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Day: March 29, 2021

Akouos Reports Fourth Quarter and Full Year 2020 Financial Results and Provides Business Highlights

– In 2020, continued to advance genetic medicine pipeline with execution of IND-enabling studies for AK-OTOF and general alignment with FDA on the path to a 2022 IND submission for AK-antiVEGF – Raised approximately $349 million in gross proceeds, which is expected to fund operations for at least two years – Due to recent third-party manufacturing delays, IND submission for AK-OTOF program now expected in the first half of 2022; all other IND-enabling activities remain on track – Establishing internal cGMP manufacturing infrastructure and capabilities in 2021 BOSTON, March 29, 2021 (GLOBE NEWSWIRE) — Akouos, Inc. (Nasdaq: AKUS), a precision genetic medicine company dedicated to developing potential gene therapies for individuals living with disabling hearing loss worldwide, today reported financial results...

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Myovant Sciences Announces European Medicines Agency Validation of Marketing Authorization Application for Relugolix for the Treatment of Advanced Prostate Cancer

If approved, relugolix would be the first and only oral androgen deprivation therapy for advanced prostate cancer in Europe Relugolix is FDA-approved and currently available in the U.S. under the trade name ORGOVYX™ Pfizer has an exclusive option to commercialize relugolix in oncology outside of the U.S. and Canada, excluding certain Asian countries, with a decision expected in the first half of 2021BASEL, Switzerland, March 29, 2021 (GLOBE NEWSWIRE) — Myovant Sciences (NYSE: MYOV), a healthcare company focused on redefining care for women and for men, today announced the European Medicines Agency (EMA) has validated the Marketing Authorization Application (MAA) for relugolix for the treatment of advanced prostate cancer. The validation of the application confirms the submission is sufficiently complete for the EMA to begin the...

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Helius Medical, Inc Receives U.S. Marketing Authorization for the PoNS™ Device

NEWTOWN, Pa., March 29, 2021 (GLOBE NEWSWIRE) — Helius Medical Technologies, Inc. (Nasdaq:HSDT) (TSX:HSM) (“Helius” or the “Company”), a neurotech company focused on neurological wellness, today announced that its wholly owned subsidiary, Helius Medical, Inc, has received marketing authorization from the U.S. Food and Drug Administration (“FDA”) for the Portable Neuromodulation Stimulator (PoNS™) device. The PoNS device is indicated for use as a short term treatment of gait deficit due to mild-to-moderate symptoms from multiple sclerosis (“MS”) and is to be used as an adjunct to a supervised therapeutic exercise program in patients 22 years of age and over by prescription only . “With the receipt of FDA marketing authorization, Helius is proud to announce that our PoNS device is now the first, and only, medical device cleared in...

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Celldex Reports 80% Complete Response Rate in Interim Data Update from Phase 1b study of CDX-0159 in Chronic Inducible Urticaria

–CDX-0159 generally well tolerated to date––Conference call to be held at 7:45 a.m. ET today– HAMPTON, N.J., March 29, 2021 (GLOBE NEWSWIRE) —  Celldex Therapeutics, Inc. (NASDAQ:CLDX) today reported interim data from the Company’s ongoing, open label clinical trial of CDX-0159 in patients with antihistamine refractory cold contact urticaria (ColdU) and symptomatic dermographism (SD), the two most common forms of chronic inducible urticaria (CIndU). In all patients treated and assessed for at least 15 days after treatment (n=10), 8 of 10 patients (80%) experienced a complete response (CR) to provocation testing post-treatment and one patient experienced a partial response (PR). CDX-0159 was generally well tolerated. CDX-0159 is a humanized monoclonal antibody developed by Celldex that binds the KIT receptor...

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Matinas BioPharma Reports Fourth Quarter and Full Year 2020 Financial Results and Operational Highlights

– Matinas to internally focus on its Lipid Nanocrystal (LNC) platform to improve the intracellular delivery of critical therapeutics – – Enrollment continues in second patient cohort of EnACT study of MAT2203 in cryptococcal meningitis; Data and Safety Monitoring Board (DSMB) evaluation of safety and efficacy data of key second patient cohort anticipated Q3 2021 – – Collaboration with National Institute of Allergy and Infectious Disease (NIAID) to formulate Gilead’s antiviral COVID-19 medication remdesivir has progressed into in vitro studies – – Data from ENHANCE-IT study of LYPDISO™ against Vascepa®support continued development of LYPDISO as a potential best-in-class prescription-only omega-3 with robust EPA-levels; partnership process ongoing – – Management to host conference call today, Monday, March 29th, at 8:00 a.m. ET – BEDMINSTER,...

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Kering : Press release – Disclosure of Transactions in Own Shares – March 22 to 26, 2021

Paris, March 29, 2021, Disclosure of Transactions in Own Shares In accordance with the authorization given by the shareholders’ annual meetingon June 16, 2020 to trade on its shares and pursuant to applicable law on share repurchase,Kering (LEI: 549300VGEJKB7SVUZR78) declares the following purchases of its own shares (FR0000121485) from March 22 to 26, 2021 (French only):Issuer’s name Issuer’s identifying code Date of transaction Identifying code of financial instrument Aggregated daily volume (in number of shares) Daily weighted average price of the purchased shares Market(MIC code)KERING 549300VGEJKB7SVUZR78 23/03/2021 FR0000121485 7 000 576.3377 XPARKERING 549300VGEJKB7SVUZR78 24/03/2021 FR0000121485 7 000 570.5468 XPARKERING 549300VGEJKB7SVUZR78 25/03/2021 FR0000121485 7 000 563.7425 XPARKERING 549300VGEJKB7SVUZR78 26/03/2021 FR0000121485 10...

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Kering : Communiqué – Déclaration des Transactions sur Actions Propres – 22 au 26 mars 2021

Paris, le 29 mars 2021 Déclaration des Transactions sur Actions Propres Dans le cadre de l’autorisation consentie par l’Assemblée générale du 16 juin 2020 pour opérer sur ses actions et conformément à la réglementation relative aux rachats d’actions,Kering (LEI : 549300VGEJKB7SVUZR78) déclare ci-après les achats d’actions propres(FR0000121485) réalisés du 22 au 26 mars 2021 :Nom de l’émetteur Code identifiant de l’émetteur (code LEI) Jour de la transaction Code identifiant de l’instrument financier Volume total journalier (en nombre de titres) Prix pondéré moyen journalier d’acquisition des actions Code identifiant marchéKERING 549300VGEJKB7SVUZR78 23/03/2021 FR0000121485 7 000 576,3377 XPARKERING 549300VGEJKB7SVUZR78 24/03/2021 FR0000121485 7 000 570,5468 XPARKERING 549300VGEJKB7SVUZR78 25/03/2021 FR0000121485 7...

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Duke Realty Closes Refinancing of Revolving Credit Facility with Sustainability-Linked Pricing Incentive

INDIANAPOLIS, March 29, 2021 (GLOBE NEWSWIRE) — Duke Realty Corporation (NYSE: DRE, or the “Company”), the largest domestic-only logistics REIT, announced today that its operating partnership, Duke Realty Limited Partnership, amended and restated its $1.2 billion unsecured revolving credit facility. The amended and restated credit facility matures March 2025 and allows two six-month extensions and includes an uncommitted incremental facility, which allows the credit facility to be increased by up to $800,000,000. Borrowings under the amended and restated facility will bear interest at the annual rate of LIBOR plus 0.775 percent (subject to a pricing grid for changes in the company’s credit rating) compared to a rate of LIBOR plus 0.875 percent (subject to a pricing grid for changes in the company’s credit rating) under its previous...

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Remarkable Turnaround Following Leronlimab Treatment in Critically Ill COVID-19 Patient After 84 days on ECMO; Case Study Published in Journal of Translational Autoimmunity

CD12 trial results also indicated that five out of six patients on ECMO recovered VANCOUVER, Washington, March 29, 2021 (GLOBE NEWSWIRE) — CytoDyn Inc. (OTC.QB: CYDY), (“CytoDyn” or the “Company”), a late-stage biotechnology company developing Vyrologix™ (leronlimab-PRO 140), a CCR5 antagonist with the potential for multiple therapeutic indications, announced today the publication in the Journal of Translational Autoimmunity “Case study of a critically ill person with COVID-19 on ECMO successfully treated with leronlimab” viewable at: https://doi.org/10.1016/j.jtauto.2021.100097. Nader Pourhassan, Ph.D., President and Chief Executive Officer of CytoDyn, noted, “We are very thankful to Sohier Elneil, M.D., University College London, for her strong contributions to this important study and to Jacob Lalezari,...

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Indkaldelse til ordinær generalforsamling – Investeringsforeningen Stonehenge

København Ø, March 29, 2021 (GLOBE NEWSWIRE) —   I henhold til vedtægterne indkalder Investeringsforeningen Stonehenge hermed til ordinær generalforsamling den 13. april 2021. Indkaldelsen med dagsorden fremgår af vedhæftede dokument, som også kan downloades fra foreningens hjemmeside www.stonehenge.dk. Bestyrelsen forInvesteringsforeningen Stonehenge Vedhæftede filerGF-indkaldelse Stonehenge 2021.04.13 Vedtægter Stonehenge 2021.04.13 mark-up

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