Immunocore Holdings Plc Stock Price, News & Analysis

Immunocore has partnered with Medison Pharma to commercialize tebentafusp in Canada, Central Eastern Europe, and Israel for metastatic uveal melanoma treatment. This agreement follows regulatory acceptances for tebentafusp in the U.S. and Europe. Medison will aid in seeking regulatory authorization, enhancing access to this therapy in 22 markets. Tebentafusp has received multiple designations from the FDA, including Priority Review and Breakthrough Therapy designation, indicating its potential impact on patient care in this aggressive cancer.

Immunocore announced the publication of phase 3 data regarding tebentafusp in The New England Journal of Medicine, demonstrating significant overall survival benefits for previously untreated patients with metastatic uveal melanoma (mUM). This marks tebentafusp as the first T cell receptor therapeutic to show a survival advantage in this patient population. The study reported a hazard ratio of 0.51 (p < 0.0001) favoring tebentafusp over investigator’s choice therapies. The FDA has accepted Immunocore’s biologics license application for tebentafusp, which has received multiple designations indicating its potential as a treatment option for mUM.

Immunocore presented significant findings at the European Society for Medical Oncology (ESMO) Congress 2021, highlighting that a reduction in circulating tumor DNA (ctDNA) while on tebentafusp correlates with improved overall survival in patients with metastatic uveal melanoma. In a Phase 2 trial, 70% of evaluable patients experienced some ctDNA reduction, with 14% achieving complete ctDNA clearance. The company submitted applications for tebentafusp approval to the FDA, EMA, and MHRA, building upon its Phase 3 study's positive outcomes.

iECURE announced the appointment of Brian Di Donato to its Board of Directors. Di Donato, who has over 20 years of financial leadership experience, currently serves as CFO and Head of Strategy at Immunocore (NASDAQ-NMS:IMCR). His expertise is expected to enhance iECURE's mission to develop gene insertion therapies for severe metabolic disorders. Di Donato holds an MBA from NYU and degrees in biology and mechanical engineering. CEO Joseph Truitt expressed optimism about Di Donato's contributions to advancing their pipeline.

Immunocore Holdings Plc (Nasdaq: IMCR) will present new data from its lead program, tebentafusp, at the European Society for Medical Oncology (ESMO) Congress 2021 from September 16-21. Key presentations include an oral presentation on ctDNA reduction associated with overall survival in metastatic uveal melanoma and several poster presentations focused on the efficacy and side effects of tebentafusp. This highlights Immunocore's innovative T cell receptor (TCR) bispecific immunotherapy platform aimed at cancer treatment and its potential impact on patient outcomes.

Immunocore Holdings plc (Nasdaq: IMCR) announced its participation in upcoming investor conferences in September 2021. The company, a pioneer in T cell receptor (TCR) bispecific immunotherapies, will present at the H.C. Wainwright 23rd Annual Global Investment Conference on September 13 and the Oppenheimer Fall Healthcare Life Sciences & MedTech Summit on September 22. Both conferences will be held virtually, with presentations accessible on Immunocore's website. The company is focused on treating various diseases, including cancer, and has a promising pipeline including its lead candidate, tebentafusp.

Immunocore announces that the UK's MHRA has accepted the Marketing Authorization Application for tebentafusp to treat metastatic uveal melanoma. This follows similar acceptances from the FDA and EMA. Tebentafusp's efficacy is supported by data from the Phase 3 IMCgp100-202 trial, which showed a 52% improvement in overall survival compared to standard options. The regulatory submissions highlight the urgent need for effective treatments for this aggressive cancer. Immunocore aims to address this gap with tebentafusp as part of its expanding oncology pipeline.

Immunocore Holdings Plc has announced that the FDA and EMA have accepted applications for the approval of tebentafusp for metastatic uveal melanoma. The FDA granted Priority Review with a target action date of February 23, 2022. Tebentafusp showed significant survival benefits in a Phase 3 trial, achieving a hazard ratio of 0.51. The EMA also recognized the treatment's major public health interest, allowing for an accelerated review process that may reduce the evaluation timeframe to 150 days. This progress marks a crucial step in bringing this promising therapy to patients.

Immunocore (IMCR) reported its Q2 2021 financial results, highlighting significant advancements in its product pipeline, particularly for tebentafusp, aimed at treating metastatic uveal melanoma. The company is on track to submit its Biologics License Application (BLA) in the U.S. by Q3 2021, with accelerated submissions for the European Market Authorization Application (MAA). Financially, while the company reported an operating loss of £34.5 million, it ended the quarter with approximately £385 million in cash. Revenue from collaborations decreased compared to the previous year, reflecting challenges in monetizing its innovations.