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Free Biopharma Daily Stock Updates - 09/09/21

$XBI $132.82 +0.39%


Covid Updates

$HGEN -47.3% FDA has declined Humanigen’s Emergency Use Authorization (EUA) Request for Lenzilumab in Hospitalized COVID-19 Patients. source

Pipeline Updates

$GRTS +2.9% Gritstone to Host Data Update on Neoantigen Oncology Programs for the Treatment of Solid Tumors During ESMO 2021. source

$APLS +0.1% Apellis Announces Top-Line Results from Phase 3 DERBY and OAKS Studies in Geographic Atrophy (GA) and Plans to Submit NDA to FDA in the First Half of 2022. source

$CORT -0.8% Corcept Announces Presentation of Positive Results From Randomized, Controlled, Phase 2 Trial of Relacorilant in Patients With Recurrent Platinum-Resistant Ovarian Cancer at ESMO 2021. source

$DNLI -0.4% Denali Therapeutics Announces Initiation of Phase 1b Study of EIF2B Activator DNL343 in ALS. source

$PDSB +2.2% PDS Biotech Completes Enrollment of Lead-In Safety Cohort in VERSATILE-002 Phase 2 Combination Trial of PDS0101-KEYTRUDA® in Recurrent or Metastatic Head and Neck Cancer. source

$BDSI +3.0% BioDelivery Sciences International Completes Acquisition of ELYXYB™ for Acute Migraine Treatment in the U.S. and Canada. source

$ALEC +3.6% Alector Announces First Participant Dosed in Phase 2 Study Evaluating AL001 in Amyotrophic Lateral Sclerosis (ALS). source

$WVE +3.1% Wave Life Sciences Announces Initiation of Dosing in Phase 1b/2a SELECT-HD Clinical Trial of WVE-003 in Huntington’s Disease. source

$MTCR +1.0% Metacrine Achieves Full Enrollment for MET642 Phase 2a Trial in Patients With Nash. source

$ELOX +10.1% Eloxx Pharmaceuticals Announces Fast Track Designation for ELX-02 for the Treatment of Cystic Fibrosis Patients with Nonsense Mutations. source

$LGVN +7.4% Longeveron Announces Final Results of Phase 1 Clinical Study of Lomecel-B Injection in Hypoplastic Left Heart Syndrome Patients. source

$VOR +0.5% VOR33 Granted U.S. FDA Fast Track Designation for AML. source

$SYRS +0.8% Syros Announces First Patient Dosed in SELECT-AML-1 Trial of Tamibarotene in Combination with Venetoclax and Azacitidine in Newly Diagnosed Unfit AML. source

$BHVN -0.8% Biohaven Spotlights Nurtec® ODT (rimegepant), the only dual-therapy indicated for both the acute and preventive treatment of migraine, at the 2021 International Headache Society - European Headache Federation Joint Congress. source

$DBTX +1.7% Decibel Therapeutics Receives Orphan Drug and Rare Pediatric Disease Designations for DB-OTO for the Treatment of Otoferlin-Related Congenital Hearing Loss. source

$DTIL +1.9% Precision BioSciences and iECURE Announce License and Collaboration Agreement to Develop ARCUS-Based Gene Editing Therapies. source

$CLSD +2.6% Clearside Biomedical Expands XIPERE™ License Agreement with Arctic Vision to Include Australia, New Zealand, India and ASEAN Countries. source

$SIOX +6.3% Sio Gene Therapies Announces Dosing of First GM1 Gangliosidosis Early Infantile (Type I) Patient in Ongoing Phase 1/2 Study of AXO-AAV-GM1 Gene Therapy. source

$ZNTL -0.1% Zentalis Pharmaceuticals to Present at the European Society for Medical Oncology (ESMO) Congress 2021. source

$BCRX +1.9% BioCryst Announces Approval of ORLADEYO® (berotralstat) in United Arab Emirates. source

$CLNN +2.2% Clene Completes Final Patient Visit in Phase 2 RESCUE-ALS Study: Topline Data Readout Expected Q4 2021. source

$SGTX -0.5% Sigilon Therapeutics Announces Acceptance of Clinical Trial Application in the UK for SIG-005 for the Treatment of Mucopolysaccharidosis Type I. source

$EVLO -1.0% Evelo Biosciences Announces Issuance of U.S. Patent for Pharmaceutical Compositions of Single Strains of Naturally Occurring Bacteria as Medicines. source

$APLT +0.7% Applied Therapeutics Reports Initial Pediatric Biomarker Data from ACTION-Galactosemia Kids . source

$GMTX +3.5% Gemini Therapeutics Announces Presentation of Previously Released Data from Its Ongoing Phase 2a Study of GEM103 at EURETINA 2021 Virtual. source

$MYOV -2.8% Myovant Sciences and Pfizer Announce FDA Acceptance of Supplemental New Drug Application for MYFEMBREE® for the Management of Moderate to Severe Pain Associated With Endometriosis. source

$GLSI +4.4% Greenwich LifeSciences Provides Updates on Recent and Upcoming Developments. source

Finance & Business Updates

$IMPL +27.3% On 9/7 Impel NeuroPharma Announces Launch of Proposed Public Offering. source


Posted by FS

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