Streetwise Reports' Article Archives — September 2021 back to current month (22)
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.
"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.
Algernon Pharmaceuticals will now pursue Ifenprodil in chronic cough based on encouraging recent study results in a Phase 2 trial.
"The expansion is expected to drive topline sales with greater efficiency," noted a Noble Capital Markets report.
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.
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.
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.
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.
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.
AzurRx BioPharma now has five additional shots on goal "with the imminent full acquisition of just one compound," a ROTH Capital Partners report noted.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.