Biostock

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🟢 $ENTA — Clinical Milestone
Successful End-of-Phase 2 FDA Meeting - Zelicapavir Advances to Registrational Phase 2b/3
Enanta announced advancement of zelicapavir into a registrational Phase 2b/3 clinical trial in adults at high risk of severe RSV outcomes (HR3 population: C…

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🔴 $NVCR — Clinical Readout
Phase 3 TRIDENT Trial Topline Results - Primary Endpoint Missed
The Phase 3 TRIDENT trial in newly diagnosed glioblastoma did not meet its primary endpoint of demonstrating a statistically significant improvement in overall survival for the Early S…

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🟢 $KPRX — Clinical Readout
KIO-300 Preclinical Data - Significant Seizure Suppression in Temporal Lobe Epilepsy Model
KIO-300, the active pharmaceutical ingredient of KIO-301, significantly suppressed seizure-associated electrophysiological activity in an ex vivo temporal lo…

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🟢 $GSK — FDA Approval
FDA Approval - First and Only Oral Carbapenem Antibiotic for cUTIs
The US FDA approved Utebzi (tebipenem pivoxil) for the treatment of complicated urinary tract infections (cUTIs), including pyelonephritis, caused by certain susceptible pathogens in adu…

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🟢 $VSTM — Clinical Readout
RAMP 205 RP2D Cohort - Positive Updated Results in 1L mPDAC (52% ORR)
Verastem announced positive updated safety and efficacy results from the RAMP 205 Phase 1b/2a RP2D cohort of 29 patients evaluating avutometinib plus defactinib in combination wi…

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🔴 $AZTR — Clinical Milestone
Phase 1b Trial Enrollment Paused
Azitra announced it plans to pause further enrollment in the ATR-12 Phase 1b trial for Netherton syndrome to conserve capital, redirecting funds toward the ATR-COSF cosmetic program. The company cited encouraging …

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🟢 $MIRA — Clinical Milestone
Phase 2a Protocol Submitted to FDA - Protocol Mira-002
MIRA submitted a Phase 2a clinical trial protocol (Protocol Mira-002) to the FDA for Ketamir-2 in CIPN. The FDA issued an acknowledgment of receipt confirming acceptance of the submission. Th…

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🟢 $ELTX — Clinical Readout
100% Complete Responses in Metastatic PDAC Post ELI-002 7P + Nivolumab
Preliminary clinical observations: 3 patients who progressed after ELI-002 7P in Phase 2 AMPLIFY-7P and received subsequent nivolumab-based therapy achieved confirmed complete r…

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🟢 $QURE — Clinical Milestone
Type B FDA Meeting Outcome - 3-Year Phase I/II Data Acceptable as Primary Basis for AMT-130 BLA Accelerated Approval
Following a Type B meeting with the FDA, the FDA communicated that the 3-year analysis from the Phase I/II study would be accepta…

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🟢 $IRD — Clinical Readout
Comprehensive Phase 1/2 Data Presented at Virtual R&D Science Forum - Adult 24M and Pediatric 6M
At the June 16, 2026 Virtual R&D Science Forum, Opus Genetics presented comprehensive OPGx-LCA5 Phase 1/2 data including adult cohort (N=3) with visual …

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🟢 $HCWB — Clinical Readout
Phase 1 Positive Preliminary Data Readout - First Two Dose Cohorts
Positive preliminary human data readout for first two dose cohorts from the dose-escalating Phase 1 trial (NCT07049328) of HCW9302 monotherapy in alopecia areata. All three particip…

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🟢 $AVTX — Clinical Milestone
AVTX-010 Pipeline Expansion Announced
Avalo Therapeutics announced the advancement of AVTX-010, a long-acting next-generation anti-IL-1beta monoclonal antibody, with potential development in hidradenitis suppurativa and additional inflammatory di…

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🟢 $NBP — FDA Designation
FDA Fast Track Designation for Givastomig - 1L HER2-Negative Metastatic Gastric Cancer
FDA granted Fast Track Designation to givastomig in combination with nivolumab and chemotherapy for patients with previously untreated HER2-negative advanced or me…

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🟢 $RYTM — Clinical Readout
ENDO 2026 - Setmelanotide 2.5-Year Long-Term Efficacy in Acquired HO (-18.9% Mean BMI Reduction)
Rhythm presented long-term efficacy and safety data for setmelanotide in acquired HO at ENDO 2026, covering up to 2.5 years of treatment in a Phase 2 s…

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🟢 $RYTM — Clinical Readout
ENDO 2026 - Bivamelagon Phase 2 One-Year Data Showing Progressive BMI Reductions in Acquired HO
Rhythm presented 1-year Phase 2 efficacy and safety data for oral bivamelagon in acquired HO at ENDO 2026. Of 28 enrolled patients, 26 remained on thera…

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🟢 $INBX — NDA/BLA Submission
FDA Accepts BLA for Ozekibart in Conventional Chondrosarcoma - No Filing Review Issues
FDA accepted for filing the BLA for ozekibart (INBRX-109) in patients with unresectable or metastatic conventional chondrosarcoma. The FDA identified no filing…

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🔴 $ELTX — Clinical Readout
Phase 2 AMPLIFY-7P Primary DFS Endpoint Not Met in ITT Population
Phase 2 AMPLIFY-7P trial of ELI-002 7P in adjuvant mKRAS-driven PDAC did not meet its pre-specified primary DFS endpoint in the intent-to-treat population (HR 0.85, p=0.5329, n=144).…

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🟢 $CNTX — Clinical Readout
CTIM-76 Phase 1a Interim Data - 29% Confirmed ORR in PROC
Context Therapeutics presented Phase 1a interim data for CTIM-76 (CLDN6 x CD3 T cell engaging bispecific antibody) at target doses (140-280 mcg). In RECIST-evaluable PROC patients (n=9), 29%…

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🔴 $NMRA — Clinical Readout
Navacaprant Phase 3 KOASTAL-2 and KOASTAL-3 Fail Primary Endpoint - Development Discontinued
Both KOASTAL-2 (430 patients) and KOASTAL-3 (422 patients) Phase 3 studies of navacaprant 80 mg for MDD failed to achieve statistical significance on the p…

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🟢 $TELO — Clinical Readout
Peer-Reviewed Preclinical Publication - Restoration of Insulin Sensitivity and Glucose Homeostasis in Type 2 Diabetes Model
Telomir Pharmaceuticals announced peer-reviewed publication in Biomedicine & Pharmacotherapy showing Telomir-Zn produced dos…