Fast Track

EQS-News: AdrenoMed Receives FDA Fast Track Designation for Enibarcimab for Treatment of Septic Shock

Retrieved on: 
Wednesday, April 10, 2024
Sepsis, Communication, Patient, Public, Fast Track, Adrenomedullin, Biomarker, Accelerated approval (FDA), Mortality, Septic shock, Death, DPP3, Septic, Medicine, Priority review, Organ dysfunction, Intensive care medicine, CMO, Collection, FDA, Infection, RCI, Food, Pharmaceutical industry

AdrenoMed is now preparing a confirmatory Phase IIb/III clinical trial to confirm the reduced septic shock mortality under enibarcimab treatment employing a precision medicine approach.

Key Points: 
  • AdrenoMed is now preparing a confirmatory Phase IIb/III clinical trial to confirm the reduced septic shock mortality under enibarcimab treatment employing a precision medicine approach.
  • AdrenoMed’s CEO Dr. Richard Jones commented: “We are very pleased that enibarcimab has received Fast Track designation from the FDA, recognizing its potential as an innovative biomarker-guided treatment against septic shock to fill the unmet medical need in this very serious condition with a high death toll.
  • With a mortality rate of 20-30% for sepsis [1] and 30%-50% for septic shock in developed countries, [2] sepsis represents an enormous public health burden and is responsible for almost 20% of all deaths worldwide.
  • Dr. Stephan Witte, CMO of AdrenoMed, said: “We are very confident that the use of enibarcimab in combination with two biomarkers, Adrenomedullin (bio-ADM) and circulating dipeptidyl peptidase 3 (cDPP3), holds the promise to become the first effective targeted treatment against septic shock.

Cardiol Therapeutics Announces Year-End 2023 Update on Operations

Retrieved on: 
Tuesday, April 2, 2024
Hypertrophy, Heart, CRDL, Patient, Mayo Clinic, PPAR, Agent handling, Cleveland Clinic, Fibrosis, European, Therapy, Myocarditis, Analysis, American Heart Association, Human, Massachusetts General Hospital, Pericarditis, MMT, Heart failure, American College, Safety, ODD, Cardiology, Clinical professor, Disease, Pericardium, Research, World Heart Federation, Management, University, Death, Pericardial effusion, Maverick, Reactive oxygen species, TSX, Priority review, FDA, Conversation, Financial statement, Inflammation, Fast Track, Calcium, Wound healing, API, Pharmaceutical industry

"Cardiol Therapeutics made important progress in 2023 and early 2024 as we pursued our primary objective of providing new therapeutic options to patients with poorly served heart diseases," said David Elsley, President and Chief Executive Officer of Cardiol Therapeutics.

Key Points: 
  • "Cardiol Therapeutics made important progress in 2023 and early 2024 as we pursued our primary objective of providing new therapeutic options to patients with poorly served heart diseases," said David Elsley, President and Chief Executive Officer of Cardiol Therapeutics.
  • In January 2023, Cardiol announced the first patient had been enrolled in the Company's Phase II open-label pilot study ("MAvERIC-Pilot") investigating the tolerance, safety, and efficacy of CardiolRx™ in patients with recurrent pericarditis.
  • In November 2023, Cardiol announced that it had exceeded 50% of the patient enrollment target for the MAvERIC-Pilot study.
  • In January 2024, Cardiol announced that ARCHER had exceeded 50% patient enrollment and was progressing ahead of the original study timeline.

Longeveron Issues Letter to Shareholders Highlighting Corporate Strategy, Clinical Pipeline and 2024 Key Priorities and Goals

Retrieved on: 
Monday, April 8, 2024
SOC, CDMO, Orphan drug, Letter, Cell, Science, Bone marrow, Disease, Partnership, Caregiver, Hypoplastic left heart syndrome, Patient, Fast Track, Research, Microsoft Exchange Server, Standard of care, Security (finance), CLEAR, Surgeon, Regenerative medicine, FDA, BLA, Development, Pharmaceutical industry

MIAMI, April 08, 2024 (GLOBE NEWSWIRE) -- Longeveron Inc. (NASDAQ: LGVN), a clinical stage biotechnology company developing regenerative medicines, today announced that the Company’s CEO, Wa’el Hashad, issued the following letter to Longeveron shareholders.

Key Points: 
  • MIAMI, April 08, 2024 (GLOBE NEWSWIRE) -- Longeveron Inc. (NASDAQ: LGVN), a clinical stage biotechnology company developing regenerative medicines, today announced that the Company’s CEO, Wa’el Hashad, issued the following letter to Longeveron shareholders.
  • Today, I am excited to update you on our overall strategy, business objectives, approach to capital allocation, and 2024 key priorities and goals.
  • Our focus remains steadfast on raising the funds necessary to continue our operations and delivering transformative solutions to patients and creating sustainable value for our shareholders.
  • In 2024, we are focusing our efforts on two of our most promising programs: Hypoplastic Left Heart Syndrome (HLHS); and Alzheimer’s Disease.

Genmab to Broaden and Strengthen Oncology Portfolio with Acquisition of ProfoundBio

Retrieved on: 
Wednesday, April 3, 2024
Ovarian cancer, BofA Securities, PIN, U.S. FDA, Shearman, Webcast, Patient, Fast Track, Goldman Sachs, Morgan Stanley, LLP, Acquisition, Cancer, Spacecraft, Cooley LLP, DKK, Shearman & Sterling, ADC, USD, Law, Food, Pharmaceutical industry

Genmab will acquire ProfoundBio for USD 1.8 billion in cash, payable at closing (subject to adjustment for ProfoundBio’s closing net debt and transaction expenses).

Key Points: 
  • Genmab will acquire ProfoundBio for USD 1.8 billion in cash, payable at closing (subject to adjustment for ProfoundBio’s closing net debt and transaction expenses).
  • The transaction will further broaden Genmab’s mid- to late-stage clinical pipeline and strengthen and complement Genmab’s already validated suite of proprietary technology platforms.
  • The addition of Rina-S to Genmab’s portfolio will enable Genmab to deepen its presence in the gynecologic oncology space and establish a firm foundation in solid tumors.
  • Based on the data from the ongoing Phase 1/2 clinical trial Genmab intends to broaden the development plans for Rina-S within ovarian cancer and other FRα-expressing solid tumors.

SELLAS Life Sciences Reports Full Year 2023 Financial Results and Provides Corporate Update

Retrieved on: 
Thursday, March 28, 2024
Ovarian cancer, SLS, Survival, Lymphoma, Fast track (FDA), PTCL, National Cancer Institute, CMC, Clinical trial, Committee, Research, NCI, European School, Bone marrow, AML, GPS, Pembrolizumab, Doctor of Science, Nivolumab, Safety, MRD, CDK9, BLA, Food, CR2, Zanubrutinib, Mesothelioma, BIW, MD, Completeness, WT1, FDA, DLBCL, IDMC, Therapeutic index, Type, Fast Track, Biomarker, BTK, Pharmaceutical industry

The SLS009 aza-ven treatment was well-tolerated and evoked anti-leukemic effects in 67% of patients across all levels dosed.

Key Points: 
  • The SLS009 aza-ven treatment was well-tolerated and evoked anti-leukemic effects in 67% of patients across all levels dosed.
  • The first patient who achieved a complete response continues on the study and remains leukemia-free 9 months post-enrollment.
  • The net proceeds from the offering strengthen the Company’s financial position and will be used for research and development activities, working capital, and general corporate purposes.
  • Cash Position: As of December 31, 2023, cash and cash equivalents totaled approximately $2.5 million.

Cellectar Biosciences Reports Financial Results for Year Ended 2023 and Provides a Corporate Update

Retrieved on: 
Wednesday, March 27, 2024
Research, NCI, AON, Development, Sarcoma, Disease, Neuroblastoma, Shareholder, Patient, CNS, Fast Track, Cash, SBIR, NDA, Syndrome, Cancer, MRR, CLR, BNS, University, Head, External beam radiotherapy, Cure, Wisconsin Alumni Research Foundation, WAM, HERE, Completeness, Safety, Tat, Intellectual property, Patent, PLE, WARF, Symantec Endpoint Protection, Tranche, UW, Pharmaceutical industry

FLORHAM PARK, N.J., March 27, 2024 (GLOBE NEWSWIRE) -- Cellectar Biosciences, Inc. (NASDAQ: CLRB), a late-stage clinical biopharmaceutical company focused on the discovery, development, and commercialization of drugs for the treatment of cancer, today announced financial results for the year ended December 31, 2023, and provided a corporate update.

Key Points: 
  • FLORHAM PARK, N.J., March 27, 2024 (GLOBE NEWSWIRE) -- Cellectar Biosciences, Inc. (NASDAQ: CLRB), a late-stage clinical biopharmaceutical company focused on the discovery, development, and commercialization of drugs for the treatment of cancer, today announced financial results for the year ended December 31, 2023, and provided a corporate update.
  • Net cash used in operating activities during the twelve months ended December 31, 2023, was approximately $32.4 million.
  • General and Administrative Expense: G&A expense for the year ended December 31, 2023, was $10.7 million, compared to $9.6 million for the year ended December 31, 2022.
  • Cellectar management will host a conference call for investors today, March 14, 2024, beginning at 8:30 am Eastern Time to discuss these results and answer questions.

Atea Pharmaceuticals Completes Patient Enrollment in Global Phase 3 SUNRISE-3 Trial Evaluating Oral Antiviral Bemnifosbuvir for COVID-19 in High-Risk Patients

Retrieved on: 
Wednesday, March 27, 2024
Infection, Risk, COVID-19, Patient, Fast Track, Viral, Data monitoring committee, Death, Doctor of Philosophy, Safety, DSMB, Immunodeficiency, Atea, Food, Hospital, Pharmaceutical industry

BOSTON, March 27, 2024 (GLOBE NEWSWIRE) -- Atea Pharmaceuticals, Inc. (Nasdaq: AVIR) (Atea), a clinical-stage biopharmaceutical company engaged in the discovery and development of oral antiviral therapeutics for serious viral diseases, today announced that the company has completed enrollment of the global Phase 3 SUNRISE-3 trial evaluating bemnifosbuvir, an oral nucleotide polymerase inhibitor, or placebo for the treatment of COVID-19. Over 2,200 patients were randomized into the supportive care monotherapy cohort and less than 80 patients were randomized into the combination cohort. The primary endpoint of the trial is all-cause hospitalization or death through Day 29 post-treatment in the bemnifosbuvir supportive care monotherapy cohort of high-risk patients. Secondary endpoints include other measurements of patient outcomes through Day 60 post-treatment.

Key Points: 
  • Over 2,200 patients were randomized into the supportive care monotherapy cohort and less than 80 patients were randomized into the combination cohort.
  • The primary endpoint of the trial is all-cause hospitalization or death through Day 29 post-treatment in the bemnifosbuvir supportive care monotherapy cohort of high-risk patients.
  • Secondary endpoints include other measurements of patient outcomes through Day 60 post-treatment.
  • “COVID-19 continues to be a threat, leaving the most vulnerable at risk for severe outcomes from infection.

Altimmune Announces Positive Lean Mass Preservation Data for Pemvidutide and Reports Fourth Quarter and Full Year 2023 Financial Results

Retrieved on: 
Wednesday, March 27, 2024
Research, Blood pressure, Body composition, LDL, Adipose tissue, Obesity, Development, Cirrhosis, Three Months, Exercise, Arrhythmia, Hepatitis B virus, Diabetes, Lipid, Patient, Heart rate, Fast Track, Weight loss, Sarcopenia, MASH, Woman, Diet, Investment, Fibrosis, Safety, Optimism, FDA, Triglyceride, IMPACT, Dietary supplement

“We are extremely pleased with the results of the body composition analysis from our recently completed MOMENTUM 48-week Phase 2 obesity trial of pemvidutide.

Key Points: 
  • “We are extremely pleased with the results of the body composition analysis from our recently completed MOMENTUM 48-week Phase 2 obesity trial of pemvidutide.
  • “There is a growing appreciation that the quality of weight loss is as important as the quantity of weight loss.
  • Achieved mean weight loss of 15.6% on 2.4 mg dose of pemvidutide at week 48, with weight loss continuing at the end of treatment.
  • Financial Results for the Three Months Ended December 31, 2023
    Altimmune had cash, cash equivalents and short-term investments totaling $198.0 million at December 31, 2023.

Syros Receives Fast Track Designation from the FDA for Tamibarotene for the Treatment of Newly Diagnosed Unfit AML with RARA gene overexpression

Retrieved on: 
Tuesday, April 9, 2024
Biotechnology, FDA, Health, Pharmaceutical, Clinical Trials, Toxicity, Aplastic anemia, Syros, Tamibarotene, AML, Patient, Fast Track, Venetoclax, Acute myeloid leukemia, Azacitidine, Prognosis, MDS, Bone marrow, RARA, Pharmaceutical industry

Tamibarotene, an oral first-in-class selective retinoic acid receptor alpha (RARα) agonist, is currently being evaluated in combination with venetoclax and azacitidine for the treatment of newly diagnosed AML patients with RARA gene overexpression.

Key Points: 
  • Tamibarotene, an oral first-in-class selective retinoic acid receptor alpha (RARα) agonist, is currently being evaluated in combination with venetoclax and azacitidine for the treatment of newly diagnosed AML patients with RARA gene overexpression.
  • “We are pleased to receive Fast Track designation for tamibarotene for the treatment of AML.
  • Syros is evaluating tamibarotene in combination with venetoclax and azacitidine in newly diagnosed, unfit AML patients with RARA overexpression in the ongoing SELECT-AML-1 Phase 2 trial.
  • In January 2023, the FDA granted Fast Track Designation to tamibarotene for the treatment of HR-MDS patients with RARA overexpression.

Phanes Therapeutics' PT217 granted Fast Track Designation by the FDA

Retrieved on: 
Monday, April 8, 2024
Diagnosis, Survival, Carcinoma, Monoclonal antibody, Patient, SAN, Lung, Fast Track, Cancer, CD47, DLL3, Therapy, Safety, Pharmacokinetics, Platinum, FDA, SCLC, Food, Pharmaceutical industry

SAN DIEGO, April 8, 2024 /PRNewswire/ -- Phanes Therapeutics, Inc. (Phanes), a clinical stage biotech company focused on innovative drug discovery and development in oncology, announced today that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to PT217 for the treatment of patients with extensive-stage small cell lung cancer (ES-SCLC) with disease progression following platinum chemotherapy with or without a checkpoint inhibitor.

Key Points: 
  • SAN DIEGO, April 8, 2024 /PRNewswire/ -- Phanes Therapeutics, Inc. (Phanes), a clinical stage biotech company focused on innovative drug discovery and development in oncology, announced today that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to PT217 for the treatment of patients with extensive-stage small cell lung cancer (ES-SCLC) with disease progression following platinum chemotherapy with or without a checkpoint inhibitor.
  • PT217 was also granted orphan drug designation for the treatment of small cell lung cancer by the FDA in 2022.
  • "PT217 has the potential to be a transformative treatment option for patients with SCLC, LCNEC and EP-NECs in various settings," said Ming Wang, Founder and CEO of Phanes Therapeutics.
  • Last month, PT886 was granted Fast Track designation for the treatment of patients with metastatic claudin 18.2-positive pancreatic adenocarcinoma.