Investigational New Drug

Lamassu Awarded NIH Grant For Breakthrough Cancer Treatment

Retrieved on: 
Tuesday, March 12, 2024
Sarcoma, Principal, NCI, Radiation, MDM2, Disease, Patient, Research, National Cancer Institute, Cancer, NIH, IND, Cleveland Clinic, Clinical trial, Investigational New Drug, National Institutes of Health, Cleveland Clinic Children's, Hematology, Metastasis, Pharmaceutical industry

CLEVELAND, March 12, 2024 /PRNewswire/ -- Lamassu Bio Inc., a cutting-edge biotech company dedicated to innovative cancer therapies, has been awarded a grant from the  National Institutes of Health (NIH) and National Cancer Institute ( NCI) for the development of their groundbreaking treatment for p53 wild-type sarcomas. The $2.05 million grant will help fund the clinical trial integral to this new cancer treatment. The trial will be conducted in collaboration with Cleveland Clinic Taussig Cancer Center and Cleveland Clinic Children's Pediatric Hematology and Oncology Department.

Key Points: 
  • The $2.05 million grant will help fund the clinical trial integral to this new cancer treatment.
  • Its role in preventing tumor formation by inducing programmed cell death in response to cellular stress makes it a key target for cancer therapy.
  • This innovative approach offers promising prospects for addressing chemo-resistant cancer and presents a significant pathway for advancing cancer care.
  • "The NIH grant will play a pivotal role in facilitating the transition of our research from the laboratory to the bedside.

Olema Oncology Reports Fourth Quarter and Full-Year 2023 Financial Results and Provides Corporate Update

Retrieved on: 
Monday, March 11, 2024
Breast cancer, SAN, Cancer, Investigational New Drug, Woman, ESMO, Biomedical Research, FDA, Everolimus, Corporation, Ribociclib, GAAP, SVB, Patient, Clinical trial, Novartis, Congress, Silicon Valley Bank, Oncology, Initiate, IND, Trial of the century, Research, Pharmaceutical industry

“In 2023 we demonstrated the unique opportunity ahead for palazestrant to make a meaningful impact on improving treatment options for women with ER+/HER2- breast cancer.

Key Points: 
  • “In 2023 we demonstrated the unique opportunity ahead for palazestrant to make a meaningful impact on improving treatment options for women with ER+/HER2- breast cancer.
  • Presented palazestrant monotherapy Phase 2 clinical results at the European Society for Medical Oncology (ESMO) Congress 2023 in Madrid, Spain, as an oral presentation demonstrating compelling activity in both wild-type and ESR1-mutant tumor types.
  • Non-GAAP G&A expenses were $3.1 million and $13.3 million for the quarter and year ended December 31, 2023, respectively, excluding $1.4 million and $5.5 million non-cash stock-based compensation expense respectively.
  • A reconciliation of GAAP to non-GAAP financial measures used in this press release can be found at the end of this press release.

CytomX Therapeutics Reports 2023 Financial Results and Provides Business Update

Retrieved on: 
Monday, March 11, 2024
Therapy, EDT, Head, CD3, SAN, Investigational New Drug, Cancer, EGFR, Research, Biotechnology, Partnering, TCE, Epithelial cell adhesion molecule, Investment, Melanoma, FDA, Amgen, Therapeutic index, Food, Camptothecin, Gastrointestinal tract, Bladder cancer, Drug discovery, CRC, ADC, Bristol Myers Squibb, BMS, Safety, Kidney, Cytokine, Webcast, Tumor microenvironment, PDT, Patient, Workforce, IND, Trial of the century, Colorectal cancer, Pharmaceutical industry

SOUTH SAN FRANCISCO, Calif., March 11, 2024 (GLOBE NEWSWIRE) -- CytomX Therapeutics, Inc. (Nasdaq: CTMX), a leader in the field of conditionally activated, localized biologics, today reported full year 2023 financial results and provided a business update.

Key Points: 
  • Throughout 2023, CytomX made substantial progress across all research partnerships including the commencement of programs under its new alliances with Regeneron and Moderna.
  • In 2023, CytomX remained focused on controlling costs and efficiently allocating capital towards its lead pipeline programs.
  • General and administrative expenses in the fourth quarter of 2023 were $7.8 million compared to $10.1 million in the corresponding period in 2022.
  • CytomX management will host a conference call and simultaneous webcast today at 5 p.m. EDT (2 p.m. PDT) to discuss the financial results and provide a business update.

Genflow Biosciences Plc to Present Live at the Virtual Life Science Investor Forum March 7th

Retrieved on: 
Tuesday, March 5, 2024
Therapy, Research, NASH, QMS, Investigational New Drug, Longevity, IND, Patient, Pharmaceutical industry

LONDON, March 05, 2024 (GLOBE NEWSWIRE) -- Genflow Biosciences Plc (LSE:GENF) (OTCQB:GENFF), an emerging leader in the field of longevity research developing therapeutics that can potentially halt or slow the ageing process, today announces that Dr. Eric Leire Chief Executive Officer, will present live at the virtual Life Science Investor Forum, hosted by VirtualInvestorConferences.com, on March 7, 2024.

Key Points: 
  • LONDON, March 05, 2024 (GLOBE NEWSWIRE) -- Genflow Biosciences Plc (LSE:GENF) (OTCQB:GENFF), an emerging leader in the field of longevity research developing therapeutics that can potentially halt or slow the ageing process, today announces that Dr. Eric Leire Chief Executive Officer, will present live at the virtual Life Science Investor Forum, hosted by VirtualInvestorConferences.com, on March 7, 2024.
  • This will be a live, interactive online event where investors are invited to ask Dr. Leire questions in real-time.
  • If attendees are not able to join the event live on the day of the conference, an archived webcast will also be made available after the event.
  • It is recommended that online investors pre-register and run the online system check to expedite participation and receive event updates.

Purple Biotech Reports Fourth Quarter and Full-Year 2023 Financial Results

Retrieved on: 
Tuesday, March 5, 2024
Neoplasm, Cetuximab, Jefferies Group, Research, Chemistry, Nivolumab, Table, NETS, IRS, NK, Pancreatic cancer, Head, 5T4, DCR, Investigational New Drug, Escape Room, SCCHN, Interim, MD Anderson Cancer Center, Congress, Net, Three Months, International Financial Reporting Standards, CMC, Immune system, International, ESMO, Neutrophil extracellular traps, University, STAT3, AACR, CM24, Conference, Tumor microenvironment, MOA, IND, Insurance, Acquisition, ADS, Drug resistance, Food, Average cost, CEACAM1, PDAC, Administration, Patient, Pharmaceutical industry

REHOVOT, Israel, March 05, 2024 (GLOBE NEWSWIRE) -- Purple Biotech Ltd. ("Purple Biotech" or "the Company") (NASDAQ/TASE: PPBT), a clinical-stage company developing first-in-class therapies that harness the power of the tumor microenvironment to overcome tumor immune evasion and drug resistance, today announced financial results for the fourth quarter and full year ended December 31, 2023.

Key Points: 
  • REHOVOT, Israel, March 05, 2024 (GLOBE NEWSWIRE) -- Purple Biotech Ltd. ("Purple Biotech" or "the Company") (NASDAQ/TASE: PPBT), a clinical-stage company developing first-in-class therapies that harness the power of the tumor microenvironment to overcome tumor immune evasion and drug resistance, today announced financial results for the fourth quarter and full year ended December 31, 2023.
  • At the American Association for Cancer Research (AACR) Special Conference on pancreatic cancer, Purple Biotech presented new potential PDAC biomarker data for CM24.
  • In February 2023, Purple Biotech acquired a platform of conditionally activated T cell and NK cell engagers that selectively activate immune response within the tumor microenvironment.
  • As of December 31, 2023, Purple Biotech had cash and cash equivalents and short-term deposits of $15.3 million, compared to $31.7 million on December 31, 2022.

Lipella Pharmaceuticals Announces FDA Clearance of IND for LP-410 for Oral Graft-Versus-Host Disease, Advancing Clinical Pipeline

Retrieved on: 
Tuesday, March 5, 2024
Investigational New Drug, Toxicity, FDA, Food, Tacrolimus, GVHD, Patient, Graft-versus-host disease, Efficacy, Trial of the century, Pharmaceutical industry

Lipella’s clinical study, titled, A Multicenter, Dose-Ranging Trial Evaluating the Safety, Tolerability, and Efficacy of LP-410 in Subjects with Symptomatic Oral GVHD, is expected to commence in the second half of 2024.

Key Points: 
  • Lipella’s clinical study, titled, A Multicenter, Dose-Ranging Trial Evaluating the Safety, Tolerability, and Efficacy of LP-410 in Subjects with Symptomatic Oral GVHD, is expected to commence in the second half of 2024.
  • Dr. Jonathan Kaufman, CEO of Lipella, said, “We are extremely pleased to announce the approval of our IND application, and we look forward to initiating clinical testing in patients in 2024.
  • We believe that Lipella’s proprietary oral rinse formulation of liposomal tacrolimus has the potential to effectively treat oral GVHD, while minimizing systemic toxicity.
  • Lipella received FDA Orphan Drug Designation on tacrolimus for treatment of GVHD on November 8, 2023.

VYNE Reports 2023 Fourth Quarter and Year-End Financial Results and Provides Business Update

Retrieved on: 
Thursday, February 29, 2024
Investigational New Drug, Psoriasis, FDA, Food, Conference, Vitiligo, Biomarker, Therapy, Patient, Drug discovery, IND, BET, Pharmaceutical industry

“We have made excellent progress with our VYN201 program and remain on track to initiate a Phase 2b trial in nonsegmental vitiligo next quarter.

Key Points: 
  • “We have made excellent progress with our VYN201 program and remain on track to initiate a Phase 2b trial in nonsegmental vitiligo next quarter.
  • Trial startup activities are ongoing with patient enrollment expected to begin in the second quarter of 2024.
  • VYNE recently completed this study and achieved preliminary results consistent with its expectations at the outset of the study.
  • VYNE plans to submit the requested nonclinical information to the FDA by the end of the first quarter of 2024.

Supernus Announces Fourth Quarter and Full Year 2023 Financial Results

Retrieved on: 
Tuesday, February 27, 2024
Central nervous system, Topiramate, Investigational New Drug, PD, Total, New Drug Application, FDA, Food, Growth, PDUFA, Safety, GAAP, CNS, Depreciation, IQVIA, Patient, AISRS, Attention deficit hyperactivity disorder, DSM-IV codes, ADHD, Phase, MDD, Prescription, MADRS, Pharmaceutical industry

ROCKVILLE, Md., Feb. 27, 2024 (GLOBE NEWSWIRE) -- Supernus Pharmaceuticals, Inc. (Nasdaq: SUPN), a biopharmaceutical company focused on developing and commercializing products for the treatment of central nervous system (CNS) diseases, today announced financial results for the fourth quarter and full year of 2023 and associated Company developments.

Key Points: 
  • Fourth quarter 2023 net sales of Qelbree® increased 97% to $46.4 million compared to fourth quarter 2022; Full year 2023 net sales of Qelbree increased 129% to $140.2 million compared to full year 2022.
  • Fourth quarter 2023 net sales of GOCOVRI® increased 10% to $32.0 million compared to fourth quarter 2022; Full year 2023 net sales of GOCOVRI increased 15% to $119.6 million compared to full year 2022.
  • Full year 2023 operating loss (GAAP) was $(5.3) million; Full year 2023 operating earnings (non-GAAP)(2), were $125.1 million.
  • ROCKVILLE, Md., Feb. 27, 2024 (GLOBE NEWSWIRE) -- Supernus Pharmaceuticals, Inc. (Nasdaq: SUPN), a biopharmaceutical company focused on developing and commercializing products for the treatment of central nervous system (CNS) diseases, today announced financial results for the fourth quarter and full year of 2023 and associated Company developments.

ABVC's New Horizon for Oncology and Hematology Aims at Cancer Market of Several Hundred Billion Dollars

Retrieved on: 
Tuesday, February 27, 2024
NSCLC, Therapy, Reflection nebula, Ophthalmology, Marketing, Investigational New Drug, Immune system, Myelodysplastic syndrome, Immunotherapy, Collateral damage, Shogun, FDA, Dietary supplement, US FDA, Polysaccharide, Nausea, Grifola frondosa, Hair loss, CDMO, Safety, MDS, Fatigue, CNS, TNBC, Edible, Ergosterol, Patient, Quality of life, Drug, Immunity, IND, Cancer

The Investigational New Drug (IND) application proposed the clinical investigation of BLEX 404 as the primary active ingredient.

Key Points: 
  • The Investigational New Drug (IND) application proposed the clinical investigation of BLEX 404 as the primary active ingredient.
  • The global cancer therapeutics market is expected to be worth around US$ 393.61 billion by 2032 from US$ 164 billion in 2022, growing at a CAGR of 9.20% from 2023 to 2032.
  • [4] Straits Research reports that the global botanical drug market size was valued at $163 million in 2021 and is expected to be valued at $3.2 billion.
  • The market is expected to grow at a CAGR of 39% during the forecast period (2022–2030).

SpringWorks Therapeutics Reports Fourth Quarter and Full Year 2023 Financial Results and Highlights Recent Business Updates

Retrieved on: 
Tuesday, February 27, 2024
Research, New Drug Application, Vomiting, Common, Rash, Multiple myeloma, Patient, Orange Book, Investigational New Drug, Neoplasm, Nausea, Panitumumab, BCMA, Therapy, European Medicines Agency, Food and Drug Administration, Plantar fibromatosis, MAPK, NDA, EGFR, Diarrhea, Patent, B-cell maturation antigen, IND, MEK, NRAS, Security, EMA, Aes, MAA, FDA, Research and development, Food, TEA, RAF, Medicare, NCCN, Administration, Cancer, Pharmaceutical industry

Launched OGSIVEO in the U.S. and achieved net product revenue of $5.4 million in the first partial quarter of the launch.

Key Points: 
  • Launched OGSIVEO in the U.S. and achieved net product revenue of $5.4 million in the first partial quarter of the launch.
  • Presented additional patient-reported outcome data from the Phase 3 DeFi trial at the 2023 Connective Tissue Oncology Society Annual Meeting.
  • Revenues: OGSIVEO net product revenues were $5.4 million in the fourth quarter of 2023, the first partial quarter of the U.S. launch.
  • Cash Position: Cash, cash equivalents and marketable securities were $662.6 million as of December 31, 2023.