Mycobacterium avium complex

Insmed Provides Business Update at 42nd Annual J.P. Morgan Healthcare Conference

Retrieved on: 
Friday, January 5, 2024

BRIDGEWATER, N.J., Jan. 5, 2024 /PRNewswire/ -- Insmed Incorporated (Nasdaq: INSM), a global biopharmaceutical company on a mission to transform the lives of patients with serious and rare diseases, today provided an update on the Company's four pillars and outlook for 2024. These updates will be discussed as part of the Company's presentation at the 42nd Annual J.P. Morgan Healthcare Conference in San Francisco on Monday, January 8, 2024, at 3:00 p.m. PT (6:00 p.m. ET).

Key Points: 
  • Insmed received encouraging written feedback from the U.S. Food and Drug Administration (FDA) on the patient-reported outcome data produced in the Phase 3 ARISE study in December 2023.
  • Presentation at the 42nd Annual J.P. Morgan Healthcare Conference
    Will Lewis, Chair and Chief Executive Officer of Insmed, will present at the 42nd Annual J.P. Morgan Healthcare Conference on Monday, January 8, 2024, at 3:00 p.m. PT (6:00 p.m.
  • A live audio webcast of the presentation will be available on the Investor Relations section of the Company's website at www.insmed.com .
  • A replay will also be archived for a period of 30 days following the conclusion of the live event.

Spero Therapeutics Provides Corporate Update and 2024 Outlook

Retrieved on: 
Friday, January 5, 2024

CAMBRIDGE, Mass., Jan. 05, 2024 (GLOBE NEWSWIRE) -- Spero Therapeutics, Inc. (Nasdaq: SPRO), a multi-asset, clinical-stage, biopharmaceutical company, focused on identifying and developing novel therapies for rare diseases and multi-drug resistant (MDR) bacterial infections with high unmet need, today provided a corporate update highlighting its recent accomplishments and anticipated milestones for 2024.

Key Points: 
  • Entitled to receive $95 million in development milestones, payable over two years, as part of the GSK license agreement
    CAMBRIDGE, Mass., Jan. 05, 2024 (GLOBE NEWSWIRE) -- Spero Therapeutics, Inc. (Nasdaq: SPRO), a multi-asset, clinical-stage, biopharmaceutical company, focused on identifying and developing novel therapies for rare diseases and multi-drug resistant (MDR) bacterial infections with high unmet need, today provided a corporate update highlighting its recent accomplishments and anticipated milestones for 2024.
  • “We look forward to another productive year for Spero in 2024, having achieved important clinical and regulatory milestones over the past twelve months,” said Sath Shukla, President, and CEO of Spero Therapeutics.
  • Our Phase 2a trial of SPR720 in nontuberculous mycobacterial pulmonary disease is on track, and we look forward to reporting topline data, which is expected in the second half of 2024.
  • The trial is expected to enroll up to 35 treatment-naïve or treatment-experienced non-refractory participants with NTM-PD, due to Mycobacterium avium complex.

European Medicines Agency COMP Recommends Positive Opinion on Orphan Medicinal Product Designation for NUZYRA® (omadacycline) for Treatment of Nontuberculous Mycobacterial (NTM) Lung Disease

Retrieved on: 
Tuesday, June 27, 2023

NTM is an orphan disease with limited approved therapies. Paratek’s scientific program exploring NUZYRA’s potential in the treatment of NTM includes an ongoing U.S. Phase 2b study -- the first randomized, placebo-controlled Phase 2b study of its kind -- in patients with NTM pulmonary disease caused by M. abscessus, as well as other studies ranging from in vitro to real-world evidence.

Key Points: 
  • The COMP opinion applies to all species of NTM, including Mycobacterium abscessus (MAB) and Mycobacterium avium complex (MAC).
  • Orphan designation in the European Union (EU) is granted by the European Commission within 30 days of a positive opinion being issued by the COMP.
  • Today’s standard of care for NTM typically involves a combination of multiple antibiotics, many of which are not approved for this disease.
  • Paratek is currently in discussions with potential partners to develop and commercialize NUZYRA in Japan and in Europe as a potential treatment for NTM.

Global Infectious Diseases Partnering Deal Trends, Players and Financials Analysis Report 2015-2022 - ResearchAndMarkets.com

Retrieved on: 
Tuesday, October 25, 2022

The "Global Infectious Diseases Partnering 2015-2022: Deal trends, players and financials" report has been added to ResearchAndMarkets.com's offering.

Key Points: 
  • The "Global Infectious Diseases Partnering 2015-2022: Deal trends, players and financials" report has been added to ResearchAndMarkets.com's offering.
  • The Global Infectious Diseases Partnering 2015-2022 report provides comprehensive access to available deals and contract documents for over 2,900 infectious diseases deals.
  • The report takes readers through the comprehensive Infectious Diseases disease deal trends, key players and top deal values allowing the understanding of how, why and under what terms companies are currently entering Infectious Diseases deals.
  • Chapter 6 provides a comprehensive directory of all Infectious Diseases partnering deals by specific Infectious Diseases target announced since 2015.

AN2 Therapeutics to Present New Epetraborole Data at IDWeek 2022

Retrieved on: 
Wednesday, October 19, 2022

MENLO PARK, Calif., Oct. 19, 2022 (GLOBE NEWSWIRE) -- AN2 Therapeutics, Inc. (Nasdaq: ANTX), a clinical-stage biopharmaceutical company focused on developing treatments for rare, chronic, and serious infectious diseases with high unmet needs, today announced one oral presentation and nine data poster presentations at the Infectious Disease Society of American (IDSA) IDWeek 2022 Conference from October 19-24, 2022 in Washington D.C. highlighting new data for epetraborole.

Key Points: 
  • MENLO PARK, Calif., Oct. 19, 2022 (GLOBE NEWSWIRE) -- AN2 Therapeutics, Inc. (Nasdaq: ANTX), a clinical-stage biopharmaceutical company focused on developing treatments for rare, chronic, and serious infectious diseases with high unmet needs, today announced one oral presentation and nine data poster presentations at the Infectious Disease Society of American (IDSA) IDWeek 2022 Conference from October 19-24, 2022 in Washington D.C. highlighting new data for epetraborole.
  • AN2 Therapeutics is currently enrolling patients in its pivotal Phase 2/3 clinical trial evaluating once-daily, oral epetraborole for treatment-refractory Mycobacterium avium complex (MAC) lung disease, the most common form of nontuberculous mycobacterial (NTM) lung disease.
  • Our lead candidate is epetraborole, which we are studying in a pivotal Phase 2/3 trial as a once-daily, oral treatment with a novel mechanism of action for patients with NTM lung disease, a rare, chronic, and progressive infectious disease caused by bacteria, known as mycobacteria, that leads to irreversible lung damage and can be fatal.
  • For more information, please visit our website at www.an2therapeutics.com.

NIH Awards Contract to AN2 Therapeutics Valued Up to $17.8 Million

Retrieved on: 
Thursday, September 29, 2022

AN2 Therapeutics is currently developing epetraborole in an ongoing pivotal Phase 2/3 trial for treatment refractory Mycobacterium avium complex (MAC) lung disease, the most common form of nontuberculous mycobacterial (NTM) lung disease.

Key Points: 
  • AN2 Therapeutics is currently developing epetraborole in an ongoing pivotal Phase 2/3 trial for treatment refractory Mycobacterium avium complex (MAC) lung disease, the most common form of nontuberculous mycobacterial (NTM) lung disease.
  • Epetraborole has shown significant promise in non-clinical models of infection for melioidosis and could have the potential to reduce mortality in patients suffering from the disease.
  • We are pleased to partner with the NIH on this meaningful global health work that is core to our corporate mission and values.
  • AN2 Therapeutics, Inc. is a clinical-stage biopharmaceutical company developing treatments for rare, chronic, and serious infectious diseases with high unmet needs.

Paratek Pharmaceuticals Announces Second Quarter 2022 Revenue of $29.6 Million

Retrieved on: 
Wednesday, August 3, 2022

BOSTON, Aug. 03, 2022 (GLOBE NEWSWIRE) --  Paratek Pharmaceuticals, Inc. (Nasdaq: PRTK), today reported financial results and provided an update on corporate activities for the quarter ended June 30, 2022.

Key Points: 
  • Sales of $25.1 Million from the Core Commercial Business, a 68% increase over Second Quarter 2021
    BOSTON, Aug. 03, 2022 (GLOBE NEWSWIRE) -- Paratek Pharmaceuticals, Inc. (Nasdaq: PRTK), today reported financial results and provided an update on corporate activities for the quarter ended June30, 2022.
  • Total revenue for the second quarter of 2022 was $29.6 million compared to $19.6 million for the same period in the prior year when excluding the first procurement of NUZYRA under the BARDA contract of $37.9 million.
  • Revenue earned in the second quarter of 2022 was comprised of $25.1 million in net U.S. sales from the NUZYRA core commercial business, a 68% increase from $14.9 million for the same period in the prior year, $4.0 million in revenue earned under the BARDA contract, and $0.6 million in royalty revenue.
  • Research and development (R&D) expenses were $7.6 million for the second quarter of 2022, compared to $6.5 million for the same period in the prior year.

Paratek Pharmaceuticals’ NUZYRA® Receives FDA Fast Track Designation for the Treatment of Pulmonary Nontuberculous Mycobacterial (NTM) Disease Caused by Mycobacterium Avium Complex (MAC) and Mycobacterium Abscessus (MAB)

Retrieved on: 
Tuesday, June 21, 2022

BOSTON, June 21, 2022 (GLOBE NEWSWIRE) -- Paratek Pharmaceuticals, Inc. (Nasdaq: PRTK) today announced the U.S. Food and Drug Administration has granted Fast Track designation for the oral and IV formulations of the company’s novel, broad-spectrum antibiotic NUZYRA® (omadacycline) for the treatment of pulmonary Nontuberculous Mycobacterial (NTM) disease caused by both Mycobacterium avium complex (MAC) and Mycobacterium abscessus (MAB). These NTM indications are rare diseases for which new therapies are desperately needed. FDA granted NUZYRA orphan drug designation for these infections in August 2021.

Key Points: 
  • FDA granted NUZYRA orphan drug designation for these infections in August 2021.
  • In the United States alone, currently NTM pulmonary infections caused by MAB affect approximately 11,500 patients while an estimated 100,000 cases are caused by MAC.
  • Treatment can often be life-long in duration and complicated by long-term tolerability challenges and multiple adverse events.
  • As noted above, Paratek is conducting a Phase 2b study with NUZYRA in a rare disease, non-tuberculous mycobacterial (NTM) pulmonary disease caused by MAB.

Beyond Air® Presents Positive Study Update from the At-Home LungFit® GO Pilot Study for Nontuberculous Mycobacterial Lung Disease at the American Thoracic Society International Conference 2022

Retrieved on: 
Tuesday, May 17, 2022

GARDEN CITY, N.Y., May 17, 2022 (GLOBE NEWSWIRE) -- Beyond Air, Inc. (NASDAQ: XAIR), a clinical-stage medical device and biopharmaceutical company focused on developing inhaled nitric oxide (NO) for the treatment of patients with respiratory conditions, including serious lung infections and pulmonary hypertension and, through its affiliate Beyond Cancer, ultra-high concentration nitric oxide (UNO) for the treatment of solid tumors, today announced positive new interim data from the ongoing LungFit® GO pilot at-home study in Australia.

Key Points: 
  • The run-in period provides a baseline for the efficacy endpoints, such as patient physical function and bacterial load.
  • During this first treatment phase subjects receive NO for 40 minutes, four times per day while methemoglobin and nitrogen dioxide (NO2) levels are monitored.
  • For the second treatment phase, a 10-week maintenance phase, the inhalation treatments are administered twice daily at the same NO level.
  • The study evaluates safety, tolerability, quality of life, physical function, and bacterial load among other parameters, as compared to baseline measurements.

AN2 Therapeutics Reports First Quarter 2022 Financial Results and Provides Business Updates

Retrieved on: 
Tuesday, May 10, 2022

First Quarter & Recent Business Updates:

Key Points: 
  • First Quarter & Recent Business Updates:
    Raised Total of $79.4 Million Through Upsized Initial Public Offering.
  • During the quarter, AN2 Therapeutics appointed Dr. Mel Spigelman to its Board of Directors.
  • Topline results for the ongoing Phase 1 study evaluating epetraborole in renally impaired subjects is expected in the second half of 2022.
  • AN2 Therapeutics, Inc. is a clinical-stage biopharmaceutical company developing treatments for rare, chronic, and serious infectious diseases with high unmet needs.