Immunocore Holdings Plc - IMCR STOCK NEWS

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.

Immunocore presented clinical data regarding tebentafusp at the 2021 ASCO Annual Meeting, highlighting its overall survival benefit in metastatic uveal melanoma. In a subset analysis from the Phase 3 study, tebentafusp showed a superior overall survival (OS) with a hazard ratio of 0.43 compared to the investigator's choice. Notably, over half of the patients with progressive disease responded positively to treatment, and no new safety signals were reported. Tebentafusp has received several designations from the FDA and plans for a BLA submission are expected in Q3 2021.

Immunocore (Nasdaq: IMCR) announces its management will present at key investor conferences in June 2021. The Jefferies Virtual Healthcare Conference will feature a fireside chat on June 3 at 8:00 a.m. ET, followed by the Goldman Sachs 42nd Annual Global Healthcare Conference on June 9 at 10:30 a.m. ET. Both events will be accessible via live webcasts on Immunocore's website. As a late-stage biotechnology company, Immunocore is focused on developing TCR bispecific immunotherapies for various diseases, including cancer and autoimmune disorders.

Immunocore announced the dosing of the first patient in a clinical trial for IMC-I109V, a bispecific immunotherapy for chronic hepatitis B (CHB). This marks the first use of Immunocore's ImmTAV® platform in clinical trials. The trial will assess the safety, antiviral activity, and pharmacokinetics of IMC-I109V in non-cirrhotic, HBeAg-negative patients. The aim is to achieve a 'functional cure' by eliminating HBV-infected hepatocytes. Approximately 240 million individuals are chronic carriers of HBV, highlighting the urgent need for new treatment options.

Immunocore Holdings Plc (Nasdaq: IMCR) reported its first quarter 2021 financial results, showcasing a cash position of $431 million. The company plans to submit a Biologics License Application for tebentafusp to the FDA in Q3 2021. This candidate demonstrated a median overall survival of 21.7 months for metastatic uveal melanoma. Total revenue from collaborations remained stable at $11.4 million. The operating loss increased to $44 million, primarily due to rising employee-related expenses. Immunocore continues advancing its clinical programs with expectations for data releases later in 2021 and 2022.

Immunocore announced its presentations at the 2021 ASCO Annual Meeting from June 4-8, 2021, showcasing significant findings regarding tebentafusp. The oral presentation will focus on the overall survival benefit from tebentafusp in patients with progressive disease. Additionally, three posters will highlight key clinical trial results, including the co-primary endpoint of overall survival and the characterization of cytokine release syndrome in metastatic uveal melanoma patients. These presentations reflect Immunocore's commitment to advancing immunotherapy in oncology.

Immunocore presented positive phase 3 data for tebentafusp, showing a statistically significant improvement in overall survival (OS) for patients with metastatic uveal melanoma (mUM) during the AACR 2021 Annual Meeting. The trial indicated a Hazard Ratio of HR=0.51 (p<0.0001) compared to investigator's choice treatments. This marks the first successful phase 3 trial for any T cell receptor therapeutic in solid tumors. Tebentafusp has received several designations from the FDA and will undergo a BLA submission in Q3 2021.

Immunocore (Nasdaq: IMCR) provided a business update reporting its full year 2020 financial results. The company received FDA Breakthrough Therapy Designation for tebentafusp in metastatic uveal melanoma, showing a significant overall survival improvement in a Phase 3 trial (HR=0.51). As of December 31, 2020, Immunocore had $177 million in cash and raised an additional $287 million from its IPO. Revenue grew to £30.1 million, while R&D expenses decreased to £74.8 million. The company expects to submit a Biologics License Application for tebentafusp in Q3 2021.