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Day: September 17, 2021

CN Outlines Details of Strategic Plan

Ambitious value creation plan targeting C$700 million of additional operating income, as well as a 57% operating ratio for 2022 Leveraging previous strategic investments and the strong condition of the existing network will bring capital spending down to approximately 17% of revenue for 2022 while retaining commitment to safety and customer service CN to resume share repurchase program previously authorized by Board of Directors with remaining C$1.1 billion in share repurchases to be completed by end of January 2022 MONTREAL, Sept. 17, 2021 (GLOBE NEWSWIRE) — CN (TSX: CNR, NYSE: CNI) today announced the details of its strategic and financial value creation plan, “Full Speed Ahead – Redefining Railroading,” which will allow CN to continue delivering high-quality service to customers while generating profitable growth and enhanced...

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Novartis announces findings from a real-world study of alpelisib demonstrating clinical benefit in people with PIK3CA-Related Overgrowth Spectrum (PROS)

PROS is a spectrum of rare disorders caused by PIK3CA mutations and is characterized by atypical, visible overgrowths and anomalies in blood vessels, the lymphatic system and other tissuesAt 24 weeks, 38% of patients achieved ≥20% reduction in the volume of the PROS lesions assessed in the primary endpoint analysis; no patients experienced disease progression or death  Alpelisib is the first potential treatment to specifically address the root cause of PROS conditionsEPIK-P1 study findings presented at ESMO Virtual Congress 2021 support FDA submissionBasel, September 17, 2021— Novartis today announced important findings from a real-world study evaluating the safety and efficacy of alpelisib for people living with PIK3CA-Related Overgrowth Spectrum (PROS) who received treatment daily for at least 24 weeks. Results from EPIK-P1 showed...

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TCR² Therapeutics Announces Positive Interim Results from Ongoing Phase 1/2 Trial of Gavo-cel for Treatment Refractory Mesothelin-Expressing Solid Tumors

– Clinical activity observed in all three mesothelin-expressing tumor types treated – Gavo-cel disease control rate (DCR) 81% with tumor regression in 15 of 16 evaluable patients – Overall response rate (ORR) 31% in patients infused with gavo-cel following lymphodepletion – Meaningful survival benefit at 11.2 months for patients with refractory mesothelioma – Recommended Phase 2 Dose (RP2D) being refined after identification of the Maximum Tolerated Dose (MTD) – TCR2 to host a conference call on Friday, September 17 at 9:00a.m. ET CAMBRIDGE, Mass., Sept. 17, 2021 (GLOBE NEWSWIRE) — TCR2 Therapeutics Inc. (Nasdaq: TCRR), a clinical-stage cell therapy company with a pipeline of novel T cell therapies for patients suffering from cancer, today announced positive interim results from the ongoing Phase...

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Central Ohio Transit Authority exercises options for 18 additional buses from NFI’s New Flyer

NFI is Leading the ZEvolutionNFI is Leading the ZEvolution to zero-emission and electric mobilityST. CLOUD, Min., Sept. 17, 2021 (GLOBE NEWSWIRE) — (TSX: NFI) NFI Group Inc. (“NFI” or the “Company”), a leading independent bus and coach manufacturer and a leader in electric mass mobility solutions, today announced that the Central Ohio Transit Authority (“COTA”) has exercised options for 18 Xcelsior® compressed natural gas (“CNG”) forty-foot, heavy-duty transit buses, converted from NFI subsidiary New Flyer of America Inc.’s (“New Flyer”) backlog. The award follows COTA’s second option conversion of 28 CNG buses, delivered earlier this year. The options were exercised from a five-year contract originally announced in 2018 for 154 Xcelsior CNG forty-foot transit buses. Both purchases were supported by Federal Transit...

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Captor Capital Expands California Retail Footprint with Additional Dispensary

Pacifica, California location will become Captor’s Tenth Location TORONTO, Sept. 17, 2021 (GLOBE NEWSWIRE) — Captor Capital Corp. (CSE: CPTR; FRANKFURT: NMVA; STUTTGART: NMVA), (“Captor” or the “Company”), is pleased to announce that it has entered into a binding agreement to purchase a majority interest in a licensed dispensary location in Pacifica, California. The Pacifica dispensary location, which is approved for adult-use and medicinal cannabis use as well as delivery, is slated to become the tenth dispensary in Captor Capital’s California network, joining locations in Antioch, Atwater, El Sobrante, Salinas, Castroville, Santa Cruz, Lompoc, Goleta and Palm Springs. This location will be operated by Captor Retail Group (“CRG”) and the dispensary will become part of the One Plant brand. “We are excited...

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InMed Pharmaceuticals and BayMedica Participating in Tribe Public’s Webinar “Accelerating The Commercialization of Rare Cannabinoids”

Registration for the September 21, 2021 event now open VANCOUVER, British Columbia, Sept. 17, 2021 (GLOBE NEWSWIRE) — InMed Pharmaceuticals Inc. (“InMed” or the “Company”) (Nasdaq: INM), a leader in the manufacturing and clinical development of rare cannabinoids, today announces that Eric A. Adams, CEO of InMed, and Shane Johnson, Co-Founder of BayMedica Inc. (“BayMedica”) will present at Tribe Public’s Webinar Presentation and Q&A event titled “Accelerating The Commercialization of Rare Cannabinoids”. The event is scheduled to begin at 8.30 am Pacific/11.30 am Eastern on September 21, 2021. To register to join the complimentary, ZOOM webinar-based event, please visit Tribe Public LLC at INM.TribePublic.com. Once registered, participants may begin forwarding their questions for InMed’s & BayMedica’s management to Tribe...

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Thryv announces Connect21 small business conference dates and keynote speakers

Dallas, Sept. 17, 2021 (GLOBE NEWSWIRE) — Thryv Holdings, Inc. (NASDAQ:THRY), the provider of Thryv® software, the end-to-end customer experience platform built for growing small businesses and emerging franchises, announced today the dates for Connect21, Thryv’s annual conference designed to bring small business owners together to network, learn and celebrate their entrepreneurial spirit.  The 2-day virtual event, to be held on November 10 and 11, will focus on the latest tips and proven strategies that help small business owners build and grow their businesses in today’s digital environment. From established businesses to aspiring business owners, attendees will take away key insights from the conference’s fast-paced agenda full of lively interactive discussions with top speakers.  “Thryv brought greater value to my business...

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GALAPAGOS ANNOUNCES POSITIVE CHMP OPINION FOR JYSELECA® (FILGOTINIB) FOR THE TREATMENT OF ADULTS WITH MODERATELY TO SEVERELY ACTIVE ULCERATIVE COLITIS

Mechelen, Belgium; 17 September 2021; 13.15 CET; Galapagos NV (Euronext & Nasdaq: GLPG) announced today that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion for Jyseleca® (filgotinib), a once–daily, oral, JAK1 preferential inhibitor for the treatment of adult patients with moderately to severely active ulcerative colitis (UC) who have had an inadequate response with, lost response to, or were intolerant to either conventional therapy or a biologic agent. Following this positive opinion, a final decision from the European Commission is expected later this year. The CHMP positive opinion is based on data from the pivotal Phase 2b/3 SELECTION program, which evaluated filgotinib as an induction and maintenance therapy in adult patients with moderately...

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Roche receives positive CHMP opinion for Gavreto® (pralsetinib) for the treatment of adults with RET fusion-positive advanced non-small cell lung cancer

Gavreto showed robust and durable clinical responses in people with NSCLC with RET fusions If approved, Gavreto will be the first and only targeted treatment approved by the EMA that includes first-line treatment of people with RET fusion-positive advanced NSCLCBasel, 17 September 2021 – Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has recommended the approval of Gavreto® (pralsetinib) as a monotherapy for the treatment of adult patients with rearranged during transfection (RET) fusion-positive advanced non-small cell lung cancer (NSCLC) not previously treated with a RET inhibitor. “This positive CHMP opinion for Gavreto represents another important step towards our goal of providing effective therapeutics that target genomic...

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Gritstone Announces Dosing of First Solid Tumor Patient with Optimized SLATE “Off-the-Shelf” Mutant KRAS-directed Neoantigen Immunotherapy in Phase 2 Clinical Trial

SLATE version (v) 1, Gritstone’s “off the-shelf” neoantigen immunotherapy (including KRAS, TP53 mutations), elicited multiple molecular responses and an unconfirmed RECIST radiologic response in patients with NSCLC who had progressed on prior immunotherapy SLATE v2 (a mutant KRAS-focused version), which is optimized for increased immune response, has been administered to the first patient in Phase 2 testingEMERYVILLE, Calif., Sept. 17, 2021 (GLOBE NEWSWIRE) —  Gritstone bio, Inc. (Nasdaq: GRTS), a clinical-stage biotechnology company developing next generation cancer and infectious disease immunotherapies, today announced results with its SLATE v1 product (“off-the-shelf” shared neoantigen immunotherapy in combination with intravenous nivolumab and subcutaneous ipilimumab) and dosing of the first patient in a Phase...

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