Year: 2021

Roivant began trading on Nasdaq under “ROIV”; cash balance increased to $2.5 billion. Dermavant announced final results from the Phase 3 PSOARING 3 long-term extension study of tapinarof in patients with plaque psoriasis (n=763). The study demonstrated 58% of patients who entered the study with a PGA score ≥2 achieved a PGA score of 0 or 1 and long-term use of tapinarof provided improved and durable effects for up to 52 weeks. 41% of patients in the study achieved complete disease clearance; also observed a median remittive effect of approximately four months for those patients who entered the study with a PGA of 0 after tapinarof treatment. Tapinarof was well tolerated consistent with the previously reported interim analysis. Aruvant released clinical data from third and fourth patients dosed in ongoing Phase 1/2 trial of ARU-1801 in...

– Initiated RECONNECT, a confirmatory pivotal Phase 3 trial of Zygel™ in patients with Fragile X Syndrome (FXS); topline results expected second-half 2023 – – Cash runway well into the first half of 2024; $75.6 million at September 30, 2021 – DEVON, Pa., Nov. 15, 2021 (GLOBE NEWSWIRE) — Zynerba Pharmaceuticals, Inc. (Nasdaq: ZYNE), the leader in innovative pharmaceutically-produced transdermal cannabinoid therapies for rare and near-rare neuropsychiatric disorders, today reported financial results for the third quarter ended September 30, 2021, and provided an overview of recent operational highlights and a pipeline update. “We remain focused on enrolling patients into our confirmatory pivotal Phase 3 RECONNECT trial in children and adolescents with Fragile X Syndrome,” said Armando Anido, Chairman and Chief Executive Officer of...

BOISE, Idaho, Nov. 15, 2021 (GLOBE NEWSWIRE) — PCS Edventures!, Inc., (PCSV) a leading provider of K-12 Science, Technology, Engineering and Mathematics (STEM) education programs and drone products, today announced unaudited results of operations for its second quarter of Fiscal Year 2022, which ended on September 30, 2021. Revenue was $0.99 million, which was 154% higher than the $0.39 million in revenue for the same period last year. Net income for the second quarter was $0.09 million compared to ($0.21 million) for the second quarter of Fiscal Year 2021. The Company ended the quarter with $0.46 million in cash. Michael Bledsoe, President, commented, “We had another strong quarter, with revenue rebounding significantly from last year’s comparable quarter. Operationally, we are preparing for record sales levels and a surge of...

— Advanced OLINVYK commercial launch with expanded field medical team and additional target markets Announced new OLINVYK cognitive function study vs. IV morphine, enrollment expected to start in Q1 2022 Initiated enrollment for Cleveland Clinic-led OLINVYK outcomes study, topline data expected in mid-2022 Progressed TRV027 with NIH / ACTIV-4 trial for COVID-19 on track for topline data in mid-2022 $78.6M cash at Q3 funds operations through YE 2022 — Company to host conference call today, November 15th, 2021, at 8:00 a.m. ET — CHESTERBROOK, Pa., Nov. 15, 2021 (GLOBE NEWSWIRE) — Trevena, Inc. (Nasdaq: TRVN), a biopharmaceutical company focused on the development and commercialization of novel medicines for patients with central nervous system (CNS) disorders, today reported its financial results for the third quarter...

Patients enrolled and recruitment ongoing in Phase 2 trial of ITIL-168 in melanoma (DELTA-1) Fast Track Designation granted by FDA for ITIL-168 in metastatic melanoma CoStAR mechanism of action data presented at SITC 2021 Successful pre-IND meeting for ITIL-306DALLAS, Nov. 15, 2021 (GLOBE NEWSWIRE) — Instil Bio, Inc. (“Instil”) (NASDAQ: TIL), a clinical-stage biopharmaceutical company focused on developing tumor infiltrating lymphocyte, or (TIL), therapies for the treatment of patients with cancer, today reported its third quarter 2021 financial results and provided a corporate update. “We have achieved key milestones in our continued development of ITIL-168 with clearance of our IND for the DELTA-1 study, Fast Track Designation approval and initiation of enrollment in DELTA-1,” said Bronson Crouch, Chief Executive Officer...

-Positive topline results from COMP360’s Phase 2b study- -RL-007 Phase 2a topline data in cognitive impairment associated with schizophrenia expected end of Q4- -Continued progress across 11 therapeutic programs, including initiation of Perception’s Phase 2a and DemeRx’s Phase 1/2 trials as well as interim Phase 2a RL-007 readout of first cohort- -Launch of atai Impact, a philanthropic program to harness the power of innovative mental health approaches for social change- -Company to host a webcast and conference call today at 08:30am EST- BERLIN and NEW YORK, Nov. 15, 2021 (GLOBE NEWSWIRE) — atai Life Sciences N.V. (Nasdaq: ATAI) (“atai”), a clinical-stage biopharmaceutical company aiming to transform the treatment of mental health disorders, today reported its financial results for the third quarter ended September 30, 2021, and...

VANCOUVER, British Columbia, Nov. 15, 2021 (GLOBE NEWSWIRE) — K92 Mining Inc. (“K92” or the “Company”) (TSX: KNT; OTCQX: KNTNF) is pleased to announce financial results for the three and nine months ended September 30, 2021. Third Quarter 2021 Highlights SafetyStrong focus on safety with zero lost time incidents (“LTI”) in the third quarter. Since the start of operations, Kainantu has had one of the best safety records in the Australasia region. Proactive and focused management of COVID-19. K92 has continuously operated throughout the COVID-19 pandemic, has strong preventative and response plans, with pandemic resiliency strengthening through ongoing vaccination programs.ProductionRecord quarterly tonnage of 87,621 tonnes treated, a 35% increase from Q3 2020. Stage 2 Expansion run-rate processing throughput achieved in September,...

FDA Feedback Supports Planned Emergency Use Authorization (EUA) Submission for ADG20 for Prevention of COVID-19; Interim Clinical Data Package from EVADE Prevention Trial to Support EUA Submission Expected in Second Quarter 2022 Enrollment Progressing in ADG20 STAMP Trial for Treatment of COVID-19; Planned Interim Efficacy Analysis Expected in Second Quarter 2022 to Support Potential EUA Submission WALTHAM, Mass., Nov. 15, 2021 (GLOBE NEWSWIRE) — Adagio Therapeutics, Inc., (Nasdaq: ADGI) a clinical-stage biopharmaceutical company focused on the discovery, development and commercialization of antibody-based solutions for infectious diseases with pandemic potential, today provided an update on its lead COVID-19 antibody program, ADG20, and reported third quarter 2021 financial results. ADG20 is an investigational monoclonal antibody...