Fast track

Aerpio Pharmaceuticals and Aadi Bioscience Enter into a Definitive Merger Agreement

Retrieved on: 
Monday, May 17, 2021
Corporate finance, Breakthrough therapy, Pharmacy, Mergers and acquisitions, Fast track, Perivascular epithelioid cell tumour, Articles, Economy, Health care

Aadi has received Orphan designation, Fast Track designation and Breakthrough Therapy designation from the FDA for FYARRO for the treatment of patients with advanced malignant PEComa.

Key Points: 
  • Aadi has received Orphan designation, Fast Track designation and Breakthrough Therapy designation from the FDA for FYARRO for the treatment of patients with advanced malignant PEComa.
  • Following the closing of the concurrent PIPE financing, Aerpio shareholders will own approximately 14.7% of the combined company.
  • The terms and conditions of the CVRs will be pursuant to a CVR Agreement Aerpio will enter into prior to the closing of the merger (the \xe2\x80\x9cCVR Agreement\xe2\x80\x9d).\nThe merger agreement has been approved by the boards of directors of both companies.
  • In connection with the proposed transaction between Aerpio and Aadi, Aerpio will file a proxy statement with the Securities and Exchange Commission (\xe2\x80\x9cSEC\xe2\x80\x9d).

BridgeBio Pharma Receives FDA Fast Track Designation for Investigational Gene Therapy for Congenital Adrenal Hyperplasia

Retrieved on: 
Friday, May 14, 2021
Branches of biology, Biology, Life sciences, Enzymes, Metabolism, Gene therapy, Genetic engineering, Fast track, 21-Hydroxylase, Aldosterone

The FDA\xe2\x80\x99s Fast Track designation reinforces the urgency to address the unmet needs of patients with CAH as quickly and safely as possible.

Key Points: 
  • The FDA\xe2\x80\x99s Fast Track designation reinforces the urgency to address the unmet needs of patients with CAH as quickly and safely as possible.
  • We are grateful to have received Fast Track along with other key designations granted by the FDA and the EMA,\xe2\x80\x9d said Eric David, M.D., J.D., CEO at BridgeBio Gene Therapy, which is focused on developing gene therapy treatment options for patients in need.
  • The disease is caused by deleterious mutations in the gene encoding an enzyme called 21-hydroxylase, leading to lack of endogenous cortisol and aldosterone production.
  • The presentation covered three key Investigational New Drug (IND)-enabling studies that informed the anticipated upcoming clinical trial for BBP-631.

UroGen Pharma Reports First Quarter 2021 Financial Results and Recent Corporate Developments

Retrieved on: 
Thursday, May 13, 2021
Oncology, Health, Hospitals, Other Health, Pharmaceutical, Biotechnology, Health sciences, Pharmacology, Health, Breakthrough therapy, Orphan drugs, Antineoplastic drugs, Aziridines, Enones, Mitomycin C, Hydrogel, Fast track, Modified-release dosage, Jelmyto®, Upper Tract Urothelial Cancer (UTUC), UGN-102, the Phase 3 ATLAS Trial, UroGen Pharma Ltd., JELMYTO®, UPPER TRACT UROTHELIAL CANCER (UTUC), UGN-102, THE PHASE 3 ATLAS TRIAL, UROGEN PHARMA LTD.

The U.S. FDA previously granted Orphan Drug, Fast Track, and Breakthrough Therapy Designations to Jelmyto for the treatment of LG-UTUC.

Key Points: 
  • The U.S. FDA previously granted Orphan Drug, Fast Track, and Breakthrough Therapy Designations to Jelmyto for the treatment of LG-UTUC.
  • It is important that you receive all 6 doses of JELMYTO according to your healthcare provider\xe2\x80\x99s instructions.
  • If you miss any appointments, call your healthcare provider as soon as possible to reschedule your appointment.
  • UroGen has developed RTGelTM reverse-thermal hydrogel, a proprietary sustained release, hydrogel-based platform technology that has the potential to improve therapeutic profiles of existing drugs.

FDA Grants Fast Track Designation to CERC-002 for Treatment of Hospitalized Patients with COVID-19

Retrieved on: 
Tuesday, May 11, 2021
Life sciences, Biotechnology, Pharmacy, Fast track, Food and Drug Administration, Biopharmaceutical

and CHESTERBROOK, Pa., May 11, 2021 (GLOBE NEWSWIRE) -- Cerecor Inc. (NASDAQ: CERC), a biopharmaceutical company focused on becoming a leader in development and commercialization of treatments for rare and orphan diseases, today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to CERC-002 for treatment of hospitalized patients with COVID-19.

Key Points: 
  • and CHESTERBROOK, Pa., May 11, 2021 (GLOBE NEWSWIRE) -- Cerecor Inc. (NASDAQ: CERC), a biopharmaceutical company focused on becoming a leader in development and commercialization of treatments for rare and orphan diseases, today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to CERC-002 for treatment of hospitalized patients with COVID-19.
  • CERC-002 is a first-in-class fully human monoclonal antibody targeting LIGHT (tumor necrosis factor superfamily member 14, TNFSF14).\nFast Track designation is granted to drugs being developed for the treatment of serious or life-threatening diseases or conditions where there is an unmet medical need.
  • Sponsors of drugs that receive Fast Track designation have the opportunity for more frequent interactions with the FDA review team throughout the development program.
  • Actual results may differ from those set forth in the forward-looking statements.

ImmunoMet Therapeutics Granted Fast Track Designation by U.S. FDA for IM156 in Idiopathic Pulmonary Fibrosis

Retrieved on: 
Monday, May 3, 2021
Research, Venture capital, FDA, Clinical trials, Professional services, Biotechnology, Pharmaceutical, Health, Science, Oncology, Fast track, Food and Drug Administration

Phase 1 study in healthy volunteers.\xe2\x80\x9d\nFast Track designation is intended to facilitate the development and review of drugs used to treat serious conditions and to fill an unmet medical need.

Key Points: 
  • Phase 1 study in healthy volunteers.\xe2\x80\x9d\nFast Track designation is intended to facilitate the development and review of drugs used to treat serious conditions and to fill an unmet medical need.
  • ImmunoMet\xe2\x80\x99s lead molecule, IM156, is a PC1 inhibitor and is the first potent PC1 inhibitor to complete Phase 1 with good tolerability.
  • In addition to IM156, ImmunoMet owns a large library of biguanides with the potential for development, internally or with partners, for multiple indications.
  • ImmunoMet undertakes no obligation to update any forward-looking statements for any reason.\nView source version on businesswire.com: https://www.businesswire.com/news/home/20210503005641/en/\n'

HUTCHMED Completes Rolling Submission of NDA to U.S. FDA for Surufatinib for the Treatment of Advanced Neuroendocrine Tumors

Retrieved on: 
Monday, May 3, 2021
Food and Drug Administration, Fast track, National Defence Academy, Life sciences, Biotechnology, Health care, Pharmaceutical industry

HUTCHMED previously announced that it had reached an agreement with the FDA during a pre-NDA meeting , whereby these studies may serve as the basis to support an NDA submission.

Key Points: 
  • HUTCHMED previously announced that it had reached an agreement with the FDA during a pre-NDA meeting , whereby these studies may serve as the basis to support an NDA submission.
  • Fast Track Designations granted in April 2020 by the FDA have permitted HUTCHMED to submit sections of the NDA on a rolling basis.
  • Filing acceptance of the NDA is subject to the FDA\xe2\x80\x99s review of the complete application.
  • A U.S. FDA NDA rolling submission was initiated in December 2020 , to be followed by a MAA submission to the EMA in Europe.

Akari Therapeutics Receives FDA Fast Track Designation for Nomacopan for the Treatment of Bullous Pemphigoid

Retrieved on: 
Wednesday, April 28, 2021
Life sciences, Health, Biotechnology, Pharmaceuticals policy, Food and Drug Administration, Fast track, Orphan drug, XC2, European Medicines Agency

Nomacopan has also been granted orphan drug designation for nomacopan for the treatment of BP by the FDA and the European Medicines Agency (EMA).\nFast track is a process designed to facilitate the development and expedite the review of drugs to treat serious conditions and fill an unmet medical need.

Key Points: 
  • Nomacopan has also been granted orphan drug designation for nomacopan for the treatment of BP by the FDA and the European Medicines Agency (EMA).\nFast track is a process designed to facilitate the development and expedite the review of drugs to treat serious conditions and fill an unmet medical need.
  • The purpose is to get important new drugs to the patient earlier.
  • The prevalence of BP is estimated to be approximately 120,000 patients in\xc2\xa0U.S.\xc2\xa0and\xc2\xa0EU5 with moderate and severe patients making up around three-quarters of the patient population.
  • We caution investors not to place considerable reliance on the forward-looking statements contained in this press release.\n"

Can-Fite Initiates Preclinical Studies Required by FDA and EMA for the Registration of its Two Lead Drug Candidates

Retrieved on: 
Tuesday, April 20, 2021
Biotechnology, Health, Pharmaceutical, Clinical trials, Oncology, Medical specialties, Drugs, Health care, Immunosuppressants, Food and Drug Administration, Monoclonal antibodies, TNF inhibitors, Arthritis, Fast track, Psoriasis, Briakinumab, Janus kinase inhibitor

Namodenoson has Orphan Drug Status in the U.S. and Europe and Fast Track Status with the FDA.

Key Points: 
  • Namodenoson has Orphan Drug Status in the U.S. and Europe and Fast Track Status with the FDA.
  • The Company's lead drug candidate, Piclidenoson, is currently in Phase III trials for rheumatoid arthritis and psoriasis.
  • These drugs have an excellent safety profile with experience in over 1,500 patients in clinical studies to date.
  • Forward-looking statements relate to anticipated or expected events, activities, trends or results as of the date they are made.

Aprea Therapeutics Receives FDA Orphan Drug Designation for Eprenetapopt for the Treatment of Acute Myeloid Leukemia (AML)

Retrieved on: 
Thursday, April 8, 2021
Health sciences, Health, Life sciences, Orphan drugs, Myelodysplastic syndrome, Acute myeloid leukemia, Fast track, Breakthrough therapy, Tumors of the hematopoietic and lymphoid tissues, Devimistat, Vadastuximab talirine

We look forward to continued productive dialogue with FDA and bringing eprenetapopt to patients as soon as possible.

Key Points: 
  • We look forward to continued productive dialogue with FDA and bringing eprenetapopt to patients as soon as possible.
  • The Companys lead product candidate is eprenetapopt (APR-246), a small molecule in clinical development for hematologic malignancies and solid tumors.
  • Eprenetapopt has received Breakthrough Therapy, Orphan Drug and Fast Track designations from the FDA for myelodysplastic syndromes (MDS), Orphan Drug and Fast Track designations from the FDA for acute myeloid leukemia (AML), and Orphan Drug designation from the European Commission for MDS, AML and ovarian cancer.
  • Eprenetapopt has received Breakthrough Therapy, Orphan Drug and Fast Track designations from the FDA for MDS, Orphan Drug and Fast Track designations from the FDA for AML, and Orphan Drug designation from the European Medicines Agency for MDS, AML and ovarian cancer.

Immutep Achieves Fast Track Designation From US FDA For Efti, A Soluble Lag-3 Protein, In First Line Recurrent/Metastatic Head & Neck Cancer

Retrieved on: 
Thursday, April 8, 2021
Medical specialties, Immutep, Health care, Medicine, Society for Immunotherapy of Cancer, Fast track, Cancer immunotherapy

Interim clinical data from TACTI-002 was presented at the Society for Immunotherapy of Cancer (SITC) in November 2020.

Key Points: 
  • Interim clinical data from TACTI-002 was presented at the Society for Immunotherapy of Cancer (SITC) in November 2020.
  • FDA Fast Track designation is awarded to help important new therapies reach patients earlier.
  • More information on Fast Track designation is available on the US FDAs website.
  • Immutep is listed on the Australian Securities Exchange (IMM), and on the NASDAQ (IMMP) in the United States.