MAD

Immunovant Reports Financial Results and Provides Corporate Updates for the Quarter Ended September 30, 2023

Retrieved on: 
Donnerstag, November 9, 2023
Neonatal Fc receptor, Research, MAD, Information technology, Immunoglobulin G, Common stock, LDL, CIDP, Safety, IPR, Calendar, Serum albumin, D, Pharmaceutical industry, Clothing, Cryptocurrency, TED

Financial Highlights for Fiscal Second Quarter Ended September 30, 2023:

Key Points: 
  • Financial Highlights for Fiscal Second Quarter Ended September 30, 2023:
    R&D Expenses: Research and development expenses were $48.0 million for the three months ended September 30, 2023, compared to $37.7 million for the three months ended September 30, 2022.
  • G&A Expenses: General and administrative expenses were $13.8 million for the three months ended September 30, 2023, compared to $11.9 million for the three months ended September 30, 2022.
  • Financial Highlights for Fiscal Six Months Ended September 30, 2023:
    R&D Expenses: Research and development expenses were $98.5 million for the six months ended September 30, 2023, compared to $66.2 million for the six months ended September 30, 2022.
  • Net loss for the six months ended September 30, 2023 and 2022 included $21.2 million and $15.8 million, respectively, related to non-cash stock-based compensation expense.

Third Harmonic Bio Announces Third Quarter 2023 Financial Results

Retrieved on: 
Donnerstag, November 9, 2023
Molecule, Research, KIT, IND, Journal of the European Academy of Dermatology and Venereology, G&A, Inflammation, MAD, Cold urticaria, R, Pharmacokinetics, European Academy of Management, Medicine, Venereology, Safety, D, SAN, Pharmaceutical industry, Cryptocurrency, Patient, Dermatology

SAN FRANCISCO, Nov. 09, 2023 (GLOBE NEWSWIRE) -- Third Harmonic Bio, Inc. (Nasdaq: THRD), a biopharmaceutical company focused on advancing the next wave of medicine for inflammatory diseases, today announced financial results for the third quarter ended September 30, 2023.

Key Points: 
  • On October 31, 2023, Third Harmonic Bio announced the transition of Adrian S. Ray, Ph.D., from Chief Scientific Officer to Scientific Advisor effective November 1, 2023.
  • Additionally, the company announced that Robert Ho, Chief Financial Officer, is departing the organization on November 10, 2023.
  • R&D expenses for the nine months ended September 30, 2023 increased to $18.0 million, from $15.1 million for the same period in 2022.
  • G&A expenses for the nine months ended September 30, 2023 increased to $15.5 million, from $9.0 million for the same period in 2022.

Zealand Pharma Announces Financial Results for the First Nine Months of 2023

Retrieved on: 
Donnerstag, November 9, 2023
DREAM, Short bowel syndrome, FDA, PDUFA, Congenital hyperinsulinism, BMI, Alexion, S&M, Obesity, GIP, Weight loss, KCNA3, G&A, CMC, RCF, MAD, SBS, Zealand Pharma, Chronic kidney disease, CGM, Danske Bank, Hypoglycemia, NASH, Boehringer Ingelheim, Risk, Partnership, EUR, Credit, Part, NDA, Overweight, Patient, Human, Cardiovascular disease, Pharmaceutical industry, Birth control, Fine chemical, CHI, Sanofi

Milestone payments from existing partnerships were recognized in the third quarter of 2023, with cash inflow expected in the fourth quarter of 2023, contributing to the company’s solid financial position.

Key Points: 
  • Milestone payments from existing partnerships were recognized in the third quarter of 2023, with cash inflow expected in the fourth quarter of 2023, contributing to the company’s solid financial position.
  • Boehringer Ingelheim and Zealand Pharma expect to report topline results from the Phase 2 trial with survodutide in NASH in the first half of 2024.
  • In the second half of 2024, Zealand expects topline results from the 13-week dose titration trial.
  • Zealand has completed pre-clinical activities for the Kv1.3 ion channel blocker to support potential first-in-human clinical trials in 2024.

Tenaya Therapeutics Reports Third Quarter 2023 Financial Results and Provides Business Update

Retrieved on: 
Mittwoch, November 8, 2023
FDA, CGMP, MYBPC3, Heart failure, IND, ARV, AAV, Food, PD, Heart, Fast track (FDA), PKP2, ARVC, G&A, Ischemia, European Medicines Agency, Research and development, SGLT2, HCMS, MAD, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, SAD, R, Orphan, Hypertrophic cardiomyopathy, American Heart, Plasma, Clinical trial, HDAC6, EMA, Cardiomyopathy, Gene, General Administration of Sport of China, Heart failure with preserved ejection fraction, Safety, HCM, Therapy, Patient, Investment, AHA, Administration, SAN, Investigational New Drug, Pharmaceutical industry, Vaccine, Medical device, Rare-earth element, Tenaya

SOUTH SAN FRANCISCO, Calif., Nov. 08, 2023 (GLOBE NEWSWIRE) -- Tenaya Therapeutics, Inc. (NASDAQ: TNYA), a clinical-stage biotechnology company with a mission to discover, develop and deliver potentially curative therapies that address the underlying causes of heart disease, today reported financial results and provided a corporate update for the third quarter ended September 30, 2023.

Key Points: 
  • In October 2023, Tenaya shared positive Phase 1 data for TN-301 at the 2023 Heart Failure Society of America (HFSA) Annual Scientific Meeting.
  • General & Administrative (G&A) Expenses: G&A expenses for the quarter ended September 30, 2023, were $7.8 million.
  • Non-cash stock-based compensation included in G&A expense was $2.2 million for the quarter ended September 30, 2023.
  • Net Loss: Net loss for the quarter ended September 30, 2023, was $29.1 million, or $0.39 per share.

Equillium Reports Third Quarter 2023 Financial Results and Provides Corporate and Clinical Updates

Retrieved on: 
Mittwoch, November 8, 2023
Oncology, Health, Clinical Trials, Research, Science, Pharmaceutical, Biotechnology, American College, Lupus nephritis, Harvard Medical School, Education, Gastrointestinal tract, Itolizumab, MPH, Therapy, MPA, Dermatology, G&A, Organic acid, MAD, SAD, R, Society, American Society of Nephrology, ASN, Partnership, Abstract, American College of Rheumatology, UPCR, Investment, Patient, ACR, Alopecia areata, Pharmaceutical industry, MD, Nephrology

Equillium , Inc. (Nasdaq: EQ), a clinical-stage biotechnology company leveraging a deep understanding of immunobiology to develop novel therapeutics to treat severe autoimmune and inflammatory disorders, today announced financial results for the third quarter 2023 and provided corporate and clinical development updates.

Key Points: 
  • Equillium , Inc. (Nasdaq: EQ), a clinical-stage biotechnology company leveraging a deep understanding of immunobiology to develop novel therapeutics to treat severe autoimmune and inflammatory disorders, today announced financial results for the third quarter 2023 and provided corporate and clinical development updates.
  • “The third quarter was focused on clinical execution and expanding education on our multi-cytokine platform and clinical programs ahead of initial data expected later this year,” said Bruce Steel, chief executive officer at Equillium.
  • Cash, cash equivalents and short-term investments totaled $46.3 million as of September 30, 2023, compared to $48.4 million as of June 30, 2023.
  • Net cash used in operating activities in the third quarter of 2023 was $1.9 million.

Rallybio Reports Third Quarter 2023 Financial Results and Provides Business Updates

Retrieved on: 
Donnerstag, November 9, 2023
Professional Services, Health, Finance, General Health, Clinical Trials, Pharmaceutical, Biotechnology, Trial of the century, Phase II, Pregnancy, Toxicology, G&A, Research and development, MAD, SAD, R, Poster, Society, Pharmacokinetics, Hematology, Phase 10, Risk, Corporation, General Administration of Sport of China, Woman, Safety, Patient, Administration, Pharmaceutical industry, Vaccine, Dietary supplement

Rallybio Corporation (Nasdaq: RLYB) today reported financial results for the third quarter ended September 30, 2023 and provided an update on recent program and corporate developments.

Key Points: 
  • Rallybio Corporation (Nasdaq: RLYB) today reported financial results for the third quarter ended September 30, 2023 and provided an update on recent program and corporate developments.
  • Poster presentation of abstract for the ongoing natural history study at the 65th American Society of Hematology Annual Meeting in December 2023.
  • Third Quarter 2023 Financial Results:
    Research & Development (R&D) Expenses: R&D expenses were $13.3 million for the third quarter of 2023, compared to $12.1 million for the same period in 2022.
  • Cash Position: As of September 30, 2023, cash, cash equivalents and marketable securities were $121.4 million.

PepGen Reports Third Quarter 2023 Financial Results and Recent Corporate Developments

Retrieved on: 
Mittwoch, November 8, 2023
DM1, FDA, Research, EDO, Clinical trial, Food, Three Months, Therapy, Health Canada, News, Conference, CTA, MAD, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Development, Clinical, BioCompute Object, PGN, Myotonia, Biology, Duchenne muscular dystrophy, Research and development, Letter, Safety, DMD, Patient, Administration, NHP, Investigational New Drug, Neuromuscular disease, Pharmaceutical industry, Cryptocurrency, Rare-earth element

BOSTON, Nov. 08, 2023 (GLOBE NEWSWIRE) -- PepGen Inc. (Nasdaq: PEPG), a clinical-stage biotechnology company advancing the next generation of oligonucleotide therapies with the goal of transforming the treatment of severe neuromuscular and neurological diseases, today reported financial results for the third quarter ended September 30, 2023 and highlighted recent corporate developments.

Key Points: 
  • Orphan Drug Designation granted to PGN-EDODM1: In September 2023, the FDA granted Orphan Drug Designation to PGN-EDODM1 for the treatment of DM1.
  • PepGen expects to report initial results from this study in 2024.
  • Financial Results for the Three Months Ended September 30, 2023
    Cash and cash equivalents were $129.5 million as of September 30, 2023, which is anticipated to fund currently planned operations into 2025.
  • PepGen had approximately 23.8 million shares outstanding on September 30, 2023.

Vigil Neuroscience Reports Third Quarter 2023 Financial Results and Provides Business Update

Retrieved on: 
Dienstag, November 7, 2023
FDA, Research, Data analysis, Research and development, AD, IGNITE, Half-life, Genetic testing, Event, Food, European Commission, Publication, European Medicines Agency, Microglia, CSF1R, MAD, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, SAD, R, HCP, ANA, Approximation error, Civil service commission, Growth, Caregiver, PK, KOL, Medicine, EMA, TREM2, Patient, Administration, Investigational New Drug, Pharmaceutical industry, Cryptocurrency, IND, ALSP

WATERTOWN, Mass., Nov. 07, 2023 (GLOBE NEWSWIRE) -- Vigil Neuroscience, Inc. (Nasdaq: VIGL), a clinical-stage biotechnology company committed to harnessing the power of microglia for the treatment of neurodegenerative diseases, today announced financial results for the third quarter ended September 30, 2023, and provided an update on recent progress.

Key Points: 
  • In September, we also proudly introduced our oral small molecule TREM2 agonist candidate, VG-3927, with the opening of our IND.
  • Cash Position: Cash, cash equivalents, and marketable securities were $133.6 million as of September 30, 2023, compared to $150.2 million as of June 30, 2023.
  • General and Administrative (G&A) Expenses: G&A expenses for the third quarter ended September 30, 2023, were $6.9 million, compared to $4.8 million for the same period in 2022.
  • Net Loss: Loss from operations for the third quarter ended September 30, 2023, were $20.5 million, compared to $17.5 million for the same period in 2022.

Immunocore Reports Third Quarter 2023 Financial Results and Provides Business Update

Retrieved on: 
Dienstag, November 7, 2023
Research, European Organisation for Research and Treatment of Cancer, Treatment, Ipilimumab, Record, Melanoma, Viral load, OS, Neoplasm, PIWIL1, BRAF, Sale, ESMO, EORTC, HIV, Circulating tumor DNA, World Games, The New England Journal of Medicine, Cancer, Patient, DNA, Nivolumab, Congress, CTA, MAD, Insming, Oncology, RFS, PRAME, Nivolumab/relatlimab, TCR International, European Society of Gynaecological Oncology, IND, SVP, TCR, Gastrointestinal cancer, European Society for Medical Oncology, Observation, Senior, Infection, Book, James A. Schlipmann Melanoma Cancer Foundation, HBV, Pharmaceutical industry, Cryptocurrency, Medical imaging, USD, IMC, Immunocore

& ROCKVILLE, Md., US, 07 November 2023) Immunocore Holdings plc (Nasdaq: IMCR), a commercial-stage biotechnology company pioneering the development of a novel class of T cell receptor (TCR) bispecific immunotherapies designed to treat a broad range of diseases, including cancer, infectious diseases and autoimmune conditions, today announced its financial results for the third quarter ended September 30, 2023, and provided a business update.

Key Points: 
  • & ROCKVILLE, Md., US, 07 November 2023) Immunocore Holdings plc (Nasdaq: IMCR), a commercial-stage biotechnology company pioneering the development of a novel class of T cell receptor (TCR) bispecific immunotherapies designed to treat a broad range of diseases, including cancer, infectious diseases and autoimmune conditions, today announced its financial results for the third quarter ended September 30, 2023, and provided a business update.
  • Commercial sales have increased in the United States and European countries, including France, Germany and Italy, during the third quarter.
  • Since the beginning of 2023, we have launched KIMMTRAK in Austria, Israel, Italy, Finland, Switzerland and Belgium, and have recently reached price agreements with Canada and Australia.
  • Cash and cash equivalents were £364.0 million ($444.5 million) as of September 30, 2023, compared to £332.5 million as of December 31, 2022.

Autobahn Therapeutics Announces Positive Topline Results from Phase 1 Study of ABX-002, its Lead Oral Treatment for Major Depressive Disorder

Retrieved on: 
Dienstag, November 7, 2023
Health, Neurology, Clinical Trials, Research, Science, Pharmaceutical, Biotechnology, Trial of the century, IND, PD, MDD, Food, DSM-IV codes, CNS, MAD, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, SAD, Development, Pharmacokinetics, Autobahn, PK, Biology, Safety, Vital signs, Therapy, TSH, Central nervous system, Pharmaceutical industry, Vaccine

ABX-002, a potent and selective thyroid hormone beta receptor (TRβ) agonist, is an orally administered small molecule being evaluated as a potential adjunctive treatment for people with major depressive disorder (MDD).

Key Points: 
  • ABX-002, a potent and selective thyroid hormone beta receptor (TRβ) agonist, is an orally administered small molecule being evaluated as a potential adjunctive treatment for people with major depressive disorder (MDD).
  • Results from the Phase 1 study:
    Across the range of doses tested, ABX-002 was safe and well-tolerated.
  • There were no serious adverse events and no premature discontinuations related to safety, with all 48 subjects completing the study.
  • “The positive data from this Phase 1 study represent a major milestone for ABX-002 and support its advancement into Phase 2 development,” said Kevin Finney, President and Chief Executive Officer of Autobahn Therapeutics.