Month: February 2022

FDA Approved TYRVAYA™ (varenicline solution) Nasal Spray for the Treatment of the Signs and Symptoms of Dry Eye Disease on October 15, 2021 TYRVAYA Nasal Spray Net Product Revenue of $1.2 Million in Q4’21, plus $5.4 Million Recognized from Ji Xing Pharmaceuticals (Ji Xing) License Agreement in Q4’21 Over 5,500 TYRVAYA Prescriptions Filled; Prescriptions Written by Approximately 1,900 Unique Eye Care Professionals in November and December 2021 $50 Million Drawn on Second Tranche from OrbiMed Royalty & Credit Opportunities III, LP (OrbiMed), Cash Received on November 4, 2021 Continue to Enroll OLYMPIA Phase 2 Clinical Trial, Study Results Expected in 2H 2022 Conference Call and Webcast Scheduled for 4:30 pm ET TodayPRINCETON, N.J., Feb. 24, 2022 (GLOBE NEWSWIRE) — Oyster Point Pharma, Inc. (Nasdaq: OYST), (“Oyster Point Pharma”,...

Expanded leadership team to drive strategic partnerships, accelerate new commercial launches, and grow overall enterprise value AUSTIN, Texas, Feb. 24, 2022 (GLOBE NEWSWIRE) — Aspira Women’s Health Inc. (Nasdaq: AWH), a bioanalytical-based women’s health company, today named Valerie Palmieri as Executive Chair of the Board, and Nicole Sandford as President and CEO of the Company. Jim LaFrance, Aspira’s current Board Chair, will step into the role of Lead Independent Director and Audit Committee Chair. All changes will be effective as of March 1, 2022. “I am thrilled to announce Valerie as our new Executive Chair of the Board. During her eight years as CEO, she has taken the company to a new level with her passion and commitment to establishing a premier women’s health company. As we continue to evolve and grow under her watch,...

Recent Highlights:Signed a definitive agreement with ACME Metal Enterprise Co., Ltd. (ACME) to deploy and license AquaRefining equipment and technologies at its facility in Keelung, Taiwan.Commenced AquaRefining equipment shipments to first Asia Pacific Licensee, ACME MetalReached agreement to lease-to-sell AquaRefinery plant in Tahoe-Reno Industrial Center for $14.5-15.5M to emerging Li-Ion recycler LiNiCo. Received non-refundable deposit of $1.25M plus monthly lease payments and expect to receive full payment between October, 2022 and March, 2023 with a $1M incentive for LiNiCo to exercise option prior to October 1, 2022Made an initial investment in LiNiCo in February, 2021Developed and filed provisional patent for work on AquaRefining for lithium-ion battery recycling which has yielded promising results, meeting vital benchmarks...

SOUTH SAN FRANCISCO, Calif., Feb. 24, 2022 (GLOBE NEWSWIRE) — CareDx, Inc. (Nasdaq: CDNA) — The Transplant Company™ focused on the discovery, development, and commercialization of clinically differentiated, high-value healthcare solutions for transplant patients and caregivers — today reported financial results for the fourth quarter and full year ended December 31, 2021. Recent Highlights:Achieved total revenue of $79.2 million for the three months ended December 31, 2021, increasing 35% over prior year fourth quarter Delivered full year revenue of $296.4 million, an increase of 54% compared with full year 2020 revenue Provided approximately 41,900 AlloSure and AlloMap patient results in the fourth quarter, growing 67% from prior year quarter. Full year 2021 AlloSure and AlloMap testing volumes grew year over year by 94%...

Initiating Phase 1 dose escalation study of MGC018 in combination with lorigerlimab (formerly MGD019) in coming weeks Prioritizing MGD024 as lead CD3-based DART® molecule targeting CD123 and discontinuing development of flotetuzumab Presented encouraging preclinical combinatorial anti-tumor activity with MGD024 at ASH in December Conference call scheduled for today at 4:30 p.m. ET.ROCKVILLE, Md., Feb. 24, 2022 (GLOBE NEWSWIRE) — MacroGenics, Inc. (NASDAQ: MGNX), a biopharmaceutical company focused on developing and commercializing innovative antibody-based therapeutics for the treatment of cancer, today provided an update on its recent corporate progress and reported financial results for the year ended December 31, 2021. “We are excited about our 2022 plans for our B7-H3-directed programs for the potential treatment of multiple...

SUNNYVALE, Calif., Feb. 24, 2022 (GLOBE NEWSWIRE) — Silk Road Medical, Inc. (Nasdaq: SILK), a company focused on reducing the risk of stroke and its devastating impact, today reported financial results for the three months and full year ended December 31, 2021. “Our team and physicians had a tremendous impact in 2021, performing nearly 14,000 cases and driving record annual revenue of $101.5 million,” said Erica Rogers, President and Chief Executive Officer of Silk Road Medical. “We drove measurable progress on regulatory and clinical fronts in anticipation of standard surgical risk approval in the U.S., entry into Japan and China, and development of our long-term pipeline, and we are well positioned to continue establishing TCAR as the new standard of care in carotid artery disease through 2022 and beyond.” Fourth Quarter 2021...

NDA submission of sparsentan in IgA nephropathy on-track for first quarter 2022 Company positioned for potential NDA submission for accelerated approval of sparsentan in FSGS and combined IgA nephropathy and FSGS MAA submission mid-year 2022 Recently reported positive topline results from the ongoing Phase 1/2 COMPOSE Study of pegtibatinase in classical homocystinuria Net product sales increased six percent to $211 million for the full year 2021 SAN DIEGO, Feb. 24, 2022 (GLOBE NEWSWIRE) — Travere Therapeutics, Inc. (NASDAQ: TVTX) today reported its fourth quarter and full year 2021 financial results and provided a corporate update.The Company is on-track to submit a New Drug Application (NDA) for accelerated approval of sparsentan in IgA nephropathy (IgAN) in the first quarter of 2022 Preparations underway to submit NDA for...

SCOTTSDALE, Ariz., Feb. 24, 2022 (GLOBE NEWSWIRE) — TPI Composites, Inc. (Nasdaq: TPIC), today reported financial results for the fourth quarter and full year ended December 31, 2021. “We achieved record net sales in 2021 despite the ongoing challenges the broader wind industry faced, including supply chain costs and constraints, logistics costs and the lingering effects of COVID,” said Bill Siwek, President and CEO of TPI Composites. “Our results of operations for 2021 and the fourth quarter were adversely impacted by approximately $52 million and $40 million, respectively, primarily due to deferral of revenue relating to extensions of our customer contracts and estimates of costs to complete these contracts under ASC 606. However, these factors did not impact our 2021 billings, which exceeded expectations for 2021 and the fourth...

Announced completion of pre-BLA meeting with the FDA for omburtamab BLA resubmission expected by the end of first quarter 2022 DANYELZA® adoption drives sequential revenue increase Completed IND submission to the FDA for first SADA construct Appointed Sue Smith as Chief Commercial Officer Strong cash position with $181.6 million as of December 31, 2021, providing runway through the end of 2023 The Company will host a conference call on Friday, February 25, 2022, at 9 a.m. ESTNEW YORK, Feb. 24, 2022 (GLOBE NEWSWIRE) — Y-mAbs Therapeutics, Inc. (the “Company” or “Y-mAbs”) (Nasdaq: YMAB) a commercial-stage biopharmaceutical company focused on the development and commercialization of novel, antibody-based therapeutic products for the treatment of cancer, today reported financial results for the fourth quarter and the full year...

New York, NY, Feb. 24, 2022 (GLOBE NEWSWIRE) — iQSTEL, Inc. (OTCQX: IQST) today released another in an ongoing series of shareholder updates from CEO Leandro Iglesias as the company progresses toward its Nasdaq uplisting objective.  The letter is included in its entirety below. Dear Shareholders: Even though the geopolitical situation in Europe is complicated by the war in Ukraine, our company is running better and better. We are on track to reach our business goals for this Fiscal Year $90 Million Revenue and reach Net Income Positive, let’s review our business lines: Telecommunications: With $6.7 Million in revenue in January, and the synergistic strategies in place between subsidiaries, our Telecom Business Line remains the flagship of our company. Internet of Things: Our business development team, in addition to the installation...