Novartis delivers solid sales and core operating income growth with strong pipeline progress in Q3; reaffirms FY 2025 guidance

Novartis delivers solid sales and core operating income growth with strong pipeline progress in Q3; reaffirms FY 2025 guidance




Novartis delivers solid sales and core operating income growth with strong pipeline progress in Q3; reaffirms FY 2025 guidance

Ad hoc announcement pursuant to Art. 53 LR

  • Q3 net sales grew +7% (cc1, +8% USD) and core operating income1 grew +7% (cc, +6% USD)
    • Sales growth was driven by continued strong execution on priority brands including Kisqali (+68% cc), Kesimpta (+44% cc), Pluvicto (+45% cc) and Scemblix (+95% cc)
    • Core operating income margin1 was stable (cc) at 39.3% despite increasing generic impact
  • Q3 operating income grew +27% (cc, +24% USD); net income rose +25% (cc, +23% USD)
  • Q3 core EPS1 grew +10% (cc, +9% USD) to USD 2.25
  • Q3 free cash flow1 was USD 6.2 billion (+4% USD) driven by higher net cash flows from operating activities
  • Strong nine months performance with net sales up +11% (cc, +11% USD) and core operating income up +18% (cc, +16% USD)
  • Q3 selected innovation milestones:
    • Rhapsido FDA approval as the only oral, targeted BTK inhibitor for CSU
    • Ianalumab positive replicate Phase III readouts in Sjogren’s disease
    • Pluvicto positive Phase III PSMAddition data at ESMO
    • Scemblix positive CHMP opinion for all lines of CML treatment
    • Cosentyx positive Phase III readout in PMR
    • Fabhalta positive Phase III eGFR readout in IgA nephropathy
  • Full-year 2025 guidance2 reaffirmed
    • Sales expected to grow high single-digit
    • Core operating income expected to grow low-teens

1. Constant currencies (cc), core results and free cash flow are non-IFRS measures. An explanation of non-IFRS measures can be found on page 42 of the Condensed Interim Financial Report. Unless otherwise noted, all growth rates in this Release refer to same period in prior year.    2. Please see detailed guidance assumptions on page 7.    

Basel, October 28, 2025 – Commenting on Q3 2025 results, Vas Narasimhan, CEO of Novartis, said:
Novartis delivered solid financial performance in Q3, more than offsetting the impact of increasing generic erosion in the US. Our key growth drivers performed well, including Kisqali, Kesimpta, Pluvicto and Scemblix. Importantly, we achieved FDA approval for Rhapsido in CSU and positive Phase III readouts for ianalumab in Sjogren’s disease – two assets with pipeline-in-a-pill potential that could underpin our growth through 2030 and beyond. In addition, we completed several deals in the quarter to further strengthen our pipeline in core therapeutic areas. We remain well on track to achieve our guidance for 2025 and over the mid-term.”

Key figures

Q3 2025 Q3 2024 % change 9M 2025 9M 2024 % change

USD m USD m USD cc
USD m USD m USD cc
Net sales 13 909 12 823 8 7
41 196 37 164 11 11
Operating income 4 501 3 627 24 27
14 028 11 014 27 31
Net income 3 930 3 185 23 25
11 563 9 119 27 29
EPS (USD) 2.04 1.58 29 31
5.94 4.50 32 35
Free cash flow 6 217 5 965 4

15 941 12 618 26
Core operating income 5 460 5 145 6 7
16 960 14 635 16 18
Core net income 4 330 4 133 5 6
13 522 11 822 14 17
Core EPS (USD) 2.25 2.06 9 10
6.94 5.83 19 21

Strategy 

Our focus

Novartis is a “pure-play” innovative medicines company. We have a clear focus on four core therapeutic areas (cardiovascular-renal-metabolic, immunology, neuroscience and oncology), with multiple significant in-market and pipeline assets in each of these areas, that address high disease burden and have substantial growth potential. In addition to two established technology platforms (chemistry and biotherapeutics), three emerging platforms (gene & cell therapy, radioligand therapy and xRNA) are being prioritized for continued investment into new R&D capabilities and manufacturing scale. Geographically, we are focused on growing in our priority geographies – the US, China, Germany and Japan.

Our priorities

  1. Accelerate growth: Renewed attention to deliver high-value medicines (NMEs) and focus on launch excellence, with a rich pipeline across our core therapeutic areas.
  2. Deliver returns: Continuing to embed operational excellence and deliver improved financials. Novartis remains disciplined and shareholder-focused in our approach to capital allocation, with substantial cash generation and a strong capital structure supporting continued flexibility.
  3. Strengthen foundations: Unleashing the power of our people, scaling data science and technology and continuing to build trust with society.

Financials

Third quarter

Net sales were USD 13.9 billion (+8%, +7% cc), with volume contributing 16 percentage points to growth. Generic competition had a negative impact of 7 percentage points, driven by Promacta, Tasigna and Entresto generics in the US. Pricing had a negative impact of 2 percentage points, driven by revenue deduction adjustments mainly in the US. Currency had a positive impact of 1 percentage point.

Operating income was USD 4.5 billion (+24%, +27% cc), mainly driven by higher net sales and lower impairments, partly offset by higher R&D investments.

Net income was USD 3.9 billion (+23%, +25% cc), mainly driven by higher operating income. EPS was USD 2.04 (+29%, +31% cc), benefiting from the lower weighted average number of shares outstanding.

Core operating income was USD 5.5 billion (+6%, +7% cc), mainly driven by higher net sales, partly offset by higher R&D investments. Core operating income margin was 39.3% of net sales (-0.8 percentage points, stable in cc).

Core net income was USD 4.3 billion (+5%, +6% cc), mainly due to higher core operating income, partly offset by other core financial income and expense. Core EPS was USD 2.25 (+9%, +10% cc), benefiting from the lower weighted average number of shares outstanding.

Free cash flow amounted to USD 6.2 billion (+4% USD), compared with USD 6.0 billion in the prior-year quarter, driven by higher net cash flows from operating activities.

Nine months

Net sales were USD 41.2 billion (+11%, +11% cc), with volume contributing 14 percentage points to growth. Generic competition had a negative impact of 3 percentage points, while pricing and currency had no impact.

Operating income was USD 14.0 billion (+27%, +31% cc), mainly driven by higher net sales and lower impairments, partly offset by higher investments behind priority brands and launches.

Net income was USD 11.6 billion (+27%, +29% cc), mainly driven by higher operating income. EPS was USD 5.94 (+32%, +35% cc), benefiting from the lower weighted average number of shares outstanding.

Core operating income was USD 17.0 billion (+16%, +18% cc), mainly driven by higher net sales, partly offset by higher investments behind priority brands and launches. Core operating income margin was 41.2% of net sales, increasing 1.8 percentage points (2.5 percentage points cc).

Core net income was USD 13.5 billion (+14%, +17% cc), mainly due to higher core operating income. Core EPS was USD 6.94 (+19%, +21% cc), benefiting from the lower weighted average number of shares outstanding.

Free cash flow amounted to USD 15.9 billion (+26% USD), compared with USD 12.6 billion in the prior-year period, driven by higher net cash flows from operating activities.

Q3 priority brands

Underpinning our financial results in the quarter is a continued focus on key growth drivers (ranked in order of contribution to Q3 growth) including:

Kisqali (USD 1 329 million, +68% cc) sales grew strongly across all regions, including +91% growth in the US with strong momentum from the recently launched early breast cancer indication as well as continued share gains in metastatic breast cancer.
Kesimpta (USD 1 222 million, +44% cc) sales grew across all regions driven by increased demand and strong access.
Pluvicto (USD 564 million, +45% cc) showed sustained demand growth in the US following the pre-taxane metastatic castration-resistant prostate cancer (mCRPC) approval, as well as continued access expansion ex-US in the post-taxane mCRPC setting, with 25 countries now approved including Japan.
Scemblix (USD 358 million, +95% cc) sales grew across all regions, demonstrating the continued high unmet need in CML, with strong momentum from the early-line indication in the US and Japan.
Leqvio (USD 308 million, +54% cc) continued steady growth across all regions, with a focus on increasing account and patient adoption, and continuing medical education.
Fabhalta (USD 149 million, +236% cc) sales grew, reflecting market share gains in PNH globally and continued launch progress in IgAN and C3G in the US.
Lutathera (USD 213 million, +11% cc) sales grew mainly in the US, Japan and Europe due to increased demand and earlier-line adoption.
Cosentyx (USD 1 698 million, -1% cc) sales were broadly stable, as strong volume growth in the US was partially offset by higher revenue deductions, and ex-US declined due to a one-time price effect in the prior year. Novartis remains confident in Cosentyx USD 8 billion+ peak sales guidance.
Zolgensma (USD 301 million, -5% cc) sales declined reflecting a lower incidence of SMA compared to prior year.

Net sales of the top 20 brands in the third quarter and nine months


Q3 2025 % change 9M 2025 % change

USD m USD cc USD m USD cc
Entresto 1 877 1 -1 6 495 15 15
Cosentyx
– excl. revenue deduction adjust.*
1 698

0
5
-1
4
4 861

7
9
7
9
Kisqali 1 329 69 68 3 462 62 63
Kesimpta 1 222 46 44 3 198 41 40
Tafinlar + Mekinist 550 3 1 1 675 9 9
Jakavi 539 8 4 1 555 7 6
Promacta/Revolade 362 -36 -38 1 410 -14 -14
Pluvicto 564 46 45 1 389 33 33
Ilaris 473 27 26 1 369 25 24
Xolair 440 5 3 1 339 8 8
Tasigna 221 -47 -48 925 -27 -26
Zolgensma 301 -2 -5 925 -3 -4
SandostatinGroup 302 -1 -1 922 -5 -5
Scemblix 358 97 95 894 85 84
Leqvio 308 56 54 863 63 61
Lutathera 213 12 11 613 15 14
ExforgeGroup 176 1 0 546 0 2
Lucentis 148 -40 -42 510 -39 -39
DiovanGroup 143 -5 -5 447 -1 0
GalvusGroup 126 -21 -20 373 -19 -16
Top 20 brands total 11 350 10 9 33 771 14 14

*Sales growth impacted by a one-time revenue deduction adjustment in the US

R&D update – key developments from the third quarter

New approvals

Rhapsido
(remibrutinib)
Rhapsido was approved by the FDA as an oral treatment for adult patients with chronic spontaneous urticaria (CSU) who remain symptomatic despite H1 antihistamine treatment. It is the first FDA-approved Bruton’s tyrosine kinase inhibitor (BTKi) for CSU. Remibrutinib is also in Phase III development for chronic inducible urticaria, hidradenitis suppurativa and food allergy, as well as multiple sclerosis and myasthenia gravis.

Regulatory updates

Scemblix (asciminib) The CHMP of the EMA adopted a positive opinion and recommended granting marketing authorization for Scemblix for the treatment of adult patients with Philadelphia chromosome-positive chronic myeloid leukemia in chronic phase (Ph+ CML-CP) in all lines of treatment.

Results from ongoing trials and other highlights

Ianalumab
(VAY736)
The Phase III NEPTUNUS-1 and -2 trials evaluating ianalumab in adults with active Sjögren’s disease met their primary endpoint, showing statistically significant improvements in disease activity as measured by a reduction in ESSDAI compared to placebo. Ianalumab was well tolerated and demonstrated a favorable safety profile, supporting its potential to become the first targeted treatment for this chronic autoimmune disease. Novartis plans to submit ianalumab to health authorities globally and was granted Fast Track Designation by the FDA.

In the Phase III VAYHIT2 trial, ianalumab plus eltrombopag significantly extended the time to treatment failure compared to placebo plus eltrombopag in adult patients with primary immune thrombocytopenia (ITP), previously treated with corticosteroids. The safety profile was consistent with previous studies. Data will be presented at an upcoming medical meeting and included in regulatory submissions in 2027.

Ianalumab is also in Phase III development for systemic lupus erythematosus, lupus nephritis and warm autoimmune hemolytic anemia.

Pluvicto
(lutetium Lu177
vipivotide
tetraxetan)
In the Phase III PSMAddition trial, Pluvicto plus standard-of-care (SoC) reduced risk of progression or death by 28% versus SoC alone, with a positive trend in overall survival in patients with PSMA+ metastatic hormone-sensitive prostate cancer (mHSPC). Safety remained consistent with PSMAfore and VISION trials. Data presented at ESMO.
Kisqali
(ribociclib)
The five-year analysis of the pivotal Phase III NATALEE trial in the broadest population of high-risk stage II and III HR+/HER2- early breast cancer (eBC) showed the addition of Kisqali to endocrine therapy (ET) reduced the risk of recurrence by 28.4% compared to ET alone. Data also showed a 29.1% risk reduction in distant disease-free survival, a positive trend in overall survival, and no new safety signals. Data presented at ESMO.
Cosentyx
(secukinumab)
The Phase III REPLENISH study met its primary endpoint, with Cosentyx demonstrating statistically significant and clinically meaningful sustained remission compared to placebo at week 52 in adults with relapsing polymyalgia rheumatica (PMR). Full data will be presented at an upcoming medical congress and submitted to health authorities in 2026.
Fabhalta
(iptacopan)
In the Phase III APPLAUSE-IgAN final analysis, Fabhalta demonstrated statistically significant, clinically meaningful superiority compared to placebo in slowing IgAN progression measured by annualized total slope of estimated glomerular filtration rate (eGFR) decline over two years. Full data will be presented at future medical meetings and included in regulatory submissions in 2026.
Leqvio
(Inclisiran)
In the Phase IV V-DIFFERENCE study, 85% of patients with hypercholesterolemia who had not reached guideline-recommended LDL-C targets despite optimized lipid-lowering therapy (LLT) achieved their goals with Leqvio plus LLT, versus 31% with placebo plus LLT, with benefits evident in as early as 30 days. Leqvio also reduced LDL-C by 59% over 360 days, outperforming placebo plus LLT by 35%. Data presented at ESC.
Entresto
(sacubitril/ valsartan)
Data from the Phase IV PARACHUTE-HF study in patients with heart failure with reduced ejection fraction due to chronic Chagas disease showed that Entresto outperformed enalapril on a composite endpoint of cardiovascular death, heart failure hospitalization or NT-proBNP change. Entresto was well tolerated, with no new safety signals identified. Data presented at ESC.
Kesimpta
(ofatumumab)
In the ARTIOS Phase IIIb study, patients with RMS who switched to Kesimpta after breakthrough disease on fingolimod or fumarate-based therapies showed a substantial reduction in disease activity. This was reflected in a low annualized relapse rate (ARR of 0.06 over 96 weeks), near-complete suppression of MRI activity, and over 90% of participants achieving no evidence of disease activity (NEDA-3). No new safety concerns were identified, regardless of prior disease-modifying treatment.

In the separate ALITHIOS open-label extension study, more than 90% of naïve patients receiving Kesimpta showed no evidence of disease activity (NEDA-3) at 7 years, with no new safety concerns, reinforcing the benefit of introducing Kesimpta early. Data from both studies presented at ECTRIMS.

Selected transactions Novartis entered into an agreement to acquire Tourmaline Bio, a clinical-stage biopharmaceutical company developing pacibekitug, a Phase III-ready anti-IL-6 monoclonal antibody for atherosclerotic cardiovascular disease (ASCVD). In Phase II, pacibekitug reduced median high-sensitivity C-reactive protein (hsCRP) levels by up to 86% compared to placebo, with similar incidence rates of adverse events and serious adverse events. The transaction is expected to close on October 28, 2025.

Novartis entered a second collaboration with Monte Rosa Therapeutics, in addition to the existing license agreement for VAV1 degraders, announced in October 2024. Under the new agreement, Novartis receives an exclusive license to an undisclosed discovery target and options to license two programs from Monte Rosa’s preclinical immunology portfolio.

Novartis continued its collaboration with Argo Biopharma, adding two new agreements: an exclusive license to an siRNA candidate currently in IND-enabling studies and expected to enter Phase I in 2026, and an option to exclusively license two second-generation siRNA molecules currently in development, with a right of first negotiation to the Phase II ANGPTL3 program.

Novartis entered into a global licensing and collaboration agreement with Arrowhead Pharmaceuticals for ARO-SNCA, a preclinical-stage siRNA therapy targeting alpha-synuclein for the treatment of synucleinopathies such as Parkinson’s disease. The agreement also includes additional collaboration targets leveraging Arrowhead’s proprietary Targeted RNAi Molecule (TRiM™) platform.

Capital structure and net debt

Retaining a good balance between investment in the business, a strong capital structure, and attractive shareholder returns remains a priority.

During the first nine months of 2025, Novartis repurchased a total of 66.4 million shares for USD 7.5 billion on the SIX Swiss Exchange second trading line. These repurchases included 49.1 million shares (USD 5.4 billion) under the USD 15 billion share buyback (announced in July 2023 and completed in July 2025) and 6.6 million shares (USD 0.8 billion) under the new up-to USD 10 billion share buyback announced in July 2025. In addition, 10.7 million shares (USD 1.3 billion) were repurchased to mitigate anticipated full-year dilution related to the equity-based compensation plans of associates. Further, 1.6 million shares (equity value of USD 0.2 billion) were repurchased from associates. In the same period, 11.7 million shares (equity value of USD 0.9 billion) were delivered to associates related to equity-based compensation plans. Consequently, the total number of shares outstanding decreased by 56.3 million versus December 31, 2024. These treasury share transactions resulted in an equity decrease of USD 6.8 billion and a net cash outflow of USD 7.7 billion.

Net debt increased to USD 20.4 billion at September 30, 2025, compared to USD 16.1 billion at December 31, 2024. The increase was mainly due to the free cash flow of USD 15.9 billion being more than offset by the USD 7.8 billion annual dividend payment, cash outflows for treasury share transactions of USD 7.7 billion and net cash outflow for M&A, intangible assets transactions and other acquisitions of USD 3.7 billion.

As of Q3 2025, the long-term credit rating for the company is Aa3 with Moody’s Ratings and AA- with S&P Global Ratings.

2025 outlook

Barring unforeseen events; growth vs. prior year in cc
Net sales Expected to grow high single-digit
Core operating income Expected to grow low-teens

Foreign exchange impact

If late-October exchange rates prevail for the remainder of 2025, the foreign exchange impact for the year would be neutral to positive 1 percentage point on net sales and negative 2 percentage points on core operating income. The estimated impact of exchange rates on our results is provided monthly on our website.

Key figures1


Q3 2025 Q3 2024 % change 9M 2025 9M 2024 % change

USD m USD m USD cc
USD m USD m USD cc
Net sales 13 909 12 823 8 7
41 196 37 164 11 11
Operating income 4 501 3 627 24 27
14 028 11 014 27 31
As a % of sales 32.4 28.3


34.1 29.6

Net income 3 930 3 185 23 25
11 563 9 119 27 29
EPS (USD) 2.04 1.58 29 31
5.94 4.50 32 35
Net cash flows from
operating activities
6 571 6 286 5

16 880 13 426 26
Non-IFRS measures








Free cash flow 6 217 5 965 4

15 941 12 618 26
Core operating income 5 460 5 145 6 7
16 960 14 635 16 18
As a % of sales 39.3 40.1


41.2 39.4

Core net income 4 330 4 133 5 6
13 522 11 822 14 17
Core EPS (USD) 2.25 2.06 9 10
6.94 5.83 19 21

1. Constant currencies (cc), core results and free cash flow are non-IFRS measures. An explanation of non-IFRS measures can be found on page 42 of the Condensed Interim Financial Report. Unless otherwise noted, all growth rates in this Release refer to same period in prior year.

Detailed financial results accompanying this press release are included in the Condensed Interim Financial Report at the link below:
https://ml-eu.globenewswire.com/resource/download/7781ab26-6902-4024-a9c8-49124629eb37/
  

Disclaimer

This press release contains forward-looking statements within the meaning of the United States Private Securities Litigation Reform Act of 1995, that can generally be identified by words such as “anticipate,” “can,” “will,” “continue,” “ongoing,” “growth,” “launch,” “expect,” “expand,” “deliver,” “accelerate,” “guidance,” “outlook,” “priority,” “potential,” “momentum,” “commitment,” or similar expressions, or by express or implied discussions regarding potential new products, potential new indications for existing products, potential product launches, or regarding potential future revenues from any such products; or regarding results of ongoing clinical trials; or regarding potential future, pending or announced transactions; regarding potential future sales or earnings; or by discussions of strategy, plans, expectations or intentions, including discussions regarding our continued investment into new R&D capabilities and manufacturing; or regarding our capital structure. Such forward-looking statements are based on the current beliefs and expectations of management regarding future events and are subject to significant known and unknown risks and uncertainties. Should one or more of these risks or uncertainties materialize, or should underlying assumptions prove incorrect, actual results may vary materially from those set forth in the forward-looking statements. You should not place undue reliance on these statements. There can be no guarantee that the investigational or approved products described in this press release will be submitted or approved for sale or for any additional indications or labeling in any market, or at any particular time. Nor can there be any guarantee that such products will be commercially successful in the future. Neither can there be any guarantee that the expected benefits or synergies from the transactions described in this press release will be achieved in the expected timeframe, or at all. In particular, our expectations could be affected by, among other things: uncertainties concerning global healthcare cost containment, including ongoing government, payer and general public pricing and reimbursement pressures and requirements for increased pricing transparency; uncertainties regarding the success of key products, commercial priorities and strategy; uncertainties in the research and development of new products, including clinical trial results and additional analysis of existing clinical data; our ability to obtain or maintain proprietary intellectual property protection, including the ultimate extent of the impact on Novartis of the loss of patent protection and exclusivity on key products; uncertainties regarding our ability to realize the strategic benefits, operational efficiencies or opportunities expected from our external business opportunities; uncertainties in the development or adoption of potentially transformational digital technologies, including artificial intelligence, and business models; uncertainties surrounding the implementation of our new IT projects and systems; uncertainties regarding potential significant breaches of information security or disruptions of our information technology systems; uncertainties regarding actual or potential legal proceedings, including regulatory actions or delays or government regulation related to the products and pipeline products described in this press release; safety, quality, data integrity, or manufacturing issues; our performance on and ability to comply with environmental, social and governance measures and requirements; major macroeconomic and geo- and socio-political developments, including the impact of any potential tariffs on our products or the impact of war in certain parts of the world; uncertainties regarding future global exchange rates; uncertainties regarding future demand for our products; and other risks and factors referred to in Novartis AG’s most recently filed Form 20-F and in subsequent reports filed with, or furnished to, the US Securities and Exchange Commission. Novartis is providing the information in this press release as of this date and does not undertake any obligation to update any forward-looking statements as a result of new information, future events or otherwise.

All product names appearing in italics are trademarks owned by or licensed to Novartis.

About Novartis 

Novartis is an innovative medicines company. Every day, we work to reimagine medicine to improve and extend people’s lives so that patients, healthcare professionals and societies are empowered in the face of serious disease. Our medicines reach nearly 300 million people worldwide.

Reimagine medicine with us: Visit us at https://www.novartis.com and connect with us on LinkedIn, Facebook, X and Instagram.

Novartis will conduct a conference call with investors to discuss this news release today at 14:00 Central European time and 9:00 Eastern Time. A simultaneous webcast of the call for investors and other interested parties may be accessed by visiting the Novartis website. A replay will be available after the live webcast by visiting https://www.novartis.com/investors/event-calendar.

Detailed financial results accompanying this press release are included in the Condensed Interim Financial Report at the link below. Additional information is provided on our business and pipeline of selected compounds in late-stage development. A copy of today’s earnings call presentation can be found at https://www.novartis.com/investors/event-calendar.

Important dates
October 30, 2025    Immunology pipeline event at ACR (virtual)
November 19-20, 2025 Meet Novartis Management 2025 (London, UK)
December 1, 2025 Social Impact & Sustainability annual investor event (virtual)
February 4, 2026 Fourth quarter & full year 2025 results

# # #

Novartis Media Relations
E-mail: media.relations@novartis.com

Novartis Investor Relations
Central investor relations line: +41 61 324 7944
E-mail: investor.relations@novartis.com 

Please find full media release in English attached and on the following link:
Media Release (PDF)

Further language versions are available through the following links:

German version is available through the following link:
Medienmitteilung (PDF)

Press release: Sanofi successfully prices USD 3 billion of bond issue

Press release: Sanofi successfully prices USD 3 billion of bond issue




Press release: Sanofi successfully prices USD 3 billion of bond issue

Sanofi successfully prices USD 3 billion of bond issue  

Paris, France – October 28, 2025 – Sanofi announces that it has successfully priced its offering of $3 billion of notes across 5 tranches: 

  • $400 million fixed rate notes, due November 2027, bearing interest at a rate of 3.75%. 
  • $500 million floating rate notes, due November 2027, bearing interest at compounded SOFR plus 0.46%. 
  • $400 million fixed rate notes, due November 2028, bearing interest at a rate of 3.80%. 
  • $500 million floating rate notes, due November 2028, bearing interest at compounded SOFR plus 0.54%. 
  • $1,200 million fixed rate notes, due November 2032, bearing interest at a rate of 4.20%. 

The notes are being issued pursuant to the company’s shelf registration statement filed with the US Securities and Exchange Commission on April 4, 2024.

Sanofi intends to use the net proceeds of the offering for general corporate purposes.  

Barclays Capital Inc., BNP Paribas Securitis Corp. and BofA Securities, Inc. acted as Global Coordinators, and Barclays Capital          Inc., BNP Paribas Securities Corp., BofA Securities, Inc., J.P. Morgan Securities LLC, Morgan Stanley & Co. LLC, MUFG Securities Americas Inc. and Natixis Securities Americas LLC acted as Joint Book-Running Managers. 
  
About Sanofi  
Sanofi is an R&D driven, AI-powered biopharma company committed to improving people’s lives and delivering compelling growth. We apply our deep understanding of the immune system to invent medicines and vaccines that treat and protect millions of people around the world, with an innovative pipeline that could benefit millions more. Our team is guided by one purpose: we chase the miracles of science to improve people’s lives; this inspires us to drive progress and deliver positive impact for our people and the communities we serve, by addressing the most urgent healthcare, environmental, and societal challenges of our time.

Sanofi is listed on EURONEXT: SAN and NASDAQ: SNY

Media Relations 

Sandrine Guendoul| + 33 6 25 09 14 25 | sandrine.guendoul@sanofi.com 
Evan Berland | +1 215 432 0234 | evan.berland@sanofi.com  
Victor Rouault| + 33 6 70 93 71 40 | victor.rouault@sanofi.com
Léo Le Bourhis | + 33 6 75 06 43 81 | leo.lebourhis@sanofi.com  
Timothy Gilbert| + 1 516 521 2929 | timothy.gilbert@sanofi.com 
Léa Ubaldi | +33 6 30 19 66 46 | lea.ubaldi@sanofi.com

Investor Relations 
Thomas Kudsk Larsen |+ 44 7545 513 693 | thomas.larsen@sanofi.com 
Alizé Kaisserian| + 33 6 47 04 12 11 | alize.kaisserian@sanofi.com 
Felix Lauscher| + 1 908 612 7239 | felix.lauscher@sanofi.com  
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Nathalie Pham| + 33 7 85 93 30 17 | nathalie.pham@sanofi.com  
Tarik Elgoutni | + 1 617 710 3587 | tarik.elgoutni@sanofi.com  
Thibaud Châtelet | + 33 6 80 80 89 90 | thibaud.chatelet@sanofi.com  
Yun Li | +33 6 84 00 90 72 | yun.li3@sanofi.com

  

Disclaimer 
This communication shall not constitute an offer to sell or the solicitation of an offer to buy nor shall there be any sale of these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.  When available, a written prospectus meeting the requirements of Section 10 of the US Securities Act of 1933, as amended, may be obtained, subject to applicable law, from Sanofi, 46, avenue de la Grande Armée, 75017 Paris, France.

This communication shall not constitute an offer to sell or the solicitation of an offer to buy nor shall there be any sale of these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction. This is neither an advertisement and not a prospectus for the purposes of Regulation (EU) 2017/1129 of June 14, 2017 (as amended, the “Prospectus Regulation”), nor a prospectus within the meaning of Regulation (EU) 2017/1129 as it forms part of domestic law by virtue of the European Union (Withdrawal) Act 2018 (the “UK Prospectus Regulation”), and has not been approved, filed or reviewed by any regulatory authority of a member state of the EEA or the United Kingdom. 

PROHIBITION OF SALES TO EUROPEAN ECONOMIC AREA (“EEA”) AND UNITED KINGDOM (“UK”) RETAIL INVESTORS – The Notes are not intended to be offered, sold or otherwise made available to and should not be offered, sold or otherwise made available to any retail investor in a member state of the EEA and in the UK. For these purposes, a retail investor means a person who is one (or more) of: (i) a retail client as defined in point (11) of Article 4(1) of Directive 2014/65/EU (“MiFID II”) or in point (8) of Article 2 of Regulation (EU) No 2017/565 as it forms part of UK domestic law by virtue of the European Union (Withdrawal) Act 2018 (the “EUWA”); or (ii) a customer within the meaning of Directive (EU) 2016/97 (as amended or superseded the “Insurance Distribution Directive”) or within the meaning of the provisions of the Financial Services and Markets Act 2000, as amended (the “FSMA”) and any rules or regulations made under the FSMA which were relied on immediately before exit day to implement the Insurance Distribution Directive, where that customer would not qualify as a professional client as defined in point (10) of Article 4(1) of MiFID II or in point (8) of Article 2(1) of Regulation (EU) No 600/2014 as it forms part of UK domestic law by virtue of the EUWA. Consequently no key information document required by Regulation (EU) No 1286/2014 (as amended, the “PRIIPs Regulation”, including as it forms part of domestic law by virtue of the EUWA) for offering or selling the Notes or otherwise making them available to retail investors (as defined above) in a member state of the EEA or in the UK has been or will be prepared and therefore offering or selling the Notes or otherwise making them available to any such retail investor in a member state of the EEA or in the UK may be unlawful under the PRIIPS Regulation. 
  
This communication is only being distributed to and is only directed at (i) persons who are outside the United Kingdom or (ii) persons in the United Kingdom who have professional experience in matters related to investments and who are investment professionals falling within Article 19(5) of the Financial Services and Markets Act 2000 (Financial Promotion) Order 2005 (the “Order“) or (iii) high net worth companies, and other persons to whom it may lawfully be communicated, falling within Article 49(2)(a) to (d) of the Order or (iv) persons to whom an invitation or inducement to engage in investment activity (within the meaning of section 21 of the Financial Services and Markets Act 2000) may otherwise lawfully be communicated or cause to be communicated (all such persons together being referred to as “relevant persons”). The Notes are only available to, and any invitation, offer or agreement to subscribe, purchase or otherwise acquire such Notes will be engaged in only with, relevant persons. Any person who is not a relevant person should not act or rely on this document or any of its contents.

Notes have only been offered or sold and will only be offered or sold, directly or indirectly, in France to qualified investors (investisseurs qualifiés) as referred to in Article L.411-2 1° of the French Code monétaire et financier and defined in Article 2(e) of the Prospectus Regulation, and any offering materials relating to the Notes have only been distributed or caused to be distributed and will only be distributed or caused to be distributed in France to such qualified investors. 

Sanofi forward-looking statements
This press release contains forward-looking statements as defined in the Private Securities Litigation Reform Act of 1995, as amended. Forward-looking statements are statements that are not historical facts. These statements include projections and estimates and their underlying assumptions, statements regarding plans, objectives, intentions, and expectations with respect to future financial results, events, operations, services, product development and potential, and statements regarding future performance. Forward-looking statements are generally identified by the words “expects”, “seeks”, “targets”, “goal”, “anticipates”, “believes”, “intends”, “estimates”, “plans” and similar expressions. Although Sanofi’s management believes that the expectations reflected in such forward-looking statements are reasonable, investors are cautioned that forward-looking information and statements are subject to various risks and uncertainties, many of which are difficult to predict and generally beyond the control of Sanofi, that could cause actual results and developments to differ materially from those expressed in, or implied or projected by, the forward-looking information and statements. These risks and uncertainties include among other things, the uncertainties inherent in research and development, future clinical data and analysis, including post marketing, decisions by regulatory authorities, such as the FDA or the EMA, regarding whether and when to approve any drug, device or biological application that may be filed for any such product candidates as well as their decisions regarding labelling and other matters that could affect the availability or commercial potential of such product candidates, the fact that product candidates if approved may not be commercially successful, the future approval and commercial success of therapeutic alternatives, political pressure to provide beneficial pricing in the United States including to State Medicaid programs of “most favored nation” drug prices and elsewhere, Sanofi’s ability to benefit from external growth opportunities, to complete related transactions and/or obtain regulatory clearances, risks associated with intellectual property and any related pending or future litigation and the ultimate outcome of such litigation, trends in exchange rates and prevailing interest rates, volatile economic and market conditions, cost containment initiatives and subsequent changes thereto, and the impact that global crises may have on us, our customers, suppliers, vendors, and other business partners, and the financial condition of any one of them, as well as on our employees and on the global economy as a whole. The risks and uncertainties also include the uncertainties discussed or identified in the public filings with the SEC and the AMF made by Sanofi, including those listed under “Risk Factors” and “Cautionary Statement Regarding Forward-Looking Statements” in Sanofi’s annual report on Form 20-F for the year ended December 31, 2024. Other than as required by applicable law, Sanofi does not undertake any obligation to update or revise any forward-looking information or statemen

Attachment

Qualigen Therapeutics to Rebrand as AIxCrypto After Stockholder Meeting on November 12, with Three Core Goals for 2025

Qualigen Therapeutics to Rebrand as AIxCrypto After Stockholder Meeting on November 12, with Three Core Goals for 2025




Qualigen Therapeutics to Rebrand as AIxCrypto After Stockholder Meeting on November 12, with Three Core Goals for 2025

Dubai, UAE / Beijing, China, Oct. 27, 2025 (GLOBE NEWSWIRE) — Qualigen Therapeutics Inc. (NASDAQ: QLGN) (“Qualigen”, “QLGN” or the “Company”), a publicly-traded technology company majority owned by Faraday Future Intelligent Electric Inc. (NASDAQ: FFAI) (“Faraday Future” or “FF”), today announced that it will rebrand as AIxCrypto following its stockholder meeting on November 12, 2025.

AIxCrypto’s Strategic Roadmap

QLGN (soon to be AIxCrypto) has launched its new Web3 and crypto asset business initiatives. Following its targeted rebranding on November 12, the Company will launch the public beta of its BesTrade DeAI Agent by the end of November and release its EAI RWA Utility Token Whitepaper.

By the end of 2025, AIxCrypto aims to achieve three major milestones:

  1. Expand the C10 Treasury to $50 Million AUM

Strengthen its role as the core reserve asset of the Web3 ecosystem through key products such as C10 Treasury and C10 Index — serving as the first engine of the Crypto Flywheel – as of October 17, QLGN’s C10 Treasury completed $12 million in crypto asset allocations.

  1. Accelerate Global Growth of the BesTrade DeAI Agent

As the Company’s flagship product, the BesTrade DeAI Agent acts as a Meta Exchange that intelligently connects users and value by optimizing transaction pathways and returns. Following the beta release, a global user growth campaign will begin — positioning BesTrade as a top-tier AI trading platform and the second engine of the Crypto Flywheel.

  1. Launch Crypto Ecosystem Tokens on Leading Exchanges

Supported by a potential C10 stablecoin and EAI + Crypto RWA dual-bridge products, AIxCrypto could build a sustainable on-chain value growth system — serving as the third engine of the Crypto Flywheel.

About Qualigen Therapeutics, Inc.

Qualigen Therapeutics, Inc. (NASDAQ: QLGN) is a biotechnology company based in Carlsbad, California, specializing in the development and commercialization of innovative oncology and immunology therapies. The company is also actively expanding into crypto asset and Web3 strategies, integrating cutting-edge technology with capital market innovation to accelerate global growth and ecosystem expansion.

Forward-Looking Statements

This news release contains “forward-looking statements” within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. The Company may in some cases use terms such as “predicts,” “believes,” “potential,” “continue,” “anticipates,” “estimates,” “expects,” “plans,” “intends,” “may,” “could,” “might,” “likely,” “will,” “should” or other words that convey uncertainty of the future events or outcomes to identify these forward-looking statements. The Company’s forward-looking statements are based on current beliefs and expectations of its management team that involve risks, potential changes in circumstances, assumptions, and uncertainties, including statements regarding the timing of the offering. Any or all of the forward-looking statements may turn out to be wrong or be affected by assumptions the Company makes that later turn out to be incorrect, or by known or unknown risks and uncertainties. These forward-looking statements are subject to risks and uncertainties including risks related to the Company’s ability to regain compliance with Nasdaq’s continued listing requirements, including the Company’s ability to file its Form 10-Q for the period ended September 30, 2025, or otherwise in the future, or otherwise maintain compliance with any other listing requirement of The Nasdaq Capital Market, the potential de-listing of the Company’s shares from The Nasdaq Capital Market due to its failure to comply with the Nasdaq’s continued listing requirement, or its alternatives, or otherwise in the future, and the other risks set forth in the Company’s filings with the Securities and Exchange Commission, including in its Annual Reports on Form 10-K and its Quarterly Reports on Form 10-Q. For all these reasons, actual results and developments could be materially different from those expressed in or implied by the Company’s forward-looking statements. You are cautioned not to place undue reliance on these forward-looking statements, which are made only as of the date of this news release. The Company disclaims any intent or obligation to update these forward-looking statements beyond the date of this news release, except as required by law. This caution is made under the safe harbor provisions of the Private Securities Litigation Reform Act of 1995.

Investor & Media Contact:
Investor Relations Department
Qualigen Therapeutics, Inc.
5857 Owens Avenue, Suite 300, Carlsbad, CA 92008
Tel: +1 (760) 452-8111
Email: info@qualigeninc.com

Anteris Technologies Announces First Patients Treated in DurAVR® THV Global Pivotal Trial (the “PARADIGM Trial”)

Anteris Technologies Announces First Patients Treated in DurAVR® THV Global Pivotal Trial (the “PARADIGM Trial”)




Anteris Technologies Announces First Patients Treated in DurAVR® THV Global Pivotal Trial (the “PARADIGM Trial”)

MINNEAPOLIS, United States and BRISBANE, Australia, Oct. 27, 2025 (GLOBE NEWSWIRE) — Anteris Technologies Global Corp. (Anteris or the Company) (NASDAQ: AVR, ASX: AVR) a global structural heart company committed to designing, developing, and commercializing cutting-edge medical devices to restore healthy heart function, today announced the first patients have been enrolled and successfully treated in the DurAVR® Transcatheter Heart Valve (THV) global pivotal trial for patients with severe calcific aortic stenosis (the “PARADIGM Trial”). The procedures were performed by Prof. Dr. Ole De Backer at, The Heart Center, Rigshospitalet, Copenhagen University Hospital, Copenhagen, Denmark.

“We are proud to be the first enrolling center for this important trial,“ said Prof. Dr. De Backer. “Our initial experience with the DurAVR® THV System has been very positive, and we look forward to providing definitive comparative evidence which could transform patient care.”

“With the first patients now randomized in the PARADIGM Trial, we are actively generating the clinical evidence required to advance the DurAVR® THV toward commercialisation, expanding treatment options for aortic stenosis patients,” said Anteris Chief Medical Officer, Chris Meduri, M.D. “This head-to-head study will provide robust comparative evidence across all surgical risk groups, which we believe will differentiate our platform based on efficacy, safety and ease of use.”

The PARADIGM Trial builds on Anteris’ existing clinical data set of 130 patients successfully treated with the DurAVR® THV, including de novo (first time) aortic stenosis cases, valve-in-valve (ViV) patients and complex anatomies such as bicuspid aortic valve patients. Anteris aims to drive the global PARADIGM Trial through the addition of further countries and sites in the near term, with planned expansion across the United States, Europe and Canada. Management believes strong enthusiasm from investigators is expected to translate into efficient recruitment and timely study advancement.

About the PARADIGM Trial

The PARADIGM Trial is a prospective randomized controlled trial* (RCT) which will evaluate the safety and effectiveness of the DurAVR® THV compared to commercially available transcatheter aortic valve replacements (TAVRs).

This head-to-head study will enroll approximately 1,000 patients in the ‘All Comers Randomized Cohort’ with 1:1 randomization of patients who will receive either the DurAVR® THV or TAVR using commercially available and approved THVs. The PARADIGM Trial will assess non-inferiority on a primary composite endpoint of all-cause mortality, all stroke and cardiovascular hospitalization at one year post procedure.

For further information, please refer to ClinicalTrials.gov (ClinicaTrials.gov ID NCT07194265). The planned expansion across other geographies includes additional cohorts.

*A Premarket Approval (PMA) application requires a high level of clinical evidence to demonstrate reasonable assurance of safety and effectiveness for the intended use. Randomized controlled trials are generally considered Level 1 evidence, the highest level for determining the effectiveness of interventions in evidence-based medicine given RCTs mimimize bias and allow a clear comparison between treatment groups.

About Anteris

Anteris Technologies Global Corp. (NASDAQ: AVR, ASX: AVR) is a global structural heart company committed to designing, developing, and commercializing cutting-edge medical devices to restore healthy heart function. Founded in Australia, with a significant presence in Minneapolis, USA, Anteris is a science-driven company with an experienced team of multidisciplinary professionals delivering restorative solutions to structural heart disease patients.

Anteris’ lead product, the DurAVR® Transcatheter Heart Valve (THV), was designed in partnership with the world’s leading interventional cardiologists and cardiac surgeons to treat aortic stenosis – a potentially life-threatening condition resulting from the narrowing of the aortic valve. The balloon-expandable DurAVR® THV is the first biomimetic valve, which is shaped to mimic the performance of a healthy human aortic valve and aims to replicate normal aortic blood flow. DurAVR® THV is made using a single piece of molded ADAPT® tissue, Anteris’ patented anti-calcification tissue technology. ADAPT® tissue, which is FDA-cleared, has been used clinically for over 10 years and distributed for use in over 55,000 patients worldwide. The DurAVR® THV System is comprised of the DurAVR® valve, the ADAPT® tissue, and the balloon-expandable ComASUR® Delivery System.

Forward-Looking Statements

This announcement contains forward-looking statements, including statements regarding the planned expansion of the PARADIGM Trial, the results of the PARADIGM Trial, the quotes from Prof. Dr. De Backer and Chris Meduri, M.D., the contours of the PARADIGM Trial, and the expansion of the PARADIGM trial to other countries and cohorts. Forward-looking statements include all statements that are not historical facts. Forward-looking statements generally are identified by the words “believe,” “project,” “expect,” “anticipate,” “estimate,” “intend,” “budget,” “target,” “aim,” “strategy,” “plan,” “guidance,” “outlook,” “may,” “should,” “could,” “will,” “would,” “will be,” “will continue,” “will likely result” and similar expressions, although not all forward-looking statements contain these identifying words. These forward-looking statements are subject to a number of risks, uncertainties, and assumptions, including those described under “Risk Factors” in Anteris’ Annual Report on Form 10-K for the fiscal period ended December 31, 2024 that was filed with the SEC and ASX. Readers are cautioned not to put undue reliance on forward-looking statements, and except as required by law, Anteris does not assume any obligation to update any of these forward-looking statements to conform these statements to actual results or revised expectations.

For more information:    
     
Investor Relations       Investor Relations (US)
investor@anteristech.com     mchatterjee@bplifescience.com
Debbie Ormsby     Malini Chatterjee, Ph.D.
Anteris Technologies Global Corp.      Blueprint Life Science Group
+61 1300 550 310 | +61 7 3152 3200      +1 917 330 4269
     
Website         www.anteristech.com     
X                    @AnterisTech    
LinkedIn        https://www.linkedin.com/company/anteristech     

Aurora Spine Launches New Biologics Portfolio

Aurora Spine Launches New Biologics Portfolio




Aurora Spine Launches New Biologics Portfolio

New Aurora Biologics Division Establishes Aurora Spine as a Vertically Integrated Source for Spinal Implants and Biologics

CARLSBAD, CA, Oct. 27, 2025 (GLOBE NEWSWIRE) — Aurora Spine Corporation (“Aurora Spine”) (TSXV: ASG) (OTCQB: ASAPF), a leader in minimally invasive spine and interventional pain solutions, today announced the launch of Aurora Biologics, a new division dedicated to advancing spinal fusion success through best-in-class biologic innovation.

The establishment of Aurora Biologics creates seamless synergy across Aurora’s growing spine ecosystem—including its renowned interspinous, lumbar, and sacroiliac fusion systems such as ZIP™, Hydra A.E.R.O.™, DEXA™, and SiLO™ portfolios. These mechanical and regenerative technologies now converge within one integrated platform designed to enhance patient outcomes, improve surgical efficiency, and promote long-term fusion integrity.

Please click to view image

Comprehensive Biologic Solutions

Aurora Biologics launches with a complete suite of allograft solutions, including:

  • TURBO FUSE™ Fiber Putty – a bone graft substitute composed of demineralized bone fibers that increase surface area and promote cellular attachment.
  • OSTEO GRAFT™ DBM Putty – a demineralized cortical bone graft with a cohesive, moldable consistency to support bone formation without synthetic carriers.
  • OSTEO BRIDGE™ Sponge Strips – a sponge-like bone graft substitute that conforms to patient anatomy and fills bone voids to support structural regeneration.

Each biologic is formulated from 100 percent allograft bone, free of synthetic carriers, delivering natural osteoconductive and osteoinductive properties for predictable, high-quality bone growth. Fully moldable and cohesive, these materials are designed to fill bony defects or augment fusion sites, providing a natural biologic scaffold for bone regeneration.

Engineered to work synergistically with Aurora’s implant technologies, the Aurora Biologics line creates a comprehensive, biologically active fusion environment that optimizes outcomes for both patients and surgeons.

Executive Commentary

“Aurora Biologics completes our strategy of providing customers with a seamless, fully integrated portfolio,” said Mathew Goldstone, Chief Commercial Officer of Aurora Spine. “Each of our mechanical fusion systems—whether lumbar, SI, or cervical—is designed to promote bone growth. With the addition of Aurora Biologics, we now enhance the healing phase as well, allowing surgeons to deliver a fully optimized fusion procedure from start to finish.”

“Our new Aurora Biologics platform not only reinforces our commitment to improved clinical outcomes but also serves as a strong growth catalyst,” said Trent J. Northcutt, President & CEO of Aurora Spine. “By integrating biologics across our minimally invasive product portfolio, we anticipate more than a 30 percent increase over prior biologic offerings—driving stronger margins and creating a powerful new profit engine for Aurora Spine.”

Setting a New Standard in Spine Care

Aurora Spine believes the introduction of Aurora Biologics will set a new benchmark for biologic performance in spine care. True to the company’s philosophy of “Simplifying the Complex,” these products are designed to be best-in-class—easy to use, clinically effective, and backed by Aurora Spine’s unwavering commitment to innovation and quality.

About Aurora Spine

Aurora Spine Corporation (TSXV: ASG) (OTCQB: ASAPF) is an innovative designer and manufacturer of minimally invasive spinal implants and interventional pain management technologies. Headquartered in Carlsbad, California, the company’s mission is to improve spinal surgery outcomes through simplified, integrated, and cost-effective solutions that advance patient care worldwide.

Additional information can be accessed at www.aurora-spine.com or www.aurorapaincare.com. Neither TSX Venture Exchange nor its Regulation Services Provider (as that term is defined in the policies of the TSX Venture Exchange) accepts responsibility for the adequacy or accuracy of this release.

Forward-Looking Statements

This news release contains statements that constitute “forward-looking information” within the meaning of applicable Canadian securities laws and “forward-looking statements” within the meaning of the U.S. Private Securities Litigation Reform Act of 1995 (collectively, “forward-looking statements”). Forward-looking statements include, but are not limited to, statements regarding the expected performance, commercial success, or market adoption of the Aurora Biologics product line; anticipated revenue growth or margin improvements; and the company’s plans, objectives, expectations, or intentions.

Forward-looking statements are based on management’s current expectations and assumptions and are subject to known and unknown risks, uncertainties, and other factors that may cause actual results, performance, or achievements to differ materially from those expressed or implied. Such factors include, among others, changes in regulatory environments, competitive conditions, demand for the company’s products, and other risks detailed from time to time in Aurora Spine’s public filings with securities regulators.

Readers are cautioned not to place undue reliance on forward-looking statements. Aurora Spine undertakes no obligation to update or revise any forward-looking statement, except as required by applicable securities laws.

Company and investor Contacts

Aurora Spine Corporation
Trent Northcutt
President and Chief Executive Officer
Phone: (760) 424-2004

Chad Clouse
Chief Financial Officer
Phone: (760) 424-2004
Website: www.aurora-spine.com

Investor Relations
Adam Lowensteiner
Lytham Partners
Phone: (646) 829-9702
Email: asapf@lythampartners.com

Elixir Medical Announces Significant Late Breaking Clinical Results for DynamX® Bioadaptor Demonstrating Nearly 50% Reduction in Coronary Event Rates vs. Current PCI Standard of Care

Elixir Medical Announces Significant Late Breaking Clinical Results for DynamX® Bioadaptor Demonstrating Nearly 50% Reduction in Coronary Event Rates vs. Current PCI Standard of Care




Elixir Medical Announces Significant Late Breaking Clinical Results for DynamX® Bioadaptor Demonstrating Nearly 50% Reduction in Coronary Event Rates vs. Current PCI Standard of Care

Results were presented at the Transcatheter Cardiovascular Therapeutics (TCT) Conference 2025 in San Francisco on October 27, 2025

DynamX® bioadaptor is the first interventional technology to demonstrate significant benefit with a reduction in long term adverse events in two consecutive randomized controlled trials

MILPITAS, Calif., Oct. 27, 2025 (GLOBE NEWSWIRE) — Elixir Medical, a developer of disruptive technologies to treat cardiovascular disease, today announced new landmark clinical results for its DynamX® bioadaptor, a coronary implant designed to restore a blood vessel’s natural movement and function, also known as hemodynamic modulation, demonstrating a 48% risk reduction in device-related cardiac events compared to current-generation drug-eluting stent.

The findings, presented on October 27th at the Transcatheter Cardiovascular Therapeutics (TCT) Conference 2025 in San Francisco, mark a major advance in coronary interventions after two decades of attempts to improve stenting outcomes.

The results show that the DynamX® bioadaptor achieved a 48% reduction in Target Lesion Failure (TLF) endpoint encompassing reductions in cardiac death, target vessel myocardial infarction, and ischemia-driven target lesion revascularization – from six months through two years (HR: 0.52 [0.29–0.93], p=0.027) in prespecified landmark superiority analysis.

Additional findings include:

  • Significant reduction in Target Vessel Failure (TVF) (p=0.048) from six months through two years in prespecified landmark analysis.
  • Substantial clinical benefit for high-risk patients with Acute Coronary Syndrome (ACS) (p=0.018) from six months through two years in prespecified landmark analysis.

“The INFINITY-SWEDEHEART long-term landmark results confirm our trial design hypothesis, demonstrating separation of the event curves for Target Lesion Failure (TLF) at six months and maintaining consistency up to two years with a reduction of TLF by 48%. Our data validates the unique property of the bioadaptor of restoring coronary physiology after unlocking after half a year, which translates into improved clinical outcomes long-term,” said Principal Investigator David Erlinge, M.D., Ph.D., Head of the Cardiology Department at Lund University, Lund, Sweden.

The TCT presentation comes amid renewed global focus on rethinking coronary artery disease management. The recent Lancet Commission on rethinking coronary disease called for a paradigm shift from symptom-based treatment to earlier prevention and intervention, citing that cardiovascular disease affects roughly 19% of the global population and remains the world’s leading cause of death.

In addition to delivering the DynamX® bioadaptor’s impressive results, presentations from multiple leading physicians investigating and demonstrating successful clinical outcomes with Elixir Medical technologies garnered a heavy podium presence each day at the TCT Conference. From October 25th through the 28th, investigators are unveiling new clinical and case performance data regarding the company’s LithiX™ Hertz Contact Intravascular Lithotripsy (HC-IVL) device while leading the discussion on topics like Is It Time to Move Beyond Stents for Lasting Patient Outcomes? and The Rebirth of Novel Technologies for Coronary PCI.

As highlighted in a recent Wall Street Journal piece on physicians’ efforts to improve coronary artery disease treatment, in-stent restenosis and thrombosis after angioplasty (PCI) continue to drive repeat interventions and adverse outcomes despite widespread use of drug-eluting stents, adding to worsening long-term patient prognosis and significant healthcare costs. The DynamX® bioadaptor directly addresses these stent related issues by unlocking, adapting, and allowing the artery to heal and return to natural motion after fixated support is no longer needed: a key limitation of drug-eluting stents.

About DynamX® Coronary Bioadaptor System

The DynamX® bioadaptor is the first coronary implant technology designed to restore coronary artery hemodynamic modulation as demonstrated by restored vessel pulsatility, compliance, and adaptive increase in blood flow volume, and reduction in plaque progression. With its unique mechanism of action (MOA), it addresses the shortcomings of drug-eluting stents and bioresorbable scaffolds (BRS) with remarkably low clinical event rates that showed a plateau from six months through three-year clinical follow-up in BIOADAPTOR-RCT trial.

The DynamX® Sirolimus Eluting Coronary Bioadaptor System is an investigational device in the United States limited by United States law to investigational use. The DynamX® Coronary Bioadaptor System is CE-mark approved.

About Elixir Medical

Elixir Medical Corporation, a privately held company based in Milpitas, California, develops disruptive platforms to treat coronary and peripheral artery disease. Our transformative technologies have multiple applications across the cardiovascular space capable of delivering improved clinical outcomes for millions of patients. Elixir Medical was named to Fast Company’s prestigious list of the World’s Most Innovative Companies of 2025 and Fierce Medtech’s 2025 Fierce 15 list. Visit us at www.elixirmedical.com and on LinkedIn and X.

Media Contact

Richard Laermer
RLM PR
elixir@rlmpr.com
(212) 741-5106 X 216

Neuphoria Therapeutics Adopts Limited-Duration Stockholder Rights Plan to Protect Integrity of Process

Neuphoria Therapeutics Adopts Limited-Duration Stockholder Rights Plan to Protect Integrity of Process




Neuphoria Therapeutics Adopts Limited-Duration Stockholder Rights Plan to Protect Integrity of Process

BURLINGTON, Mass., Oct. 27, 2025 (GLOBE NEWSWIRE) — Neuphoria Therapeutics Inc. (“Neuphoria” or the “Company”) (Nasdaq: NEUP), a clinical-stage biotechnology company developing impactful treatments for neuropsychiatric disorders, today announced that its Board of Directors (the “Board”) has determined to adopt a limited-duration stockholder rights plan (the “Rights Plan”), effective immediately. The Board adopted the Rights Plan in response to significant and rapid accumulations of the Company’s publicly traded common stock by certain investors.  

The Rights Plan is intended to protect the interests of the Company and its stockholders, help ensure that all interested parties have the opportunity to participate fairly in any strategic review process and to provide the Board time to make informed decisions. The Rights Plan will reduce the likelihood that any entity, person or group gains control of Neuphoria through open-market accumulation without paying all stockholders an appropriate control premium.

It is important to note that the Rights Plan does not preclude the Board from engaging with parties or considering proposals or other strategic alternatives that it believes recognize the full value of the Company and are in the best interests of Neuphoria and all stockholders.

The Rights Plan, which is similar to other plans adopted by publicly held companies, does not contain any dead-hand, slow-hand, no-hand or similar feature that limits the ability of the Board to redeem the rights.

In connection with the adoption of the Rights Plan, the Board declared a dividend of one preferred share purchase right for each outstanding share of the Company’s common stock as of the close of business on October 27, 2025, the record date. Under the Rights Plan, the rights will become exercisable if an entity, person or group acquires beneficial ownership of 15% or more of Neuphoria’s outstanding common stock in a transaction not approved by the Board.

In the event that the rights become exercisable due to the ownership threshold being crossed after the date hereof, each right will entitle its holder (other than the person, entity or group triggering the Rights Plan, whose rights will become void and will not be exercisable) to purchase additional shares of common stock having a then-current market value of twice the exercise price of the rights. Any stockholders with beneficial ownership of the Company’s outstanding common stock at or above the applicable threshold prior to this announcement are grandfathered at their current ownership levels but are not permitted to increase their ownership without triggering the Rights Plan. In addition, the Rights Plan has customary flip-over and exchange features.

Subject to the terms of the Rights Plan, the rights will expire on October 27, 2026, unless the rights are earlier redeemed or exchanged by Neuphoria. Additional information regarding the Rights Plan will be contained in a Form 8-K to be filed by Neuphoria with the U.S. Securities and Exchange Commission.

About Neuphoria Therapeutics Inc.

Neuphoria (Nasdaq: NEUP) is a clinical-stage biotechnology company dedicated to developing therapies that address the complex needs of individuals affected by neuropsychiatric disorders. Neuphoria was previously advancing its lead drug candidate, BNC-210, an oral, proprietary, selective negative allosteric modulator of the α7 nicotinic acetylcholine receptor, for the acute, “as needed” treatment of social anxiety disorder (SAD) and for chronic treatment of post-traumatic stress disorder (PTSD). BNC-210 is a first-of-its-kind, well-tolerated, broad spectrum anti-anxiety experimental therapeutic, designed to restore neurotransmitter balance in relevant brain areas, providing rapid relief from stress and anxiety symptoms without the common pitfalls of sedation, cognitive impairment, or addiction; however, following the announcement from the AFFIRM-1 Phase 3 clinical trial on October 20, 2025, in which the Company announced that the trial missed its primary and secondary endpoints, the Company has halted development of BNC-210 in SAD and is conducting a strategic review. In addition, Neuphoria has a strategic partnership with Merck & Co., Inc. (known as MSD outside the United States and Canada) with two drugs in early-stage clinical trials for the treatment of cognitive deficits in Alzheimer’s disease and other central nervous system conditions. Neuphoria’s pipeline also includes the α7 nicotinic acetylcholine receptor next generation and the Kv3.1/3.2 preclinical programs, both in the lead optimization development stage.

Forward-Looking Statements

Neuphoria cautions that statements included in this press release that are not a description of historical facts are forward-looking statements. Words such as “may,” “could,” “will,” “would,” “should,” “expect,” “plan,” “anticipate,” “believe,” “estimate,” “intend,” “predict,” “seek,” “contemplate,” “potential,” “continue” or “project” or the negative of these terms or other comparable terminology are intended to identify forward-looking statements. The forward-looking statements are based on our current beliefs, plans, burn rate and expectations. Certain forward-looking statements, including (without limitation) about (1) Neuphoria’s ability to develop and expand its business, successfully complete development of its current product candidates, the timing of commencement and/or completion, as well as any successful or other outcome of various clinical trials, and receipt of data and current and future collaborations for the development and commercialization of its product candidates, (2) the market for drugs to treat CNS diseases and pain conditions, and the Company’s ability to realize the commercial potential of its products, as well as its regulatory strategy related to its clinical trials and, if successful, the regulatory pathway to any next stage in development or commercialization, (3) Neuphoria’s financial resources, and capital allocation and corporate development strategy, and (4) assumptions underlying any such statements. The inclusion of forward-looking statements should not be regarded as a representation by Neuphoria that any of its plans will be achieved. Future events and actual results could differ materially from those set out in, contemplated by or underlying the forward-looking statements due to a number of important factors. Certain forward-looking statements involve contracts, licenses and arrangements involving third parties and their respective clinical trial and research and development projects that are out of our control, including our agreements with Merck and Carina. They may terminate or delay any or all such projects in their discretion pursuant to the terms of our agreements with them, which could result in the Company not realizing any further milestone payments or further progress on the respective product pathways. Actual results may differ materially from those set forth in this release due to the risks and uncertainties inherent in the Company’s business and other risks described in the Company’s filings with the SEC, including the Company’s Annual Report on Form 10-K, Quarterly Report on Form 10-Q, Current Reports on Form 8-K, each filed with the SEC, and its other reports. Investors are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof, and Neuphoria undertakes no obligation to revise or update this news release to reflect events or circumstances after the date hereof. Further information regarding these and other risks, uncertainties and other factors is included in Neuphoria’s filings with the SEC, copies of which are available from the SEC’s website (www.sec.gov) and on Neuphoria’s website (www.neuphoriatx.com) under the heading “Investor Center.” All forward-looking statements are qualified in their entirety by this cautionary statement. This caution is made under the safe harbor provisions of Section 21E of the Private Securities Litigation Reform Act of 1995. Neuphoria expressly disclaims all liability in respect to actions taken or not taken based on any or all the contents of this press release.

FOR FURTHER INFORMATION PLEASE CONTACT:

General
Spyridon (Spyros) Papapetropoulos
spyros@neuphoriatx.com
IR & PR
Argot Partners
neuphoria@argotpartners.com
   

Amwell® to report third quarter 2025 operating results; company leaders to attend upcoming investor conferences

Amwell® to report third quarter 2025 operating results; company leaders to attend upcoming investor conferences




Amwell® to report third quarter 2025 operating results; company leaders to attend upcoming investor conferences

BOSTON, Oct. 27, 2025 (GLOBE NEWSWIRE) — Amwell® (NYSE: AMWL), a leading provider of a comprehensive SaaS-based software platform for technology-enabled healthcare, will report third quarter 2025 operating results after stock market trading hours on Tuesday, Nov. 4.

Following the distribution of the earnings alert via wire services, the Amwell management team will host a live conference call and webcast at 5 p.m. ET to review the company’s operating results and provide a general business update.

The full earnings report and the live audio webcast can be accessed by visiting the Investors section of the company’s website. A webcast replay of the call will be available at investors.amwell.com for approximately 90 days.

In addition, company executives will attend these upcoming investor conferences:

  • Mark Hirschhorn, CFO and COO, will participate in one-on-one meetings at the UBS Global Healthcare Conference on Nov. 11 in Palm Beach Gardens. Fl.
  • Mark Hirschhorn, will participate in a panel discussion titled “Transforming a Sick-Care System into a Health-Care System,” taking place virtually at 8:00 a.m. ET at the BTIG Digital Health Forum on Nov. 24.

An audio webcast of the fireside chat will be available at investors.amwell.com.

About Amwell  
Amwell offers payers and health systems a single, comprehensive, technology-enabled care platform. We use technology to provide patients with better access to more convenient, affordable and effective care. The Amwell platform includes software and services that power many clinical programs from Amwell and our growing number of partners. Our platform allows patients to experience unified, personalized and simple access to diversified clinical programs across the care continuum. As more people seek care online and more clinical programs become available, we offer integrated, future-ready, consistent solutions. The Amwell platform is proven, operating at a large scale, enabling care for millions of patients and their sponsors while delivering dependable outcomes. For almost two decades, Amwell has proudly served some of the largest and most sophisticated healthcare organizations in the U.S. and worldwide. For more information, visit business.amwell.com or LinkedIn.

Investors:
Asher Dewhurst
amwell@icrhealthcare.com

Media:
press@amwell.com

Myriad Genetics to Release Third Quarter 2025 Financial Results on November 3, 2025

Myriad Genetics to Release Third Quarter 2025 Financial Results on November 3, 2025




Myriad Genetics to Release Third Quarter 2025 Financial Results on November 3, 2025

SALT LAKE CITY, Oct. 27, 2025 (GLOBE NEWSWIRE) — Myriad Genetics, Inc. (NASDAQ: MYGN), a leader in molecular diagnostic testing and precision medicine, will hold its third quarter 2025 earnings conference call at 4:30 pm ET on Monday, Nov. 3, 2025. The company’s quarterly earnings will be released the same day after the market closes. During the call, Myriad management will provide a financial overview and business update of the company’s performance for the third quarter 2025.

A live webcast of the conference call can be accessed on Myriad’s Investor Relations website at investor.myriad.com. To participate in the live conference call via telephone, please register here. Upon registering, a dial-in number and unique PIN will be provided to join the conference call. An archived webcast of the call will be available at investor.myriad.com following the call.

About Myriad Genetics
Myriad Genetics is a leading molecular diagnostic testing and precision medicine company dedicated to advancing health and well-being for all. Myriad Genetics develops and offers molecular tests that help assess the risk of developing disease or disease progression and guide treatment decisions across medical specialties where molecular insights can significantly improve patient care and lower healthcare costs. For more information, visit www.myriad.com.

Investor Contact 
Matt Scalo 
(801) 584-3532 
IR@myriad.com 

Media Contact 
Kate Schraml
(224) 875-4493
PR@myriad.com

Hapbee Appoints New Leaders to Accelerate Women’s Wellness Through Frequency Healing Technology

Hapbee Appoints New Leaders to Accelerate Women’s Wellness Through Frequency Healing Technology




Hapbee Appoints New Leaders to Accelerate Women’s Wellness Through Frequency Healing Technology

Expanding focus into FemTech positions Hapbee to scale across a USD 177 billion market by uniting neuroscience, sleep optimization, and women-led innovation

VANCOUVER, British Columbia, Oct. 27, 2025 (GLOBE NEWSWIRE) — Hapbee Technologies Inc. (“Hapbee” or the “Company”) (TSXV: HAPB | OTCQB: HAPBF | FWB: HA1) — Hapbee Technologies Inc. (“Hapbee”), the pioneer in frequency-based digital wellness technology, today announced the appointment of Jodie Jackson as Chief Neural Optimization Officer and Nancy H. Rothstein as Chief Sleep Officer.

These additions mark a defining moment for Hapbee’s evolution as the company deepens its commitment to women’s wellness – a sector rapidly transforming the global health landscape. The initiative aligns with Hapbee’s long-term growth strategy to scale its proprietary frequency-based platform across the expanding FemTech market, which is projected to surpass USD 177 billion by 2033 with annual growth exceeding 13% CAGR (Straits Research, 2025).

Jodie Jackson, an authority in behavioral neuroscience and neuroplasticity, will lead Hapbee’s efforts to design personalized neural frequency protocols that address cognitive, emotional, and hormonal balance. Nancy H. Rothstein, MBA – internationally known as The Sleep Ambassador® – will oversee the development of Hapbee’s sleep programs and hospitality integrations, drawing on decades of experience in providing sleep information and education to optimize its impact on productivity, health, and life.

“No one is better equipped to inform the world – and shape the products that serve women – than women themselves,” said Riz Shah, Chairman of Hapbee Technologies. “As a father, son, sibling, and husband, I’ve seen firsthand how women shoulder immense emotional and physical demands. Supporting women’s wellness isn’t a marketing campaign; it’s essential to Hapbee’s mission and a major part of the next chapter of our growth. We’re incredibly proud to lead with empathy, science, and purpose.”

The company’s upcoming innovations will include new frequency routines designed to support hormonal harmony, stress management, and restorative sleep. Partnerships with women’s health networks, wellness practitioners, and hotel groups will further scale the reach of Hapbee’s technology globally.

“Everyone deserves technologies created with them in mind—not retrofitted after the fact, particularly for women,” said Nancy H. Rothstein, Chief Sleep Officer. “Sleep is critical to our health – and Hapbee offers a safe, natural path to restore rest, recharge energy, and reclaim emotional balance without consuming unnecessary pills or medicines.”

“It’s a privilege to join Hapbee in advancing women’s wellness through innovative frequency technologies,” added Jodie Jackson, Chief Neural Optimization Officer. “As a mother and working professional focused on unlocking human potential, I am excited to contribute to shaping how Hapbee’s technology can empower people to optimize focus, rest and resilience.”

About Hapbee

Hapbee Technologies Inc. is a leading wearable neuro-wellness company using proprietary ultra-low frequency technology to help people enhance their sleep, focus, and relaxation—safely and naturally. Hapbee’s products are trusted by wellness professionals, high performers, and consumers across more than 40 countries.

Forward‑Looking Information

This news release contains “forward‑looking information” within the meaning of applicable securities laws, including statements regarding Hapbee’s anticipated expansion in FemTech, and growth opportunities in wellness markets. Forward‑looking information is subject to risks and uncertainties that may cause actual results to differ materially. Hapbee undertakes no obligation to update forward‑looking information except as required by law.

Forward-looking statements involve known and unknown risks, uncertainties and other factors which may cause the actual results, performance or achievements of the Company to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements. Such factors include, among others, the receipt of applicable regulatory approvals, closing of the offering; anticipated product development, consumer confidence and general business, economic, competitive, political and social uncertainties. Although the Company has attempted to identify important factors that could cause actual actions, events or results to differ materially from those described in forward-looking statements, there may be other factors that cause actions, events or results to differ from those anticipated, estimated or intended. Forward-looking statements contained herein are made as of the date of this news release and the Company disclaims any obligation to update any forward-looking statements, whether as a result of new information, future events or results, except as may be required by applicable securities laws. There can be no assurance that forward-looking statements will prove to be accurate as actual results, and future events could differ materially from those anticipated in such statements.

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

For further information, please contact:

On behalf of the Board of Directors:

Kenny Adessky – Corporate Secretary

1 888 841 7086

invest@hapbee.com

www.hapbee.com