bluebird bio, Inc. - BLUE STOCK NEWS

bluebird bio, Inc. (NASDAQ: BLUE) will participate in the Goldman Sachs 42^nd Annual Global Healthcare Conference on June 8 at 8:50 a.m. ET. The live webcast of the presentation can be accessed on their Investors & Media page. A replay will be available for 90 days post-event. bluebird bio is focused on developing gene therapies for severe genetic diseases and cancer, aiming to improve access and education in healthcare. The company operates from multiple locations, including Cambridge, Mass., Seattle, Durham, and Zug.

bluebird bio (Nasdaq: BLUE) announced the FDA has lifted clinical holds on several studies, including LentiGlobin for sickle cell disease and betibeglogene autotemcel for β-thalassemia. This decision allows the resumption of clinical trial activities for both gene therapies, which are significant advancements in treating these inherited conditions. The company emphasizes its commitment to patient safety and adheres to regulatory standards, while preparing for major submissions in the near future. Notably, LentiGlobin remains investigational and has not yet received approval in any region.

bluebird bio, Inc. (Nasdaq: BLUE) has announced the approval of inducement grants for stock options and restricted stock units (RSUs) totaling 50,000 shares and 25,000 RSUs to Chief Commercial Officer Tom Klima. The stock options have an exercise price of $31.11 and will vest over four years. The RSUs will also vest over four years, starting with 25% on the first anniversary of the grant date. This move complies with NASDAQ Listing Rule 5635(c)(4) as part of Mr. Klima's employment agreement.

bluebird bio (Nasdaq: BLUE) announced a positive opinion from the CHMP of the EMA recommending marketing authorization for SKYSONA™ (elivaldogene autotemcel, Lenti-D™). This one-time gene therapy targets early cerebral adrenoleukodystrophy (CALD) in children under 18 who lack a matched sibling donor. If approved by the European Commission, SKYSONA would be the first gene therapy for CALD, offering hope to patients with this severe condition. The final decision is expected in mid-2021.

Bristol Myers Squibb (BMY) and bluebird bio (BLUE) revealed new findings from the pivotal KarMMa study on Abecma (idecabtagene vicleucel), a CAR T cell therapy for multiple myeloma. Updated results show a consistent overall response rate of 73% and a complete response in 33% of patients after a median follow-up of 24.8 months. The safety profile indicates common adverse events include cytopenias (97%) and cytokine release syndrome (84%). Abecma remains the first BCMA-directed CAR T therapy approved by the FDA, with ongoing reviews in other regions.

bluebird bio (Nasdaq: BLUE) will present significant data from its gene therapy programs for transfusion-dependent β-thalassemia and sickle cell disease, as well as its cell therapy for relapsed or refractory multiple myeloma during the EHA2021 Virtual Congress from June 9-17, 2021.

Key presentations include updates on betibeglogene autotemcel from the Phase 3 Northstar studies and the LentiGlobin study results for sickle cell disease. The company will also present long-term efficacy data for ABECMA in multiple myeloma, as part of its collaboration with Bristol Myers Squibb.

bluebird bio reported Q1 2021 financial results, showing revenues of $12.8 million, down from $21.9 million in Q1 2020, primarily due to lower ide-cel revenue. R&D expenses rose slightly to $154.5 million, while SG&A expenses increased to $86.9 million, attributed to higher compensation and consulting fees. The net loss widened to $205.8 million. Highlights include FDA approval for Abecma, the first CAR T therapy for multiple myeloma, and the planned separation into two companies by year-end 2021. The cash position decreased to $1.09 billion.

bluebird bio, Inc. (NASDAQ: BLUE) announced upcoming participation in two investor conferences: the BofA Securities 2021 Health Care Conference on May 13 at 9:30 am ET and the 2021 RBC Capital Markets Global Healthcare Conference on May 19 at 1:55 pm ET. Interested investors can access live webcasts through the company's website, with replays available for 90 days post-event.

The company focuses on gene therapy for severe genetic diseases and cancer, aiming to provide treatment options for those facing life-threatening conditions.

bluebird bio (Nasdaq: BLUE) has provided significant updates regarding its gene therapy programs addressing severe genetic diseases. The company corrected a previous diagnosis of MDS in a patient, moving it to transfusion-dependent anemia, aiding its regulatory efforts to lift clinical holds on studies HGB-206 and HGB-210 for LentiGlobin. Following unsuccessful reimbursement negotiations for ZYNTEGLO in Germany, bluebird is restructuring its workforce to align with strategic priorities. The company remains optimistic about advancing its gene therapies in Europe while addressing ongoing safety evaluations.