The Gross law firm has filed a class action lawsuit against Bluebird on behalf of shareholders who purchased between April 24 2023 and December 8 2023.

IMO, Blue has not committed the securities law violations alleged (which have not been named or enumerated, btw), and any lawsuit going forward should be filed against the FDA for their issuance of the "Blackbox" warning. Blue stated previously they intend to address the non-award of the PRV with the FDA. They should also be pursuing removal of the "Blackbox" warning; if the Blackbox warning had teeth, the clinical trial hold should never have been lifted in the first place - but the FDA vindicated BLUE from this previously. Furthermore, if BLUE did commit securities fraud (again, unspecified how), then that falls onto the regulatory agency moreso than BLUE, IMO.

Honestly - if not a single analyst anticipated the Blackbox warning, this is all a malignant waste of time by the FDA.

[ALLEGATIONS: According to the complaint, on December 8, 2023, Blue announced that the Food and Drug Administration (FDA) approved its drug Lyfgenia (lovotibeglogene autotemcel), also known as lovo-cel for the treatment of sickle cell disease in patients ages 12 and older who have a history of vaso-occlusive events (VOEs). However, the Lyfgenia approval came with a black box warning for haematological malignancies after two patients developed AML during the clinical trials. Analysts noted that they did not expect the black box warning or the absence of a priority review voucher. Following this news, Blue's stock price fell by $1.95 per share, or approximately 40% to close at $2.86 per share.]

That seeking alpha article is behind a paywall, unfortunately. I'm sure I wouldn't be the only happy person if you posted the sentences that you find informative.

I believe in the power of BlueBird's medicines, but I am concerned about the shorts, as I've had a ridiculous amount of calls get just completely disintegrated by the pressure on this stock in the last 2.5 years. Hopefully, we find that Blue management is honest and also correct about their projections going forward. In addition to that, I'm keeping my fingers crossed that it is Hercules's goal to help facilitate the healthcare options that BLUE has created, and not to steal the entirety of the companies I.P. The agreement does hinge somewhat on the company trading, if I am correct in my calculations, above $2.63 USD for the preceding 30 days of the first day of any financial quarter.

I've lost out significantly to other companies' management teams over the years that were malignant, and I am deeply disturbed that BLUE eliminated the graphic of "Misc Undisclosed" from their pipeline page in the summer of '23. I'm disappointed they haven't addressed that, and have significant thoughts about addressing management over the issue myself. If any of these class action examinations have solid footing, that is one aspect that will be exposed.

I will be reducing my holdings, starting next week, by ~11% for tax harvesting purposes, but I am not going anywhere. I am hoping it tanks a bit more so I can keep more than 89% of my current holdings.

I hope you got in, I think it's worth it means nothing financially on the filing they found while securing financing and going over the books. The shorts were killing it but now that Hercules is the lender they have slowed and its non-dilutive financing. Read this transcript and watch the trading action if you haven't bought in yet. You can always buy calls. https://seekingalpha.com/article/4680564-bluebird-bio-inc-blue-q4-2023-earnings-call-transcript

OK! Checking out this error that's driving the price to a discount. Is this worth grabbing? I see that it used to be very high. I made the mistake of the same thing with other bios.....

BLUE under $2

Also, if it's the last quarter results that are public, why would this not be relevant might I ask? It's pretty standard in the industry for the last posted quarter results to stay relevant untill the next quarter or year end becomes publicly available. Do you know something the market does not on why the most recent c.c. would not be relevant??

Just wondering because the fact you question this would make one think you are fairly new to the investing world, which is fine, but I like to know where you're coming from that's all 🤔🤔🤔

I have a hard time cheering someone who posts 4 month old info without a qualifier that it is 4 month old information. Couple that with your sudden appearance and flip from bearish to bullish within 3 weeks of each other....

I posted this because it was the last earnings on record. Q3 2023 results are a good indicator of growth and ramp for BLUE. The next c.c. is only weeks away for full year 2023 and fourth quarter 2023 which are normally combined into 1 earnings report and c.c.

Cheers

Nov 7, 2023 at 8:00 AM EST has long since passed.

Why did you post this?

NICE!

https://investor.bluebirdbio.com/events/event-details/bluebird-bio-3rd-quarter-2023-results-call

One of the top 25 Bio companies of 2024.

https://thehealthcaretechnologyreport.com/the-top-25-biotechnology-companies-of-2024/

BLUE..................................................https://stockcharts.com/h-sc/ui?s=BLUE&p=W&b=5&g=0&id=p86431144783

FDA Ramrod x2, + shorts.

Honestly -- what happened to this company?

I have never actually invested in BLUE but I have been following it for a while. I live near by and know some people who work for them. From what they could talk about and the press releases and journal articles i've read, it seems like they have an amazing technology that works to find solutions (cures) to unique problems. How did they go from trading over 200+ a share to this?

That would be lovely, but what's your info?

At 190.4mm shares to 20 per, that's 3.8 Billion - or over 1000 drug sales at 2.75m avg. BLUE forecasted 80-100 sales this year.

Buyout is in the works. Very short time will be made public. Anything below $20.00 vote no. 3 blockbusters here

BLUE.......................................https://stockcharts.com/h-sc/ui?s=BLUE&p=W&b=5&g=0&id=p86431144783

I believe the bottom has come and gone. I wouldn't expect to see anything below $0.95 again.

On average, Wall Street analysts predict that Bluebird Bio's share price could reach $6.87 by Dec 21, 2024. The average Bluebird Bio stock price prediction forecasts a potential upside of 566.8% from the current BLUE share price of $1.03.

This guy wants your shares of BLUE ruhl bad, me thinks.

BLUEnew 52 week low

Bottom is far from in. Amrn hit .65 cents just a few months ago. Sadly, blue won't recover imho

Amrn dropped to .65 cents before making any recovery. Unfortunately, this is not bottom for bluebird bio

Reverse split inevitable here. Too many shares on the market now thanks to recent share sales. Float reduction is needed to move this bloated pig anywhere now unfortunately and that's why it continues below $1.00. Amrn hit .65 cents before it's bounce so prepare yourself this isn't even close to bottom

BLUE new 52 week low

BLUE new 52 week low

I seen this Bio and did little DD. But in the few minutes, one thing stood out. It causes cancer. You guys that did more DD might know something or see something that gives you confidence to invest here. I pass. Good luck guys.

I seen this Bio and did little DD. But in the few minutes, one thing stood out. It causes cancer. You guys that did more DD might know something or see something that gives you confidence to invest here. I pass. Good luck guys.

BLUE new 52 week low

Ask, and you shall receive! Lol

Item 7.01
Regulation FD Disclosure.
bluebird bio, Inc. (the "Company") has signed a second outcomes-based agreement for LYFGENIA, bringing the cumulative total of covered lives for LYFGENIA to approximately 200 million, less than one month since FDA approval of LYFGENIA on December 8, 2023 for sickle cell disease in patients 12 and older with a history of vaso-occlusive events. Additional updates on the commercial launch of LYFGENIA will be presented at the 42nd Annual J.P. Morgan Healthcare Conference on Tuesday, January 9, 2024.

Let’s see if we get any updated guidance ( Rev’s, cash burn, PRV dispute, Payers, etc)…biggest Conf on earth, LFG!!!


bluebird bio, Inc. (Nasdaq: BLUE) today announced that Andrew Obenshain, chief executive officer, bluebird bio, will present a corporate update at the 42nd Annual J.P. Morgan Healthcare Conference on Tuesday, January 9, 2024, at 10:30am PT/1:30pm ET.

$BLUE
https://x.com/hannahadad8890/status/1738151403640508421?s=61

What's that about BLUE?

Oh boy

"In connection with the approval of LYFGENIA, we did not receive a Rare Pediatric Disease Priority Review Voucher that we requested as part of the FDA’s review. We are evaluating the FDA’s denial and plan to dispute this decision with the FDA."

https://ih.advfn.com/stock-market/NASDAQ/bluebird-bio-BLUE/stock-news/92864211/form-424b5-prospectus-rule-424b5

That's one interpretation, for sure.

There should have been an adcom meeting. This has been one hell of a hit job by the FDA, from the scheduling and early announcement for Lyfgenia, all the way back to the fall of '21.

IMO, the FTC should be examining anti-trust action against the FDA.

What this pricing says, is that Goldman/JPM could NOT get their clients interested unless a 50% haircut from the Closing price ($3ish) beginning of week!! Brutal!! But bought some now @ $1.40preM and will step in post open!

I understand giving a discount to sell shares, but 40% is quite steep.

Things like that keep people away from the market.

After getting burned a couple of times in bio, I basically refuse to hold overnight.

I trade to generate an income and the possibility of a 40% haircut is real.

Crap like this dissuades people from getting involved.

And if you get stung, you can't trade for a few days/weeks as you try to force back to even. (Revenge trading)

bluebird bio, Inc. (Nasdaq: BLUE) ("bluebird") today announced the pricing of its underwritten public offering of 83,333,333 shares of its common stock at a public offering price of $1.50 per share, before deducting underwriting discounts and commissions. bluebird also granted the underwriters a 30-day option to purchase up to an additional 12,499,999 shares of its common stock at the public offering price per share, less underwriting discounts and commissions. The gross proceeds from the public offering are expected be $125 million, before deducting underwriting discounts and commissions and offering expenses payable by bluebird and assuming no exercise of the underwriters' option to purchase additional shares of common stock. All shares in the offering are to be sold by bluebird.

Goldman Sachs & Co. LLC and J.P. Morgan Securities LLC are acting as joint book running managers for the offering. Raymond James & Associates, Inc. is acting as co-manager for the offering.

bluebird intends to use the net proceeds of the offering (i) to support commercialization and manufacturing for its three approved gene therapies, ZYNTEGLO, SKYSONA and LYFGENIA; and (ii) to fund working capital and other general corporate purposes.

The offering is expected to close on or about December 22, 2023, subject to customary closing conditions.

The

BLUE new 52 week low

Giddy Up! Let the fireworks begin:

bluebird bio, Inc. (Nasdaq: BLUE) (“bluebird”) today announced that it has commenced an underwritten public offering of $150,000,000 of shares of its common stock. bluebird also intends to grant the underwriters a 30-day option to purchase up to an additional $22,500,000 of shares of its common stock to be sold in the offering. The offering, actual size and terms are subject to market conditions, and there can be no assurance as to whether or when the offering may be completed. All shares in the offering are to be sold by bluebird.

Goldman Sachs & Co. LLC and J.P. Morgan Securities LLC are acting as joint book running managers for the offering. Raymond James & Associates, Inc. is acting as co-manager for the offering.

Oh, of course.

It'll moon out someday, I'm not worried about any of that.

Let’s just be ready for the next positive PR, and bump in SP , followed by rai$e( which btw isn’t a total bummer, and we have all seen this event be short lived dilution) BUT if a ‘tight’ Syndicate, a parabolic rally post close:) GLTA

8k out
"Following the FDA approval of LYFGENIA on December 8, 2023 for sickle cell disease in patients 12 and older with a history of vaso-occlusive
events, bluebird bio, Inc. (the “Company”) has signed an outcomes-based agreement with an organization representing approximately 100 million covered
lives in the U.S. Additionally, the Company is in advanced discussions with a number of the nation’s other large commercial payers and more than 15
Medicaid agencies collectively representing 80% of individuals with sickle cell disease in the U.S. The Company anticipates 85 to 105 patient starts (cell
collections) combined across all three of its commercial products (LYFGENIA, ZYNTEGLO, SKYSONA) in 2024."

https://investor.bluebirdbio.com/static-files/a9da7005-b393-4e1b-bf28-71850b6a47a8

80% is ...wow.

"several more to go"

Say what?

Early Barchart 100
https://www.barchart.com/stocks/performance/percent-change/advances?timeFrame=today&viewName=main&screener=overall&orderBy=percentChange&orderDir=desc

One down, several more to go!

Item 7.01
Regulation FD Disclosure.


Following the FDA approval of LYFGENIA on December 8, 2023 for sickle cell disease in patients 12 and older with a history of vaso-occlusive events, bluebird bio, Inc. (the “Company”) has signed an outcomes-based agreement with an organization representing approximately 100 million covered lives in the U.S. Additionally, the Company is in advanced discussions with a number of the nation’s other large commercial payers and more than 15 Medicaid agencies collectively representing 80% of individuals with sickle cell disease in the U.S. The Company anticipates 85 to 105 patient starts (cell collections) combined across all three of its commercial products (LYFGENIA, ZYNTEGLO, SKYSONA) in 2024.

Bluebird Bio Said Anticipates 85 To 105 Patient Starts Combined Across All Three Of Its Commercial Products In 2024…

Thanks, guess that's it then about the PRV. Disappointing for sure,but BLUE will do okay even without. Let's hope there will be breakthroughs on the Insurance cover or treatment pricing.

Spot on Moose, no PRV because of same ‘active ingredient’…I received a message from a Highly Respected poster and he replied back to my same question:

DewDiligence
Member Level
Re: stocksrising post# 250000
Saturday, 12/09/2023 5:38:10 PM
BLUE didn’t get a priority-review voucher for FDA approval of Lyfgenia because the FDA deemed that the “active ingredient” in Lyfgenia is the same as in BLUE’s Zynteglo, which was approved in 2022 for beta thalassemia (#msg-169711368).

This is a seemingly odd interpretation by the FDA of the term, “active ingredient,” but the FDA is given broad discretion by the legal system in these kinds of decisions