Bluebird Bio Inc (BLUE)

[stocksrising]

Adam F confirmed what/why sell off


$VRTX $CRSP Casgevy $2.2 million, no black box.

$BLUE Lyfengia $3.1 million, black box.

Bluebird will have to lower its price, right? How can it not?

Also, Bluebird confirmed to us that it DID NOT get a pediatric rare disease voucher for this approval.

Recall, the company had presold the voucher for $100M, assuming it would get one.

[stocksrising]

Yes!!!! GLTA

Bluebird bio has won U.S. Food and Drug Administration approval of its Lyfgenia gene therapy for sickle-cell disease, making it one the first two cell-based gene therapies to win a U.S. green light for the inherited blood disorder.

The FDA on Friday said the approval covers Lyfgenia for the treatment of patients 12 years of age and older with sickle-cell disease and a history of vaso-occlusive events.

The FDA nod, nearly two weeks ahead of the target action date of Dec. 20, comes on the same day the agency cleared the Casgevy gene-therapy from CRISPR Therapeutics and Vertex Pharmaceuticals, marking the first U.S. approval for a drug using the gene-editing technology known as Crispr.

[murocman]

Approved!

[Monksdream]

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

[Golden Cross]

Think it will get that $7 target very soon

[stocksrising]

Morgan Stanley Upgrades
Bluebird Bio to Equalweight From Underweight, Boosts Price Target to $7 From $3

[Golden Cross]

Nice..

[stocksrising]

As end of Q3 —-
Ended quarter with $227M in cash, cash equivalents, marketable securities and restricted cash –But they do burn, so for sure Cap raise in Q1, 2024 ( mgmt said the same)

[Golden Cross]

Really liking $BLUE here... Believe they have $171.0M. cash...

[stocksrising]

From your lips to market Gods ears 🙏
In excess of 100k shares in various accts!! $1mm value by e.o.m sets up a very Merry Happy New Year!! :) GLTA

[Moose412]

Approval will be had, making the run 3/3. The big breaker will be pricing reveal and contrast against whatever CRSPR/Vertex do. I'm anticipating $10 by end of month/year. My conviction is even more so given that practically nobody is talking about Blue. Absolutely my biggest position ever, value wise. IMO, Blue will never see $3.50 again, let lone the 2s!

[stocksrising]

Yes, either double digit run with Approval or back into 2-3’s or less!! Fingers crossed, 2nd biggest position after RVNC & TARA ;)

[Golden Cross]

Dec 20th Big date here $BLUE

[stocksrising]

bluebird bio to Present New and Updated Data from Gene Therapy Programs in Sickle Cell Disease and Beta-Thalassemia at the 65th American Society of Hematology (ASH) Annual Meeting and Exposition
Mentioned: BLUE
--Updated long-term efficacy, safety, quality of life data and iron management outcomes from adult and pediatric patients with transfusion-dependent beta-thalassemia (n=63) treated with beti-cel through 9 years of follow-up (n=1) will be delivered in two poster presentations

bluebird bio, Inc. (Nasdaq: BLUE) today announced that new long-term efficacy, safety and health-related quality of life (HRQoL) follow-up data from its lentiviral vector (LVV) gene therapy programs in patients with sickle cell disease who have a history of vaso-occlusive events and patients with beta-thalassemia who require regular red blood cell transfusions will be presented at the 65th American Society of Hematology (ASH) Annual Meeting and Exposition. The meeting will take place December 9-12, 2023 at the San Diego Convention Center and online.

[stocksrising]

Good guess , but history shows this company burns cash, and ~$103mm could help if approved…they will still come to market for raise, but hopefully at higher levels, especially if Sickle Cell approved..

FYI:
FDA panel greenlights approval of first human drug using CRISPR

Food and Drug Administration (FDA) advisers cleared the way for the first FDA approval of a human drug using CRISPR technology.

The news: FDA’s Cellular, Tissue, and Gene Therapies Advisory Committee said exa-cel, the sickle cell gene therapy developed by BIO members Vertex Pharmaceuticals and CRISPR Therapeutics, is safe for clinical use.

[Moose412]

Been quite the sell-off, as you predicted. But with yesterday's 8-K w the pre-sale of the PRV, this is looking really nice.

[Monksdream]

[Monksdream]

BLUE trying to break the $4 resistance

[Moose412]

And IT is in! Edit: Going back to review, other notices like this I received in April 4th for two other tickers, and noticed there was the same notice from April 4 23 for BLUE. Still bullish AF!

[The maintenance requirement for your holding below has changed. This may increase or decrease your available purchasing power.

Account: XXXX-ZZZZ
Holding Ticker Symbol: BLUE
Holding Description: BLUEBIRD BIO INC COM
New requirement: 100%
Old requirement: 25%]

[Moose412]

Bear raid over soon, me thinks.

[stocksrising]

2 approved Drugs, Priority review and Pdufa date in Q4 on Sickle Cell, and this pig can’t move out of the sloppp!! Wtf

Prob sold off bcuz Auth. shares doubling and near term Capital raise again!! Dilution should be in its corporate name!! Certainly in its DNA

[Moose412]

Crazy action today. Waiting patiently for a brokerage notice about margin requirements for BLUE.

[Moose412]

Continuously.

[stocksrising]

Bear Raid!

[stocksrising]

If we can get this PR , should move high single digits.. then sell off on Capital raise, then double digits!! Otherwise, down she goes to $2-3ish!


• The Company anticipates BLA acceptance of lovo-cel for SCD in Q2 2023.

[Moose412]

I expect *new* news soon.

[stocksrising]

8K filing couple days ago showing $350mm shelf dinging ticker

[Moose412]

That's a pretty nice 10Q and a terribly sweet 8k today.

https://app.quotemedia.com/data/downloadFiling?webmasterId=90423&ref=317472177&type=HTML&symbol=BLUE&cdn=49eb2e78599a3f8993e1dbd77103d6c4&companyName=bluebird+bio+Inc.&formType=10-Q&formDescription=General+form+for+quarterly+reports+under+Section+13+or+15%28d%29&dateFiled=2023-05-09


https://app.quotemedia.com/data/downloadFiling?webmasterId=90423&ref=317472175&type=PDF&symbol=BLUE&cdn=a27bb9bb8a132409a5d38d92346a9d24&companyName=bluebird+bio+Inc.&formType=8-K&formDescription=Current+report+pursuant+to+Section+13+or+15%28d%29&dateFiled=2023-05-09

["The first quarter of 2023 saw us continue to establish and scale the commercial model for ex-vivo gene therapy in the US through the
launches of ZYNTEGLO and SKYSONA and lay the foundation for revenue generation for years to come for bluebird," said Andrew
Obenshain, chief executive officer, bluebird bio. "Additionally, with the submission of the lovo-cel BLA for sickle cell disease in April,
bluebird has taken a pivotal step towards realizing its most significant opportunity yet -- bringing a transformative gene therapy to
individuals living with sickle cell disease."]

[Moose412]

I have a similar position - 98,050 in the high $4 avg., from $3 -$7.6x.

BLUE will be 3/3. Patience.

[stocksrising]

FYI

bluebird bio Submits Biologics License Application (BLA) to FDA for lovotibeglogene autotemcel (lovo-cel) for Patients with Sickle Cell Disease (SCD) 12 years and Older with a History of Vaso-Occlusive Events.

The severity of sickle cell disease, and its impact on patients and caregivers, has been underappreciated and overlooked for far too long. Transformative therapies for this community are long overdue," said Andrew Obenshain, chief executive officer, bluebird bio. "We are pleased to have satisfied the Agency's questions about comparability to enable our BLA submission, and to take this important step toward making lovo-cel available for individuals living with SCD."

Lovo-cel is the most deeply studied gene therapy in development for sickle cell disease. The BLA submission is based on efficacy results from 36 patients in the HGB-206 Group C cohort with a median 32 months of follow-up and two patients in the HGB-210 study with 18 months of follow-up each. The BLA submission also includes safety data from 50 patients treated across the entire lovo-cel program, including six patients with six or more years of follow-up.

The FDA previously granted lovo-cel orphan drug designation, fast track designation, regenerative medicine advanced therapy (RMAT) designation, and rare pediatric disease designation for the treatment of SCD.
Plus a new 13g filing last week :)

[stocksrising]

Here is an example from a few accounts that hold Blue( cant show all, don’t need certain peeps to see, lol but it adds up to ~100k :)

Total value
Shares owned
Average cost
Today's gain/loss
$154,800.00
45,000.000
$5.59
+$3,600.00 (+2.38%)


Shares owned
Average cost
$17,200.00
5,000.000
$4.50

[Moose412]

You picked up 90k shares since September?

[stocksrising]

I have ~100,000 reasons why I’m hoping
So! Lol :)

[Moose412]

I fully believe it will be 3 for 3.

[stocksrising]

Either kevin Tang buying more,
Or these tards are close to Application approval…we shall see soon

[scotsand]

She be chirping

[stocksrising]

Maybe we woke the bird up? Lol

[stocksrising]

CEO a clown, as are all the C-suite’s at Blue! Wish I had a redo, aka Mulligan!! Dumped so Much $$$ in this pig( and friends / family)!!

[Moose412]

This walk-down has been just amazing. For all the hype on manipulation and BKcy, I'm really surprised this doesn't have more attention.

[stocksrising]

Yep, they’ll be fine for a bit, but cash burn high with launch(s).. All good, Sickle cell goes thru, $30’s…funny, I posted (#225 day before offering and used ~100mm share count , lol ..

[Moose412]

I'm not worried about anything regarding BLUE. The June 22 offering sold roughly 10-12m of 17-18 mil offered. I might have to drop some deep green for liquidity, but I'd rather not! I'd like to see BLUE at 100m O/S, makes the math easy.

This is a very short-term offering. It will be interesting.

[stocksrising]

Dilution always hurts , Temporarily…unless they blow the $$$ on their own salaries! So now their balance sheet is stronger, meaning runway prob until mid-2024…picked up a bunch in the $6’s, shooting for $8-9 soon as Mr. Market settles..

[Moose412]

And...it's $6.00.

https://www.nasdaq.com/articles/bluebird-bio-prices-public-offering-of-20-mln-shares-at-%246.00-shr

[Moose412]

"We are offering 20,000,000 shares of our common stock."

https://www.otcmarkets.com/filing/html?id=16319489&guid=Mxs-kH0-h3EaKLh

Guess that kill Jan 20 Calls. Lol.

Although it looks like the offering from earlier this year only sold 2/3 @ 4.16.

https://www.otcmarkets.com/filing/html?id=15906129&guid=Mxs-kH0-h3EaKLh

[stocksrising]

This ticker is never easy to understand price movement and Valuation but I adding anyway! Someday a takeout in the 30’s (~$3b cap)..

[LexTrader]

Great news today! (8>)

[Moose412]

Gobble gobble - Better early than late.

[Moose412]

Just gen market dip, IMO. This 4th qtr (pending) announcement is going to establish a new base-level going into 2023.

[stocksrising]

Lots of action today,
Hmmm

[scotsand]

Looking strong