Streetwise Reports' Article Archives — September 2021 back to current month (22)

Alzamend Shares Rise After FDA Gives Positive Response to Pre-IND Filing for Immune-Boosting Alzheimer's Vaccine (09/30/2021)

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 (09/30/2021)

"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.

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Biopharma Expands Clinical Program of Lead Drug Candidate to Treat Chronic Cough (09/29/2021)

Algernon Pharmaceuticals will now pursue Ifenprodil in chronic cough based on encouraging recent study results in a Phase 2 trial.

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Cannabis Firm Expands Footprint in Central California With New Distribution Center (09/28/2021)

"The expansion is expected to drive topline sales with greater efficiency," noted a Noble Capital Markets report.

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Telemedicine Tech Firm Poised to Generate $11 Million of Revenue (09/24/2021)

Reliq Health Technologies signs contracts with three new clients for its proprietary remote healthcare delivery and care tracking platform, which has particularly significant implications during the era of the COVID-19 pandemic.

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Nanotech Co.'s Shares Trade Higher After Developing Antimicrobial Coating for PPE (09/23/2021)

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.

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Dynavax Shares Shoot Up 30% After Its Partner Clover Biopharma Met All Key Efficacy Endpoints in Ph. 2/3 COVID-19 Vaccine Trial (09/22/2021)

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.

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'Poised for Two Key Readouts in Q1/22' as Biopharma Advances Pipeline (09/21/2021)

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.

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Inotiv Makes $545 Million Bid for Envigo RMS Holdings to Fortify Research and Drug Discovery Platforms (09/21/2021)

Shares of Inotiv Inc. traded 27% higher to a new 52-week high after the company reported it entered into agreement to acquire Envigo RMS Holding Corp. in a cash and stock deal valued at $545 million which will serve to create a one-stop-shop, discovery-to-approval solution for drug developers.

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Target Price Raised on Biopharma After It Acquires Company, Splits Stock (09/20/2021)

AzurRx BioPharma now has five additional shots on goal "with the imminent full acquisition of just one compound," a ROTH Capital Partners report noted.

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Edessa Biotech Shares Rise 87% on Positive Findings in Phase 2 Monoclonal Antibody COVID-19 Study (09/20/2021)

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.

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Innate Pharma Shares Rise After AstraZeneca Presents Positive Data From NSCLC Trial to European Conference (09/18/2021)

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.

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Leap Therapeutics Shares Skip Higher on Positive Preliminary Data From Gastric Cancer Study (09/16/2021)

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.

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French Biotech Firm Initiates Pivotal Phase 3 Study of Lanifibranor in 900 NASH Patients (09/15/2021)

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.

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Instil Bio Receives FDA Approval to Initiate Expanded Phase 2 Advanced Melanoma Study (09/15/2021)

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.

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Biopharma Co. Posts Positive Objective Response & Disease Control Rates in Ovarian Cancer Studies (09/14/2021)

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.

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aTyr Pharma's Fusion Protein Achieves Consistent Dose Response in Pulmonary Sarcoidosis Trial (09/13/2021)

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.

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Sanofi Makes US$1.9 Billion Offer to Buy Kadmon Holdings to Solidify Its Transplant Business (09/08/2021)

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 Rezurock™ (belumosudil), an FDA-approved, first-in-class treatment for patients 12 years and older with chronic graft-versus-host disease.

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Medical Device Company's Improved Fundamentals Offer Multiple Expansion Potential (09/07/2021)

ROTH Capital Partners LLC commented in a research report that it is maintaining its "Buy" rating and raising its FY/22 revenue estimates for Dynatronics Corp. to $41 million after the firm pre-announced Q4/21 revenue figures that exceeded prior estimates.

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Adaptimmune Partners With Genentech to Develop & Market Cancer-Targeted Allogeneic T-Cell Therapies (09/07/2021)

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.

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Impel NeuroPharma Gains FDA Approval for First Therapeutic to Deliver DHE to Vascular-Rich Upper Nasal Space for Migraine Treatment Using POD Tech (09/04/2021)

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 TRUDHESA™ (dihydroergotamine mesylate), a patient friendly nasal spray that delivers rapid relief and treatment for acute migraine.

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Reliq Health Technologies Rides Telehealth Reimbursement Wave (09/02/2021)

Global telemedicine company will turn a profit in the current quarter and experience rapid growth after new contracts to provide chronic care management and medicare and medicaid reimbursements expand.

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