Phase 1 Trial

Vallon Pharmaceuticals Inc (NASDAQ: VLON) shares are plunging after releasing topline results from its Phase 1 SEAL study evaluating ADAIR, an abuse-deterrent formulation of immediate-release (IR) dextroamphetamine for attention deficit hyperactivity disorder (ADHD). The study...

The FDA has cleared Adagene Inc's (NASDAQ: ADAG) Phase 1b/2 clinical trial of its anti-CTLA-4 monoclonal antibody (mAb), ADG126, in combination with Merck & Co Inc's (NYSE: MRK) Keytruda (pembrolizumab).  The global trial (ADG126-P001 / KEYNOTE-C98) will...

The FDA has signed off Sonnet BioTherapeutics Holdings Inc's (NASDAQ: SONN) Investigational New Drug (IND) application for SON-1010, a proprietary version of Interleukin 12 (IL-12) configured using Sonnet's Fully Human Albumin Binding (FHAB) technology.  Sonnet will...

IDEAYA Biosciences Inc (NASDAQ: IDYA) has announced interim Phase 1 data for IDE397 in patients with solid tumors with methylthioadenosine phosphorylase (MTAP) deletion, estimated to represent approximately 15% of solid tumors. The observed steady-state plasma SAM exceeds the target...

Cortexyme Inc (NASDAQ: CRTX) has announced results from the single ascending dose (SAD) portion of the Phase 1 trial of COR588 for diseases related to P. gingivalis infection.  The SAD trial was designed to evaluate the safety and pharmacokinetics of COR588 in healthy volunteers. In the...

Eight months after delivering promising biomarker data from one of the first CRISPR trials, Intellia Therapeutics Inc (NASDAQ: NTLA) presented additional data from the Phase 1 trial for NTLA-2001 in transthyretin, or ATTR, amyloidosis. In the initial study, Intellia showed that...

Alkermes plc (NASDAQ: ALKS) presented new data from the ongoing phase 1/2 ARTISTRY-1 trial for nemvaleukin alfa, engineered interleukin-2 (IL-2) variant immunotherapy for advanced renal cell carcinoma (RCC). The data were presented at the American Society of Clinical Oncology (ASCO...

Enanta Pharmaceuticals Inc (NASDAQ: ENTA) has dosed the first subject in its Phase 1 trial of EDP-235, a coronavirus 3CL protease inhibitor, specifically designed as a once-daily, oral treatment for COVID-19. The Company plans to report data from this study in Q2 of 2022, and, assuming...

Amgen Inc (NASDAQ: AMGN) announced the presentation of efficacy and safety data from the CodeBreaK 100 Phase 1/2 trial in KRAS G12C-mutated advanced pancreatic cancer patients who received Lumakras (sotorasib).  The data will be presented at the American Society of...

The FDA has instituted a clinical hold on Legend Biotech Corporation's (NASDAQ: LEGN) Phase 1 trial for LB1901.  LB1901 is the company's investigational autologous chimeric antigen receptor T-cell (CAR-T) therapy targeting malignant CD4+ T-cells for relapsed or...

Moleculin Biotech Inc (NASDAQ: MBRX) has announced preliminary results supporting the successful conclusion of its second Phase 1 trial in Poland, evaluating Annamycin for relapsed and refractory acute myeloid leukemia (AML). Moleculin determined a dose of 240 mg/m2 as the...

Avalon GloboCare Corp (NASDAQ: AVCO) is expanding its cellular immuno-oncology program with the addition of novel Chimeric Antigen Receptor – Natural Killer (CAR-NK) cell therapies. Avalon is leveraging its mRNA-based FLASH-CAR platform to develop autologous and universal CAR-NK...

UNITY Biotechnology Inc's (NASDAQ: UBX) 24-week data from the Phase 1 study of UBX1325 was presented at the Bascom Palmer Eye Institute Angiogenesis, Exudation, and Degeneration 2022 conference.  UBX1325 was well-tolerated without signs of intraocular inflammation or other...

Pardes Biosciences Inc's (NASDAQ: PRDS) has presented interim data from its ongoing PBI-0451 Phase 1 trial in healthy adult volunteers at the Conference on Retroviruses and Opportunistic Infections (CROI) 2022.  The presentation shared details around the nonclinical profile...

The FDA has signed off Cidara Therapeutics Inc's (NASDAQ: CDTX) Investigational New Drug (IND) application for its lead flu drug-Fc conjugate (DFC), CD388 for influenza. CD388 is a highly potent, long-acting antiviral immunotherapy designed to deliver universal prevention and...