Author Archives:

Guardian Pharmacy Services Announces Launch of Underwritten Public Offering of Class A Common Stock

Posted on by

Guardian Pharmacy Services Announces Launch of Underwritten Public Offering of Class A Common Stock




Guardian Pharmacy Services Announces Launch of Underwritten Public Offering of Class A Common Stock

ATLANTA–(BUSINESS WIRE)–Guardian Pharmacy Services, Inc. (“Guardian”) (NYSE: GRDN) today announced the launch of a proposed underwritten public offering (the “Offering”) of 5,000,000 shares of its Class A common stock, consisting of 3,980,000 shares being offered by certain selling stockholders and 1,020,000 newly issued shares being offered by Guardian as part of a non-dilutive “synthetic secondary” transaction, as described below. In addition, the selling stockholders intend to grant the underwriters a 30-day option to purchase up to an additional 750,000 shares of Class A common stock at the public offering price, less the underwriting discount.

The proposed Offering is considered non-dilutive as Guardian intends to use all of the net proceeds it receives in the Offering to repurchase from certain stockholders a number of shares of Class A common stock equal to the number of shares being issued and sold by Guardian in the Offering, at a purchase price per share equal to the public offering price in the Offering, less the underwriting discount (the “Synthetic Secondary”). Accordingly, Guardian will not retain any proceeds from the Offering and, upon completion of the Offering and the Synthetic Secondary, the total number of outstanding shares of Class A common stock will remain the same. The shares to be repurchased by Guardian consist of shares of Class A common stock that were issued upon conversion of shares of Guardian’s Class B common stock that were originally issued in connection with its corporate reorganization in September 2024. Guardian will not receive any proceeds from the offering of shares by the selling stockholders in the Offering.

BofA Securities, Jefferies and Raymond James are acting as joint bookrunners for the proposed Offering. Stephens Inc. and Oppenheimer & Co. are acting as co-managers for the proposed Offering.

A shelf registration statement on Form S-3 relating to the shares being offered in the proposed Offering was filed with the U.S. Securities and Exchange Commission (the “SEC”) on October 14, 2025 and became effective on November 3, 2025. This press release does not constitute an offer to sell or the solicitation of an offer to buy any securities, and shall not constitute an offer, solicitation, or sale in any state or jurisdiction in which such offer, solicitation, or sale would be unlawful prior to registration or qualification under the securities laws of that state or jurisdiction. Any offers, solicitations or offers to buy, or any sales of securities will be made in accordance with the registration requirements of the Securities Act of 1933, as amended.

The proposed Offering will be made only by means of a preliminary prospectus supplement and accompanying prospectus. Copies of the preliminary prospectus supplement and the accompanying prospectus related to the proposed Offering can be obtained from: BofA Securities, Attention: Prospectus Department, NC1-022-02-25, 201 North Tryon Street, Charlotte, NC 28255-0001, by email at dg.prospectus_requests@bofa.com; or Jefferies LLC, Attn: Equity Syndicate Prospectus Department, 520 Madison Avenue, New York, NY 10022, by telephone at 877-821-7388 or by email at prospectus_department@jefferies.com.

About Guardian Pharmacy Services

Guardian Pharmacy Services is a leading long-term care pharmacy services company that provides an extensive suite of technology-enabled services designed to help residents of long-term health care facilities (“LTCFs”) adhere to their appropriate drug regimen, which in turn helps reduce the cost of care and improve clinical outcomes. As of December 31, 2025, our 61 pharmacies, 54 of which are full-service, served approximately 205,000 residents in approximately 8,400 LTCFs across 38 states.

Cautionary Note Regarding Forward-Looking Statements

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements are all statements other than those of historical fact. Words such as “aims,” “anticipates,” “believes,” “contemplates,” “continues,” “estimates,” “expects,” “intends,” “may,” “plans,” “seeks,” “should,” “will,” “would” and similar expressions are often, but not always, used to identify forward-looking statements. These forward-looking statements include statements regarding the proposed Offering and the Synthetic Secondary, and Guardian’s use of the net proceeds to it from the proposed Offering. These forward-looking statements are based on management’s current expectations and beliefs and are inherently subject to risks and uncertainties, including, among others, uncertainties related to market conditions, and those other risks and uncertainties more fully described under “Risk Factors” in Guardian’s Annual Report on Form 10-K for the year ended December 31, 2025 and the preliminary prospectus relating to the proposed Offering. Except to the extent required by applicable law, Guardian undertakes no obligation to update or revise any information contained in this press release beyond the published date, whether as a result of new information, future events or otherwise.

Contacts

Ashley Stockton

Vice President, Investor Relations

IR@guardianpharmacy.net

GE HealthCare completes Intelerad acquisition – accelerating shift to cloud-first enterprise solutions to deliver precision care

Posted on by

GE HealthCare completes Intelerad acquisition – accelerating shift to cloud-first enterprise solutions to deliver precision care




GE HealthCare completes Intelerad acquisition – accelerating shift to cloud-first enterprise solutions to deliver precision care

  • Expands GE HealthCare’s enterprise imaging footprint by delivering comprehensive, end‑to‑end solutions across ambulatory, teleradiology, and hospital care settings
  • Advances GE HealthCare’s D3 strategy by accelerating the development of disease‑focused smart devices and solutions enabled by digital (cloud and software) and artificial intelligence (AI) capabilities
  • Enhances a fully connected, cloud‑first imaging ecosystem with an expanded GE HealthCare portfolio of AI, digital tools, and SaaS offerings designed to improve clinical operations
  • Tuck‑in acquisition expected to strengthen the Imaging portfolio, increase recurring revenue mix, and support sustainable top‑line growth and profitability over time

CHICAGO–(BUSINESS WIRE)–GE HealthCare today announced that it has completed the acquisition of Intelerad, a leading medical imaging software provider for the healthcare industry, for a base purchase price of $2.3 billion in cash (subject to customary adjustments). Intelerad’s technology and customer base will extend GE HealthCare’s reach into high-growth specialized clinics and ambulatory care environments, complementing the company’s strength in hospital-based imaging. These combined capabilities will create a more comprehensive, cloud-first and AI-enabled imaging offering, which is expected to help reduce imaging infrastructure costs and enable faster deployment times.

“We are excited to welcome Intelerad to the GE HealthCare team to create an end-to-end, cloud-first and AI-enabled enterprise imaging solution for customers,” said Roland Rott, President and CEO, Imaging, GE HealthCare. “Intelerad’s cloud-enabled software will support GE HealthCare’s imaging technologies and AI capabilities by simplifying complex workflows, and providing patients and customers with more precise, connected care across the continuum.”

“Intelerad enhances our ability to deliver a cloud-first enterprise imaging platform at scale. Together, we are connecting imaging across care settings with interoperable, AI-enabled solutions that simplify operations, improve clinical insight, and help our customers deliver more precise, personalized care,” said Scott Miller, CEO, Solutions for Enterprise Imaging, GE HealthCare.

With the closing of the acquisition, Intelerad will operate as part of GE HealthCare’s Imaging business and continue to serve its enterprise imaging solution customers in the US, Canada, the UK, and Oceania.

“Joining GE HealthCare accelerates our vision for a more intelligent, connected imaging ecosystem. Together, we can harness the cloud and AI to break down longstanding barriers in healthcare, empowering clinicians with faster insights and giving patients a more seamless, precise care experience,” said Jordan Bazinsky, CEO of Intelerad.

GE HealthCare estimates that Intelerad’s revenues in the first full year of ownership will be approximately $270 million, of which approximately 90% is recurring, and Adjusted Earnings before Interest, Taxes, Depreciation and Amortization (EBITDA) margin will be in excess of 30%. Intelerad revenue is growing in the low-double-digit range annually and is expected to accelerate under GE HealthCare ownership. GE HealthCare expects this transaction to be immediately accretive to top line growth and Adjusted Earnings before Interest and Taxes (EBIT) margin1. Inclusive of the impact of financing costs, GE HealthCare expects the transaction to be slightly dilutive to Adjusted Earnings per Share (EPS)1 in the short term, and the company plans to offset this with cost efficiencies. GE HealthCare expects a high-single-digit return on invested capital by year five.

GE HealthCare funded this transaction with cash on hand and proceeds from debt financing.

For more information on GE HealthCare’s Intelerad offerings and full portfolio of solutions, please visit https://www.intelerad.com/en/.

Forward-Looking Statements

This release contains forward-looking statements. These forward-looking statements might be identified by words, and variations of words, such as “will,” “expect,” “may,” “would,” “could,” “plan,” “believe,” “anticipate,” “intend,” “estimate,” “potential,” “position,” “forecast,” “target,” “guidance,” “outlook,” and similar expressions. These forward-looking statements may include, but are not limited to, statements about the transaction, the expected results of the transaction, and GE HealthCare Technologies Inc.’s (the “Company’s”) markets, business, products, financial performance, growth opportunities, and strategy. These forward-looking statements involve risks and uncertainties, many of which are beyond the control of the Company. Factors that could cause the Company’s actual results to differ materially from those described in its forward-looking statements include, but are not limited to, the Company may be unable to achieve the anticipated benefits of the transaction; operating costs and business disruptions (including, without limitation, difficulties in maintaining relationships with employees, customers, and suppliers) may be greater than expected; and the Company may assume unexpected risks and liabilities. Other factors that may cause such a difference also include those discussed in the “Risk Factors” section of the Company’s Annual Report on Form 10-K filed with the U.S. Securities and Exchange Commission and any updates or amendments it makes in future filings. There may be other factors not presently known to the Company or which it currently considers to be immaterial that could cause the Company’s actual results to differ materially from those projected in any forward-looking statements the Company makes. The Company does not undertake any obligation to update or revise its forward-looking statements except as required by applicable law or regulation.

About GE HealthCare Technologies Inc.

GE HealthCare is a leading global healthcare solutions provider of advanced medical technology, pharmaceutical diagnostics, and AI, cloud and software solutions that help clinicians tackle the world’s most complex diseases. Serving patients and providers for 130 years, GE HealthCare is delivering bold innovations designed for the next era of medicine across its Imaging, Advanced Visualization Solutions, Patient Care Solutions, and Pharmaceutical Diagnostics segments to help clinicians deliver more personalized, precise patient care. We are a $20.6 billion business with approximately 54,000 colleagues working to create a world where healthcare has no limits.

GE HealthCare is proud to be among 2026 Fortune World’s Most Admired Companies™.

Follow us on LinkedIn, Facebook, Instagram, or visit our website for our latest news and perspectives.

1 Non-GAAP financial measure; see our earnings release dated February 4, 2026, for definition.

Contacts

GE HealthCare Media Contact:
Linh Dinh

Linh.Dinh@gehealthcare.com
M +408 275 5682

GE HealthCare Investor Relations Contact:
Carolynne Borders

Carolynne.Borders@gehealthcare.com
M (631) 662-4317

Formycon AG postpones the publication of its audited annual and consolidated financial statements for 2025

Posted on by

Formycon AG / Key word(s): Annual Report / Postponement of the publication/Annual Report / Postponement of the publication

Formycon AG postpones the publication of its audited annual and consolidated financial statements for 2025

18-March-2026 / 18:53 CET/CEST

Disclosure of an inside information acc. to Article 17 MAR of the Regulation (EU) No 596/2014, transmitted by EQS News – a service of EQS Group.

The issuer is solely responsible for the content of this announcement.

Disclosure of inside information pursuant to Article 17 of Regulation (EU) No 596/2014

Formycon AG postpones the publication of its audited annual and consolidated financial statements for 2025

Planegg-Martinsried, Germany, March 18, 2026 – Formycon AG (ISIN: DE000A1EWVY8 / WKN: A1EWVY) (the “Company”) announces that the publication of the audited 2025 annual and consolidated financial statements, originally scheduled for March 26, 2026, will be postponed.

A key reason is the change to a new internal financial planning system, which was rolled out companywide during the reporting period. Furthermore, in the course of closing process, additional reconciliation and validation work have arisen, requiring more time and documentation than originally anticipated. Against this background, not all documents have been finalized yet, and the required audit measures could not yet be completed.

The publication of the audited annual and consolidated financial statements for the 2025 fiscal year is scheduled for April 2026 and will therefore continue to comply with statutory and stock exchange deadlines. The company will announce the exact date in due course.

————-

Contact:
Formycon AG,
Fraunhoferstraße 15,
82152 Planegg/Martinsried,
Germany

Phone +49 (0) 89 – 86 46 67 149 | Fax + 49 (0) 89 – 86 46 67 110
ir@formycon.com // www.formycon.com

 

Disclaimer

Certain statements contained in this release may constitute “forward-looking statements” that involve a number of risks and uncertainties. Forward-looking statements can generally be identified by the use of the words “may”, “will”, “should”, “plan”, “expect”, “anticipate”, “estimate”, “believe”, “intend”, “project”, or “target” or the negative of these words or other variations of these words or comparable terminology. Forward-looking statements are based on assumptions, forecasts, estimates, predictions, opinions or plans that are inherently subject to significant risks, uncertainties and uncertainties that are subject to change. The Company makes no representation and does not make any representation that any forward-looking statement will be achieved or prove to be accurate. Actual future business, financial condition and results of operations and prospects may differ materially from those projected or projected in the forward-looking statements. Subject to applicable legal requirements, neither the Company nor any other person intends to update, review, revise or conform to actual events or developments any forward-looking statements contained in this announcement, whether as a result of the availability of new information, new developments in the future or otherwise, nor does they assume any such obligation.

End of Inside Information

18-March-2026 CET/CEST The EQS Distribution Services include Regulatory Announcements, Financial/Corporate News and Press Releases.
Language: English
Company: Formycon AG
Fraunhoferstraße 15
82152 Planegg-Martinsried
Germany
Phone: +49 89 864667 100
Fax: +49 89 864667 110
E-mail: ir@formycon.com
Internet: www.formycon.com
ISIN: DE000A1EWVY8, NO0013586024
WKN: A1EWVY, A4DFJH
Listed: Regulated Market in Frankfurt (Prime Standard); Regulated Unofficial Market in Dusseldorf, Hamburg, Munich, Stuttgart, Tradegate BSX; Oslo
EQS News ID: 2293864

 
End of Announcement EQS News Service

2293864  18-March-2026 CET/CEST

Nia Therapeutics Receives FDA Breakthrough Device Designation for AI-Guided Brain Implant to Treat Memory Loss

Posted on by

Nia Therapeutics Receives FDA Breakthrough Device Designation for AI-Guided Brain Implant to Treat Memory Loss




Nia Therapeutics Receives FDA Breakthrough Device Designation for AI-Guided Brain Implant to Treat Memory Loss

The Smart Neurostimulation System is the first neurostimulation device to receive Breakthrough designation for TBI-related memory loss; the implant decodes memory states from neural activity on 60 channels spanning four brain regions and delivers AI-guided personalized stimulation therapy to lateral temporal cortex




BOSTON–(BUSINESS WIRE)–Nia Therapeutics announced that the U.S. Food and Drug Administration has granted Breakthrough Device Designation to its Smart Neurostimulation System (SNS) for the treatment of episodic memory loss in adult patients with prior moderate-to-severe traumatic brain injury (TBI) and persistent memory deficits. The SNS is the first device to receive Breakthrough designation for TBI-related memory loss. There is significant unmet need in this indication, with no FDA-cleared or approved therapies to treat memory loss and more than 4.3 million Americans living with TBI-related disability.1

“The Breakthrough designation validates the approach we’ve spent a decade building—that memory can be improved by listening to the brain and stimulating at precisely the right moment,” said Michael Kahana, PhD, co-founder and CEO of Nia Therapeutics, and the Edmund and Louise Kahn Term Professor at the University of Pennsylvania. “This designation provides a framework to work closely with the FDA as we bring this technology from the laboratory into the clinic.”

A New Approach to Treating Memory Disorders

The SNS is a fully implantable, wireless neuromodulation platform that records neural activity from 60 channels across four brain regions. Using machine-learning classifiers trained on each patient’s own brain signals, the device detects moments of impaired memory encoding in real time and delivers targeted electrical stimulation to the lateral temporal cortex. This closed-loop approach improved recall by 19% in a randomized, sham-controlled study of neurosurgical patients with epilepsy and a history of moderate-to-severe TBI.2 Randomly timed stimulation produced no benefit, underscoring the importance of delivering therapy at the right moment.3

“Memory depends on coordinated activity across widespread brain networks—so we built a device that can sense and respond across the entire network. With 60 channels across four brain regions, the SNS offers an order of magnitude improvement over currently approved DBS devices,” said Daniel Rizzuto, PhD, co-founder and CTO of Nia Therapeutics.

Path Forward

The designation provides Nia with prioritized review, increased FDA interaction, and senior management involvement in future submissions. Building on the first in vivo validation of the SNS platform in a large-animal model, published in Brain Stimulation in 2026 (link), this designation will support the company as it advances toward an Investigational Device Exemption (IDE) application this year to support a first-in-human early feasibility study.

“Patients with TBI-related memory loss represent a profoundly underserved population,” said Dr. Ramon Diaz-Arrastia, Presidential Professor of Neurology and Director of the TBI Clinical Research Center at the University of Pennsylvania, and advisor to Nia Therapeutics. “Their disability is invisible but devastating—it affects the ability to work, maintain relationships, and live independently. We are committed to bringing them the first treatment that directly restores the capacity to form new memories.”

About Nia Therapeutics

Nia Therapeutics develops implantable brain-computer interfaces for memory disorders. Founded in 2018, the company’s SNS platform enables closed-loop neuromodulation by detecting brain states linked to impaired memory encoding and delivering targeted stimulation. Visit www.niatx.com.

Sources

  1. Center for Disease Control and Prevention. (2015). Report to Congress on traumatic brain injury in the United States: Epidemiology and rehabilitation (cdc:29215). https://stacks.cdc.gov/view/cdc/29215
  2. Kahana, M. J., Ezzyat, Y ., Wanda, P. A., Solomon, E. A., Adamovich-Zeitlin, R., Lega, B. C., Jobst, B. C., Gross, R. E., Ding, K., & Diaz-Arrastia, R. R. (2023). Biomarker-guided neuromodulation aids memory in traumatic brain injury. Brain Stimulation, 16(4), 1086–1093. https://doi.org/10.1016/j.brs.2023.07.002
  3. Ezzyat, Y ., Kragel, J. E., Solomon, E. A., Lega, B. C., Aronson, J. P., Jobst, B. C., Gross, R. E., Sperling, M. R., Worrell, G. A., Sheth, S. A., Wanda, P. A., Rizzuto, D. S., & Kahana, M. J. (2024). Functional and anatomical connectivity predict brain stimulation’s mnemonic effects. Cerebral Cortex, 34(1), bhad427. https://doi.org/10.1093/cercor/bhad427

Contacts

For media inquiries, contact media@niatx.com.

Tevogen CIO and Head of Tevogen.AI Mittul Mehta to Speak at Microsoft Fabric Community Conference (FabCon 2026)

Posted on by

Tevogen CIO and Head of Tevogen.AI Mittul Mehta to Speak at Microsoft Fabric Community Conference (FabCon 2026)




Tevogen CIO and Head of Tevogen.AI Mittul Mehta to Speak at Microsoft Fabric Community Conference (FabCon 2026)

WARREN, N.J., March 18, 2026 (GLOBE NEWSWIRE) — Tevogen (“Tevogen Bio Holdings Inc.” or “Company”) (Nasdaq: TVGN) today announced that Mittul Mehta, Chief Information Officer and Head of Tevogen.AI, will speak at the Microsoft Fabric Community Conference (FabCon 2026), taking place March 16–20, 2026, in Atlanta, Georgia.

Mr. Mehta will participate in two sessions focused on the evolving intersection of data engineering and artificial intelligence:

  • From Risk to Reward: Modernizing the Data Estate to Power Enterprise AI
    Wednesday, March 18, 4:30PM – 5:05PM alongside Dipti Borkar, VP & GM OneLake & ISVs at Microsoft and Tripti Sethi, Data & AI Lead at Avanade.
  • Agentic Data Engineering on Microsoft Fabric: Building Adaptive Pipelines
    Thursday, March 19, 4:15PM – 5:15PM alongside Nina Arora-Rowland, Data and AI Practice Lead at Avanade/Accenture, and Colin Pop, Senior Director, Analytics Architect at Avanade.

The sessions will explore how agentic AI is transforming modern data engineering, shifting pipelines from static, rules-based systems to adaptive, context-aware workflows. Topics will include emerging architectural patterns, real-world applications, and key considerations around governance, trust, and enterprise readiness as organizations adopt more autonomous data environments.

These themes align with Tevogen.AI’s broader efforts to apply advanced machine learning to biomedical discovery, including its published international patent application (WO 2025/129197), which outlines novel systems for predicting immunologically active peptides.

FabCon is Microsoft’s premier conference dedicated to its Fabric data platform, bringing together industry leaders, engineers, and innovators to explore the future of data and AI.

For more information or to connect with Mittul Mehta during the conference, please contact mittul.mehta@tevogen.com.

About Tevogen

Tevogen is a socially integrated healthcare enterprise built on the principles of affordability, efficiency, and scientific rigor. The company leverages artificial intelligence and precision T cell therapy platforms, a patient-first and cost-disciplined operating model, and engagements with global technology leaders to support the development of advanced, life-saving therapies across multiple therapeutic areas and scalable solutions for the broader healthcare system.

Tevogen Bio, the company’s lead initiative, has completed a proof-of-concept clinical trial demonstrating the potential of its single-HLA-restricted, genetically unmodified allogeneic T cells. Tevogen Bio’s pipeline spans virology, oncology, and neurology, with programs built on the company’s proprietary ExacTcell™ platform.

Tevogen.AI is designed to transform drug development by accelerating target detection, helping reduce failure rates, and supporting optimized clinical trial design through proprietary predictive technologies. The platform utilizes cloud and data services from leading technology providers, including Microsoft and Databricks, to advance its long-term ambition to predict the proteome for any given protein–HLA combination, enabling rapid and cost-efficient therapeutic discovery.

Tevogen is exploring future strategic initiatives that may include domestic generics, biosimilars, medical devices, and innovative insurance solutions for healthcare providers. Together, these programs reflect Tevogen’s mission to advance sustainable innovation and broaden patient access through a faster, more efficient, and more equitable healthcare model.

Contact

Tevogen Bio Communications
T: 1 877 TEVOGEN, Ext 701
Communications@Tevogen.com

A photo accompanying this announcement is available at https://www.globenewswire.com/NewsRoom/AttachmentNg/8feb8757-d993-45e3-a5da-3c4087c40abb

Azalea Therapeutics Highlights Nature Publication Demonstrating In Vivo Site-Specific TRAC-CAR T Cell Engineering

Posted on by

Azalea Therapeutics Highlights Nature Publication Demonstrating In Vivo Site-Specific TRAC-CAR T Cell Engineering




Azalea Therapeutics Highlights Nature Publication Demonstrating In Vivo Site-Specific TRAC-CAR T Cell Engineering

  • Foundational research led by co-founder Justin Eyquem, Ph.D., underpins Azalea’s proprietary in vivo CAR T platform
  • Peer-reviewed publication demonstrates stable, cell-specific transgene expression through in vivo site-specific integration of large DNA payloads
  • Findings show integration of a promoterless CAR at the TRAC locus enables physiologic CAR expression and durable anti-tumor activity in preclinical models

BERKELEY, Calif., March 18, 2026 (GLOBE NEWSWIRE) — Azalea Therapeutics, Inc., a biotechnology company redefining precision genomic medicines in vivo, today highlighted the publication of foundational research in Nature describing in vivo site-specific genomic integration to reprogram T cells. The research originated as an academic collaboration between the Eyquem laboratory at the University of California, San Francisco and the Doudna laboratory at the University of California, Berkeley. Three of the study’s authors – Justin Eyquem, Ph.D., Jenny Hamilton, Ph.D. and Jennifer Doudna, Ph.D. – subsequently co-founded Azalea Therapeutics to advance precise, programmable in vivo cell engineering toward the development of next-generation in vivo CAR T and other cell-based therapies.

The publication, titled “In vivo site-specific engineering to reprogram T cells,” demonstrates that stable and cell-specific transgene expression can be achieved through in vivo integration of large DNA payloads using a two-vector system consisting of enveloped delivery vehicles (EDVs) and adeno-associated viruses (AAVs). In preclinical models, the approach enabled targeted integration of a promoterless chimeric antigen receptor (CAR) transgene at the TRAC locus, resulting in physiologic CAR expression, robust T cell expansion and durable anti-tumor activity.

The research shows that placing CAR expression under control of the endogenous T cell receptor alpha (TRAC) promoter produces regulated CAR expression compared to conventional approaches relying on random integration or constitutive exogenous promoters. In humanized mouse models of B cell aplasia and hematologic malignancies, in vivo-generated TRAC-CAR T cells achieved therapeutic levels of CAR-positive T cells and sustained tumor control.

“This work demonstrates that stable, cell-specific transgene expression can be achieved through in vivo site-specific integration,” said Justin Eyquem, Ph.D., co-founder of Azalea Therapeutics and associate professor of medicine at UCSF. “By integrating a promoterless CAR into the TRAC locus, we place expression under control of the endogenous T cell promoter, resulting in physiologic regulation and durable functional activity in preclinical models. These findings establish a foundation for precise in vivo T cell engineering without ex vivo manufacturing.”

The research further describes optimization of both delivery components, including evolution of an AAV variant for improved T cell targeting and incorporation of an anti-CD3-targeted EDV to enhance specificity and activation. In humanized mouse models, the optimized system enabled generation of TRAC-CAR T cells representing up to ~20% of splenic T cells following a single administration, accompanied by complete B cell aplasia and tumor clearance.

“The research described in this publication establishes the scientific foundation for precise, programmable CAR insertion directly inside the body,” said Jenny Hamilton, Ph.D., co-founder, president and chief executive officer of Azalea Therapeutics. “At Azalea, we are building on these findings with our proprietary EDV-based platform to advance in vivo CAR T programs toward clinical development. Our goal is to generate physiologically regulated, durable CAR T cells in patients through targeted genomic integration, while avoiding the complexity of ex vivo cell manufacturing.”

Azalea is advancing TRAC-targeted in vivo CAR T programs toward IND-enabling studies, building on the foundational work described in this publication, which is available online in Nature.

About Azalea Therapeutics
Azalea Therapeutics is a biotechnology company redefining precision genomic medicines in vivo. Its proprietary Enveloped Delivery Vehicles (EDV) platform is engineered to deliver transient CRISPR-Cas9 cargo to specific cells in the body for site-specific genome editing with curative intent. Azalea’s first programs leverage T cell-targeting EDVs and highly efficient T cell-tropic AAVs to enable programmable CAR gene insertion at a defined genomic locus, placing expression under control of the cell’s endogenous promoter for physiologic and sustained activity. This approach aims to generate potent, durable and safe therapies directly inside patients, avoiding the complexity of ex vivo manufacturing and unlocking new treatment modalities – including in vivo CAR T cell therapies – across cancer, autoimmune disease and genetic disorders. Azalea is headquartered in Berkeley, California. For more information, please visit azaleatx.com and follow us on LinkedIn.

CONTACT: Contact:
Noopur Batsha Liffick, MPH
NBL LifeSci Advisory
noopur@azaleatx.com

Totus Medicines Presents Phase 1a Clinical Data for TOS-358, a Covalent PI3Ka Inhibitor, at ESMO TAT 2026

Posted on by

Totus Medicines Presents Phase 1a Clinical Data for TOS-358, a Covalent PI3Ka Inhibitor, at ESMO TAT 2026




Totus Medicines Presents Phase 1a Clinical Data for TOS-358, a Covalent PI3Ka Inhibitor, at ESMO TAT 2026

Oral presentation of Ph 1a clinical data highlights potential best-in-class drug profile in heavily pretreated patients with PI3Ka-mutant metastatic breast cancer and other solid tumors

Overall, TOS-358 demonstrated 50% clinical benefit rate (CBR), 75% disease control rate (DCR) and 45% of patients remained on drug for >24 weeks

67% of PI3K/AKT/mTOR (“PAM”)-resistant patients and 100% of PAM-intolerant patients achieved clinically meaningful disease control

TOS-358 demonstrated a class-leading safety profile with no evidence of bone marrow, hepatic, ocular, or dermatologic toxicities (rash or stomatitis/mucositis), and <5% G2 diarrhea or nausea. Hyperglycemia requiring insulin for ongoing blood glucose control was <4% – positioning TOS-358 well for combination therapies

Ph1b initiated in January 2026, exploring doublet- and triplet combination with fulvestrant & CDK4/6 inhibitors

EMERYVILLE, Calif., March 18, 2026 (GLOBE NEWSWIRE) — Totus Medicines, a clinical stage, precision medicine company leveraging a novel covalent DNA-encoded library + AI-powered small molecule drug discovery platform to advance a differentiated pipeline of therapeutics against high-value, historically difficult to drug targets in multiple therapeutic areas, today announced the presentation by Dr. Antonio Giordano of Dana Farber Cancer Center of new clinical data for TOS-358, its lead oral covalent PI3Ka inhibitor, in an oral presentation at the European Society for Medical Oncology Targeted Anticancer Therapies (ESMO TAT) Congress in Paris, France.

“TOS-358 was designed to overcome the limitations of currently available PI3Ka inhibitors by delivering sustained and specific, >90% covalent inhibition of the target combined with a best-in-class safety profile,” said Zelanna Goldberg, M.D., Chief Medical Officer of Totus Medicines. “We are very encouraged by the early clinical efficacy data, which demonstrate durable tumor control and class-leading tolerability in heavily pretreated patients, including those who had previously progressed on other PI3K pathway therapies.

“TOS-358 is amongst the most interesting agents in this class to emerge. It appears to be a well-tolerated and straightforward drug to give for PI3Ka mutant disease with early data suggesting the potential for meaningfully durable tumor control. This may help inhibit tumor growth and maintain quality of life, which is a promising combination for our patients” said Dr. Antonio Giordano.

TOS-358 is an oral, highly selective, pan-mutant, covalent PI3Ka inhibitor that achieves >95% continuous target engagement for deep and durable inhibition of PI3K-AKT signaling which is required for optimal efficacy and durability.

Phase 1a Key Clinical Findings:

Clinical results from the efficacy cohort demonstrated encouraging anti-tumor activity and durability of response:

Overall efficacy profile:

  • CBR: 50%
  • DCR: 75%
  • ORR: 15%
  • ≥20% tumor shrinkage: 40%
  • Patients on therapy for ≥24 weeks: 45%

Clinically meaningful disease control in heavily pre-treated patients:

  • DCR in PAM-resistant patients: 67%
  • DCR in PAM-intolerant patients: 100%

Class-leading Safety & Tolerability Profile:

TOS-358 demonstrated a favorable and differentiated safety profile, with minimal gastrointestinal or epithelial toxicities.

Key observations included:

  • No bone marrow toxicity
  • No hepatic toxicity
  • No renal toxicity
  • No ocular symptoms
  • No rash
  • No stomatitis or mucositis
  • <5% of patients required medication for nausea or diarrhea

Hyperglycemia, an expected on-target effect of PI3Ka inhibition, was primarily low grade and manageable with oral medications. Only 3.6% (2/54 pts) required ongoing insulin, which is similar to, or lower than, other PI3Ka inhibitors in development including mutant selective and/or allosteric compounds.

Phase 1b study design:

TOS-358 is currently being evaluated in an ongoing Ph1b study designed to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics and preliminary antitumor activity of TOS-358 in combination with fulvestrant and in combination with fulvestrant and CDK inhibitors in patients with PI3Ka-mutated, HR+/HER2- metastatic breast cancer. Initial data from these combination cohorts are expected to be presented at future medical and scientific conferences.

About Totus Medicines
Totus Medicines is a clinical-stage, precision medicines company, discovering novel covalent small molecules against previously undrugged or difficult to drug targets, based on its proprietary AI-powered OmniDEL platform (DNA-encoded covalent library technology). The company’s lead program, TOS-358, the first and only covalent PI3Ka inhibitor in clinical development, has shown efficacy, response and long-term disease control with class-leading tolerability in breast, endometrial and head & neck cancers. The company’s lead pre-clinical program is targeting IRF5, a key genetically validated but previously undrugged target across multiple I&I indications.

For more information, please visit www.totusmedicines.com.

Contact:
ir@totusmedicines.com 

External Contact:
Brian Mullen
LifeSci Advisors, LLC
Managing Director
bmullen@lifesciadvisors.com 
+1.203.461.1175 

Centre for Neuro Skills Expands Employer Partnerships Strategy, Appoints Jay Varma as Director

Posted on by

Centre for Neuro Skills Expands Employer Partnerships Strategy, Appoints Jay Varma as Director




Centre for Neuro Skills Expands Employer Partnerships Strategy, Appoints Jay Varma as Director

CNS strengthens its engagement with employers, health plans and benefits advisors to expand access to specialized neuro center of excellence

BAKERSFIELD, Calif., March 18, 2026 (GLOBE NEWSWIRE) — Centre for Neuro Skills (CNS), a national provider of brain injury rehabilitation and neuro-specialty care, has appointed Jay Varma as director of employer partnerships, a strategic leadership role designed to expand the organization’s collaboration with employers, health plans, benefits brokers and consultants.

Jay Varma Picture
Jay Varma,
Director of Employer Partnerships at
Centre for Neuro Skills

As employers increasingly look to specialized Centers of Excellence to address complex neurological conditions and improve workforce recovery outcomes, CNS is expanding its engagement with the employer and benefits ecosystem. Varma will help advance CNS’s role as a Neuro Center of Excellence within employer and health plan ecosystems.

With nearly a decade of enterprise experience across health technology, employer health benefits, biotech and life sciences, including roles at Amazon (One Medical), One Medical and BioXcel/Inveni AI, Varma brings deep expertise in employer health solutions, benefits strategy and C-suite partnership development. At One Medical and Amazon, she worked with large, self-insured employers across the West Coast to expand access to high-quality care through employer-sponsored benefits programs. Her background in specialty care, employer health strategy and enterprise partnerships positions her well to expand CNS’s reach into the employer market.

“Neurological conditions—from traumatic brain injury and stroke to concussion, cognitive complications and long COVID, carry serious and often hidden costs for employers, including extended disability, lost productivity, and fragmented care pathways,” said David Harrington, president and CEO of Centre for Neuro Skills. “Jay’s arrival signals our commitment to solving that problem directly with employers. CNS has 45 years of clinical expertise and outcomes data. Jay’s role is to help translate that expertise into meaningful partnerships with employers— ensuring access, measurable outcomes and better workforce recovery.”

While CNS has long served patients whose care was supported through employer-sponsored benefits, the creation of this role formalizes a direct-to-employer strategy. Varma will work with employers, brokers and consultants to structure partnerships that provide employees with coordinated access to CNS’s full care continuum. The specialty program is set to support in-person day treatments and telerehabilitation for various neuro-injuries/conditions as well as intensive in-patient rehab for catastrophic and traumatic brain injuries. This care is supported by clinical data and outcomes reporting that benefits decision-makers require.

“Employers today are under growing pressure to manage the long-tail impact of neurological conditions—from concussion and stroke to complex brain injuries—which often fall outside the scope of traditional benefits design,” said Varma. “CNS brings together decades of clinical expertise, outcomes data and a full continuum of neurorehabilitation care. My focus is helping employers and their advisors better understand how specialized neurological care can support workforce recovery, improve employee quality of life and reduce the long-term costs associated with fragmented care pathways.”

CNS’s employer partnership initiative reflects a broader shift in how companies are addressing complex medical conditions through specialized Centers of Excellence that improve outcomes while reducing long-term costs.

Varma joins CNS with a career that spans enterprise healthcare solutions, specialty pharma and biotech AI/ML platform strategic sales. She holds a M.S. degree in Pharmacology.

About Centre for Neuro Skills 

Centre for Neuro Skills is an experienced and respected world leader in providing intensive rehabilitation and medical programs for those recovering from all types of brain injury. Recognized as one of America’s Greatest Midsize Workplaces 2025 by Newsweek, CNS covers a full spectrum of advanced care, from residential and assisted living to outpatient and day treatment. Founded by Dr. Mark Ashley in 1980, CNS has eight locations in California and Texas. For more information, visit neuroskills.com, Facebook, X, LinkedIn and YouTube. For a video overview, visit CNS’s YouTube channel. 

Media note: To request an interview with CNS leadership or clinical staff, contact Robin Carr at 415.766.0927 or CNS@landispr.com. 

Media Contact: 
Landis Communications Inc. 
Robin Carr 
415.766.0927 
CNS@landispr.com

A photo accompanying this announcement is available at https://www.globenewswire.com/NewsRoom/AttachmentNg/5c455fa5-3851-44db-a709-2163c02ad8cf

Cortisol Detox App Supports Healthy Fat Loss With Meal Plans and Mindfulness

Posted on by

Cortisol Detox App Supports Healthy Fat Loss With Meal Plans and Mindfulness




Cortisol Detox App Supports Healthy Fat Loss With Meal Plans and Mindfulness

Cortisol Detox Combines Anti-Cortisol Diet, Workouts, and Meditation to Support Weight Loss

NEW YORK, March 18, 2026 (GLOBE NEWSWIRE) — Cortisol Detox offers a personalized weight-loss program designed to help individuals manage stress, reduce cortisol-related weight gain, and support healthy fat-loss. The app combines anti-cortisol meal plans, simple workouts, guided meditations, motivating challenges, and progress tracking to help users be consistent.

Personalized Wellness That Fits Everyday Life

App starts with an onboarding quiz evaluating stress levels, lifestyle, dietary preferences, and fitness. Then, Cortisol Detox creates a personalized anti-cortisol plan, including:

  • 1000+ Anti-Cortisol Diet Recipes – Personalized meal plans to balance cortisol and support weight loss without restrictive dieting.
  • 100+ Workouts & Exercises – Simple workouts, yoga routines, and meditation guides for stress reduction and fat loss.
  • Guided Meditations – Tailored mindfulness exercises to reduce stress, boost confidence, and increase energy.
  • Motivating Challenges – Daily and weekly challenges to maintain consistency and engagement.
  • Nutrition & Health Guides – Expert advice on food, movement, and lifestyle from nutritionists, trainers, and psychologists.

Guided Workouts and Mindfulness for Stress Relief

Cortisol Detox program emphasizes convenience with short workouts, yoga sessions, and meditation exercises that fit busy schedules. The program adjusts to different ability levels, helping beginners and experienced users progress comfortably while building consistent habits.

Clear Billing and Transparency

Cortisol Detox app stands out with straightforward, transparent billing practices. Subscription details, pricing, and renewal terms are clearly presented before purchase, so users know exactly what to expect. Canceling a subscription is simple, ensuring full control without hidden conditions. 

Reliable and Responsive Customer Support

Customer support is a key strength of the Cortisol Detox app. Users can expect fast, helpful, and friendly assistance with any questions about plans, billing, or app features. This responsive customer support system ensures users stay focused on their progress rather than dealing with app issues.

Cortisol Detox App Reviews From the Wellness Community

Users on Reddit describe Cortisol Detox as a stress-focused wellness app that just works. The biggest benefit is removing guesswork – opening the app daily to find personalized meal plans, workouts, and meditations without wondering what comes next. 

For those seeking a structured and lasting approach to a stress-free lifestyle, Cortisol Detox provides a clear path to real results. A personalized plan can be started today, turning nutrition and movement into an effective routine.

Photo accompanying this announcement is available at https://www.globenewswire.com/NewsRoom/AttachmentNg/54b4d882-04e7-4f02-b2fc-30251a4d8930

CONTACT: Contact: help@cortisoldetox.com

Dyno Therapeutics Launches Dyno Psi-Phi, an Agentic AI Suite for Protein Binder Design, at NVIDIA GTC 2026

Posted on by

Dyno Therapeutics Launches Dyno Psi-Phi, an Agentic AI Suite for Protein Binder Design, at NVIDIA GTC 2026




Dyno Therapeutics Launches Dyno Psi-Phi, an Agentic AI Suite for Protein Binder Design, at NVIDIA GTC 2026

Dyno’s Psi-Phi generative protein design and agentic interfaces provide versatile AI models and agents that connect physical outcomes with computational workflows


WATERTOWN, Mass.–(BUSINESS WIRE)–Dyno Therapeutics, Inc., a genetic technologies company applying AI to empower patients everywhere with genetic agency, today announced the launch of Dyno Psi-Phi (pronounced “sci-fi”), a suite of AI-powered protein design tools to help therapeutic developers create sequence-based medicines with the potential to transform patient lives. The announcement took place at NVIDIA GTC 2026 and arose from a collaboration between Dyno and NVIDIA to accelerate therapeutic discovery and design with high-performance computing.

AI technologies that can precisely design the amino acid sequences of protein molecules to bind therapeutic targets have the potential to dramatically accelerate the development of new medicines.

“Dyno’s Psi-Phi design suite is a step toward solving a major challenge in modern AI: connecting in silico benchmarks to real-world outcomes,” said Sam Sinai, Ph.D., Head of Machine Learning and Cofounder at Dyno Therapeutics. “Much of today’s progress is measured against a narrow set of computational filters. While effective, they can limit exploration of the broader functional space of proteins. With Psi-Phi, we democratize the filters that work, while introducing models that generate greater diversity and pair naturally with high-throughput experiments, so designs succeed not just at binding, but across downstream requirements.”

Dyno Psi-Phi is a suite of integrated tools:

Dyno Phi is a collection of filters that strongly predict real-world outcomes. Dyno iteratively calibrates and improves these filters with real-world experimental data to enable users to accurately assess the likelihood that resulting designs will validate in experimental settings. Furthermore, users can easily combine and modify the application of these filters to fit their design needs, balancing confidence in design success with diversity of designs. Dyno Phi can be used with any generative model to increase the confidence of translating designs to a wet-lab setting.

Dyno Psi-1 is the first open-weight model from the Dyno Psi protein design family. It is influenced by the NVIDIA La-Proteina family of models and trained on the NVIDIA DGX Cloud using NVIDIA Hopper GPUs. With a flow-matching backbone generative model optimized for scaling to complex multimeric interfaces, Psi-1 prioritizes structural diversity and controllability over pure in silico scoring objectives, producing more novel binders and demonstrating excellent experimental performance across common lab assays. The next-generation development of these models has already integrated the NVIDIA Transformer Engine to accelerate training and inference. To facilitate broader development of models within the community, Dyno is also openly releasing a curated dataset of synthetic domain interfaces (SDI) on which Dyno Psi-1 has been trained to improve the diversity of designed binders.

Dyno Psi-Phi APIs are a collection of community-tier REST APIs that provide programmatic access to Dyno Psi-1 for binder generation, and Dyno Phi for sequence filtering and experimental grounding. Developers can generate and evaluate protein designs through a unified interface without provisioning GPUs or building custom calibration pipelines, enabling structure-conditioned design and probabilistic estimation of real-world binding performance, and incorporating NVIDIA BioNeMo NIMs such as OpenFold3. These APIs are accessible at design.dynotx.com.

Dyno Psi-Phi Claude Code Skills are a one-click extension of the Psi-Phi platform that provide authenticated access to the same GPU-backed APIs directly within Anthropic’s Claude Code. They invoke inference and experimentally grounded filtering in real time, allowing scientists to iterate on protein design conversationally while leveraging Dyno’s computational infrastructure.

“Our collaboration with NVIDIA opens a new world of extraordinary AI leverage for Dyno’s partners, making frontier AI accessible to an even broader community of therapeutic developers,” said Eric Kelsic, Ph.D., Chief Executive Officer and Cofounder of Dyno Therapeutics. “Many genetic diseases can be treated by modulating protein binding, but historically it has been challenging to control and scale generative AI models for protein binder design. Our close technical partnership with NVIDIA, along with NVIDIA’s advanced hardware and software infrastructure, has enabled us to make rapid progress training Dyno Psi-1, and to create effective filtering methods with Dyno Phi agents. Now therapeutic developers can more confidently apply AI to create exceptionally effective new medicines for the patients who need them most.”

“Bridging the persistent gap between computational workflows and successful real-world experimental outcomes is critical for modern molecular design, and NVIDIA DGX Cloud equipped with H200 GPUs provides developers with the advanced infrastructure necessary to train complex generative models at scale,” said Anthony Costa, Director of Digital Biology at NVIDIA.

Dyno Psi-1 is available at https://huggingface.co/dynotx/dynopsi.

Dyno Phi is available at design.dynotx.com and through Claude Code.

Dyno SDI dataset is available at https://huggingface.co/datasets/dynotx/synthetic_dimers.

About Dyno Therapeutics

Dyno Therapeutics is on a mission to build high-performance genetic technologies that transform patients’ lives. Dyno applies AI to create better technologies for gene delivery and sequence design to increase “Genetic Agency” – a person’s ability to take action at the genetic level to live a healthier life – through safe, effective and widely accessible genetic medicines. Dyno partners across industries to ensure these life-transforming technologies can help as many patients as possible, including through strategic collaborations with leading gene therapy developers Astellas and Roche. Visit www.dynotx.com.

Contacts

Media Contact:

Thermal for Dyno Therapeutics

dynotx@thermalpr.com