It will likely be run over by better-funded peers. To obtain regulatory approval for lovo-cel, it will have to show that its manufacturing process ends up being similar to that which was achieved during ongoing clinical trials. Then, there is the possibility of a 3rd FDA approved gene therapy candidate from its pipeline in 2023 as well. Bluebird scored two approvals from the Food and Drug Administration (FDA) earlier this year for its one-and-done gene therapies: Skysona for cerebral adrenoleukodystrophy (CALD) and Zynteglo for. However, there are three risks that you should be aware of. It believes it has enough cash to fund its operations through first half of 2023. Founded in 1993 in Alexandria, VA., by brothers David and Tom Gardner, The Motley Fool is a multimedia financial-services company dedicated to building the world's greatest investment community. The stock fell . All these patients are still being treated with lovo-cel. Cons. That's because advisory committees give companies and investors a better idea of whether or not a drug will be approved by the FDA. Manufacturing problems, long-term side effects in patients, and allegations of stolen intellectual property by the company and Memorial Sloan Kettering collided to send shares tumbling over 98% from all-time highs. Upon completion of the separation, current chief bluebird, Nick Leschly, will lead Oncology [] The biotech's stock appears to be. Both earned unanimous positive recommendations. For more information, visit bluebirdbio.com. In addition, there is no guarantee that bluebird bio will receive approval for any of its gene therapies. The stock closed at $5.93 on Monday, then opened at $5.81 on Tuesday before rising to a high of $6.97. Bluebird Bio Inc (NASDAQ: BLUE) is about to become the seller of the two most expensive drugs in the U.S. and probably the world. This suggests a possible upside of 38.7% from the stock's current price. bluebird bio, Inc. will retain focus on SGD and will launch its oncology business ("Oncology Newco") as a new entity. Another risk might be the need to raise cash. Both eli-cel and beti-cel are lentiviral vector (LVV) gene therapies, which are useful but limited tools. About bluebird bio, Inc. bluebird bio is pursuing curative gene therapies to give patients and their families more bluebird days. *Stock Advisor returns as of November 20, 2020. The price tag of $3 million is already facing backlash. The two companies plan to collaborate on the next phase of 2seventys pipeline, each applying their respective innovations in cell therapy development and manufacturing through a risk-sharing model. Action Alerts PLUS is a registered trademark of TheStreet, Inc. 5 RULES FOR TRADING DURING EARNINGS SEASON, MANAGING YOUR TRADING DURING A BEAR MARKET, eli-cel, a gene therapy for a rare genetic condition called cerebral adrenoleukodystrophy (CALD) primarily affecting children, beti-cel, a gene therapy for a rare blood disorder called beta-thalassemia that requires risky blood transfusions, They can damage DNA near the edit site, potentially. On average, they predict the company's stock price to reach $8.50 in the next year. When the symbol you want to add appears, add it to My Quotes by selecting it and pressing Enter/Return. The global sickle-cell disease treatment market is expected to reach 7.71 billion by 2027. bluebird bio is headquartered at 455 Grand Union Blvd., Somerville, MA 02145, U.S. The main phone number is (339) 499-9300 When was the company founded? About bluebird bio, Inc. With that In mind I seek stocks that have long term value! ET Friday morning. I am the Founder of Biotech Analysis Central, A subscription service on Seeking Alpha's Marketplace. Do Not Sell My Personal Information (CA Residents Only). Of course, the FDA doesn't have to listen to its advisory committee, but it does hold a huge weight over whether or not a drug is approved. Out of an abundance of caution, the company also decided to halt the marketing of Zynteglo in Europe, although no cases of cancer have been reported in patients treated with it. Meanwhile, more precise DNA editing tools such as CRISPR gene editing, CRISPR base editing, and peptide nucleic acids (PNAs) could offer patients safer, more effective, and more convenient outcomes. We have the largest and deepest ex-vivo gene therapy data set in the worlddriving the field forward, but we aren't doing this alone. Not many i'm afraid, at least until the new facility opens in Assembly Row. Bluebird Bio has acquired Pregenen on Jul 1, 2014. Bluebird Bio 's (NASDAQ: BLUE) stock was down more than 14.5% on Tuesday as of 12:40 p.m., with its shares falling more than the Nasdaq 's gain of close to 0.2%. Bluebird Bio has invested in TC BioPharm on Dec 7, 2017. General Where is bluebird bio's corporate headquarters? Forward-looking statements in this press release should be evaluated together with the many risks and uncertainties that affect bluebird bios business, which include the risk that bluebirds and 2seventys collaboration with Resilience will not continue or be successful; the risk that our product candidates will not be successfully developed or commercialized; the risks related to our reliance on a third party for our suspension vector needs. Join me in my quest to find the best biotechnology stocks that deliver results to help patients with new treatment options. It is common for some problems to be reported throughout the day. I Write for the Healthcare Sector and Stock market in general. bluebird bio is a human company powered by human stories. Shares of Bluebird Bio(NASDAQ: BLUE)jumped 15.7% on Tuesday. A second thing that bluebird bio needs to make sure is correct before a possible BLA filing is its manufacturing process. Shares of gene therapy company Bluebird Bio ( BLUE -5.86%) fell by 10.7% through the first four full days of trading this week, according to data provided by S&P Global Market . It has been beaten down to a series of bad events over the last few years. The facility includes drug substance and drug product production suites, quality control testing laboratories and warehousing space as well as additional footprint for future expansion. Founded in 2020, the company is building a sustainable network of high-tech, end-to-end manufacturing solutions to ensure the medicines of today and tomorrow can be made quickly, safely, and at scale. It is looking for ways to raise cash with many financial measures like selling stock or other means. If all goes well for bluebird bio it expects a BLA filing by Q1 of 2023. 10 stocks we like better than Bluebird BioWhen investing geniuses David and Tom Gardner have a stock tip, it can pay to listen. Shares of Bluebird Bio ( BLUE -2.23%) jumped 15.7% on Tuesday. What happened. Investors: The stock closed at $5.93 on Monday, then opened at $5.81 on Tuesday before rising to a high of $6.97. The Motley Fool owns shares of and recommends Bluebird Bio. We learn from the realities of others. By continuously advancing the science of biopharmaceutical manufacturing and development, Resilience frees partners to focus on the discoveries that improve patients lives. Please refer to conference ID number 5780005. However, what may also be possible is the ability to obtain two Priority Review Vouchers. The first risk is that there is a partial clinical hold in place for patients under the age of 18 with SCD. As the limitations of the tools became clear, scientists developed new technologies with more flexibility. The closing of the transaction will be subject to the expiration of the waiting period under the Hart-Scott-Rodino Antitrust Improvements Act, the negotiation of certain definitive agreements and other customary closing conditions. While I'm hopeful that the company can wait to raise cash in the first half of 2023, the stock market environment is very shaky right now and in bearish territory. Once one of its greatest advantages, the fast pace of innovation in biotech now presents challenges for bluebird bio. Last week, two advisory committee (AdComm) meetings met to discuss the risk/reward profile of two drug candidates put forward by the company. All patients in the HGB-206 study in Group have been treated. For more information, visit www.Resilience.com. Nonetheless, the AdComm votes were unanimous in recommending beti-cel and eli-cel for approval, respectively. You can follow me on stocktwits.com under the name BiopharmaPro where I currently have (62.5K) followers. These forward-looking statements include statements as to the parties intention for Resilience to continue to deliver vector supply for bluebird bio and 2seventy bio, including suspension LVV; the intention and plans of Resilience to continue to invest in manufacturing capacity and technologies following the completion of the transaction; and the parties intention to collaborate on future pipeline projects. How is bluebird bio stock traded? Bluebird bio may be "first-in-class" in some ways, but it's not the place where something "best-in-class" is produced. epingpank@bluebirdbio.com If you have an ad-blocker enabled you may be blocked from proceeding. This investment - Series B - TC BioPharm - was valued at $16M. Downdetector only reports an incident when the number of problem reports is significantly higher . 28, 2021-- That's the thing though, it's not just that these cells die off early. What happened Shares of Bluebird Bio (NASDAQ: BLUE) jumped 15.7% on Tuesday. But there's finally some good news for shareholders. bluebird bio is a human company powered by human stories. That presents a tricky scenario for individual investors. When did bluebird bio go public? As I noted in the beginning above, there are going to be two FDA advisory committees expected to happen first consecutively June 9 and 10 of 2022. Manufacturing in Durham, NC. This is a possible way to raise cash, of course, that depends upon whether or not it receives FDA approvals for beti-cel or eli-cel. bluebird bio is pioneering gene therapy with purpose. It can choose to keep them or sell them. What happened. Delivering more bluebird days for patients and their families requires a different approach to treating disease. The good news here is that bluebird has still been able to treat patients who are the age 18 and older. Regulators were primarily concerned with safety risks associated with LVV gene therapy after multiple patients treated in clinical trials developed cancers. The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc. 2022, Nasdaq, Inc. All Rights Reserved. This means it may choose to raise cash earlier than expected. The forward-looking statements included in this document are made only as of the date of this document and except as otherwise required by applicable law, bluebird bio undertakes no obligation to publicly update or revise any forward-looking statement, whether as a result of new information, future events, changed circumstances or otherwise. bluebird bio has announced its intent to separate its severe genetic disease (SGD) and oncology businesses into differentiated and independent publicly traded companies. Flagship . If you like what you read here and would like to subscribe to, I'm currently offering a two-week free trial period for subscribers to take advantage of. What happened Shares of gene therapy company Bluebird Bio (NASDAQ: BLUE) were up by a healthy 12.4% on heavy volume as of 11:16 a.m. They can be used to speed up the approval process to 6 months, instead of standard review time of 12 months. If the two advisory committees turn out to be good votes, then I expect FDA approval to be possible for beti-cel and eli-cel later in 2022. However, there is potential to invest in this name in a speculative fashion. bluebird and 2seventy will continue to benefit from flexible and guaranteed access to LVV manufacturing for their emerging pipeline programs and the facility will be the primary source of suspension LVV. We're putting our care and expertise to work across a spectrum of disorders including cerebral adrenoleukodystrophy, sickle cell disease, -thalassemia and multiple myeloma using three gene therapy technologies: gene addition, cell therapy and (megaTAL-enabled) gene editing. Bluebird was investigating LentiGlobin as a potential treatment for SCD in a phase 1/2 study and a separate phase 3 clinical trial. At bluebird, our proprietary lentiviral vector gene therapies are one-time treatments that are designed to deliver a functional copy of a gene to a patients own cells. These involve the PDUFA dates of August 19, 2022, for beti-cel for beta thalassemia and then September 16, 2022, of eli-cel for cerebral adrenoleukodystrophy. The two companies are also finalizing a definitive agreement to establish partner programs that will share expense and revenue for successful commercialized oncology products and in parallel establish a next-generation manufacturing R&D collaboration. I have a Bachelors of Applied Science Degree In Technology Management, Industrial and Business Services Management from St. Petersburg College Florida. Adeno-associated virus (AAV) vectors offer higher capacity and little cancer risk, while emerging herpes simplex virus (HSV) vectors offer even larger capacities and can be re-dosed infinitely. Nonetheless, investors may not have much time to celebrate. The red blood cells bend into a sickle-shape, thus the name SCD. Please disable your ad-blocker and refresh. Nonetheless, investors may not have much time to celebrate. I contribute to Seeking Alpha. For more than a decade, weve forged new paths for gene therapies and are improving and advancing at every step. It leaves the patient without the proper amount of red blood cells needed to receive the proper oxygen for the body. From our Cambridge, Mass., headquarters, were developing gene and cell therapies for severe genetic diseases and cancer, with the goal that people facing potentially fatal conditions with limited treatment options can live their lives fully. Our approach utilizes gene addition to introduce a functional gene into a patient's own stem cells. Shares of Bluebird Bio (NASDAQ: BLUE) were crashing 23.3% lower as of 12:18 p.m. EDT on Monday. I believe it offers a great trade opportunity now, especially trading at only 3.60 per share. We have the largest and deepest ex-vivo gene therapy data set in the worlddriving the field forward, but we arent doing this alone. When the symbol you want to add appears, add it to Watchlist by selecting it and pressing Enter/Return. bluebird bio announces strategic manufacturing agreement with Lonza Houston, Inc., providing for future commercial production of our drug products Our First EU Bird Joins The Nest June Gabriella joined the nest as our first hire in Italy. The spin-off is expected to be completed by early November 2021. bluebird bio's corporate filing announced they have appointed Najoh Tita-Reid and Sarah Glickman to the bluebird bio board of directors. ET Friday morning. A 3rd FDA approved gene therapy by the name of lovo-cel for SCD is possible as a BLA filing for this program is expected in Q1 of 2023. And we make sure to be good humans who are all-in every day. I showed you how powerful these Priority Review Vouchers can be, where Biomarin obtained $110 million from one of them. That's because these are allowed to be sold if the company doesn't want to hold onto them. Type a symbol or company name. Further, the acquisition of the bRT facility gives us an important strategic presence in the Research Triangle region with one of the largest and most technically advanced facilities focused exclusively on cell and gene therapy manufacturing. The Motley Fool has a disclosure policy. Funding Rounds Number of Funding Rounds 9 Total Funding Amount $484M To ensure this doesnt happen in the future, please enable Javascript and cookies in your browser. The latter could potentially be dosed directly to patients. It remains to be seen whether or not the partial clinical hold for lovo-cel for SCD gets lifted. Cambridge, Mass.-based Bluebird Bio a biotechnology company that develops gene therapies for severe genetic disorders and cancer could suffer that fate. I am not receiving compensation for it (other than from Seeking Alpha). Ryan FlinnHead of Communications I do much more than just articles at Biotech Analysis Central: Members get access to model portfolios, regular updates, a chat room, and more. Where is the company incorporated? Although a string of promising clinical data readouts launched the company to a $12 billion market valuation in 2018 on what seemed like imminent approvals, the glow quickly wore off. These symbols will be available throughout the site during your session. Some analysts believe this could have been the result of blood cancer or other disruption occurring with respect to stem cells. Sure, the company's investigation could uncover that LentiGlobin is not associated with a higher risk of cancer, but no one knows how long the inquiry will last or what its findings will be. Gene Addition Therapy: Were building platforms with broad therapeutic potential because incremental improvements wont do. For more than a decade, we've forged new paths for gene therapies and are improving and advancing at every step. Data presented to date suggest the treatment provides durable outcomes for patients so far, anyway. What happened. Biotechnology company, bluebird bio, Inc. BLUE announced late Friday that the Food and Drug Administration approved its gene therapy for a rare neurodegenerative disease. However, there are two other possible FDA approvals expected later this year in 2022. Shares of Bluebird Bio (NASDAQ: BLUE) were trending higher today in premarket trading on news that the U.S. Food and Drug Administration (FDA) approved the biotechnology company's gene therapy. Bluebird Bio Stock Price & Analysis 2,075 Followers BLUE Stock Chart & Stats Advanced Chart > Day's Range $0 - $0 52-Week Range $2.87 - $12.62 Previous Close $6.13 Volume 3.75M Average Volume (3M) 7.41M Market Cap N/A Enterprise Value N/A Total Cash (Recent Filing) $132.51M Total Debt (Recent Filing) $292.97M P/E Ratio -0.7 Beta -0.08 | The multiple R&D, regulatory and commercialization setbacks have hit home for bluebird bio. Prosper Junior Bakiny for Bluebird outages reported in the last 24 hours. The final risk is due to the weak environment. Jenn Snyder, 617-448-0281 Poor work/life balance, color-blind and tone-deaf executive and leadership team, little opportunity for growth or career development. bluebird bio accepts no responsibility for the content of linked sites. The good news is that bluebird has 3 possible shots on goal for FDA approvals of its gene therapies. bluebird bio has additional nests in Seattle, Wash.; Durham, N.C.; and Zug, Switzerland. 510-207-7616 On Tuesday morning, gene therapy specialist bluebird bio (NASDAQ: BLUE) announced the temporary suspension of two of its clinical trials for LentiGlobin, an experimental gene therapy for sickle cell disease (SCD). The stock may trade lower because of the weak market and may even reach below $1 per share. That's why it has been able to extend its cash runway through the first half of 2023. Nick Leschly, CEO of Bluebird, said, "The safety of every patient who has participated in our studies or is treated with our gene therapies is the utmost priority for us. Despite the potential for near-term gains, investors need to acknowledge the elevated risks associated with the gene therapy pioneer. The fall is likely . 1.0. on April 2, 2021. Burnout and attrition rates are very high though. | The rollout of bluebird bio's blood disease gene therapy Zynteglo is off to a . On Tuesday morning, gene therapy specialist bluebird bio (NASDAQ: BLUE) announced the temporary suspension of two of its clinical trials for LentiGlobin, an experimental gene. bluebird bio Cautionary Statement Regarding Forward-Looking Statements bluebird bio also encountered manufacturing problems when attempting to produce commercial batches of viral vectors. Biotechnology company, bluebird bio, Inc. (NASDAQ:BLUE) announced late Friday that the Food and Drug Administration approved its gene therapy for a rare neurodegenerative disease. Daron's bluebird Day April bluebird bio has done well with several studies of lovo-cel for the treatment of patients with SCD. The company's name was taken from Shakespeare, whose wise fools both instructed and amused, and could speak the truth to the king -- without getting their heads lopped off. That's right -- they think these 10 stocks are even better buys. The FDA sometimes invites independent scientists and stakeholders to debate the risk/reward profile of controversial drug candidates. or It may not be time to celebrate. Shares of bluebird bio were halted on June 9 and June 10 ahead of the regulatory de-risking events, but the successful milestones are likely to launch the stock higher this week, albeit from a significantly depressed starting point. SCD is a rare and potentially deadly group of blood-related disorders for which there are few treatment options. The partial hold may or may not be resolved, but it pertains to one patient who developed persistent anemia a year and half following treatment with lovo-cel. It has treated nearly 50 SCD patients with this gene therapy and testing has shown thus far that it helps these patients. Contacts for bluebird bio: Overworked and Stressed. Just hit the "Learn More" button on the bottom of the Marketplace Research Tab. Most have to go through taking a lot of medications and blood transfusions. Elizabeth Pingpank, 617-914-8736 The sharp decline came after two analysts downgraded Bluebird. A major reason for extending cash runway is because the company ended up cutting 30% of its workforce. Bluebird Bio Inc (NASDAQ: BLUE) is about to become the seller of the two most expensive drugs in the U.S. and probably the world. the jump in its shares appears to have been caused by two things: an upbeat video message presented by its ceo andrew obenshain late on june 16 at the european hematology association hybrid 2022. Beyond our labs, were working to positively disrupt the healthcare system to create access, transparency, and education so that gene therapy can become available to all those who can benefit. Create your Watchlist to save your favorite quotes on Nasdaq.com. The FDA advisory committees coming up in June 9 and 10 of 2022 should shed some light on whether or not the biotech has a good shot at receiving approval from the FDA. CAMBRIDGE, Mass. The stock closed at $5.93 on Monday, then opened at $5.81 on Tuesday before rising to a high of $6.97. bluebird bio, Inc. ( NASDAQ: BLUE) has great potential for the long-term if it can obtain 3 FDA approvals for its gene therapies in the coming years. The decline came. Resilience to acquire bluebirds clinical and commercial suspension lentiviral vector manufacturing facility in North Carolina, retaining all current employees at the site, Alliance designed to foster best in class cell therapy product and manufacturing innovation through risk-sharing and royalty-based model, bluebird to receive $110M upfront, preferred LVV manufacturing access and significantly reduce operational expenses over coming years. We look forward to working closely with bluebird as they continue to advance important therapies for patients., Our mission of developing the next generation of cell therapies requires a thoughtful balance of innovation from both a scientific, medical and regulatory perspective as well as manufacturing perspective. Because incremental improvements wont do also another problem that arises, known as vaso-occlusive crisis ( ) This program is still okay because the company & # x27 ; s year-end! For approval, respectively might be best to stay away from this biotech stock for now 2023 For FDA approval and has shown to help patients with this gene candidate, N.C. ; and Zug, Switzerland the acquisition of the weak market may! 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To VOC, they predict the company does n't have to follow the recommendations from independent stakeholders but!, forward-looking statements company ended up cutting 30 % of its greatest advantages, the, //Downdetector.Com/Status/Bluebird/ '' > bluebird bio ( Finally ) Nears approval study and a separate phase clinical. For shareholders many gene therapies, which are useful but limited tools are even better. Have 12 to 18 months of market exclusivity that bluebird bio accepts no responsibility for the Motley Fool shares! Latter could potentially be dosed directly to patients candidate, full release here: https: ''. Team, little opportunity for growth or career development, N.C. ; and Zug, Switzerland of. $ 8.50 in the future, please enable Javascript and cookies in your browser SCD patients with this therapy! > < /a > What happened work/life balance, color-blind and tone-deaf executive and leadership team, little for. 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