Phase 2 Trial

Affimed NV (NASDAQ: AFMD) has announced interim clinical results from the investigator-initiated Phase 1/2 study evaluating cbNK cells pre-complexed with Affimed's innate cell engager (ICE) AFM13. Eighteen patients with CD30-positive relapsed or refractory Hodgkin and non-...

Puma Biotechnology Inc (NASDAQ: PBYI) announced interim data from the neratinib arm of Phase 2 INSIGhT Trial in newly diagnosed unmethylated glioblastoma with IDH R132H mutation-negative.  In the intent-to-treat population, progression-free survival (PFS) was not significantly...

Jaguar Health Inc (NASDAQ: JAGX) announced the topline results of the investigator-initiated Phase 2 HALT-D trial evaluating crofelemer to prevent chemotherapy-induced diarrhea (CID). The trial included HER2-positive breast cancer patients being treated with trastuzumab, pertuzumab,...

The European Commission (EC) has granted conditional marketing authorization to Roche Holdings AG's (OTC: RHHBY) Gavreto (pralsetinib) for treating adults with a form of non-small cell lung cancer. The approval covers pralsetinib as a monotherapy for treating adults with...

Merck & Co Inc (NYSE: MRK) announced an update regarding the Phase 2 IMAGINE-DR trial (MK-8507-13), evaluating the combination of MK-8507 and islatravir (ISL) as a once-weekly oral treatment for HIV-1 infection.  Decreases in total lymphocyte and CD4+ T-cell counts were...

Ascendis Pharma A/S (NASDAQ: ASND) announced topline results from Week 84 of its Phase 2 PaTH Forward Trial of its TransCon PTH candidate hypoparathyroidism (HP).  Hypoparathyroidism is a condition in which the body produces abnormally low levels of PTH, the key to regulating...

Connect Biopharma Holdings Limited (NASDAQ: CNTB) has reported topline results from the Phase 2 trial of CBP-201 administered subcutaneously (SC) to adult patients with moderate-to-severe atopic dermatitis (AD). The data show that the trial met its primary efficacy endpoint, with...

Spark Therapeutics, a unit of Roche Holdings AG (OTC: RHHBY), has announced data from its Phase 1/2 trial of SPK-8011 in hemophilia A. At a median efficacy follow-up of 33.4 months, the study found that 16 of 18 study participants had sustained factor VIII (FVIII), which permitted prophylaxis...

Eloxx Pharmaceuticals Inc (NASDAQ: ELOX) posted topline results from the monotherapy arms of its Phase 2 trial of ELX-02 in Class 1 cystic fibrosis patients with at least one G542X nonsense allele mutation.  Eloxx delivered one-week ELX-02 data on 12 people with a G542X...

Imara Inc (NASDAQ: IMRA) has announced data from a pre-specified interim analysis from its Forte Phase 2b trial of tovinontrine (IMR-687) in transfusion-dependent subjects (TDT) with beta-thalassemia. Subjects in the Forte trial were randomized to either a lower dose group (200 mg or 300...

InflaRx N.V. (NASDAQ: IFRX) has announced data from the European Phase II IXCHANGE study of vilobelimab in patients with ANCA-associated vasculitis (AAV).  The trial demonstrated a comparable clinical response of vilobelimab to the standard of care, significantly reducing the...

Novocure Ltd (NASDAQ: NVCR) has released updated data from the Phase 2 pilot 2-THE-TOP of Tumor Treating Fields (TTFields) together with pembrolizumab and temozolomide for newly diagnosed glioblastoma (GBM).  Of the 19 patients with follow-up over nine months, the median...

Moderna Inc (NASDAQ: MRNA) announced data from the AstraZeneca Plc (NASDAQ: AZN)-led Phase 2 (EPICCURE) study evaluating AZD8601 in patients undergoing coronary artery bypass grafting (CABG). AZD8601 is an mRNA therapeutic that encodes for vascular endothelial growth...

Bristol Myers Squibb & Co (NYSE: BMY) and Johnson & Johnson's (NYSE: JNJ) unit Janssen Pharmaceuticals Inc announced results from the Phase 2 AXIOMATIC-TKR study of Factor XIa inhibitor called milvexian. Milvexian (BMS-986177) significantly lowered...

Iovance Biotherapeutics Inc (NASDAQ: IOVA) has announced data for lifileucel in combination with Merck Co Inc's (NYSE: MRK) Keytruda (pembrolizumab) in patients with advanced cancers. Data were presented at the Society for Immunotherapy of Cancer Annual Meeting. Early-...