FDA Extends INCY's Application for Opzelura Label Expansion
FDA Review Extension: Incyte's supplemental new drug application for ruxolitinib cream, aimed at treating mild to moderate atopic dermatitis in children aged 2-11, has had its review period extended by three months to September 19, 2025, due to the need for additional data review.
Market Performance and Drug Portfolio: Despite a slight decline in shares year-to-date, Incyte is expanding its portfolio beyond its lead drug Jakafi, with recent approvals of other drugs like Monjuvi and Zynyz contributing to growth, although competition and patent expiration concerns for Jakafi remain significant challenges.
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Immunocore Announces R&D Leadership Changes
- Executive Departure: Immunocore announced that Executive Vice President of R&D David Berman will leave the company on February 27, 2026, to take a role at another biotech firm, indicating a significant leadership transition for the company.
- Internal Promotions: The company is promoting current Chief Medical Officer Mohammed Dar and Head of Regulatory Sciences Mark Moyer to Executive Vice President roles, with expanded responsibilities for clinical development and regulatory strategies, aiming to enhance R&D efficiency by leveraging the existing leadership team.
- R&D Achievements: Dar has led clinical development since 2019, successfully advancing KIMMTRAK to regulatory approval, which is now approved in 39 countries, showcasing the company's strong capabilities in oncology immunotherapy.
- Strategic Commitment: CEO Bahija Jallal expressed confidence in the R&D team despite the executive changes, committing to continue advancing clinical programs to meet patient needs for transformative therapies.
Immunocore to Showcase at Upcoming Investor Events
Company Overview: Immunocore Holdings plc is a biotechnology company focused on developing immunomodulating medicines for cancer, infectious diseases, and autoimmune diseases, utilizing its ImmTAX platform for TCR bispecific immunotherapies.
Upcoming Conferences: The company will participate in the Guggenheim 2nd Annual Healthcare Innovation Conference on November 11, 2025, and the Jefferies London Healthcare Conference on November 19, 2025, with live webcasts available on their website.
Product Highlight: Immunocore's leading oncology therapy, KIMMTRAK, is approved for treating HLA-A*02:01-positive adult patients with unresectable or metastatic uveal melanoma in several countries, including the US and EU.
Contact Information: For inquiries, Immunocore provides contact details for communications and investor relations, including email addresses and phone numbers.
HC Wainwright & Co. Affirms Buy Rating for Immunocore Holdings, Keeps $100 Price Target Intact
Real-time Intelligence: Benzinga Pro offers the fastest news alerts for traders, helping them stay informed and make timely decisions in the stock market.
Exclusive Content: The platform provides exclusive stories and insights generated by Benzinga reporters, enhancing the trading experience for its users.
Community Engagement: Over 10,000 serious traders are part of the Benzinga Pro community, indicating a robust network for sharing market intelligence.
Market Winning Tools: Benzinga Pro is designed to equip traders with the tools and information necessary to succeed in the markets daily.
H.C. Wainwright Maintains Positive Outlook on Immunocore Holdings plc (IMCR)
Analyst Ratings: Immunocore Holdings plc (NASDAQ: IMCR) received a Buy rating from H.C. Wainwright with a price target of $100, while Guggenheim initiated a Neutral rating, citing limited commercial growth potential for its drug KIMMTRAK.
Product Overview: Immunocore is a biotechnology company specializing in TCR bispecific immunotherapies, with KIMMTRAK as its lead product for treating metastatic uveal melanoma, and a diverse pipeline of additional therapies in development.
Resolution Therapeutics names Lucy Singah as CFO and Daniel Kennedy as CBO
New Executive Appointments: Resolution Therapeutics has appointed Lucy Singah as Chief Financial Officer and Daniel Kennedy as Chief Business Officer to enhance its leadership team as it progresses in its clinical studies.
Focus on Regenerative Therapies: The company is advancing its lead product, RTX001, a regenerative macrophage therapy aimed at treating inflammatory and fibrotic diseases, with ongoing recruitment for its Phase I/II EMERALD study.
Immunocore Holdings plc (IMCR) Q2 2025 Earnings Call Transcript
Earnings Conference Call: Immunocore Holdings plc held its Q2 2025 earnings conference call on August 7, 2025, featuring key company executives discussing financial performance and future outlook.
Participants: The call included participation from various analysts representing major financial institutions, indicating strong interest in the company's developments.
Immunocore Announces R&D Leadership Changes
- Executive Departure: Immunocore announced that Executive Vice President of R&D David Berman will leave the company on February 27, 2026, to take a role at another biotech firm, indicating a significant leadership transition for the company.
- Internal Promotions: The company is promoting current Chief Medical Officer Mohammed Dar and Head of Regulatory Sciences Mark Moyer to Executive Vice President roles, with expanded responsibilities for clinical development and regulatory strategies, aiming to enhance R&D efficiency by leveraging the existing leadership team.
- R&D Achievements: Dar has led clinical development since 2019, successfully advancing KIMMTRAK to regulatory approval, which is now approved in 39 countries, showcasing the company's strong capabilities in oncology immunotherapy.
- Strategic Commitment: CEO Bahija Jallal expressed confidence in the R&D team despite the executive changes, committing to continue advancing clinical programs to meet patient needs for transformative therapies.
Immunocore to Showcase at Upcoming Investor Events
Company Overview: Immunocore Holdings plc is a biotechnology company focused on developing immunomodulating medicines for cancer, infectious diseases, and autoimmune diseases, utilizing its ImmTAX platform for TCR bispecific immunotherapies.
Upcoming Conferences: The company will participate in the Guggenheim 2nd Annual Healthcare Innovation Conference on November 11, 2025, and the Jefferies London Healthcare Conference on November 19, 2025, with live webcasts available on their website.
Product Highlight: Immunocore's leading oncology therapy, KIMMTRAK, is approved for treating HLA-A*02:01-positive adult patients with unresectable or metastatic uveal melanoma in several countries, including the US and EU.
Contact Information: For inquiries, Immunocore provides contact details for communications and investor relations, including email addresses and phone numbers.
HC Wainwright & Co. Affirms Buy Rating for Immunocore Holdings, Keeps $100 Price Target Intact
Real-time Intelligence: Benzinga Pro offers the fastest news alerts for traders, helping them stay informed and make timely decisions in the stock market.
Exclusive Content: The platform provides exclusive stories and insights generated by Benzinga reporters, enhancing the trading experience for its users.
Community Engagement: Over 10,000 serious traders are part of the Benzinga Pro community, indicating a robust network for sharing market intelligence.
Market Winning Tools: Benzinga Pro is designed to equip traders with the tools and information necessary to succeed in the markets daily.
H.C. Wainwright Maintains Positive Outlook on Immunocore Holdings plc (IMCR)
Analyst Ratings: Immunocore Holdings plc (NASDAQ: IMCR) received a Buy rating from H.C. Wainwright with a price target of $100, while Guggenheim initiated a Neutral rating, citing limited commercial growth potential for its drug KIMMTRAK.
Product Overview: Immunocore is a biotechnology company specializing in TCR bispecific immunotherapies, with KIMMTRAK as its lead product for treating metastatic uveal melanoma, and a diverse pipeline of additional therapies in development.
Resolution Therapeutics names Lucy Singah as CFO and Daniel Kennedy as CBO
New Executive Appointments: Resolution Therapeutics has appointed Lucy Singah as Chief Financial Officer and Daniel Kennedy as Chief Business Officer to enhance its leadership team as it progresses in its clinical studies.
Focus on Regenerative Therapies: The company is advancing its lead product, RTX001, a regenerative macrophage therapy aimed at treating inflammatory and fibrotic diseases, with ongoing recruitment for its Phase I/II EMERALD study.
Immunocore Holdings plc (IMCR) Q2 2025 Earnings Call Transcript
Earnings Conference Call: Immunocore Holdings plc held its Q2 2025 earnings conference call on August 7, 2025, featuring key company executives discussing financial performance and future outlook.
Participants: The call included participation from various analysts representing major financial institutions, indicating strong interest in the company's developments.
