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Day: June 9, 2023

LGI Homes Opens New Community in Charlotte, McKee Creek Village

The Ashley by LGI Homes at McKee Creek Village The Ashley floor plan provides a flexible layout featuring a chef-ready kitchen with stainless steel appliances, granite countertops and white cabinets with hardware.CHARLOTTE, N.C., June 09, 2023 (GLOBE NEWSWIRE) — LGI Homes, Inc. (NASDAQ: LGIH) announced the company is now selling brand-new, single-family homes at McKee Creek Village. Ideally positioned in east Charlotte, North of Mint Hill, McKee Creek Village provides residents with easy access to the best shopping, dining and employment opportunities in Uptown Charlotte. Just minutes down the road, the highly desirable town, Mint Hill, hosts an assortment of concerts, farmer’s markets and holiday celebrations. Within the community residents have access to an array of amenities, including a community park, children’s playground,...

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FDA Advisory Committee Votes Unanimously to Confirm the Clinical Benefit of LEQEMBI® (lecanemab-irmb) for the Treatment of Alzheimer’s Disease

Peripheral and Central Nervous System Drugs Advisory Committee voted based on data from large global confirmatory Phase 3 Clarity AD clinical trial in patients living with early Alzheimer’s disease The PDUFA action date for traditional approval of LEQEMBI has been set for July 6, 2023, with designation of priority review LEQEMBI received accelerated approval from the FDA for the treatment of early Alzheimer’s disease on January 6, 2023 TOKYO and CAMBRIDGE, Mass., June 09, 2023 (GLOBE NEWSWIRE) — Eisai Co., Ltd. (Headquarters: Tokyo, CEO: Haruo Naito, “Eisai”) and Biogen Inc. (Nasdaq: BIIB, Corporate headquarters: Cambridge, Massachusetts, CEO: Christopher A. Viehbacher, “Biogen”) announced today that the U.S. Food and Drug Administration’s (FDA) Peripheral and Central Nervous System Drugs Advisory Committee (PCNS) voted unanimously...

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Allogene Therapeutics Announces Oral Presentation of Phase 1 Data on ALLO-501/501A in Large B Cell Lymphoma at the International Conference on Malignant Lymphoma (ICML) Lugano

Long-Term Follow Up Data from Phase 1 ALPHA/ALPHA2 Trials Demonstrates Potential of Allogeneic CD19 CAR T to Generate Durable Complete Responses Similar to Approved Autologous Therapies Presentation Recaps 12 Patients Treated with Phase 2 Dose Regimen and Includes Additional Data on All 33 CAR T Naïve Patients Treated with the Alloy™ Manufacturing Process Potentially Pivotal Phase 2 ALPHA2 Trials Ongoing in the US; Sites in Europe, Canada and Australia Expected to Enroll During 2023SOUTH SAN FRANCISCO, Calif., June 09, 2023 (GLOBE NEWSWIRE) — Allogene Therapeutics, Inc. (Nasdaq: ALLO), a clinical-stage biotechnology company pioneering the development of allogeneic CAR T (AlloCAR T™) products for cancer, today announced it will present data from the Phase 1 ALPHA/ALPHA2 trials of ALLO-501/501A in patients with relapsed/refractory...

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ETC Announces Fiscal 2023 Full Year and Fourth Quarter Results

SOUTHAMPTON, Pa., June 09, 2023 (GLOBE NEWSWIRE) — Environmental Tectonics Corporation (OTC Pink: ETCC) (“ETC” or the “Company”) today reported its financial results for the thirteen week period ended February 24, 2023 (the “2023 fourth quarter”) and the fifty-two week period ended February 24, 2023 (“fiscal 2023”). Robert L. Laurent, Jr., ETC’s Chief Executive Officer and President stated, “We are pleased with sales increasing 37.7% to $26.3 million and gross profit increasing 52.1% to $6.6 million. A better indication of future sales comes from the $110 million in orders received, representing an $88 million increase from the prior year and bringing our backlog to $104 million compared to $19 million at prior year-end.” Fiscal 2023 Results of Operations Bookings / Sales Backlog Bookings in fiscal 2023 were $110.1 million, leaving...

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Kymera Therapeutics Announces Updated Clinical Data from the Phase 1 Trials of STAT3 Degrader KT-333 and IRAKIMiD Degrader KT-413

Data shared today in abstracts from the International Conference on Malignant Lymphoma (ICML) Both programs continue to demonstrate substantial target knockdown in ongoing clinical trials, with no dose limiting toxicities observed Data on additional KT-333 and KT-413 patient cohorts to be shared in conjunction with next week’s ICML meeting WATERTOWN, Mass., June 09, 2023 (GLOBE NEWSWIRE) — Kymera Therapeutics, Inc. (NASDAQ: KYMR), a clinical-stage biopharmaceutical company advancing targeted protein degradation (TPD) to deliver novel small molecule protein degrader medicines, today announced new data demonstrating that its oncology programs KT-333 and KT-413 continue to demonstrate substantial target knockdown in ongoing Phase 1a dose escalation clinical trials, with no dose limiting toxicities (DLTs) observed. The data were shared...

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Affimed Announces Acceptance of Abstracts at the 17th International Conference on Malignant Lymphoma (17-ICML)

A pre-clinical data set of AFM13 in combination with Artiva Biotherapeutics Inc.’s allogeneic NK cell AB-101 shows that AFM13 enhances the cytotoxic activity of AB-101 against tumor cells and has been accepted for poster presentation An encore oral presentation will share the safety and efficacy results from the phase 2 REDIRECT study, investigating AFM13 monotherapy in patients with CD30-positive relapsed or refractory (r/r) peripheral T-cell lymphoma (PTCL)HEIDELBERG, Germany, June 09, 2023 (GLOBE NEWSWIRE) — Affimed N.V. (Nasdaq: AFMD) (“Affimed”, or the “Company”), a clinical-stage immuno-oncology company committed to giving patients back their innate ability to fight cancer, today announced that two abstracts have been accepted for presentation at the 17th International Conference on Malignant Lymphoma (17-ICML) taking...

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Titan Medical Reports Operating and Financial Results for the First Quarter 2023

TORONTO, Ontario, June 09, 2023 (GLOBE NEWSWIRE) — Titan Medical Inc. (“Titan” or the “Company”) (TSX: TMD; OTC: TMDIF), announced today financial results for the three months ended March 31, 2023. Recent Activities:On May 26th and June 5th, respectively, the Company announced IP licensing transactions for total upfront payments of -$15.5 million. Subsequent to the quarter, the Company improved its working capital position further by settling multiple trade-related payables that cancelled approximately $0.9 million of its financial obligations. On May 29th, as a result of the strategic review process (“Strategic Review”) announced on November 30, 2022, the Board of Directors of Titan (the “Board”) approved a strategic transition in the Company’s business from the development and commercialization of robotic-assisted surgeries...

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HERITAGE CANNABIS HOLDINGS CORP. REPORTS ANNUAL GENERAL MEETING RESULTS

Toronto, ON, June 09, 2023 (GLOBE NEWSWIRE) — Heritage Cannabis Holdings Corp. (CSE: CANN) (OTCQX: HERTF) (“Heritage” or the “Company”), is pleased to announce that at the Company’s annual general meeting held on June 7, 2023, shareholders of the Company approved all of the items put forth, including:The election of David Schwede, Clinton Sharples, and Celine Arsenault as directors of the Company; and The appointment of Welch LLP as auditor of the Company.About Heritage Cannabis Holdings Corp. Heritage is a leading cannabis company offering innovative products to both the medical and recreational legal cannabis markets in Canada and the U.S., operating under two licensed manufacturing facilities in Canada. The company has an extensive portfolio of high-quality cannabis products under the brands Purefarma, Pura Vida, RAD, Premium...

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InterCure Provides an Update About The Lawsuit it Filed Against Cann Pharmaceuticals to Recover Funds Following Failed Merger

NEW YORK and TORONTO and HERZLIYA, Israel, June 09, 2023 (GLOBE NEWSWIRE) — InterCure Ltd. (NASDAQ: INCR) (TSX: INCR.U) (TASE: INCR) (dba Canndoc)(“InterCure” or the “Company“), reports today that, further to the Company’s press release issued on February 1, 2023, where the Company had reported the termination of the merger agreement (the “Agreement”) with Cann Pharmaceutical Ltd. (“Better“) due to fundamental disagreements between the parties thereto and that the closing conditions contained in the Agreement were not met, and further to the Company press release issued on February 14, 2023, where the Company had reported that it had filed  a lawsuit against Better to recover funds loaned to Better in the course of their dealings in connection with the Agreement, Better has filed a statement...

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IX Acquisition Corp. Announces Third Extension of Deadline to Complete Initial Business Combination

NEW YORK, June 09, 2023 (GLOBE NEWSWIRE) — IX Acquisition Corp. (Nasdaq: IXAQ) (“IXAQ” or the “Company”) announced today that its board of directors (the “Board”) has decided to extend the date by which the Company must consummate an initial business combination (the “Deadline Date”) from June 12, 2023 for an additional month, to July 12, 2023. This is the third of twelve potential one-month extensions of the Deadline Date available to the Company pursuant to its Amended and Restated Memorandum and Articles of Association. IXAQ further announced that on or before June 12, 2023, IX Acquisition Sponsor LLC will deposit $160,000 into IXAQ’s trust account in connection with this extension. About IX Acquisition Corp. IX Acquisition Corp. is a blank check company formed for the purpose of effecting a merger, capital stock exchange, asset...

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