stocksrising
4週前
And follow up data for Sickle Cell as well:
bluebird bio Presents Positive Long-Term Data On LYFGENIA™ (lovotobegligene autotemcel) Gene Therapy for Sickle Cell Disease at 66th American Society of Hematology (ASH) Annual Meeting and Exposition
December 08 2024 - 12:30PM
Stable production of anti-sickling adult hemoglobin (HBAT87Q) and elimination or significant reduction of vaso-occlusive events sustained through last follow-up for all evaluable patients (n=38), underscoring potentially transformative and durable clinical impact
Results from first and only focused analysis of patients with sickle cell disease with a history of overt or silent stroke (n=27) show no stroke recurrence through 9 years of follow-up (n=2)
bluebird bio, Inc. (Nasdaq: BLUE) today announced new and updated data from LYFGENIA™ (lovotobegligene autotemcel, or lovo-cel) gene therapy for patients with sickle cell disease who have a history of vaso-occlusive events (VOEs). The data will be presented at the 66th American Society of Hematology (ASH) Annual Meeting and Exposition in an oral presentation on Sunday, December 8 at 9:30 a.m. Pacific Time and a poster presentation on Sunday, December 8 at 6 p.m. Pacific Time. As of July 2024, 70 patients were treated across the full lovo-cel clinical development program, with follow-up beyond 9 years in the earliest treated patients.
https://ih.advfn.com/p.php?pid=nmona&article=95055524&_gl=1*re3woq*_gcl_au*ODQyNDIxNDQ1LjE3MjY0MjkyNjk.
georgie18
1月前
BLUE...6832...HOD...🥳SOMERVILLE, Mass.--(BUSINESS WIRE)--bluebird bio, Inc. (NASDAQ: BLUE) (“bluebird bio”) today announced it has reached an agreement with the Center for Medicare and Medicaid Innovation to offer an outcomes-based agreement for LYFGENIA gene therapy under the Cell and Gene Therapy (CGT) Access Model. LYFGENIA is a one-time gene therapy approved for the treatment of patients 12 years of age and older with sickle cell disease and a history of vaso-occlusive events (VOEs).
“Ensuring timely, equitable access to gene therapy for people living with sickle cell disease insured through Medicaid has been a cornerstone of our commercial approach since approval, and we are pleased to build on this commitment by offering an outcomes-based agreement to state Medicaid agencies through the Cell and Gene Therapy Access Model,” said Tom Klima, Chief Commercial & Operating Officer at bluebird bio. “We are also pleased to be able to offer fertility preservation support to eligible patients insured by Medicaid in states that opt into the Model, as we recognize these services address an important potential barrier to access.”
Participation in the CGT Access Model builds on bluebird’s established leadership in developing and implementing innovative outcomes-based agreements and has the potential to further strengthen the coverage landscape for LYFGENIA. To date, more than half of all states have affirmed coverage for LYFGENIA through Preferred Drug Lists or published coverage policies, and over 50% of Medicaid-insured individuals with sickle cell disease in the U.S. live in a state that has approved at least one prior authorization for LYFGENIA.
bluebird currently offers two outcomes-based agreements for LYFGENIA to State Medicaid Agencies, and the CGT Access Model may be a bandwidth extender for states that are unable to implement outcomes-based agreements on their own or in a timely fashion. bluebird’s offering through the CGT Access Model is rooted in its validated principles of meaningful risk sharing for payers, and tying performance to clinically meaningful outcomes that are easily tracked through established data sources over a defined period of time.
The model will enroll patients for a period of 6 years and individual patients will be followed for 5 years to track performance-related outcomes. Participation in the CGT Access Model is voluntary and open to all states that participate in the Medicaid Drug Rebate Program (MDRP). With key terms in place, states have until February 28, 2025 to opt-in to participate and states may begin participation in the Model between January 2025 and January 2026.
BLUE ...6469...Volume...🥳
georgie18
Member Level
Re: None
Wednesday, December 04, 2024 3:40:50 PM
Post#
386447
of 386450
BLUE...5164...Open Gap filled at .57...🥳
georgie18
Member Level
Re: georgie18 post# 505
Monday, September 30, 2024 9:55:35 AM
Post#
511
of 540
BLUE...5368...Like to see the Open Gap filled in the .57 range...🥳
georgie18
Member Level
Re: georgie18 post# 496
Friday, September 27, 2024 5:29:48 PM
Post#
505
of 510
BLUE...50...🥳...September 27, 2024 04:30 PM Eastern Daylight Time
SOMERVILLE, Mass.--(BUSINESS WIRE)--bluebird bio, Inc. (Nasdaq: BLUE) today announced that it has completed the filing of its Form 10-Q for the quarter ended June 30, 2024 (the “Q2 2024 Form 10-Q”) with the Securities and Exchange Commission (“SEC”).
With the completion of this filing, the Company is now current in its SEC periodic reporting obligations.
georgie18
1月前
BLUE ...6469...Volume...🥳
georgie18
Member Level
Re: None
Wednesday, December 04, 2024 3:40:50 PM
Post#
386447
of 386450
BLUE...5164...Open Gap filled at .57...🥳
georgie18
Member Level
Re: georgie18 post# 505
Monday, September 30, 2024 9:55:35 AM
Post#
511
of 540
BLUE...5368...Like to see the Open Gap filled in the .57 range...🥳
georgie18
Member Level
Re: georgie18 post# 496
Friday, September 27, 2024 5:29:48 PM
Post#
505
of 510
BLUE...50...🥳...September 27, 2024 04:30 PM Eastern Daylight Time
SOMERVILLE, Mass.--(BUSINESS WIRE)--bluebird bio, Inc. (Nasdaq: BLUE) today announced that it has completed the filing of its Form 10-Q for the quarter ended June 30, 2024 (the “Q2 2024 Form 10-Q”) with the Securities and Exchange Commission (“SEC”).
With the completion of this filing, the Company is now current in its SEC periodic reporting obligations.
georgie18
1月前
BLUE...5164...Open Gap filled at .57...🥳
georgie18
Member Level
Re: georgie18 post# 505
Monday, September 30, 2024 9:55:35 AM
Post#
511
of 540
BLUE...5368...Like to see the Open Gap filled in the .57 range...🥳
georgie18
Member Level
Re: georgie18 post# 496
Friday, September 27, 2024 5:29:48 PM
Post#
505
of 510
BLUE...50...🥳...September 27, 2024 04:30 PM Eastern Daylight Time
SOMERVILLE, Mass.--(BUSINESS WIRE)--bluebird bio, Inc. (Nasdaq: BLUE) today announced that it has completed the filing of its Form 10-Q for the quarter ended June 30, 2024 (the “Q2 2024 Form 10-Q”) with the Securities and Exchange Commission (“SEC”).
With the completion of this filing, the Company is now current in its SEC periodic reporting obligations.
Moose412
2月前
[Based on the votes cast prior to the adjournment and the approval of Proposal 7, the Company elected to adjourn the Annual Meeting with respect to the proposal to approve amendments to the Certificate of Incorporation to effect a reverse stock split of the Company’s common stock at a ratio ranging from any whole number between 1-for-15 and 1-for-20, as determined by the Board in its discretion (“Proposal 4”), in order to permit the Company to allow for the solicitation of additional proxies to approve Proposal 4. The Annual Meeting will reconvene on Wednesday, December 4, 2024 at 8:30 a.m., Eastern Time, at the Company’s offices at 455 Grand Union Boulevard, Somerville, MA 02145.]
https://ih.advfn.com/stock-market/NASDAQ/bluebird-bio-BLUE/stock-news/94854006/form-8-k-current-report
[Proposal 3 was not approved by the requisite vote of the Company's stockholders. The voting results were as follows:
Votes For Votes Against Abstentions Broker Non-Votes
45,628,050 28,241,869 1,082,543 53,804,436]
stocksrising
2月前
Having just read and spoke to proxy solicitors, I believe Blue is having problems with 1:20 rs…
I recommended they amend Prop 4 to vote 1:10 and many of us would Approve..let’s see what happens ….
November 1, 2024
Fellow Stockholder:
bluebird bio, Inc!'s Annual Meeting of Stockholders is quickly approaching on November 6, 2024. We urge you to vote in favor of all the proposals on the ballot, and in particular, Proposal 4 related to the reverse stock split, which is critical to restoring stockholder value and the Company's future.
bluebird's gene therapies provide transformative - and even potentially curative - benefits to patients, but today, due to our current stock price we are at risk of being de-listed from Nasdaq. In addition, further capital is required in the near term to reach our expected breakeven point in the second half of next year.
A vote FOR Proposal 4 would enable us to regain compliance with Nasdaq's minimum bid price requirement and avoid delisting. It would also increase the number of shares on a relative basis that the Company is authorized to issue, a necessary step to enable us to raise additional capital to extend our cash runway.
ISS and Glass Lewis, independent proxy advisory firms to thousands of institutional stockholders and pension funds, recognize these issues and have both recommended in favor of the reverse stock split in Proposal 4.
If you have not voted, please vote today FOR Proposal 4. If you already voted against Proposal 4, we ask that you please reconsider.
Moose412
2月前
I hear ya, but here's the deal: when BLUE trades, it trades. The real sharks bank on wash sale resolution through the power of Biotechnology volatility. A RS appears bad - but the stability it will bring, including stopping out wash sale resolutions, will bring the true value out, IMO.
Never invest what you can't afford to lose. There's a valid reason this isn't dropping farther. To that end, any prospective talent won't be scared away from employment by the possibility of seasoned BLUE employees facing culpability for whatever criminal actions they've engaged in, if any. Personally, I don't think BLUE management is guilty of anything beyond hubris and true belief in their technology. To that end, I share the belief.
stocksrising
2月前
Voted AGAINST ALL proposals except E&Y auditors!!! If C-Ste doesn’t get enough votes for #’s 4&5, it’s because clocking back by factor of 20 is ridiculous!!! Yes, they say lower band, but they will dilute the shit out of us long term holders!!!
If they amend to 1:10, I’ll vote FOR because a raise is needed by year end!! It baffles me why they can’t/wont find a JV to offer capital/royalities/etc..????
I want them to survive, because to get 3 FDA approved drugs is tremendous, but expenditures will crush if overly excessive ( they finally cut head count, but management should take pay hit and offer shares(RSA) at a premium to post split price in lieu of)…GLTA
Moose412
2月前
10.25.2024: DefA14A, urging stake holders to voted FOR Proposals 4 and 5, the RS and Incentive plan. I voted NO on Proposal 3, which adopts EXCULPATION to attract talent, but also holds this sentence: [Certain of our officers would stand to benefit if Proposal 3 is adopted, as it could reduce their potential monetary liability for certain breaches of fiduciary duties.]
It is time for BLUEBIRD management to have actual ownership. This ship burns or sails, it's a big swing.
That all being said, projection of break-even for mid-2025 is dependent upon 40 drug sales per quarter, but is not detailed to be for the first quarter or first two quarters of the year - I would like to think that it is limited to 40 sales in the first quarter, which would still be terribly impressive.
Go Bluebird. The value is here, IMO.
jondoeuk
3月前
From the paper: ''Hematologic cancer developed in a subgroup of patients who were treated with eli-cel; the cases are associated with clonal vector insertions within oncogenes and clonal evolution with acquisition of somatic genetic defects.'' https://www.nejm.org/doi/full/10.1056/NEJMoa2405541
Myeloablative conditioning also leads to a higher risk of certain cancers and can cause infertility.
Lyfgenia is the value driver for the company, but uses a viral vector, has a boxed warning, and costs more than Casgevy*.
On top of this, there is little cash (and needed raise), a R/S on the cards, patent/IP issues and more.
* CRSP and VRTX are working on ways to overcome the need for myeloablative conditioning.
Moose412
3月前
Details are important. One might even say RELEVANT. The following paragraph, from the article in the post this comment is responding to, details that 5 of those 7 are fine, 1 of the seven is awaiting the treatment that those 5 received, and the 7th died from complications that had absolutely NOTHING to do with a developed blood cancer.
[Of the patients who developed hematologic cancers, five with MDS underwent allogeneic HSCT, and four remain free of MDS without recurrence of symptoms of CALD, and one died from presumed graft-versus-host disease 20 months after transplant and 49 months after receiving eli-cel. The patient with the most recent case of MDS is awaiting HSCT.
The patient with AML is alive and had full donor chimerism after HSCT.]
stocksrising
3月前
Sorry to break in on your reply, but if poster is talking bout Blue, they do have an ‘ATM’ available but don’t think they are utilizing*( as of Q2 period end)
In August 2023, the Company entered into an Open Market Sales Agreement (the "Sales Agreement") with Jefferies LLC ("Jefferies") to sell shares of the Company's common stock up to $125.0 million, from time to time, through an "at the market" equity offering program under which Jefferies will act as sales agent. As of June 30, 2024, the Company has made no sales pursuant to the Sales Agreement.
On December 19, 2023, the Company entered into an underwriting agreement (the "December Underwriting Agreement") with Goldman and J.P. Morgan Securities LLC, in connection with the public offering, issuance, and sale by the Company of 83.3 million shares of the Company's common stock at a public offering price of $1.50 per share, less underwriting discounts and commissions, pursuant to an effective shelf registration statement on Form S-3 and a related prospectus supplement filed with the Securities and Exchange Commission. Under the terms of the December Underwriting Agreement, the Company also granted the underwriters an option exercisable for 30 days to purchase up to an additional 12.5 million shares of common stock at the public offering price, less underwriting discounts and commissions, which option was not exercised. The offering closed on December 22, 2023. The Company received aggregate net proceeds of $118.1 million.
12. Stock-based compensation
In June 2023, the Company's stockholders approved the bluebird bio, Inc. 2023 Incentive Award Plan (the "2023 Plan"), which replaced the 2013 Stock Option and Incentive Plan ("2013 Plan"). Following approval of the 2023 Plan, no further awards will be granted under the 2013 Plan. As of June 30, 2024, the total number of shares of common stock available for issuance under the 2023 Plan was approximately 2.7 million.
georgie18
3月前
BLUE...5368...Like to see the Open Gap filled in the .57 range...🥳
georgie18
Member Level
Re: georgie18 post# 496
Friday, September 27, 2024 5:29:48 PM
Post#
505
of 510
BLUE...50...🥳...September 27, 2024 04:30 PM Eastern Daylight Time
SOMERVILLE, Mass.--(BUSINESS WIRE)--bluebird bio, Inc. (Nasdaq: BLUE) today announced that it has completed the filing of its Form 10-Q for the quarter ended June 30, 2024 (the “Q2 2024 Form 10-Q”) with the Securities and Exchange Commission (“SEC”).
With the completion of this filing, the Company is now current in its SEC periodic reporting obligations.
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