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Year: 2021

Cara Therapeutics Announces CMS Grants TDAPA to KORSUVA™ (difelikefalin) Injection

KORSUVA receives TDAPA reimbursement beginning April 2022 U.S. commercial launch on track for early second quarter 2022 STAMFORD, Conn., Dec. 20, 2021 (GLOBE NEWSWIRE) — Cara Therapeutics, Inc. (Nasdaq: CARA) today announced that the U.S. Centers for Medicare & Medicaid Services (CMS) has granted Transitional Drug Add-On Payment Adjustment (TDAPA) to KORSUVA™ (difelikefalin) injection in the anti-pruritic functional category. TDAPA will apply to KORSUVA injection beginning April 4, 2022, for two years. KORSUVA injection was approved by the U.S. Food and Drug Administration (FDA) in August 2021 for the treatment of moderate-to-severe pruritus associated with chronic kidney disease in adults undergoing hemodialysis. TDAPA enables payment for new injectable end-stage renal disease (ESRD)-related therapies to be reimbursed outside...

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Mesa Air Group Reports November 2021 Operating Performance

PHOENIX, Dec. 20, 2021 (GLOBE NEWSWIRE) — Mesa Air Group, Inc. (NASDAQ: MESA) today reported Mesa Airlines’ operating performance for November 2021. Mesa Airlines reported 28,465 block hours in November 2021, a 23 percent increase from November 2020 as a result of continued increased flying with the relaxation of certain COVID travel restrictions. The Company also reported a controllable completion factor of 98.58 percent and 98.48 percent for its American and United operations, respectively. Operating statistics for November 2021 and fiscal year 2021 YTD are included in the table below.  Nov-21 Nov-20 % Change YTD FY2022 YTD FY2021 % ChangeBlock Hours            American 11,276   10,643   5.9 % 22,659   18,968   19.5 %United 16,969   12,302   37.9 % 36,074   24,073   49.9 %DHL 220   201   9.4 % 427   273   56.3 %Total 28,465   23,146   23.0 % 59,159   43,314   36.6 %               Nov-21 Nov-20 %...

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Black Diamond Group Limited Announces Renewal of Asset-Based Credit Facility

CALGARY, Alberta, Dec. 20, 2021 (GLOBE NEWSWIRE) — Black Diamond Group Limited (“Black Diamond” or the “Company”) (TSX: BDI), a leading provider of space rental and workforce accommodation, today announced the renewal of its secured asset-based revolving credit facility (“Facility”). The renewal extends the maturity of the Facility out to October 31, 2026. The lending syndicate is unchanged and is co-led by The Bank of Nova Scotia and Bank of Montreal. There were no changes to the pricing grid and the size of the Facility remains unchanged at $300 million, with an uncommitted accordion of $50 million. All other major terms of the Facility, including financial covenants, are carried forward and are unaffected by the renewal. The Company is required to maintain a Fixed Charge Coverage Ratio of 1.1 to 1; however, this covenant...

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Checkmate Pharmaceuticals Strengthens Board of Directors with Appointment of Joy Yan, M.D., Ph.D.

Nilesh Kumar, Ph.D. departs Board of Directors upon transition to new role at Wellington Management CAMBRIDGE, Mass., Dec. 20, 2021 (GLOBE NEWSWIRE) — Checkmate Pharmaceuticals, Inc. (NASDAQ: CMPI) (“Checkmate”), a clinical stage biopharmaceutical company focused on developing its proprietary technology to harness the power of the immune system to combat cancer, today announced the addition of Joy Yan, M.D., Ph.D. to its Board of Directors (“Board”). “Joy’s impressive track record in immuno-oncology focused clinical development will be valuable as we continue to advance vidutolimod toward registration in melanoma and proof of concept in additional indications,” commented Alan Fuhrman, Interim CEO and President of Checkmate. “We are pleased to welcome Joy to Checkmate’s Board.” Dr. Yan currently serves as Chief Medical Officer at...

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Checkmate Pharmaceuticals Announces Initiation of Patient Dosing in Phase 2 Multi-Indication Trial Using Vidutolimod

CAMBRIDGE, Mass., Dec. 20, 2021 (GLOBE NEWSWIRE) — Checkmate Pharmaceuticals, Inc. (NASDAQ: CMPI) (“Checkmate”), a clinical stage biopharmaceutical company focused on developing its proprietary technology to harness the power of the immune system to combat cancer, today announced that patient dosing was initiated in the anti-PD-1 refractory cutaneous squamous cell carcinoma (CSCC) arm of a Phase 2 multi-indication study evaluating the efficacy and safety of vidutolimod in combination with cemiplimab for the treatment of patients with anti-PD-1 refractory CSCC. Vidutolimod is an advanced generation Toll-like receptor 9 (TLR9) agonist, delivered as a biologic virus-like particle utilizing a CpG-A oligodeoxynucleotide as a key component. “Initiation of dosing in this trial marks a significant step forward in our pursuit of a potential...

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Microbix Launches Multiplex Respiratory PCR-Test Control

Helping Ensure Workflow Accuracy of Tests for COVID, Flu A, Flu B, and RSV MISSISSAUGA, Ontario, Dec. 20, 2021 (GLOBE NEWSWIRE) — Microbix Biosystems Inc. (TSX: MBX, OTCQX: MBXBF, Microbix®), a life sciences innovator and exporter, announces the expansion of its portfolio of Quality Assessment Products (“QAPs™”) to include single-unit swab-formatted controls that simultaneously support PCR tests for SARS-CoV-2 (“COVID”), Influenza A (“Flu A”), Influenza B (“Flu B”), and Respiratory Syncytial Virus (“RSV”), four of the most-common causes of viral infectious respiratory illness globally. Specifically, Microbix is commercializing In-Vitro Diagnostic (“IVD”) quality controls to support workflow accuracy of “multiplex” clinical laboratory PCR tests that detect COVID, Flu A, Flu B, and RSV from a single patient-sample. These innovative,...

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ValOre Drills 21 m at 1.67 g/t 2PGE+Au from 27 m at Massapê and 22 m at 1.40 g/t 2PGE+Au from 13 m at Santo Amaro South, Pedra Branca

Massapê TargetFigure 1: Plan Map of at Massapê TargetMassapê TargetFigure 2: Cross Section A-A’, Massapê TargetMassapê TargetFigure 3: Cross Section B-B’, Massapê TargetSanto Amaro South Target and Santo Amaro DepositFigure 4: Plan Map of Santo Amaro South Target and Santo Amaro DepositVANCOUVER, British Columbia, Dec. 20, 2021 (GLOBE NEWSWIRE) — ValOre Metals Corp. (“ValOre”; TSX‐V: VO; OTC: KVLQF; Frankfurt: KEQ0, “the Company”) reports core drilling assay results from the Massapê and Santo Amaro South targets at ValOre’s 100%-owned Pedra Branca Platinum Group Elements (“PGE”, “2PGE+Au”) Project (“Pedra Branca”) in northeastern Brazil. “ValOre’s proven exploration methodology has led to exciting near-surface 2021 drilling results at both Massapê and Santo Amaro...

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Reviva Pharmaceuticals to Participate in the Upcoming January Virtual Investor Conferences

CUPERTINO, Calif., Dec. 20, 2021 (GLOBE NEWSWIRE) — Reviva Pharmaceuticals Holdings, Inc. (NASDAQ: RVPH) (“Reviva” or the “Company”), a clinical-stage pharmaceutical company developing therapies that seek to address unmet medical needs in the areas of central nervous system (CNS), cardiovascular, metabolic, and inflammatory diseases, today announced that Laxminarayan Bhat, Ph.D., Founder, President, and CEO of Reviva will participate in the following conferences in January and invites investors to participate in virtual one-on-one meetings. Please see additional details below: 11th Annual LifeSci Partners Corporate Access EventWednesday, January 5th – Friday, January 7th Registration LinkTo submit one-on-one meeting requests Click Here H.C. Wainwright BioConnect Virtual ConferenceMonday, January 10th – Wednesday, January...

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Talaris Therapeutics Announces Addition to the Nasdaq Biotechnology Index

BOSTON and LOUISVILLE, Ky., Dec. 20, 2021 (GLOBE NEWSWIRE) — Talaris Therapeutics, Inc., (Nasdaq: TALS), a late-clinical stage cell therapy company developing therapies with the potential to transform the standard of care in solid organ transplantation, certain severe autoimmune diseases, and certain severe non-malignant blood, immune and metabolic disorders, today announced that the company has been added to the NASDAQ Biotechnology Index (NASDAQ: NBI), active prior to market open today. The NASDAQ Biotechnology Index, launched in 1993, is designed to track the performance of a set of securities listed on the NASDAQ Stock Market® (NASDAQ®) that are classified according to the Industry Classification Benchmark as biotechnology or pharmaceutical companies. The NASDAQ Biotechnology Index is calculated under a modified capitalization-weighted...

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Advicenne announces positive opinion from the French Transparency Commission (HAS) for its drug SibnayalTM in dRTA

                                                                              Advicenne announces positive opinion from the French Transparency Commission (HAS) for its drug SibnayalTM in dRTASibnayalTMeligible for reimbursement by the French public health insurance system ASMR IV: Recognition of the contribution of SibnayalTMin the treatment of dRTAParis, France, 20 December 2021 – 7:00 am CEST – Advicenne (Euronext: ADVIC), a specialty pharmaceutical company dedicated to developing and commercializing innovative treatments for those suffering from rare renal diseases, announces is has received a positive opinion from the French Transparency Commission (HAS) with its lead asset, SibnayalTM eligible for reimbursement with a Moderate Level SMR (Medical Rendered Service) and a Level IV ASMR (Medical Rendered Service Improvement), in...

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