DMD), a severe inherited condition caused by mutations in the dystrophin gene on the X chromosome. These mutations result in a lack of dystrophin protein, which is essential for muscle function. The company plans to initiate this study by year-end. With shares trading at just $1.06 and a major catalyst on the horizon, Oppenheimer analyst Leland Gershell sees QNCX as deeply undervalued with substantial upside. 'We like the setup into QNCX's Phase 3 results in ataxia-telangiectasia (A-T)… We see a $1B+ global opportunity for lead candidate EryDex [eDSP] and project $200M in 2031 US sales. Our enthusiasm for development and commercial success is driven by our KOL checks, prior clinical data, and a pivotal design we see as heavily derisked. Upside potential stems from EryDex's prospects to meaningfully improve the standard of care in Duchenne muscular dystrophy (DMD), a second indication on which we have good visibility. The company's drug/device platform could serve a growing number of rare disorders over time and offers durable market exclusivity,' the analyst opined. Looking ahead, Gershell emphasizes the attractive setup: 'We see favorable risk-reward and encourage investors to build a position. We would expect positive results in NEAT to yield considerable stock upside potential and enable the company to strengthen its capital base by attracting strong interest from dedicated healthcare institutional investors.' Gershell backs his bullish stance on QNCX with an Outperform (i.e., Buy) rating and a $10 price target, implying a massive ~840% upside over the next 12 months. (To watch Gershell's track record, click here) Overall, the stock earns a unanimous thumbs up from the analyst consensus, with 3 recent Buy reviews supporting a Strong Buy rating. The average price target of $6.67 implies a potential gain of 529% from current levels. (See QNCX stock forecast) Sarepta Therapeutics (SRPT) The next stock catching Oppenheimer's attention is Sarepta Therapeutics, a cutting-edge biotech firm specializing in precision genetic medicine. With a strong focus on rare diseases, Sarepta has emerged as a leader in developing breakthrough treatments for Duchenne muscular dystrophy. Backed by a robust pipeline, Sarepta is advancing a wide range of drug candidates currently in human clinical trials, with multiple gene therapy programs in the mix. The latest expansion of that pipeline comes through a collaboration with Arrowhead Pharmaceuticals, announced last November. The deal gives Sarepta exclusive global rights to seven of Arrowhead's programs – four already in clinical stages and three in preclinical development. These include drug candidates with potential as best-in-class siRNA treatments for myotonic dystrophy type 1 (DM1) and facioscapulohumeral muscular dystrophy (FSHD). While there is much to say about Sarepta, perhaps the most notable issue involves its commercial drug, Elevidys. Approved in June 2023, Elevidys is the first, and currently only, gene therapy approved for the treatment of DMD. The big news on this front came in March of this year, when Sarepta reported the death of a patient who had been treated with Elevidys. The cause of death was acute liver failure. Although liver damage is a known potential side effect of Elevidys and other gene therapies in its class, this marked the first reported fatality associated with the drug. As a result of the reported patient death, the European Medicines Agency (EMA) has temporarily paused several ongoing clinical trials of Elevidys. Conducted by Sarepta in collaboration with Roche, these trials aim to support label expansion of the already approved drug. Enrollment and dosing have been halted while Sarepta and Roche review the data and work to determine the exact cause of the fatality. Looking at the financial side, Sarepta's latest earnings report – covering 4Q24 – shows the company generating strong revenue and turning a profit. The top line came in at $658.4 million, up 66% year-over-year and beating the forecast by $27.37 million. This total included $638.2 million in net product revenue, a 75% increase from the prior year. At the bottom line, Sarepta reported non-GAAP EPS of $1.90, more than double the 4Q23 figure – although it fell 16 cents short of expectations. Investors won't have to wait long for the next update, with Q1 earnings set to be released on Tuesday, May 6. In his coverage of Sarepta for Oppenheimer, analyst Andreas Argyrides sees plenty of reasons to feel optimistic about the stock, despite the headwind of the tragic patient death. 'Feedback from a KOL call with a leading neurologist supports ELEVIDYS' favorable benefit/risk profile as the only gene therapy approved in DMD. Overall, the KOL was not surprised by the first patient death following treatment with ELEVIDYS, since acute liver injury is a known side effect of AAV-based gene therapies. While another fatality is possible, he sees little risk of ELEVIDYS being pulled or restricted, expects an expanded label for children <4-y/o, and his overall perception remains unchanged. We view the recent selloff in the stock, pricing in revisions to ELEVIDYS sales, as overdone, driven by initial fears following the death and EMA's temporary clinical hold and see an opportunity for a rebound potentially supported by the share repurchase of up to $500M… We believe SRPT is investing considerable resources to become the leader in gene therapy and muscular dystrophies in particular,' Argyrides stated. Argyrides goes on to rate Sarepta's shares as Outperform (i.e., Buy), with a $184 price target that points toward a one-year gain of ~190%. (To watch Argyrides' track record, click here) Wall Street is largely in agreement. SRPT holds a Strong Buy consensus rating based on 22 recent analyst reviews, including 18 Buys and 4 Holds. With shares currently trading at $63.51, the $148.25 average price target suggests a 133% upside over the next year. (See SRPT stock forecast) To find good ideas for stocks trading at attractive valuations, visit TipRanks' Best Stocks to Buy, a tool that unites all of TipRanks' equity insights. Disclaimer: The opinions expressed in this article are solely those of the featured analysts. The content is intended to be used for informational purposes only. It is very important to do your own analysis before making any investment. Disclaimer & DisclosureReport an Issue Sign in to access your portfolio
