NEW YORK, May 21, 2024 /PRNewswire/ -- The Gross Law Firm issues the following notice to shareholders of bluebird bio, Inc. (NASDAQ: BLUE).Shareholders who purchased shares of BLUE during the class period listed are encouraged to contact the firm regarding possible lead plaintiff appointment. Appointment as lead plaintiff is not required to partake in any recovery.CONTACT US HERE:https://securitiesclasslaw.com/securities/bluebird-bio-loss-submission-form/?id=80713&from=4CLASS PERIOD: April 24, 2023 to Decem ...

LOS ANGELES, May 16, 2024 /PRNewswire/ -- Glancy Prongay & Murray LLP ("GPM") announces that investors with substantial losses have opportunity to lead the securities fraud class action lawsuit against bluebird bio, Inc. ("bluebird" or the "Company") (NASDAQ: BLUE).Class Period: April 24, 2023 – December 8, 2023Lead Plaintiff Deadline: May 28, 2024If you wish to serve as lead plaintiff of the bluebird lawsuit, you can submit your contact information at www.glancylaw.com/cases/bluebird-bio-Inc-1/. You can al ...

It won't be easy for the company to bounce back.Being a highly innovative company isn't a sufficient condition for success in the biotech industry. Bluebird Bio (BLUE), a small-cap gene-editing specialist, is a good example of this. Though the company has developed groundbreaking therapies, the stock has significantly lagged the market in recent years. Still, if Bluebird Bio can turn things around, the company could deliver explosive returns to investors who initiate a position today. Is Bluebird Bio worth ...

Financial Data and Key Metrics - Total revenue for Q1 2024 was $18.6 million, driven by ZYNTEGLO [13] - Cash on hand as of March 31, 2024, was $264 million, including $52 million in restricted cash [13] - The company anticipates gross to net discounts in the range of 20% to 25% for 2024 [13] - Cash runway is projected through Q1 2026, assuming the receipt of $50 million from the term loan facility [13] Business Line Data and Key Metrics - LYFGENIA achieved its first commercial patient start, marking a significant milestone [5] - ZYNTEGLO saw 11 patient starts since the beginning of 2024, with strong linear growth [9] - SKYSONA completed 3 patient starts since the beginning of 2024 [9] - The company expects between 85 and 105 patient starts across its commercial portfolio in 2024 [9] Market Data and Key Metrics - 64 qualified treatment centers (QTCs) have been activated for LYFGENIA and ZYNTEGLO [11] - More than half of the LYFGENIA QTCs are actively evaluating patients for gene therapy initiation [8] - 11 QTCs have started their first patient for one of the company's products, with many starting their second or third [11] Company Strategy and Industry Competition - The company is focused on establishing a robust network of QTCs, ensuring timely access to therapies, and optimizing the patient and provider experience [7] - The cost-effectiveness model for LYFGENIA was peer-reviewed and published, supporting its value proposition [10] - The company is not currently focused on ex-US markets but may consider partnerships in the future [53] Management Commentary on Operating Environment and Future Outlook - Management is optimistic about the momentum building for LYFGENIA, with the majority of patient starts expected in the second half of 2024 [8] - The company is confident in achieving its 2024 patient start guidance of 85 to 105, with a ramp-up expected in the latter half of the year [59] Other Important Information - The company is working on a restatement of its financials, which is not expected to impact cash position or revenue [13] - Manufacturing capacity for LYFGENIA is robust, with the ability to increase supply as demand grows [51] Q&A Session Summary Question: Medicaid reimbursement and its impact on patient starts for LYFGENIA [16] - Medicaid is not a rate-limiting factor, and patients can access therapy through medical exceptions if needed [19] Question: Study of LYFGENIA in younger patients [20] - A trial (HGB-210) is ongoing for pediatric patients aged 2 to 12, with completion expected by Q4 2024 [21] Question: Patient pull-through in the bluebird support system [22] - The company is not commenting on individual pull-through rates but notes strong patient interest and commitment to the treatment process [23] Question: QTC activity and patient choice between LYFGENIA and Casgevy [25] - Most QTCs are expected to offer both therapies, with patient choice being a key factor [26] Question: QTC activation and cell collection cycles [28] - 64 QTCs are activated, with about 50 receiving referrals for LYFGENIA [32] Question: Factors influencing the pace of patient starts [33] - Early adopters and patient readiness are key factors, with time being a significant component in the patient journey [34] Question: Definition of a new patient start [39] - A new patient start is defined by the completion of the first unique cell collection [40] Question: Financial trends and restatement impact [41] - The restatement will not impact cash or key metrics, but no further details on financial trends were provided [42] Question: Pace of cell collections for LYFGENIA [45] - The company expects an acceleration in patient starts, particularly in Q3 and Q4, with field teams focusing on patient pull-through [46] Question: Hydroxyurea washout and manufacturing capacity [47][50] - The company is not providing specific guidance on hydroxyurea washout but notes variability in patient readiness [49] - Manufacturing capacity for LYFGENIA is robust, with plans to increase supply as demand grows [51] Question: Ex-US market launch considerations [52] - The company is currently focused on the US market but may consider ex-US launches with a partner in the future [53] Question: Bottlenecks to patient starts and ZYNTEGLO treatment status [55] - Time is the primary factor, with medical readiness and insurance processes taking longer for sickle cell patients [56] Question: Confidence in achieving patient start guidance [58] - The company remains confident in achieving 85 to 105 patient starts in 2024, with momentum building in the second half of the year [59]

Core Insights - bluebird bio (BLUE) reported revenues of $18.6 million in Q1, significantly up from $2.4 million in the same quarter last year, surpassing the Zacks Consensus Estimate of $18 million, driven by increased Zynteglo product revenues [1] - The FDA approved bluebird's third gene therapy, lovotibeglogene autotemcel (lovo-cel), branded as Lyfgenia, for sickle cell disease treatment in December 2023 [1] - Despite positive quarterly results, bluebird's shares have declined 18.8% year-to-date, compared to a 6.3% decline in the industry [2] Financial Position - As of March 31, 2024, bluebird had approximately $264 million in cash, cash equivalents, and restricted cash [4] - The company secured a $175 million five-year term loan facility from Hercules Capital, extending its cash runway by two years [4] - bluebird expects its cash reserves, including potential proceeds from the term loan, to cover operating expenses and capital expenditures through Q1 2026 [4] Product Updates - bluebird has completed 14 patient starts for Zynteglo and Skysona in 2024, with the first patient start for Lyfgenia occurring this month [6] - The company activated 64 qualified treatment centers for Lyfgenia and Zynteglo, and six centers for Skysona [7] - For 2024, bluebird anticipates 85 to 105 patient starts across its three FDA-approved therapies, with gross-to-net discounts expected to be 20-25% of gross revenue [8] Market Challenges - Gaining market share in the competitive gene therapy sector remains a significant challenge for bluebird, particularly with the boxed warning for Lyfgenia regarding hematologic malignancy [9] - The presence of competitors like Vertex and CRISPR Therapeutics, particularly with their CRISPR/Cas9 therapy Casgevy, poses additional challenges for Lyfgenia's market penetration [9] Regulatory and Approval Status - bluebird confirmed prior authorization approval for commercial and Medicaid-insured patients for Lyfgenia [10]

UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 __________________________ Securities registered pursuant to Section 12(b) of the Act: FORM 8-K __________________________ CURRENT REPORT Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 Date of Report (Date of earliest event reported): May 9, 2024 __________________________ Delaware (State or Other Jurisdiction 455 Grand Union Boulevard, Somerville, MA 02145 (Address of Principal Executive Offices) (Zip Code) blue ...

bluebird bio’s (BLUE) shares have lost 25.4% year to date compared with the industry’s decline of 7.9%.As of now, the going is challenging for bluebird. While the approval of its three gene therapies bodes well, the uptake of the same has not gained traction as expected.Image Source: Zacks Investment ResearchThe FDA approved Zynteglo for the treatment of beta-thalassemia in adult and pediatric patients requiring regular red blood cell transfusion on Aug 17, 2022. It also approved Skysona for treating early, ...

Who wins this face-to-face between two beaten-down biotechs?If there is one thing Bluebird Bio (BLUE -5.17%) and Novavax (NVAX -0.47%) have in common, other than their belonging to the biotech industry, it is that both have seen their shares drop catastrophically in recent years. Bluebird's stock is down by 91% in the past three years, while Novavax's has declined by 97%.The market doesn't have much faith in either company, but if they can turn things around, opportunistic investors who initiate positions n ...

For most stocks, a 25% cut in an analyst's target price following an earnings release would send investors scrambling for the exit door. That wasn't the case with Bluebird Bio (BLUE -6.23%), however.The clinical-stage biotech saw a decent price rise after those two events in late March. What helped was that, despite the cut, said analyst believes the shares are on track to double in price and then some.The price target is cut. However...That prognosticator is Wells Fargo's Yanan Zhu, who now feels Bluebird ...

bluebird bio, Inc. (NASDAQ:BLUE) Q4 2023 Earnings Conference Call March 26, 2024 8:00 AM ET Company Participants Courtney O'Leary - Director of IR Andrew Obenshain - CEO Tom Klima - Chief Commercial and Operating Officer Chris Krawtschuk - CFO Conference Call Participants Jason Gerberry - Bank of America Securities Danielle Brill - Raymond James Jack Allen - Baird Gena Wang - Barclays Eric Joseph - JPMorgan Mani Foroohar - Leerink Jeffrey Hung - Morgan Stanley Salveen Richter - Goldman Sachs Sami Corwin - ...