MG

Cabaletta Bio Reports Third Quarter 2023 Financial Results and Provides Business Update

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Thursday, November 9, 2023
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PHILADELPHIA, Nov. 09, 2023 (GLOBE NEWSWIRE) -- Cabaletta Bio, Inc. (Nasdaq: CABA), a clinical-stage biotechnology company focused on developing and launching the first curative targeted cell therapies for patients with autoimmune diseases, today reported financial results for the third quarter ended September 30, 2023, and provided a business update.

Key Points: 
  • In November 2023, Cabaletta announced the Company’s fourth IND application for CABA-201 was cleared by the FDA for a Phase 1/2 study in patients with generalized myasthenia gravis (gMG).
  • Cabaletta will present new preclinical data for CABA-201 in a poster presentation and Cabaletta Bio Scientific Advisory Board members Carl June, M.D., and Georg Schett, M.D.
  • Cabaletta plans to participate in the following upcoming investor conferences:
    Stifel 2023 Healthcare Conference, which is being held from November 14-15, 2023 in New York, NY.
  • As of September 30, 2023, Cabaletta had cash, cash equivalents and short-term investments of $164.4 million, compared to $106.5 million as of December 31, 2022.

MISTRAS Group to Participate in Sidoti Micro Cap Virtual Conference on November 15-16, 2023

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Wednesday, November 8, 2023
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The presentation will begin at 10:45 AM ET on November 16.

Key Points: 

Cabaletta Bio Receives FDA Clearance of CABA-201 IND Application for Treatment of Generalized Myasthenia Gravis

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Monday, November 6, 2023
GMG, Steroid, FDA, IND, Respiratory failure, Food, Enzyme inhibitor, Myositis, MG, Lupus, Autoantibody, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Protein, Disease, Clinical trial, Acetylcholine receptor, Risk, Neurology, Neuromuscular junction, Autoimmune disease, Scleroderma, NMJ, Patient, Investigational New Drug, Rheumatology, Fatigue, Pharmaceutical industry

PHILADELPHIA, Nov. 06, 2023 (GLOBE NEWSWIRE) -- Cabaletta Bio, Inc. (Nasdaq: CABA), a clinical-stage biotechnology company focused on developing and launching the first curative targeted cell therapies for patients with autoimmune diseases, today announced that the Company’s fourth Investigational New Drug (IND) application for CABA-201, a 4-1BB-containing fully human CD19-CAR T cell investigational therapy, has been allowed to proceed by the U.S. Food and Drug Administration (FDA) for a Phase 1/2 study in patients with generalized myasthenia gravis (gMG). The Company plans to initiate a Phase 1/2 clinical trial of CABA-201 across two parallel gMG cohorts based on autoantibody status – one cohort of six patients with acetylcholine receptor (AChR) antibody-positive gMG and a second cohort of six patients with AChR antibody-negative gMG. Consistent with the previously announced CABA-201 IND application clearances for lupus, myositis and systemic sclerosis, the starting dose for the Phase 1/2 trial evaluating CABA-201 in gMG will be 1 x 106 cells/kg.

Key Points: 
  • Consistent with the previously announced CABA-201 IND application clearances for lupus, myositis and systemic sclerosis, the starting dose for the Phase 1/2 trial evaluating CABA-201 in gMG will be 1 x 106 cells/kg.
  • The announcement of our fourth CABA-201 IND clearance is also our first IND clearance for the product candidate in a predominantly autoantibody mediated disease.
  • Generalized MG affects approximately 85% of the between 50,000 and 80,000 estimated MG patients in the United States.
  • Standard of care therapies include cholinesterase inhibitors, steroids, immunomodulators, and biologics, which often provide modest clinical effect and require chronic administration, increasing the risk of serious long-term side effects.

MISTRAS Provides Update on Project Phoenix

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Thursday, November 2, 2023
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PRINCETON JUNCTION, N.J., Nov. 02, 2023 (GLOBE NEWSWIRE) -- MISTRAS Group, Inc. (MG: NYSE), a leading "one source" multinational provider of integrated technology-enabled asset protection solutions, today provided an update on the status of Project Phoenix, the Company’s strategic program to increase Income from Operations through reductions in corporate administrative overhead and enhancements to pricing.

Key Points: 
  • PRINCETON JUNCTION, N.J., Nov. 02, 2023 (GLOBE NEWSWIRE) -- MISTRAS Group, Inc. (MG: NYSE), a leading "one source" multinational provider of integrated technology-enabled asset protection solutions, today provided an update on the status of Project Phoenix, the Company’s strategic program to increase Income from Operations through reductions in corporate administrative overhead and enhancements to pricing.
  • In February 2023, the Board of Directors announced that the Company engaged with Alix Partners to undertake an operational review designed to accelerate profitable growth by identifying meaningful margin improvement opportunities and steps to achieve sustained cost savings, referred to as Project Phoenix.
  • In addition, as part of this initiative a new commercial function was established, to drive top-line profitable revenue growth via strategic pricing and sales enablement.
  • Project Phoenix identified various opportunities, which the Company subsequently vetted through a comprehensive diligence process and has completed the validation of a majority of the initial Project Phoenix opportunities.

MISTRAS Announces Third Quarter 2023 Results

Retrieved on: 
Thursday, November 2, 2023
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PRINCETON JUNCTION, N.J., Nov. 02, 2023 (GLOBE NEWSWIRE) -- MISTRAS Group, Inc. (MG: NYSE), a leading "one source" multinational provider of integrated technology-enabled asset protection solutions, reported financial results for its third quarter and nine months ended September 30, 2023.

Key Points: 
  • Gross profit margin was up 210 basis points sequentially from the second quarter of 2023, driven by an improved revenue mix.
  • Selling, general and administrative expenses (“SG&A”) in the third quarter of 2023 were $39.5 million, down 3.0% compared to $40.8 million in the third quarter of 2022 and were also down 4.7% sequentially from the second quarter of 2023, as a result of the ongoing implementation of Project Phoenix.
  • Performance by certain segments during the third quarter was as follows:
    North America segment (Referred to as “Services” in prior filings) third quarter 2023 revenue was $148.8 million, down 2.6% from $152.8 million in the prior year quarter.
  • International segment third quarter 2023 revenue was $31.0 million, up 20.6% from $25.7 million in the prior year quarter inclusive of favorable foreign currency exchange.

MISTRAS Group Announces Conference Call to Discuss Third Quarter Results on November 3, 2023

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Friday, October 27, 2023
MG, NYSE, PIN

PRINCETON JUNCTION, N.J., Oct. 27, 2023 (GLOBE NEWSWIRE) -- MISTRAS Group, Inc. (MG: NYSE) has scheduled a conference call for Friday, November 3, 2023 at 9:00 am Eastern Time to discuss its results for the third quarter of 2023.

Key Points: 
  • PRINCETON JUNCTION, N.J., Oct. 27, 2023 (GLOBE NEWSWIRE) -- MISTRAS Group, Inc. (MG: NYSE) has scheduled a conference call for Friday, November 3, 2023 at 9:00 am Eastern Time to discuss its results for the third quarter of 2023.
  • A press release with the third quarter results will be issued after the close of market on Thursday, November 2, 2023.
  • To listen to the live webcast of the conference call, visit the Investor Relations section of MISTRAS Group’s website at www.mistrasgroup.com .
  • Following the conference call, an archived webcast of the call will be available for one year by visiting the Investor Relations section of MISTRAS Group’s website.

Alpine Immune Sciences Presents New Preclinical Data on Povetacicept in Myasthenia Gravis at the American Association of Neuromuscular & Electrodiagnostic Medicine 2023 Annual Meeting

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Friday, November 3, 2023
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Alpine Immune Sciences, Inc. (NASDAQ: ALPN), a leading clinical-stage immunotherapy company focused on developing innovative treatments for autoimmune and inflammatory diseases, announced the Company presented new preclinical data on povetacicept in myasthenia gravis at the American Association of Neuromuscular & Electrodiagnostic Medicine Annual Meeting (AANEM), November 1-3, 2023 in Phoenix, Arizona.

Key Points: 
  • Alpine Immune Sciences, Inc. (NASDAQ: ALPN), a leading clinical-stage immunotherapy company focused on developing innovative treatments for autoimmune and inflammatory diseases, announced the Company presented new preclinical data on povetacicept in myasthenia gravis at the American Association of Neuromuscular & Electrodiagnostic Medicine Annual Meeting (AANEM), November 1-3, 2023 in Phoenix, Arizona.
  • In addition, the Company presented safety, tolerability, pharmacokinetic, and pharmacodynamic data from RUBY-1, a phase 1 study of povetacicept in healthy adult volunteers.
  • In a model of murine experimental autoimmune myasthenia gravis (EAMG), povetacicept improved disease activity, with clinical scores superior to treatment with either the FcRn inhibitor efgartigimod or an anti-CD20 depleting antibody.
  • “These data indicate that povetacicept might deliver efficacy superior to some therapeutics currently in clinical use for myasthenia gravis and other autoantibody-related neurological diseases.

Molson Coors Beverage Company Reports 2023 Third Quarter Results

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Thursday, November 2, 2023
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Dollars, and all quarterly comparative results are for the Company’s third quarter ended September 30, 2023 compared to the third quarter ended September 30, 2022.

Key Points: 
  • Dollars, and all quarterly comparative results are for the Company’s third quarter ended September 30, 2023 compared to the third quarter ended September 30, 2022.
  • Molson Coors Beverage Company will conduct an earnings conference call with financial analysts and investors at 11:00 a.m. Eastern Time today to discuss the Company’s 2023 third quarter results.
  • For more than two centuries Molson Coors Beverage Company has been brewing beverages that unite people to celebrate all life’s moments.
  • To learn more about Molson Coors Beverage Company, visit molsoncoors.com , MolsonCoorsOurImprint.com or on X (formerly Twitter) through @MolsonCoors .

Globalstar Announces Third Quarter 2023 Results

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Thursday, November 2, 2023
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Globalstar, Inc. (NYSE American: GSAT) today announced its operating and financial results for the third quarter and year to date period ended September 30, 2023.

Key Points: 
  • Globalstar, Inc. (NYSE American: GSAT) today announced its operating and financial results for the third quarter and year to date period ended September 30, 2023.
  • Total revenue increased $20.1 million, or 53%, to $57.7 million during the third quarter of 2023 compared to the third quarter of 2022, due to higher service revenue.
  • Second quarter 2023 was the first full quarter of normal production of these devices, and we have seen a correlated increase in activations.
  • Subscriber equipment sales decreased $0.3 million or 7% in the third quarter of 2023 compared to the third quarter of 2022.

UCB announces U.S. FDA approval of ZILBRYSQ® (zilucoplan) for the treatment of adults with generalized myasthenia gravis

Retrieved on: 
Tuesday, October 17, 2023
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It is the only once-daily gMG target therapy for self-administration by adult patients with anti-AChR antibody-positive gMG.

Key Points: 
  • It is the only once-daily gMG target therapy for self-administration by adult patients with anti-AChR antibody-positive gMG.
  • Patients were randomized in a 1:1 ratio to receive daily subcutaneous injections of 0.3 mg/kg ZILBRYSQ or placebo for 12 weeks.
  • The most common adverse reactions (≥10%) in patients with gMG were injection site reactions, upper respiratory tract infection, and diarrhea.
  • The primary endpoint for the RAISE study was change from baseline to Week 12 in the Myasthenia Gravis-Activities of Daily Living (MG-ADL) score.