NMPA批准云顶新耀引进的etripamil鼻喷剂治疗中国成人PSVT，触发Milestone 200万美元里程碑付款

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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):
September
3, 2026
MILESTONE
PHARMACEUTICALS INC.
(Exact name of registrant as specified in its
charter)
Québec
001-38899
Not
applicable
(state or other jurisdiction of incorporation)
(Commission File Number)
(I.R.S. Employer Identification No.)
1111
Dr. Frederik-Philips Boulevard
,
Suite
420
Montréal
,
Québec
CA
H4M
2X6
(Address of principal executive offices)
(Zip Code)
Registrant's telephone number, including area
code:
(
514
)
336-0444
(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 (see General
Instruction A.2. below):
¨
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))
Securities registered pursuant to Section 12(b)
of the Act:
Title of each class
Trading Symbol(s)
Name of each exchange on which
registered
Common
Shares
MIST
The
Nasdaq Stock Market LLC
Indicate by check mark
whether the registrant is an emerging growth company as defined in 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.
¨
Item 8.01
Other Events
On September
3, 2026, Milestone Pharmaceuticals Inc. issued a press release announcing that China’s National Medical Products Administration
has approved etripamil nasal spray for the treatment of paroxysmal supraventricular tachycardia (PSVT) in adults. A copy of the press
release is filed herewith as Exhibit 99.1 to this Current Report on Form 8-K and incorporated herein by reference.
Item
9.01
Financial
Statements and Exhibits
(d) Exhibits.
Exhibit Number
Description of Exhibit
99.1
Press Release dated September 3, 2026
104
Cover Page Interactive Data (embedded within the Inline XBRL document)
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.
MILESTONE PHARMACEUTICALS INC.
By:
/s/Amit Hasija
Amit Hasija
Chief Financial Officer
Dated: September 3, 2026

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EX-99.1
2
tm2624766d1_ex99-1.htm
EXHIBIT 99.1
Exhibit 99.1
Milestone Pharmaceuticals Announces NMPA Approval
of Etripamil Nasal Spray for PSVT in China, Marking First Regulatory Approval of Etripamil Outside of the United States
Everest Medicines to Lead Commercialization
in Greater China, Bringing Novel Innovation to Estimated 3-6 Million Chinese Patients with PSVT
Approval Triggers $2.0 Million Payment to Milestone
Pharmaceuticals
MONTREAL and CHARLOTTE, N.C.,
–
September 3, 2026 – Milestone® Pharmaceuticals Inc. (Nasdaq: MIST), a biopharmaceutical company focused on
the development and commercialization of innovative cardiovascular medicines, today announced that China’s National Medical Products
Administration (NMPA) has approved etripamil nasal spray for the treatment of paroxysmal supraventricular tachycardia (PSVT) in adults.
Etripamil, marketed in the United States as CARDAMYST® nasal spray, is a self-administered treatment for adults with PSVT.
The NMPA decision marks the first regulatory
approval of etripamil outside the United States and triggers a $2.0 million milestone payment to Milestone Pharmaceuticals.
Everest
Medicines
has an exclusive license with Milestone to develop etripamil nasal spray in Greater China (including Mainland China, Hong
Kong, Macau and Taiwan). Under the License Agreement with Everest, Milestone is also eligible to receive up to $98.0 million in commercial
and development milestones and tiered royalties of up to 18% on future sales of etripamil in Greater China.
The NMPA approval was based on data from the
global pivotal
Phase 3 RAPID study
and the Phase 3 JX02002 study conducted in China. JX02002 met its primary endpoint, demonstrating
that etripamil was significantly superior to placebo in converting PSVT to sinus rhythm within 30 minutes of treatment (hazard ratio
= 3.002 [95% CI: 1.578, 5.711]; p = 0.0005). Overall, treatment-emergent adverse events were comparable between the etripamil and placebo
groups, and no serious adverse events were reported within 24 hours after dosing across Phase 3 studies.
“We believe the approval of etripamil nasal
spray in China represents exciting progress toward our vision to help patients around the world living with PSVT,” said Joseph
Oliveto, President and Chief Executive Officer of Milestone Pharmaceuticals. “We congratulate Everest on this achievement and look
forward to continued collaboration as they launch the product in this important market.”
About Paroxysmal Supraventricular Tachycardia
(PSVT)
An estimated three to six million people in
China and two million people in the United States are currently diagnosed with PSVT, which is a type of arrhythmia or abnormal heart
rhythm. PSVT is characterized by episodes of sudden onset rapid heartbeats often exceeding 150 to 200 beats per minute. The heart
rate spike is unpredictable and may last several hours. The rapid heart rate often causes disabling severe palpitations, shortness
of breath, chest discomfort, dizziness or lightheadedness, and distress, forcing patients to limit their daily activities. The
uncertainty of when an episode of PSVT will strike or how long it will persist can provoke anxiety in patients and negatively impact
their day-to-day life between episodes. The impact and morbidity from an attack can be especially detrimental in patients with
underlying cardiovascular or medical conditions, such as heart failure, obstructive coronary disease, or dehydration. Many health
care providers are dissatisfied with the lack of effective treatment options, with patients often electing to pursue prolonged,
burdensome, and costly trips to the emergency department or even undergo invasive cardiac ablation procedures.
About CARDAMYST in the United States
CARDAMYST® (etripamil) nasal spray is approved
by the U.S. Food and Drug Administration (FDA) for the conversion of acute symptomatic episodes of paroxysmal supraventricular
tachycardia (PSVT) to sinus rhythm in adults. It is a novel calcium channel blocker nasal spray designed as a self-administered rapid
response therapy for patients, thereby bypassing the need for immediate medical oversight. The product is intended to provide health
care providers with a new treatment option to enable on-demand care and patient self-management. This portable treatment may provide
patients with active management and a greater sense of control over their condition. CARDAMYST is well studied with a robust clinical
trial program that includes a completed Phase 3 clinical-stage program for the treatment of PSVT. Currently, etripamil is in Phase 2
development for treatment of PSVT in pediatric patients and Phase 3 development for control of acute atrial fibrillation with rapid ventricular
rate (AFib-RVR) in adults. For more information, please visit
CARDAMYST.com
.
U.S. FDA Indication
CARDAMYST is indicated for the conversion
of acute symptomatic episodes of paroxysmal supraventricular tachycardia (PSVT) to sinus rhythm in adults.
IMPORTANT SAFETY INFORMATION FOR CARDAMYST
(etripamil)
What is CARDAMYST?
CARDAMYST is a prescription medicine used
to help restore normal sinus heart rhythm in adults who have symptoms of sudden episodes of fast heartbeat called paroxysmal supraventricular
tachycardia (PSVT).
It is not known if CARDAMYST is safe and effective
in children.
Do not use CARDAMYST if you:
·
are
allergic to CARDAMYST or any of its ingredients. See the Patient Information for a complete
list of ingredients in CARDAMYST.
·
have
limitations in activities due to heart failure (moderate to severe heart failure).
·
have
Wolff-Parkinson-White (WPW) syndrome, Lown-Ganong-Levine syndrome, or an abnormal heart rhythm
pattern called pre-excitation (delta wave) on an electrocardiogram (ECG).
·
have
sick sinus syndrome without a permanent pacemaker.
·
have
second degree or higher atrioventricular (AV) block.
Before using CARDAMYST, tell your healthcare
provider about all of your medical conditions, including if you:
·
have
a history of fainting.
·
have
low blood pressure.
·
are
pregnant or plan to become pregnant. It is not known if CARDAMYST will harm your unborn baby.
·
are
breastfeeding or plan to breastfeed. It is not known if CARDAMYST passes into your breast
milk. You should stop breastfeeding for 12 hours after treatment with CARDAMYST. During this
time, pump and throw away your breast milk. Talk to your healthcare provider about the best
way to feed your baby after using CARDAMYST.
Tell your healthcare provider about all the
medicines you take,
including prescription and over-the-counter medicines, vitamins, and herbal supplements.
What are the possible side effects of CARDAMYST?
CARDAMYST may cause serious side effects,
including:
·
Fainting
due to CARDAMYST effects on blood pressure, heart rate, and electrical activity of the heart.
CARDAMYST may cause dizziness
and fainting, especially in people with a history of fainting and certain heart problems, or people with a history of fainting during
an episode of PSVT. Use CARDAMYST while sitting in a safe area where you will not fall if you become dizzy or lightheaded. Lie down if
you feel dizzy or lightheaded after using CARDAMYST. If fainting occurs after using CARDAMYST, caregivers should place you on your back
and seek medical help.
The most common side effects of CARDAMYST
include:
·
nasal
discomfort
·
throat
irritation
·
nasal
congestion
·
nosebleed
·
runny
nose
These are not all of the possible side effects for CARDAMYST. Call your doctor for medical advice about side effects. You may report
side effects to FDA at 1-800-FDA-1088.
Please see the full Prescribing Information
https://milestonepharma.com/etripamilprescribinginformation.pdf
for CARDAMYST.
About Milestone
Pharmaceuticals
Milestone Pharmaceuticals Inc. (Nasdaq:
MIST) is an emerging commercial-stage biopharmaceutical company advancing innovative cardiovascular medicines to benefit people living
with certain heart conditions. Milestone’s lead product is CARDAMYST® (etripamil) nasal spray, a novel calcium channel
blocker, which is FDA-approved for the conversion of acute symptomatic episodes of paroxysmal supraventricular tachycardia (PSVT) to
sinus rhythm in adults. Etripamil is also in Phase 3 development for the control of symptomatic episodic attacks associated with AFib-RVR.
https://milestonepharma.com/
Cautionary Note on Forward-Looking Statements
This press release contains forward-looking
statements within the meaning of the Private Securities Litigation Reform Act of 1995. Words such as “believe,” “continue,”
“could,” “demonstrate,” “designed,” “develop,” “estimate,” “expect,”
“may,” “pending,” “plan,” “potential,” “progress,” “will,” “intend”
and similar expressions (as well as other words or expressions referencing future events, conditions, or circumstances) are intended
to identify forward-looking statements. These forward-looking statements are based on Milestone’s expectations and assumptions
as of the date of this press release. Each of these forward-looking statements involves risks and uncertainties. Actual results may differ
materially from these forward-looking statements. Forward-looking statements contained in this press release include statements regarding:
the commercialization and adoption of CARDAMYST; the ability of Milestone to receive up to $98 million in milestone payments and royalties
on future sales of etripamil in Greater China; the expected timing of initiation, completion, and results and data of Milestone’s
ongoing and planned clinical studies, including the Phase 3 study in AFib-RVR; and other statements not related to historical facts.
Important factors that could cause actual results to differ materially from those in the forward-looking statements include, but are
not limited to, the risks inherent in biopharmaceutical product development and clinical trials, including the lengthy and uncertain
regulatory approval process; uncertainties related to the timing of initiation, enrollment, completion, evaluation and results of Milestone’s
clinical trials; risks and uncertainty related to the complexity inherent in cleaning, verifying and analyzing trial data; and whether
the clinical trials will validate the safety and efficacy of etripamil for PSVT or other indications, among others, general economic,
political, and market conditions, including deteriorating market conditions due to investor concerns regarding inflation, international
tariffs and conflicts, and overall fluctuations in the financial markets in the United States and abroad, risks related to pandemics
and public health emergencies, and risks related to the sufficiency of Milestone’s capital resources and its ability to raise additional
capital in the current economic climate. These and other risks are set forth in Milestone’s filings with the U.S. Securities and
Exchange Commission (SEC), including in its annual report on Form 10-K for the year ended December 31, 2025, under the caption “Risk
Factors,” as such discussions may be updated from time to time by subsequent filings Milestone may make with the SEC. Except as
required by law, Milestone assumes no obligation to update any forward-looking statements contained herein to reflect any change in expectations,
even as new information becomes available.
# # #
Contact:
Investor
Relations
Kevin Gardner,
kgardner@lifesciadvisors.com
Media Relations
Rebecca Novak,
rnovak@milestonepharma.com