Pfizer Recommends Shareholders Reject the Mini-Tender Offer by Tutanota LLC

Pfizer Recommends Shareholders Reject the Mini-Tender Offer by Tutanota LLC




Pfizer Recommends Shareholders Reject the Mini-Tender Offer by Tutanota LLC

NEW YORK–(BUSINESS WIRE)–Pfizer Inc. (NYSE: PFE) today announced that it has received notice of an unsolicited mini-tender offer by Tutanota LLC (“Tutanota”) to purchase up to 1 million shares of Pfizer common stock at a price of $32.00 per share in cash. The offer price of $32.00 per share is conditioned on, among other things, the closing price per share of Pfizer common stock exceeding $32.00 per share on the last trading day before the offer expires. This means that unless this condition is waived by Tutanota, Pfizer shareholders who tender their shares in the offer will receive a below-market price. The offer states that as of the date of the offer, Tutanota expects to extend the offer until the market price of Pfizer’s common stock exceeds the offer price. The offer is for approximately 0.02% of the shares of Pfizer common stock outstanding as of the March 9, 2026 offer date.


Pfizer recommends that shareholders do not tender their shares in response to Tutanota’s offer because the offer requires that the closing stock price for Pfizer’s common stock exceed the offer price, and it is subject to numerous additional conditions, including Tutanota obtaining financing for the offer, which Tutanota states it does not currently have. There is no guarantee the conditions of the offer will be satisfied. Under the terms of the offer, Tutanota can extend the offer and delay payment beyond the expiration date of the offer, currently scheduled for 5:00 p.m., New York City time, on Monday, April 13, 2026. The offer states that Tutanota intends to extend the offer until Pfizer’s stock price exceeds $32.00 per share. Per the terms of the offer, any shareholders who tender (or have already tendered) their shares can withdraw them prior to the expiration of the offer, currently scheduled for April 13, 2026, in accordance with the offering documents.

Pfizer does not endorse Tutanota’s unsolicited mini-tender offer and is not affiliated or associated in any way with Tutanota, its mini-tender offer or its offer documentation.

Tutanota has made many similar mini-tender offers for shares of other companies. Mini-tender offers seek to acquire less than 5 percent of a company’s shares outstanding, thereby avoiding many disclosure and procedural requirements of the U.S. Securities and Exchange Commission (“SEC”) that apply to offers for more than 5 percent of a company’s shares outstanding. As a result, mini-tender offers do not provide investors with the same level of protections as provided for larger tender offers under U.S. securities laws.

The SEC has cautioned investors that some bidders making mini-tender offers at below-market prices are “hoping that they will catch investors off guard if the investors do not compare the offer price to the current market price.” More on the SEC’s guidance to investors on mini-tender offers is available at SEC.gov | Mini-Tender Offers: Tips for Investors.

Pfizer urges investors to obtain current market quotations for their shares, to consult with their broker or financial advisor and to exercise caution with respect to Tutanota’s offer. Pfizer recommends that stockholders who have not responded to Tutanota’s offer take no action. Stockholders who have already tendered their shares may withdraw them at any time prior to the expiration of the offer, in accordance with Tutanota’s offer documentation. The offer is currently scheduled to expire at 5:00 p.m., New York City time, on April 13, 2026. Tutanota may extend the offering period at its discretion.

Pfizer encourages brokers and dealers, as well as other market participants, to review the SEC’s letter regarding broker-dealer mini-tender offer dissemination and disclosure at Letter to SIA re: Broker-Dealer Mini-Tender Offer Dissemination and Disclosures and the NASD Notice to Members 99-53 issued in July 1999 regarding guidance to members forwarding mini-tender offers to their customers, which can be found at https://www.finra.org/sites/default/files/NoticeDocument/p004221.pdf.

Pfizer requests that a copy of this news release be included with all distributions of materials relating to Tutanota’s mini-tender offer related to shares of Pfizer common stock.

About Pfizer: Breakthroughs That Change Patients’ Lives

At Pfizer, we apply science and our global resources to bring therapies to people that extend and significantly improve their lives. We strive to set the standard for quality, safety and value in the discovery, development and manufacture of health care products, including innovative medicines and vaccines. Every day, Pfizer colleagues work across developed and emerging markets to advance wellness, prevention, treatments and cures that challenge the most feared diseases of our time. Consistent with our responsibility as one of the world’s premier innovative biopharmaceutical companies, we collaborate with health care providers, governments and local communities to support and expand access to reliable, affordable health care around the world. For 175 years, we have worked to make a difference for all who rely on us. We routinely post information that may be important to investors on our website at www.Pfizer.com. In addition, to learn more, please visit us on www.Pfizer.com and follow us on X at @Pfizer and @Pfizer News, LinkedIn, YouTube and like us on Facebook at Facebook.com/Pfizer.

Category: Financial

Contacts

Media Contact:
PfizerMediaRelations@Pfizer.com

Investor Contact:
IR@Pfizer.com

Garaherb Claims Evaluated: Complete Scientific Investigation of Ingredients’ Effectiveness

Garaherb Claims Evaluated: Complete Scientific Investigation of Ingredients’ Effectiveness




Garaherb Claims Evaluated: Complete Scientific Investigation of Ingredients’ Effectiveness

An informational report compiling GaraHerb’s publicly available product materials, ingredient-level research references, formulation transparency considerations, and consumer details for 2026

Aurora, CO, March 20, 2026 (GLOBE NEWSWIRE) — Editor’s Note: The terms “Complete Scientific Investigation” and “Effectiveness” in the headline refer to a compilation of ingredient-level research and publicly cited studies related to compounds in the GaraHerb formulation. These terms describe how ingredients are positioned within available research literature and do not indicate independent clinical evaluation of the finished GaraHerb product.

This informational report is based on publicly available materials provided by GARAPLUS, including official product descriptions, ingredient references, and company disclosures. It compiles how GaraHerb is presented by the company alongside relevant ingredient-level research context. This report contains affiliate links. If a purchase is made through these links, a commission may be earned at no additional cost to the buyer. This content does not constitute medical, health, or dietary advice. All product details described below are stated as presented by the company and should be verified directly on the official website before any purchasing decision.

In this report, the term “effectiveness” refers strictly to how GaraHerb’s marketing language describes potential outcomes. It does not indicate that the finished product has been clinically proven effective, and no published clinical trial appears to evaluate GaraHerb as a proprietary formula.

Garaherb Claims Evaluated Complete Scientific Investigation of Ingredients' Effectiveness

GaraHerb has been generating attention across social media and wellness sites among men in their 30s through 70s looking for natural approaches to energy, stamina, and overall vitality. Consumers often look to understand how products in this category are described and supported by available information before making a purchasing decision — and with that visibility come questions worth exploring through the company’s own materials.

This report compiles what the company presents in its official materials alongside ingredient-level research that has been published in peer-reviewed journals. The information presented reflects the company’s publicly available product descriptions and cited research on individual compounds.

Current product details, pricing, and terms can be confirmed by View the current GaraHerb offer (official GaraHerb page).

Individual results vary. Dietary supplements are not substitutes for balanced nutrition, regular physical activity, or professional medical guidance. Consult a qualified healthcare provider before starting any new supplement regimen.

What Is GaraHerb

According to the company’s published materials, GaraHerb is a dietary supplement marketed as a natural male vitality formula. The company positions it as a once-daily capsule and describes it as a plant-based approach to supporting energy, stamina, and male performance. The product is distributed by GARAPLUS out of Aurora, Colorado.

The company states that GaraHerb is manufactured in the United States in a facility described as FDA-registered and GMP-certified. The label identifies the supplement as gluten-free and vegetarian. Each container provides 30 capsules at one capsule per serving.

The formula includes two individually dosed ingredients — Vitamin B3 (as Niacin) at 20 mg and Zinc (as Zinc Oxide) at 11 mg — along with a 570 mg proprietary blend containing L-Citrulline, L-Carnitine, Pine Bark Extract, Velvet Bean Seed Extract, Maca Root Extract, Grape Skin Extract, and Saffron Stigmas Extract. Other ingredients include the vegetable capsule shell, microcrystalline cellulose, magnesium stearate, and silicon dioxide.

How GaraHerb Is Described in Company Materials and Related Research

The company’s sales page describes GaraHerb as helping men “reclaim their vitality” and references renewed energy, confidence, and performance. According to the company’s marketing materials, results unfold in stages — with improvements in energy and mental clarity described in the first stage, firmer muscles and erections in the second, and lasting results by the third stage when taken continuously for at least three months.

These are the company’s marketing descriptions. No published clinical trial appears to have evaluated GaraHerb as a finished multi-ingredient supplement to verify these staged outcome claims. The staged timeline framework functions as a consumer-facing narrative presented by the company rather than a clinically validated progression.

Several individual ingredients within the proprietary blend have been studied in published research. The following section compiles what that research covers and the dosages used in those studies, which provides useful context for anyone looking into this product.

Ingredient-Level Research Context

In this context, “scientific investigation” refers to a compilation of ingredient-level research and publicly cited studies rather than clinical trials conducted on the finished GaraHerb formulation. The studies referenced below evaluate individual compounds under controlled conditions and are not presented as clinical validation of the GaraHerb product itself.

This is ingredient-level research; GaraHerb as a finished product has not been clinically studied.

L-Citrulline has been studied for its role in nitric oxide production and blood flow support. Published research, including a 2011 study in the journal Urology, examined L-Citrulline supplementation at 1,500 mg daily and reported improvements in certain measures of erectile function in a small group of men with mild concerns. The dosage used in that study — 1,500 mg of L-Citrulline alone — is more than double GaraHerb’s entire 570 mg proprietary blend shared across seven ingredients.

Pine Bark Extract (Pinus pinaster) has been reviewed in studies examining its antioxidant properties and potential effects on circulation. Some research has combined pine bark extract with L-Arginine at specific dosages and reported positive outcomes related to blood flow. These studies typically used pine bark extract at 40–120 mg daily alongside other compounds — not as one component among seven in a shared blend.

Maca Root Extract (Lepidium meyenii) has a body of published research examining its effects on libido, energy, and stamina. A 2009 systematic review noted limited but suggestive evidence for maca’s effects on sexual desire. Clinical studies generally used maca at dosages between 1,500 and 3,000 mg daily — significantly more than what a 570 mg shared blend could deliver.

Velvet Bean Seed Extract (Mucuna pruriens) contains L-DOPA, a precursor to dopamine, and has been studied for its potential effects on testosterone levels and reproductive health. Published research on Mucuna pruriens typically used dosages of 5,000 mg of seed powder daily in studies involving male fertility parameters. The extract form may concentrate active compounds, but the specific amount present in GaraHerb’s blend is not disclosed.

Saffron Stigmas Extract (Crocus sativus) has been examined in published studies for potential mood and libido-related effects. A 2012 study published in Psychopharmacology reported modest improvements in certain sexual function parameters using 30 mg of saffron daily. Whether GaraHerb’s blend delivers a comparable amount of saffron is unknown based on the label.

Zinc is the one ingredient dosed individually at 11 mg (100% Daily Value). Zinc plays a well-established role in testosterone production, immune function, and reproductive health. Published research, including a widely cited 1996 study, demonstrated that zinc restriction in young men was associated with decreased testosterone levels. The 11 mg dosage in GaraHerb aligns with the recommended daily intake and falls within ranges used in published studies.

Vitamin B3 (Niacin) at 20 mg supports energy metabolism and circulation. This dosage falls within standard supplementation ranges, though it is significantly lower than the therapeutic doses (500–3,000 mg) used in research examining cardiovascular effects.

These individual findings do not mean GaraHerb replaces prescribed treatment. Each study examined individual compounds at known dosages under controlled conditions — not GaraHerb’s specific proprietary formulation.

The Proprietary Blend Dosing Question

This is the most important transparency factor for anyone comparing the company’s ingredient references against published research.

According to the product label, the proprietary blend totals 570 mg across seven botanical ingredients. FDA labeling rules require ingredients to appear by weight from highest to lowest, meaning L-Citrulline is present in the largest amount and Saffron in the smallest. But the exact amount of each ingredient is not disclosed.

Here’s the practical math. If even two ingredients were dosed at their published research ranges, the remaining five would share a very small fraction of the blend. For context, published L-Citrulline research used 1,500 mg alone. Published maca studies used 1,500–3,000 mg. A single 570 mg blend containing seven ingredients cannot simultaneously deliver research-level dosages for multiple compounds.

This isn’t unique to GaraHerb — many supplements use proprietary blends. But understanding this structure helps set realistic expectations when the company’s marketing references potential outcomes without disclosing individual ingredient amounts.

A Note About the Scientific References on the GaraHerb Website

The official website lists 15 scientific references at the bottom of the sales page. When comparing these citations against the product label, several of the listed studies examine compounds that do not appear on GaraHerb’s Supplement Facts label.

For example, the reference list includes studies on magnesium and testosterone, saw palmetto, hawthorn berry, Cissus quadrangularis, chrysin, horny goat weed (icariin), and Tribulus terrestris. None of these ingredients are listed on the GaraHerb product label. The actual label ingredients — L-Citrulline, L-Carnitine, Pine Bark Extract, Velvet Bean Seed Extract, Maca Root Extract, Grape Skin Extract, and Saffron — are a different set of compounds.

The presence of citations for ingredients not found in the product is a detail consumers may want to be aware of. It does not necessarily indicate intent to mislead, but it means the reference list should be cross-checked against the actual Supplement Facts panel rather than taken as direct research support for the specific formula.

GaraHerb Pricing and Purchase Details

According to pricing published on the official website at the time of this report, GaraHerb is available in three package options: a single bottle (30-day supply) listed at $89 plus $9.99 shipping, a three-bottle package (90-day supply) listed at $59 per bottle with free shipping, and a six-bottle package (180-day supply) listed at $49 per bottle with free shipping. The company states that multi-bottle packages include bonus digital materials described on the sales page.

According to the company, all purchases are one-time payments with no subscriptions or automatic rebilling. The company states that orders ship within 1–2 business days via premium carriers, with delivery typically within 5–10 business days for domestic orders. Pricing and availability can change, so readers should verify current terms by View the current GaraHerb offer (official GaraHerb page).

GaraHerb Refund Policy Details

According to the company’s published policy, purchases are covered by a 60-day satisfaction period from the original purchase date, subject to specific return conditions, processing terms, and applicable fees.

The policy states that refund requests require a Return Merchandise Authorization (RMA) number obtained through customer support before returning product. All bottles — including empty, partially used, and any bonus or free bottles — must be returned within the 60-day window. According to the company, approved refunds are subject to a return-processing fee of up to 20% of the order value. Shipping charges are described as non-refundable, and return shipping is the buyer’s responsibility. The company limits refunds to one per product per household within a 12-month period. Full details are available on the official website.

Consumer Considerations Based on Company Materials

Cross-check the scientific references against the actual label. The references listed on the company’s sales page include studies on ingredients not present in the GaraHerb formula. Confirming which studies apply to ingredients actually in the product is a useful step.

Understand the proprietary blend structure. Without individual ingredient dosages disclosed, the formula cannot be directly compared to published research dosages. If exact amounts matter to your evaluation, the company’s contact information is listed below.

Read the full refund policy before ordering. According to the company’s published terms, the 60-day satisfaction period includes conditions such as a return-processing fee of up to 20%, an RMA requirement, and buyer-paid return shipping. Full terms are available on the official website.

Consider the staged results timeline in context. The three-stage progression described on the company’s website is a marketing framework, not a clinically validated timeline. According to published research, individual responses to any supplement depend on numerous personal health factors.

Talk to your healthcare provider. This is especially relevant for men taking medications for blood pressure, cardiovascular conditions, diabetes, hormonal imbalances, or erectile dysfunction. Several ingredients in GaraHerb’s blend interact with biological pathways that may overlap with prescription medications. Professional medical guidance should come before any supplement purchase.

Consumer Context Described in Company Materials

Based on the company’s published positioning and the product’s ingredient profile, GaraHerb may be of interest to men who prefer plant-based supplement options and who are exploring natural vitality support as one component of a broader wellness approach that includes balanced nutrition and regular physical activity.

The product may be less suited for consumers who need transparent individual ingredient dosing for clinical comparison. It may also not align with those seeking product-level clinical trial evidence rather than ingredient-level research, or individuals expecting rapid results from a single supplement without accompanying lifestyle changes.

As with any dietary supplement, individual outcomes depend on a wide range of personal health factors. Supplements are regulated differently than pharmaceutical drugs, and the FDA does not evaluate dietary supplement claims for efficacy before products reach the market. The FDA disclaimer printed on GaraHerb’s own label confirms that the product’s statements have not been evaluated by the Food and Drug Administration and that the product is not intended to diagnose, treat, cure, or prevent any disease.

Readers who want to confirm the full ingredient label, pricing tiers, and current availability can do so by View the current GaraHerb offer (official GaraHerb page).

Common Consumer Questions About GaraHerb

Is GaraHerb FDA approved?

GaraHerb is a dietary supplement. Under current federal regulations, dietary supplements do not require FDA approval before being sold. The company states the product is manufactured in an FDA-registered, GMP-certified facility, which relates to manufacturing standards — not product approval or efficacy verification.

Does GaraHerb have clinical trials?

No published clinical trial appears to have evaluated GaraHerb as a finished proprietary formula. The research cited on the product’s website pertains to individual ingredients or compounds not in the formula, often at dosages that may differ from what the proprietary blend delivers.

Why does GaraHerb use a proprietary blend?

Proprietary blends allow manufacturers to disclose which ingredients are included without revealing exact amounts for each one. This protects formulation trade secrets but limits a consumer’s ability to compare individual ingredient dosages against published research ranges.

How long does GaraHerb take to show results?

According to the company’s FAQ, most people notice differences within the first week, with optimal outcomes after three or more months of consistent use. These are the company’s marketing statements. Individual timelines depend on factors including baseline health, dietary habits, and physical activity levels.

What is GaraHerb’s refund process?

According to the company’s published policy, refund requests must be submitted within 60 days of the original purchase date. An RMA number is required, all bottles (including empty and bonus bottles) must be returned, and return shipping is the buyer’s responsibility. A processing fee of up to 20% may apply to approved refunds.

Do the scientific references on the website match the ingredients?

Not entirely. Several references cite studies on ingredients — including magnesium, saw palmetto, hawthorn berry, chrysin, horny goat weed, Tribulus terrestris, and Cissus quadrangularis — that are not listed on the GaraHerb Supplement Facts panel. Cross-referencing the citations with the actual label is recommended.

Additional Consumer Research

Consumers researching GaraHerb may benefit from additional publicly available information on this product. A 2026 informational overview of GaraHerb supplement facts, ingredient label details, and product disclosures provides additional context on what the Supplement Facts panel does and does not reveal. Readers may also find it helpful to explore the label-verified ingredient breakdown and manufacturing transparency details compiled earlier this year.

Evaluating multiple sources is recommended before making any purchasing decision. Consumers may also wish to review the FDA’s general guidance on dietary supplement labeling and claims.

Summary of Key Considerations

GaraHerb is a dietary supplement that the company positions as a natural male vitality formula built around botanical ingredients. The product contains individual compounds that have published research at the ingredient level — particularly zinc for testosterone support and L-Citrulline for nitric oxide production. However, the proprietary blend structure limits visibility into individual dosing, several of the scientific references on the sales page cite ingredients not present in the formula, and no published clinical trial has evaluated the finished product as formulated.

According to the company, GaraHerb is backed by a 60-day refund period with specific conditions including a processing fee of up to 20%, one-time purchase pricing with no subscriptions, and manufacturing under GMP standards in an FDA-registered facility.

Complete product details, current pricing, and published terms are available by View the current GaraHerb offer (official GaraHerb page).

Contact Information

According to the company’s published contact details:

Company: GARAPLUS

Return Address: 19655 E 35th Drive, Suite 100, Aurora, CO 80011, USA

Email: support@garaherb.com

U.S. Support: 1-302 455 7162

E.U. Support: +44 1704 320405

Website: https://garaherb.com/

Disclaimers

Content and Consumer Information Disclaimer: This is an informational report compiled from publicly available product materials, ingredient-level research references, and the company’s published disclosures. It does not constitute medical, health, dietary, financial, or legal advice. All product details, ingredient information, pricing, and policy terms described in this report are stated as presented by the company on its publicly available website and product labeling. This content has not been independently audited or verified unless specifically noted. Readers are encouraged to verify all claims directly with the manufacturer and to consult a qualified healthcare professional before beginning any dietary supplement.

FDA Health Disclaimer: These statements have not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure, or prevent any disease. Always consult your physician before starting any new supplement, especially if you have existing health conditions, take medications, or are pregnant or nursing.

Professional Medical Disclaimer: This content is educational and does not constitute medical advice. GaraHerb is a dietary supplement, not a medication. If you are currently taking medications, have existing health conditions, are pregnant or nursing, or are considering any major changes to your health regimen, consult your physician before starting GaraHerb or any new supplement. Do not change, adjust, or discontinue any medications or prescribed treatments without your physician’s guidance and approval.

Results May Vary: Individual results will vary based on factors including age, baseline health condition, lifestyle factors, consistency of use, genetic factors, current medications, and other individual variables. Results are not guaranteed. These are individual experiences and should not be interpreted as typical or guaranteed results.

FTC Affiliate Disclosure: This report contains affiliate links. If a purchase is made through these links, a commission may be earned at no additional cost to the buyer. This compensation does not influence the accuracy, neutrality, or integrity of the information presented. All descriptions are based on published research and publicly available information.

Pricing Disclaimer: All prices, discounts, and promotional offers mentioned were accurate at the time of publication (March 2026) but are subject to change without notice. Always verify current pricing and terms on the official GaraHerb website before making your purchase.

Publisher Responsibility: The publisher of this report has made every effort to ensure accuracy at the time of publication. No responsibility is assumed for errors, omissions, or outcomes resulting from the use of the information provided. Readers are encouraged to verify all details directly with GaraHerb and their healthcare provider before making decisions.

CONTACT: Email: support@garaherb.com
U.S Support 1-302 455 7162
E.U. Support +44 1704 320405 

Zevra Therapeutics Reports Inducement Grant to New Chief Financial Officer Under Nasdaq Listing Rule 5635(c)(4)

Zevra Therapeutics Reports Inducement Grant to New Chief Financial Officer Under Nasdaq Listing Rule 5635(c)(4)




Zevra Therapeutics Reports Inducement Grant to New Chief Financial Officer Under Nasdaq Listing Rule 5635(c)(4)

BOSTON, March 20, 2026 (GLOBE NEWSWIRE) — Zevra Therapeutics, Inc. (NasdaqGS: ZVRA) (Zevra, or the Company), a commercial-stage company focused on providing therapies for people living with rare disease, today announced that the Company has granted as of March 18, 2026 an equity inducement award to Justin Renz, the Company’s new Chief Financial Officer pursuant to the Company’s 2023 Employment Inducement Award Plan (as amended and/or restated, the “Inducement Award Plan”). The equity award was approved by the Compensation Committee of the Board of Directors in accordance with Nasdaq Rule 5635(c)(4) and made as a material inducement to Mr. Renz upon acceptance of employment with Zevra.

The Company granted Mr. Renz a new hire option to purchase 300,000 shares of Zevra’s common stock. The option has a 10-year term and an exercise price per share equal to $9.55, which was the closing price of Zevra’s common stock on March 18, 2026. The option vests over four years, subject to Mr. Renz’s continued service through the applicable vesting dates.

About Zevra Therapeutics, Inc.

Zevra Therapeutics, Inc. is a commercial-stage company with a late-stage pipeline committed to redefining what is possible in bringing life-changing therapies to people living with rare diseases. The Company is focused on broadening access through geographic expansion opportunities, progressing its pipeline toward key milestones, and delivering meaningful therapeutics. The commercialization of its lead product, marketed in the U.S. for Niemann-Pick disease type C (NPC), a rare, progressive neurodegenerative disease, provides a strong corporate foundation and validates its ability to advance therapies from development to market. Zevra’s vision is realized through disciplined execution of its strategic plan and core values — patient centricity, integrity, accountability, innovation, and courage — which guide its efforts to deliver long-term value.

For more information, please visit www.zevra.com or follow us on X and LinkedIn.

Investor Contact

Nichol Ochsner 
+1 (732) 754-2545 
nochsner@zevra.com  

Media Contact

Julie Downs
+1 (508) 246-3230
jdowns@zevra.com

Imaginostics Receives Siemens Healthineers Letter of Support as Companies Advance Quantitative MRI Dialogue

Imaginostics Receives Siemens Healthineers Letter of Support as Companies Advance Quantitative MRI Dialogue




Imaginostics Receives Siemens Healthineers Letter of Support as Companies Advance Quantitative MRI Dialogue

ORLANDO, Fla.–(BUSINESS WIRE)–#Alzheimers–Imaginostics, Inc. today announced that it has received a Letter of Support from Siemens Healthineers in connection with ongoing exploratory discussions regarding potential collaboration in quantitative MRI and imaging biomarkers.


As part of these discussions, Imaginostics and Siemens Healthineers intend to continue dialogue concerning potential technical and commercial pathways for Imaginostics’ envisioned ImagiView™ and ImagiSight™ offerings and their potential applications for Siemens Healthineers MAGNETOM MRI systems.

“Quantitative MRI and imaging biomarkers have the potential to make imaging more objective, reproducible, and clinically actionable,” said Dr. Codi Gharagouzloo, Scientific Founder & CSO. “This Letter of Support marks an important milestone for Imaginostics, and we look forward to continuing the technical and commercial dialogue with Siemens Healthineers,” added Valerie Gharagouzloo, Co-Founder and CEO.

The companies plan to continue evaluating potential opportunities within their respective technical, development, regulatory, and commercial frameworks. Any future collaboration or commercial activity would remain subject to further discussions, internal approvals, and definitive agreements.

About Imaginostics

Imaginostics is building vascular intelligence from the ground up through precision diagnostic and prognostic imaging. The company is developing a first-of-its-kind quantitative MRI technology designed to enable AI-powered, data-driven digital twin insights aimed at detecting complex diseases earlier and enabling more personalized care. By transforming imaging into quantitative biological insights, Imaginostics seeks to support a shift from reactive to preventative healthcare and contribute to improved outcomes across a lifetime. Vascular Health for Life™.

The company is currently in a pre-FDA stage and is not yet providing clinical services.

Contacts

Valerie Gharagouzloo, CEO, media@imaginostics.com

ImmunityBio Announces Approval in Macau SAR, China for ANKTIVA® in BCG-Unresponsive NMIBC with CIS ± Papillary Tumors

ImmunityBio Announces Approval in Macau SAR, China for ANKTIVA® in BCG-Unresponsive NMIBC with CIS ± Papillary Tumors




ImmunityBio Announces Approval in Macau SAR, China for ANKTIVA® in BCG-Unresponsive NMIBC with CIS ± Papillary Tumors

  • Macau SAR, China regulator grants approval for ANKTIVA® (nogapendekin alfa inbakicept-pmln) in patients with BCG-unresponsive NMIBC with CIS ± papillary tumors
  • Authorization follows a reliance-based review referencing prior FDA and EMA decisions
  • First ANKTIVA authorization in Asia, supporting ongoing global expansion across 34 countries and territories

CULVER CITY, Calif.–(BUSINESS WIRE)–ImmunityBio, Inc. (NASDAQ: IBRX), today announced that the Pharmaceutical Administration Bureau (ISAF) of the Macau Special Administrative Region of the People’s Republic of China has granted regulatory approval for ANKTIVA® (nogapendekin alfa inbakicept-pmln).


The approval establishes ANKTIVA’s initial presence in Asia and reflects the Company’s strategy to expand global access through reliance-based regulatory pathways. In Macau, ANKTIVA is approved in combination with Bacillus Calmette-Guérin (BCG) for adult patients with BCG-unresponsive non-muscle invasive bladder cancer (NMIBC) with carcinoma in situ (CIS) ± papillary tumors, consistent with its approved use in the United States.

The authorization was granted following a review that considered prior regulatory decisions by the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA), in accordance with applicable local requirements.

“This approval in Macau reflects the strength of the clinical and regulatory foundation supporting ANKTIVA in BCG-unresponsive NMIBC CIS, with or without papillary tumors,” said Patrick Soon-Shiong, M.D., Founder, Executive Chairman and Global Chief Scientific and Medical Officer of ImmunityBio. “The data from QUILT 3.032, published in NEJM Evidence and The Journal of Urology, demonstrate durable responses in this disease setting. As we continue to work with regulatory authorities, our focus remains on enabling global access to an immunotherapy designed to activate NK and T-cell function and address the underlying immune deficit in bladder cancer.”

This approval in Macau represents the first authorization for ANKTIVA in Asia. The Company continues to engage with additional health authorities across the region as part of its international regulatory strategy.

“This authorization marks an important step in establishing ANKTIVA in Asia and advancing our broader international expansion strategy,” said Richard Adcock, President and CEO of ImmunityBio. “We are engaging with additional health authorities across the Asia-Pacific region and, in parallel, beginning to prepare for potential commercial distribution, recognizing there is still meaningful work ahead as we pursue further regulatory authorizations. Our focus is on executing this expansion in a disciplined manner, building on our existing approvals to support long-term global access for patients.”

About ANKTIVA®

ANKTIVA® (nogapendekin alfa inbakicept-pmln) is a first-in-class interleukin-15 (IL-15) receptor agonist designed to activate and proliferate natural killer (NK) cells and CD8+ T cells. In the QUILT-3.032 study in patients with Bacillus Calmette-Guérin (BCG)-unresponsive non-muscle invasive bladder cancer (NMIBC) with carcinoma in situ (CIS) with or without papillary tumors, ANKTIVA in combination with BCG demonstrated a complete response rate of 71%, with a median duration of response of 26.6 months.

About ImmunityBio

ImmunityBio, Inc. is a biotechnology company focused on innovating, developing, and commercializing next-generation immunotherapies designed to activate the patient’s immune system and deliver durable protection against cancer and infectious diseases. Our approach harnesses both the adaptive and innate immune systems with the goal of restoring immune function and generating lasting immunological memory in patients. At the core of our strategy is the Cancer BioShield platform, which is designed to stimulate critical lymphocytes, including natural killer (NK) cells, cytotoxic T cells, and memory T cells via our proprietary IL-15 superagonist, ANKTIVA® (nogapendekin alfa inbakicept). Our Cancer BioShield platform is anchored by this antibody-cytokine fusion protein and is complemented by a portfolio that includes adenovirus-vectored vaccines, allogeneic (off-the-shelf) and autologous NK-cell therapies, and additional immunomodulators intended to promote immunogenic cell death and support durable immune responses while potentially reducing reliance on high-dose chemo-radiation therapy. For more information, visit ImmunityBio.com and connect with us on X (Twitter), Facebook, LinkedIn, and Instagram.

Forward-Looking Statements

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, including statements regarding ImmunityBio’s regulatory activities in Macau and other jurisdictions; the potential pursuit, timing, and outcome of additional regulatory submissions and authorizations; the Company’s plans for potential commercial distribution; and its broader international expansion strategy for ANKTIVA.

These forward-looking statements are based on the Company’s current expectations and are subject to risks and uncertainties that could cause actual results to differ materially from those described herein. Such risks and uncertainties include, among others, the determinations of regulatory authorities, including ISAF, the U.S. Food and Drug Administration (FDA), the European Medicines Agency (EMA), and other global health authorities; the possibility that additional data, analyses, or clinical studies may be required; risks related to manufacturing, supply, and distribution; and other factors affecting the Company’s business.

Additional information regarding these and other risks can be found under the heading “Risk Factors” in ImmunityBio’s Annual Report on Form 10-K filed with the U.S. Securities and Exchange Commission, as well as in subsequent filings with the SEC, which are available at www.sec.gov. ImmunityBio cautions you not to place undue reliance on these forward-looking statements, which speak only as of the date of this press release, and the Company undertakes no obligation to update any forward-looking statements except as required by law.

Contacts

ImmunityBio Contacts:

Investors

Hemanth Ramaprakash, PhD, MBA

ImmunityBio, Inc.

+1 858-746-9289

Hemanth.Ramaprakash@ImmunityBio.com

Media

Sarah Singleton

ImmunityBio, Inc.

+1 415-290-8045

Sarah.Singleton@ImmunityBio.com

Disclosure of a transparency notification from Aberdeen Group plc

Disclosure of a transparency notification from Aberdeen Group plc




Disclosure of a transparency notification from Aberdeen Group plc

Regulated information
Nazareth (Belgium)/Rotterdam (The Netherlands), 20 March 2026 – 6 PM CET

Disclosure of a transparency notification from Aberdeen Group plc

Pursuant to the Belgian act of 2 May 2007 on the disclosure of major shareholdings in listed companies, Fagron received a transparency notification from Aberdeen Group plc, dated 16 March 2026.

Notification from Aberdeen Group plc

  • On 19 March 2026, Fagron received a transparency notification from Aberdeen Group plc, informing the Company that its shareholding has crossed the lowest 3% disclosure threshold downwards, following a disposal of voting securities or voting rights attached to shares in Fagron.
  • The notification was submitted by ‘a parent undertaking or a controlling person’.
  • According to the notification, as of 13 March 2026, Aberdeen Group plc holds a total of 2,195,403 shares in Fagron, consisting of 1,850,845 shares held through abrdn Investment Management Limited and 344,558 shares held through abrdn Investments Limited. The total number of 2,195,403 shares corresponds to the same number of voting rights.
  • According to the notification, Aberdeen Group plc is the parent company of the underlying intermediate holding companies abrdn Investments (Holdings) Limited (which is the holding company of the underlying investment management entity abrdn Investment Management Limited), and abrdn Holdings Limited (which is the holding company of the underlying investment management entity abrdn Investments Limited).
  • Based on the total number of outstanding voting rights (73,668,904 as the applicable denominator), this shareholding represents 2.98% of the total voting rights.
  • The full transparency notification from Aberdeen Group plc is available on the Fagron website via the link.

Further information
Ignacio Artola
Global Head of Investor Relations
investors@fagron.com

About Fagron

Fagron is the leading global company active in pharmaceutical compounding, focusing on delivering personalized medicine to hospitals, pharmacies, clinics, and patients in more than 38 countries around the world.

The Belgian company Fagron NV is based in Nazareth and is listed on Euronext Brussels and Euronext Amsterdam under the ticker symbol ‘FAGR’. Fagron’s operational activities are managed through the Dutch company Fagron BV with head office in Rotterdam.

Important information regarding forward-looking statements

Certain statements in this press release may be deemed to be forward-looking. Such forward-looking statements are based on current expectations and are influenced by various risks and uncertainties. Consequently, Fagron cannot provide any guarantee that such forward-looking statements will, in fact, materialize and cannot accept any obligation to update or revise any forward-looking statement as a result of new information, future events or for any other reason.

In the event of differences between the English translation and the Dutch original of this press release, the latter prevails.

Attachment

SafeSpace Global Corporation Reports Q2 Fiscal 2026 Financial Results; Company Transitions from Pre-Revenue to Revenue-Generating Stage, Expands Footprint with Nashville Office, and Initiates Steps Toward National Exchange Uplisting

SafeSpace Global Corporation Reports Q2 Fiscal 2026 Financial Results; Company Transitions from Pre-Revenue to Revenue-Generating Stage, Expands Footprint with Nashville Office, and Initiates Steps Toward National Exchange Uplisting




SafeSpace Global Corporation Reports Q2 Fiscal 2026 Financial Results; Company Transitions from Pre-Revenue to Revenue-Generating Stage, Expands Footprint with Nashville Office, and Initiates Steps Toward National Exchange Uplisting

KNOXVILLE, TN., March 20, 2026 (GLOBE NEWSWIRE) — SafeSpace Global Corporation (OTCID: SSGC) (SafeSpace Global or the Company), a leader in multimodal AI-powered safety and security solutions company dedicated to safety innovation across multiple industries, on March 17, 2026 announced the filing of its Quarterly Report on Form 10-Q for the quarter ended January 31, 2026 (Q2 FY2026) with the U.S. Securities and Exchange Commission.

Q2 FISCAL 2026 | KEY HIGHLIGHTS

  • Transition to Revenue-Generating Stage: SafeSpace has successfully exited its pre-revenue phase, having deployed AI safety solutions across its first of four core verticals, marking a significant operational milestone.
  • Nashville Office Expansion: The Company announced the opening of additional office space in Nashville, Tennessee, reflecting accelerating commercial momentum and geographic growth to support scaling partnerships.
  • Uplisting Initiative: SafeSpace has initiated the corporate governance process required for a national stock exchange listing, including seeking shareholder approval; a move designed to broaden investor access and enhance the Company’s capital markets profile.
  • Strong Working Capital Position: Working capital surplus of $3.6 million as of January 31, 2026, providing the Company with a solid financial foundation to execute its growth strategy.
  • Significant Asset Build-Out: Total intangible assets, net, increased to $1.26 million (from $290,469 at fiscal year-end July 31, 2025), driven by continued investment in proprietary technology and patents.
  • Operating Expense Reduction in Q2: Total operating expenses for Q2 decreased 7% year-over-year to $1.16 million, reflecting early-stage cost discipline even as the team scaled.
  • Interest Income Generated: The Company generated $109,130 in interest income for the six-month period, reflecting prudent management of its cash balances.
  • Zero Debt: All outstanding debt has been fully repaid, resulting in no interest expense and a clean balance sheet.
  • 189.4 Million Shares Outstanding: As of March 12, 2026, with 189,429,097 common shares outstanding.

MANAGEMENT COMMENTARY

“This quarter represents a defining inflection point for SafeSpace Global,” said Scott M. Boruff, Chief Executive Officer. “After spending the past year systematically building out our four vertical markets; laying the technology, partnerships, and client infrastructure required to scale, we have now entered the revenue-generating phase of our commercial journey. The opening of our Nashville office is a direct reflection of that progress, as is the board’s decision to initiate the shareholder approval process for certain required action as part of its Corporate Governance undertakings for uplisting to a national exchange. We believe these milestones, taken together, position SafeSpace for rapid and meaningful growth in the months ahead.”

“Our balance sheet remains strong, with over $5.6 million in total assets and $3.6 million in working capital as of January 31, 2026 and zero debt ,” Scott M. Boruff continued. “This financial stability, combined with the strategic partnerships and client relationships we have and will continue to establish across our verticals, gives us the confidence and the runway to scale aggressively. We look forward to sharing further updates on revenue progress and expansion milestones as we execute on our growth plan.”

SUMMARY FINANCIAL RESULTS | SIX MONTHS ENDED JANUARY 31, 2026

The following table presents selected unaudited financial data for the six months ended January 31, 2026 compared with the prior-year-end period:

Balance Sheet (as of January 31, 2026 vs. July 31, 2025)

  • Cash and cash equivalents: $3,861,070 (vs. $7,546,390 at July 31, 2025; reflecting investment in capital expenditures and operations)
  • Total current assets: $3,960,157
  • Total assets: $5,646,993
  • Total current liabilities: $320,725; a decrease of $45,286 from $366,011 on July 31, 2025
  • Working capital surplus: $3,639,432 (vs. $7,274,432 at July 31, 2025)
  • Total stockholders’ equity: $5,326,268

Income Statement (Six Months Ended January 31, 2026 vs. 2025)

  • Total operating expenses: $2,851,117 vs. $1,918,937; increase reflects full-scale build-out of operations, headcount, and go-to-market infrastructure
  • Interest income: $109,130 vs. $0; new, reflecting cash balances from prior equity raises
  • Interest expense: $0 vs. $(31,637); all debt extinguished)
  • Net loss: $(2,741,987) vs. $(1,950,574)
  • Net loss per common share (basic and diluted): $(0.01) vs. $(0.02)
  • Weighted average common shares outstanding: 186,831,829

Investing Activity

  • Capital expenditures of $1,238,678 (During Six Months Ended January 31, 2026); significant investment in equipment and intangible assets to build four-vertical commercial infrastructure; no material capital expenditure commitments outstanding as of January 31, 2026.

BUSINESS UPDATE: FOUR VERTICALS POSITIONED TO SCALE

SafeSpace Global has spent the past fiscal year executing a deliberate build-out strategy across its four key target verticals, each of which utilizes the Company’s proprietary multimodal AI monitoring and safety platform. With commercial deployments now underway, SafeSpace Global is positioned to accelerate revenue growth through its growing network of strategic partnerships and direct client relationships.

The Company’s advanced AI platform is designed to enhance situational awareness and safety outcomes, reduce operational risk, and improve care efficiency; capabilities that are broadly applicable across the verticals it serves. Management believes this cross-sector approach creates multiple independent pathways to revenue while amplifying the overall commercial potential of the SafeSpace technology ecosystem.

STRATEGIC UPDATES: NASHVILLE EXPANSION & NATIONAL EXCHANGE UPLISTING

SafeSpace recently announced the opening of additional office space in Nashville, Tennessee. This expansion positions the Company to better serve clients and partners in a strategically important market, and reflects the operational scaling underway as the Company transitions from development to commercial execution.

In parallel, the Company’s board of directors has initiated the process of seeking shareholder approval in connection with the Company’s corporate governance requirements for uplisting to a national stock exchange. Management believes that listing on a national exchange would expand the Company’s investor base, improve trading liquidity, and enhance the overall visibility and credibility of the SafeSpace brand with institutional investors and strategic partners.

FULL FILING AVAILABILITY

Readers are encouraged to review the Company’s full 10-Q filing, available at www.sec.gov, for a complete discussion of risks and uncertainties.

SafeSpace Global Corporation’s Quarterly Report on Form 10-Q for the period ended January 31, 2026 is available at https://www.sec.gov/Archives/edgar/data/1584693/000149315226010534/form10-q.htm and on the OTC Markets website under the ticker: SSGC.

ABOUT SAFESPACE GLOBAL CORPORATION

SafeSpace Global Corporation (OTCID: SSGC) is a publicly traded technology company providing proprietary multimodal, advanced, AI safety solutions in their mission to help save lives. The Company’s platform delivers advanced threat detection, incident notification, and comprehensive security capabilities designed to protect people and property across multiple sectors, verticals and use-cases.

As of February 2026, SafeSpace Global is generating recurring monthly revenue through service contracts with senior living facilities utilizing its AI-powered safety monitoring platform. The Company now has offices in both Knoxville and Nashville, Tennessee.

SafeSpace Global Corporation: https://www.safespaceglobal.ai

CAUTIONARY NOTE REGARDING FORWARD-LOOKING STATEMENTS

This press release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. These statements involve known and unknown risks, uncertainties, and other factors that may cause the Company’s actual results, performance, or achievements to be materially different from any future results, performances, or achievements expressed or implied by the forward-looking statements. Forward-looking statements include, but are not limited to, statements regarding revenue generation, commercial expansion, partnership development, the Company’s uplisting initiative, and future financial performance. SafeSpace Global Corporation undertakes no obligation to update or revise any forward-looking statements, whether as a result of new information, future events, or otherwise, except as required by applicable law. Investors are cautioned not to place undue reliance on these forward-looking statements.

Investor Relations Contact:

Carmel Fisher
Investor Relations | SafeSpace Global Corporation
+1 (310) 745-9171
Investors@safespaceglobal.ai

Media Contact:
Harvest Communications
info@harvestcomms.com

Results from Real-World, Long-Term Treatment Persistence with LEQEMBI® (lecanemab-irmb) in the United States Presented at AD/PD™ 2026

Results from Real-World, Long-Term Treatment Persistence with LEQEMBI® (lecanemab-irmb) in the United States Presented at AD/PD™ 2026




Results from Real-World, Long-Term Treatment Persistence with LEQEMBI® (lecanemab-irmb) in the United States Presented at AD/PD™ 2026

Real-World LEQEMBI Data Shows Patients Choose to Stay on Long-Term Treatment

TOKYO and CAMBRIDGE, Mass., March 20, 2026 (GLOBE NEWSWIRE) — Eisai Co., Ltd. (Headquarters: Tokyo, CEO: Haruo Naito, “Eisai”) and Biogen Inc. (Nasdaq: BIIB, Corporate headquarters: Cambridge, Massachusetts, CEO: Christopher A. Viehbacher, “Biogen”) announced today that new real‑world findings from an analysis of long‑term treatment persistence and baseline characteristics among people receiving intravenous (IV) lecanemab (generic name, brand name LEQEMBI®), an anti‑amyloid‑β (Aβ) protofibril antibody, showed that most patients continue with ongoing lecanemab therapy after the initial 18 months of treatment. The analysis was presented at the 20th International Conference on Alzheimer’s and Parkinson’s Diseases and Related Neurological Disorders (AD/PD™ 2026) in Copenhagen, Denmark, and online.

In real‑world clinical practice, patients with chronic diseases who stay on their treatments longer tend to experience better clinical outcomes and higher satisfaction.1,2 Ninety-four percent of patients who completed 18 months of lecanemab treatment in the Phase III Clarity AD chose to continue maintenance treatment by enrolling in the subsequent open-label, long-term extension (OLE) study. In the OLE of Clarity AD study, patients continue to benefit from four years of lecanemab treatment compared with the natural course of Alzheimer’s disease (Alzheimer’s Disease Neuroimaging Initiative: ADNI*).

Long-Term Persistence and Patient Characteristics for Lecanemab in Real-World Use in the United States (Presentation: March 20, 17:05 CET)
This analysis is the first time real-world lecanemab data on treatment persistence beyond 18 months has been reported.

This study was a retrospective observational analysis using the PurpleLab® CLEAR Claims database, a comprehensive dataset based on medical insurance claims across the United States and was conducted to evaluate the long‑term treatment persistence of lecanemab in real‑world clinical practice.

■ Patient background and dosing
The analysis population consisted of 10,763 individuals who met the requirement for continuous healthcare encounters, out of the 13,388 individuals recorded in the database who received at least one intravenous treatment with lecanemab between January 6, 2023 and November 30, 2025. At baseline, the mean age was 73.8 years and 56.5% were female. The most common comorbidities were dyslipidemia (42.2%) and hypertension (36.9%). The mean follow-up duration was 350.9 days. The average number of administrations was 1.7 per month, and the mean dosing interval was 16.4 days (median 14 days), which was generally consistent with the recommended every two weeks dosing.

■ Long-Term persistence results
The time-dependent proportion of patients who remained on lecanemab treatment was evaluated, using the Kaplan–Meier method in a subgroup of 371 patients who initiated treatment in 2023 and had 20 months of continuous follow-up, thereby enabling assessment of long-term treatment persistence beyond 18 months. As a result, 78.4% of individuals continued lecanemab treatment at 18 months, 71.7% at 20 months, and 67.3% at 24 months. Of the 78.4% of patients who remained on lecanemab at 18 months, the majority of them continued treatment during the maintenance period beyond 18 months, confirming a high rate of treatment persistence with lecanemab in real-world clinical practice. The patient characteristics and dosing patterns observed in this claims-based analysis were generally similar to those reported in the Clarity AD. Furthermore, the relatively high treatment adherence observed among individuals suggests that potential delays due to MRI monitoring requirements, adverse events, and other factors did not substantially affect lecanemab dosing.

Eisai serves as the lead for lecanemab’s development and regulatory submissions globally with Eisai and Biogen co-commercializing and co-promoting the product and Eisai having final decision-making authority.

* ADNI is a clinical research project launched in 2005 to develop methods to predict the onset and progression of AD and to confirm the effectiveness of treatments. The project involves a multi-year longitudinal observation targeting healthy elderly individuals as well as patients with mild cognitive impairment (MCI) and early stages of AD.

MEDIA CONTACTS  
Eisai Co., Ltd.
Public Relations Department
TEL: +81 (0)3-3817-5120

Eisai Europe, Ltd.
(Europe, Australia, New Zealand and Russia)
EMEA Communications Department
+44 (0) 7739-600-678
EMEA-comms@eisai.net

Eisai Inc. (U.S.)
Libby Holman
+1-201-753-1945
Libby_Holman@Eisai.com

Biogen Inc.
Madeleine Shin
+1-781-464-3260
public.affairs@biogen.com

INVESTOR CONTACTS  
Eisai Co., Ltd.
Investor Relations Department
TEL: +81 (0) 3-3817-5122
Biogen Inc.
Tim Power
+ 1-781-464-2442
IR@biogen.com


Notes to Editors

1. About lecanemab (generic name, brand name: LEQEMBI)
Lecanemab is the result of a strategic research alliance between Eisai and BioArctic. It is a humanized immunoglobulin gamma (IgG1) monoclonal antibody directed against aggregated soluble (protofibril) and insoluble forms of amyloid-beta (Aβ).

Lecanemab has been approved in 53 countries and regions including Japan, the United States, China, Europe, South Korea, Taiwan, and Saudi Arabia, and is under regulatory review in 6 countries. Following the initial phase with treatment every two weeks for 18 months, intravenous (IV) maintenance dosing with treatment every four weeks was approved in 7 countries including the U.S., China, the UK, and others, and applications have been filed in 10 countries and regions. The U.S. FDA approved Eisai’s Biologics License Application (BLA) for subcutaneous maintenance dosing with LEQEMBI IQLIK in August 2025. A Supplemental Biologics License Application (sBLA) for initiation treatment was accepted in January 2026. The sBLA has been granted Priority Review, with a Prescription Drug User Fee Act (PDUFA) action date of May 24, 2026. In November 2025, an application for a subcutaneous injectable formulation in Japan was submitted. In January 2026, the Biologics License Application (BLA) for the subcutaneous formulation was accepted in China. In December 2025, Lecanemab (IV) has been included in the “Commercial Insurance Innovative Drug List”, recently introduced by the National Healthcare Security Administration (NHSA) of China.

In the global Phase 3 placebo-controlled, double-blind, parallel-group, randomized Clarity AD core study, the mean change from baseline between the lecanemab treated group and the placebo group after 18 months was -0.45 (P=0.00005) on the primary endpoint of CDR-SB global cognitive and functional scale. To provide context, a change from 0.5 to 1 on the Clinical Dementia Rating (CDR) score domains of Memory, Community Affairs and Home/Hobbies reflects a shift from mild impairment to loss of independence. This can affect a person’s ability to be left alone safely, recall recent events, participate in daily activities, manage household tasks, and engage in hobbies and intellectual interests.3,4

Over three years of treatment, including both the core study and the OLE, data showed lecanemab demonstrated a reduction in cognitive decline—measured by CDR-SB—of 1.01 points compared to the expected decline observed in the Alzheimer’s Disease Neuroimaging Initiative (ADNI) cohort. This benefit grew more pronounced after four years, with a reduction of 1.75 points. Similarly, when benchmarked against the expected decline in the BioFINDER** cohort, lecanemab showed a reduction of 1.40 points at three years and an even greater reduction of 2.17 points at the four years mark.

Since July 2020 the Phase 3 clinical study (AHEAD 3-45) for individuals with preclinical AD, meaning they are clinically normal and have intermediate or elevated levels of amyloid in their brains, is ongoing. AHEAD 3-45 is conducted as a public-private partnership between the Alzheimer’s Clinical Trial Consortium that provides the infrastructure for academic clinical trials in AD and related dementias in the U.S, funded by the National Institute on Aging, part of the National Institutes of Health, Eisai and Biogen. Since January 2022, the Tau NexGen clinical study for Dominantly Inherited AD (DIAD), that is conducted by Dominantly Inherited Alzheimer Network Trials Unit (DIAN-TU), led by Washington University School of Medicine in St. Louis, is ongoing and includes lecanemab as the backbone anti-amyloid therapy.

** BioFINDER subjects are similar to Study 301 and ADNI subjects, except all BioFINDER subjects are in the MCI stage and no mild AD subjects are included, and their baseline CDR-SB is lower. BioFINDER is a large-scale, long-term prospective study led by Lund University in Sweden, aiming to establish early. diagnosis and elucidate pathophysiology of neurodegenerative diseases. In addition to AD, the study also focuses on conditions including Parkinson’s Disease. Individuals participating in the study undergo regular clinical assessments, cognitive function tests, brain imaging (MRI, Aβ PET, Tau PET), and collection of biomarkers from blood and cerebrospinal fluid (CSF).

2. About Protofibrils
Protofibrils are believed to contribute to the brain injury that occurs with AD and are considered to be the most toxic form of soluble Aβ, having a primary role in the cognitive decline associated with this progressive, debilitating condition.3 Protofibrils cause injury to neurons in the brain, which in turn, can negatively impact cognitive function via multiple mechanisms, not only increasing the development of insoluble Aβ plaques but also increasing direct damage to brain cell membranes and the connections that transmit signals between nerve cells or nerve cells and other cells. It is believed the reduction of protofibrils may prevent the progression of AD by reducing damage to neurons in the brain and cognitive dysfunction.4

3. About the Collaboration between Eisai and Biogen for AD
Eisai and Biogen have been collaborating on the joint development and commercialization of AD treatments since 2014. Eisai serves as the lead of lecanemab development and regulatory submissions globally with both companies co-commercializing and co-promoting the product and Eisai having final decision-making authority.

4. About the Collaboration between Eisai and BioArctic for AD
Since 2005, Eisai and BioArctic have had a long-term collaboration regarding the development and commercialization of AD treatments. Eisai obtained the global rights to study, develop, manufacture and market lecanemab for the treatment of AD pursuant to an agreement with BioArctic in December 2007. The development and commercialization agreement on the antibody lecanemab back-up was signed in May 2015.

5. About Eisai Co., Ltd.
Eisai’s Corporate Concept is “to give first thought to patients and people in the daily living domain, and to increase the benefits that health care provides.” Under this Concept (also known as human health care (hhc) Concept), we aim to effectively achieve social good in the form of relieving anxiety over health and reducing health disparities. With a global network of R&D facilities, manufacturing sites and marketing subsidiaries, we strive to create and deliver innovative products to target diseases with high unmet medical needs, with a particular focus in our strategic areas of Neurology and Oncology.

In addition, we demonstrate our commitment to the elimination of neglected tropical diseases (NTDs), which is a target (3.3) of the United Nations Sustainable Development Goals (SDGs), by working on various activities together with global partners.

For more information about Eisai, please visit www.eisai.com (for global headquarters: Eisai Co., Ltd.), and connect with us on X, LinkedIn and Facebook. The website and social media channels are intended for audiences outside of the UK and Europe. For audiences based in the UK and Europe, please visit www.eisai.eu and Eisai EMEA LinkedIn.

6. About Biogen
Founded in 1978, Biogen is a leading biotechnology company that pioneers innovative science to deliver new medicines to transform patient’s lives and to create value for shareholders and our communities. We apply deep understanding of human biology and leverage different modalities to advance first-in-class treatments or therapies that deliver superior outcomes. Our approach is to take bold risks, balanced with return on investment to deliver long-term growth.

The company routinely posts information that may be important to investors on its website at www.biogen.com. Follow Biogen on social media – Facebook, LinkedIn, X, YouTube.


Biogen Safe Harbor

This news release contains forward-looking statements, including about the potential clinical effects of lecanemab (marketed as LEQEMBI); the potential benefits, safety and efficacy of lecanemab; potential regulatory discussions, submissions and approvals and the timing thereof including for LEQEMBI (lecanemab) subcutaneous autoinjector (SC-AI); the potential to expand options and reduce healthcare resources by treating Alzheimer’s disease at home; the anticipated benefits and potential of Biogen’s collaboration arrangements with Eisai; the potential of Biogen’s commercial business and pipeline programs, including lecanemab; and risks and uncertainties associated with drug development and commercialization. These forward-looking statements may be accompanied by such words as “aim,” “anticipate,” “assume,” “believe,” “contemplate,” “continue,” “could,” “estimate,” “expect,” “forecast,” “goal,” “guidance,” “hope,” “intend,” “may,” “objective,” “outlook,” “plan,” “possible,” “potential,” “predict,” “project,” “prospect,” “should,” “target,” “will,” “would” or the negative of these words or other words and terms of similar meaning. Drug development and commercialization involve a high degree of risk, and only a small number of research and development programs result in commercialization of a product. Results in early-stage clinical trials may not be indicative of full results or results from later stage or larger scale clinical trials and do not ensure regulatory approval. You should not place undue reliance on these statements. Given their forward-looking nature, these statements involve substantial risks and uncertainties that may be based on inaccurate assumptions and could cause actual results to differ materially from those reflected in such statements.

These forward-looking statements are based on management’s current beliefs and assumptions and on information currently available to management. Given their nature, we cannot assure that any outcome expressed in these forward-looking statements will be realized in whole or in part. We caution that these statements are subject to risks and uncertainties, many of which are outside of our control and could cause future events or results to differ materially from those stated or implied in this document, including, among others, uncertainty of our long-term success in developing, licensing, or acquiring other product candidates or additional indications for existing products; expectations, plans, prospects and timing of actions relating to product approvals, approvals of additional indications for our existing products, sales, pricing, growth, reimbursement and launch of our marketed and pipeline products; the potential impact of increased product competition in the biopharmaceutical and healthcare industry, as well as any other markets in which we compete, including increased competition from new originator therapies, generics, prodrugs and biosimilars of existing products and products approved under abbreviated regulatory pathways; our ability to effectively implement our corporate strategy; difficulties in obtaining and maintaining adequate coverage, pricing, and reimbursement for our products; the drivers for growing our business, including our dependence on collaborators and other third parties for the development, regulatory approval, and commercialization of products and other aspects of our business, which are outside of our full control; risks related to commercialization of biosimilars, which is subject to such risks related to our reliance on third-parties, intellectual property, competitive and market challenges and regulatory compliance; the risk that positive results in a clinical trial may not be replicated in subsequent or confirmatory trials or success in early stage clinical trials may not be predictive of results in later stage or large scale clinical trials or trials in other potential indications; risks associated with clinical trials, including our ability to adequately manage clinical activities, unexpected concerns that may arise from additional data or analysis obtained during clinical trials, regulatory authorities may require additional information or further studies, or may fail to approve or may delay approval of our drug candidates; and the occurrence of adverse safety events, restrictions on use with our products, or product liability claims; and any other risks and uncertainties that are described in other reports we have filed with the U.S. Securities and Exchange Commission, which are available on the SEC’s website at www.sec.gov.

These statements speak only as of the date of this press release and are based on information and estimates available to us at this time. Should known or unknown risks or uncertainties materialize or should underlying assumptions prove inaccurate, actual results could vary materially from past results and those anticipated, estimated or projected. Investors are cautioned not to put undue reliance on forward-looking statements. A further list and description of risks, uncertainties and other matters can be found in our Annual Report on Form 10-K for the fiscal year ended December 31, 2025, and in our subsequent reports on Form 10-Q. Except as required by law, we do not undertake any obligation to publicly update any forward-looking statements whether as a result of any new information, future events, changed circumstances or otherwise.

Digital Media Disclosure
From time to time, we have used, or expect in the future to use, our investor relations website (investors.biogen.com), the Biogen LinkedIn account (linkedin.com/company/biogen-) and the Biogen X account (https://x.com/biogen) as a means of disclosing information to the public in a broad, non-exclusionary manner, including for purposes of the SEC’s Regulation Fair Disclosure (Reg FD). Accordingly, investors should monitor our investor relations website and these social media channels in addition to our press releases, SEC filings, public conference calls and websites, as the information posted on them could be material to investors.

References

  1. Guerci B et al. Lack of treatment persistence and treatment nonadherence as barriers to glycaemic control in patients with type 2 diabetes. Diabetes Therapy, 2019; 10(2), 437-449.
  2. Menditto E et al. Persistence as a robust indicator of medication adherence-related quality and performance. International journal of environmental research and public health, 2021; 18(9), 4872.
  3. Cohen S., et al. J Prev Alzheimers Dis.2022;9(3):507-522.
  4. Morris JC. Neurology. 1993;43(11):2412-4.
  5. Amin L, Harris DA. Aβ receptors specifically recognize molecular features displayed by fibril ends and neurotoxic oligomers. Nat Commun. 2021; 12:3451. doi:10.1038/s41467-021-23507-z
  6. Ono K, Tsuji M. Protofibrils of Amyloid-β are Important Targets of a Disease-Modifying Approach for Alzheimer’s Disease. Int J Mol Sci. 2020;21(3):952. doi: 10.3390/ijms21030952. PMID: 32023927; PMCID: PMC7037706.

Aclaris Therapeutics Announces Poster on Results from Phase 2a Trial of ATI-2138 at the 2026 American Academy of Dermatology (AAD) Annual Meeting

Aclaris Therapeutics Announces Poster on Results from Phase 2a Trial of ATI-2138 at the 2026 American Academy of Dermatology (AAD) Annual Meeting




Aclaris Therapeutics Announces Poster on Results from Phase 2a Trial of ATI-2138 at the 2026 American Academy of Dermatology (AAD) Annual Meeting

WAYNE, Pa., March 20, 2026 (GLOBE NEWSWIRE) — Aclaris Therapeutics, Inc. (NASDAQ: ACRS), a clinical-stage biopharmaceutical company focused on developing novel product candidates for immuno-inflammatory diseases, today announced that an ePoster on the results from its open-label Phase 2a trial of ATI-2138, a potent and selective investigational oral covalent inhibitor of interleukin-2-inducible T cell kinase (ITK) and Janus kinase 3 (JAK3), will be available during the 2026 American Academy of Dermatology (AAD) Annual Meeting in Denver, CO. The poster will include results not previously reported from Aclaris’ Phase 2a trial in patients with moderate-to-severe atopic dermatitis (AD).

Electronic Poster Details:

   
Title  Results from an Open-Label Phase 2 Trial of ATI-2138, an Investigational Oral Covalent Inhibitor of Interleukin-2-Inducible T Cell Kinase (ITK) And Janus Kinase 3 (JAK3), in Patients with Moderate-To-Severe Atopic Dermatitis
Authors Ajay Aggarwal1, Aparna Kaul1, Loreen Stillwell1, Nancy McGraw1, Robert Mahe1, Rakesh Basavalingappa1, Emma Huff1, David R. Anderson1, Emma Guttman2, Joseph Monahan1, Neal Walker1
  Affiliations: 1Aclaris Therapeutics Inc.; 2Department of Dermatology, Icahn School of Medicine at Mount Sinai, New York, NY
   

About Aclaris Therapeutics, Inc.

Aclaris Therapeutics, Inc. is a clinical-stage biopharmaceutical company developing a pipeline of novel product candidates to address the needs of patients with immuno-inflammatory diseases who lack satisfactory treatment options. The company has a multi-stage portfolio of product candidates powered by a robust R&D engine. For additional information, please visit www.aclaristx.com and follow Aclaris on LinkedIn.
        
Aclaris Therapeutics Contact:

Will Roberts
Senior Vice President
Corporate Communications and Investor Relations
(484) 329-2125
wroberts@aclaristx.com

Longeviti Neuro Solutions Appoints T. Rowe Price CEO Robert W. Sharps to Board of Directors

Longeviti Neuro Solutions Appoints T. Rowe Price CEO Robert W. Sharps to Board of Directors




Longeviti Neuro Solutions Appoints T. Rowe Price CEO Robert W. Sharps to Board of Directors

–Veteran global investment leader joins neurotechnology company advancing AI-enabled brain health platforms–

BALTIMORE, March 20, 2026 (GLOBE NEWSWIRE) — Longeviti Neuro Solutions, a neurotechnology company developing advanced implantable and AI-enabled solutions for neurological health including the ClearFit AI™, the first Acoustic Brain Interface (ABI)™, today announced the appointment of Robert W. Sharps, Chief Executive Officer and President of T. Rowe Price Group, Inc. (NASDAQ: TROW), to its Board of Directors.

Sharps brings three decades of leadership experience in global asset management, capital markets, corporate governance, and strategic growth. As CEO and the Chairman of the Board of T. Rowe Price, he oversees one of the world’s leading investment firms, managing more than $1.5 trillion in assets for individuals, institutions, and retirement investors worldwide.

Robert Sharps

“Rob’s leadership and perspective at the intersection of finance, governance, and long-term value creation will be invaluable as Longeviti continues to grow,” said Jesse Christopher, Founder of Longeviti Neuro Solutions. “His experience guiding a global investment organization will help strengthen our strategic planning, governance, and partnerships as we scale the company. His perspective will support the acceleration of our clinical and commercial initiatives, the continued expansion of our ClearFit AI™ platform, and the advancement of our long-term therapeutic roadmap including work in blood-brain barrier disruption.”

Longeviti Neuro Solutions is a neuro platform company developing technologies designed to advance the understanding and treatment of neurological conditions while supporting long-term brain health and human performance. The company is known for its FDA-cleared products, including ClearFit AI™, the first Acoustic Brain Interface (ABI)™. Its ClearFit AI™ platform integrates advanced imaging, artificial intelligence, and precision engineering to enhance planning, placement, and analysis for neurotechnology and implantable solutions.

“I am pleased to join the board of Longeviti Neuro Solutions during a period of significant advancement in neuroscience and medical technology,” said Sharps. “The company’s work combining artificial intelligence, data insights, and innovative neurotechnology represents an important opportunity to improve the way neurological conditions are studied and treated. I look forward to supporting the leadership team as they continue building and scaling the company’s platform.”

Sharps joined T. Rowe Price in 1997 and has held a variety of leadership and investment roles within the organization. He became Chief Executive Officer and President in 2022 and previously served as Chief Investment Officer and Head of Investments, overseeing the firm’s global investment platform.

His appointment reflects Longeviti’s continued effort to expand its leadership team with experienced advisors from technology, medicine, and global business as the company advances its next generation of proprietary neuro-implant and AI-driven technology solutions aimed at improving neurological health, longevity, and cognitive outcomes.

About Longeviti Neuro Solutions (https://longeviti.com)
Longeviti Neuro Solutions is a neurotechnology company focused on developing advanced implantable, AI-enabled, and non-invasive solutions designed to enhance neurological health, longevity, and human potential while expanding the possibilities of brain-centered medicine. By combining engineering innovation, neuroscience, and artificial intelligence, Longeviti is redefining the future of brain-centered healthcare and therapeutics, and working to advance new approaches to understanding, treating, and optimizing brain function. Longeviti is known for its FDA-cleared products, including ClearFit AI™, the first Acoustic Brain Interface (ABI)™.

The Baltimore-based company has full in-house manufacturing, packaging, design, and sterilization capabilities, with multiple FDA clearances, successful FDA audits, and ISO 13485 certification. Longeviti holds more than 50 patents worldwide, with products approved for use in over 120 hospitals globally. To date, Longeviti neurosurgical implants have been used in more than 4,000 patients.

Contact: Nicole Halsey/Natalie Van Buskirk
  Polished Nichols PR & Marketing
  nicole@polishednichols.com
  natalie@polishednichols.com
  410.952.2122/443.956.4765
   

A photo accompanying this announcement is available at https://www.globenewswire.com/NewsRoom/AttachmentNg/bdef4106-2781-4f4a-9a2f-f52bccb9e971