Celldex Therapeutics is Soaring Celldex Therapeutics (CLDX) stock soared following the firm’s announcement of updated data from its ongoing, open-label Phase 1b clinical trial of CDX-0159 in patients with antihistamine refractory cold urticaria and symptomatic dermographism, which are the two most common forms of chronic inducible urticaria. CDX-0159 is a humanized monoclonal antibody that specifically binds the receptor tyrosine kinase KIT with high specificity and …

Important News and Results from Akero Therapeutics Akero Therapeutics (AKRO) announced that full results of the main portion of its Phase 2a BALANCED trial in biopsy-confirmed NASH patients with F1-F3 fibrosis have been published in Nature Medicine. The study shows investigational NASH Drug Efruxifermin (EFX) reduced liver fat to normal levels and reversed fibrosis after 16 weeks . . . This content is for paid subscribers. …

IVERIC bio GATHER2 Trial of Zimura® for Geographic Atrophy  IVERIC Bio (ISEE) announced that it received written agreement from the U.S. FDA under a Special Protocol Assessment (SPA) for the overall design of GATHER2, the pivotal clinical trial of IVERIC product Zimura® (avacincaptad pegol) for the treatment of . . . This content is for paid subscribers. Please click here to subscribe or here to log in.

TRxADE HEALTH Inc TRxADE HEALTH Inc (MEDS) is a health service IT company focused on digitalizing the retail pharmacy experience by optimizing drug procurement, the prescription journey, and patient engagement in the U.S.. The firm operates the TRxADE drug procurement marketplace serving a total of 12,100+ members nationwide, fostering price transparency. Under the Bonum Health brand, the firm offers patient-centric telehealth services. For more information, please visit …

Vir Biotechnology Announced Positive Safety Findings from its Ongoing Trials for Chronic HBV Vir Biotechnology (VIR) announced new data from its ongoing Phase 2 clinical trials of VIR-2218 and ongoing Phase 1 studies of VIR-3434 in patients with chronic hepatitis B virus (HBV) infection. The results comprised positive safety findings in addition to a reduction in hepatitis . . . This content is for paid …

Halozyme Therapeutics Approvals for DARZALEX®SC Halozyme Therapeutics (HALO) announced that the European Commission (EC) has granted Janssen Pharmaceutical Companies of Johnson & Johnson two marketing authorizations for the subcutaneous formulation of daratumumab, known as DARZALEX® SC in the European Union.  The first authorization relates to the use of DARZALEX® SC in combination with bortezomib . . . This content is for paid subscribers. Please click here to …

Blackstone Life Sciences, Intellia Therapeutics and Cellex Cell Professionals New Company Blackstone (BX) announced that funds managed by Blackstone Life Sciences have committed $250 million towards the launch of a new autologous and allogeneic universal chimeric antigen receptor (CAR) T-cell therapy company with Intellia Therapeutics (

Auris Medical Holding Ltd OligoPhoreTM Technology for ATLL Auris Medical Holding Ltd. (EARS) is a company focusing on addressing unmet medical needs through RNA therapeutics for allergies, viral infection protection and inner ear therapeutics. The firm has published results from an in vivo study demonstrating significant inhibition of tumor growth. The inhibition of tumor growth occurred by siRNA knock-down of . . . This content …

Inferior ways used to evaluate clinical-stage biotech firms are those that ignore the sciences, the technologies and the promising results from the products in clinical trials. It reached a stage where assessors are even ignoring the value of the approval of biotech firms’ products that succeeded in treating diseases that are yet to find treatments. We have Superior News from Blueprint Medicines The U.S. Food …

Gilead Sciences Yescarta for Relapsed or Refractory Indolent Follicula Lymphoma If Kite Pharma - a Gilead Sciences (GILD) company, had been acquired by any firm other than Gilead the stock would have gained at least 20% because of the news announced a few days ago. Kite Pharma announced outstanding Yescarta® (axicabtagene ciloleucel) results from the pivotal ZUMA-5 trial. At a minimum follow . . . This …

Jounce Therapeutics Inc: US FDA Cleared IND Application for JTX-1811 Targeting CCR8 Jounce Therapeutics Inc (JNCE) - a clinical-stage company focused on the discovery and development of novel cancer immunotherapies and predictive biomarkers, announced that the U.S. Food and Drug Administration has cleared its Investigational New Drug (IND) application for its product JTX-1811, an anti-CCR8 antibody.

Veracyte Inc Decipher® Prostate Test Veracyte Inc (VCYT): New data that demonstrated the prognostic utility of its Decipher® Prostate genomic classifier in men with non-metastatic castration-resistant prostate cancer (nmCRPC) has been published online in

Biogen Product Adulelm Approved for Alzheimer's Disease The latest news regarding Alzheimer’s disease is that of the FDA’s approval of Biogen Inc's (BIIB) Alzheimer disease product Adulelm (aducanumab). Although the approval seemed to be great news for Biogen many analysts and researchers, in highly regarded scientific institutions and universities, called it controversial. The FDA advisory committee has voted almost . . . This content is …

Vertex Pharmaceuticals Receives FDA Approval for TRIKAFTA® Vertex Pharmaceuticals (VRTX) announced the U.S. FDA approved the expanded use of TRIKAFTA® to include children with cystic fibrosis (CF) ages 6 through 11 years who have at least one F508del mutation in the cystic fibrosis transmembrane conductance regulator (CFTR) gene or a mutation in the CFTR gene that is responsive . . . This content is for paid subscribers. Please click here to …

Clinical Holds on bluebird bio Gene Therapies were Lifted by the FDA The U.S. FDA has lifted the clinical holds on the bluebird bio (BLUE) Phase 1/2 HGB-206 and Phase 3 HGB-210 studies of LentiGlobin for sickle cell disease (SCD) gene therapy (bb1111) for adult and . . . This content is for paid subscribers. Please click here to subscribe or here to log in.

Focus on Intellia Therapeutics Upcoming Presentation for NTLA-2001 Data to offer insight into safety and pharmacodynamics of NTLA-2001, the first-ever systemically administered in vivo CRISPR therapy candidate Late-breaking abstract selected for oral presentation on June 26 Intellia Therapeutics NTLA-2001 for People Living with hATTR-PN Intellia Therapeutics (NTLA) announced that Phase 1 . . . This content is for paid subscribers. Please click here to subscribe or here to log in.

BridgeBio Pharma Granted Fast Track Designation for Encaleret BridgeBio Pharma (BBIO) announced the U.S. FDA granted Fast Track designation for Encaleret – a treatment of autosomal dominant hypocalcemia (ADH1), on World Hypoparathyroidism Awareness Day, an annual global awareness event meant to support people who are living with ADH1 and with other types of hypoparathyroidism. ADH1 is a rare, genetic form of . . . This …

Sutro Biopharma Receives Milestone Payment from Merck KGaA, Darmstadt, Germany Sutro Biopharma (STRO) announced that it has received a milestone payment under its collaboration and license agreement with the healthcare division of Merck KGaA, Darmstadt,Germany. The payment is related to a patient enrollment achievement in the Phase 1 dose-escalation and expansion study of M1231 in adult patients . . . This content is for paid …

Amgen Announced FDA Approval of LUMAKRAS™  Amgen (AMGN) announced the news about the FDA approval of LUMAKRAS™ (sotorasib) on May 28, 2021. The firm indicated that the FDA granted approval is for adults with KRAS G12C-mutated locally advanced or metastatic non-small cell lung cancer (NSCLC) who have received at least one prior systemic therapy. LUMAKRAS received . . . This content is for paid subscribers. Please …

GlaxoSmithKline and Vir Biotechnology are Granted an EUA for Sotrovimab GlaxoSmithKline (GSK) and Vir Biotechnology (VIR) announced the U.S. FDA has . . . This content is for paid subscribers. Please click here to subscribe or here to log in.