NeurAxis Achieves Medical Coverage Policy Milestone, Expanding Access to Approximately 45 million additional Covered Lives




NeurAxis Achieves Medical Coverage Policy Milestone, Expanding Access to Approximately 45 million additional Covered Lives

Total national coverage footprint for PENFS increases to roughly 100 million covered lives

CARMEL, Ind., Dec. 19, 2025 (GLOBE NEWSWIRE) — NeurAxis, Inc. (“NeurAxis” or the “Company”) (NYSE American: NRXS), a medical technology company commercializing neuromodulation therapies for chronic and debilitating conditions in children and adults, today announced significant new medical policy coverage from a major national health insurer for Percutaneous Electrical Nerve Field Stimulation (“PENFS”). The coverage spans multiple states and represents approximately 45 million health plan members.

NeurAxis’ proprietary PENFS technology, IB-Stim, is FDA-cleared for the treatment of functional abdominal pain associated with irritable bowel syndrome (IBS) and Functional Dyspepsia (FD) including associated nausea symptoms in patients 8 years and older. IB-Stim is a non-invasive neuromodulation device that gently stimulates cranial nerve bundles in the ear to help regulate pain signaling between the gut and the brain. Currently, no FDA-approved drug therapies exist for pediatric patients with abdominal pain related to functional dyspepsia, a significant unmet medical need. In the absence of approved options, off-label prescription drugs are often used, despite limited efficacy data and potential safety concerns—underscoring IB-Stim’s unique position as the only FDA-cleared therapy specifically designed for this large and underserved pain related patient population.

“We are extremely pleased to see medical policy coverage for PENFS from one of the nation’s leading health insurers, and we are working aggressively to secure additional large national insurers,” said Brian Carrico, Chief Executive Officer of NeurAxis. “This milestone demonstrates the growing clinical and payer recognition of IB-Stim as a necessary, evidence-based therapy for pediatric gastrointestinal disorders. With a Category I CPT code taking effect January 1, 2026, and our proprietary PENFS technology incorporated into leading national society clinical practice guidelines, NeurAxis is well positioned for significant revenue growth and margin expansion. Supported by a strengthened balance sheet, the Company is prepared to capitalize on the accelerating demand ahead.”

About NeurAxis, Inc.
NeurAxis, Inc., is a medical technology company focused on neuromodulation therapies to address chronic and debilitating conditions in children and adults. NeurAxis is dedicated to advancing science and leveraging evidence-based medicine to drive adoption of its IB-Stim™ therapy, which is its proprietary Percutaneous Electrical Nerve Field Stimulation (PENFS) technology, by the medical, scientific, and patient communities. IB-Stim™ is FDA cleared for functional abdominal pain associated with irritable bowel syndrome (IBS) and functional dyspepsia in patients 8 years and older. Additional clinical trials of PENFS in multiple pediatric and adult conditions with large unmet healthcare needs are underway.

For more information, please visit http://neuraxis.com.

For contraindications, precautions, warnings, and IFU, please see: https://ibstim.com/important-information/.

Forward-Looking Statements

Certain statements in this press release are 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. All statements other than statements of historical fact are forward-looking statements. Forward-looking statements are based on management’s current assumptions and expectations of future events and trends, which affect or may affect the Company’s business, strategy, operations or financial performance, and actual results and other events may differ materially from those expressed or implied in such statements due to numerous risks and uncertainties. Forward-looking statements are inherently subject to risks and uncertainties, some of which cannot be predicted or quantified. There are a number of important factors that could cause actual results, developments, business decisions or other events to differ materially from those contemplated by the forward-looking statements in this press release. These factors include, among other things, the conditions in the U.S. and global economy, the trading price and volatility of the Company’s stock, public health issues or other events, the Company’s compliance with applicable laws, the results of the Company’s clinical trials and perceptions thereof, the results of submissions to the FDA, and factors described in the Risk Factors section of NeurAxis’s public filings with the Securities and Exchange Commission (SEC). Because forward-looking statements are inherently subject to risks and uncertainties, you should not rely on these forward-looking statements as predictions of future events. These forward-looking statements speak only as of the date of this press release and, except to the extent required by applicable law, the Company undertakes no obligation to update or revise these statements, whether as a result of any new information, future events and developments or otherwise.

Contacts:

Company
NeurAxis, Inc.
info@neuraxis.com
For contraindications, precautions, warnings, and IFU, please see: https://ibstim.com/important-information/.

Investor Relations
Lytham Partners
Ben Shamsian
646-829-9701
shamsian@lythampartners.com

NeurAxis Achieves Medical Coverage Policy Milestone, Expanding Access to Approximately 45 million additional Covered Lives




NeurAxis Achieves Medical Coverage Policy Milestone, Expanding Access to Approximately 45 million additional Covered Lives

Total national coverage footprint for PENFS increases to roughly 100 million covered lives

CARMEL, Ind., Dec. 19, 2025 (GLOBE NEWSWIRE) — NeurAxis, Inc. (“NeurAxis” or the “Company”) (NYSE American: NRXS), a medical technology company commercializing neuromodulation therapies for chronic and debilitating conditions in children and adults, today announced significant new medical policy coverage from a major national health insurer for Percutaneous Electrical Nerve Field Stimulation (“PENFS”). The coverage spans multiple states and represents approximately 45 million health plan members.

NeurAxis’ proprietary PENFS technology, IB-Stim, is FDA-cleared for the treatment of functional abdominal pain associated with irritable bowel syndrome (IBS) and Functional Dyspepsia (FD) including associated nausea symptoms in patients 8 years and older. IB-Stim is a non-invasive neuromodulation device that gently stimulates cranial nerve bundles in the ear to help regulate pain signaling between the gut and the brain. Currently, no FDA-approved drug therapies exist for pediatric patients with abdominal pain related to functional dyspepsia, a significant unmet medical need. In the absence of approved options, off-label prescription drugs are often used, despite limited efficacy data and potential safety concerns—underscoring IB-Stim’s unique position as the only FDA-cleared therapy specifically designed for this large and underserved pain related patient population.

“We are extremely pleased to see medical policy coverage for PENFS from one of the nation’s leading health insurers, and we are working aggressively to secure additional large national insurers,” said Brian Carrico, Chief Executive Officer of NeurAxis. “This milestone demonstrates the growing clinical and payer recognition of IB-Stim as a necessary, evidence-based therapy for pediatric gastrointestinal disorders. With a Category I CPT code taking effect January 1, 2026, and our proprietary PENFS technology incorporated into leading national society clinical practice guidelines, NeurAxis is well positioned for significant revenue growth and margin expansion. Supported by a strengthened balance sheet, the Company is prepared to capitalize on the accelerating demand ahead.”

About NeurAxis, Inc.
NeurAxis, Inc., is a medical technology company focused on neuromodulation therapies to address chronic and debilitating conditions in children and adults. NeurAxis is dedicated to advancing science and leveraging evidence-based medicine to drive adoption of its IB-Stim™ therapy, which is its proprietary Percutaneous Electrical Nerve Field Stimulation (PENFS) technology, by the medical, scientific, and patient communities. IB-Stim™ is FDA cleared for functional abdominal pain associated with irritable bowel syndrome (IBS) and functional dyspepsia in patients 8 years and older. Additional clinical trials of PENFS in multiple pediatric and adult conditions with large unmet healthcare needs are underway.

For more information, please visit http://neuraxis.com.

For contraindications, precautions, warnings, and IFU, please see: https://ibstim.com/important-information/.

Forward-Looking Statements

Certain statements in this press release are 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. All statements other than statements of historical fact are forward-looking statements. Forward-looking statements are based on management’s current assumptions and expectations of future events and trends, which affect or may affect the Company’s business, strategy, operations or financial performance, and actual results and other events may differ materially from those expressed or implied in such statements due to numerous risks and uncertainties. Forward-looking statements are inherently subject to risks and uncertainties, some of which cannot be predicted or quantified. There are a number of important factors that could cause actual results, developments, business decisions or other events to differ materially from those contemplated by the forward-looking statements in this press release. These factors include, among other things, the conditions in the U.S. and global economy, the trading price and volatility of the Company’s stock, public health issues or other events, the Company’s compliance with applicable laws, the results of the Company’s clinical trials and perceptions thereof, the results of submissions to the FDA, and factors described in the Risk Factors section of NeurAxis’s public filings with the Securities and Exchange Commission (SEC). Because forward-looking statements are inherently subject to risks and uncertainties, you should not rely on these forward-looking statements as predictions of future events. These forward-looking statements speak only as of the date of this press release and, except to the extent required by applicable law, the Company undertakes no obligation to update or revise these statements, whether as a result of any new information, future events and developments or otherwise.

Contacts:

Company
NeurAxis, Inc.
info@neuraxis.com
For contraindications, precautions, warnings, and IFU, please see: https://ibstim.com/important-information/.

Investor Relations
Lytham Partners
Ben Shamsian
646-829-9701
shamsian@lythampartners.com

Alvotech and Teva Secure U.S. Settlement Date for AVT06, a Proposed Biosimilar to Eylea®




Alvotech and Teva Secure U.S. Settlement Date for AVT06, a Proposed Biosimilar to Eylea®

• According to the settlement agreement, the proposed biosimilar to Eylea^® (aflibercept) can be marketed in the U.S., if approved by the FDA, in the fourth quarter of 2026, or earlier under certain circumstances

REYKJAVIK, Iceland and TEL AVIV, Israel, Dec. 19, 2025 (GLOBE NEWSWIRE) — Alvotech (NASDAQ: ALVO), a global biotech company specializing in the development and manufacture of biosimilar medicines for patients worldwide, and Teva Pharmaceuticals, a U.S. affiliate of Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA), today announced that they have reached a settlement and license agreement with Regeneron Pharmaceuticals Inc. concerning the launch of AVT06, Alvotech’s proposed biosimilar to Eylea^® (aflibercept) in the United States. The settlement grants a license entry date for AVT06 in the United States in the fourth quarter of 2026, or earlier under certain circumstances.

“Following recent marketing approvals in both Japan and Europe, we are delighted to secure a U.S. settlement date for our biosimilar candidate to Eylea^®, an important biologic for the treatment of retinal diseases. This positions Alvotech and our commercial partner Teva very well for a successful launch in the U.S. market next year, pending FDA approval,” said Robert Wessman, Chairman and CEO of Alvotech.

AVT06 has been approved for marketing as an aflibercept biosimilar in the United Kingdom, Japan and the 30 countries of the European Economic Area, which includes all 27 member states of the European Union in addition to Norway, Iceland and Liechtenstein.

In January 2024, Alvotech announced positive top-line results from a confirmatory clinical study comparing the efficacy, safety, and immunogenicity of AVT06 to Eylea^® (aflibercept) in patients with neovascular (wet) AMD. The study met its primary endpoint, with results demonstrating high similarity between Alvotech’s biosimilar candidate and Eylea^® [1].

About AVT06
AVT06 is a proposed biosimilar to Eylea^® (aflibercept). Aflibercept binds vascular endothelial growth factors (VEGF), inhibiting the binding and activation of VEGF receptors, neovascularization, and vascular permeability [2]. AVT06 has been approved under the brand name Mynzepli^® (aflibercept) for marketing in the European Economic Area and under the name AFLIBERCEPT BS for marketing in Japan.

Sources
[1] Agostini, H. et.al. (2025). A randomized, double-masked parallel-group, multicenter clinical study evaluating the efficacy and safety of the biosimilar candidate AVT06 compared to the reference product aflibercept in participants with neovascular age-related macular degeneration. Expert Opinion on Biological Therapy, 1–15. https://doi.org/10.1080/14712598.2025.2519531

[2] Eylea^® product label, accessed on December 18, 2025, https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/125387s087lbl.pdf

Use of trademarks
Eylea^® is a registered trademark of Regeneron Pharmaceuticals Inc.

About Alvotech
Alvotech is a biotechnolgy company, founded by Robert Wessman, focused solely on the development and manufacture of biosimilar medicines for patients worldwide. Alvotech seeks to be a global leader in the biosimilar space by delivering high quality, cost-effective products, and services, enabled by a fully integrated approach and broad in-house capabilities. Alvotech’s current pipeline includes eight disclosed biosimilar candidates aimed at treating autoimmune disorders, eye disease, osteoporosis, respiratory disease, and cancer. Alvotech has formed a network of strategic commercial partnerships to provide global reach and leverage local expertise in markets that include the United States, Europe, Japan, China, and other Asian countries and large parts of South America, Africa and the Middle East. For more information, please visit www.alvotech.com. None of the information on the Alvotech website shall be deemed part of this press release.

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 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.

Forward-Looking Statements (Alvotech)
Certain statements in this communication may be considered “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995, as amended. Forward-looking statements include, for example, Alvotech’s expectations regarding competitive advantages, business prospects and opportunities including pipeline product development, future plans and intentions, regulatory submissions, review and interactions, the potential approval and commercial launch of its product candidates, the timing of regulatory approval, market launches and financial projections. Such forward-looking statements are subject to risks, uncertainties, and other factors which could cause actual results to differ materially from those expressed or implied by such forward-looking statements. These forward-looking statements are based upon estimates and assumptions that, while considered reasonable by Alvotech and its management, are inherently uncertain and are inherently subject to risks, variability, and contingencies, many of which are beyond Alvotech’s control. Factors that may cause actual results to differ materially from current expectations include, but are not limited to factors set forth in the sections entitled “Risk Factors” and “Cautionary Note Regarding Forward-Looking Statements” in documents that Alvotech may from time-to-time file or furnish with the SEC. There may be additional risks that Alvotech does not presently know or that Alvotech currently believes are immaterial that could also cause actual results to differ from those contained in the forward-looking statements. These forward-looking statements are provided for illustrative purposes only and are not intended to serve as, and must not be relied on by an investor as, a guarantee, assurance, prediction or definitive statement of a fact or probability. Alvotech does not undertake any duty to update these forward-looking statements or to inform the recipient of any matters of which any of them becomes aware of which may affect any matter referred to in this communication. Alvotech disclaims any and all liability for any loss or damage (whether foreseeable or not) suffered or incurred by any person or entity as a result of anything contained or omitted from this communication and such liability is expressly disclaimed.

Cautionary Note Regarding Forward-Looking Statements (Teva)
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,” “project,” “guidance,” “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 commercialize the biosimilar product candidate to Eylea^® (aflibercept) under the strategic partnership with Alvotech, once regulatory approval is obtained; our ability to successfully compete in the marketplace, including our ability to develop and commercialize additional pharmaceutical products; our ability to successfully execute our Pivot to Growth strategy, including to expand our innovative and biosimilar medicines pipeline and profitably commercialize the innovative medicines and biosimilar portfolio, whether organically or through business development, and to sustain and focus our portfolio of generic medicines; and other factors discussed in our Quarterly Report on Form 10-Q for the third quarter of 2025, and in our Annual Report on Form 10-K for the year ended December 31, 2024, 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.

CONTACTS
Alvotech Global Communications
Benedikt Stefansson
Sarah Macleod
alvotech.media@alvotech.com

Alvotech Investor Relations
Balaji Prasad (US)
Benedikt Stefansson (IS)
Patrik Ling (SE)
alvotech.ir@alvotech.com

Teva Media Inquiries:

TevaCommunicationsNorthAmerica@tevapharm.com

Teva Investor Relations Inquiries:

TevaIR@Tevapharm.com

Alvotech and Teva Secure U.S. Settlement Date for AVT06, a Proposed Biosimilar to Eylea®




Alvotech and Teva Secure U.S. Settlement Date for AVT06, a Proposed Biosimilar to Eylea®

According to the settlement agreement, the proposed biosimilar to Eylea® (aflibercept) can be marketed in the U.S., if approved by the FDA, in the fourth quarter of 2026, or earlier under certain circumstances

REYKJAVIK, Iceland and TEL AVIV, Israel and PARSIPPANY, N.J., Dec. 19, 2025 (GLOBE NEWSWIRE) — Alvotech (NASDAQ: ALVO), a global biotech company specializing in the development and manufacture of biosimilar medicines for patients worldwide, and Teva Pharmaceuticals, a U.S. affiliate of Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA), today announced that they have reached a settlement and license agreement with Regeneron Pharmaceuticals Inc. concerning the launch of AVT06, Alvotech’s proposed biosimilar to Eylea^® (aflibercept) in the United States. The settlement grants a license entry date for AVT06 in the United States in the fourth quarter of 2026, or earlier under certain circumstances.

“Following recent marketing approvals in both Europe and Japan, we are delighted to secure a U.S. settlement date for our biosimilar candidate to Eylea^®, an important biologic for the treatment of retinal diseases. This positions Alvotech and our commercial partner Teva very well for a successful launch in the U.S. market next year, pending FDA approval,” said Robert Wessman, Chairman and CEO of Alvotech.

AVT06 has been approved for marketing as an aflibercept biosimilar in the United Kingdom, Japan and the 30 countries of the European Economic Area, which includes all 27 member states of the European Union in addition to Norway, Iceland and Liechtenstein.

In January 2024, Alvotech announced positive top-line results from a confirmatory clinical study comparing the efficacy, safety, and immunogenicity of AVT06 to Eylea^® (aflibercept) in patients with neovascular (wet) AMD. The study met its primary endpoint, with results demonstrating high similarity between Alvotech’s biosimilar candidate and Eylea^® [1].

CONTACTS

Alvotech Media
Benedikt Stefansson
Sarah Macleod
alvotech.media@alvotech.com

Alvotech Investors
Balaji Prasad (US)
Benedikt Stefansson (IS)
Patrik Ling (SE)
alvotech.ir@alvotech.com

Teva Media Inquiries:
TevaCommunicationsNorthAmerica@tevapharm.com

Teva Investor Relations Inquiries:
TevaIR@Tevapharm.com

About AVT06
AVT06 is a proposed biosimilar to Eylea^® (aflibercept). Aflibercept binds vascular endothelial growth factors (VEGF), inhibiting the binding and activation of VEGF receptors, neovascularization, and vascular permeability [2]. AVT06 has been approved under the brand name Mynzepli^® (aflibercept) for marketing in the United Kingdom and European Economic Area and under the name AFLIBERCEPT BS for marketing in Japan.

Sources
[1] Agostini, H. et.al. (2025). A randomized, double-masked parallel-group, multicenter clinical study evaluating the efficacy and safety of the biosimilar candidate AVT06 compared to the reference product aflibercept in participants with neovascular age-related macular degeneration. Expert Opinion on Biological Therapy, 1–15. https://doi.org/10.1080/14712598.2025.2519531

[2] Eylea^® product label, accessed on December 18, 2025, https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/125387s087lbl.pdf

Use of trademarks
Eylea^® is a registered trademark of Regeneron Pharmaceuticals Inc.

About Alvotech
Alvotech is a biotechnology company, founded by Robert Wessman, focused solely on the development and manufacture of biosimilar medicines for patients worldwide. Alvotech seeks to be a global leader in the biosimilar space by delivering high quality, cost-effective products, and services, enabled by a fully integrated approach and broad in-house capabilities. Alvotech’s current pipeline includes eight disclosed biosimilar candidates aimed at treating autoimmune disorders, eye disease, osteoporosis, respiratory disease, and cancer. Alvotech has formed a network of strategic commercial partnerships to provide global reach and leverage local expertise in markets that include the United States, Europe, Japan, China, and other Asian countries and large parts of South America, Africa and the Middle East. For more information, please visit www.alvotech.com. None of the information on the Alvotech website shall be deemed part of this press release.

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 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.

Forward-Looking Statements (Alvotech)
Certain statements in this communication may be considered “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995, as amended. Forward-looking statements include, for example, Alvotech’s expectations regarding competitive advantages, business prospects and opportunities including pipeline product development, future plans and intentions, regulatory submissions, review and interactions, the potential approval and commercial launch of its product candidates, the timing of regulatory approval, market launches and financial projections. Such forward-looking statements are subject to risks, uncertainties, and other factors which could cause actual results to differ materially from those expressed or implied by such forward-looking statements. These forward-looking statements are based upon estimates and assumptions that, while considered reasonable by Alvotech and its management, are inherently uncertain and are inherently subject to risks, variability, and contingencies, many of which are beyond Alvotech’s control. Factors that may cause actual results to differ materially from current expectations include, but are not limited to factors set forth in the sections entitled “Risk Factors” and “Cautionary Note Regarding Forward-Looking Statements” in documents that Alvotech may from time-to-time file or furnish with the SEC. There may be additional risks that Alvotech does not presently know or that Alvotech currently believes are immaterial that could also cause actual results to differ from those contained in the forward-looking statements. These forward-looking statements are provided for illustrative purposes only and are not intended to serve as, and must not be relied on by an investor as, a guarantee, assurance, prediction or definitive statement of a fact or probability. Alvotech does not undertake any duty to update these forward-looking statements or to inform the recipient of any matters of which any of them becomes aware of which may affect any matter referred to in this communication. Alvotech disclaims any and all liability for any loss or damage (whether foreseeable or not) suffered or incurred by any person or entity as a result of anything contained or omitted from this communication and such liability is expressly disclaimed.

Cautionary Note Regarding Forward-Looking Statements (Teva)
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,” “project,” “guidance,” “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 commercialize the biosimilar product candidate to Eylea^® (aflibercept) under the strategic partnership with Alvotech, once regulatory approval is obtained; our ability to successfully compete in the marketplace, including our ability to develop and commercialize additional pharmaceutical products; our ability to successfully execute our Pivot to Growth strategy, including to expand our innovative and biosimilar medicines pipeline and profitably commercialize the innovative medicines and biosimilar portfolio, whether organically or through business development, and to sustain and focus our portfolio of generic medicines; and other factors discussed in our Quarterly Report on Form 10-Q for the third quarter of 2025, and in our Annual Report on Form 10-K for the year ended December 31, 2024, 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.

Alvotech and Teva Secure U.S. Settlement Date for AVT06, a Proposed Biosimilar to Eylea®




Alvotech and Teva Secure U.S. Settlement Date for AVT06, a Proposed Biosimilar to Eylea®

• According to the settlement agreement, the proposed biosimilar to Eylea® (aflibercept) can be marketed in the U.S., if approved by the FDA, in the fourth quarter of 2026, or earlier under certain circumstances 

REYKJAVIK, ICELAND & TEL AVIV, ISRAEL & PARSIPPANY, NJ (December 19, 2025) — Alvotech (NASDAQ: ALVO), a global biotech company specializing in the development and manufacture of biosimilar medicines for patients worldwide, and Teva Pharmaceuticals, a U.S. affiliate of Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA), today announced that they have reached a settlement and license agreement with Regeneron Pharmaceuticals Inc. concerning the launch of AVT06, Alvotech’s proposed biosimilar to Eylea® (aflibercept) in the United States. The settlement grants a license entry date for AVT06 in the United States in the fourth quarter of 2026, or earlier under certain circumstances. 

“Following recent marketing approvals in both Europe and Japan, we are delighted to secure a U.S. settlement date for our biosimilar candidate to Eylea®, an important biologic for the treatment of retinal diseases. This positions Alvotech and our commercial partner Teva very well for a successful launch in the U.S. market next year, pending FDA approval,” said Robert Wessman, Chairman and CEO of Alvotech. 

AVT06 has been approved for marketing as an aflibercept biosimilar in the United Kingdom, Japan and the 30 countries of the European Economic Area, which includes all 27 member states of the European Union in addition to Norway, Iceland and Liechtenstein.  

In January 2024, Alvotech announced positive top-line results from a confirmatory clinical study comparing the efficacy, safety, and immunogenicity of AVT06 to Eylea® (aflibercept) in patients with neovascular (wet) AMD. The study met its primary endpoint, with results demonstrating high similarity between Alvotech’s biosimilar candidate and Eylea® [1].  

CONTACTS 

Alvotech Media 

Benedikt Stefansson 

Sarah Macleod 

alvotech.media@alvotech.com 

Alvotech Investors 

Balaji Prasad (US) 

Benedikt Stefansson (IS) 

Patrik Ling (SE) 

alvotech.ir@alvotech.com 

Teva Media Inquiries: 

TevaCommunicationsNorthAmerica@tevapharm.com 

Teva Investor Relations Inquiries: 

TevaIR@Tevapharm.com 

About AVT06 

AVT06 is a proposed biosimilar to Eylea® (aflibercept). Aflibercept binds vascular endothelial growth factors (VEGF), inhibiting the binding and activation of VEGF receptors, neovascularization, and vascular permeability [2]. AVT06 has been approved under the brand name Mynzepli® (aflibercept) for marketing in the United Kingdom and European Economic Area and under the name AFLIBERCEPT BS for marketing in Japan.  

Sources 

[1] Agostini, H. et.al. (2025). A randomized, double-masked parallel-group, multicenter clinical study evaluating the efficacy and safety of the biosimilar candidate AVT06 compared to the reference product aflibercept in participants with neovascular age-related macular degeneration. Expert Opinion on Biological Therapy, 1–15. https://doi.org/10.1080/14712598.2025.2519531 

[2] Eylea® product label, accessed on December 18, 2025, https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/125387s087lbl.pdf 

Use of trademarks 

Eylea® is a registered trademark of Regeneron Pharmaceuticals Inc.  

About Alvotech 

Alvotech is a biotechnology company, founded by Robert Wessman, focused solely on the development and manufacture of biosimilar medicines for patients worldwide. Alvotech seeks to be a global leader in the biosimilar space by delivering high quality, cost-effective products, and services, enabled by a fully integrated approach and broad in-house capabilities. Alvotech’s current pipeline includes eight disclosed biosimilar candidates aimed at treating autoimmune disorders, eye disease, osteoporosis, respiratory disease, and cancer. Alvotech has formed a network of strategic commercial partnerships to provide global reach and leverage local expertise in markets that include the United States, Europe, Japan, China, and other Asian countries and large parts of South America, Africa and the Middle East. For more information, please visit www.alvotech.com. None of the information on the Alvotech website shall be deemed part of this press release.  

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 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. 

Forward–Looking Statements (Alvotech) 

Certain statements in this communication may be considered “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995, as amended. Forward-looking statements include, for example, Alvotech’s expectations regarding competitive advantages, business prospects and opportunities including pipeline product development, future plans and intentions, regulatory submissions, review and interactions, the potential approval and commercial launch of its product candidates, the timing of regulatory approval, market launches and financial projections. Such forward-looking statements are subject to risks, uncertainties, and other factors which could cause actual results to differ materially from those expressed or implied by such forward-looking statements. These forward-looking statements are based upon estimates and assumptions that, while considered reasonable by Alvotech and its management, are inherently uncertain and are inherently subject to risks, variability, and contingencies, many of which are beyond Alvotech’s control. Factors that may cause actual results to differ materially from current expectations include, but are not limited to factors set forth in the sections entitled “Risk Factors” and “Cautionary Note Regarding Forward-Looking Statements” in documents that Alvotech may from time-to-time file or furnish with the SEC. There may be additional risks that Alvotech does not presently know or that Alvotech currently believes are immaterial that could also cause actual results to differ from those contained in the forward-looking statements. These forward-looking statements are provided for illustrative purposes only and are not intended to serve as, and must not be relied on by an investor as, a guarantee, assurance, prediction or definitive statement of a fact or probability. Alvotech does not undertake any duty to update these forward-looking statements or to inform the recipient of any matters of which any of them becomes aware of which may affect any matter referred to in this communication. Alvotech disclaims any and all liability for any loss or damage (whether foreseeable or not) suffered or incurred by any person or entity as a result of anything contained or omitted from this communication and such liability is expressly disclaimed. 

Cautionary Note Regarding Forward-Looking Statements (Teva) 

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,” “project,” “guidance,” “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 commercialize the biosimilar product candidate to Eylea® (aflibercept) under the strategic partnership with Alvotech, once regulatory approval is obtained; our ability to successfully compete in the marketplace, including our ability to develop and commercialize additional pharmaceutical products; our ability to successfully execute our Pivot to Growth strategy, including to expand our innovative and biosimilar medicines pipeline and profitably commercialize the innovative medicines and biosimilar portfolio, whether organically or through business development, and to sustain and focus our portfolio of generic medicines; and other factors discussed in our Quarterly Report on Form 10-Q for the third quarter of 2025, and in our Annual Report on Form 10-K for the year ended December 31, 2024, 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. 

Guerbet: Appointment of Mr. François Convenant as Senior Vice President of Interventional Radiology and his entry into the Executive Committee




Guerbet: Appointment of Mr. François Convenant as Senior Vice President of Interventional Radiology and his entry into the Executive Committee

Guerbet announces the appointment of Mr. François Convenant as Senior Vice President of Interventional Radiology and his entry into the Executive Committee

Villepinte, December 19, 2025:

GUERBET (FR0000032526 GBT), a global player in medical imaging, announces the appointment of François Convenant as Senior Vice President of Interventional Radiology.
In this role, he joins the Guerbet Group’s Executive Committee (COMEX).

This appointment marks an important milestone for Guerbet, confirming its leadership in the field of interventional radiology.

François Convenant joined GUERBET in September 2018. He has extensive international experience in the healthcare and medical device sector. Before joining Guerbet, he held management positions at leading companies, spearheading innovation and growth projects in surgical solutions and interventional devices. His expertise covers strategy, development, and commercial transformation, with a strong commitment to improving clinical practices.

Interventional Radiology: a pillar of modern medicine

Interventional radiology is a rapidly expanding medical specialty that combines advanced imaging with minimally invasive therapeutic procedures. It enables practitioners to perform targeted procedures—such as the treatment of cancer, vascular diseases, or chronic conditions—while reducing risks, hospitalization time, and recovery time for patients.
This field is at the heart of major developments in healthcare:
•    Rapid growth: driven by an aging population and demand for less invasive treatments.
•    Technological innovation: integration of AI, robotics, and precision imaging to improve the safety and effectiveness of procedures.
•    Economic and clinical impact: reduction in costs related to complications and improvement in patients’ quality of life.

At Guerbet, a pioneer in interventional radiology, our mission is to meet the needs of healthcare institutions and practitioners by offering integrated and innovative solutions. We combine drugs, medical devices, services, and technologies, while supporting them with dedicated training programs to strengthen their skills and optimize clinical practices.

About Guerbet
At Guerbet, we build lasting connections to enable better living. This is our Purpose. We are a global leader in medical imaging, offering a comprehensive range of pharmaceutical products, medical devices, and digital and AI solutions for diagnostic and interventional imaging.
Pioneers in contrast agents for 98 years, with 2,905 employees worldwide, we continuously innovate and dedicate 9% of our revenue to Research & Development across four centers in France and the United States. Guerbet (GBT) is listed on Euronext Paris, Compartment B, and achieved €841 million in revenue in 2024.
For more information, please visit www.guerbet.com.

Contact :

Matthieu BRUNEAU – Global corporate communication manager
Email : matthieu.bruneau@guerbet.com
Phone : +33 6 78 83 89 96

Attachment

• 2025 12 19_Press_Release_Francois_Convenant

Sai Life Sciences Releases Sustainability Report 2024–25




Sai Life Sciences Releases Sustainability Report 2024–25

HYDERABAD, India, Dec. 19, 2025 (GLOBE NEWSWIRE) — Sai Life Sciences Limited (BSE: 544306 | NSE: SAILIFE), one of India’s fastest-growing Contract Research, Development, and Manufacturing Organizations (CRDMO), today announced the release of its Sustainability Report for 2024–25. Aligned with the Global Reporting Initiative (GRI) Universal Standards 2021 and the Sustainability Accounting Standards Board (SASB) standards, this sixth edition is presented under the theme “Driving climate action, deepening stakeholder trust.” The full report can be accessed here.

Commenting on the release, Krishna Kanumuri, MD & CEO, Sai Life Sciences, said: “Reliability with responsibility is central to the CRDMO mandate and deeply embedded in how we operate at Sai Life Sciences. Over the past year, we translated this commitment into action through progress across climate actions, circular economy initiatives, people-led HR transformation, and tech-enabled innovation. Going forward, we are focused on scaling these efforts to build a resilient, science-forward, and sustainability-led operating model that delivers enduring value to our partners and stakeholders.”

The report outlines how the company’s sustainability strategy is anchored in nine strategic pillars that collectively guide its approach to responsible growth. These elements span water stewardship, climate action, circularity, biodiversity, sustainable procurement, human capital, governance and ethics, community engagement, and customer co-creation. Together, they constitute a cohesive framework that embeds sustainability priorities into every stage of the company’s operations. By aligning these elements with business objectives and stakeholder expectations, Sai Life Sciences positions sustainability as an intrinsic part of how it innovates, collaborates, and delivers impact.

During the year, the company advanced its internally defined Sustainable Development Goals (SDGs), which outline a clear roadmap for meeting its sustainability commitments by March 31, 2027. The report highlights ongoing progress in greenhouse gas reduction, a significant increase in renewable energy usage—with 96% of the API manufacturing unit in Bidar powered by renewables—and reductions in specific water consumption across facilities. It also documents significant community impact, with the company surpassing its commitment to provide education and livelihood opportunities for 8,000 individuals from underprivileged communities. Strengthening its people agenda, the organisation saw steady growth in diversity, with women representing 14% of the workforce.

The 2024–25 Sustainability Report reflects the company’s long-term view—one that places science, responsibility, and collaboration at the centre of its growth ambition. As Sai Life Sciences continues to expand its global footprint, sustainability remains both a compass and a catalyst for shaping resilient, future-ready operations.

About Sai Life Sciences

Sai Life Sciences is a full-service Contract Research, Development & Manufacturing Organization (CRDMO) working with innovator pharma and biotech companies globally to accelerate the discovery, development, and commercialization of small molecules and emerging modalities. The company’s vision is “to advance the frontiers of science with our partners, delivering solutions that bring innovative medicines to patients worldwide.” With operations across India, the UK, and the US, Sai Life Sciences offers deep scientific expertise, world-class infrastructure, and a culture of excellence focused on quality, safety, and sustainability. For more details visit: www.sailife.com

A photo accompanying this announcement is available at https://www.globenewswire.com/NewsRoom/AttachmentNg/87f46966-eb1f-406b-a2c6-7d5eab5de73a

CONTACT: For further information, contact:

Sriram Gopalakrishnan
Vice President, Corporate Communication
Sai Life Sciences Limited
Ph: +91 9121295355
sriram.g@sailife.com

Rezubio Announces $20 Million Series A Financing to Advance the Membrane-Anchored Therapeutics Platform and Company Pipeline, with Lead Program in Obesity and Diabetes




Rezubio Announces $20 Million Series A Financing to Advance the Membrane-Anchored Therapeutics Platform and Company Pipeline, with Lead Program in Obesity and Diabetes

ZHUHAI, China, Dec. 18, 2025 (GLOBE NEWSWIRE) — Rezubio, a China-based biotechnology company founded by former Merck scientists, today announced the closing of a $20 million Series A financing. Proceeds will be used to advance the company’s lead program into Phase 2 clinical development for obesity and diabetes, as well as other programs in IND-enabling stage and early preclinical stage.

The financing was led by Lapam Capital, with participation from Frees Fund and Riverhead Capital.

“This Series A represents an important inflection point for Rezubio,” said Yusheng Xiong, PhD, co-founder and CEO of Rezubio. “Membrane anchoring has the potential to reshape how targeted medicines are designed. Our MADD platform enables highly localized pharmacology for cell-surface targets, including GPCRs, while minimizing systemic exposure. Our gut-targeted GPCR agonist has entered clinical trials in Australia and is expected to provide a critical proof-of-concept for the platform. In parallel, an antagonist targeting a different GPCR for immune and inflammatory diseases will enter Phase 1 clinical development in early 2026.”

A Novel Approach to Tissue-Selective Delivery: Membrane-Anchored Drug Design (MADD)

Rezubio’s MADD platform uses a rationally engineered kinetophore to anchor pharmacophores to the epithelium of target tissues, enabling localized drug activity at the site of action. This approach is designed to deliver:

• Minimal systemic exposure, reducing the risk of off-target and dose-limiting adverse effects
• Enhanced efficacy through enrichment of active compounds around cell-surface target proteins
• Prolonged tissue residence time, supporting less frequent dosing

By addressing limitations of conventional small-molecule and peptide therapeutics—such as the adverse effects and frequent administration—Rezubio aims to improve both therapeutic index and patient compliance.

CONTACT: Media Contact
Muhua He
General manager
contact@rezubio.com
+86-16607569689

Is SkinnyRx the Best GLP-1 Vendor for 2026? Platform Offers Compounded Semaglutide in Three Forms Starting at $199/Month as New Year Weight Loss Season Approaches




Is SkinnyRx the Best GLP-1 Vendor for 2026? Platform Offers Compounded Semaglutide in Three Forms Starting at $199/Month as New Year Weight Loss Season Approaches

Sacramento Telehealth Company Positions Multi-Form Compounded Semaglutide Access Through Licensed Medical Providers Ahead of Peak January Demand Period

Sacramento, Dec. 18, 2025 (GLOBE NEWSWIRE) —

With the New Year fast approaching and consumer interest in weight loss solutions historically peaking in December and January, SkinnyRx is positioning its telehealth platform to meet anticipated demand for GLP-1 medication access. The Sacramento-based company, operated by Lean Rx, Inc., offers compounded semaglutide and tirzepatide in three formulations—injectable, sublingual, and tablet—with transparent subscription pricing starting at $199 per month according to the company website.

According to healthcare industry analysts, search interest for weight loss medications and services increases substantially during this period, corresponding to New Year goal-setting behavior and post-holiday weight concerns. Telehealth platforms offering rapid provider access without insurance authorization delays are positioned to serve this concentrated seasonal demand.

The question of which platform best serves individual patient needs depends on personal priorities including budget constraints, medication formulation preferences, and desired service model. SkinnyRx emphasizes its multi-form approach and published pricing structure as key differentiators in the telehealth weight loss sector.

Additional information is available at: https://skinnyrx.com/

Important Information for Readers:

Medical Disclaimer: This release is for informational purposes only and does not constitute medical advice. Only licensed healthcare providers can determine whether prescription medications are appropriate for individual patients. Patients should consult qualified healthcare providers before starting any prescription medication.

Compounded Medication Notice: The medications discussed are compounded by state-licensed pharmacies and are not FDA-approved as finished products. Compounded medications are not evaluated by the FDA for safety, effectiveness, or quality as equivalent to FDA-approved products such as Wegovy, Ozempic, or Rybelsus.

Affiliate Disclosure: This release may contain affiliate relationships. Information presented is based on publicly available data from the company website and is intended for educational purposes.

Industry Context and Market Differentiation

The telehealth weight loss sector includes multiple business models serving different patient needs. According to healthcare technology observers, key differentiation factors include pricing transparency and cost accessibility, medication formulation options, provider access speed and availability, insurance acceptance versus cash-pay models, and comprehensive programs versus medication-focused services.

The platform highlights its main value proposition through several factors according to the company website and service terms:

Multiple Medication Forms: The platform offers compounded semaglutide in three formulations—injectable (weekly administration), sublingual (daily liquid), and tablet (daily buccal)—plus compounded tirzepatide options in injectable and tablet forms.

Published Pricing Structure: Subscription costs are listed on the website starting at $199 per month for injectable and sublingual semaglutide, $249 per month for semaglutide tablets, and $299 per month for tirzepatide options according to company information.

Streamlined Access Process: The company reviews provider submissions within 24 hours for most cases and provides shipping and tracking information within 2 business days. The platform markets delivery with timing varying by location.

Cash-Pay Model: The platform does not accept commercial health insurance and is not enrolled in Medicare or Medicaid per the terms of service. The direct-pay structure eliminates prior authorization requirements, step therapy mandates, and insurance documentation processes.

Critical Regulatory Context

Which platform is “best” depends on the regulatory context. Compounded medications are made by state-licensed pharmacies with active ingredients from FDA-registered sources but are not FDA-reviewed or approved as finished products like Wegovy, Ozempic, or Rybelsus.

The FDA declared the U.S. semaglutide shortage over as of February 21, 2025. Compounding regulations can change when shortages end, so requirements may evolve. Compounded drugs should address medical needs not met by FDA-approved options as determined by a clinician.

Three-Entity Operational Structure

According to the company’s terms of service, Lean Rx, Inc. is not a healthcare provider. The platform operates through a three-entity structure:

Technology Platform (Lean Rx, Inc.) provides website infrastructure, facilitates provider-patient connections, and coordinates support services.

Independent Licensed Medical Providers review patient medical history and determine prescription appropriateness. Providers are board-certified healthcare professionals licensed in multiple states according to the platform. The platform cannot guarantee prescriptions as clinical determinations rest with evaluating clinicians.

State-Licensed Compounding Pharmacies prepare medications based on prescriptions and handle fulfillment. State boards oversee these pharmacies which must meet federal compounding requirements according to the website.

Service Model and Medication Options

According to information published on the company website:

Injectable Semaglutide (Weekly)

• Pricing starts at $199/month per website
• Once-weekly subcutaneous injection
• Includes syringes, needles, and supplies in monthly subscription
• According to published clinical trials evaluating FDA-approved Wegovy (not compounded formulations), participants experienced average weight reduction of approximately 15% over 68 weeks in controlled conditions with intensive monitoring and lifestyle interventions

Sublingual Semaglutide (Daily)

• Pricing starts at $199/month per website
• Once-daily liquid placed under tongue with 90-second hold time
• Needle-free option for patients uncomfortable with injections
• 30-minute food/drink restriction after dosing

Semaglutide Tablets (Daily)

• Pricing starts at $249/month per website
• Once-daily buccal tablet dissolving between gum and cheek
• Oral medication format

Tirzepatide Options

• Injectable and tablet forms starting at $299/month per website
• Dual GIP/GLP-1 agonist mechanism
• According to published clinical research on FDA-approved tirzepatide products, some studies suggest tirzepatide may produce slightly greater weight loss than semaglutide on average in specific study populations, though individual responses vary significantly

Important note: The clinical trial data cited above were obtained from FDA-approved products under controlled research conditions. Compounded medications have not undergone equivalent clinical trials. Individual results vary significantly and are not guaranteed.

Additional information about the platform’s approach to accessible weight loss care is available on the company website at: https://skinnyrx.com/

Patient Evaluation Process

The platform’s intake process includes an online health assessment covering medical history, current medications, weight loss goals, and qualifying conditions. Patients typically need BMI of 27 or higher with weight-related conditions (high blood pressure, high cholesterol, pre-diabetes, sleep apnea) or BMI of 30 or higher to qualify for evaluation under provider guidelines.

According to the company, provider reviews are completed within 24 hours for most submissions. Approval is not guaranteed and depends on the licensed clinician’s individual medical assessment. Patients deemed ineligible receive full refunds within 24-48 hours according to the FAQ published on the company website.

Financial Considerations for Prospective Patients

According to the company’s terms, the platform will not submit insurance claims on behalf of patients, and patients agree not to submit claims for reimbursement for services provided through the platform. The FAQ states the platform accepts FSA/HSA cards, though the company notes it cannot guarantee FSA/HSA eligibility.

Monthly subscription pricing as listed on the website includes medication at prescribed doses, shipping, unlimited messaging with care teams, ongoing provider consultations, and supplies for injectable forms. At $199-$299 per month, annual costs range from approximately $2,388 to $3,588. According to medical literature on GLP-1 medication duration, most patients require 12-24 months or more of treatment.

Safety Profile and Medical Considerations

GLP-1 medications affect digestive system function, appetite hormones, and metabolism. According to medical literature and patient protocols, common side effects include nausea (very common, especially weeks 1-4), constipation, diarrhea, bloating, gas, and fatigue. These effects often improve as patients adjust to medication.

Serious side effects requiring immediate medical attention according to prescribing information include severe abdominal pain potentially indicating pancreatitis, signs of allergic reaction including swelling of face or throat, difficulty breathing, yellowing of skin or eyes, and vision changes.

FDA Safety Alert: According to FDA safety communications, the agency has identified concerns about dosing errors with compounded semaglutide products. Some compounded products may use different salt forms (such as semaglutide sodium or semaglutide acetate) which can affect dosing calculations. Multi-dose vials also present measurement error risks. Patients should confirm with dispensing pharmacy exactly what form has been prescribed and how to measure doses correctly.

According to the FAQ, semaglutide is not recommended for pregnant or breastfeeding women, or those planning pregnancy. The medication should be stopped at least 2 months before attempting to conceive. Individuals with personal or family history of medullary thyroid carcinoma or Multiple Endocrine Neoplasia syndrome type 2 should not use semaglutide according to prescribing information.

What Patients Should Evaluate

Determining the best platform for individual needs requires considering multiple factors:

Cost Sustainability: Can monthly subscription costs be sustained for 12-24 months or more as typically required for GLP-1 treatment?

Medical Complexity: Do individual health conditions require in-person monitoring versus telehealth-only care?

Insurance Coverage: Do insurance plans cover FDA-approved alternatives (Wegovy, Ozempic) with affordable copays that may be more cost-effective than cash-pay options?

Formulation Preference: Is weekly injectable, daily sublingual, or daily tablet administration preferred based on lifestyle and comfort level?

Regulatory Understanding: Is the individual comfortable with compounded medications that are not FDA-approved as finished products and are not evaluated as equivalent to FDA-approved medications?

Industry Outlook and Regulatory Environment

The telehealth weight loss sector faces increased regulatory scrutiny as state pharmacy boards evaluate compounding practices and the FTC monitors marketing claims. The FDA’s February 21, 2025 announcement resolving the semaglutide shortage may affect compounding enforcement priorities as patient-specific need requirements can shift when drug shortages end.

State pharmacy boards regulate compounding practices within their jurisdictions. Patients should verify that dispensing pharmacies hold active licenses in good standing with relevant state boards. According to the company, partner pharmacies are state-licensed and subject to state board oversight and applicable federal compounding requirements.

Patients who experience adverse events while using compounded medications should report them to their prescribing clinician and dispensing pharmacy. Unlike FDA-approved drugs which are subject to mandatory adverse event reporting systems, compounded medications are not subject to the same post-market surveillance requirements.

Company Information and Support Access

According to the company website, SkinnyRx support is available 24/7:

Phone: +1 (888) 979-9580
Email: support@skinnyrx.com
Hours: 24/7 according to website
Address: Lean Rx, Inc., Sacramento, California

Additional information about the platform’s approach to accessible weight loss care is available on the company website at: https://skinnyrx.com/

Conclusion: Evaluating “Best” Depends on Individual Circumstances

Whether SkinnyRx represents the best option depends on individual patient priorities, medical needs, and circumstances. The platform positions its service for patients seeking transparent pricing, multiple formulation options, and rapid telehealth access without insurance authorization requirements. However, “best” is inherently subjective and must be evaluated against individual financial capacity for long-term treatment costs, medical complexity requiring in-person versus telehealth care, insurance coverage for FDA-approved alternatives, comfort level with compounded versus FDA-approved medications, and formulation preferences.

Patients should verify current pricing, service features, and regulatory compliance status on the company’s official website and consult qualified healthcare providers to determine appropriateness for their specific medical situations. The regulatory landscape for compounded GLP-1 medications continues to evolve, and patients should review updated FDA guidance and state pharmacy board requirements before proceeding with any telehealth platform.

About Lean Rx, Inc.

Lean Rx, Inc. operates SkinnyRx, a telehealth technology platform that connects patients with independent licensed medical providers for weight loss medication evaluations. The company is based in Sacramento, California. According to the company’s terms of service, Lean Rx, Inc. is not a healthcare provider; medical decisions are made by independent licensed clinicians. The platform offers multiple formulation options for compounded semaglutide and tirzepatide with subscription pricing published on the company website.

Forward-Looking Statements and Medical Disclaimer

This release contains information about compounded medications which are not FDA-approved as finished products. Compounded products are not evaluated by the FDA as equivalent to FDA-approved medications. Individual results with weight loss medications vary significantly based on numerous factors including adherence, lifestyle modifications, genetics, and baseline health status.

Medical Disclaimer: This release is for informational purposes only and does not constitute medical advice, diagnosis, or treatment recommendations. Only licensed healthcare providers can determine whether prescription medications are appropriate for individual patients based on complete medical evaluation. Weight loss results vary significantly and are not guaranteed. Common side effects include nausea, constipation, diarrhea, and GI distress. Serious side effects can occur including pancreatitis. Patients should discuss risks and benefits of any prescription medication with qualified healthcare providers before starting it.

Information about pricing, service offerings, and platform features is based on publicly available information from the company website and terms of service as of December 2025 and is subject to change. The regulatory landscape for compounded medications continues to evolve following the FDA’s February 21, 2025 announcement resolving the shortage. Patients should verify current compliance status and review updated guidance before making decisions.

Contact:

• SkinnyRx Customer Support
• Phone: +1 (888) 979-9580
• Email:support@skinnyrx.com
• Website:https://skinnyrx.com/

CONTACT: Phone: +1 (888) 979-9580
Email: support@skinnyrx.com

Mesa Labs to Present at the 44th Annual J.P. Morgan Healthcare Conference on January 14, 2026




Mesa Labs to Present at the 44th Annual J.P. Morgan Healthcare Conference on January 14, 2026

LAKEWOOD, Colo., Dec. 18, 2025 (GLOBE NEWSWIRE) — Mesa Laboratories, Inc. (NASDAQ:MLAB), a global leader in the design and manufacture of life science tools and critical quality control solutions, today announced that Gary Owens, President and CEO, and John Sakys, CFO will present at the 44th Annual J.P. Morgan Healthcare Conference on Wednesday, January 14th, 2026. Management will participate in a Formal Presentation at 4:30 p.m. Pacific Time.

A live webcast of the presentation will be accessible here and on the Events & Presentations section of Mesa Lab’s Investor Relations website at https://investors.mesalabs.com/. An archived replay of the webcast will be available through the same link following the presentation.

About Mesa Laboratories, Inc.

Mesa is a global leader in the design and manufacture of life science tools and critical quality control solutions for regulated applications in the pharmaceutical, healthcare and medical device industries. Mesa offers products and services to help our customers ensure product integrity, increase patient and worker safety, and improve the quality of life throughout the world.

For more information about Mesa, please visit its website at www.mesalabs.com.

Mesa Laboratories Contacts: 
Gary Owens; President and CEO,
John Sakys; CFO
1-303-987-8000
investors@mesalabs.com