Month: May 2021

DELRAY BEACH, Fla., May 12, 2021 (GLOBE NEWSWIRE) — AzurRx BioPharma, Inc. (NASDAQ: AZRX), (“AzurRx” or the “Company”), a clinical stage biopharmaceutical company specializing in the development of targeted, non-systemic therapies for gastrointestinal (GI) diseases, today announced that AzurRx SAS, its wholly-owned subsidiary in France, has received approximately 459,000 Euros ($550,000 U.S.) in non-dilutive funding in research tax credits from the French government for its 2020 CIR (French Research Tax Credit). James Sapirstein, Chief Executive Officer of AzurRx commented, “We are very thankful for the French government’s continued support and pleased to receive the 2020 CIR. These funds have enabled us to successfully run the European arms of our two Phase 2 MS1819 clinical trials – despite the challenges posed by the COVID...

– Research Grant Will Support Clinical Readiness Activities in Support of Upcoming Phase 3 Program with Simufilam – AUSTIN, Texas, May 12, 2021 (GLOBE NEWSWIRE) — Cassava Sciences, Inc. (Nasdaq: SAVA), a clinical-stage biotechnology company focused on Alzheimer’s disease, today announced that it has been awarded a new $2.7 million research grant award from the National Institutes of Health (NIH). This research grant is intended to fund clinical readiness activities in support of Cassava Sciences’ upcoming Phase 3 program with simufilam, its drug candidate for Alzheimer’s disease. “We appreciate the continued scientific and financial support provided by NIH for simufilam,” said Remi Barbier, President & CEO of Cassava Sciences. “We believe simufilam’s clinical safety, unique mechanism of action and constellation...

Top-line results from the open-label extension of phase 3 monotherapy trial of roluperidone for the treatment of negative symptoms of schizophrenia show continuous improvement in negative symptoms, improved functional ability, favorable safety profile and limited number of psychotic relapses over one year Pivotal bioequivalence study initiated WALTHAM, Mass., May 12, 2021 (GLOBE NEWSWIRE) — Minerva Neurosciences, Inc. (NASDAQ: NERV), a clinical-stage biopharmaceutical company focused on the development of therapies to treat central nervous system (CNS) disorders, today reported key business updates and financial results for the quarter ended March 31, 2020. Clinical update On May 11, 2021, the Company announced results of the open-label extension of the phase 3 trial of roluperidone for the treatment of negative symptoms of schizophrenia...

SAN DIEGO and TORONTO, May 12, 2021 (GLOBE NEWSWIRE) — Aptose Biosciences Inc. (Nasdaq: APTO; TSX: APS), a clinical-stage company developing highly differentiated therapeutics that target the underlying mechanisms of cancer, today announced that the Aptose management team will participate in upcoming investor conferences: 2021 RBC Capital Markets Global Healthcare Virtual ConferenceDate:       Wednesday, May 19, 2021Time:   11:30 AM – 11:55 AM EDTFormat:   Fireside Chat moderated by Gregory J. Renza, M.D., Equity Research – Biotechnology     Conference Information: LinkJefferies Virtual Healthcare ConferenceDate:       Wednesday, June 2, 2021Time:   2:00 PM – 2:25 PM EDTFormat:   Aptose Slide Presentation and Webcast     Conference Information: LinkThe Aptose management team also will be hosting...

Findings to be presented at the 24th Annual Meeting of the American Society of Gene and Cell Therapy Data demonstrate durable expression in CNS and may represent a new single-dose therapeutic strategy for treating various tauopathies CAMBRIDGE, Mass., May 12, 2021 (GLOBE NEWSWIRE) — Voyager Therapeutics, Inc. (NASDAQ: VYGR), a clinical-stage gene therapy company focused on developing life-changing treatments for serious neurological diseases today will present new preclinical data characterizing the durable expression and activity of a vectorized anti-tau antibody at the 24th Annual Meeting of the American Society of Gene and Cell Therapy (ASGCT), taking place virtually May 11-14, 2021. “Tauopathies such as progressive supranuclear palsy, frontal temporal dementia, and Alzheimer’s disease are devastating neurodegenerative disorders,...

~ Reports KEVEYIS® (dichlorphenamide) First Quarter 2021 Revenue of $8.4 Million, a 25 Percent Increase Compared to $6.7 Million of Revenue During First Quarter of 2020 ~ ~ Reiterates Full-Year 2021 KEVEYIS®(dichlorphenamide) Revenue Guidance of Approximately $34 Million to $36 Million ~ ~ Awaiting Day 74 Letter from U.S. Food & Drug Administration (FDA) for the Company’s New Drug Application (NDA) Submission for RECORLEV® (levoketoconazole) for the Treatment of Endogenous Cushing’s Syndrome ~ ~ Receives Notification from United States Patent and Trademark Office that it has Entered a Notice of Allowance Covering a Method of Treating Patients with Cushing’s Syndrome with RECORLEV® (levoketoconazole) ~ ~ Strongbridge to Host Conference Call Today at 8:30 am ET ~ DUBLIN, Ireland and TREVOSE, Pa., May 12, 2021 (GLOBE NEWSWIRE) —...

Actionable insights highlight ways entrepreneurs can regain business footing Dallas, May 12, 2021 (GLOBE NEWSWIRE) — Thryv’s “Winning on Main Street”, a weekly podcast dedicated to helping America’s small businesses modernize and automate the way they do business, has an urgent new mission: to help small business owners recover from the COVID-19 pandemic.  The weekly show, hosted by Thryv’s Gordon Henry, invites guests, many of them successful small business operators themselves, to explain how small businesses can attract and engage consumers whose expectations have changed during the pandemic. Often, guests explain that business owners must recognize we are living in a new normal where consumers expect local businesses to be as easy to do business with as big businesses with well-known brands.  “COVID-19 accelerated a change...

SAN DIEGO, May 12, 2021 (GLOBE NEWSWIRE) — Adamis Pharmaceuticals Corporation (NASDAQ: ADMP), a biopharmaceutical company developing and commercializing specialty products for respiratory disease, allergy and opioid overdose, today announced that it will host an investor conference call on Monday, May 17, 2021 at 2 p.m. Pacific Time to discuss its financial and operating results for the first quarter of 2021 as well as provide a business update. The company’s press release concerning its first quarter 2021 financial results will be available after 1 p.m. Pacific Time on May 17, 2021 and on its website at www.adamispharmaceuticals.com, and the company also expects to file its quarterly report on Form 10-Q for the quarter ended March 31, 2021 on that date. Event: Adamis Pharmaceuticals First Quarter 2021 Financial Results Conference...

VONORE, Tenn., May 12, 2021 (GLOBE NEWSWIRE) — MasterCraft Boat Holdings, Inc. (NASDAQ: MCFT) today announced financial results for its fiscal 2021 third quarter ended April 4, 2021. Highlights:Delivered the most profitable quarter in the Company’s history Net sales increased to a record $147.9 million, up 44 percent from $102.6 million in the prior-year period Gross margin expanded by 450 basis points to 25.2% Net income was $17.6 million or $0.93 per diluted share Diluted Adjusted Net Income per share, a non-GAAP measure, was a record $1.01, a 120 percent increase from $0.46 in the prior-year period Adjusted EBITDA, a non-GAAP measure, grew 97 percent to a record $27.5 million from $14.0 million in the prior-year period Adjusted EBITDA margin, a non-GAAP measure, expanded by 500 basis points to 18.6% Guidance for full-year...

Severe COVID-19 trial enrollment reaches 178 patients; interim analysis expected in Q3At the FDA’s suggestion, planning to request a Type A meeting to further discuss primary endpoint for the Phase III clinical development of vilobelimab in Hidradenitis Suppurativa Vilobelimab proved safe and well tolerated as add-on therapy to standard of care in US ANCA-associated vasculitis safety trial Completed target enrollment in Phase IIa Pyoderma Gangraenosum trial Cash, cash equivalents and financial assets of approximately €137.8 million as of March 31, 2021JENA, Germany, May 12, 2021 (GLOBE NEWSWIRE) — InflaRx (Nasdaq: IFRX), a clinical-stage biopharmaceutical company developing anti-inflammatory therapeutics by targeting the complement system, announced today financial results for the three months ended March 31, 2021. “We have...