Allogene Therapeutics Stock Price, News & Analysis

Allogene Therapeutics has received orphan-drug designation from the FDA for ALLO-605, a next-generation AlloCAR T product targeting BCMA for multiple myeloma treatment. This designation follows the Fast Track designation granted in Q2 2021, highlighting ALLO-605's potential to meet unmet medical needs for patients with relapsed/refractory multiple myeloma. The Phase 1 IGNITE trial is currently ongoing, with clinical updates expected by late 2022. The orphan-drug designation includes development incentives like tax credits and user fee exemptions, facilitating the pathway towards FDA approval.

Allogene Therapeutics has unveiled its new 136,000-square-foot cGMP manufacturing facility, Cell Forge 1, in Newark, California. The facility is operational and prepares for the pivotal trial of ALLO-501A targeting relapsed/refractory Non-Hodgkin Lymphoma. Designed for flexibility, it supports clinical trials and potential commercial production of AlloCAR T™ products. The facility prioritizes sustainability, fully powered by renewable energy, aiming for LEED Gold certification. This initiative is significant as Allogene expands its pipeline and regulatory filings while enhancing manufacturing capabilities.

Allogene Therapeutics (ALLO) announced promising preclinical results for its AlloCAR T therapy, ALLO-316, targeting CD70 to treat renal cell carcinoma (RCC) and other malignancies. Presented at the AACR Annual Meeting, these findings highlight the therapy's potential to address the unmet needs of RCC patients, with a 5-year survival rate below 15%. The FDA granted Fast Track Designation for ALLO-316 in March 2022, supporting its Phase 1 TRAVERSE trial aimed at evaluating safety and efficacy. ALLO-316 demonstrates low off-target binding and effective anti-tumor activity in studies.

Allogene Therapeutics, Inc. (Nasdaq: ALLO), a clinical-stage biotechnology firm, announced its participation in seven investor conferences throughout April to June 2022. Key events include the Canaccord Genuity Horizons in Oncology Virtual Conference on April 14, BofA Securities Healthcare Conference on May 10, and the Stifel Virtual Cell Therapy Conference on June 30. Webcasts for these events will be available on their website, with replays accessible for 30 days. Allogene focuses on developing allogeneic CAR T products aiming to provide effective cancer treatments to patients.

Allogene Therapeutics (Nasdaq: ALLO) has released promising preclinical data demonstrating that anti-BCMA CAR T cells from healthy donors exhibit superior immune fitness and cancer-killing activity compared to those derived from multiple myeloma patients. The research, published in Cancer Research Communications, indicates that these allogeneic CAR T cells have higher counts, better CD4/CD8 ratios, and effective cytotoxicity against multiple myeloma. Allogene's ongoing Phase 1 trials for ALLO-715 and ALLO-605 aim to further evaluate these promising therapies, with a clinical update expected by the end of 2022.

Allogene Therapeutics (Nasdaq: ALLO) announced FDA has granted Fast Track designation to ALLO-316, its first AlloCAR T therapy targeting CD70 for advanced clear cell renal cell carcinoma (RCC). This designation underscores ALLO-316's potential to address the unmet needs of patients resistant to standard RCC treatments, with a five-year survival rate of under 15%. The ongoing Phase 1 TRAVERSE trial aims to evaluate ALLO-316's safety and efficacy.

ALLO-316's selectivity for CD70 may offer advantages in treating both solid tumors and hematologic malignancies.

Allogene Therapeutics (ALLO) announced the resumption of its AlloCAR T clinical studies following the lifting of a clinical hold by the FDA in January 2022. The company has initiated patient enrollment for multiple trials, including the pivotal Phase 2 ALPHA2 trial for ALLO-501A targeting relapsed/refractory large B cell lymphoma. With $810 million available at the end of 2021, and a reported net loss of $257 million, Allogene anticipates 2022 operating expenses between $360 million and $390 million. Future updates are expected during a conference call scheduled today.

Allogene Therapeutics (Nasdaq: ALLO) will announce its fourth quarter and year-end 2021 financial results on February 23, 2022, after market close. A live audio webcast and conference call are scheduled for 2:00 PM PT/5:00 PM ET. The announcement highlights Allogene's work in developing allogeneic CAR T cell therapies, aiming for reliable, scalable treatments for cancer. The company emphasizes its commitment to innovation in cell therapy.