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tightly held so easily played with..shorts havent thrown in the towel yet
4.60 break and it’s on!
I have been watching this for a few days now. Looks like it’s about to go postal! Making entry. Glta
Looks like BLUE might just break its volume record AGAIN - came close today, over 63m shares traded.
Prob a meme play with the hi short interest today
And because of their dirtbag toxic history the institutions short it on every run up.
Perhaps if they stopped being the filthy toxic slobs that they are, it would be trading over $7.00, on that news, butt they rather be toxic sleaze balls like they have always been.
short sale volume is 30,700,159. The total volume is 47,598,534. The short sale volume percent is up 8% compare to Jun 10, 2022.
Looks to have been the heaviest volume day for BLUE ever.
Lol no respect for fda committee's decision?? Down with the market??
NAZ are always the most skeezy ones.Have to be fast enough with good tools and bots.
Nothing like that on ihub doh
It was halted on pending news so they issued that news just b4 the bell, hence why the buys a/h
Ah. I'll reiterate my post from Friday evening -pretty skeezy that BLUE didn't stay halted until Monday, IMO.
Letting it open trading AH's when everyone left for the weekend was a gift..... Many will be chasing next week... Scaled into a good position.... will see how $BLUE trades early Monday now that news is around... GLTA
Institutional investors hold a majority ownership of $BLUE
Institutional Ownership 87.98 %
Total Shares Outstanding (millions) 71
Total Value of Holdings (millions) $234
$BLUE---FDA Approval almost certain here $$$$
FDA advisory committee unanimous in support of Bluebird Bio’s two gene therapies
It’s a much-needed win for the struggling Cambridge biotech, but doesn’t guarantee approval.
By Ryan Cross Globe Staff,Updated June 10, 2022, 2 hours ago
A scientist at work in a Bluebird Bio lab.PAT GREENHOUSE/GLOBE STAFF
Bluebird Bio scored a much-needed win on Friday when a committee of independent scientists and doctors voted unanimously in favor of recommending Food and Drug Administration approval of the firm’s two gene therapies. The panel said that the treatments’ benefits outweighed any potential risks, including blood cancers that a few trial participants developed.
Even Bluebird was taken aback by the overwhelming support. “I was hopeful we would have positive outcomes, but this was even more than I expected,” chief executive Andrew Obenshain said. “This was an enormously gratifying moment for us.”
Trading in the struggling Cambridge biotech’s stock was halted Thursday and Friday during the two-day FDA advisory panel’s meeting. Before the meeting, the stock was down 98 percent over three years following a spate of troubles, including concerns about the safety of Bluebird’s therapies and fierce debates over their costs. In April, the company said it would lay off 30 percent of its staff to maintain enough cash to last into the first half of 2023.
But the tide could be turning for the company. Over two days, the FDA’s Cell, Tissue, and Gene Therapies Advisory Committee heard from Bluebird executives, FDA scientists, and patient advocates about the safety and effectiveness of Bluebird’s therapies: beti-cel for the rare blood disease beta-thalassemia and eli-cel for a lethal neurodegenerative disease — cerebral adrenoleukodystrophy — that afflicts young children.
While the seal of approval from the committee is welcome news for Bluebird, it is not the final word for the two therapies. The FDA must rule on the therapies, and its decision is due by mid-August for beti-cel and by mid-September for eli-cel. Even then, approval does not guarantee commercial success for the therapies, which could cost millions of dollars and meet resistance from insurers.
Both therapies are based on an engineered virus called a lentiviral vector, which is used to transfer a gene into a patient’s blood stem cells. The technique promises to give patients a permanent working copy of a gene to supplant their broken or missing copy. But depending on where that new gene lands in an individual’s DNA, it can crank up the activity of other genes linked to cancer.
Dr. Wilson W. Bryan, director of the FDA’s Office of Tissues and Advanced Therapies, opened the meeting by stating the agency’s concerns about the risk of blood cancers that arose in some patients receiving Bluebird’s therapies. Although he acknowledged a “tremendous” need for cerebral adrenoleukodystrophy therapies, “patients should not be subjected to products that are ineffective or have an unfavorable risk-benefit profile,” he said.
On Thursday, Bluebird presented data indicating that 92 percent of children with cerebral adrenoleukodystrophy were still alive two years after eli-cel treatment compared to 57 percent of those without treatment. Bluebird also compared eli-cel to standard stem cell transplants sometimes used to treat the disease. The outcomes for children on eli-cel was essentially identical to children who got stem cell transplants from genetically matched donors — such as a sibling.
But children were got eli-cel fared far better than those who got transplants from a mismatched donor; only 43 percent of them survived over two years.
Those striking results were marred by blood cancers that arose in three out of 67 patients who received eli-cel. Dr. Laura Demopoulos, Bluebird’s vice president of pharmacovigilance, said the company plans to monitor signs of cancer every six months if the therapy is approved, which should be feasible since few people are expected to receive it. “We anticipate approximately 10 patients per year will be treated given the rarity of the disease,” she said.
Dr. Christine Duncan, a physician at the Dana-Farber/Boston Children’s Cancer and Blood Disorders Center said that she was “very pleased” with the committee’s vote of confidence, especially since it was not guaranteed. “Our young patients and their families stand to benefit tremendously from eli-cel,” she said in an e-mail.
On Friday, Bluebird presented data from its beta-thalassemia study in patients who require regular blood transfusions to maintain healthy levels of oxygen-carrying blood cells. Bluebird’s gene therapy, beti-cel, provides those patients with a gene that restores their ability to make healthy blood cells. About 90 percent of patients who received the treatment were able to remain transfusion-free, some for as long as seven years.
The company said that there were no cases of cancer linked to beti-cel which uses a slightly different lentiviral vector than eli-cel.
“The therapy is effective and the benefits outweigh the risks,” said Dr. Stuart Orkin, a scientist at the Harvard Stem Cell Institute and a physician at the Dana-Farber/Boston Children’s Cancer and Blood Disorders Center. “I think things are being carefully done, and patients should feel gratified that something will come along for them.”
The fact that clinicians on the advisory committee said the benefits of eli-cel outweighed its risks was encouraging to other biotech companies developing lentiviral gene therapies, including Worcester-based Mustang Bio. “It is definitely a bellwether, because the whole field of gene and cell therapy is still very young,” said Knut Niss, chief technology officer of the firm.
But even if the FDA ultimately approves eli-cel, the ultimate question is how the market responds to the treatment, Niss added. “To me that is the bigger bellwether.”
Another company, Boston- and London-based Orchard Therapeutics, currently sells a lentiviral gene therapy in Europe. That therapy, Libmeldy, carries a price tag of about $3.8 million, and the company has only administered it to three patients since its approval. Orchard plans to submit Libmeldy to the FDA later this year or early next.
But if Bluebird’s beti-cel or eli-cel gets FDA approval in the coming months, those therapies will be the first lentiviral gene therapies for a rare disease in the United States. “That will be an important moment,” said Dr. Bobby Gaspar, chief executive of Orchard. “And I hope what happens with Bluebird is just the start.”
I suppose it will. Thanks for the informative link
Not fast enough for what? IHub has problems - but what?
BLUE opened this evening well after 4pm EST - complete after-hours, skeezy as shit. The voting and reporting of the voting was done well before 4pm EST.
This should've been halted through Monday morning. Clear evidence of institutional gerrymandering.
I personally disapprove of begging questions, and stick that there also is no purpose in debating or postulating future ownership of these therapies. That being said, god help those who try to trade biotech.
BLUE may look like a small cap. IMO, it is not. The comparative valuation of BLUE to TSVT is a wild time, and JOMG. One should watch the AdComm meetings - they are amazingly informative.
These E-trade analyst rec's are hilarious.....
FDA advisory committee unanimous in support of Bluebird Bio’s two gene therapies
It’s a much-needed win for the struggling Cambridge biotech, but doesn’t guarantee approval.
By Ryan Cross Globe Staff,Updated June 10, 2022, 2 hours ago
A scientist at work in a Bluebird Bio lab.PAT GREENHOUSE/GLOBE STAFF
Bluebird Bio scored a much-needed win on Friday when a committee of independent scientists and doctors voted unanimously in favor of recommending Food and Drug Administration approval of the firm’s two gene therapies. The panel said that the treatments’ benefits outweighed any potential risks, including blood cancers that a few trial participants developed.
Even Bluebird was taken aback by the overwhelming support. “I was hopeful we would have positive outcomes, but this was even more than I expected,” chief executive Andrew Obenshain said. “This was an enormously gratifying moment for us.”
Trading in the struggling Cambridge biotech’s stock was halted Thursday and Friday during the two-day FDA advisory panel’s meeting. Before the meeting, the stock was down 98 percent over three years following a spate of troubles, including concerns about the safety of Bluebird’s therapies and fierce debates over their costs. In April, the company said it would lay off 30 percent of its staff to maintain enough cash to last into the first half of 2023.
But the tide could be turning for the company. Over two days, the FDA’s Cell, Tissue, and Gene Therapies Advisory Committee heard from Bluebird executives, FDA scientists, and patient advocates about the safety and effectiveness of Bluebird’s therapies: beti-cel for the rare blood disease beta-thalassemia and eli-cel for a lethal neurodegenerative disease — cerebral adrenoleukodystrophy — that afflicts young children.
While the seal of approval from the committee is welcome news for Bluebird, it is not the final word for the two therapies. The FDA must rule on the therapies, and its decision is due by mid-August for beti-cel and by mid-September for eli-cel. Even then, approval does not guarantee commercial success for the therapies, which could cost millions of dollars and meet resistance from insurers.
Both therapies are based on an engineered virus called a lentiviral vector, which is used to transfer a gene into a patient’s blood stem cells. The technique promises to give patients a permanent working copy of a gene to supplant their broken or missing copy. But depending on where that new gene lands in an individual’s DNA, it can crank up the activity of other genes linked to cancer.
Dr. Wilson W. Bryan, director of the FDA’s Office of Tissues and Advanced Therapies, opened the meeting by stating the agency’s concerns about the risk of blood cancers that arose in some patients receiving Bluebird’s therapies. Although he acknowledged a “tremendous” need for cerebral adrenoleukodystrophy therapies, “patients should not be subjected to products that are ineffective or have an unfavorable risk-benefit profile,” he said.
On Thursday, Bluebird presented data indicating that 92 percent of children with cerebral adrenoleukodystrophy were still alive two years after eli-cel treatment compared to 57 percent of those without treatment. Bluebird also compared eli-cel to standard stem cell transplants sometimes used to treat the disease. The outcomes for children on eli-cel was essentially identical to children who got stem cell transplants from genetically matched donors — such as a sibling.
But children were got eli-cel fared far better than those who got transplants from a mismatched donor; only 43 percent of them survived over two years.
Those striking results were marred by blood cancers that arose in three out of 67 patients who received eli-cel. Dr. Laura Demopoulos, Bluebird’s vice president of pharmacovigilance, said the company plans to monitor signs of cancer every six months if the therapy is approved, which should be feasible since few people are expected to receive it. “We anticipate approximately 10 patients per year will be treated given the rarity of the disease,” she said.
Dr. Christine Duncan, a physician at the Dana-Farber/Boston Children’s Cancer and Blood Disorders Center said that she was “very pleased” with the committee’s vote of confidence, especially since it was not guaranteed. “Our young patients and their families stand to benefit tremendously from eli-cel,” she said in an e-mail.
On Friday, Bluebird presented data from its beta-thalassemia study in patients who require regular blood transfusions to maintain healthy levels of oxygen-carrying blood cells. Bluebird’s gene therapy, beti-cel, provides those patients with a gene that restores their ability to make healthy blood cells. About 90 percent of patients who received the treatment were able to remain transfusion-free, some for as long as seven years.
The company said that there were no cases of cancer linked to beti-cel which uses a slightly different lentiviral vector than eli-cel.
“The therapy is effective and the benefits outweigh the risks,” said Dr. Stuart Orkin, a scientist at the Harvard Stem Cell Institute and a physician at the Dana-Farber/Boston Children’s Cancer and Blood Disorders Center. “I think things are being carefully done, and patients should feel gratified that something will come along for them.”
The fact that clinicians on the advisory committee said the benefits of eli-cel outweighed its risks was encouraging to other biotech companies developing lentiviral gene therapies, including Worcester-based Mustang Bio. “It is definitely a bellwether, because the whole field of gene and cell therapy is still very young,” said Knut Niss, chief technology officer of the firm.
But even if the FDA ultimately approves eli-cel, the ultimate question is how the market responds to the treatment, Niss added. “To me that is the bigger bellwether.”
Another company, Boston- and London-based Orchard Therapeutics, currently sells a lentiviral gene therapy in Europe. That therapy, Libmeldy, carries a price tag of about $3.8 million, and the company has only administered it to three patients since its approval. Orchard plans to submit Libmeldy to the FDA later this year or early next.
But if Bluebird’s beti-cel or eli-cel gets FDA approval in the coming months, those therapies will be the first lentiviral gene therapies for a rare disease in the United States. “That will be an important moment,” said Dr. Bobby Gaspar, chief executive of Orchard. “And I hope what happens with Bluebird is just the start.”
$BLUE Could be a millionaire-maker
https://www.fool.com/investing/2022/06/10/an-fda-approval-could-send-this-stock-soaring-by-a/
Yeppers, can't wait til next week
Yep it's looking good !
$BLUE has some room to run here looking at chart
Shares o/s - 72 million
@ $10 - market cap - $ 720 million
@ $ 15 - mc = $ 1.05 Billion
@ $20 - mc = $1.5 B
The co just got approval for 2 gene therapy drugs - 3 or 4 BP are desperate to lead Gene Therapy
This small co cannot manufacture these drugs themselves
This stock will cross $1 B market cap soon and most likely be bought before year end
Over $10 by end of next week, I bet. Pretty skeezy that this opened during after-hours today, locking many out - or protecting many? I doubt the latter.
Amazed at how quiet it's been here. Early (BLUE)bird gets the worm...trading halted Thursday (yesterday) until Monday. :)
https://www.otcmarkets.com/filing/html?id=15883996&guid=LApwkaGHcQJoRhh
Pretty much same feelings, still have small positions in both .. down big, but the whole group ( bio’s) suk! Been building popo in T*ara & A*gtc… GL
I stopped shortly after the split.
Good for BLUE but I don't think it can go back to its former glory!
I returned to TSVT just three sessions ago!
I think this good news also affects TSVT
I stopped shortly after the split.
Good for BLUE but I don't think it can go back to its former glory!
I returned to TSVT just three sessions ago!
I think this good news also affects TSVT
FDA Sounds Positive On Bluebird's One Gene Therapy But Doubts Another..some life left it seems!
BLUEBIRD BIO ANNOUNCES FDA PRIORITY REVIEW OF BIOLOGICS LICENSE APPLICATION FOR BETI-CEL GENE THERAPY
BLUEBIRD BIO INC - FDA SET PDUFA DATE OF MAY 20, 2022
“The FDA’s acceptance of our BLA for beti-cel brings us one step closer to potentially providing a one-time treatment that can address the underlying cause of ß-thalassemia and offer patients freedom from regular transfusions,” said Andrew Obenshain
Additional data through August 2021 will be presented at the 63(rd) American Society of Hematology (ASH) Annual Meeting and Exposition, taking place December 11-14, 2021.
2Seventy Bio Inc
26,65 USD
+12,88 (93,54%)
Pre-market 28,00 +1,35 (5,07%)
Max 52 64,00
Min 52 13,77
2seventy will begin regular-way trading on the NASDAQ under the stock ticker symbol “TSVT” on November 5, 2021. bluebird bio will continue to trade under the stock ticker symbol “BLUE.”
LEGEND BIOTECH CORP - FDA EXTENDED PDUFA TARGET DATE FOR CILTACABTAGENE AUTOLEUCEL (CILTA-CEL) TO FEBRUARY 28, 2022
you see it takes time for everyone!
Dunno what the price was then or now, hope it's working out for you
lemonade is sweet now!
This BLA should be interesting considering recent setbacks!
No
I will add until the end of the year!
For every dip a little!
I await the division of activities for the gain!
You scared yet?
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