GlobeNewswire by notified

Idorsia presents at the 41st J.P. Morgan Healthcare Conference – Achievements in 2022 provide the foundation for our success in 2023


Ad hoc announcement pursuant to Art. 53 LR

Allschwil, Switzerland – January9, 2023

Idorsia Ltd (SIX: IDIA) today announced that Jean-Paul Clozel, Chief Executive Officer of Idorsia, will present at the 41st J.P. Morgan Healthcare Conference on January 9, 2023, at 17:15 Pacific Standard Time / 02:15 Central European Time. The conference will take place at the Westin St. Francis hotel in San Francisco, USA.

Jean-Paul will describe how Idorsia is building momentum to become a leading mid-sized biopharmaceutical company. The presentation will cover the launch of the company’s first products, PIVLAZ™ (clazosentan) in Japan and QUVIVIQ™ (daridorexant) in the US and Europe. He will also present opportunities for future growth coming from the clinical development pipeline, including the recent filing of a new drug application for aprocitentan with the US Food and Drug Administration (FDA), the eagerly anticipated Phase 3 REACT clinical results expected in the near-term, and the progress made with other late-stage assets. Follow this link to access the audio stream and find the presentation available here.

Jean-Paul Clozel MD and Chief Executive Officer of Idorsia commented:
“Our achievements in 2022 provide the foundation for our success in 2023. QUVIVIQ is on track to become the leading global brand in insomnia. The feedback from physicians has been overwhelmingly positive. In the US, the team has done a great job in creating awareness and demand with patients and physicians alike. We now need to conclude the access discussions in 2023 to translate the strong and growing demand into revenue. Meanwhile, Germany and Italy are off to a great start, and we expect to see additional European countries launching QUVIVIQ during 2023, as well as the regulatory decision in Canada. Following the excellent Phase 3 results in Japan, I also expect the filing of the daridorexant Japanese NDA.”

Jean-Paul continued:
“PIVLAZ has had a great start in Japan with around 95% of the target accounts now ordering and around 25% of patients suffering from an aSAH in November receiving PIVLAZ. I am very eager to see the results for clazosentan in the global REACT study which are expected in the coming weeks.”

Expected highlights in 2023

  • Secure additional funding through non-equity dilutive instruments to narrow the funding gap
  • Secure broader payer coverage for QUVIVIQ (daridorexant) in the US – removing an important barrier to prescribing
  • Commercial launch of QUVIVIQ (daridorexant) in additional European countries, regulatory decision in Canada, and new drug application for daridorexant in Japan
  • Results of REACT, the Phase 3 study with clazosentan for the prevention of cerebral vasospasm associated with aneurysmal subarachnoid hemorrhage outside of Japan
  • Marketing authorization application (MAA) for aprocitentan for difficult-to-treat hypertension
  • FDA decision for the NDA for aprocitentan for difficult-to-treat hypertension

Effective January 15, 2023, QUVIVIQ will be covered at parity to the other branded dual orexin receptor antagonist (DORA) products for the Express Scripts National Preferred Formulary (NPF).

Jean-Paul commented on the pipeline:
“The pipeline has also progressed in 2022. The positive results with aprocitentan were rapidly analyzed and documented to achieve the US NDA before the end of 2022. This puts us in a good position for other regulatory filings in the coming months and the decision from the FDA before the end of 2023. Our Phase 3 SOS-AMI study investigating selatogrel for the treatment of heart attack has now exceeded 2,800 patients and recruitment will ramp up in 2023, we are encouraged that the patient education material and device is performing well. Having opened recruitment into the Phase 3 OPUS program investigating cenerimod for lupus in December 2022, I expect great interest from patients to participate and it should take off in 2023.”

Jean-Paul concluded:
“For me, a very important aspect to our long-term success is that our drug discovery engine continues to deliver innovative products to the clinical development pipeline. I’m pleased to have a new compound entering the clinic this year and am very excited by what I see coming through from the drug discovery team. These highlights are perfect examples of how we have created a solid foundation in 2022 to succeed in 2023 and for our team to see the fruits of all our labors.”

Idorsia’s portfolio

Mechanism of actionTarget indicationStatus
PIVLAZ™ (clazosentan)Endothelin
receptor antagonist
Cerebral vasospasm assoc. aSAHCommercially available in Japan; Global Phase 3 complete – results expected Q1 2023
QUVIVIQ™ (daridorexant)Dual orexin
receptor antagonist
InsomniaCommercially available in the US, and the first countries in Europe; Approved in the UK and Switzerland; Under review in Canada; Phase 3 in Japan successful – filing expected in H2 2023; Phase 2 in pediatric insomnia – recruiting
Aprocitentan* Dual endothelin
receptor antagonist
Difficult-to-control hypertensionNDA under review in US, other country filings in preparation
synthase inhibitor
Fabry diseasePhase 3 primary endpoint not met; Open Label Extension ongoing
SelatogrelP2Y12 inhibitorSuspected acute
myocardial infarction
Phase 3 recruiting
CenerimodS1P1 receptor
Systemic lupus
Phase 3 recruiting
ACT-1004-1239ACKR3 / CXCR7
Multiple sclerosisPhase 2 in preparation
SinbaglustatGBA2/GCS inhibitorRare lysosomal storage disordersPhase 1 complete
ACT-1014-6470C5aR1 antagonistImmune-mediated
Phase 1
ACT-777991CXCR3 antagonistRecent-onset Type 1
Phase 1
Phase 1

* In collaboration with Janssen Biotech to jointly develop aprocitentan, Janssen Biotech has sole commercialization rights worldwide

Neurocrine Biosciences has a global license to develop and commercialize ACT-709478 (NBI-827104), Idorsia's novel T-type calcium channel blocker. ACT-709478 was investigated in a Phase 2 study for the treatment of a rare form of pediatric epilepsy. The study did not meet the primary endpoint. ACT-709478 was generally well tolerated. Neurocrine continues to analyze the data generated in the study to determine next steps.

Further details including the current status of each project in our portfolio can be found in our innovation fact sheet.

Creation of Treasury Shares
The Company today reports that it has created 10,000,000 treasury shares with a nominal value of CHF 0.05 each, thereby increasing its registered share capital from CHF 8,848,349.75 to CHF 9,348,349.75. The new shares, created on January 6, 2023, out of the Company’s authorized share capital, were subscribed at nominal value by Idorsia Pharmaceuticals Ltd, a wholly owned subsidiary, and are expected to be listed on the SIX Swiss Exchange on or around January 9, 2023. With this increase, the Company now holds treasury shares that can be used in a cash preservative manner for potential share-based compensation, effective fund raising, or business development purposes.

Notes to the editor

About Idorsia
Idorsia Ltd is reaching out for more – We have more ideas, we see more opportunities, and we want to help more patients. In order to achieve this, we will develop Idorsia into a leading biopharmaceutical company, with a strong scientific core.

Headquartered near Basel, Switzerland – a European biotech-hub – Idorsia is specialized in the discovery, development and commercialization of small molecules to transform the horizon of therapeutic options. Idorsia has a broad portfolio of innovative drugs in the pipeline, an experienced team of professionals covering all disciplines from bench to bedside, state-of-the-art facilities, and a strong balance sheet – the ideal constellation to translate R&D efforts into business success.

Idorsia was listed on the SIX Swiss Exchange (ticker symbol: IDIA) in June 2017 and has over 1’200 highly qualified specialists dedicated to realizing our ambitious targets.

For further information, please contact
Andrew C. Weiss
Senior Vice President, Head of Investor Relations & Corporate Communications
Idorsia Pharmaceuticals Ltd, Hegenheimermattweg 91, CH-4123 Allschwil
+41 58 844 10 10

The above information contains certain "forward-looking statements", relating to the company's business, which can be identified by the use of forward-looking terminology such as "estimates", "believes", "expects", "may", "are expected to", "will", "will continue", "should", "would be", "seeks", "pending" or "anticipates" or similar expressions, or by discussions of strategy, plans or intentions. Such statements include descriptions of the company's investment and research and development programs and anticipated expenditures in connection therewith, descriptions of new products expected to be introduced by the company and anticipated customer demand for such products and products in the company's existing portfolio. Such statements reflect the current views of the company with respect to future events and are subject to certain risks, uncertainties and assumptions. Many factors could cause the actual results, performance or achievements of the company to be materially different from any future results, performances or achievements that may be expressed or implied by such forward-looking statements. Should one or more of these risks or uncertainties materialize, or should underlying assumptions prove incorrect, actual results may vary materially from those described herein as anticipated, believed, estimated or expected.


To view this piece of content from, please give your consent at the top of this page.
To view this piece of content from, please give your consent at the top of this page.

About GlobeNewswire by notified

GlobeNewswire by notified
GlobeNewswire by notified
One Liberty Plaza - 165 Broadway
NY 10006 New York

GlobeNewswire by notified is one of the world's largest newswire distribution networks, specializing in the delivery of corporate press releases financial disclosures and multimedia content to the media, investment community, individual investors and the general public.

Subscribe to releases from GlobeNewswire by notified

Subscribe to all the latest releases from GlobeNewswire by notified by registering your e-mail address below. You can unsubscribe at any time.

Latest releases from GlobeNewswire by notified

Årsrapport for 2022 - Selskabsmeddelelse nr. 1/202327.3.2023 23:07:48 CEST | pressemeddelelse

ÅRSRAPPORT FOR 2022 UDBYTTESTRØM OG LIKVIDITET BEDRE END FORVENTET, TIL TRODS FOR SVÆRE MARKEDER PÅVIRKET AF COVID Hovedpunkter for 2022 - Koncernen Resultat for året blev et tab på DKK 1,5 mio. (DKK -0,5 mio.).Totale pengestrømme for året på DKK -9,1 mio. (2021: positive pengestrømme på DKK 0,8 mio.)Likvide midler pr. 31. december 2022 på DKK 13,0 (DKK 21,9 mio.), heraf DKK 3,5 mio. i moderselskabet EAC Invest, DKK 5,8 mio. i Thailand og DKK 3,7 mio. indestår i Kina og er ikke til umiddelbar disposition for EAC Invest koncernen udenfor Kina.Udbytter fra investeringer udgjorde DKK 3,4 mio., og var lidt højere end oprindeligt forventet.Thai Poly Acrylic var i 2022 hårdt ramt af efterdønninger fra Covid-19 og stigende priser på råmaterialer, hvilket påvirkede salget og resultatet var betydeligt under forventning.Udbyttebetaling på DKK 1.000 pr. aktie og i alt DKK 10 mio. blev gennemført i april 2022. Forventninger for 2023 - Koncernen Forventede driftsomkostninger (primært driftsresultat

Nyxoah Raises $3 Million from an At-the-Market Equity Offering27.3.2023 22:05:00 CEST | Press release

INSIDE INFORMATION REGULATED INFORMATION Nyxoah Raises $3 Million from an At-the-Market Equity Offering Mont-Saint-Guibert, Belgium – March 27, 2023, 10:05pm CET / 4:05pm ET – Nyxoah SA (Euronext Brussels/Nasdaq: NYXH) (“Nyxoah” or the “Company”), a medical technology company focused on the development and commercialization of innovative solutions to treat Obstructive Sleep Apnea (OSA), today announced that the Company raised $2.8 million in gross proceeds pursuant to the Company’s $50 million at-the-market ("ATM") program established on December 22, 2022 at an issue price equal to the market price on the Nasdaq Global Market at the time of the sale. The shares were purchased by historical Nyxoah shareholder Cochlear Limited, and the proceeds will be used for general corporate purposes. The ordinary shares described above were sold pursuant to the Company’s shelf registration statement on Form F-3 (File No. 333-268955), previously filed with the Securities and Exchange Commission (“SEC

Convocation of the 2023 Annual General Meeting of Shareholders and Proposed Resolutions27.3.2023 20:30:00 CEST | Press release

THIS PRESS RELEASE CONTAINS INSIDE INFORMATION WITHIN THE MEANING OF ARTICLE 7(1) OF THE EUROPEAN MARKET ABUSE REGULATION (596/2014). EINDHOVEN, Pays-Bas et LAUSANNE, Suisse, et BOSTON, MA, Etats-Unis, March 27, 2023 (GLOBE NEWSWIRE) -- ONWARD Medical N.V. (Euronext: ONWD) (the Company), the medical technology company creating innovative therapies to restore movement, independence, and health in people with spinal cord injury, today has convened the 2023 Annual General Meeting of Shareholders (AGM), including the resolutions to be submitted for adoption at the AGM, which will be held in Amsterdam, the Netherlands, on May 8, 2023. The resolutions, proposed by the Board, to be submitted for adoption at the AGM, are as follows: Adoption of the Company’s statutory annual accounts for the financial year ended December 31, 2022, prepared in accordance with International Financial Reporting Standards (IFRS-EU). The 2022 statutory accounts were filed with the Netherlands Authority for the Fina

ONWARD Reports 2022 Full Year Financial and Operating Results27.3.2023 20:00:00 CEST | Press release

Company also Provides Business Update and Outlook for 2023 - Conference Call and Webcast (in English) March 28, 2023, at 2:00 PM CEST/8:00 AM EDT THIS PRESS RELEASE CONTAINS INSIDE INFORMATION WITHIN THE MEANING OF ARTICLE 7(1) OF THE EUROPEAN MARKET ABUSE REGULATION (596/2014) EINDHOVEN, the Netherlands, LAUSANNE, Switzerland & BOSTON, MA USA, March 27, 2023 (GLOBE NEWSWIRE) -- ONWARD Medical N.V. (Euronext: ONWD), the medical technology company creating innovative therapies to restore movement, independence, and health in people with spinal cord injury, today announces its 2022 financial and operating results. The full Annual Report is available here, on the Company’s website in the Investors section (, and on the website of the Netherlands Authority for the Financial Markets ( “I am proud of the volume and significance of our team’s achievements as we prepare for commercialization of our first therapy in late 2023 or early 2024,” said Dave Marver, CEO

Nokia Corporation: Repurchase of own shares on 27.03.202327.3.2023 20:00:00 CEST | Press release

Nokia Corporation Stock Exchange Release 27 March 2023 at 21:00 EEST Nokia Corporation: Repurchase of own shares on 27.03.2023 Espoo, Finland – On 27 March 2023 Nokia Corporation (LEI: 549300A0JPRWG1KI7U06) has acquired its own shares (ISIN FI0009000681) as follows: Trading venue (MIC Code)Number of sharesWeighted average price / share, EUR*XHEL284,4184.39CEUX14,3074.40AQEU2904.39TQEX9854.38Total300,0004.39 * Rounded to two decimals On 3 February 2022, Nokia announced that its Board of Directors is initiating a share buyback program under the authorization granted by Nokia’s Annual General Meeting on 8 April 2021 to return up to EUR 600 million of cash to shareholders in tranches over a period of two years. The second phase of the share buyback program in compliance with the Market Abuse Regulation (EU) 596/2014 (MAR), the Commission Delegated Regulation (EU) 2016/1052 and under the authorization granted by Nokia’s Annual General Meeting on 5 April 2022 started on 2 January 2023 and en