$XBI $127.18 +0.4%
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Pipeline Updates
$IOVA +1.8% Receipt of regulatory feedback from the U.S. Food and Drug Administration (FDA) regarding its potency assays for lifileucel. source
$IMCR -2.9% Immunocore announces dosing of first patient with ImmTAV® bispecific molecule for chronic Hepatitis B. source
$IDRA +1.0% Will not continue ILLUMINATE-301 program of tilsotolimod with ipilimumab. source
$GLPG -2.7% Galapagos announces first patient enrolled in FILOSOPHY study to advance understanding of Jyseleca (filgotinib) effectiveness and safety in a real-world setting. source
$SRPT +8.4% Sarepta Therapeutics’ Investigational Gene Therapy for the Treatment of Duchenne Muscular Dystrophy, SRP-9001, Demonstrates Robust Expression and Consistent Safety Profile Using Sarepta’s Commercial Process Material. source
$JAGX +0.8% Jaguar Health Provides Updates on Canalevia (Crofelemer), the First Plant-based Prescription Medicine Under Development for Chemotherapy-induced Diarrhea in Dogs and Exercise-induced Diarrhea in Dogs. source
$MTCR +0.3% Metacrine Achieves Enrollment Target for MET642 Phase 2a Trial Interim Analysis. source
$IMAB -0.2% I-Mab Announces First Patient Dosed in China Phase 2 Combination Trial of Lemzoparlimab with Azacitidine in Patients with Acute Myeloid Leukemia or Myelodysplastic Syndrome. source
$CBIO +3.8% Catalyst Biosciences Announces First Patient Dosed in Marzeptacog Alfa (Activated) Phase 1/2 Study in Factor VII Deficiency, Glanzmann Thrombasthenia and Hemophilia A treated with Hemlibra. source
$MBIO +10.8% Mustang Bio and City of Hope Announce First Patient Dosed in Phase 1 Clinical Trial of MB-101 (IL13Rα2-specific CAR T cells) to Treat Leptomeningeal Brain Tumors. source
$PCRX +2.2% Pacira BioSciences Announces Notice of Allowance of New Patent for EXPAREL. source
$IMPL +0.2% Impel NeuroPharma Launches Reroute Migraine Relief, Educational Initiative That Brings to Life the Underrecognized Connection Between Migraine, the Brain and Gut. source
$AGEN +20.6% Agenus and Bristol Myers Squibb Announce Exclusive Global License for Agenus’ Anti-TIGIT Bispecific Antibody Program. source
$TLSA -1.8% Tiziana provides final results for year ended 31 December 2020. source
$CYDY -2.0% CytoDyn to Submit Newly Completed Topline Report of CD12 Trial Results to Regulatory Agencies in Multiple Countries including India and Philippines. source
$KNTE +11.3% Will initiate Phase 1 KIN-2787 trial in mid 2021. source
$ABEO +14.7% Positive interim MPS III data presented at 17th Annual WORLDSymposium. source
$IMTX -1.6% Data update for ongoing ACTengine® IMA200 clinical trial series demonstrated first anti-tumor activity in heavily pre-treated solid cancer patients during early phases of dose escalation. source
$CALT -0.1% The FDA have set a Prescription Drug User Fee Act (PDUFA) goal date of September 15, 2021. source
$IMMP +17.8% New data from TACTI-002 and INSIGHT-004 to be reported at ASCO in June 2021. source
$MGTA +11.5% Presenting at Oppenheimer Rare & Orphan Disease Summet on May 21 and Cowen Virtual Oncology Innovation Summet on May 20. source
$MRUS +13.0% Merus Announces Collaborations in Israel, Italy and Spain to Increase Screening and Identification of Cancer Patients with NRG1 Fusion Tumors and to Raise Awareness of the Phase 1/2 eNRGy Clinical Trial. source
$LEGN +14.2% New and updated cilta-cel data to be presented at the upcoming 2021 American Society of Clinical Oncology (ASCO) Annual Meeting and European Hematology Association (EHA) Virtual Congress. source
$XXII +13.2% 22nd Century VP of Regulatory Science to Present on Health Disparities Caused by Cigarette Addiction at FDLI Annual Conference. source
$AGTC +12.2% Company on track to provide multiple data readouts for its XLRP and ACHM clinical programs in 2021 and 2022. source
$SMMT +17.4% As of May 14, 2021, Summit had enrolled a total of 652 patients into its two ridinilazole Phase 3 Ri-CoDIFy clinical trials. source
$INMB +12.4% We expect to receive a ‘go/no-go’ decision by the independent Data Safety Monitoring Board following the analysis of the first 100 patients. source
$ONTX +75.0% The Phase 1 solid tumor study with ON 123300 in China is ongoing with no dose-limiting toxicities observed in the first two cohorts. Enrollment to the third cohort (120 mg) will now proceed. source
$SEEL -18.8% Seelos Therapeutics Announces Positive Topline Data from the Open-Label Study of SLS-002 (Intranasal Racemic Ketamine), Demonstrating a Significant Treatment Effect and a Well Tolerated Safety Profile for Acute Suicidal Ideation and Behavior in Patients with Major Depressive Disorder. source
$PDSB +13.9% PDS Biotechnology Appoints Immuno-Oncology Experts Dr. Olivera Finn and Dr. Mark Frohlich to Scientific Advisory Board. source
$VOR +17.8% Health Canada clears the CTA for VOR33 clinical trial. source
Finance Updates
$ANVS -4.8% Annovis Bio Appoints Accomplished Neuroscientist Dr. Cheng Fang as VP of Research. source
$EVFM -34.2% Evofem Biosciences Announces Pricing of $50 Million Public Offering. source
$CYTR +12.5% CytRx concluded the quarter ended March 31, 2021 with cash on hand of approximately $9.3 million, which management believes is sufficient to fund ongoing operations for the foreseeable future. source
Posted by FS