Breakthrough

vTv Therapeutics Announces 2023 Second Quarter Financial Results and Provides Corporate Update

Retrieved on: 
Friday, August 11, 2023
Insulin, RAGE, Research and development, VTV, G&A, Expense, Administration, R, FDA, General Administration of Sport of China, Therapy, Breakthrough, Pharmaceutical industry

HIGH POINT, N.C. , Aug. 11, 2023 (GLOBE NEWSWIRE) -- vTv Therapeutics Inc. (Nasdaq: VTVT), a clinical stage biopharmaceutical company focused on the development of cadisegliatin (TTP399) as an adjunctive therapy to insulin for the treatment of type 1 diabetes ("T1D"), today reported financial results for the second quarter ended June 30, 2023, and provided an update on recent corporate developments.

Key Points: 
  • HIGH POINT, N.C. , Aug. 11, 2023 (GLOBE NEWSWIRE) -- vTv Therapeutics Inc. (Nasdaq: VTVT), a clinical stage biopharmaceutical company focused on the development of cadisegliatin (TTP399) as an adjunctive therapy to insulin for the treatment of type 1 diabetes ("T1D"), today reported financial results for the second quarter ended June 30, 2023, and provided an update on recent corporate developments.
  • Cash Position: The Company’s cash position as of June 30, 2023, was $12.6 million compared to $12.1 million as of December 31, 2022.
  • Net Loss: Net loss attributable to vTv shareholders for the three months ended June 30, 2023, was $5.6 million or $0.07 per basic share.
  • Net loss attributable to vTv shareholders for the comparable period a year ago was $3.2 million or $0.04 per basic share.

Acorai receives Breakthrough Device Designation for their non-invasive intracardiac pressure monitor

Retrieved on: 
Thursday, August 10, 2023
Heart failure, New Standard, HF, Intracardiac injection, SPAP, Patient, Machine learning, Motivation, External carotid artery, Ethics, System, FDA, Health, ICPM, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Breakthrough, Food, Software, Pharmaceutical industry, Medical device, Management, MD

Acorai is developing a first-of-its-kind, non-invasive intracardiac pressure monitoring (IPCM) device with a unique, patented hardware technology and proprietary machine learning system.

Key Points: 
  • Acorai is developing a first-of-its-kind, non-invasive intracardiac pressure monitoring (IPCM) device with a unique, patented hardware technology and proprietary machine learning system.
  • The Breakthrough Device application was supported by preliminary data of 281 patients from their 400-patient Swedish pilot study, which demonstrated a strong correlation to the invasive gold-standard measurements of pulmonary pressure.
  • Kasper Bourdette, Chief Operating Officer and Co-Founder added that "receiving breakthrough designation is a massive inflection point in our device development journey, and we are thrilled for the decision.
  • Implications of the Breakthrough Device Designation:
    Receiving the Breakthrough Device Designation accelerates the development and review process, underscoring the potential of Acorai to address unmet medical needs in heart failure management.

Acorai receives Breakthrough Device Designation for their non-invasive intracardiac pressure monitor

Retrieved on: 
Thursday, August 10, 2023
Heart failure, New Standard, HF, Intracardiac injection, SPAP, Patient, Machine learning, Motivation, External carotid artery, Ethics, System, FDA, Health, ICPM, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Breakthrough, Food, Software, Pharmaceutical industry, Medical device, Management, MD

Acorai is developing a first-of-its-kind, non-invasive intracardiac pressure monitoring (IPCM) device with a unique, patented hardware technology and proprietary machine learning system.

Key Points: 
  • Acorai is developing a first-of-its-kind, non-invasive intracardiac pressure monitoring (IPCM) device with a unique, patented hardware technology and proprietary machine learning system.
  • The Breakthrough Device application was supported by preliminary data of 281 patients from their 400-patient Swedish pilot study, which demonstrated a strong correlation to the invasive gold-standard measurements of pulmonary pressure.
  • Kasper Bourdette, Chief Operating Officer and Co-Founder added that "receiving breakthrough designation is a massive inflection point in our device development journey, and we are thrilled for the decision.
  • Implications of the Breakthrough Device Designation:
    Receiving the Breakthrough Device Designation accelerates the development and review process, underscoring the potential of Acorai to address unmet medical needs in heart failure management.

Sol-Gel Technologies Reports Second Quarter 2023 Financial Results and Provides Corporate Update

Retrieved on: 
Thursday, August 10, 2023
Partnership, Prescription, Acne, Trial of the century, Orphan drug, Dermatology, Acquisition, Patient, Rosacea, NESS, Sol–gel process, Research, Carcinoma, Nevoid basal-cell carcinoma syndrome, Breakthrough, Pharmaceutical industry, IQVIA

“We were pleased to announce another TWYNEO and EPSOLAY partnership during the quarter which generated non-dilutive revenue for our shareholders.

Key Points: 
  • “We were pleased to announce another TWYNEO and EPSOLAY partnership during the quarter which generated non-dilutive revenue for our shareholders.
  • Patient refill rates have also remained consistent during the second quarter, indicating overall continued confidence and positive patient experience.
  • According to IQVIA data, there have been over 13,000 prescriptions of EPSOLAY written in the second quarter of 2023, and over 50,000 prescriptions written to date.
  • The balance as of June 30, 2023 includes $10 million received in April 2023 as part of the $22.8 million raised in the recent financing.

BioCardia Reports Second Quarter 2023 Business Highlights and Financial Results

Retrieved on: 
Wednesday, August 9, 2023
BCDA, DSMB, Survival, Stem cell, Data monitoring committee, Protein, Data analysis, Patent, Patient, Update, Heart, Maintenance, Therapy, Heart failure, Culture, Consultant, Facial muscles, MSC, Japan Patent Office, Security (finance), Phase, FDA, IND, Safety, Opposition procedure before the European Patent Office, Pharmaceuticals and Medical Devices Agency, Cell, IRB, PMDA, White lung, FS, Research, Breakthrough, Quality of life, Data collection, COVID, Microsoft Exchange Server, Trial of the century, MRI, European Patent Convention, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Gene, Food, Pharmaceutical industry, Medical device, Cryptocurrency, Helix, NYHA

SUNNYVALE, Calif., Aug. 09, 2023 (GLOBE NEWSWIRE) -- BioCardia, Inc. [Nasdaq: BCDA], a developer of cellular and cell-derived therapeutics for the treatment of cardiovascular and pulmonary diseases, today reports financial results for the second quarter of 2023 and filed its quarterly report on Form 10-Q for the three and six months ended June 30, 2023 with the Securities and Exchange Commission.

Key Points: 
  • SUNNYVALE, Calif., Aug. 09, 2023 (GLOBE NEWSWIRE) -- BioCardia, Inc. [Nasdaq: BCDA], a developer of cellular and cell-derived therapeutics for the treatment of cardiovascular and pulmonary diseases, today reports financial results for the second quarter of 2023 and filed its quarterly report on Form 10-Q for the three and six months ended June 30, 2023 with the Securities and Exchange Commission.
  • The Company will also hold a conference call at 4:30 PM ET today in which it will discuss business highlights.
  • On July 12, 2023, the planned Data Safety Monitoring Board (DSMB) meeting was held utilizing the adaptive statistical analysis plan reviewed by FDA in the second quarter.
  • Second Quarter 2023 Financial Results:
    Revenues were approximately $43,000 for the three months ended June 2023, compared to approximately $974,000 in the three months ended June 2022, due primarily to the timing of collaboration agreement revenues.

Vaxcyte Reports Second Quarter 2023 Financial Results and Provides Business Update

Retrieved on: 
Tuesday, August 8, 2023
Vaccine, Exercise, Advisory Committee on Immunization Practices, Immunization, OPA, Research and development, Streptococcus, University, Life, Investment, IPD, Safety, Public, Advisory Committee, Licensure, G&A, Research, National Institutes of Health, Payment Card Industry Security Standards Council, Bangladesh Technical Education Board, Stage 2, History of the University of Maryland, College Park, Data monitoring committee, Breakthrough therapy, Genetically modified bacteria, Death, PCV20, Administration, SAN, Breakthrough, Rocket launcher, Infant, Ageing, Growth, PCV, R, FDA, General Administration of Sport of China, Regulation of tobacco by the U.S. Food and Drug Administration, IND, Family, Announcement, Food, Pharmaceutical industry, Cryptocurrency, Shigella

SAN CARLOS, Calif., Aug. 08, 2023 (GLOBE NEWSWIRE) -- Vaxcyte, Inc. (Nasdaq: PCVX), a clinical-stage vaccine innovation company engineering high-fidelity vaccines to protect humankind from the consequences of bacterial diseases, today announced financial results for the second quarter ended June 30, 2023 and provided a business update.

Key Points: 
  • “Our strong balance sheet provides a solid foundation as we advance our PCV franchise and pipeline programs.
  • The six-month safety data from both studies showed safety and tolerability results for VAX-24 similar to PCV20 at all doses studied.
  • Clearance of the adult IND application by the FDA in the fourth quarter of 2023 following submission.
  • The June 30, 2023 amount includes the $545.3 million in net proceeds from the follow-on offering completed in April 2023.

Verastem Oncology Reports Second Quarter 2023 Financial Results and Highlights Recent Company Progress

Retrieved on: 
Tuesday, August 8, 2023
Research, FDA, Clinical Trials, Biotechnology, General Health, Pharmaceutical, Health, Science, Oncology, Other Science, Topotecan, Pancreatic cancer, KRAS, Verastem Oncology, Avutometinib, Table, BIW, Pancreatic Cancer Action Network, Bank statement, General Administration of Press and Publication, Pancreas, Cancer, Paclitaxel, Anastrozole, GAAP, SOC, NSCLC, FRAME, Lung cancer, PFS, RAMP, Acquisition, HIV disease progression rates, RAS, Patient, Standard of care, Investment, European Society of Gynaecological Oncology, GOG, European Network of Transmission System Operators for Electricity, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Research and development, Society, Breakthrough, ORR, Letrozole, Food, Safety, Pharmaceutical industry, Transformer

Verastem Oncology (Nasdaq: VSTM), a biopharmaceutical company committed to advancing new medicines for patients with cancer, today reported financial results for the second quarter ending June 30, 2023 and highlighted recent progress.

Key Points: 
  • Verastem Oncology (Nasdaq: VSTM), a biopharmaceutical company committed to advancing new medicines for patients with cancer, today reported financial results for the second quarter ending June 30, 2023 and highlighted recent progress.
  • Verastem Oncology ended the second quarter of 2023 with cash, cash equivalents and investments of $183.1 million.
  • Research & development expenses for the 2023 Quarter were $12.9 million, compared to $14.9 million for the 2022 Quarter.
  • Selling, general & administrative expenses for the 2023 Quarter were $7.4 million, compared to $6.5 million for the 2022 Quarter.

Genesis MedTech announces FDA Breakthrough Device designation for the J-Valve™ Transfemoral System

Retrieved on: 
Tuesday, August 1, 2023
Heart, Communication, Heart failure, Extracorporeal, Chest pain, Genesis, Patient, Aortic valve, Aortic regurgitation, Diagnosis, FDA, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Breakthrough, AR, Medtech, Food, Fatigue, Disease, Medical device

BURLINGAME Calif., Aug. 1, 2023 /PRNewswire/ -- Genesis MedTech, a leading medical device company, today announced that its J-Valve™ Transfemoral (TF) System has been granted Breakthrough Device designation by the U.S. Food and Drug Administration (FDA).

Key Points: 
  • BURLINGAME Calif., Aug. 1, 2023 /PRNewswire/ -- Genesis MedTech, a leading medical device company, today announced that its J-Valve™ Transfemoral (TF) System has been granted Breakthrough Device designation by the U.S. Food and Drug Administration (FDA).
  • J-Valve™ TF System consists of two key components including the J-Valve™ TF Bioprosthesis and the J-Valve™ TF Delivery Device.
  • The J-Valve™ TF System being granted a Breakthrough Device designation underscores the significance of this innovative development for cardiovascular patients.
  • Warren Wang, Chairman & CEO of Genesis MedTech Group shared, "We believe the Breakthrough Device designation for the J-Valve™ TF System is a testament to the innovative spirit and dedication of our team at Genesis MedTech.

FDA Grants Breakthrough Therapy Designation to NS-089/NCNP-02 for the Treatment of Duchenne Muscular Dystrophy

Retrieved on: 
Thursday, July 27, 2023
National Center for Health Research, Duchenne muscular dystrophy, Patient, Neurology, FDA, Breakthrough, Pharmaceutical industry, Psychiatry

PARAMUS, N.J., July 27, 2023 /PRNewswire/ -- NS Pharma, Inc. announced today the U.S. Food & Drug Administration (FDA) has granted Breakthrough Therapy Designation to NS-089/NCNP-02, an investigational candidate for patients with Duchenne muscular dystrophy amenable to exon 44 skipping therapy.

Key Points: 
  • NS Pharma, Inc. (NS Pharma; President, Tsugio Tanaka) is a wholly owned subsidiary of Nippon Shinyaku Co., Ltd. (Nippon Shinyaku; President, Toru Nakai)
    PARAMUS, N.J., July 27, 2023 /PRNewswire/ -- NS Pharma, Inc. announced today the U.S. Food & Drug Administration (FDA) has granted Breakthrough Therapy Designation to NS-089/NCNP-02, an investigational candidate for patients with Duchenne muscular dystrophy amenable to exon 44 skipping therapy.
  • The Breakthrough Therapy Designation for NS-089/NCNP-02 is based on results from a first-in-human, investigator-initiated clinical trial conducted in Japan.1 The FDA issues Breakthrough Therapy Designation to expedite the development and review of medicines which are intended to treat serious or life-threatening diseases.
  • The criteria require preliminary clinical evidence that indicates the drug may demonstrate substantial improvement over available therapies on a clinically meaningful endpoint(s).
  • In July 2023, NS-089/NCNP-02 was granted Rare Pediatric Disease Designation by the FDA.

MICROSOFT CANADA RECOGNIZES ADLIB SOFTWARE AS WINNER OF THE 2023 BREAKTHROUGH ISV PARTNER IMPACT AWARD

Retrieved on: 
Wednesday, July 12, 2023
Canada, Azure, Ad lib, Ecosystem, Microsoft, Breakthrough, Video game, BURLINGTON

BURLINGTON, ON, July 12, 2023 /PRNewswire/ - Adlib Software, a global leader in document transformation and workflow automation solutions, is proud to announce it has won the 2023 Microsoft Canada Breakthrough ISV Partner Impact Award.

Key Points: 
  • BURLINGTON, ON, July 12, 2023 /PRNewswire/ - Adlib Software, a global leader in document transformation and workflow automation solutions, is proud to announce it has won the 2023 Microsoft Canada Breakthrough ISV Partner Impact Award.
  • "Our relationship with Microsoft Canada is about delivering efficient outcomes for Adlib's document transformation implementations as they move to their private Azure cloud instances."
  • Microsoft Canada presented these awards in 32 categories on July 5, 2023 as part of a lead-up to Microsoft's Inspire conference.
  • "We are pleased to recognize Adlib as this year's recipient of the Breakthrough ISV Partner Impact Award," said Harp Girn, Vice President, Global Partner Solutions, Microsoft Canada.