Achilles

Prokarium Achieves Major Milestone with FDA's IND Approval for Bladder Cancer Program

Retrieved on: 
Thursday, November 2, 2023
Oncology, FDA, Health, Clinical Trials, Pharmaceutical, Biotechnology, Vanderbilt-Ingram Cancer Center, Achilles, IND, Food, Evotec, MD, Bladder cancer, GSK plc, Doctor of Philosophy, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Albright, Doctor of Pharmacy, Recurrence, Immunotherapy, Therapy, BCG, Synthetic biology, Patient, Cancer, Investigational New Drug, Pharmaceutical industry

Prokarium, a biopharmaceutical company at the forefront of applying synthetic biology to create novel cancer treatments, today announces that the U.S. Food and Drug Administration (FDA) has granted the company's Investigational New Drug (IND) application for their immunotherapy ZH9.

Key Points: 
  • Prokarium, a biopharmaceutical company at the forefront of applying synthetic biology to create novel cancer treatments, today announces that the U.S. Food and Drug Administration (FDA) has granted the company's Investigational New Drug (IND) application for their immunotherapy ZH9.
  • The approval enables initiation of the clinical development program for ZH9 in the U.S., focusing on patients with non-muscle invasive bladder cancer.
  • "The FDA’s approval of our IND application is an important milestone and a clear recognition of the preclinical data already generated for ZH9,” stated Prokarium’s CEO, Kristen Albright, PharmD.
  • Dara brings over two decades of experience in biotech and large pharma.

Positive results from first-in-human completely leadless CRT in the US, published in The Journal of the American College of Cardiology

Retrieved on: 
Wednesday, October 25, 2023
NYHA, American College, Food, CRT, LVEF, Cardiac resynchronization therapy, Heel, McCutcheon, ASX, Achilles, Institutional review board, Coronary sinus, Wise, Journal, Cardiology, Patient, Food and Drug Administration, Heart failure, MD, Nissan Micra, JACC, Research, Growth, QRS, FDA, IRB, Cardiac electrophysiology, Journal of the American College of Cardiology, EBR, Medtronic, Failure, Medical device, Television, Pharmaceutical industry

The positive results published in JACC are based on a 1-year follow-up of the first-in-human implantation in the US of totally leadless CRT pacing utilizing the Micra™ leadless pacing system in the right ventricle in conjunction with EBR's investigational WiSE® CRT Electrode in the left ventricle of the heart.

Key Points: 
  • The positive results published in JACC are based on a 1-year follow-up of the first-in-human implantation in the US of totally leadless CRT pacing utilizing the Micra™ leadless pacing system in the right ventricle in conjunction with EBR's investigational WiSE® CRT Electrode in the left ventricle of the heart.
  • This first use in the US of the WiSE CRT System as a first-line therapy is a future market expansion opportunity for EBR.
  • "It's great to see these positive results being published in a world-leading cardiology journal, such as The Journal of the American College of Cardiology," said John McCutcheon, President & CEO of EBR Systems.
  • "This case study highlights the potential of totally leadless CRT for patients struggling with traditional CRT, but also beyond these patient groups, the 64 million heart failure patients across the globe."

Learn Wall Street Teaches Teenagers the Power of Investing

Retrieved on: 
Tuesday, October 3, 2023
Boot camp (correctional), Heel, Risk, Life, Time value of money, Curriculum, Wall Street, History, The Da Vinci Code, Reward, Cost of capital, Student, Cognitive development, Achilles, Knowledge, General Motors, Tutoring, Nursing, Auction

NEW YORK, Oct. 2, 2023 /PRNewswire/ -- Learn Wall Street, a new after-school program that teaches teenagers about finance and investing, launched its first semester in September.

Key Points: 
  • NEW YORK, Oct. 2, 2023 /PRNewswire/ -- Learn Wall Street, a new after-school program that teaches teenagers about finance and investing, launched its first semester in September.
  • "Financial knowledge is somewhat unique in comparison to other subjects like math or history," says Raji Khabbaz, co-founder of Learn Wall Street.
  • Learn Wall Street trying to make finance and investing interesting in the same way.
  • Learn Wall Street is open to teenagers in grades 9-12.

Achilles Therapeutics Receives Nasdaq Deficiency Notice Regarding Minimum Bid Price Requirement

Retrieved on: 
Friday, September 22, 2023
ADS, Calendar, ACHL, Notice, Achilles, Auction

LONDON, Sept. 22, 2023 (GLOBE NEWSWIRE) -- Achilles Therapeutics plc (NASDAQ: ACHL), a clinical-stage biopharmaceutical company developing AI-powered precision T cell therapies targeting clonal neoantigens to treat solid tumors, today disclosed that the Company received notice on September 20, 2023 from the Nasdaq Stock Market LLC (“Nasdaq”) that the Company is not currently in compliance with the $1.00 minimum bid price requirement for continued listing of the Company’s American Depositary Shares (the “ADS”) on the Nasdaq Global Select Market, as set forth in Nasdaq Listing Rule 5450(a)(1) (the “Minimum Bid Price Requirement”).

Key Points: 
  • LONDON, Sept. 22, 2023 (GLOBE NEWSWIRE) -- Achilles Therapeutics plc (NASDAQ: ACHL), a clinical-stage biopharmaceutical company developing AI-powered precision T cell therapies targeting clonal neoantigens to treat solid tumors, today disclosed that the Company received notice on September 20, 2023 from the Nasdaq Stock Market LLC (“Nasdaq”) that the Company is not currently in compliance with the $1.00 minimum bid price requirement for continued listing of the Company’s American Depositary Shares (the “ADS”) on the Nasdaq Global Select Market, as set forth in Nasdaq Listing Rule 5450(a)(1) (the “Minimum Bid Price Requirement”).
  • The Notice indicated that, consistent with Nasdaq Listing Rule 5810(c)(3)(A), the Company has 180 days, or until March 18, 2024 (the “Compliance Deadline”), to regain compliance with the Minimum Bid Price Requirement by having the closing bid price of the Company’s ADSs meet or exceed $1.00 per ADS for at least ten consecutive business days.
  • The Nasdaq deficiency letter has no immediate effect on the listing of the Company’s ADSs, and its ADSs will continue to trade on The Nasdaq Global Select Market under the symbol “ACHL” at this time.
  • The Company intends to monitor the closing bid price of its ADSs and may, if appropriate, consider implementing available options to regain compliance with the Minimum Bid Price Requirement.

Forethought Introduces Autoflows, Ushers in AI-First Customer Support

Retrieved on: 
Thursday, September 21, 2023
Professional Services, Data Management, Technology, Data Analytics, Software, Artificial Intelligence, Autoflowering cannabis, Synthetic media, Upwork, Heel, AI, Intelligence, Customer support, GM, Achilles, Tree (graph theory), Automation, CRM, Sales, Planning

Forethought , the leading generative AI for customer support, today announced Autoflows – autonomous resolution capabilities for SupportGPT.

Key Points: 
  • Forethought , the leading generative AI for customer support, today announced Autoflows – autonomous resolution capabilities for SupportGPT.
  • Generative AI has promised to radically transform the customer support experience.
  • Autoflows will enable support teams to build autonomous agents that deliver the best customer experience, at scale.
  • “We’re always looking to bring new generative AI capabilities into our customer support processes – not only to provide a better customer experience but also to maximize internal efficiency,” said Brent Pliskow, GM & VP of Customer Support at Upwork.

Pathways to Progress: How Orphan Drug Designation Sparks Biotech Transformation

Retrieved on: 
Wednesday, September 20, 2023
Atezolizumab, Diabetes, Neoplasm, Doctor of Philosophy, ODA, National library, Patient, GC, Disease, Prostate cancer, Carcinoma, CD47, Hope, Research, ACHL, Lung cancer, NLM, Orphan drug, Death, Drug development, Diagnosis, Growth, Rare, FDA, Legislation, Civil service commission, ODD, Roche, Orphan Drug Act of 1983, PharmaMar, Cancer, NSCLC, Treatment of lung cancer, ES, Therapy, Stomach, ORR, European Commission, File, United States National Library of Medicine, MedImmune, Inc. v. Genentech, Inc., Clinical trial, Woman, Lung, Fast track (FDA), SCLC, American Cancer Society, Achilles, Melanoma, OTCQX, Orphan, EC, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, FTD, RET, Food, Breast cancer, Pharmaceutical industry, Medical imaging, Genentech, Pembrolizumab

NEW YORK, Sept. 20, 2023 /PRNewswire/ -- More than 30 million people in the United States suffer with a rare disease; most of them are receiving no current treatment. Supporting the development and evaluation of new treatments, particularly for rare diseases, is a key priority for the U.S. Food & Drug Administration. As part of that process, the agency can grant Orphan Drug Designation (ODD) to a drug or biological product being developed to prevent, diagnose or treat a rare disease or condition. This designation is intended to spark innovation among biotech companies that are developing treatments for these patient populations, which by definition affect fewer than 200,000 people in the U.S., by providing incentives such as tax credits, user-fee exemptions and up to seven years of market exclusivity after FDA approval. Last month, Genprex Inc. (NASDAQ: GNPX) (Profile) was granted FDA orphan drug designation for its REQORSA(R) immunogene therapy in development for the treatment of small cell lung cancer (SCLC). The Phase 1/2 clinical trial, expected to dose the first patient in the fourth quarter of 2023, uses a combination of REQORSA and Genentech Inc.'s Tecentriq(R) as maintenance therapy in patients with extensive stage small cell lung cancer ("ES-SCLC") who did not develop tumor progression after receiving Tecentriq and chemotherapy as initial standard treatment. Genprex joins other companies — including Roche Holding AG ADR (OTCQX: RHHBY), Jazz Pharmaceuticals PLC (NASDAQ: JAZZ), ALX Oncology Holdings Inc. (NASDAQ: ALXO) and Achilles Therapeutics PLC (NASDAQ: ACHL) — that have been granted ODD status or may seek ODD status as they work to develop treatments for rare diseases.

Key Points: 
  • Four decades after the Orphan Drug Act was passed, hundreds of 'orphan' drugs have been approved for use.
  • Genprex's REQORSA Immunogene Therapy has gained both Orphan Drug Designation and Fast Track Designation.
  • Specifically, the report noted that 6,340 orphan drug designations were granted, representing drug development for 1,079 rare diseases.
  • For companies looking to help those in the underserved rare-disease space, an Orphan Drug Designation is the ideal pathway to progress.

Pathways to Progress: How Orphan Drug Designation Sparks Biotech Transformation

Retrieved on: 
Wednesday, September 20, 2023
Atezolizumab, Diabetes, Neoplasm, Doctor of Philosophy, ODA, National library, Patient, GC, Disease, Prostate cancer, Carcinoma, CD47, Hope, Research, ACHL, Lung cancer, NLM, Orphan drug, Death, Drug development, Diagnosis, Growth, Rare, FDA, Legislation, Civil service commission, ODD, Roche, Orphan Drug Act of 1983, PharmaMar, Cancer, NSCLC, Treatment of lung cancer, ES, Therapy, Stomach, ORR, European Commission, File, United States National Library of Medicine, MedImmune, Inc. v. Genentech, Inc., Clinical trial, Woman, Lung, Fast track (FDA), SCLC, American Cancer Society, Achilles, Melanoma, OTCQX, Orphan, EC, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, FTD, RET, Food, Breast cancer, Pharmaceutical industry, Medical imaging, Genentech, Pembrolizumab

NEW YORK, Sept. 20, 2023 /PRNewswire/ -- More than 30 million people in the United States suffer with a rare disease; most of them are receiving no current treatment. Supporting the development and evaluation of new treatments, particularly for rare diseases, is a key priority for the U.S. Food & Drug Administration. As part of that process, the agency can grant Orphan Drug Designation (ODD) to a drug or biological product being developed to prevent, diagnose or treat a rare disease or condition. This designation is intended to spark innovation among biotech companies that are developing treatments for these patient populations, which by definition affect fewer than 200,000 people in the U.S., by providing incentives such as tax credits, user-fee exemptions and up to seven years of market exclusivity after FDA approval. Last month, Genprex Inc. (NASDAQ: GNPX) (Profile) was granted FDA orphan drug designation for its REQORSA(R) immunogene therapy in development for the treatment of small cell lung cancer (SCLC). The Phase 1/2 clinical trial, expected to dose the first patient in the fourth quarter of 2023, uses a combination of REQORSA and Genentech Inc.'s Tecentriq(R) as maintenance therapy in patients with extensive stage small cell lung cancer ("ES-SCLC") who did not develop tumor progression after receiving Tecentriq and chemotherapy as initial standard treatment. Genprex joins other companies — including Roche Holding AG ADR (OTCQX: RHHBY), Jazz Pharmaceuticals PLC (NASDAQ: JAZZ), ALX Oncology Holdings Inc. (NASDAQ: ALXO) and Achilles Therapeutics PLC (NASDAQ: ACHL) — that have been granted ODD status or may seek ODD status as they work to develop treatments for rare diseases.

Key Points: 
  • Four decades after the Orphan Drug Act was passed, hundreds of 'orphan' drugs have been approved for use.
  • Genprex's REQORSA Immunogene Therapy has gained both Orphan Drug Designation and Fast Track Designation.
  • Specifically, the report noted that 6,340 orphan drug designations were granted, representing drug development for 1,079 rare diseases.
  • For companies looking to help those in the underserved rare-disease space, an Orphan Drug Designation is the ideal pathway to progress.

Achilles Therapeutics Reports Second Quarter 2023 Financial Results and Recent Business Highlights

Retrieved on: 
Friday, August 4, 2023
Vaccine, University College London, Francis Crick Institute, Introduction, HLA, Event, G&A, NSCLC, ACHL, Lung cancer, Patent, Patient, Achilles, Melanoma, R, Research, Therapy, Summit, Pharmaceutical industry, Cryptocurrency, CNET

LONDON, Aug. 04, 2023 (GLOBE NEWSWIRE) -- Achilles Therapeutics plc (NASDAQ: ACHL), a clinical-stage biopharmaceutical company developing AI-powered precision T cell therapies targeting clonal neoantigens to treat solid tumors, today announced its financial results for the quarter ended June 30, 2023, and recent business highlights.

Key Points: 
  • LONDON, Aug. 04, 2023 (GLOBE NEWSWIRE) -- Achilles Therapeutics plc (NASDAQ: ACHL), a clinical-stage biopharmaceutical company developing AI-powered precision T cell therapies targeting clonal neoantigens to treat solid tumors, today announced its financial results for the quarter ended June 30, 2023, and recent business highlights.
  • Research and development (R&D) expenses: R&D expenses were $13.8 million for the second quarter ended June 30, 2023, a decrease of $1.0 million compared to $14.8 million for the second quarter ended June 30, 2022.
  • General and administrative (G&A) expenses: G&A expenses were $4.3 million for the second quarter ended June 30, 2023, a decrease of $1.5 million compared to $5.8 million for the second quarter ended June 30, 2022.
  • Net loss: Net loss for the second quarter ended June 30, 2023 was $16.8 million or $0.42 per share compared to $17.3 million or $0.44 per share for the second quarter ended June 30, 2022.

LTO Batteries Supercharge Electric Train Markets, Says IDTechEx

Retrieved on: 
Tuesday, August 1, 2023
Hydrogen, Heel, Travel, NCA, EV, Atmosphere, Original equipment manufacturer, BEL, Research, Siemens Mobility, LFP, Abbreviation, Siemens, NMC, US, Fuel cell, Phase transition, Siemens Mireo, Achilles, Mus, Kilowatt-hour, Siemens Desiro, Growth, Safety, Lithium, Electric battery, Rail transport

LTO brings unique high-power cell characteristics, more comparable to a supercapacitor than a battery, creating new electrification opportunities for train OEMs.

Key Points: 
  • LTO brings unique high-power cell characteristics, more comparable to a supercapacitor than a battery, creating new electrification opportunities for train OEMs.
  • The IDTechEx report " Battery Electric & Hydrogen Fuel Cell Trains 2023-2043 " assesses the global opportunities emerging for electric trains as energy storage technologies advance rapidly.
  • Despite the advantages, LTO batteries have not yet had a meaningful impact on electric vehicle markets.
  • To find out more about the IDTechEx report "Battery Electric & Hydrogen Fuel Cell Trains 2023-2043", including downloadable sample pages, please visit www.IDTechEx.com/Train .

LTO Batteries Supercharge Electric Train Markets, Says IDTechEx

Retrieved on: 
Tuesday, August 1, 2023
Hydrogen, Heel, Travel, NCA, EV, Atmosphere, Original equipment manufacturer, BEL, Research, Siemens Mobility, LFP, Abbreviation, Siemens, NMC, US, Fuel cell, Phase transition, Siemens Mireo, Achilles, Mus, Kilowatt-hour, Siemens Desiro, Growth, Safety, Lithium, Electric battery, Rail transport

LTO brings unique high-power cell characteristics, more comparable to a supercapacitor than a battery, creating new electrification opportunities for train OEMs.

Key Points: 
  • LTO brings unique high-power cell characteristics, more comparable to a supercapacitor than a battery, creating new electrification opportunities for train OEMs.
  • The IDTechEx report " Battery Electric & Hydrogen Fuel Cell Trains 2023-2043 " assesses the global opportunities emerging for electric trains as energy storage technologies advance rapidly.
  • Despite the advantages, LTO batteries have not yet had a meaningful impact on electric vehicle markets.
  • To find out more about the IDTechEx report "Battery Electric & Hydrogen Fuel Cell Trains 2023-2043", including downloadable sample pages, please visit www.IDTechEx.com/Train .