DAWNZERA™ (donidalorsen) approved in the U.S. as first and only RNA-targeted prophylactic treatment for hereditary angioedema

CARLSBAD, Calif.--(BUSINESS WIRE)--Aug 21, 2025--

Ionis Pharmaceuticals, Inc. (Nasdaq: IONS) announced today that the U.S. Food and Drug Administration (FDA) has approved DAWNZERA™ (donidalorsen) for prophylaxis to prevent attacks of hereditary angioedema (HAE) in adult and pediatric patients 12 years of age and older. DAWNZERA is the first and only RNA-targeted medicine approved for HAE, designed to target plasma prekallikrein (PKK), a key protein that activates inflammatory mediators associated with acute attacks of HAE. DAWNZERA 80mg is self-administered via subcutaneous autoinjector once every four (Q4W) or eight weeks (Q8W).

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HAE is a rare and potentially life-threatening genetic condition that involves recurrent attacks of severe swelling (angioedema) in various parts of the body, including the hands, feet, genitals, stomach, face and/or throat. HAE is estimated to affect approximately 7,000 people in the U.S.

“DAWNZERA represents a significant advance for people living with HAE who need improved treatment options. With strong and durable efficacy, convenient administration and the longest dosing option available, we believe DAWNZERA will be the prophylactic treatment of choice for many people living with HAE. Importantly, the recently published switch data empowers patients and physicians with a roadmap for switching to DAWNZERA from other prophylactic therapies,” said Brett P. Monia, Ph.D., chief executive officer, Ionis. “At Ionis, we are dedicated to turning groundbreaking science into life-changing medicines. With the early success of our first independent launch of TRYNGOLZA® for familial chylomicronemia syndrome (FCS), and now with DAWNZERA, our second independent medicine approved in less than nine months, we are proudly delivering on that vision. To the patients, families, advocacy partners and investigators who helped make this moment a reality, we express our deepest gratitude.”

The approval of DAWNZERA was based on positive results from the Phase 3 global, multicenter, randomized, double-blind, placebo-controlled OASIS-HAE study in patients with HAE. The study met its primary endpoint, with DAWNZERA Q4W significantly reducing monthly HAE attack rate by 81% compared to placebo over 24 weeks. Mean attack rate reduction increased to 87% when measured from the second dose, a key secondary endpoint. Additionally, DAWNZERA Q4W reduced moderate-to-severe HAE attacks by ~90% over 24 weeks when measured from the second dose.

These results are bolstered by the ongoing OASISplus open-label extension (OLE) study, in which DAWNZERA Q8W had a similar effect as Q4W over time. DAWNZERA demonstrated 94% total mean attack rate reduction from baseline across both dosing groups after one year in the OLE.

The OASISplus study also includes a switch cohort evaluating DAWNZERA Q4W in patients previously treated with lanadelumab, C1-esterase inhibitor or berotralstat for at least 12 weeks. Switching to DAWNZERA reduced mean HAE attack rate by 62% from prior prophylactic treatment over 16 weeks, with no mean increase in breakthrough attacks observed during the switch. A total of 84% of patients surveyed preferred DAWNZERA over their prior prophylactic treatment, citing better disease control, less time to administer and less injection site pain or reactions.

Across clinical studies, DAWNZERA demonstrated a favorable safety and tolerability profile. The most common adverse reactions (incidence ≥ 5%) were injection site reactions, upper respiratory tract infection, urinary tract infection and abdominal discomfort.

“As the first FDA-approved RNA-targeted therapy for HAE, DAWNZERA represents a welcome advance in therapeutic options for preventing attacks. Today’s approval gives people living with HAE and their physicians another important choice for aligning treatment with individual needs,” said Anthony J. Castaldo, CEO & chairman of the board, U.S. Hereditary Angioedema Association (HAEA) and Hereditary Angioedema International (HAEi).

"People living with HAE manage this condition for all their lives, and many continue to face unpredictable, painful and dangerous breakthrough attacks even with current treatments. Durable efficacy is essential in maintaining long-term disease control,” said Marc Riedl, M.D., M.S., clinical director, U.S. HAEA Angioedema Center; University of California, San Diego; OASIS-HAE and OASISplus trial investigator. "DAWNZERA is positioned to help meet patient needs, providing substantial and sustained reduction of HAE attacks, continued improvement over time and reduced burden of treatment.”

DAWNZERA will be available in the U.S. in the coming days.

Ionis is committed to helping people access the medicines they are prescribed and will offer a suite of services designed to meet the unique needs of the HAE community through Ionis Every Step™. As part of Ionis Every Step, patients and healthcare providers will have access to a wide range of support and resources including dedicated support from a Patient Education Manager, assistance with the insurance approval process, information on affordability programs, access to the DAWNZERA Direct digital companion and other ongoing services and resources to help patients stay on track. Visit DAWNZERA.com for more information.

Webcast
Ionis will hold a webcast today at 12:15pm ET to discuss the FDA approval. Interested parties may access the webcast here. A webcast replay will be available for a limited time.

IMPORTANT SAFETY INFORMATION
CONTRAINDICATIONS
DAWNZERA is contraindicated in patients with a history of serious hypersensitivity reactions, including anaphylaxis, to donidalorsen or any of the excipients in DAWNZERA.

WARNINGS AND PRECAUTIONS
Hypersensitivity Reactions
Hypersensitivity reactions, including anaphylaxis, have been reported in patients treated with DAWNZERA. If signs and symptoms of serious hypersensitivity reactions occur, discontinue DAWNZERA and institute appropriate therapy.

ADVERSE REACTIONS
Most common adverse reactions (incidence ≥ 5%) are injection site reactions, upper respiratory tract infection, urinary tract infection, and abdominal discomfort.

Please see fullPrescribing Informationfor DAWNZERA.

About DAWNZERA™ (donidalorsen)
DAWNZERA™ (donidalorsen) is approved by the U.S. Food and Drug Administration for prophylaxis to prevent attacks of hereditary angioedema (HAE) in adult and pediatric patients 12 years of age and older. DAWNZERA is an RNA-targeted medicine designed to target plasma prekallikrein (PKK), which plays an important role in activating inflammatory mediators associated with acute attacks of HAE. For more information about DAWNZERA, visit DAWNZERA.com.

About Ionis Pharmaceuticals, Inc.
For three decades, Ionis has invented medicines that bring better futures to people with serious diseases. Ionis has marketed medicines and a leading pipeline in neurology, cardiology and other areas of high patient need. As the pioneer in RNA-targeted medicines, Ionis continues to drive innovation in RNA therapies in addition to advancing new approaches in gene editing. A deep understanding of disease biology and industry-leading technology propels our work, coupled with a passion and urgency to deliver life-changing advances for patients. To learn more about Ionis, visit Ionis.com and follow us on X (Twitter), LinkedIn and Instagram.

Ionis Forward-Looking Statements
This press release includes forward-looking statements regarding Ionis' business and the therapeutic and commercial potential of DAWNZERA, our commercial medicines, additional medicines in development and technologies. Any statement describing Ionis' goals, expectations, financial or other projections, intentions or beliefs is a forward-looking statement and should be considered an at-risk statement. Such statements are subject to certain risks and uncertainties including those inherent in the process of discovering, developing and commercializing medicines that are safe and effective for use as human therapeutics, and in the endeavor of building a business around such medicines. Ionis' forward-looking statements also involve assumptions that, if they never materialize or prove correct, could cause its results to differ materially from those expressed or implied by such forward-looking statements. Although Ionis' forward-looking statements reflect the good faith judgment of its management, these statements are based only on facts and factors currently known by Ionis. Except as required by law, we undertake no obligation to update any forward-looking statements for any reason. As a result, you are cautioned not to rely on these forward-looking statements. These and other risks concerning Ionis' programs are described in additional detail in Ionis' annual report on Form 10-K for the year ended December 31, 2024, and most recent Form 10-Q, which are on file with the Securities and Exchange Commission. Copies of these and other documents are available from the Company. In this press release, unless the context requires otherwise, "Ionis," "Company," "we," "our" and "us" all refer to Ionis Pharmaceuticals and its subsidiaries.

Ionis Pharmaceuticals®, Ionis Every Step™, DAWNZERA™ and TRYNGOLZA® are trademarks of Ionis Pharmaceuticals, Inc.

Ionis headquarters in Carlsbad, CA

DAWNZERA (donidalorsen) product image

DAWNZERA (donidalorsen) logo

MCLEAN, Va.--(BUSINESS WIRE)--Jan 15, 2026--

Hilton (NYSE: HLT) today announced Apartment Collection by Hilton, a new lodging category within Hilton's growing collection brand portfolio – offering unique, spacious furnished apartments with the trusted hospitality and reliability guests expect from Hilton. Apartment Collection by Hilton will be available for booking through Hilton channels in the first half of 2026, with initial properties in the U.S. launched in partnership with Placemakr—a leading apartment hospitality brand and operator specializing in flexible, short-term and extended-stay accommodations in urban and suburban markets, with nearly a decade of experience integrating innovative hospitality solutions and trusted service.

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The launch of Apartment Collection by Hilton allows the company to build on its existing global inventory of approximately 10,000 apartment-style units, adding as many as 3,000 new units through its partnership with Placemakr. Hilton expects to significantly grow its apartment-style inventory over the next few years through this new partnership and through additional franchise agreements with new owners in the multi-family segment.

Designed to provide flexibility for guests to stay their way, Apartment Collection by Hilton offers studio to four-bedroom furnished apartments for a variety of stay occasions — from a family getaway or friends’ reunion to an extended work trip where business travelers need comfort and consistency. Featuring chef-ready kitchens, spacious separate living areas, and on-site laundry, each distinct property is located in the heart of sought-after destinations – offering guests easy access to both must-go-to destinations and unique, under-the-radar gems. Each stay delivers an elevated experience that captures the local character of its surroundings, with the convenience and smart amenities of apartment-style living. Guests will be thoughtfully hosted, with dedicated team members available on-site 24/7 to provide support and ensure guests feel cared for.

To bring this vision to life, Hilton is launching this brand in partnership with Placemakr—a leading brand and management company in the furnished and unfurnished apartment sectors. Placemakr’s proven operational model brings deep multi-family expertise to launch Hilton’s growth in this expanding segment. Placemakr has leveraged organic growth and asset-light management agreements with its business model and is centered on partnering with multi-family building owners to convert either an entire building or a subset of units in an apartment building into furnished short-term rentals. Through the partnership with Placemakr, as well as with relationships with multi-family owners, Hilton expects to see strong growth for the brand, given the popularity of the apartment-style hospitality market.

“Apartment Collection by Hilton represents the next chapter in Hilton’s growth story and the ways we are evolving to meet growing guest demand for this dynamic segment of hospitality,” said Chris Nassetta, president and CEO, Hilton. “With this new brand, we are continuing to pioneer the future of the hospitality industry, giving guests even more ways to choose Hilton for every stay, backed by our service and reliability.”

Powered by Hilton’s trusted brand standards, Apartment Collection by Hilton will maintain consistent quality across every property, with every stay integrated into Hilton’s booking and loyalty systems, ensuring reliability and peace of mind for guests and owners alike. In the first half of 2026, travelers will be able to book stays via Hilton.com at Apartment Collection by Hilton in destinations including New York City, Washington, D.C. and Atlanta.

“After an extensive search, Hilton is proud to partner with Placemakr to introduce Hilton’s new lodging category,” said Chris Silcock, president, global brands and commercial services, Hilton. “We’ve long seen the opportunity to deliver hospitality-driven apartment stays, offering spacious accommodations, thoughtful amenities, and authentic connections to local neighborhoods, and Placemakr shares that vision. For nearly a decade, they’ve demonstrated a strong commitment to guests through high product standards and exceptional service.”

Each Apartment Collection by Hilton property will be thoughtfully designed to support guests’ routines and provide flexible spaces for real life. Guests will also enjoy access to fitness centers and select properties may also feature rooftop pools and terraces, communal gathering and workspaces, and on-site dining and retail.

“Placemakr is proud to bring our deep expertise in the furnished apartment space to this innovative new brand with Hilton,” said Bao Vuong, co-founder and president, Placemakr. “We’re thrilled for Hilton guests and Hilton Honors members to experience what we’ve built over the past decade. We’ve pioneered the furnished apartments asset class property by property, stay by stay, and to continue that work alongside the world’s most valuable hotel brand is so exciting.”

“We’re also excited for what this means for our real estate partners,” added Jason Fudin, co-founder and CEO, Placemakr. “Hilton’s industry-leading commercial engine and scale will help create even more value for our partners while accelerating our mission to maximize the value of real estate through flexibility. This marks a new chapter in flexible real estate, and we couldn’t be more excited.”

Apartment Collection by Hilton will participate in Hilton Honors, the award-winning guest loyalty program with more than 235 million members for Hilton’s portfolio of world-class brands. Members will be able to book, earn and redeem Hilton Honors Points for stays through Hilton’s direct channels and have access to instant benefits, including exclusive member discounts and free standard Wi-Fi.

PJT Partners and Goldman Sachs & Co. LLC were the strategic financial advisors on this partnership for Hilton and Placemakr, respectively.

For more information, visit Stories From Hilton.

About Hilton
Hilton (NYSE: HLT) is a leading global hospitality company with a portfolio of 26 world-class brands comprising 9,000 properties and over 1.3 million rooms, in 141 countries and territories. Dedicated to fulfilling its founding vision to fill the earth with the light and warmth of hospitality, Hilton has welcomed over 3 billion guests in its more than 100-year history, was named the No. 1 World’s Best Workplace by Great Place to Work and Fortune and has been recognized as a global leader on the Dow Jones Sustainability Indices. Hilton has introduced industry-leading technology enhancements to improve the guest experience, including Digital Key Share, automated complimentary room upgrades and the ability to book confirmed connecting rooms. Through the award-winning guest loyalty program Hilton Honors, the more than 235 million Hilton Honors members who book directly with Hilton can earn Points for hotel stays and experiences money can't buy. With the free Hilton Honors app, guests can book their stay, select their room, check in, unlock their door with a Digital Key and check out, all from their smartphone. Visit stories.hilton.com for more information, and connect with Hilton on Facebook,X, LinkedIn,Instagram and YouTube.

About Placemakr
Placemakr is a hospitality brand and management company focused on the furnished apartment space. The company transforms multifamily properties into a unique blend of apartment living and hospitality and has been the pioneer of the flexible living asset class. Placemakr's innovative tech-enabled platform provides an unmatched experience for its guests and residents, combining the advantages of apartment living with the services and reliability of a hotel, all within a single building. Placemakr's thoughtfully curated spaces in carefully selected neighborhoods offer guests and residents the flexibility to stay for a night, a year, or any duration in between.

Hilton Introduces Apartment Collection by Hilton: Furnished Apartment Accommodations, Hosted by Hilton