Month: August 2020

In July 2020, Taat undertook a test production run for Beyond Tobacco™ cigarettes with its manufacturing partner, which confirmed initial production estimations of one million sticks per day. An allocation of the batch of Beyond Tobacco™ cigarettes from this test production run was reserved for market research purposes, with the balance to be offered to select retail stores in Nevada that participated in the Company’s initial retail market testing in early May 2020. Less than 72 hours after the selected stores began selling Beyond Tobacco™ cigarettes, it was confirmed that their inventories had been sold out at price points aligned with the Company’s planned pricing strategy. Purchasers continued to provide positive feedback about Beyond Tobacco™ cigarettes, in addition to expressing enthusiasm about the planned Q4 2020 launch.LAS VEGAS...

NEW YORK, Aug. 14, 2020 (GLOBE NEWSWIRE) — Avenue Therapeutics, Inc. (NASDAQ: ATXI) (“Avenue”), a company focused on the development of intravenous (“IV”) tramadol for the U.S. market, today reported financial results and recent corporate highlights for the second quarter ended June 30, 2020.“We were pleased to announce several publications pertaining to IV tramadol in peer-reviewed journals recently. These publications highlight the positive data and accomplishments from our Phase 3 program,” said Lucy Lu, M.D., Avenue’s President and CEO. “We look forward to an eventful second half of 2020 as we approach IV tramadol’s Prescription Drug User Fee Act (“PDUFA”) date of October 10, 2020.”Recent Corporate Highlights:In April 2020, Avenue announced that two e-posters highlighting efficacy and safety results from its Phase 3 program...

Two Additional Orphan Drug Designations Granted for OCU400 Modifier Gene Therapy ProgramConference Call and Webcast Today at 8:30 a.m. ETMALVERN, Pa., Aug. 14, 2020 (GLOBE NEWSWIRE) — Ocugen, Inc. (NASDAQ: OCGN), a biopharmaceutical company focused on discovering, developing and commercializing transformative therapies to cure blindness diseases, today reported second quarter 2020 financial results along with a general business update.“I am very proud of the progress we have made this quarter as we work to develop transformative therapies with the potential to cure blindness diseases. Despite the challenges of the global pandemic, we remain on track to enter the clinic next year with our first gene therapy product candidate, OCU400, for retinitis pigmentosa. Our second gene therapy product, OCU410, for dry age-related macular degeneration...

 Daron Evans to Remain Senior Science Advisor and CEO of Specialty Renal ProductsSOUTH ORANGE, NJ, Aug. 14, 2020 (GLOBE NEWSWIRE) — via NEWMEDIAWIRE — Nephros, Inc. (Nasdaq:NEPH), a commercial-stage company that develops and sells water purification products and pathogen detection systems to the medical and commercial markets, today announced that Andy Astor, currently the company’s Chief Operating Officer and Chief Financial Officer, has been named President and CEO, effective August 24, 2020. Mr. Astor was also elected to Nephros’s board of directors.Daron Evans, Nephros’s current President and CEO, will remain with the company as a special advisor focused on the pathogen detection and dialysis businesses. Mr. Evans will also continue as CEO of Specialty Renal Products (“SRP”), a Nephros subsidiary. As part of the transition,...

RUTHERFORD, N.J., Aug. 14, 2020 (GLOBE NEWSWIRE) — Cancer Genetics, Inc. (the “Company”) (Nasdaq: CGIX), a leader in drug discovery and preclinical oncology and immuno-oncology services, announced yesterday financial and operating results for the quarter ended June 30, 2020.SECOND QUARTER 2020 FINANCIAL RESULTSThe Company reported total revenue from continuing operations of $1.4 million for the second quarter of 2020 compared to revenue of $1.5 million in the second quarter of 2019, a decrease of approximately $0.1 million or 5% principally due to the timing of discovery services studies.Gross profit remained approximately the same in both of the comparable quarters of 2019 and 2020, while the overall gross margin increased by 4 percentage points, from approximately 52% to 56%. The Discovery Services business unit gross margin increased...

CELEBRATION, Fla., Aug. 14, 2020 (GLOBE NEWSWIRE) — KemPharm, Inc. (OTCQB: KMPH), a specialty pharmaceutical company engaged in the discovery and development of proprietary prodrugs, today announced that the Company participated in a mid-cycle communication meeting on August 13, 2020, with the U.S. Food and Drug Administration (FDA) regarding the ongoing review of the New Drug Application (NDA) for KP415, KemPharm’s investigational product candidate for the treatment of attention deficit hyperactivity disorder (ADHD).  The FDA did not raise any substantive issues at the meeting and indicated that no major safety concerns have been noted at this point in their review.  Additionally, the PDUFA date of March 2, 2021, was re-affirmed. The FDA also tentatively scheduled a late-cycle communication meeting to be held on December 1, 2020,...

Exebacase Phase 2 study results published in the Journal of Clinical InvestigationContinued patient enrollment in ongoing Phase 3 DISRUPT study of exebacaseSuccessful public equity offering, private placement with Pfizer Inc., and CARB-X grant provide significant funding to advance lead product candidatesYONKERS, New York, Aug. 14, 2020 (GLOBE NEWSWIRE) — ContraFect Corporation (Nasdaq: CFRX), a clinical-stage biotechnology company focused on the discovery and development of direct lytic agents (DLAs), including lysins and amurin peptides, as new medical modalities for the treatment of life-threatening, antibiotic-resistant infections, today announced financial results and business updates for the second quarter ended June 30, 2020.“We continued to advance the Phase 3 DISRUPT superiority study of our FDA designated Breakthrough...