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Month: January 2024

Vincerx Pharma Announces Compelling Clinical Efficacy of Enitociclib in Combination with Venetoclax and Prednisone in Lymphoma

Investigators from the National Institutes of Health (NIH) report 2 partial responses (PR) in 3 peripheral T-cell lymphoma (PTCL) patients and 1 PR in 2 double-hit diffuse large b-cell lymphoma (DH-DLBCL) patients in ongoing dose-escalation trial of enitociclib in combination with venetoclax and prednisone Vincerx remains on target to report early clinical data from lead VersAptx™ platform compounds, VIP236 (early 2024) and VIP943 (mid 2024) PALO ALTO, Calif., Jan. 07, 2024 (GLOBE NEWSWIRE) — Vincerx Pharma, Inc. (Nasdaq: VINC) (“Vincerx”), a biopharmaceutical company aspiring to address the unmet medical needs of patients with cancer through paradigm-shifting therapeutics, today announced promising clinical results from a Phase 1 NIH-sponsored study of enitociclib in combination with venetoclax and prednisone for the treatment...

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QIAGEN announces plans to return approximately $300 million to shareholders

Capital return to be conducted through synthetic share repurchase // Return of up to $300 million – maximum approved by shareholders in 2023 – designed to enable efficient return of cash to shareholders and enhance EPS // Implementation planned to be completed in late January 2024 Venlo, the Netherlands, Jan. 07, 2024 (GLOBE NEWSWIRE) — QIAGEN N.V. (NYSE: QGEN; Frankfurt Prime Standard: QIA) today announced a plan to return up to approximately $300 million (maximum EUR 273 million) to shareholders through a synthetic share repurchase that combines a direct capital repayment with a reverse stock split. QIAGEN has decided to implement the maximum $300 million value of the mandate given at the Annual General Meeting in June 2023, where shareholders gave virtually unanimous approval for the related resolutions. This approach is designed...

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Exagen Inc. Announces Select Preliminary Full-Year 2023 Results and Reaffirms Guidance

CARLSBAD, Calif., Jan. 07, 2024 (GLOBE NEWSWIRE) — Exagen Inc. (Nasdaq: XGN), a leading provider of autoimmune testing solutions, today announces select preliminary unaudited financial results for the full year ended December 31, 2023, and reaffirms its full-year 2023 financial guidance. Select Preliminary Unaudited Financial ResultsRecord AVISE® CTD testing volume of approximately 137,000 units delivered during the year ended December 31, 2023. Cash balance of $36.5 million as of December 31, 2023. Accounts receivables balance of approximately $7 million as of December 31, 2023.Reaffirms Financial GuidanceThe company reaffirms its full-year 2023 total revenue guidance of at least $50 million and full-year 2023 non-GAAP adjusted EBITDA guidance of approximately negative $20 million.“I’m very proud of the strides the Exagen...

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Ultragenyx Reports Preliminary 2023 Revenue; Guidance for 2024 Revenue and Cash Usage; Pipeline Updates and 2024 Milestones

Preliminary 2023 Total Revenue of $430 million to $435 million, Crysvita® Revenue of $325 million to $330 million and Dojolvi® revenue of $70 million to $71 million 2024 expected Total Revenue guidance between $500 million to $530 million, Crysvita revenue of $375 million to $400 million, and Dojolvi revenue of $75 million to $80 million Year-end 2023 cash balance of approximately $776 million and 2024 guidance for net cash used in operations expected to be less than $400 million NOVATO, Calif., Jan. 07, 2024 (GLOBE NEWSWIRE) — Ultragenyx Pharmaceutical Inc. (NASDAQ: RARE), a biopharmaceutical company focused on the development and commercialization of novel products for serious rare and ultrarare genetic diseases, today reported preliminary unaudited 2023 revenue results, cash and investments at year end 2023, and provided 2024...

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Caribou Biosciences Appoints Tim Kelly as Chief Technology Officer and Highlights Multiple Clinical Catalysts Expected in 2024

Tim Kelly, chief technology officer, Caribou BiosciencesTim Kelly to lead Caribou’s technical operations strategy and execution— Tim Kelly to lead Caribou’s technical operations strategy and execution — — CB-010 ANTLER Phase 1 trial initial dose expansion data and RP2D to be disclosed Q2 2024; Caribou plans to initiate pivotal Phase 3 trial in 2L LBCL by YE 2024 — — CB-011 CaMMouflage Phase 1 trial enrolling patients at dose level 3; initial dose escalation data in r/r MM expected by YE 2024 — — CB-012 AMpLify Phase 1 trial first sites active; trial initiation in r/r AML expected H1 2024 — — Caribou to present at 42nd Annual J.P. Morgan Healthcare Conference on Thursday, January 11, at 11:15 am PST — BERKELEY, Calif., Jan. 07, 2024 (GLOBE NEWSWIRE) — Caribou...

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Pandora exceeds guidance: Strong Q4 sales lift full year organic growth to 8%

Following a strong end to 2023 with double-digit organic growth in the fourth quarter and solid profitability, the preliminary and unaudited results for 2023 exceed the full-year guidance communicated on 8 November 2023. Key Q4 2023 highlights (preliminary and unaudited):Q4 2023 organic growth accelerates to +12% boosted by LFL (Like-for-Like) growth of +9%. Continued brand momentum drove strong performance across the key trading events of Black Friday and Christmas. Broad-based LFL growth across markets: key markets in Europe remained solid at 5% growth, US accelerated to +10% growth and Rest of Pandora continued strong double-digit growth at +16%.  Strong LFL growth across collections with Moments and Pandora ME delivering +4% and +6% growth, respectively. Timeless accelerated further with +31% growth whilst Pandora Lab-Grown...

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RxSight, Inc. Announces Preliminary Unaudited Fourth Quarter and Full-Year 2023 Financial and Operational Results and 2024 Guidance

ALISO VIEJO, Calif., Jan. 07, 2024 (GLOBE NEWSWIRE) — RxSight, Inc., an ophthalmic medical device company dedicated to providing high-quality customized vision to patients following cataract surgery, today announced certain preliminary unaudited financial and operational results for the fourth quarter and full-year 2023 and provided full-year 2024 guidance. Preliminary Unaudited Fourth Quarter and Full-year 2023 ResultsPreliminary unaudited fourth quarter 2023 revenue is expected to be approximately $28.6 million, representing growth of approximately 78% compared to the prior year period, driven by:The sale of 77 Light Delivery Devices (LDD™s), expanding the installed base to 666 LDDs as of December 31, 2023; and The sale of 18,071 Light Adjustable Lenses (LAL®s).Preliminary unaudited 2023 fiscal year revenue is expected...

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Akoya Biosciences Deploys the MaxFuse Algorithm Co-Developed by Dr. Garry Nolan and His Laboratory at Stanford University for Multiomic Integration of Spatial and Single-cell Data on the Enable Medicine Platform

MaxFuse enables matching and integration of datasets from spatial proteomics, spatial transcriptomics, single-cell sequencing, or other modalities Development and application of MaxFuse were described in two recent Nature publications MARLBOROUGH, Mass., Jan. 07, 2024 (GLOBE NEWSWIRE) — Akoya Biosciences, Inc., (NASDAQ: AKYA), The Spatial Biology Company®, in collaboration with Enable Medicine, a leading provider of AI-powered biological insights, announces the availability of MaxFuse, an advanced algorithm co-developed in the laboratory of Dr. Garry Nolan for integrating multiomic single-cell and spatial datasets*. Dr. Nolan is a co-founder and member of the Board of Directors of Akoya Biosciences. Recent technology advancements have enabled analyses of the proteome, metabolome, transcriptome, and epigenome both spatially and...

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Akoya Biosciences Announces Preliminary Financial Results for the Fourth Quarter and Full Year 2023 and Provides 2024 Outlook

MARLBOROUGH, Mass., Jan. 07, 2024 (GLOBE NEWSWIRE) — Akoya Biosciences, Inc. (Nasdaq: AKYA) (“Akoya”), The Spatial Biology Company®, today announced preliminary unaudited revenue for the fourth quarter and full year ended December 31, 2023, and projected year end 2023 cash, cash equivalents, and restricted cash balance, which remain subject to quarter end closing adjustments and are also unaudited.Revenue for the fourth quarter of 2023 is expected to be between $25.5 million and $26.5 million, as compared to $21.2 million for the corresponding quarter of 2022. For the fiscal year of 2023, revenue is expected to be between $95.6 million and $96.6 million, as compared to $74.9 million for the fiscal year of 2022. Year end 2023 projected cash, cash equivalents, and restricted cash balance is expected to be between $83.0 million...

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Gentex Announces eSight Acquisition Set to Showcase Advanced Vision Tech at CES 2024

Gentex’s eSight GoeSight is a wearable assistive technology that allows people living with visual impairments to stay on the go while performing the tasks of daily living. The comprehensive medical equipment enhances vision for individuals with over 20 distinct ocular disorders, frequently enabling users to attain 20/20 vision.Gentex’s eSight GoeSight eyewear combines a high-definition camera, proprietary algorithms, and powerful processing platform to relay and magnify real-time imagery onto two high-resolution screens positioned before each eye, resulting in enhanced binocular vision.LAS VEGAS, Jan. 07, 2024 (GLOBE NEWSWIRE) — Gentex Corporation (NASDAQ: GNTX) announced today the asset acquisition of eSight, a leading provider of vision enhancement technologies, to develop and manufacture the next...

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