Tablet

Tonix Pharmaceuticals Reports Improvement in “Brain Fog,” in Fibromyalgia Patients Treated with Tonmya™ in RESILIENT, an NDA-Enabling Phase 3 Clinical Trial, at the 6th International Congress on Controversies in Fibromyalgia

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星期一, 三月 11, 2024

CHATHAM, N.J., March 11, 2024 (GLOBE NEWSWIRE) -- Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP) (Tonix or the Company), a biopharmaceutical company with marketed products and a pipeline of development candidates, today announced the presentation of additional efficacy data from RESILIENT, the second positive Phase 3 study evaluating Tonmya (also known as TNX-102 SL, cyclobenzaprine HCl sublingual tablets) for the management of fibromyalgia, at the 6th International Congress on Controversies in Fibromyalgia in Brussels, Belgium, March 7-8, 2024.

Key Points: 
  • We now report that the effect sizes of the five continuous key secondary outcomes measures ranged from 0.3 to 0.5.
  • The FIQ-R cognitive item showed nominal improvement in Tonmya-treated patients vs placebo-treated patients with a p=0.001 and effect size of 0.31.
  • RELIEF, the first Phase 3 trial of Tonmya 5.6 mg in fibromyalgia, was completed in December 2020.
  • We also believe the favorable tolerability and side effect profiles will be important to patients and doctors managing this debilitating condition on a long-term basis.”

Cherry Launches Disinfectable Mouse and Keyboard Set for Hygiene-Sensitive Areas at HIMSS

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星期一, 三月 11, 2024

The new hygiene desktop is ideal for extensive entry in hospitals, doctors' surgeries, laboratories, other healthcare facilities, where disinfecting devices is mandatory.

Key Points: 
  • The new hygiene desktop is ideal for extensive entry in hospitals, doctors' surgeries, laboratories, other healthcare facilities, where disinfecting devices is mandatory.
  • When cleaning standard office keyboards, (even when internally sealed) contaminated cleaning fluids can potentially leak out of the gaps.
  • It is also possible the functionality could be impaired if liquids seep into the keyboard housing.
  • The Hygiene Desktop 2 is an individually configurable set consisting of the AK-C8112 hygiene keyboard and the AK-PMH3 3-Button Scroll and AK-PMH3 Scroll Sensor hygienic mice.

Entera Bio Announces Full Year 2023 Financial Results and Provides Business Updates

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星期五, 三月 8, 2024

JERUSALEM, March 08, 2024 (GLOBE NEWSWIRE) -- Entera Bio Ltd. (NASDAQ: ENTX), (“Entera” or the “Company”) a leader in the development of orally delivered peptides, today reported financial results and key business updates for the fourth quarter and year ended December 31, 2023.

Key Points: 
  • JERUSALEM, March 08, 2024 (GLOBE NEWSWIRE) -- Entera Bio Ltd. (NASDAQ: ENTX), (“Entera” or the “Company”) a leader in the development of orally delivered peptides, today reported financial results and key business updates for the fourth quarter and year ended December 31, 2023.
  • Following our December 2023 financing, we expect to have sufficient cash to fund operations through the first half of 2025,” said Miranda Toledano, CEO of Entera.
  • Financial Results for the year Ended December 31, 2023
    As of December 31, 2023, Entera had cash and cash equivalents of $11.0 million.
  • Operating expenses for year ended December 31, 2023 were $8.9 million, as compared to $13.0 million for the year ended December 31, 2022.

Phathom Pharmaceuticals Reports Fourth Quarter and Full Year 2023 Financial Results and Provides Business Update

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星期四, 三月 7, 2024

Net loss: Net loss for the fourth quarter 2023 was $79.6 million, compared to $55.0 million for fourth quarter 2022.

Key Points: 
  • Net loss: Net loss for the fourth quarter 2023 was $79.6 million, compared to $55.0 million for fourth quarter 2022.
  • Fourth quarter 2023 net loss included a non-cash charge related to stock-based compensation of $24.6 million compared to $6.7 million for fourth quarter 2022.
  • Phathom will host a conference call and webcast to discuss its fourth quarter and full year 2023 financial results and business highlights today, March 7, 2024, at 8:30 a.m.
  • Phathom believes the presentation of these non-GAAP financial measures provides useful information to management and investors regarding Phathom's results of operations.

AB Science provides a summary of the live webcast held on March 4, 2024 giving an update on AB Science development

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星期四, 三月 7, 2024

SUMMARY OF THE WEBCAST HELD ON MARCH 4, 2024 PROVIDING AN UPDATE ON AB SCIENCE DEVELOPMENT

Key Points: 
  • SUMMARY OF THE WEBCAST HELD ON MARCH 4, 2024 PROVIDING AN UPDATE ON AB SCIENCE DEVELOPMENT
    AB Science SA (Euronext - FR0010557264 - AB) is providing a summary of the live webcast held on March 4, 2024, giving an update on AB Science development.
  • Regarding Health Canada, a Notice of Deficiency-Withdrawal (NOD/w) has been issued and AB Science intends to submit a Request for Reconsideration.
  • Based on the supporting arguments and counterarguments outlined above, AB Science intends to submit a Request for Reconsideration.
  • AB Science will be free to continue the development of masitinib in SCD based on phase 2 data with biomarkers.

Nexxen Reports Results for the Fourth Quarter and Year Ended December 31, 2023

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星期三, 三月 6, 2024

NEW YORK, March 06, 2024 (GLOBE NEWSWIRE) -- Nexxen International Ltd. (AIM/NASDAQ: NEXN) (“Nexxen” or the “Company”), a global, unified advertising technology platform with deep expertise in video and Connected TV (“CTV”), announced today its financial results for the fourth quarter and year ended December 31, 2023. The Company’s financial results for the fourth quarter and year ended December 31, 2023, as well as the fourth quarter ended December 31, 2022, reflect the combined financial performance of Nexxen and Amobee, while comparative figures for the year ended December 31, 2022 include Amobee contribution only from September 12, 2022 through December 31, 2022.

Key Points: 
  • The Company’s financial results for the fourth quarter and year ended December 31, 2023, as well as the fourth quarter ended December 31, 2022, reflect the combined financial performance of Nexxen and Amobee, while comparative figures for the year ended December 31, 2022 include Amobee contribution only from September 12, 2022 through December 31, 2022.
  • CTV Revenue: CTV revenue was $19.9 million in Q4 2023, compared to $33.0 million in Q4 2022.
  • CTV revenue was $85.5 million for the year ended December 31, 2023, reflecting a 12% decrease from $97.2 million for the year ended December 31, 2022.
  • The Company added 372 new supply partners during the twelve months ended December 31, 2023, including 327 in the U.S.

Tonix Pharmaceuticals Selects EVERSANA® to Support Launch Strategy and Commercialization Planning of Tonmya™ for the Management of Fibromyalgia

Retrieved on: 
星期三, 三月 6, 2024

CHATHAM, N.J., March 06, 2024 (GLOBE NEWSWIRE) -- Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP) (Tonix or the Company), a biopharmaceutical company with marketed products and a pipeline of development candidates, announced today that EVERSANA®, a leading provider of commercialization services to the global life sciences industry, has been selected to support the launch strategy and commercial planning of Tonmya (also known as TNX-102 SL, cyclobenzaprine HCl sublingual tablets) in the U.S. Specifically, EVERSANA will work with Tonix to assess the fibromyalgia landscape and help plan an efficient go-to-market strategy.

Key Points: 
  • Specifically, EVERSANA will work with Tonix to assess the fibromyalgia landscape and help plan an efficient go-to-market strategy.
  • “EVERSANA shares our commitment to delivering novel therapeutics to patients in need,” said Seth Lederman, M.D., Chief Executive Officer of Tonix Pharmaceuticals.
  • “We are excited to further refine our business strategy for the anticipated launch of Tonmya in 2025.
  • As previously announced, Tonix’s second positive Phase 3 study, RESILIENT, met its pre-specified primary endpoint, significantly reducing daily pain compared to placebo (p=0.00005) in participants with fibromyalgia.

Paratek Pharmaceuticals Announces Positive Efficacy Data for NUZYRA® as Post-Exposure Prophylaxis of Inhalational Anthrax, Triggering Additional Procurement under BARDA Project BioShield Contract

Retrieved on: 
星期二, 三月 5, 2024

Anthrax (B. anthracis) is an infectious disease caused by gram-positive, rod-shaped, spore-forming bacteria that can lead to severe illness and death.

Key Points: 
  • Anthrax (B. anthracis) is an infectious disease caused by gram-positive, rod-shaped, spore-forming bacteria that can lead to severe illness and death.
  • Oral NUZYRA tablets associated with this procurement were manufactured in the United States as part of the company’s U.S. onshoring efforts.
  • “This procurement also represents a significant milestone in the company’s onshoring efforts as for the first time Paratek is providing BARDA with NUZYRA tablets produced on U.S. soil.
  • In December 2019, BARDA awarded Paratek a contract (75A50120C00001) that is now valued at up to approximately $304 million.

Cassava Sciences Reports Full-year 2023 Financial Results and Corporate Updates

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星期三, 二月 28, 2024

AUSTIN, Texas, Feb. 28, 2024 (GLOBE NEWSWIRE) -- Cassava Sciences, Inc. (Nasdaq: SAVA), a biotechnology company focused on Alzheimer’s disease, today reported financial and operating results for the full year ended December 31, 2023 and presented corporate updates.

Key Points: 
  • AUSTIN, Texas, Feb. 28, 2024 (GLOBE NEWSWIRE) -- Cassava Sciences, Inc. (Nasdaq: SAVA), a biotechnology company focused on Alzheimer’s disease, today reported financial and operating results for the full year ended December 31, 2023 and presented corporate updates.
  • Net cash used in operations full-year 2023 was $82.0 million, consistent with previous guidance.
  • (This amount is not included in the above cash and cash equivalents at December 31, 2023.)
  • Recent corporate highlights include the following:
    In January 2024, we completed a dividend distribution of common stock warrants to shareholders.

Tonix Pharmaceuticals Announces Positive Results from Clinical Pharmacokinetic Bridging Study of Tonmya™ to Support Development and Partnering in Japan and China

Retrieved on: 
星期二, 二月 27, 2024

CHATHAM, N.J., Feb. 27, 2024 (GLOBE NEWSWIRE) -- Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP) (Tonix or the Company), a biopharmaceutical company with marketed products and a pipeline of development candidates, announced positive results from its clinical pharmacokinetic (PK) bridging study of Tonmya™ (also known as TNX-102 SL, cyclobenzaprine HCl sublingual tablets) in healthy adult male and female ethnic Japanese and Chinese volunteers. Results indicate that key pharmacokinetic parameters of cyclobenzaprine are comparable in ethnic Japanese and Chinese volunteers to Caucasian volunteers from a prior PK study. Tonmya was generally well tolerated in the ethnic Japanese and Chinese healthy volunteers. The company expects these data to fulfill the requirement for a bridging study, and to support regulatory filings for clinical studies in Japan and China where cyclobenzaprine is a new chemical entity (NCE). Tonix holds issued patents for market exclusivity rights of Tonmya in Japan, China, Hong Kong and Taiwan.

Key Points: 
  • Results indicate that key pharmacokinetic parameters of cyclobenzaprine are comparable in ethnic Japanese and Chinese volunteers to Caucasian volunteers from a prior PK study.
  • The company expects these data to fulfill the requirement for a bridging study, and to support regulatory filings for clinical studies in Japan and China where cyclobenzaprine is a new chemical entity (NCE).
  • Tonix holds issued patents for market exclusivity rights of Tonmya in Japan, China, Hong Kong and Taiwan.
  • “This bridging study is an important first step as we begin evaluating the potential for approval and marketing Tonmya in Japan and China.