Current Report Filing (8-k)
30 Giugno 2023 - 12:08PM
Edgar (US Regulatory)
0001597264
false
0001597264
2023-06-30
2023-06-30
iso4217:USD
xbrli:shares
iso4217:USD
xbrli:shares
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 8-K
CURRENT REPORT
Pursuant to Section 13 or 15(d)
of the Securities Exchange Act of 1934
Date of Report (Date of Earliest Event
Reported): June 30, 2023
Blueprint Medicines Corporation
(Exact name of registrant as specified in its charter)
Delaware |
|
001-37359 |
|
26-3632015 |
(State or other jurisdiction
of incorporation) |
|
(Commission File Number) |
|
(I.R.S. Employer
Identification No.) |
45 Sidney Street
Cambridge, Massachusetts |
|
02139 |
(Address of principal executive offices) |
|
(Zip Code) |
Registrant’s telephone
number, including area code: (617) 374-7580
(Former name or former address,
if changed since last report)
Check the appropriate box below if the Form 8-K
filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:
|
¨ | Written communications pursuant to Rule 425 under the
Securities Act (17 CFR 230.425) |
|
¨ | Soliciting material pursuant to Rule 14a-12 under the
Exchange Act (17 CFR 240.14a-12) |
|
¨ | Pre-commencement communications pursuant to Rule 14d-2(b) under
the Exchange Act (17 CFR 240.14d-2(b)) |
|
¨ | Pre-commencement communications pursuant to Rule 13e-4(c) under
the Exchange Act (17 CFR 240.13e-4(c)) |
Indicate by check mark whether the registrant is
an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2
of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).
Emerging growth
company ¨
If an emerging growth
company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or
revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act.
Securities registered pursuant to Section 12(b) of
the Exchange Act:
Title of each class |
Trading symbol(s) |
Name
of each exchange on which
registered |
Common stock, par value $0.001 per share |
BPMC |
Nasdaq Global Select Market |
Genentech, Inc. (“Genentech”),
a member of the Roche Group, today announced the voluntary withdrawal of the U.S. indication of GAVRETO® (pralsetinib) for the treatment
of adult and pediatric patients 12 years of age and older with advanced or metastatic rearranged during transfection (RET)-mutant medullary
thyroid cancer (“MTC”) who require systemic therapy. Genentech stated that its decision to withdraw the indication is not
due to any new safety or efficacy data for GAVRETO or a product safety or quality issue, and other approved indications for GAVRETO in
the United States are unaffected. Under Blueprint Medicines Corporation’s (the “Company,” “our” or “we”)
collaboration, Genentech remains the New Drug Application sponsor in the United States.
This decision was made
in consultation with the U.S. Food and Drug Administration (“FDA”), in accordance with the requirements of the FDA’s
Accelerated Approval Program. Specifically, AcceleRET-MTC, a Phase III clinical trial required by the FDA to convert the accelerated approval
of GAVRETO for MTC to a full approval, will no longer be pursued due to feasibility. The confirmatory studies to meet the commitments
required to convert the remaining indications for GAVRETO, also approved under accelerated approval, to full approval, are ongoing.
Genentech has previously
disclosed that the MTC indication contributes a small fraction of its annual GAVRETO revenues in the United States. The Company anticipates
that this decision will have no impact to its 2023 collaboration revenue guidance of $40 to $50 million. In February 2023, Roche provided
written notification of their decision to terminate the collaboration agreement, which will become effective in February 2024.
The Company, in partnership
with Genentech, remains committed to supporting appropriate treatment continuity for MTC patients in the United States who are currently
treated with GAVRETO, and to supporting patients and healthcare practitioners navigate the near-term impacts of this update.
SIGNATURES
Pursuant to the requirements of the Securities
Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
|
BLUEPRINT MEDICINES CORPORATION |
|
|
Date: June 30, 2023 |
By: |
/s/ Kathryn Haviland |
|
|
Kathryn Haviland |
|
|
Chief Executive Officer |
Grafico Azioni Blueprint Medicines (NASDAQ:BPMC)
Storico
Da Mag 2024 a Giu 2024
Grafico Azioni Blueprint Medicines (NASDAQ:BPMC)
Storico
Da Giu 2023 a Giu 2024