Relay Therapeutics Receives FDA Breakthrough Therapy Designation
Written by Emily J. Thompson, Senior Investment Analyst
Updated: 5d ago
0mins
Should l Buy RLAY?
Source: Newsfilter
- FDA Breakthrough Therapy Designation: Relay Therapeutics' zovegalisib in combination with fulvestrant has received FDA Breakthrough Therapy designation for treating PIK3CA mutant HR+/HER2- advanced breast cancer, indicating significant clinical potential to improve patient outcomes.
- Clinical Trial Data Support: This designation is supported by clinical data from the ReDiscover trial, which evaluated safety and efficacy at doses of 600mg BID fasted (N=52) and 400mg BID fed (N=57), demonstrating good tolerability and preliminary antitumor activity of zovegalisib.
- Significant Market Potential: Approximately 140,000 patients in the U.S. with HR+/HER2- breast cancer harbor PIK3CA mutations annually, and the approval of zovegalisib could provide new treatment options, addressing a significant unmet need in the market.
- Accelerated Development Process: The FDA's Breakthrough Therapy designation will expedite the development and review of zovegalisib, providing Fast Track eligibility and enhanced guidance, allowing Relay Therapeutics to work closely with the FDA to advance this program efficiently.
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Analyst Views on RLAY
Wall Street analysts forecast RLAY stock price to rise over the next 12 months. According to Wall Street analysts, the average 1-year price target for RLAY is 14.75 USD with a low forecast of 13.00 USD and a high forecast of 17.00 USD. However, analyst price targets are subjective and often lag stock prices, so investors should focus on the objective reasons behind analyst rating changes, which better reflect the company's fundamentals.
6 Analyst Rating
5 Buy
1 Hold
0 Sell
Strong Buy
Current: 8.150
Low
13.00
Averages
14.75
High
17.00
Current: 8.150
Low
13.00
Averages
14.75
High
17.00
About RLAY
Relay Therapeutics Inc. is a clinical-stage precision medicine company. The Company’s initial focus is on enhancing small molecule therapeutic discovery in targeted oncology and genetic disease indications. Its Dynamo platform integrates an array of computational and experimental approaches designed to drug protein targets that have previously been intractable or inadequately addressed. The Company’s lead product candidates, such as RLY-2608. It is advancing a pipeline of medicine candidates to address targets in precision oncology and genetic disease, including RLY-2608. RLY-2608 is an allosteric, pan-mutant and isoform-selective phosphoinostide 3 kinase alphas (PI3Kα), inhibitor in clinical development. It is the lead program in its efforts to discover and develop mutant selective inhibitors of PI3Kα.
About the author
Emily J. Thompson
Emily J. Thompson, a Chartered Financial Analyst (CFA) with 12 years in investment research, graduated with honors from the Wharton School. Specializing in industrial and technology stocks, she provides in-depth analysis for Intellectia’s earnings and market brief reports.
Relay Therapeutics Executive Large Share Sale Analysis
- Executive Transaction Overview: Donald A. Bergstrom, President of R&D at Relay Therapeutics, executed open-market sales of 21,581 shares on January 27 and 28, 2026, totaling approximately $166,700, indicating significant changes in his holdings.
- Transaction Size Analysis: The 21,581 shares sold are substantially higher than Bergstrom's recent median sale of 2,698 shares, suggesting that a 32.65% decrease in his direct holdings may have driven this larger sale size.
- Impact on Ownership Percentage: This transaction represented 4.89% of Bergstrom's direct ownership, more than ten times the recent median percentage of holdings disposed of per open-market sale, reflecting a shift in his ownership structure.
- Market Reaction and Outlook: Despite the insider sale, Relay Therapeutics' stock closed at $7.65 on January 28, 2026, marking a 65.58% increase over the past year, and the company received FDA Breakthrough Therapy designation, indicating strong future growth potential.
See More
Oncolytics Biotech Receives FDA Fast Track Designation
- FDA Fast Track Designation: Oncolytics Biotech's cancer treatment pelareorep has received Fast Track Designation from the FDA for KRAS-mutant microsatellite-stable metastatic colorectal cancer, which is expected to expedite the approval process and enhance market competitiveness.
- Clinical Data Advantage: The 33% response rate of pelareorep combined with standard chemotherapy significantly surpasses the 10% rate of chemotherapy alone, with a median survival of 27 months, indicating its potential value in hard-to-treat cancer populations.
- Significant Market Opportunity: The annual revenue for second-line treatment of KRAS-mutant colorectal cancer ranges between $3 billion and $5 billion, positioning Oncolytics' innovative therapy to capture a substantial share in this rapidly growing market.
- Team Expansion and Strategic Positioning: Oncolytics Biotech has recently appointed two executives to support its expansion plans, demonstrating the company's commitment to future clinical trials and market outreach, thereby strengthening its leadership position in the biotech sector.
See More
FDA Accelerates Oncology Drug Approvals, Boosting Market Potential
- Regulatory Acceleration: In 2025, the FDA approved over 50 oncology drugs, with a notable shift towards targeted therapies for high-unmet-need solid tumors in 2026, projecting a market opportunity of $326.82 billion by 2031, indicating robust commercial potential.
- Fast Track Designation: Oncolytics Biotech's pelareorep received FDA Fast Track Designation for KRAS-mutant colorectal cancer, showing a 33% response rate when combined with standard chemotherapy, significantly higher than the 10% with chemotherapy alone, which will expedite its approval process.
- Clinical Trial Plans: Oncolytics plans to launch a controlled study comparing pelareorep with standard care in March 2026, with interim data expected by year-end, providing crucial clinical evidence in a competitive market.
- Team Expansion: Oncolytics Biotech recently appointed two key executives to enhance its strategic and operational capabilities, supporting its expanding R&D projects, reflecting the company's confidence and preparedness for future growth.
See More
Relay Therapeutics Receives FDA Breakthrough Therapy Designation
- FDA Breakthrough Therapy Designation: Relay Therapeutics' zovegalisib in combination with fulvestrant has received FDA Breakthrough Therapy designation for treating PIK3CA mutant HR+/HER2- advanced breast cancer, indicating significant clinical potential to improve patient outcomes.
- Clinical Trial Data Support: This designation is supported by clinical data from the ReDiscover trial, which evaluated safety and efficacy at doses of 600mg BID fasted (N=52) and 400mg BID fed (N=57), demonstrating good tolerability and preliminary antitumor activity of zovegalisib.
- Significant Market Potential: Approximately 140,000 patients in the U.S. with HR+/HER2- breast cancer harbor PIK3CA mutations annually, and the approval of zovegalisib could provide new treatment options, addressing a significant unmet need in the market.
- Accelerated Development Process: The FDA's Breakthrough Therapy designation will expedite the development and review of zovegalisib, providing Fast Track eligibility and enhanced guidance, allowing Relay Therapeutics to work closely with the FDA to advance this program efficiently.
See More
Oppenheimer Upgrades Relay Therapeutics Rating
- Rating Upgrade: Oppenheimer has upgraded Relay Therapeutics (RLAY) from 'perform' to 'outperform', anticipating that its lead asset zovegalisib could benefit if Celcuity's (CELC) gedatolisib data underperforms, with a price target of $14 representing an 88% upside from the January 23 close.
- Data Expectations: Analyst Matthew Biegler believes that the data from the gedatolisib VIKTORIA-1 study will underperform expectations and may even fail, creating a 'beatable bar' for zovegalisib, which could positively impact its market performance.
- Therapeutic Advantages: As a mutant-selective inhibitor, zovegalisib may have advantages over gedatolisib in breast cancer treatment, as key opinion leaders indicate a preference for treatment segmentation based on ESR1 and PI3K mutation statuses, providing a strategic edge for Relay Therapeutics' product.
- Market Outlook: Relay Therapeutics is set to showcase its potential at the upcoming Jefferies London Healthcare Conference, and combined with the analyst's optimistic rating, it may attract more investor attention towards its future growth opportunities.
See More
Oncolytics Biotech Secures FDA Approval with 33% Efficacy for New Drug
- Clinical Trial Breakthrough: Oncolytics Biotech's pelareorep achieves a 33% objective response rate in KRAS-mutant metastatic colorectal cancer patients, significantly surpassing the historical benchmark of 6-11%, indicating its potential in cancer treatment.
- Broad Market Outlook: The total addressable market for pelareorep in colorectal cancer is projected to reach $20 billion by 2033, highlighting the drug's significance in addressing unmet medical needs.
- Strategic Planning: The company plans to initiate a controlled study in second-line KRAS-mutant colorectal cancer following consultations with key opinion leaders and regulatory authorities, enhancing the analytical rigor of data to support potential regulatory submissions.
- Expert Endorsement: Dr. Sanjay Goel from Rutgers Cancer Institute emphasizes that a 33% response rate is highly unusual in this setting, underscoring the necessity for further studies and indicating the clinical value of the drug.
See More
Relay Therapeutics Executive Large Share Sale Analysis
- Executive Transaction Overview: Donald A. Bergstrom, President of R&D at Relay Therapeutics, executed open-market sales of 21,581 shares on January 27 and 28, 2026, totaling approximately $166,700, indicating significant changes in his holdings.
- Transaction Size Analysis: The 21,581 shares sold are substantially higher than Bergstrom's recent median sale of 2,698 shares, suggesting that a 32.65% decrease in his direct holdings may have driven this larger sale size.
- Impact on Ownership Percentage: This transaction represented 4.89% of Bergstrom's direct ownership, more than ten times the recent median percentage of holdings disposed of per open-market sale, reflecting a shift in his ownership structure.
- Market Reaction and Outlook: Despite the insider sale, Relay Therapeutics' stock closed at $7.65 on January 28, 2026, marking a 65.58% increase over the past year, and the company received FDA Breakthrough Therapy designation, indicating strong future growth potential.
See More
Oncolytics Biotech Receives FDA Fast Track Designation
- FDA Fast Track Designation: Oncolytics Biotech's cancer treatment pelareorep has received Fast Track Designation from the FDA for KRAS-mutant microsatellite-stable metastatic colorectal cancer, which is expected to expedite the approval process and enhance market competitiveness.
- Clinical Data Advantage: The 33% response rate of pelareorep combined with standard chemotherapy significantly surpasses the 10% rate of chemotherapy alone, with a median survival of 27 months, indicating its potential value in hard-to-treat cancer populations.
- Significant Market Opportunity: The annual revenue for second-line treatment of KRAS-mutant colorectal cancer ranges between $3 billion and $5 billion, positioning Oncolytics' innovative therapy to capture a substantial share in this rapidly growing market.
- Team Expansion and Strategic Positioning: Oncolytics Biotech has recently appointed two executives to support its expansion plans, demonstrating the company's commitment to future clinical trials and market outreach, thereby strengthening its leadership position in the biotech sector.
See More
FDA Accelerates Oncology Drug Approvals, Boosting Market Potential
- Regulatory Acceleration: In 2025, the FDA approved over 50 oncology drugs, with a notable shift towards targeted therapies for high-unmet-need solid tumors in 2026, projecting a market opportunity of $326.82 billion by 2031, indicating robust commercial potential.
- Fast Track Designation: Oncolytics Biotech's pelareorep received FDA Fast Track Designation for KRAS-mutant colorectal cancer, showing a 33% response rate when combined with standard chemotherapy, significantly higher than the 10% with chemotherapy alone, which will expedite its approval process.
- Clinical Trial Plans: Oncolytics plans to launch a controlled study comparing pelareorep with standard care in March 2026, with interim data expected by year-end, providing crucial clinical evidence in a competitive market.
- Team Expansion: Oncolytics Biotech recently appointed two key executives to enhance its strategic and operational capabilities, supporting its expanding R&D projects, reflecting the company's confidence and preparedness for future growth.
See More
Relay Therapeutics Receives FDA Breakthrough Therapy Designation
- FDA Breakthrough Therapy Designation: Relay Therapeutics' zovegalisib in combination with fulvestrant has received FDA Breakthrough Therapy designation for treating PIK3CA mutant HR+/HER2- advanced breast cancer, indicating significant clinical potential to improve patient outcomes.
- Clinical Trial Data Support: This designation is supported by clinical data from the ReDiscover trial, which evaluated safety and efficacy at doses of 600mg BID fasted (N=52) and 400mg BID fed (N=57), demonstrating good tolerability and preliminary antitumor activity of zovegalisib.
- Significant Market Potential: Approximately 140,000 patients in the U.S. with HR+/HER2- breast cancer harbor PIK3CA mutations annually, and the approval of zovegalisib could provide new treatment options, addressing a significant unmet need in the market.
- Accelerated Development Process: The FDA's Breakthrough Therapy designation will expedite the development and review of zovegalisib, providing Fast Track eligibility and enhanced guidance, allowing Relay Therapeutics to work closely with the FDA to advance this program efficiently.
See More
Oppenheimer Upgrades Relay Therapeutics Rating
- Rating Upgrade: Oppenheimer has upgraded Relay Therapeutics (RLAY) from 'perform' to 'outperform', anticipating that its lead asset zovegalisib could benefit if Celcuity's (CELC) gedatolisib data underperforms, with a price target of $14 representing an 88% upside from the January 23 close.
- Data Expectations: Analyst Matthew Biegler believes that the data from the gedatolisib VIKTORIA-1 study will underperform expectations and may even fail, creating a 'beatable bar' for zovegalisib, which could positively impact its market performance.
- Therapeutic Advantages: As a mutant-selective inhibitor, zovegalisib may have advantages over gedatolisib in breast cancer treatment, as key opinion leaders indicate a preference for treatment segmentation based on ESR1 and PI3K mutation statuses, providing a strategic edge for Relay Therapeutics' product.
- Market Outlook: Relay Therapeutics is set to showcase its potential at the upcoming Jefferies London Healthcare Conference, and combined with the analyst's optimistic rating, it may attract more investor attention towards its future growth opportunities.
See More
Oncolytics Biotech Secures FDA Approval with 33% Efficacy for New Drug
- Clinical Trial Breakthrough: Oncolytics Biotech's pelareorep achieves a 33% objective response rate in KRAS-mutant metastatic colorectal cancer patients, significantly surpassing the historical benchmark of 6-11%, indicating its potential in cancer treatment.
- Broad Market Outlook: The total addressable market for pelareorep in colorectal cancer is projected to reach $20 billion by 2033, highlighting the drug's significance in addressing unmet medical needs.
- Strategic Planning: The company plans to initiate a controlled study in second-line KRAS-mutant colorectal cancer following consultations with key opinion leaders and regulatory authorities, enhancing the analytical rigor of data to support potential regulatory submissions.
- Expert Endorsement: Dr. Sanjay Goel from Rutgers Cancer Institute emphasizes that a 33% response rate is highly unusual in this setting, underscoring the necessity for further studies and indicating the clinical value of the drug.
See More
