Cassava Sciences Soared Cassava Sciences (SAVA) stock soared today. The firm announced that it will present two new clinical datasets for its product candidates at the 2021 Alzheimer’s Association International Conference (AAIC), which will be held virtually in Denver, CO from July 26th through July 30th. Cassava Sciences’ investigational product candidates include simufilam treatment . . . This content is for paid subscribers. Please click here to subscribe or …

Immunome Inc: Neutralizing SARS-C0V-2 Delta Variant Immunome Inc (IMNM) is a small biotech firm whose stock soared after announcing today that its three-antibody cocktail (IMM-BCP-01) demonstrated potent neutralizing activity against the SARS-CoV-2 (the virus that cause COVID-19) Delta variant in pre-clinical pseudovirus testing. The IMM-BCP-01 cocktail demonstrated in-vitro activity via non-neutralizing mechanisms, such as complement fixation, which Immunome expects will enable viral clearance. From the …

Cytokinetics Positive Topline Results of CK-274 Cytokinetics (CYTK) announced positive topline results of Phase 2 clinical trial of CK-274 - an investigational cardiac myosin inhibitor in development for the potential treatment of hypertrophic cardiomyopathy (HCM). The results inform dose selection. They also support the progression of CK-274 to a planned Phase 3 registrational clinical trial, expected to start before . . . This content is …

Vir Biotechnology Vir Biotechnology (VIR) announced the dosing of the first patient in the Phase 2 MARCH (Monoclonal Antibody siRNA Combination against Hepatitis B) trial to evaluate VIR-2218 together with VIR-3434 for the treatment of patients with chronic hepatitis B virus (HBV) infection – a combination designed to achieve a functional cure. VIR-2218 is an investigational . . . This content is for paid subscribers. …

Hoth Therapeutics Hoth Therapeutics (HOTH) announced that its product, HT-003, has yielded positive results in an in vivo acne therapeutic model. The model showed that HT-003 reduces the expression of toll-like receptor 2 (TLR2

Halozyme Therapeutics Announced US FDA Approval for Janssen Biotech's DARZALEX FASPRO® Halozyme Therapeutics (HALO) announced that Janssen Biotech, Inc. (Janssen) received U.S. FDA approval of DARZALEX FASPRO® (daratumumab + hyaluronidase-fihj) in combination with pomalidomide and dexamethasone (Pd) for adult patients with multiple myeloma who have received at least one prior line of therapy, including . . . This content is for paid subscribers. Please click here to …

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 …