Fast Track

D&D Pharmatech Granted Fast Track Designation from US FDA for DD01 for the Treatment of NASH/MASH

Retrieved on: 
Tuesday, April 2, 2024
FDA, Health, Diabetes, Clinical Trials, Pharmaceutical, Biotechnology, Overweight, D&D, Obesity, Patient, Fatty liver disease, Fast Track, Weight loss, MASH, Fibrosis, Type 2 diabetes, T2D, Safety, MAFLD, NASH, Liver disease, Food, Dietary supplement

FDA Fast Track designation is intended to bring promising drugs to patients sooner by facilitating the development and expediting the review of drugs that fulfill unmet needs in serious diseases.

Key Points: 
  • FDA Fast Track designation is intended to bring promising drugs to patients sooner by facilitating the development and expediting the review of drugs that fulfill unmet needs in serious diseases.
  • In animal models, DD01 treatment reduced hepatic steatosis, lobular inflammation, ballooning, and signs of fibrosis, all key diagnostic criteria MASH.
  • “We are pleased with the FDA’s decision to grant Fast Track designation for DD01 and look forward to initiating a Phase 2 study in biopsy-confirmed MASH patients,” said Seulki Lee, Ph.D., CEO of D&D.
  • DD01 provides rapid reductions in liver fat and beneficial effects on glucose control; thus, we anticipate further studying DD01 in biopsy-confirmed MASH patients after prolonged treatment in an upcoming Phase 2.”

Genmab to Broaden and Strengthen Oncology Portfolio with Acquisition of ProfoundBio

Retrieved on: 
Wednesday, April 3, 2024
Biotechnology, General Health, Health, Pharmaceutical, Oncology, 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 A/S (Nasdaq: GMAB) and ProfoundBio, Inc. announced today that the companies have entered into a definitive agreement for Genmab to acquire ProfoundBio in an all-cash transaction.

Key Points: 
  • Genmab A/S (Nasdaq: GMAB) and ProfoundBio, Inc. announced today that the companies have entered into a definitive agreement for Genmab to acquire ProfoundBio in an all-cash transaction.
  • 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.

4 Greenberg Traurig Attorneys in Delaware, Philadelphia Recognized by ALM

Retrieved on: 
Tuesday, April 2, 2024
Employment, Delmarva Peninsula, Labour, Child, Associate, Big Brothers Big Sisters, Fast Track, ALM, Lawyer, LLP, PSFS Building, Volunteering, Unsung Heroes, Intellectual property, Book, Nursing

NEW YORK, April 2, 2024 /PRNewswire-PRWeb/ -- Global law firm Greenberg Traurig, LLP Shareholders Diane N. Ibrahim, Samuel L. Moultrie, and Shira R. Yoshor, and Associate Renée Mosley Delcollo will be recognized at the 2024 Pennsylvania Legal Awards (PALA), sponsored by ALM's Legal Intelligencer. Honorees will be recognized at the awards celebration May 15 at the Loews Philadelphia Hotel.

Key Points: 
  • Honorees will be recognized at the awards celebration May 15 at the Loews Philadelphia Hotel.
  • Honorees will be recognized at the awards celebration May 15 at the Loews Philadelphia Hotel.
  • Yoshor, a Labor & Employment Practice shareholder in the Philadelphia office , is a finalist for "2024 Best Law Firm Mentor."
  • As the Career Development Liaison previously in Houston and now in Philadelphia, she has been involved in mentoring lawyers extensively since she joined Greenberg Traurig.

Jill Roth of Laffey, Bucci & Kent Named Among 'Lawyers on the Fast Track' by The Legal Intelligencer

Retrieved on: 
Monday, March 25, 2024
Crime, Legislation, University, Personal injury, Abuse, DA, Domestic violence, Fast Track, The Legal Intelligencer, Lawyer, Hospital, PSFS Building, Internet, District Attorney of Philadelphia, Survivor, Rape, Intimidation, Multimedia, Commonwealth, Property management

PHILADELPHIA, March 25, 2024 /PRNewswire-PRWeb/ -- Personal injury law firm Laffey, Bucci & Kent is pleased to announce that victims' advocate Jill Roth has been named among the Lawyers on the Fast Track in the small/midsize firms category by The Legal Intelligencer. This recognition is part of the publication's 2024 Pennsylvania Legal Awards, which highlight great work and achievements across the full breadth of the legal communities in Pennsylvania and Delaware.

Key Points: 
  • "We congratulate Jill on this well-deserved recognition of her deeply impactful work on behalf of victims of crime," said Jeff Laffey, Co-Managing Partner.
  • Roth is currently defending a client from a frivolous lawsuit filed by social media influencer Andrew Tate seeking $5 million.
  • "I am grateful to be recognized by The Legal Intelligencer and my colleagues in the Pennsylvania legal community for my work in support of survivors," said Roth.
  • Laffey, Bucci & Kent was founded in 2009 by Jeff Laffey, Paul Bucci & Brian Kent.

Biotech/Oncology Stocks Targeting the Pancreatic Cancer Market - A Race Worth Winning

Retrieved on: 
Wednesday, March 6, 2024
Radiation, Doctor of Philosophy, Immunotherapy, News, FOLFIRINOX, Growth, CADL, PR, CXCR4, Lead, PRS, Multiple myeloma, Poster, Pancreatic cancer, Gemcitabine, Fast Track, Liver, Incidence, Cancer, City, HSC, Chung, TME, Overalls, FACP, Therapy, Sickle cell disease, Columbia University, MAPK, Immune system, SNF, G-CSF, Woman, AIO, SCD, AACR, PD-1, Conference, TILS, Tumor microenvironment, BioLineRx, Clinical trial, Survival, Oncology, Filgrastim, Collection, American Cancer Society, Caregiver, USD, SWI, MD, Blood, FDA, TSX, Biotechnology, Pancreatic Cancer Action Network, Stem cell, RAS, Valaciclovir, PDAC, Patient, Natalizumab, ONC, PEI, Pharmaceutical industry

Research Nester says , "The global pancreatic cancer market size is slated to expand at ~18% CAGR between 2024 and 2036.

Key Points: 
  • Research Nester says , "The global pancreatic cancer market size is slated to expand at ~18% CAGR between 2024 and 2036.
  • The American Cancer Society's estimates for pancreatic cancer in the United States for 2024 are: "About 66,440 people (34,530 men and 31,910 women) will be diagnosed with pancreatic cancer.
  • Pancreatic cancer accounts for about 3% of all cancers in the US and about 7% of all cancer deaths."
  • Biotech/oncology stocks targeting the growing global pancreatic cancer market have made headlines with recent developments and breakthroughs in treatments.

Mustang Bio Reports Full-Year 2023 Financial Results and Recent Corporate Highlights

Retrieved on: 
Monday, March 11, 2024
Fast Track, ICT, ICV, Research, WM, Indolent lymphoma, XSCID, NHL, ASH, FDA, Birmingham School of Law, City, Cancer, DSM-IV codes, Mustang, Sale, Nature, Tocilizumab, GBM, Standard of care, Safety, Dexamethasone, Society, University, Mayo Clinic, Clinical professor, Translation, University of Washington, Foreign investment, Tumor microenvironment, Associate, CRS, Patient, Clinical trial, Disease, Survival, CFIUS, Cytokine release syndrome, Follicular lymphoma, Pharmaceutical industry

WORCESTER, Mass., March 11, 2024 (GLOBE NEWSWIRE) -- Mustang Bio, Inc. (“Mustang” or the “Company”) (Nasdaq: MBIO), a clinical-stage biopharmaceutical company focused on translating today’s medical breakthroughs in cell and gene therapies into potential cures for difficult-to-treat cancers and rare genetic diseases, today announced financial results and recent corporate highlights for the full-year ended December 31, 2023.

Key Points: 
  • WORCESTER, Mass., March 11, 2024 (GLOBE NEWSWIRE) -- Mustang Bio, Inc. (“Mustang” or the “Company”) (Nasdaq: MBIO), a clinical-stage biopharmaceutical company focused on translating today’s medical breakthroughs in cell and gene therapies into potential cures for difficult-to-treat cancers and rare genetic diseases, today announced financial results and recent corporate highlights for the full-year ended December 31, 2023.
  • Research and development expenses were $40.5 million for the year ended December 31, 2023, compared to $62.5 million for 2022.
  • 2023 and Recent Corporate Highlights:
    In July 2023, Mustang announced that it amended its previously announced asset purchase agreement with uBriGene (Boston) Biosciences Inc. (“uBriGene”) and closed the transaction.
  • In October 2023, Mustang completed a registered direct offering priced at-the-market for approximately $4.4 million in gross proceeds.

Caribou Biosciences Reports Fourth Quarter and Full Year 2023 Financial Results and Provides Business Update

Retrieved on: 
Monday, March 11, 2024
Fast Track, Regenerative Medicine Advanced Therapy, Cancer Immunology Research, Research, CRISPR, Rachel Haurwitz, Doctor of Philosophy, Orphan drug, AML, FDA, Food, Reindeer, AACR, Manuscript, Bone marrow, Amplification, Patent, Patient, ASCT, Asian literature, Acute myeloid leukemia, G&A, IND, Insurance, Pharmaceutical industry

BERKELEY, Calif., March 11, 2024 (GLOBE NEWSWIRE) --  Caribou Biosciences, Inc. (Nasdaq: CRBU), a leading clinical-stage CRISPR genome-editing biopharmaceutical company, today reported financial results for the fourth quarter and full year 2023 and reviewed recent pipeline progress.

Key Points: 
  • “For our lead program, CB-010, we plan to present initial dose expansion data and the RP2D in the second quarter of 2024.
  • For our third program, CB-012, we are thrilled to have recently dosed the first patient in the AMpLify trial.
  • In December 2023, Caribou shared regulatory feedback from the U.S. Food and Drug Administration (FDA) following a Type B clinical meeting.
  • CB-012: Caribou plans to provide updates on dose escalation as the AMpLify Phase 1 clinical trial in r/r AML advances.

Lexeo Therapeutics Reports Fourth Quarter and Full Year 2023 Financial Results and Operational Highlights

Retrieved on: 
Monday, March 11, 2024
Fast Track, Cohort, Research, Orphan drug, FDA, Cardiovascular disease, Treatment, Clinical trial, Exercise, FTD, ODD, Phenotype, Patient, Public expenditure, Hypertrophy, FXN, Heart, Cadaver, G&A, Development, FA, Pharmaceutical industry

NEW YORK, March 11, 2024 (GLOBE NEWSWIRE) -- Lexeo Therapeutics, Inc. (Nasdaq: LXEO), a clinical stage genetic medicine company dedicated to pioneering treatments for genetically defined cardiovascular diseases and APOE4-associated Alzheimer’s disease, today reported fourth quarter and full year 2023 financial results and provided operational highlights.

Key Points: 
  • Data to date suggest that FA patients may have lower FXN levels in the heart versus peripheral tissues.
  • Across all three cardiac biopsies, we observed an increase in FXN levels as measured by liquid chromatography mass spectrometry relative to pre-treatment baseline levels.
  • Lexeo anticipates the gross proceeds from the private placement to be approximately $95.0 million, before deducting any offering related expenses.
  • G&A expenses were $15.4 million for the year ended December 31, 2023, compared to $12.0 million for the same period in 2022.

Plus Therapeutics Completes Dosing in Cohort 5 of ReSPECT-LM Phase 1 Trial of Rhenium (186Re) Obisbemeda in Leptomeningeal Metastases

Retrieved on: 
Monday, March 11, 2024
Fast Track, Breast cancer, Central nervous system, PSTV, Cohort, Rhenium, FDA, Cancer, Data monitoring committee, Learning, Therapy, CNS, Plus Therapeutics, Patient, DSMB, LM, Pharmaceutical industry

AUSTIN, Texas, March 11, 2024 (GLOBE NEWSWIRE) -- Plus Therapeutics, Inc. (Nasdaq: PSTV) (the “Company”), a clinical-stage pharmaceutical company developing targeted radiotherapeutics with advanced platform technologies for central nervous system (CNS) cancers, today announced it has completed dosing in Cohort 5 of the ReSPECT-LM Phase 1 dose escalation clinical trial of rhenium (186Re) obisbemeda for the treatment of leptomeningeal metastases (LM) from solid tumors.

Key Points: 
  • Three patients were dosed as part of Cohort 5, bringing the total to 18 patients dosed in the ReSPECT-LM trial to date.
  • There have been no dose limiting toxicities observed to date with administered radiation doses up to 66.14 millicuries in Cohort 5, a ten-fold increase over Cohort 1.
  • The Company plans to initiate dosing in Cohort 6 in the second quarter of 2024, pending Data Safety Monitoring Board (DSMB) approval.
  • In addition, five new clinical trial sites were added to this trial over the last year, bringing the total number of sites to seven.

SpringWorks Therapeutics Initiates Rolling Submission of New Drug Application to the FDA for Mirdametinib for the Treatment of Children and Adults with NF1-PN

Retrieved on: 
Monday, March 4, 2024
Fast Track, European Commission, Orphan drug, Aes, Diarrhea, FDA, Quality of life, Food, Pain, Nausea, Vomiting, Civil service commission, Therapy, Disease, Rash, Patient, NF1, NDA, MEK, MRI, Cancer, Pharmaceutical industry

Mirdametinib treatment showed deep and durable responses and demonstrated significant improvements in key secondary patient-reported outcome measures.

Key Points: 
  • Mirdametinib treatment showed deep and durable responses and demonstrated significant improvements in key secondary patient-reported outcome measures.
  • The FDA and the European Commission have granted Orphan Drug designation for mirdametinib for the treatment of NF1.
  • In July 2023, the FDA granted mirdametinib Rare Pediatric Disease designation for the treatment of NF1, which provides eligibility for a priority review voucher upon FDA approval.
  • SpringWorks expects to complete the NDA submission in the second quarter of 2024.