Stockwinners Market Radar for May 01, 2022 - Earnings, Upgrades downgrades, option trades, Best Stock Advisory Service

19:24 EDT First Internet Bancorp announces termination of First Century merger agreement - First Internet Bancorp, the parent company of First Internet Bank, announced that First Century Bancorp. has terminated the agreement and plan of merger between the two companies. Under the agreement, announced November 2, 2021, the consummation of the merger was to have occurred on or before April 30, 2022. The Board of Governors of the Federal Reserve approved the merger on April 29, 2022, but the parties were precluded from closing immediately thereafter due to statutory waiting periods. The parties were unable to agree on extension terms; First Century terminated the agreement on May 1, 2022.

17:49 EDT Nio delivers 5,074 vehicles in April 2022 - Nio delivered 5,074 vehicles in April 2022. The deliveries consisted of 4,381 premium smart electric SUVs, including 1,251 ES8s, 1,878 ES6s and 1,252 EC6s, and 693 ET7s, the company's flagship premium smart electric sedan. As of April 30, 2022, cumulative deliveries reached 197,912 vehicles. "In late March and April 2022, the company's vehicle production and delivery have been impacted by the supply chain volatilities and other constraints caused by a new wave of the COVID-19 outbreaks in certain regions in China. The vehicle production has been recovering gradually. The company will closely monitor the situation and its impact to the company's business and financial conditions, and continue to work with its supply chain partners to accelerate the recovery of production to its full capacity," Nio said. On April 29, 2022, the first batch of tooling trial builds of the ET5 rolled off the production line at the new manufacturing plant at NeoPark in Hefei. The company expects to start delivery of the ET5 in September 2022.

17:39 EDT TJX issues allergy alert on undeclared milk in certain vegan chocolate products - The TJX Companies is recalling certain vegan chocolate products because they may contain undeclared milk. People who have allergies to milk run the risk of serious or life-threatening allergic reactions if they consume these products. The products being recalled are: "Pimlico Confectioners Vegan Fine Hazelnut Truffles" in a 3.88-ounce green plastic package; "Keats London Vegan Hazelnut Dark Chocolate" in a 4.93-ounce round green plastic package; "Keats London Vegan Irish Cream Truffles" in a 4.93-ounce round blue plastic package. The products recalled were distributed at TJX retail stores nationwide. TJX operates T.J. Maxx, Marshalls, HomeGoods, Sierra, and Homesense. One illness has been reported to date in connection with the recalled products. The recall was initiated after it was discovered that the products labelled as "Dairy Free" contained milk. Subsequent investigation indicated that this was caused by a manufacturing error at the supplier's facility. As a result, TJX is recalling all items for sale in our stores that were manufactured in this facility.

17:11 EDT Adverum presents additional efficacy, safety data from OPTIC trial of ADVM-022 - Adverum Biotechnologies announced the presentation of new post-hoc analysis from the OPTIC study of ADVM-022 in wet age-related macular degeneration during The Association for Research in Vision and Ophthalmology 2022 Annual Meeting in Denver, Colorado and virtually. The new data from OPTIC assessed the potential impact of baseline levels of neutralizing antibodies on efficacy and safety outcomes with ADVM-022. It is a common practice for companies developing adeno-associated viruses vector therapies to consider how the presence of pre-existing NAbs might influence treatment efficacy or safety parameters. In all subjects, a single intravitreal injection gene therapy at the 2 X 10^11 vg/eye dose demonstrated a greater than 80% reduction in annualized anti-vascular endothelial growth factor injections, as previously reported. In subjects with baseline NAbs less than1:125, the reductions in mean annualized injection frequency increased to 94%. There was no correlation between baseline NAbs and safety events. The mean annualized anti-VEGF injection rate was reduced by 81% in all participants receiving 2E11 vg/eye and 94% in participants with NAbs titers less than1:125, suggesting that those with baseline NAbs to AAV2.7m8 less than1:125 were likely to demonstrate more robust aflibercept protein expression and require even fewer supplemental anti-VEGF injections. 67% of 2E11 vg/eye subjects had baseline NAbs titers of less than1:125. Both doses of ADVM-022 were well tolerated with the 2x10^11 vg/eye dose requiring less topical corticosteroid therapy to alleviate inflammation. At most recent follow-up, no participants in the 2E11 vg/eye required any topical corticosteroids to treat inflammation. No correlation between baseline NAbs and safety events was observed. Additionally, baseline NAbs were not associated with occurrence or duration of inflammation.

09:27 EDT Kanzhun announces changes to board compositions - Kanzhun announced that the company has appointed Xiehua Wang to the company's board of directors and Xin Xu has resigned from its Board, effective on April 30, 2022. Xu's resignation did not result from any disagreement with the company, Kanzhun said.

09:19 EDT Kala Pharmaceuticals to present clinical data for KPI-012 at ARVO Annual Meeting - Kala Pharmaceuticals reported clinical data from a Phase 1b trial of KPI-012, its novel, cell-free secretome therapy for the treatment of severe ocular diseases driven by impaired healing. As previously disclosed, treatment with KPI-012 was well tolerated and resulted in significant improvements in patients with various persistent corneal epithelial defect etiologies, with complete healing of the PCED in six of eight evaluable patients. The data will be presented on Tuesday, May 3 in a poster session at the 2022 Association for Research in Vision and Ophthalmology Annual Meeting. The single-arm, prospective, open-label Phase 1b clinical trial enrolled 12 patients, including three who were enrolled in a safety lead-in cohort and nine enrolled in an efficacy cohort. Within the efficacy cohort, patients presented with PCED of various etiologies and durations ranging from 15 to 871 days. Patients were treated with twice daily KPI-012 for up to four weeks, with follow-up occurring at two, four and 12 weeks after their last dose of therapy. The key efficacy endpoint was complete healing of the corneal defects evaluated by corneal staining. Other efficacy endpoints included reduction in defect size, visual acuity, and corneal opacity. Safety measures included tolerability/pain, intraocular pressure and adverse events. Eight patients were evaluable for efficacy assessment; one participant was ineligible due to a non-treatment related adverse event. Improvement was seen in seven of the eight evaluable patients, with six of the eight achieving complete healing by the end of Week 4, including four patients who were healed by the end of Week 1 and one patient who was healed by the end of Week 2. All six healed patients remained healed through the end of the follow-up period. In addition, improvement in PCED lesion size was observed in both patients who did not experience full wound healing. Across all eight patients, the mean improvement in lesion size from baseline to end of treatment was -16.23 mm. KPI-012 was well-tolerated in the trial. Kala plans to file an investigational new drug application with the U.S. Food and Drug Administration and, subject to regulatory clearance, initiate a Phase 2/3 clinical trial of KPI-012 in PCED patients in the fourth quarter of 2022. Kala believes this trial could serve as the first of two required pivotal trials. The FDA has granted KPI-012 Orphan Designation for the treatment of PCED and the company believes it could also meet the criteria for fast-track and breakthrough designations. In addition, Kala believes the multifactorial mechanism of action of KPI-012 also makes it a platform technology and is evaluating KPI-012 for potential expansion to indications for rare front of the eye diseases, such as limbal stem cell deficiency and Sjogren's Syndrome, as well as select rare back of the eye diseases, such as retinitis pigmentosa and optic neuritis.