ChemoCentryx Shares Double After FDA Approves TAVNEOSâ„¢ for Treatment of ANCA-Associated Vasculitis
Source: Streetwise Reports  (10/10/21)
Shares of ChemoCentryx Inc. traded 96% higher after the company reported the U.S. FDA approved its orally administered TAVNEOSâ„¢ (avacopan) for use in treatment of ANCA-associated vasculitis, a systemic autoimmune disease that often results in kidney or other major organ damage and failure that can be fatal if left untreated. More >

Merus Shares Rise 37% After Firm Presents Multiclonic Antibodies Clinical Data to Molecular Targets & Cancer Therapeutics Summit
Source: Streetwise Reports  (10/7/21)
Shares of Dutch oncology company Merus NV traded higher after the firm presented early and preclinical data for two full-length, multispecific antibodies, MCLA-158 and zenocutuzumab, to the AACR-NCI-EORTC Virtual International Conference on Molecular Targets and Cancer Therapeutics. More >

Voyager Shares Lift Off After Firm Signs License Deal With Pfizer for Next-Gen AAV Capsids for Gene Therapy Programs
Source: Streetwise Reports  (10/6/21)
Shares of Voyager Therapeutics Inc. traded 51% higher after the company reported it entered into a license and option agreement with Pfizer Inc. for two of its TRACERᵀᴹ AAV capsids that will be utilized to enhance Pfizer's neurologic and cardiovascular gene therapy programs. Voyager will receive an upfront payment of $30 million and is eligible to receive up to $600 million more plus product sales-based royalties, if all options are exercised and certain milestones are achieved. More >

Xenon Pharma Shares Gain 80% on Positive Data in Phase 2b Focal Epilepsy Trial
Source: Streetwise Reports  (10/4/21)
Shares of Xenon Pharmaceuticals Inc. soared to a new 52-week high after the company reported topline data from its Phase 2b X-TOLE clinical study demonstrating that its epilepsy drug candidate XEN1101 successfully met several primary and secondary efficacy endpoints and decreased monthly focal seizure frequency by 50% or greater from baseline. More >

Merck and Ridgeback Post Interim Data From Phase 3 Antiviral Drug Trial Showing 50% Reductions in Hospitalizations and Deaths in Mild and Moderate COV
Source: Streetwise Reports  (10/3/21)
Shares of Merck & Co. Inc. traded 9% higher after the company reported that in a global Phase 3 clinical trial conducted together with its partner Ridgeback Biotherapeutics, oral antiviral molnupiravir reduced risk of hospitalization or death by 50% versus placebo in patients with mild or moderate COVID-19. Merck plans to submit an Emergency Use Authorization application to the U.S. FDA and if authorized it would make molnupiravir the first approved oral antiviral medicine for COVID-19. More >

Coverage Initiated on Nanomedicine Firm, Upside 'Potentially Significant' With Upcoming Trial Results
Source: Streetwise Reports  (10/1/21)
"With Clene's potential to realize several multibillion-dollar revenue opportunities, we see its roughly $480 million enterprise value as offering attractive risk-reward," an Oppenheimer report noted. More >

Alzamend Shares Rise After FDA Gives Positive Response to Pre-IND Filing for Immune-Boosting Alzheimer's Vaccine
Source: Streetwise Reports  (9/30/21)
Shares of Alzamend Neuro Inc. traded 36% higher after the company reported that the U.S. FDA responded favorably to its Pre-IND application for AL002, a cell-based therapeutic vaccine designed to restore patients' immunological systems, providing them with the ability to combat Alzheimer's Disease. The FDA has granted the firm approval to initiate a combined Phase 1/2 clinical trial in Q1/22.

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COVID-19 Vaccine Could Be Approved in Q4/21 for 5 to 11 Year Olds
Source: Streetwise Reports  (9/30/21)
"Label extension for BioNTech and Pfizer's Comirnaty [vaccine] to include use in these younger individuals ought to buoy revenue growth near term," noted an H.C. Wainwright & Co. report. More >

Biopharma Expands Clinical Program of Lead Drug Candidate to Treat Chronic Cough
Source: Streetwise Reports  (9/29/21)
Algernon Pharmaceuticals will now pursue Ifenprodil in chronic cough based on encouraging recent study results in a Phase 2 trial. More >

Nanotech Co.'s Shares Trade Higher After Developing Antimicrobial Coating for PPE
Source: Streetwise Reports  (9/23/21)
ZEN Graphene Solutions Ltd. shares traded 13.5% higher after the company reported it delivered its first revenue-generating shipment of ZENGuard, a patent-pending coating with 99% antimicrobial activity. The first commercial shipment follows the firm's announcement yesterday that Health Canada determined ZENGuard enhanced surgical masks are safe for use by Canadians. More >

Dynavax Shares Shoot Up 30% After Its Partner Clover Biopharma Met All Key Efficacy Endpoints in Ph. 2/3 COVID-19 Vaccine Trial
Source: Streetwise Reports  (9/22/21)
Shares of Dynavax Technologies Corp. established a new 52-week high after the company reported that in the global Phase 2/3 SPECTRA COVID-19 vaccine study its collaborative partner Clover Biopharmaceuticals met all primary and secondary efficacy endpoints. Clover's vaccine, which was developed using Dynavax's CpG 1018 adjuvant, demonstrated 100% efficacy against severe COVID-19 and 84% efficacy against moderate-to-severe COVID-19 caused by any strain of SARS-CoV-2, including the Delta, Gamma, and Mu variants. More >

'Poised for Two Key Readouts in Q1/22' as Biopharma Advances Pipeline
Source: Streetwise Reports  (9/21/21)
Rezolute's two drug candidates, one for congenital hyperinsulinism and the other for diabetic macular edema, are discussed in an H.C. Wainwright & Co. report. More >

Target Price Raised on Biopharma After It Acquires Company, Splits Stock
Source: Streetwise Reports  (9/20/21)
AzurRx BioPharma now has five additional shots on goal "with the imminent full acquisition of just one compound," a ROTH Capital Partners report noted. More >

Edessa Biotech Shares Rise 87% on Positive Findings in Phase 2 Monoclonal Antibody COVID-19 Study
Source: Streetwise Reports  (9/20/21)
Edesa Biotech Inc. shares reached a new 52-week high after the company reported positive results from its Phase 2/3 monoclonal antibody study in hospitalized COVID-19 patients. More >

Innate Pharma Shares Rise After AstraZeneca Presents Positive Data From NSCLC Trial to European Conference
Source: Streetwise Reports  (9/18/21)
Innate Pharma S.A. shares traded 38% higher after the company reported its development partner AstraZeneca Plc. reported positive interim results from its Phase 2 COAST Study to the European Society for Medical Oncology Congress. When taken together with durvalumab, monalizumab was shown to improve progression-free survival and objective response rates in patients with unresectable, Stage III non-small cell lung cancer. More >

Leap Therapeutics Shares Skip Higher on Positive Preliminary Data From Gastric Cancer Study
Source: Streetwise Reports  (9/16/21)
Shares of Leap Therapeutics Inc. traded 38% higher after the company reported positive preliminary data from the Phase 2a DisTinGuish Study of DKN-01 plus tislelizumab at the European Society for Medical Oncology Congress. More >

French Biotech Firm Initiates Pivotal Phase 3 Study of Lanifibranor in 900 NASH Patients
Source: Streetwise Reports  (9/15/21)
ROTH Capital Partners LLC advised in a research report that Inventiva S.A. has initiated enrollment in its highly anticipated pivotal Phase 3 Study of Lanifibranor in individuals diagnosed with nonalcoholic steatohepatitis. ROTH rates Inventiva a "Buy" with a 12-month price target of €55/share which represents a nearly four-fold increase over the current share price. More >

Instil Bio Receives FDA Approval to Initiate Expanded Phase 2 Advanced Melanoma Study
Source: Streetwise Reports  (9/15/21)
Shares of Instil Bio Inc. traded 16% higher after the company reported it received IND clearance from the U.S. FDA to initiate a Phase 2 clinical trial in advanced melanoma patients. More >

Biopharma Co. Posts Positive Objective Response & Disease Control Rates in Ovarian Cancer Studies
Source: Streetwise Reports  (9/14/21)
H.C. Wainwright & Co. advised in a research report that updated data from Mersana Therapeutics Inc.'s expansion study supports its UPLIFT Study and will provide the basis for a new Phase 3 study in 2022. H.C. Wainwright rates Mersana a "Buy" with a target price of $28.00/share. More >

aTyr Pharma's Fusion Protein Achieves Consistent Dose Response in Pulmonary Sarcoidosis Trial
Source: Streetwise Reports  (9/13/21)
Shares of aTyr Pharma Inc. traded 48% higher after the firm reported its ATYR1923 produced positive results in a Phase 1b/2a clinical study by demonstrating consistent favorable dose responses in pulmonary sarcoidosis patients. More >

Sanofi Makes US$1.9 Billion Offer to Buy Kadmon Holdings to Solidify Its Transplant Business
Source: Streetwise Reports  (9/8/21)
Shares of Kadmon Holdings Inc. traded 70% higher after the firm reported it agreed to be acquired by Sanofi SA for $9.50 per share in cash. Sanofi aims to strengthen its transplant business with the addition of Kadmon's Rezurockâ„¢ (belumosudil), an FDA-approved, first-in-class treatment for patients 12 years and older with chronic graft-versus-host disease. More >

Adaptimmune Partners With Genentech to Develop & Market Cancer-Targeted Allogeneic T-Cell Therapies
Source: Streetwise Reports  (9/7/21)
Adaptimmune Therapeutics Plc. shares traded 33% higher after the firm reported it formed a strategic partnership with Genentech to develop several "off-the-shelf" and advanced personalized cancer-targeting allogeneic T-cell therapies. More >

Impel NeuroPharma Gains FDA Approval for First Therapeutic to Deliver DHE to Vascular-Rich Upper Nasal Space for Migraine Treatment Using POD Tech
Source: Streetwise Reports  (9/4/21)
Shares of Impel NeuroPharma Inc. traded to a new 52-week high after the company reported that the U.S. Food and Drug Administration has approved TRUDHESAâ„¢ (dihydroergotamine mesylate), a patient friendly nasal spray that delivers rapid relief and treatment for acute migraine. More >

Biopharma's Antibody Approved as Hodgkin's Lymphoma Treatment in China
Source: Streetwise Reports  (8/31/21)
"This marks the first regulatory approval of an OmniAb antibody discovery engine-derived antibody since Ligand Pharmaceuticals first acquired the technology in 2016," noted an H.C. Wainwright & Co. report. More >

AC Immune Shares Rise 16% After Phase 2 Alzheimer's Trial Data Shows Significant Reductions in Cognitive Decline
Source: Streetwise Reports  (8/31/21)
AC Immune SA shares set a new 52-week intraday high after the company reported positive cognitive results for tau-targeting monoclonal antibody semorinemab in a clinical study of patients with mild-to-moderate Alzheimer's disease. More >