Market News & Trends
Catalent Signs Commercial Supply Agreement With Phathom Pharmaceuticals
Catalent recently announced it has signed a commercial supply agreement with Phathom Pharmaceuticals, a late clinical-stage biopharmaceutical company focused on developing and commercializing novel treatments…
Excision Receives FDA Clearance of IND for Phase 1/2 Trial of EBT-101 CRISPR-Based Therapeutic for Treatment of HIV
Excision BioTherapeutics, Inc. recently announced the US FDA has accepted the Investigational New Drug (IND) application for EBT-101, a CRISPR-based therapeutic candidate in development as…
Denali Therapeutics Announces Initiation of Phase 1b Study of EIF2B Activator DNL343 in ALS
Denali Therapeutics Inc. recently announced that dosing recently commenced in a Phase 1b study of DNL343, its brain-penetrant small molecule activator of EIF2B, in participants diagnosed…
Kinnate Biopharma Inc. Presents Preclinical Data on its Lead FGFR Inhibitor Candidate
Kinnate Biopharma Inc. recently announced results from preclinical studies evaluating its lead Fibroblast Growth Factor Receptor (FGFR) inhibitor candidate, KIN-3248. These findings were presented during…
Pii Invests in Expansion of Sterile Fill-Finish Capacity & Capabilities
Pii has strategically invested in expansion of our sterile fill-finish capacity and capabilities, with production lines capable of supporting large commercial scale batch sizes. Specifically,…
Evelo Biosciences Announces Issuance of US Patent for Pharmaceutical Compositions of Single Strains of Naturally Occurring Bacteria as Medicines
Evelo Biosciences, Inc. recently announced the US Patent and Trademark Office has issued a new composition of matter patent (No. 11,090,341) for medicines comprising pharmaceutical…
Decibel Therapeutics Receives Orphan Drug & Rare Pediatric Disease Designations for DB-OTO for the Treatment of Otoferlin-Related Congenital Hearing Loss
Decibel Therapeutics recently announced the US FDA has granted both Orphan Drug Designation and Rare Pediatric Disease Designation for the company’s lead gene therapy product…
PolyPid Announces Positive Preclinical Data of its Intra-Tumoral OncoPLEX in Brain Cancer
PolyPid Ltd. recently announced positive preclinical data in two key Glioblastoma Multiform (GBM) animal models of its OncoPLEX intra-tumoral cancer therapy program. OncoPLEX utilizes the…
Newron Initiates First Potentially Pivotal Study With Evenamide in Patients With Schizophrenia
Newron Pharmaceuticals S.p.A. recently announced the initiation of Study 008A, the first potentially pivotal study with evenamide in patients with schizophrenia. Study 008A, a 4-week,…
AIM ImmunoTech Submits Pre-IND Application to the FDA for Phase 2 Clinical Study of Ampligen as a Potential Infusion Therapy for Post-COVID-19 Cognitive Dysfunction
AIM ImmunoTech Inc. recently announced it has submitted a Pre-Investigational New Drug application (Pre-IND) to the US FDA for a Phase 2 clinical study of…
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Acer Therapeutics & Relief Therapeutics Announce NDA Submission for ACER-001 for Treatment of Urea Cycle Disorders
Acer Therapeutics Inc. Relief Therapeutics recently announced the submission of a New Drug Application (NDA) to the US FDA for ACER-001 (sodium phenylbutyrate) for the treatment of Urea Cycle Disorders (UCDs)….