GRAND FALLS-WINDSOR, Newfoundland and Labrador, Sept. 18, 2026 (GLOBE NEWSWIRE) — First Atlantic Nickel & Cobalt Corp. (TSXV: FAN) (OTCQB: FANCF) (FSE: P210) (“First Atlantic” or the “Company”) is pleased to announce that it has closed a non-brokered private placement (the “Offering”), raising aggregate gross proceeds of $6,157,500 through the issuance of 8,210,000 flow-through common shares (each, an “FT Share”) at a price of $0.75 per FT Share. The FT Shares were issued on a “flow-through” basis pursuant to the Income Tax Act (Canada). No warrants were issued in connection with this closing.

The Company’s planned exploration program will focus on the approximately 30-kilometre mineralized trend at the Pipestone XL Nickel-Cobalt Alloy Project, extending from the RPM Zone in the south to the historic Atlantic Lake Zone in the north. Proceeds will fund follow-up and expansion drilling at the Alloy Max South and Alloy Max North Zones, continued drilling at the RPM Zone, and drilling at other targets that were previously accessible only by helicopter. Proceeds will also fund continued metallurgical recovery and processing test work at the Alloy Max and RPM Zones, as well as exploration of additional awaruite targets along the 30 km trend, large parts of which could not be thoroughly explored before due to the lack of ground access.

To support the planned exploration program, proceeds will also fund ongoing upgrades to project access trails, which are expected to enable year-round drilling through seasonal weather and provide new ground access to targets currently not accessible by ground and unexplored areas of the project, in each case to the extent the expenditures qualify as Qualifying Expenditures (as defined below).

First Atlantic welcomes calls directly from shareholders and prospective investors. For questions about the Company or the Pipestone XL project, or simply to learn more, investors are invited to call Rob Guzman, Investor Relations, at +1-844-592-6337 or email rob@fanickel.com.

The gross proceeds will be used to incur eligible “Canadian exploration expenses” that qualify as “flow-through mining expenditures,” as those terms are defined in the Income Tax Act (Canada) (the “Qualifying Expenditures”), in connection with the exploration programs described above at the Company’s Pipestone XL Nickel-Cobalt Alloy Project and exploration activities at its Ophiolite X Project in Newfoundland. The Company will incur the Qualifying Expenditures on or before December 31, 2027 and renounce them in favour of subscribers effective December 31, 2026.

All securities issued in connection with this closing are subject to a statutory hold period of four months and one day, expiring on January 19, 2027, under applicable Canadian securities laws. The Offering remains subject to final acceptance by the TSX Venture Exchange (the “Exchange”).

No finder’s fees were paid in connection with the Offering.

This news release does not constitute an offer to sell or a solicitation of an offer to buy any securities in the United States. The securities have not been and will not be registered under the United States Securities Act of 1933, as amended (the “U.S. Securities Act”), or any applicable state securities laws, and may not be offered or sold within the United States or to U.S. persons unless registered under the U.S. Securities Act and applicable state securities laws, or an exemption from such registration is available.

PIPESTONE XL: A DISTRICT-SCALE NICKEL-COBALT ALLOY PROJECT

Pipestone XL is First Atlantic’s wholly owned, district-scale project spanning the entire 30-kilometre Pipestone Ophiolite Complex in central Newfoundland, a belt of ultramafic rock enriched in nickel, cobalt, and chromium. The Project hosts multiple zones of awaruite (Ni₃Fe) mineralization, including RPM, Alloy Max, Super Gulp, Atlantic Lake, and Chrome Pond. The RPM Zone is the most advanced, with drilling having outlined magnetically recoverable awaruite over more than 1.2 kilometres of strike and more than 800 metres of width. Drilling is ongoing at Alloy Max, a second large-scale zone spanning approximately 4 kilometres of strike and up to 1.5 kilometres in width, making it larger than the RPM Zone.

Awaruite at Pipestone XL is the product of serpentinization, which drives sulphur out of the system and leaves a sulphur-free alloy which carries no acid mine drainage risk and can be concentrated by the Company’s ONSHORE MAX™ process without smelting, roasting, or high-pressure acid leaching. This smelter-free pathway addresses the midstream bottleneck in North America, where the United States has no operating nickel smelters and only two remain in Canada, and supports a vertically integrated supply chain moving directly from mine to downstream battery refining, stainless steel and specialty alloy production. The Company is also evaluating secondary chromium mineralization as a potential co-product, along with low-carbon Engineered Mineral Hydrogen (EMH) in partnership with VEMA Hydrogen1.

Figure 1

Figure 1: Map showing multiple target zones across the 30-kilometer nickel trend over total magnetic intensity (TMI) at the Pipestone XL Project highlighting the showing, the 30-kilometre Pipestone Ophiolite Complex and the RPM, Alloy Max, Super Gulp, Atlantic Lake and Chrome Pond Zones.

Pipestone XL is located in an established infrastructure corridor with year-round road access, nearby high-voltage transmission and clean hydroelectric power from the Bay d’Espoir generating station. It is also located approximately 200 kilometres from Gander International Airport and Vale’s Long Harbour nickel processing plant. This positioning aligns with growing U.S. and allied policy focus on critical mineral supply chains, including nickel’s addition to the U.S. critical minerals list in 2022, the January 2026 White House proclamation on processed critical minerals2, the Company’s acceptance into the U.S. Defense Industrial Base Consortium3, and the June 2026 G7 Leaders’ Declaration naming nickel one of two pilot critical minerals for allied investment and offtake4.

Newfoundland and Labrador is consistently recognized as one of the world’s leading mining jurisdictions in the Fraser Institute’s Annual Survey of Mining Companies, ranking 7th globally on the Policy Perception Index in the most recent survey, published in February 2026, and placing in the global top 10 for overall investment attractiveness in each of the three prior surveys. Pipestone XL is positioned to become a secure and reliable North American source of nickel and cobalt for the stainless steel, electric vehicle, aerospace, and defense industries.

AWARUITE AT PIPESTONE XL: A SMELTER-FREE NICKEL-COBALT ALLOY (Ni₃Fe)

Awaruite is a naturally occurring, magnetic, sulphur-free nickel-iron-cobalt alloy (Ni₃Fe) containing approximately 77% nickel. Because it already exists in a metallic state, awaruite can be concentrated without smelting, roasting, or high-pressure acid leaching. Mineralogical and electron microprobe analysis at the Company’s RPM Zone has confirmed the awaruite averages 77.62% nickel and 1.69% cobalt, with grades as high as 86.68% nickel and 6.05% cobalt5.

Initial metallurgical test work using the Company’s ONSHORE MAX™ (Magnetic Alloy eXtraction) process upgraded rock samples from the project’s RPM Zone into a high-grade alloy concentrate averaging 67.4% nickel and grading up to 71.9% nickel and 1.76% cobalt6. Low-intensity magnetic separation first produced a magnetic concentrate grading approximately 1.6% nickel, which flotation then upgraded to the final concentrate. By comparison, a typical nickel concentrate grades 10% to 15% nickel, according to the Nickel Institute. This concentrate can move directly to downstream battery chemical refining or the manufacture of specialty alloys and stainless steel.

The absence of sulphur reduces acid mine drainage risk and related permitting challenges, positioning Pipestone XL to supply North American industries including stainless steel, electric vehicles, aerospace, and defence.

Figure 2

Figure 2: USGS quote on awaruite nickel-iron-cobalt alloy.

The Company also announces that it has entered into a renewal agreement dated September 17, 2026 with Xander Capital Partners Inc. (“Xander”), effective April 2, 2026, in respect of its investor relations and marketing consulting agreement originally dated April 1, 2024 and previously renewed on April 1, 2025.

The renewal formalizes the continuation of the engagement following the expiry of the previous term on April 1, 2026. Payments to Xander have continued without interruption at the existing rate of US$10,000 per month. Under the renewal, the engagement will continue on an ongoing basis without a fixed expiry date, subject to either party’s right to terminate upon 30 days’ prior written notice. All other terms remain unchanged.

Xander’s services include increasing brand awareness, facilitating introductions to industry participants and digital marketing professionals, and providing investor relations and corporate consulting support. The monthly fee covers services and management fees, with Xander providing weekly budget proposals and spending allocations. No securities will be issued as compensation under the renewal.

The renewal remains subject to acceptance by the Exchange.

INVESTOR INFORMATION

The Company’s common shares trade on the TSX Venture Exchange under the symbol “FAN”, on the OTCQB under the symbol “FANCF”, and on several German exchanges, including Frankfurt and Tradegate, under the symbol “P210”. Investors can get updates about First Atlantic by signing up to receive news via email and SMS text at www.fanickel.com.

QUALIFIED PERSON

Adrian Smith, P.Geo., a director and the Chief Executive Officer of the Company, is a qualified person as defined by NI 43-101. The qualified person is a member in good standing of the Professional Engineers and Geoscientists Newfoundland and Labrador (PEGNL) and is a registered professional geoscientist (P.Geo.). Mr. Smith has reviewed and approved the technical information disclosed herein.

ABOUT FIRST ATLANTIC NICKEL & COBALT CORP.

First Atlantic Nickel & Cobalt Corp. (TSXV: FAN | OTCQB: FANCF | FSE: P210) is a critical mineral exploration company in Newfoundland and Labrador developing the Pipestone XL Nickel-Cobalt (Ni-Fe-Co) Alloy Project. The project spans the entire 30-kilometre Pipestone Ophiolite Complex, where multiple zones, including RPM, Alloy Max, Super Gulp, Atlantic Lake and Chrome Pond, contain awaruite (Ni₃Fe), a naturally occurring magnetic nickel-iron-cobalt alloy of approximately 77% nickel with no sulphur and no sulphides, along with secondary chromium mineralization. Awaruite’s sulphur-free composition removes acid mine drainage risk, while its magnetic properties enable processing through magnetic separation and flotation, eliminating the electricity requirements, emissions and environmental impacts of conventional smelting, roasting or high-pressure acid leaching, while reducing dependence on overseas nickel processing infrastructure.

The U.S. Geological Survey recognized awaruite’s strategic importance in its 2012 Annual Report on Nickel, noting that these deposits may help alleviate prolonged nickel concentrate shortages since the natural alloy is much easier to concentrate than typical nickel sulphide. In 2026, initial metallurgical test work using the Company’s ONSHORE MAX™ (Magnetic Alloy eXtraction) process upgraded RPM Zone material into a high-grade alloy concentrate averaging 67.4% nickel and grading up to 71.9% nickel and 1.76% cobalt, demonstrating a smelter-free, mine-to-refinery pathway. First Atlantic is a member of the U.S. Defense Industrial Base Consortium. The Company is also advancing a parallel geologic hydrogen initiative at Pipestone XL, where the same serpentinization process that formed awaruite also generates natural hydrogen, and has signed a letter of intent with VEMA Hydrogen to jointly develop low-carbon Engineered Mineral Hydrogen (EMH) through a proposed 50/50 joint venture. The Pipestone XL project is located near existing infrastructure with year-round road access and proximity to hydroelectric power, providing favorable logistics for exploration and future development and strengthening First Atlantic’s role to establish a secure and reliable source of North American nickel and cobalt production for the stainless steel, electric vehicle, aerospace, and defense industries. This mission gained importance when the U.S. added nickel to its critical minerals list in 2022, recognizing it as a non-fuel mineral essential to economic and national security with a supply chain vulnerable to disruption.

Neither the TSX Venture Exchange nor its Regulation Services Provider (as that term is defined in policies of the TSX Venture Exchange) accepts responsibility for the adequacy or accuracy of this release.

Forward looking statements

Certain information contained in this news release constitutes “forward-looking information” or “forward-looking statements” within the meaning of applicable Canadian securities legislation (collectively, “forward-looking information”). Forward-looking information is often identified by words such as “anticipates,” “believes,” “expects,” “intends,” “plans,” “may,” “will,” “potential,” and similar expressions.

Forward-looking information in this news release includes statements regarding: final acceptance of the Offering by the Exchange; the intended use of proceeds; the qualification of expenditures as Canadian exploration expenses and flow-through mining expenditures, the incurrence of those expenditures by December 31, 2027 and their renunciation in favour of subscribers effective December 31, 2026; the scope, timing and anticipated results of exploration and metallurgical programs at the Pipestone XL Nickel-Cobalt Alloy Project and Ophiolite X Project, including district-scale drilling, expansion of the RPM Zone and testing of newly identified targets; the continuation of Xander’s engagement, the services to be provided and Exchange acceptance of the renewal; the potential capabilities, scalability and benefits of the ONSHORE MAX™ process; the potential to concentrate awaruite without smelting, roasting or high-pressure acid leaching; the suitability of concentrates for downstream refining and the manufacture of battery chemicals, specialty alloys and stainless steel; potential environmental and permitting benefits; and the potential for Pipestone XL to supply North American industrial markets.

This forward-looking information is based on management’s current expectations and assumptions, including that required regulatory approvals will be obtained; planned expenditures will satisfy applicable tax requirements and be incurred and renounced within the specified timelines; necessary permits, personnel, contractors, equipment and laboratory capacity will be available; exploration and metallurgical programs can be completed within anticipated budgets and schedules; further testing will support the applicability of initial metallurgical results to representative project material and larger-scale operations; any resulting concentrates will meet relevant downstream processing and customer specifications; further environmental studies will support the anticipated environmental benefits; and Xander will continue to perform its services in accordance with the renewed agreement.

Forward-looking information is subject to risks and uncertainties that could cause actual results to differ materially from those expressed or implied. These include failure to obtain regulatory approvals or complete additional financing; changes in market conditions, commodity prices, costs or the availability of financing; failure to incur sufficient qualifying expenditures within the required period, adverse tax determinations or changes in tax laws or their interpretation; exploration results that do not support anticipated mineralization or expansion targets; geological and metallurgical variability; the preliminary nature of test results and the risk that such results cannot be replicated at larger scale or achieved economically; concentrate impurities, recovery limitations or failure to meet downstream specifications; permitting delays, environmental liabilities and findings that differ from anticipated environmental benefits; operational, weather, equipment, contractor and laboratory delays; changes to or termination of Xander’s engagement; and other risks described in the Company’s continuous disclosure filings available on SEDAR+ at www.sedarplus.ca.

Initial metallurgical results do not establish commercial viability or guarantee future recoveries, concentrate quality or processing performance. There can be no assurance that the anticipated exploration, processing, environmental or commercial outcomes will be achieved.

Although management considers its expectations and assumptions reasonable as of the date of this news release, forward-looking information is not a guarantee of future performance. Readers are cautioned not to place undue reliance on it. Except as required by applicable securities laws, the Company undertakes no obligation to update forward-looking information to reflect subsequent events, circumstances or changes in expectations.

1https://fanickel.com/20260608-vema-hydrogen-and-first-atlantic-nickel-cobalt-sign-loi-to-develop-engineered-mineral-hydrogen-at-pipestone-xl-awaruite-project-in-newfoundland
2https://fanickel.com/20260115-first-atlantic-nickel-highlights-relevance-of-pipestone-xl-awaruite-nickel-cobalt-alloy-discovery-to-address-u-s–critical-mineral-supply-chain-vulnerabilities-identified-in-january-14-2026-white-house-proclamation
3https://fanickel.com/20260331-first-atlantic-nickel-announces-acceptance-into-defense-industrial-base-consortium-dibc—pipestone-xl-smelter-free-nickel-cobalt-alloy-project-addresses-midstream-smelting-bottleneck-in-u-s–defense-supply-chain
4https://fanickel.com/20260619-first-atlantic-nickel-cobalt-highlights-g7-leaders-declaration-on-critical-minerals-g7-names-nickel-one-of-only-two-pilot-minerals-for-a-new-allied-traceability-framework-moves-to-mobilize-equity-investment-and-offtake-and-establishes-a-critical-
5https://fanickel.com/20260521-first-atlantic-nickel-cobalt-reports-electron-microprobe-analysis-returning-77-62-nickel-and-1-69-cobalt-in-awaruite-at-the-rpm-zone-pipestone-xl-project-a-rare-naturally-magnetic-ni-fe-co-high-grade-alloy-mineralogically-capable-of-bypassing-mid
6https://fanickel.com/20260624-first-atlantic-nickel-cobalt-produces-high-grade-alloy-concentrate-up-to-71-9-nickel-and-1-76-cobalt-from-its-pipestone-xl-nickel-cobalt-alloy-project-using-its-first-ever-onshore-max-magnetic-alloy-extraction-recovery-concentration-process-unvei

Photos accompanying this announcement are available at

https://www.globenewswire.com/NewsRoom/AttachmentNg/b34a461c-efab-4946-8239-a734fc3015a3
https://www.globenewswire.com/NewsRoom/AttachmentNg/e74b7b16-ea63-43e0-b924-9e641b115db5

SAN JOSÉ, Calif.–(BUSINESS WIRE)–Power Integrations (Nasdaq: POWI) today announced that on September 15, 2026 (the September Grant Date), it granted a total of 43,396 RSUs and 2,048 PSUs at target to fifteen employees who began their employment with Power Integrations in August 2026, and that on August 15, 2026 (the August Grant Date), it granted a total of 18,283 RSUs and 1,099 PSUs at target to nine employees who began their employment with Power Integrations in July 2026.The inducement gran

SAN JOSÉ, Calif.–(BUSINESS WIRE)–Power Integrations (Nasdaq: POWI) today announced that on September 15, 2026 (the September Grant Date), it granted a total of 43,396 RSUs and 2,048 PSUs at target to fifteen employees who began their employment with Power Integrations in August 2026, and that on August 15, 2026 (the August Grant Date), it granted a total of 18,283 RSUs and 1,099 PSUs at target to nine employees who began their employment with Power Integrations in July 2026.The inducement gran

TORONTO–(BUSINESS WIRE)–PIMCO Canada Corp. (“PIMCO Canada”) is pleased to announce today that it has declared monthly distributions on its Class A Units (the “Units”) of the PIMCO Canada closed end funds (the “Funds”). The distributions will be paid on October 15, 2026 to the holders of record at the close of business on September 29, 2026. Details of the distribution amounts are as follows: Fund Name Ticker Cash Distribution per Unit Change from Previous Month Percentage Change from Previous

NEW YORK–(BUSINESS WIRE)– #HamiltonReserveBank–Hamilton Reserve Bank (HRB), the largest global bank in the Caribbean region with offices worldwide and US $25+ billion in custodial assets and deposits, serving clients from 150 countries in 126 currencies and 15 languages, announces that Hamilton Reserve Bank has won the coveted 2026 IDC FinTech Real Results Award alongside banking technology giant Temenos, the world’s largest core banking software firm that powers 80% of the world’s largest banks fast, safe, and co

SAN DIEGO–(BUSINESS WIRE)—- $DKS #DicksSportingGoods–Shareholder rights law firm Robbins LLP reminds investors that a class action was filed on behalf of all persons and entities who purchased or otherwise acquired Dick’s Sporting Goods, Inc. (NYSE: DKS) common stock between September 8, 2025 and August 24, 2026, inclusive (the “Class Period”). Dick’s is the largest sporting goods retailer in the United States, offering sports equipment, footwear, and accessories, among other products.The complaint alleges that defendan

WASHINGTON–(BUSINESS WIRE)–A Yim Leak kambodzsai üzletember globális jogi képviseletét ellátó Seiden Law LLP a mai napon bejelentette, hogy Jared Genser nemzetközi emberi jogi ügyvéd, valamint Lanny J. Davis – aki két korábbi amerikai elnökkel is szoros kapcsolatot ápol, és világszerte arról ismert, hogy hazugságok és lejárató kampányok célpontjává vált személyek védelmét látja el, illetve helyreállítja megtépázott hírnevüket -, csatlakozott a Yim Leak kambodzsai üzletembert támogató jogi és

SAN DIEGO–(BUSINESS WIRE)—- $CELH #Beverages–Shareholder rights law firm Robbins LLP reminds investors that a class action was filed on behalf of all persons and entities who purchased or otherwise acquired Celsius Holdings, Inc. (NASDAQ: CELH) securities between February 21, 2025 and June 3, 2026, inclusive (the “Class Period”). Celsius develops, processes, manufactures, markets, sells, and distributes products including energy drinks.The complaint alleges that defendants misled investors regarding the safety o

WASHINGTON–(BUSINESS WIRE)–Internationaal mensenrechtenadvocaat Jared Genser en Lanny J. Davis – die nauwe banden heeft met twee voormalige Amerikaanse presidenten en wereldwijd bekendstaat om het verdedigen van personen die worden aangevallen met leugens en laster, en om het herstellen van hun beschadigde reputatie – zijn toegetreden tot het team dat de Cambodjaanse zakenman Yim Leak bijstaat. Dit is vandaag bekendgemaakt door Seiden Law LLP, het kantoor dat optreedt als hoofdadviseur van Yi

  • New data revealed that healthcare providers prioritize drowsiness risk, duration of available data demonstrating long-term response and drug-drug interaction profile when selecting a treatment for tardive dyskinesia (TD) in patients aged ≥55 years
  • Across all four patient profiles, AUSTEDO® (deutetrabenazine) was most closely related to the attributes most valued by healthcare providers
  • These findings from Teva detail specific healthcare provider preferences around tolerability and efficacy, while reinforcing the importance of treatment for TD

PARSIPPANY, N.J., Sept. 18, 2026 (GLOBE NEWSWIRE) — Teva Pharmaceuticals, a U.S. affiliate of Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA), today announced new data from a discrete choice experiment highlighting preferred healthcare provider (HCP) treatment attributes when selecting a VMAT2 inhibitor for the treatment of TD in older patients (aged ≥55 years). The new findings were presented at Psych Congress, held September 15 – 19, 2026, in New Orleans, LA.

“At the heart of every treatment decision for tardive dyskinesia is a patient looking for improvement in their burdensome physical symptoms, and the impact those symptoms have on daily life,” said Eric Hughes, MD, PhD, Executive Vice President, Global R&D and Chief Medical Officer at Teva. “At Teva, we’re committed to developing therapies and delivering clinical solutions for TD communities that help eliminate challenges to treat. Offering a treatment like AUSTEDO, with attributes healthcare providers value, is essential to delivering effective, patient-centered care.”

HCP Preference Driven by Tolerability and Efficacy
In a discrete choice experiment (DCE), 489 HCPs representing a variety of specialties prioritized key attributes driving their TD treatment preferences for patients aged ≥55 years. Participants prioritized somnolence risk and short-term Abnormal Involuntary Movement Scale (AIMS) improvement, followed by dose formulation, drug-drug interaction risk and demonstrated long-term response, as the key drivers for VMAT2 inhibitor selection across four different patient profiles. Applying these preferences to the available VMAT2 inhibitor treatment options, AUSTEDO® had the highest predicted choice probability across all patient profiles; this preference was mainly driven by somnolence risk, duration of available data demonstrating long-term response, and drug-drug interaction.

Data from the DCE revealed:

  • HCPs identified somnolence (drowsiness) risk (accounting for 26.8% – 36.2% of decision-making weight) and short-term symptom improvement (24.4% – 29.5%) as their top priorities when evaluating VMAT2 inhibitors for TD treatment, followed by dose formulation (16.7% – 20.2%) and drug-drug interaction risk (14.4% – 17.3%).
  • HCPs distinctly adapt their prescribing criteria based on patient presentation. The risk of somnolence was prioritized higher for outpatients (ex-long-term care) (up to 36.2% decision weight) than for those being treated in long-term care settings (up to 29.5%).
  • Driven directly by these clinical priorities, HCPs were predicted to prefer AUSTEDO across all four patient profiles.

“Selecting a treatment for those living with tardive dyskinesia involves weighing a range of factors, from symptom improvement and tolerability to practical considerations,” said Gustavo Alva, MD, board-certified psychiatrist. “By shedding light on the attributes healthcare professionals prioritize, these findings may support more informed, individualized treatment discussions and provide healthcare providers with greater confidence in selecting a TD treatment that addresses immediate patient needs and supports long-term treatment success.”

Persistent Burden of Untreated TD
Also presented at Psych Congress, a new interim analysis from the IMPACT-TD Registry examined changes in TD severity and quality of life for individuals with probable TD who remained untreated with any VMAT2 inhibitor for 24 months. TD burden persisted, with approximately 89%–96% of participants experiencing at least a mild global impact of TD, including 60%–74% who experienced moderate-to-severe impact. Most patients (55%–69%) reported stable or worsening TD severity relative to baseline, with no evidence of spontaneous resolution. Depression and anxiety scores also fluctuated over the two-year period without sustained improvement.

Together, these findings reinforce the critical need for proactive, effective management of TD. By understanding the enduring consequences of untreated TD in the real-world, as well as the specific treatment attributes HCPs value most, like early symptom control and tolerability, Teva remains deeply committed to advancing care, empowering HCPs and driving long-term adherence for patients managing this complex condition.

About Tardive Dyskinesia (TD)
Tardive dyskinesia (TD) is a highly debilitating, chronic movement disorder that affects one in four people who take certain mental health treatments and is characterized by uncontrollable, abnormal and repetitive movements of the face, torso and/or other body parts, which may be disruptive and negatively impact individuals.1,2,3

About AUSTEDO XR® Extended-Release Tablets and AUSTEDO Tablets
AUSTEDO XR and AUSTEDO are the first vesicular monoamine transporter 2 (VMAT2) inhibitors approved by the U.S. Food and Drug Administration in adults for the treatment of tardive dyskinesia and for the treatment of chorea associated with Huntington’s disease. Safety and effectiveness in pediatric patients have not been established. AUSTEDO XR is the once-daily formulation of AUSTEDO.

INDICATIONS AND USAGE
AUSTEDO XR (deutetrabenazine) extended-release tablets and AUSTEDO (deutetrabenazine) tablets are indicated in adults for the treatment of chorea associated with Huntington’s disease and for the treatment of tardive dyskinesia.

IMPORTANT SAFETY INFORMATION 

Depression and Suicidality in Patients with Huntington’s Disease: AUSTEDO XR and AUSTEDO can increase the risk of depression and suicidal thoughts and behavior (suicidality) in patients with Huntington’s disease. Balance the risks of depression and suicidality with the clinical need for treatment of chorea. Closely monitor patients for the emergence or worsening of depression, suicidality, or unusual changes in behavior. Inform patients, their caregivers, and families of the risk of depression and suicidality and instruct them to report behaviors of concern promptly to the treating physician. Exercise caution when treating patients with a history of depression or prior suicide attempts or ideation. AUSTEDO XR and AUSTEDO are contraindicated in patients who are suicidal, and in patients with untreated or inadequately treated depression. 

Contraindications: AUSTEDO XR and AUSTEDO are contraindicated in patients with Huntington’s disease who are suicidal, or have untreated or inadequately treated depression. AUSTEDO XR and AUSTEDO are also contraindicated in: patients with hepatic impairment; patients taking reserpine or within 20 days of discontinuing reserpine; patients taking monoamine oxidase inhibitors (MAOIs), or within 14 days of discontinuing MAOI therapy; and patients taking tetrabenazine or valbenazine.   

Clinical Worsening and Adverse Events in Patients with Huntington’s Disease: AUSTEDO XR and AUSTEDO may cause a worsening in mood, cognition, rigidity, and functional capacity. Prescribers should periodically re-evaluate the need for AUSTEDO XR or AUSTEDO in their patients by assessing the effect on chorea and possible adverse effects. 

QTc Prolongation: AUSTEDO XR and AUSTEDO may prolong the QT interval, but the degree of QT prolongation is not clinically significant when AUSTEDO XR or AUSTEDO is administered within the recommended dosage range. AUSTEDO XR and AUSTEDO should be avoided in patients with congenital long QT syndrome and in patients with a history of cardiac arrhythmias.  

Neuroleptic Malignant Syndrome (NMS), a potentially fatal symptom complex reported in association with drugs that reduce dopaminergic transmission, has been observed in patients receiving tetrabenazine. The risk may be increased by concomitant use of dopamine antagonists or antipsychotics. The management of NMS should include immediate discontinuation of AUSTEDO XR and AUSTEDO; intensive symptomatic treatment and medical monitoring; and treatment of any concomitant serious medical problems.   

Akathisia, Agitation, and Restlessness: AUSTEDO XR and AUSTEDO may increase the risk of akathisia, agitation, and restlessness. The risk of akathisia may be increased by concomitant use of dopamine antagonists or antipsychotics. If a patient develops akathisia, the AUSTEDO XR or AUSTEDO dose should be reduced; some patients may require discontinuation of therapy. 

Parkinsonism: AUSTEDO XR and AUSTEDO may cause parkinsonism in patients with Huntington’s disease or tardive dyskinesia. Parkinsonism has also been observed with other VMAT2 inhibitors. The risk of parkinsonism may be increased by concomitant use of dopamine antagonists or antipsychotics. If a patient develops parkinsonism, the AUSTEDO XR or AUSTEDO dose should be reduced; some patients may require discontinuation of therapy. 

Sedation and Somnolence: Sedation is a common dose-limiting adverse reaction of AUSTEDO XR and AUSTEDO. Patients should not perform activities requiring mental alertness, such as operating a motor vehicle or hazardous machinery, until they are on a maintenance dose of AUSTEDO XR or AUSTEDO and know how the drug affects them. Concomitant use of alcohol or other sedating drugs may have additive effects and worsen sedation and somnolence. 

Hyperprolactinemia: Tetrabenazine elevates serum prolactin concentrations in humans. If there is a clinical suspicion of symptomatic hyperprolactinemia, appropriate laboratory testing should be done and consideration should be given to discontinuation of AUSTEDO XR and AUSTEDO.   

Binding to Melanin-Containing Tissues: Deutetrabenazine or its metabolites bind to melanin-containing tissues and could accumulate in these tissues over time. Prescribers should be aware of the possibility of long-term ophthalmologic effects. 

Common Adverse Reactions: The most common adverse reactions for AUSTEDO (>8% and greater than placebo) in a controlled clinical study in patients with Huntington’s disease were somnolence, diarrhea, dry mouth, and fatigue. The most common adverse reactions for AUSTEDO (4% and greater than placebo) in controlled clinical studies in patients with tardive dyskinesia were nasopharyngitis and insomnia.  Adverse reactions with AUSTEDO XR extended-release tablets are expected to be similar to AUSTEDO tablets. 

Please see accompanying full Prescribing Information, including Boxed Warning. 

About Teva
Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA) is transforming into a leading innovative biopharmaceutical company, enabled by a world-class generics business. For over 120 years, Teva’s commitment to bettering health has never wavered. From innovating in the fields of neuroscience and immunology to providing complex generic medicines, biosimilars and pharmacy brands worldwide, Teva is dedicated to addressing patients’ needs, now and in the future. At Teva, We Are All In For Better Health. To learn more about how, visit www.tevapharm.com.

Teva Cautionary Note Regarding Forward Looking Statements
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, which are based on management’s current beliefs and expectations and are subject to substantial risks and uncertainties, both known and unknown, that could cause our future results, performance or achievements to differ significantly from that expressed or implied by such forward-looking statements. You can identify these forward-looking statements by the use of words such as “should,” “expect,” “anticipate,” “estimate,” “target,” “may,” “intend,” “plan,” “believe” and other words and terms of similar meaning and expression in connection with any discussion of future operating or financial performance. Important factors that could cause or contribute to such differences include risks relating to: our ability to successfully develop and commercialize AUSTEDO and AUSTEDO XR for the treatment of tardive dyskinesia and for the treatment of chorea associated with Huntington’s disease; our ability to successfully compete in the marketplace, including our ability to develop and commercialize additional pharmaceutical products; our ability to successfully execute on our Pivot to Growth strategy, including to expand our innovative and biosimilar medicines pipeline and profitably commercialize our innovative medicines and biosimilar portfolio, whether organically or through business development; and other factors discussed in our Quarterly Report on Form 10-Q for the second quarter of 2026 and in our Annual Report on Form 10-K for the year ended December 31, 2025, including in the sections captioned “Risk Factors,” and “Forward-Looking Statements.” Forward-looking statements speak only as of the date on which they are made, and we assume no obligation to update or revise any forward-looking statements or other information contained herein, whether as a result of new information, future events or otherwise. You are cautioned not to put undue reliance on these forward-looking statements.

###

References:

  1. Carbon M, Hsieh CH, Kane JM, Correll CU. Tardive Dyskinesia Prevalence in the Period of Second-Generation Antipsychotic Use: A Meta-Analysis. J Clin Psychiatry. 2017;78(3):e264-e278. doi: 10.4088/JCP.16r10832.
  2. Waln O, Jankovic J. An Update on Tardive Dyskinesia: From Phenomenology to Treatment. Tremor Other Hyperkinet Mov. 2013;3:1-11.
  3. Tardive dyskinesia. National Alliance on Mental Illness website. https://www.nami.org/Learn-More/Treatment/Mental-Health-Medications/Tardive-Dyskinesia. Accessed August 19, 2026.

Teva Media Inquiries: TevaCommunicationsNorthAmerica@tevapharm.com

Teva Investor Relations Inquiries: TevaIR@Tevapharm.com

Privacy Overview

This website uses cookies so that we can provide you with the best user experience possible. Cookie information is stored in your browser and performs functions such as recognising you when you return to our website and helping our team to understand which sections of the website you find most interesting and useful.