Form 6-K GSK plc For: Jun 09
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UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
Form 6-K
REPORT OF FOREIGN PRIVATE ISSUER PURSUANT TO RULE 13a-16 OR
15d-16
UNDER THE SECURITIES EXCHANGE ACT OF 1934
For the
month of June 2026
Commission
File Number 001-15170
GSK plc
(Translation
of registrant's name into English)
79 New Oxford Street, London, WC1A 1DG
(Address
of principal executive office)
Indicate
by check mark whether the registrant files or will file annual
reports under cover of Form 20-F or Form 40-F.
Form
20-F . . . .X. . . . Form 40-F . . . . . . . .
Issued: 9 June 2026, London UK
GSK enters agreement to acquire Nuvalent, Inc.
●
Multi-product
oncology deal for assets that have validated targets and aim to
address efficacy and/or tolerability limitations of existing
therapies
●
Includes two late-stage,
potential best-in-class ROS1 (zidesamtinib) and
ALK (neladalkib)
inhibitors for non-small cell lung cancer (NSCLC), currently under
US FDA review for 2026 approvals
●
Accelerates
entry into lung cancer, providing a platform for expansion with
Ris-Rez, GSK's B7-H3 antibody-drug conjugate (ADC)
●
Acquisition
expected to be accretive to sales and core operating profit in 2027
and core EPS in 2029 inclusive of synergies and
reprioritisation
GSK plc (LSE/NYSE: GSK) today announced that it has entered an
agreement to acquire Nuvalent, Inc. ("Nuvalent") (NASDAQ: NUVL) a
Boston-based clinical-stage biopharmaceutical company focused on
creating precisely targeted oncology therapies, for $10.6 billion.
The acquisition is consistent with GSK's strategy of acquiring
assets that have validated targets and meaningfully address
efficacy and/or tolerability limitations of existing
standard-of-care therapies. It includes three products in lung
cancer in a single transaction.
Zidesamtinib (NVL-520) and neladalkib (NVL-655) are two late-stage,
potential best-in-class, next-generation, highly selective ROS1 and
ALK inhibitors for treatment of NSCLC. Both assets have received
FDA Breakthrough Therapy and Orphan Drug
Designations* and
are in review with target decision dates of 18 September 2026 for
zidesamtinib and 27 November 2026 for neladalkib. Subject to FDA
approval, they are expected to launch in 2026 and have
multi-blockbuster potential. The third asset, NVL-330, is a
potential best-in-class HER2 inhibitor currently in phase I trials
for HER2-altered NSCLC. The acquisition also includes Nuvalent's
preclinical portfolio of multiple programmes, built from their
proven precision medicine capabilities and clinical insights from
industry-leading physician-scientists.
Luke Miels, Chief Executive Officer, GSK said: "Today's
acquisition is a multi-product deal, consistent with our approach
to acquire assets that have clinically proven targets and
meaningfully address an efficacy and/or tolerability gap. The two
lead products are potential best-in-class assets that could launch
this year if approved by the FDA and offer significant new
treatment options to patients with two forms of non-small cell lung
cancer.
The acquisition provides GSK with immediate new sales growth
opportunities, improving profit contributions from 2027, and a
platform in lung cancer for rapid expansion with Ris-Rez, our B7-H3
targeted ADC in phase III clinical development."
Pivotal data presented at the IASLC 2025 World Conference on Lung
Cancer and the 2026 ASCO Annual Meeting show potential
best-in-class profiles for zidesamtinib and
neladalkib.1,2 Both
assets aim for longer effective treatment with better quality of
life through high target-selectivity, durable treatment response,
improved tolerability, enhanced blood-brain barrier penetration for
tumour spread, and broader coverage of ALK and ROS1 mutations,
potentially addressing efficacy and/or tolerability
limitations of existing therapies. ROS1- and ALK-altered NSCLC
primarily affect non-smoking adults aged 40-50, a uniquely defined
and engaged patient population. There is substantive treatment
experience with zidesamtinib and neladalkib already through their
clinical development and patient assistance
programmes.3,4
James Porter, PhD, Chief Executive Officer, Nuvalent,
said: "Since our founding, we
have leveraged our deep expertise in chemistry and structure-based
drug design to develop a portfolio of novel, potentially
best-in-class kinase inhibitors. Our close collaboration with
leading physician-scientists and patient advocates has driven
remarkable enrolment, accelerating development and building
confidence in the clinical profile of these drugs. We're excited
that GSK has recognised the significant value these programmes can
offer patients and shares our vision for practice-changing
innovation. GSK's proven track record, infrastructure, and
expertise will support the successful commercialisation of
zidesamtinib and neladalkib, as well as accelerate advancement of
our broader discovery pipeline."
Financial considerations
Under the terms of the merger agreement, GSK will commence a tender
offer to acquire all of Nuvalent's outstanding shares of Class A
and Class B common stock at a purchase price of $124 per share in
cash within 10 business days. The aggregate equity value of the
transaction is estimated to be $10.6 billion (£8.0 billion).
Net of cash acquired, GSK's aggregate investment is estimated to be
$9.4 billion (£7.1 billion). The expected purchase price of
$124 per share represents a 40% premium to the last closing price
and a 26% premium to the 30 calendar day Volume-Weighted Average
Price (VWAP).
There is no change to GSK's 2026 full-year guidance range of 7-9%
core operating profit and core EPS growth. The acquisition is
expected to contribute to revenue growth from 2027, be incremental
to the Group's existing ambition for sales of >£40 billion
by 2031 and to strengthen core operating profit through the
dolutegravir loss of exclusivity period (2028-2030). We expect
accretion to core operating profit in 2027 and core EPS in 2029
inclusive of synergies and reprioritisation. Assuming the
transaction closes in Q3 2026, we expect low single-digit
percentage dilution to core EPS for the current year, FY 2027 and
FY 2028.
The transaction will be funded primarily from new and existing debt
facilities plus cash, with no impact expected to GSK's credit
rating. GSK will maintain a strong investment grade credit profile
and retains balance sheet capacity for further accretive business
development.
GSK remains committed to its 70p expected dividend for 2026 and to
its progressive dividend policy thereafter.
The transaction is subject to customary closing conditions,
including the tender of a majority of Nuvalent's outstanding shares
of Class A common stock in the tender offer and the expiration or
termination of the applicable waiting period under the
Hart-Scott-Rodino Act in the US. Promptly following the closing of
the tender offer, GSK expects to acquire any remaining shares of
Nuvalent through a second-step merger under Delaware law at the
same price per share.
GSK will account for the transaction as a business combination. GSK
will also assume Nuvalent's existing revenue-sharing arrangements
of low-single-digit royalties payable to Royalty Pharma and
Deerfield.
Advisors
Leerink Partners LLC and Citigroup Inc. are acting as financial
advisors and Davis Polk & Wardwell LLP and Slaughter and May
are serving as legal counsel to GSK in connection with the
transaction. Centerview Partners LLC is serving as financial
advisor and Ropes & Gray LLP is serving as legal counsel to
Nuvalent. Jefferies
LLC also provided financial advice to Nuvalent. Sidley Austin LLP
is corporate counsel to Nuvalent.
About NSCLC
NSCLC is the most common form of lung cancer and is often
characterised by specific genetic alterations, such as those in
ALK, ROS1, or HER2. It can often metastasise (i.e. spread) to the
central nervous system. It primarily affects working-age
individuals. Current treatments are associated with mutation
resistance and side effects, including metabolic and neurologic
events, that can adversely impact patients' quality of
life.
Additional information
This press announcement is for informational purposes only and is
neither an offer to purchase nor a solicitation of an offer or a
recommendation to sell securities, nor is it a substitute for the
tender offer materials that GSK plc, GlaxoSmithKline LLC ("GSK
LLC") and its wholly-owned subsidiary, Harmony Row Acquisition Co.
will file with the Securities and Exchange Commission (the "SEC").
The tender offer for the outstanding shares of Nuvalent Class A
common stock and Class B common stock described in this press
announcement has not commenced. At the time the tender offer is
commenced, GSK plc, GSK LLC and Harmony Row Acquisition Co. will
file, or will cause to be filed, a Schedule TO Tender Offer
Statement with the SEC, and, thereafter, Nuvalent will file a
Schedule 14D-9 Solicitation/Recommendation Statement with the SEC,
in each case with respect to the tender
offer. The Schedule TO Tender Offer
Statement (including an offer to purchase, a related letter of
transmittal and other offer documents) and the Schedule 14D-9
Solicitation/Recommendation Statement will contain important
information that should be read carefully before any decision is
made with respect to the tender offer. Those materials (once they become available)
will be made available to Nuvalent stockholders at no expense to
them by the information agent for the tender offer, which will be
announced. In addition, those materials and all other documents
filed by or caused to be filed by Nuvalent or GSK plc with the SEC
will be available at no charge on the SEC's website
at www.sec.gov.
In addition to the Schedule 14D-9 Solicitation/Recommendation
Statement and Schedule TO Offer Statement (once each becomes
available), Nuvalent and GSK plc file or furnish, as applicable,
annual, quarterly and current reports and other information with
the SEC. Nuvalent and GSK plc filings with the SEC are available to
the public from commercial document-retrieval services and at the
SEC's website at www.sec.gov.
About Nuvalent
Nuvalent (NASDAQ:
NUVL) is a clinical-stage biopharmaceutical company focused on
creating precisely targeted therapies for patients with cancer,
designed to overcome the limitations of existing therapies for
clinically proven kinase targets. Leveraging deep expertise in
chemistry and structure-based drug design, Nuvalent develops
innovative small molecules that have the potential to overcome
resistance, minimize adverse events, address brain metastases, and
drive more durable responses. Nuvalent is
advancing a robust pipeline with investigational candidates for
ROS1-positive, ALK-positive, and HER2-altered non-small cell lung
cancer, and multiple discovery-stage research
programs.
About GSK
GSK is a global biopharma company with a purpose to unite science,
technology, and talent to get ahead of disease together. Find out
more at www.gsk.com.
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Cautionary statement regarding forward-looking
statements
GSK plc cautions investors that any forward-looking statements or
projections made by GSK plc, including those made in this
announcement, are subject to risks and uncertainties that may cause
actual results to differ materially from those projected. Such
factors include, but are not limited to, those described in the
"Risk Factors" section in GSK plc's Annual Report on Form 20-F for
the year ended December 31, 2025, and GSK's Q1 Results for 2026.
This communication includes forward-looking statements related
to Nuvalent,
neladalkib, zidesamtinib and the acquisition of Nuvalent by
GSK plc that are subject to risks, uncertainties and other factors.
All statements other than statements of historical fact are
statements that could be deemed forward-looking statements,
including all statements regarding the intent, belief or current
expectation of Nuvalent and
members of its senior management team and can typically be
identified by words such as "believe," "expect," "estimate,"
"predict," "target," "potential," "likely," "continue," "ongoing,"
"could," "should," "intend," "may," "might," "plan," "seek,"
"anticipate," "project" and similar expressions, as well as
variations or negatives of these words. Forward-looking statements
include, without limitation, statements regarding the merger,
similar transactions, prospective performance, future plans,
events, expectations, performance, objectives and opportunities and
the outlook for Nuvalent's
business; the ability of Nuvalent to
successfully commercialize its key products, including neladalkib
and zidesamtinib; the anticipated timing of clinical data and
regulatory filings or approvals relating to products; the
possibility of favorable or unfavorable results from clinical
trials; the anticipated benefits of the acquisition; filings and
approvals relating to the transaction; the expected timing of the
completion of the transaction; the parties' ability to complete the
transaction; and the accuracy of any assumptions underlying any of
the foregoing. Investors are cautioned that any such
forward-looking statements are not guarantees of future performance
and involve risks and uncertainties and are cautioned not to place
undue reliance on these forward-looking statements. Actual results
may differ materially from those currently anticipated due to a
number of risks and uncertainties. Risks and uncertainties that
could cause the actual results to differ from expectations
contemplated by forward-looking statements include: uncertainties
as to the timing of the tender offer and completion of the merger;
the possibility that various closing conditions for the transaction
may not be satisfied or waived, including that Nuvalent stockholders
may not tender into the offer a majority of the shares of Class A
common stock outstanding at the time of the expiration of the offer
or that required regulatory approvals may not be obtained or are
obtained subject to conditions that are not anticipated; the
occurrence of any event, change or other circumstance that could
give rise to the termination of the merger agreement; the failure
to realize anticipated benefits of the proposed acquisition when
expected or at all; potential adverse reactions or changes to
business relationships resulting from the proposed acquisition,
including the effect of the announcement, pendency or consummation
of the acquisition on the ability of Nuvalent to
retain and hire key personnel or maintain key vendor, supplier or
partner relationships; risks that the proposed acquisition disrupts
the current plans and operations of Nuvalent;
transaction costs; risks associated with potential litigation or
regulatory actions related to the transaction; and other risks and
uncertainties described from time to time in documents filed with
the SEC by Nuvalent,
including current reports on Form 8-K, quarterly reports on Form
10-Q and annual reports on Form 10-K, as well as the Schedule 14D-9
to be filed by Nuvalent,
or in GSK plc's Annual Report on Form 20-F for the year ended
December 31, 2025 filed with the SEC by GSK plc, as well as the
Schedule TO to be filed by GSK plc. All forward-looking statements
are based on information currently available to GSK plc
and Nuvalent,
and neither GSK plc nor Nuvalent assumes
any obligation to update any forward-looking
statements.
GSK uses number of adjusted measures, including Core results, to
report the performance of its business, which are non-IFRS
measures. These measures are defined and reconciliations to the
nearest IFRS measure are available in GSK's Q1 2026 Results and
GSK's Annual Report on Form 20-F for FY 2025.
GSK provides earnings guidance to the investor community on the
basis of Core results. This is in line with peer companies and
expectations of the investor community, supporting easier
comparison of the Group's performance with its peers. GSK is not
able to give guidance for Total results as it cannot reliably
forecast certain material elements of the Total results,
particularly the future fair value movements on contingent
consideration and put options that can and have given rise to
significant adjustments driven by external factors such as currency
and other movements in capital markets.
All expectations, guidance and outlooks regarding future
performance should be read together with the section "Guidance and
outlooks, assumptions and cautionary statements" on pages 44 and 45
of GSK's Q1 2026 Results and the statements on page 328 of GSK's
Annual Report for FY 2025.
This announcement contains inside information. The person
responsible for arranging the release of this announcement on
behalf of GSK is Victoria Whyte, Company Secretary.
Registered in England & Wales:
No. 3888792
Registered Office:
79 New Oxford Street
London
WC1A 1DG
References
1 Drilon, A.E., et al. "Pivotal ARROS-1 Efficacy and Safety Data:
Zidesamtinib in TKI Pretreated Patients with Advanced/Metastatic
ROS1+ NSCLC". IASLC 2025. Available at:
https://cdn.sanity.io/files/8miuua0t/production/49fc755646f2da35f684876f37076d73a9fff7c0.pdf.
Last accessed: 8 June 2026.
2 Lin, J.J., et al. "ALKOVE-1: Efficacy and safety of neladalkib in
patients with advanced ALK+ NSCLC". ASCO 2026. Available at:
https://cdn.sanity.io/files/8miuua0t/production/781d64797149fd79d2fdb9c732bd964560f3fd68.pdf.
Last accessed: 8 June 2026.
3 Nuvalent Pipeline. Available at: https://nuvalent.com/pipeline.
Last accessed: 7 June 2026.
4 Nuvalent Expanded Access Policy. Available at:
https://nuvalent.com/expanded-access-policy. Last accessed: 7 June
2026.
_____________________________________________________
* The
FDA Breakthrough Therapy designation is designed to expedite the
development and review of medicines for serious conditions, where
preliminary clinical evidence indicates the potential for
substantial improvement over available therapy. Orphan
Drug Designation is granted to support the development and
evaluation of potential new medicines intended for the treatment,
diagnosis or prevention of rare diseases or
disorders.
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, thereunto duly authorised.
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GSK plc
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(Registrant)
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Date: June
09, 2026
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By:/s/ VICTORIA
WHYTE
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Victoria Whyte
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Authorised
Signatory for and on
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behalf
of GSK plc
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