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

Nokia Corporation: Repurchase of own shares on 31.01.202331.1.2023 20:00:00 CET | Press release

Nokia Corporation Stock Exchange Release 31 January 2023 at 21:00 EET Nokia Corporation: Repurchase of own shares on 31.01.2023 Espoo, Finland – On 31 January 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*XHEL261,4854.33CEUX19,9384.34AQEU23,7644.33TQEX12,8134.34Total318,0004.33 * 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 20

GA-ASI's Eaglet Takes Its First Flight31.1.2023 19:00:00 CET | Press release

SAN DIEGO, Jan. 31, 2023 (GLOBE NEWSWIRE) -- General Atomics Aeronautical Systems, Inc. (GA-ASI) flew a new survivable Air-Launched Effect (ALE) for the first time as part of a flight demonstration based out of the Dugway Proving Grounds, Utah, on Dec. 8, 2022. The ALE, known as Eaglet, was launched from a U.S. Army MQ-1C Gray Eagle Extended Range (GE-ER) Unmanned Aircraft System (UAS). The Eaglet flight was jointly funded by GA-ASI and the U.S. Army Combat Capabilities Development (DEVCOM) Army Research Laboratory (ARL) and Aviation & Missile Center (AvMC). "The first flight of the Eaglet was an important milestone for the GA-ASI/U.S. Army team," said GA-ASI President David R. Alexander. "Eaglet is intended to be a low-cost, survivable UAS with the versatility to be launched from a Gray Eagle, rotary-wing aircraft, or ground vehicles. It enables extended reach of sensors and increased lethality while providing survivability for manned aircraft." Eaglet fits into the 'ALE Large' catego

Changes to Vallourec’s management team31.1.2023 18:41:38 CET | Press release

Changes to Vallourec’s management team Meudon, France, 31January 2023 – As part of its "New Vallourec" plan, led by Philippe Guillemot, Chairman and Chief Executive Officer, the Group has developed a three-region organization (North America, South America, and Eastern Hemisphere) to simplify and optimize the operations. This new organization aims at making the Group more efficient and more agile, closer to its customers, and to enhance its industrial performance, through two export bases, Brazil, and Asia. This new organization has led to changes in its Executive Committee, effective February 1, 2023: - Laurent Dubedout is appointed Senior Vice-President, Business Line OCTG, Services and Accessories, Group & Eastern Hemisphere and joins the Executive Committee. - Jacky Massaglia is appointed Senior Vice-President Business Line Project Line Pipe and Process and joins the Executive Committee. - Philippe Carlier, who was SVP Technology and Industry, becomes SVP Group Industry and Eastern

Information on the total number of voting rights and shares31.1.2023 18:00:00 CET | Press release

Ghent, Belgium, Jan. 31, 2023 (GLOBE NEWSWIRE) -- Press release - regulated information Biotalys NV (hereafter the “Company” or “Biotalys”), an Agricultural Technology (AgTech) company protecting crops and food with protein-based biocontrol solutions (Euronext - BTLS), today announces that 10,000 new shares were issued on 18 January 2023 as a result of the exercise of subscription rights under the Company’s long term incentive plan. In view hereof, and in accordance with article 15 of the Belgian Act of 2 May 2007 on the disclosure of major shareholdings (the “Belgian Act”), the outstanding share capital and outstanding voting securities of the Company can be summarised as follows: Share capital: EUR 44,564,320.02Total number of securities carrying voting rights: 30,959,454 (all ordinary shares)Total number of voting rights (= denominator): 30,959,454 (all relating to ordinary shares)Number of rights to subscribe for securities carrying voting rights not yet issued: 2,162,109 “ESOP War

Mendus AB: Mendus announces request for conversion of convertible bonds by Negma Group31.1.2023 18:00:00 CET | Press release

Mendus AB (“Mendus” publ; IMMU.ST), a biopharmaceutical company focused on immunotherapies addressing tumor recurrence, today announced that Negma Group (“Negma”) has by notice to Mendus requested the conversion of convertible bonds that have been issued to Negma in accordance with the financing agreement announced by Mendus through press releases on 26 August and 26 October 2022. Negma has requested conversion of ten (10) convertible bonds issued on 3 January 2023, corresponding to SEK 250,000 of the convertible loan amounting to a total of SEK 13,650,000, into 101,626 shares. Upon registration at the Swedish Companies Registration Office, Mendus’ total share capital will amount to SEK 9,976,127.50 and the total number of shares and votes will amount to 199,522,550. The conversion price per share is SEK 2.46, equivalent to 92% of the second lowest closing volume weighted average share price (VWAP) of the 10 consecutive trading days preceding the issuance of conversion request by Negma