Year: 2019

NEW YORK and BASEL, Switzerland, Nov. 18, 2019 (GLOBE NEWSWIRE) — Axovant Gene Therapies Ltd. (NASDAQ: AXGT), a clinical-stage company developing innovative gene therapies, today announced that the U.S. Food and Drug Administration (FDA) has granted orphan drug designation for the Company’s investigational gene therapy, AXO-AAV-GM1, for the treatment of GM1 gangliosidosis. GM1 gangliosidosis is a progressive and fatal pediatric lysosomal storage disorder caused by mutations in the GLB1 gene leading to impaired production of the beta-galactosidase enzyme. The Company is planning to complete enrollment of patients in Part A of the AXO-AAV-GM1 registrational program evaluating safety and efficacy and expects to announce 6-month data from Part A in mid-2020. “We are pleased to receive orphan drug designation for our GM1 gangliosidosis...

DUBLIN, Ireland and CHICAGO, Nov. 18, 2019 (GLOBE NEWSWIRE) — Iterum Therapeutics plc (Nasdaq: ITRM), a clinical-stage pharmaceutical company focused on developing next generation oral and IV antibiotics to treat infections caused by multi-drug resistant pathogens in both community and hospital settings, today announced the completion of patient enrollment in its Sulopenem for Resistant Enterobacteriaceae (SURE) 2 clinical trial in complicated urinary tract infections (cUTI).“The completion of enrollment in our cUTI trial marks the achievement of another critical milestone in our development program,” said Corey Fishman, Chief Executive Officer of Iterum Therapeutics. “Completing enrollment in this phase 3 trial brings us another step closer to providing physicians and patients with the first and only oral and intravenous (IV) penem...

NEW YORK, Nov. 18, 2019 (GLOBE NEWSWIRE) — SIGA Technologies, Inc. (SIGA) (NASDAQ: SIGA), a commercial-stage pharmaceutical company focused on the health security market, today announced that the Canadian Department of National Defence (CDND) has issued an advanced contract award notice (ACAN), indicating that it intends to award a contract to fund regulatory filing with Health Canada for approval of oral TPOXX®.  The ACAN is required to remain open for approximately 15 days, during which time a potential alternative supplier who meets the ACAN requirements for a smallpox anti-viral therapy that has been approved by national regulatory authority may submit a competing Statement of Capabilities. SIGA is the only company currently able to fulfill this requirement.“The ACAN represents an important first step by the Canadian military,...

VANCOUVER, British Columbia, Nov. 18, 2019 (GLOBE NEWSWIRE) — FIREWEED ZINC LTD. (“Fireweed” or the “Company”) (TSXV: FWZ) is pleased to announce receipt of a Class 4 Land Use Permit for the Macmillan Pass Zinc Project in Yukon, Canada. The Class 4 permit applies to the parts of the property covering the main deposits at Tom, Jason and End Zones. It replaces a Class 3 permit and allows a larger and more ambitious work program with up to a 150-person camp, larger and more extensive exploration programs, and sets out environmental, wildlife, infrastructure, reclamation and First Nations heritage requirements for ongoing work.CEO StatementFireweed CEO Brandon Macdonald stated, “We are very pleased to have received the Class 4 permit through a well-defined procedure that included First Nations consultations. We are grateful to our partners...

NEW YORK, Nov. 18, 2019 (GLOBE NEWSWIRE) — Acreage Holdings, Inc. (“Acreage”) (CSE: ACRG.U) (OTC: ACRGF) (FSE: 0ZV) announced that on November 15, certain of its subsidiaries and Compassionate Care Foundation, Inc. (“CCF”), a New Jersey vertically integrated cannabis nonprofit corporation, entered into a Reorganization Agreement, pursuant to which Acreage will acquire 100% of the equity interests in CCF, and subsequently consolidate their financials.  Closing of the transaction is subject to state approval.With a population of approximately nine million, New Jersey is estimated to generate $317 million in legal medical cannabis sales by 2022, according to Arcview Market Research.“I’m thrilled to finally welcome CCF into the Acreage family,” said Kevin Murphy, Chairman and Chief Executive Officer of Acreage.  “This reorganization...

SALT LAKE CITY, UT, Nov. 18, 2019 (GLOBE NEWSWIRE) — SINTX Technologies, Inc. (NASDAQ: SINT) (the “Company”), an original equipment manufacturer (OEM) ceramics company that develops and commercializes silicon nitride for medical and non-medical applications, today announced financial results for the three and nine month periods ended September 30, 2019 and provided a business update.THIRD QUARTER 2019 FINANCIAL RESULTSSINTX reported revenue of $0.2 million for the three months ended September 30, 2019, and $0.4 million for the nine months ended September 30, 2019. Generally accepted accounting principles (GAAP) basic net loss from continuing operations for the three months ended September 30, 2019, was $0.68 per share, compared to a basic net loss from continuing operations of $7.09 per share for the three months ended September...

~ The Company Remains Focused on Completing the LOGICS Study and Submitting a New Drug Application (NDA) for RECORLEV™ (levoketoconazole), While Ensuring Continued Growth and Profitability of KEVEYIS® (dichlorphenamide) and Serving the Unmet Needs of the Primary Periodic Paralysis Community ~DUBLIN, Ireland and TREVOSE, Pa., Nov. 18, 2019 (GLOBE NEWSWIRE) — Strongbridge Biopharma plc, (Nasdaq: SBBP), a global commercial-stage biopharmaceutical company focused on the development and commercialization of therapies for rare diseases with significant unmet needs, today announced that the Company is eliminating approximately 15 positions through a reduction in headcount across the organization. This reduction is in addition to the previously announced elimination of all commercial costs related to MACRILEN™ (macimorelin), including the...

FOOTHILL RANCH, Calif., Nov. 18, 2019 (GLOBE NEWSWIRE) — Kaiser Aluminum Corporation (Nasdaq:KALU) announced today that it plans to offer $500.0 million aggregate principal amount of senior notes due 2028 (the “notes”) in a private transaction that is exempt from the registration requirements of the Securities Act of 1933 (the “Act”). The notes will be guaranteed by each of Kaiser Aluminum’s existing and future domestic subsidiaries that is a borrower or guarantor under Kaiser Aluminum’s revolving credit facility.Kaiser Aluminum intends to use the net proceeds from the offering of the notes to redeem all remaining amounts of Kaiser Aluminum’s existing 5.875% senior notes due 2024 (the “2024 notes”), consisting of aggregate principal amount of $375 million and a redemption premium of approximately $16.5 million, and for general corporate...

PETAH TIKVA, Israel, Nov. 18, 2019 (GLOBE NEWSWIRE) — Gilat Satellite Networks Ltd. (NASDAQ, TASE: GILT), a worldwide leader in satellite networking technology, solutions and services, announced today that it has reached a major landmark with the selection by SES for development and deployment of a global multiple application VSAT platform for its O3b mPOWER Medium Earth Orbit (MEO) communications system. This multi-million-dollar contract establishes Gilat as a significant Non-Geostationary Orbit (NGSO) player through the technological innovation of its multi-orbit GEO/NGSO platform.“We are honored to be partnering again with SES, this time for their next generation O3b mPOWER system,” said Ron Levin, VP Mobility and Global Accounts at Gilat.  “Gilat was selected due to our innovative ground segment design that significantly...

Den 18. november 2019 blev der afholdt ekstraordinær generalforsamling i Kapitalforeningen Independent InvestBestyrelsen havde fremsat forslag om at ændre kapitalforeningens vedtægter § 8 stk. 4 til ordlyden ”Andele skal være noteret på navn i kapitalforeningens ejerbog”.