MK2

Aclaris Therapeutics Announces Preliminary Topline Data from 12-Week Phase 2a Study of Oral Zunsemetinib (ATI-450) for Moderate to Severe Hidradenitis Suppurativa

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星期一, 三月 6, 2023

WAYNE, Pa., March 06, 2023 (GLOBE NEWSWIRE) -- Aclaris Therapeutics, Inc. (NASDAQ: ACRS), a clinical-stage biopharmaceutical company focused on developing novel drug candidates for immuno-inflammatory diseases, today announced preliminary topline results from a 12-week, Phase 2a, multicenter, randomized, placebo-controlled clinical study to investigate the efficacy, safety, tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) of zunsemetinib (ATI-450), an investigational oral MK2 inhibitor, in patients with moderate to severe hidradenitis suppurativa (HS) (ATI-450-HS-201).

Key Points: 
  • The study did not meet its primary endpoint of change from baseline in inflammatory nodule/abscess count (AN) of zunsemetinib 50mg BID versus placebo at week 12.
  • The study also did not meet the secondary efficacy endpoints assessed in the topline data, including percentage of patients achieving HiSCR-50.
  • The placebo effect observed across all efficacy endpoints was higher than what has been observed in other published HS studies reported to date.
  • Thirty-seven patients discontinued study treatment (22 on zunsemetinib and 15 on placebo), with 15 patients discontinuing treatment due to AEs (11 on zunsemetinib and 4 on placebo).

Elbit Systems Awarded a $120 Million Follow-on Contract to Supply Unmanned Turrets, Weapon Stations and Mortar Systems to the Romanian Armed Forces

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星期四, 三月 2, 2023

Under the follow-on contract, Elbit Systems will supply UT30 MK2 turrets, RCWS and the SPEAR mortar systems, all fully integrated onboard the GDELS' 'Piranha V' APC.

Key Points: 
  • Under the follow-on contract, Elbit Systems will supply UT30 MK2 turrets, RCWS and the SPEAR mortar systems, all fully integrated onboard the GDELS' 'Piranha V' APC.
  • Elbit Systems' UT30 MK2 is a 30mm unmanned light turret that integrates weapon systems, fire control systems, sensors and display systems for enhanced combat effectiveness, situational awareness and target acquisition capabilities.
  • In addition to Romania, Elbit Systems' turrets, RCWS and mortar systems have been selected to date by dozens of customers across the world including Israel, U.S.A, Denmark, Austria, Belgium, Brazil, and Croatia.
  • Bezhalel (Butzi) Machlis, Elbit Systems President & CEO: "This follow-on contract award is yet another vote of confidence in Elbit Systems' portfolio of solutions for armoured platforms.

Aclaris Therapeutics Reports Fourth Quarter and Full Year 2022 Financial Results and Provides a Corporate Update

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星期四, 二月 23, 2023

Aclaris initiated a Phase 1 MAD (multiple ascending dose) trial of ATI-2138 in healthy volunteers in December of 2022.

Key Points: 
  • Aclaris initiated a Phase 1 MAD (multiple ascending dose) trial of ATI-2138 in healthy volunteers in December of 2022.
  • Aggregate cash, cash equivalents and marketable securities as of December 31, 2022 included proceeds received during the fourth quarter under a license agreement with Pediatrix Therapeutics, Inc. (Pediatrix).
  • Net loss was $27.6 million for the fourth quarter of 2022 compared to $22.8 million for the fourth quarter of 2021.
  • Total revenue was $7.8 million for the fourth quarter of 2022 compared to $1.5 million for the fourth quarter of 2021.

EQS-News: Mynaric delivers CONDOR Mk2 terminals to Telesat Government Solutions for DARPA’s Blackjack program

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星期一, 二月 13, 2023

LOS ANGELES and MUNICH, February 8, 2023 – Mynaric (NASDAQ: MYNA) (FRA: M0YN), a leading provider of industrialized, cost-effective, and scalable laser communications products, today announced the delivery of multiple CONDOR Mk2 optical communications terminals to Telesat Government Solutions (GS), a wholly-owned U.S.-based subsidiary of leading satellite operator Telesat (NASDAQ and TSX: TSAT).

Key Points: 
  • LOS ANGELES and MUNICH, February 8, 2023 – Mynaric (NASDAQ: MYNA) (FRA: M0YN), a leading provider of industrialized, cost-effective, and scalable laser communications products, today announced the delivery of multiple CONDOR Mk2 optical communications terminals to Telesat Government Solutions (GS), a wholly-owned U.S.-based subsidiary of leading satellite operator Telesat (NASDAQ and TSX: TSAT).
  • Mynaric’s first delivery of flight-ready CONDOR optical communications terminals for space applications marks an important milestone towards the product family’s space flight heritage.
  • In Q4 2020, Mynaric was selected by Telesat GS to supply optical communications terminals to the Blackjack satellite program which were now delivered.
  • The delivery of flight-ready CONDOR Mk2 units to Telesat GS follows shortly after Mynaric’s delivery of HAWK units to an energy customer in Q4 2022.

Aclaris Therapeutics Provides 2023 Outlook

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星期五, 一月 6, 2023

WAYNE, Pa., Jan. 06, 2023 (GLOBE NEWSWIRE) -- Aclaris Therapeutics, Inc. (NASDAQ: ACRS), a clinical-stage biopharmaceutical company focused on developing novel drug candidates for immuno-inflammatory diseases, today is providing a corporate outlook for 2023.

Key Points: 
  • WAYNE, Pa., Jan. 06, 2023 (GLOBE NEWSWIRE) -- Aclaris Therapeutics, Inc. (NASDAQ: ACRS), a clinical-stage biopharmaceutical company focused on developing novel drug candidates for immuno-inflammatory diseases, today is providing a corporate outlook for 2023.
  • “2023 is setting up to be an incredibly exciting year for Aclaris with several important expected data read-outs for our two lead clinical programs, zunsemetinib (ATI-450) and ATI-1777,” stated Douglas Manion, M.D., Aclaris’ Chief Executive Officer and President.
  • Aclaris expects topline data in the second half of 2023.
  • A copy of Aclaris’ corporate presentation will be posted to the Investor’s page of the Aclaris corporate website prior to the event.

Aclaris Therapeutics Reports Third Quarter 2022 Financial Results and Provides a Corporate Update

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星期二, 十一月 8, 2022

WAYNE, Pa., Nov. 08, 2022 (GLOBE NEWSWIRE) -- Aclaris Therapeutics, Inc. (NASDAQ: ACRS), a clinical-stage biopharmaceutical company focused on developing novel drug candidates for immuno-inflammatory diseases, today announced its financial results for the third quarter of 2022 and provided a corporate update.

Key Points: 
  • If allowed, Aclaris intends to initiate a Phase 1 MAD trial of ATI-2138 in healthy subjects by the end of 2022.
  • Net loss was $20.0 million for the third quarter of 2022 compared to $21.1 million for the third quarter of 2021.
  • Total revenue was $19.0 million for the third quarter of 2022 compared to $1.7 million for the third quarter of 2021.
  • These statements involve risks and uncertainties that could cause actual results to differ materially from those reflected in such statements.

SKY-HERO and AARDVARK Tactical Announce World's First NDAA-Compliant Interior sUAS Platform

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星期四, 十月 27, 2022

LA VERNE, Calif., Oct. 27, 2022 (GLOBE NEWSWIRE) -- AARDVARK Tactical and Sky-Hero are pleased to announce the release of the world's first National Defense Authorization Act (NDAA)-compliant interior use tactical sUAS, LOKI Mk2US.

Key Points: 
  • LA VERNE, Calif., Oct. 27, 2022 (GLOBE NEWSWIRE) -- AARDVARK Tactical and Sky-Hero are pleased to announce the release of the world's first National Defense Authorization Act (NDAA)-compliant interior use tactical sUAS, LOKI Mk2US.
  • In response, Sky-Hero, the world's leading manufacturer of interior tactical robotics, redesigned and resourced the LOKI Mk2 to eliminate all of the covered Chinese components and replace them with European or American items.
  • About AARDVARK: Founded in 1987, AARDVARK is a leading manufacturer, distributor, and system integrator of products to protect tactical operators from Local, State, Federal, and Military Units.
  • About LOKI-Mk2 - LOKI Mk2 is a rugged, purpose-built sUAS intended to act as a scout for close-quarter, confined space, and indoor missions.

SKY-HERO and AARDVARK Announce World's First NDAA-Compliant Interior sUAS Platform

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星期三, 十月 26, 2022

LA VERNE, Calif., Oct. 26, 2022 (GLOBE NEWSWIRE) -- AARDVARK and Sky-Hero are pleased to announce the release of the world's first National Defense Authorization Act (NDAA)-compliant interior use tactical sUAS, LOKI Mk2US.

Key Points: 
  • LA VERNE, Calif., Oct. 26, 2022 (GLOBE NEWSWIRE) -- AARDVARK and Sky-Hero are pleased to announce the release of the world's first National Defense Authorization Act (NDAA)-compliant interior use tactical sUAS, LOKI Mk2US.
  • After two years of work, we are pleased to announce that we have reengineered and redesigned these components and located American or European sources for them."
  • About AARDVARK: Founded in 1987, AARDVARK is a leading manufacturer, distributor, and system integrator of products to protect tactical operators from Local, State, Federal, and Military Units.
  • About LOKI-Mk2 - LOKI Mk2 is a rugged, purpose-built sUAS intended to act as a scout for close-quarter, confined space, and indoor missions.

Aclaris Therapeutics Reports Second Quarter 2022 Financial Results and Provides a Corporate Update

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星期三, 八月 3, 2022

WAYNE, Pa., Aug. 03, 2022 (GLOBE NEWSWIRE) -- Aclaris Therapeutics, Inc. (NASDAQ: ACRS), a clinical-stage biopharmaceutical company focused on developing novel drug candidates for immuno-inflammatory diseases, today announced its financial results for the second quarter of 2022 and provided a corporate update.

Key Points: 
  • WAYNE, Pa., Aug. 03, 2022 (GLOBE NEWSWIRE) -- Aclaris Therapeutics, Inc. (NASDAQ: ACRS), a clinical-stage biopharmaceutical company focused on developing novel drug candidates for immuno-inflammatory diseases, today announced its financial results for the second quarter of 2022 and provided a corporate update.
  • During the second quarter we also were able to raise additional capital, which extended our expected cash runway to the end of 2025.
  • Net loss was $20.5 million for the second quarter of 2022 compared to $18.2 million for the second quarter of 2021.
  • Total revenue was $1.5 million for the second quarter of 2022 compared to $1.8 million for the second quarter of 2021.

Aclaris Therapeutics Reports First Quarter 2022 Financial Results and Provides a Corporate Update

Retrieved on: 
星期二, 五月 10, 2022

WAYNE, Pa., May 10, 2022 (GLOBE NEWSWIRE) -- Aclaris Therapeutics, Inc. (NASDAQ: ACRS), a clinical-stage biopharmaceutical company focused on developing novel drug candidates for immuno-inflammatory diseases, today announced its financial results for the first quarter of 2022 and provided a corporate update.

Key Points: 
  • WAYNE, Pa., May 10, 2022 (GLOBE NEWSWIRE) -- Aclaris Therapeutics, Inc. (NASDAQ: ACRS), a clinical-stage biopharmaceutical company focused on developing novel drug candidates for immuno-inflammatory diseases, today announced its financial results for the first quarter of 2022 and provided a corporate update.
  • Additionally, in April 2022, Aclaris sold approximately 4.8 million shares under its ATM facility for aggregate net proceeds of $73 million.
  • Net loss was $18.8 million for the first quarter of 2022 compared to $28.8 million for the first quarter of 2021.
  • Total revenue was $1.5 million for the first quarter of 2022 compared to $1.8 million for the first quarter of 2021.