Made progress deploying all components of the Nanox solution including Nanox.ARC and Nanox.AI Expanded US sales and support staff a key component of global strategic growth plan Management to host conference call and webcast Thursday, November 21, 2024 at 8:30 AM ET PETACH TIKVA, Israel, Nov. 21, 2024 (GLOBE NEWSWIRE) -- November 21, 2024 — NANO-X IMAGING LTD (NASDAQ: NNOX) (“Nanox” or the “Company”), an innovative medical imaging...Read more
Company Achieved 50% YoY Revenue Growth & Positive EBITDA CALGARY, AB, Nov. 21, 2024 /CNW/ - Nanalysis Scientific Corp. ("the Company") (TSXV: NSCI) (OTCQX: NSCIF) (FRA: 1N1), a leader in portable NMR machines and MRI technology for industrial and research applications announces third quarter results for the period ending on September 30, 2024, achieving 50% year-over-year revenue growth to $10.6 million in Q3. Chief...Read more
Completed Initial Public Offering (IPO) of common stock, raising gross proceeds of $82.1M Single Ascending Dose (SAD) portion of Phase 1 study of CMP-CPS-001 completed; safety data anticipated in Q1 2025 Entered strategic research collaboration with BioMarin valued at over $370M CAMBRIDGE, Mass., Nov. 21, 2024 (GLOBE NEWSWIRE) -- CAMP4 Therapeutics Corporation (“CAMP4”) (Nasdaq: CAMP), a clinical-stage biotechnology company...Read more
MISSISSAUGA, Ontario, Nov. 20, 2024 (GLOBE NEWSWIRE) -- BioSyent Inc. (“BioSyent”, TSX Venture: RX) released today its financial results for the three months (Q3) and nine months (YTD) ended September 30, 2024. Key highlights include: (CAD) Q3 2024 % Change vs. Q3 2023 YTD 2024 % Change vs. YTD 2023 Trailing Twelve Months (TTM) Sept 30, 2024 % Change vs. TTM Sept 30,...Read more
BEIJING, Nov. 20, 2024 /PRNewswire/ -- So-Young International Inc. (Nasdaq: SY) ("So-Young" or the "Company"), the largest and most vibrant social community in China for consumers, professionals and service providers in the medical aesthetics industry, today announced its unaudited financial results for the third quarter ended September 30, 2024. Third Quarter 2024 Financial Highlights Total revenues were RMB371.8 million...Read more
Deep Pipeline of GPCR Programs Focused Initially on Indications in Endocrinology, Immunology and Inflammation, and Metabolic Diseases Phase 1 Clinical Trial Ongoing for SEP-786, Oral Small Molecule for Hypoparathyroidism, with Data Expected in Mid-2025 Well-Capitalized with Balance Sheet to Support a Planned Operating Runway into Second Half of 2027 SOUTH SAN FRANCISCO, Calif., Nov. 20, 2024 (GLOBE NEWSWIRE) -- Septerna, Inc....Read more
Delivering on commitments, executing ahead of expectations, and raising guidance Innovation driving sustained growth across many franchises: TAVR, PFA, Leadless Pacemakers, Diabetes, Spine, and Neuromodulation GALWAY, Ireland, Nov. 19, 2024 /CNW/ -- Medtronic plc (NYSE: MDT) today announced financial results for its second quarter (Q2) of fiscal year 2025 (FY25), which ended October 25, 2024. Key Highlights Revenue of...Read more
SALT LAKE CITY / Nov 19, 2024 / Business Wire / Varex Imaging Corporation (Nasdaq: VREX) today announced its unaudited financial results for the fourth quarter and fiscal year 2024. Q4 FY24 Summary Revenues of $206 million GAAP gross margin 33% | Non-GAAP gross margin* 33% GAAP operating expense $56 million | Non-GAAP operating expense* $53 million GAAP operating margin 5% | Non-GAAP operating margin* 7% GAAP net earnings $(1.22)...Read more
Adjusted EBITDA increases 23% YoY FXN, maintaining strong growth Leverage ratio decreases 0.4x to 3.7x LUXEMBOURG / Nov 19, 2024 / Business Wire / Auna (NYSE: AUNA) (“Auna” or the “Company”), a leading healthcare platform in Latin America with operations in Mexico, Peru and Colombia, today announced unaudited financial results for the third quarter ended September 30, 2024 (“third quarter 2024” or “3Q24”). Financial results are...Read more
Alpha DaRT® accepted into the prestigious Total Product Life Cycle Advisory Program (TAP) of the FDA, to accelerate market access to the Alpha DaRT® for patients with recurrent glioblastoma multiforme (GBM) First patient treated in Recurrent Lung Cancer study in Israel, which will assess the safety and feasibility of delivering Alpha DaRT® sources into the lung using an endobronchial ultrasound procedure FDA approval of an...Read more
SOUTH SAN FRANCISCO, Calif. / Nov 18, 2024 / Business Wire / Twist Bioscience Corporation (NASDAQ: TWST), a core mid-cap growth and value equity company in the life sciences segment of the health care sector, today announced financial results and business highlights for the fourth quarter and full year fiscal 2024 ended September 30, 2024. Visit the Events and Presentations page of the Investor Relations section under the “Company” tab at...Read more
The Company will now target five major cancer types with its four clinically active compounds across both TCR-T cell therapies and TCR-based Bispecifics Today, Company discloses first clinical data from the TCR Bispecific molecule, TCER® IMA402 targeting PRAME, in the Phase 1 dose escalation trial, demonstrating a favorable tolerability profile and signs of dose-dependent and PRAME expression-dependent clinical activity,...Read more
Announced positive interim clinical data with 1E15 vg dose of NGN-401 gene therapy trial for Rett syndrome Neurogene to advance NGN-401 at 1E15 vg dose Expects to provide an update on registrational trial design in first half of 2025 Strong cash position provides runway into the second half of 2027 NEW YORK / Nov 18, 2024 / Business Wire / Neurogene Inc. (Nasdaq: NGNE), a clinical-stage company founded to bring life-changing genetic...Read more
Phase 2 CLOVER-WaM pivotal study data selected for oral presentation at 66th Annual American Society of Hematology Meeting and Exposition Raised approximately $19.4 million with potential to raise up to an additional $73.3 million Company to hold webcast and conference call at 8:30 AM ET today FLORHAM PARK, N.J., Nov. 18, 2024 (GLOBE NEWSWIRE) -- Cellectar Biosciences, Inc. (NASDAQ: CLRB), a late-stage clinical biopharmaceutical...Read more
Aligned with FDA on operationally seamless Phase 2/3 trial for Actimab-A + CLAG-M in relapsed/refractory acute myeloid leukemia Actimab-A selected for National Cancer Institute's recently opened myeloMATCH precision medicines program for patients with acute myeloid leukemia and myelodysplastic syndromes Two Iomab-ACT INDs cleared by FDA: Commercial CAR-T trial at University of Texas Southwestern and sickle cell transplant trial at...Read more
Actively Exploring Partnership for Alzheimer’s Development Supplementary Financing Concluded in Q4 ROCHESTER, N.Y., Nov. 18, 2024 (GLOBE NEWSWIRE) -- Vaccinex, Inc. (Nasdaq: VCNX), a clinical-stage biotechnology company pioneering a differentiated approach to treating neurodegenerative disease and cancer through the inhibition of Semaphorin 4D (SEMA4D), today announced financial results for the third quarter ended September 30, 2024...Read more
This revised news release replaces the one issued on November 14, 2024, contains several non-financial changes throughout and removes the name of and references to a new customer, at the customer’s request. The agreement with the new customer remains in effect. Revenues of $8.8 million compare with $3.9 million in the prior-year quarter, adjusted EBITDA (a non-GAAP measure) of $1.6 million compares with negative $1.7 million a year...Read more
MDNA11 continues to show best-in-class potential in the ABILITY-1 study with an objective response rate (ORR) of 30% in the monotherapy dose expansion cohort among patients with cancer progression after one or more immune checkpoint inhibitor (ICI) therapy Two PRs were observed among 3 microsatellite instability high (MSI-H) ICI resistant patients (ORR 66.7%) with both responders having pancreatic cancer including one patient with 100%...Read more
Company accelerated enrollment in global multisite pilot study and significantly reduced operating expenses while refocusing resources to clinical and regulatory deliverables ANN ARBOR, Mich. / Nov 15, 2024 / Business Wire / ENDRA Life Sciences Inc. (NASDAQ: NDRA), a pioneer of Thermo Acoustic Enhanced UltraSound (TAEUS®), today reported financial results for the three and nine months ended September 30, 2024 and provided a business...Read more
BEIJING, CHINA / ACCESSWIRE / November 15, 2024 / CASI Pharmaceuticals, Inc. (Nasdaq:CASI) ("CASI" or the "Company"), a Cayman incorporated biopharmaceutical company specializing in the development and commercialization of innovative therapeutics and pharmaceutical products, today reported business updates and financial results for the three months ended September 30, 2024. Dr. Wei-Wu He, Chairman and CEO of CASI, said "The third quarter...Read more
VANCOUVER, British Columbia / Nov 15, 2024 / Business Wire / Alpha Cognition Inc. (NASDAQ: ACOG) (CSE: ACOG) (“Alpha Cognition”, or the “Company”), a biopharmaceutical company developing novel therapeutics for debilitating neurodegenerative disorders, today reported financial results for the second quarter and six months ended September 30, 2024, and provided a corporate update. “The FDA approval of ZUNVEYL represents an important...Read more
Topline Data from Phase 2b clinical trial of OST-HER2 in Osteosarcoma expected to be released in December 2024 NEW YORK / Nov 15, 2024 / Business Wire / OS Therapies, Inc. (NYSE-A: OSTX) (“OS Therapies” or “the Company”), a clinical-stage cancer immunotherapy and antibody drug conjugate biotechnology company, today reported financial results for the third quarter of 2024 ended September 30, 2024 and provided a business update. “The...Read more
SHELTON, CT / ACCESSWIRE / November 15, 2024 / SHELTON, CT / ACCESSWIRE / November 15, 2024 / NanoViricides, Inc. (NYSE American:NNVC) (the "Company"), reports that it has filed its Quarterly Report on Form 10-Q for the quarter ending September 30, 2024 with the Securities and Exchange Commission (SEC) on Thursday, November 14, 2024. The report can be accessed at the SEC website (Click Here). We reported that, as of September 30, 2024,...Read more
Continued execution across Ampligen® clinical development programs in areas with critical unmet needs, especially in the high-value pancreatic cancer space Driving significant momentum with positive clinical trial data, underscoring big pharma collaboration and commercialization opportunities Company to host conference call and webcast today, November 15th, at 8:30 AM ET OCALA, Fla., Nov. 15, 2024 (GLOBE NEWSWIRE) -- AIM ImmunoTech...Read more
Stable revenue and gross profit despite cost-cutting initiatives, indicating the strength of underlying segments and brands. Solid liquidity position, with cash and cash equivalents exceeding $3.3 million. Hard assets, mainly comprised of debt-free properties, valued at over $12 million; exceeding total debt and providing financing flexibility. Liquid inventory position and accounts receivable that are collected at an...Read more
Mori Arkin's appointment as interim CEO as of January 1, 2025 approved by shareholders Phase 3 clinical trial of SGT-610 for Gorlin Syndrome is ongoing with over 40 clinical sites activated SGT-210 proof-of-concept study in patients suffering from Darier disease is ongoing NESS ZIONA, Israel, Nov. 15, 2024 (GLOBE NEWSWIRE) -- Sol-Gel Technologies, Ltd. (NASDAQ: SLGL), a dermatology company, pioneering treatments for patients...Read more
Q3 2024 total revenue of $15.2 million grew +3% Y/Y based on strong demand and output in the TrinScreen HIV business Point-of-Care product revenue of $4.3 million grew 60% Y/Y Reiterates guidance to achieve approximately $20 million of annualized run-rate EBITDASO1 on annualized run-rate revenues of approximately $75 million by Q2 2025 Reiterates guidance to achieve 2024 sales revenue for TrinScreen HIV of approximately $10 million...Read more
BOULDER, CO / ACCESSWIRE / November 15, 2024 / Encision Inc. (OTC PINK:ECIA), a medical device company owning patented Active Electrode Monitoring (AEM®) Technology that prevents dangerous radiant energy burns in minimally invasive surgery, today announced financial results for its fiscal 2025 second quarter that ended September 30, 2024. The Company posted quarterly product net revenue of $1.65 million and service net revenue of $101...Read more
Primary analysis data in potentially pivotal GBM study with lead program, Berubicin, on track for the first half of 2025 Company strengthens cash position to extend runway to fund operations beyond data readout of Berubicin potentially pivotal GBM study Quarter marked by pipeline expansion with in-license of TPI 287, a late stage novel potential blood brain barrier permeable abeotaxane for treatment of brain malignancies HOUSTON,...Read more
Topline data from Phase 2 CM24 pancreatic cancer trial expected by the end of 2024 New CM24 biomarkers data presented during the third quarter of 2024 including two predicting serum biomarkers identified and associated with CM24 novel targets CAPTN-3 tri-specific antibody platform data presented at the ENA Symposium October 2024 REHOVOT, Israel, Nov. 15, 2024 (GLOBE NEWSWIRE) -- Purple Biotech Ltd. ("Purple Biotech" or "the...Read more
Expands DNAbilize® Technology Beyond Oncology into Obesity Conference Call to be Held Today at 8:30 A.M. ET HOUSTON, Nov. 15, 2024 (GLOBE NEWSWIRE) -- Bio-Path Holdings, Inc., (NASDAQ:BPTH), a biotechnology company leveraging its proprietary DNAbilize® antisense RNAi nanoparticle technology to develop a portfolio of targeted nucleic acid cancer drugs, today announced its financial results for the third quarter ended September 30,...Read more
YORVIPATH launching in U.S. with product availability expected mid-January 2025; ex-U.S. YORVIPATH revenue of €8.5 million in Q3 TransCon CNP NDA submission for achondroplasia planned for Q1 2025 followed by MAA submission planned for Q3 2025 SKYTROFA Q3 revenue of €47.2 million – 60%+ year-over-year volume growth offset by current and prior period sales deductions Full year 2024 SKYTROFA revenue excluding sales deductions related to...Read more
SOL-1 expected to be fully randomized by YE 2024 with topline data expected in Q4 2025 Active clinical trial sites now enrolling patients directly into SOL-R Cash balance of $427.2M as of September 30, 2024, expected to fund operations into 2028 Ocular to host a Q3 2024 conference call and webcast today, November 14th, at 8:00 AM ET BEDFORD, Mass., Nov. 14, 2024 (GLOBE NEWSWIRE) -- Ocular Therapeutix, Inc. (NASDAQ: OCUL,...Read more
Company Sees Initial Sales Momentum in China for OPKO Health Products as it Prepares for the Launch of its Florida Sunshine Brand of Vitamins and Supplements COCONUT GROVE, Fla., Nov. 14, 2024 /PRNewswire/ -- NextPlat Corp (NASDAQ: NXPL, NXPLW) ("NextPlat" or the "Company"), a global e-Commerce provider, today announced results for its third fiscal quarter ended September 30, 2024 which includes the consolidation of the operations of...Read more
Robust firmonertinib monotherapy activity in front-line EGFR PACC mutant NSCLC including in patients with brain metastases Top-line pivotal data from global Phase 3 FURVENT trial for firmonertinib in front-line NSCLC harboring EGFR exon 20 insertion mutations expected 2025 Cash and cash equivalents of $282.9 million as of September 30, 2024 NEWTOWN SQUARE, Pa., Nov. 14, 2024 (GLOBE NEWSWIRE) -- ArriVent BioPharma, Inc. (Company or...Read more
Conference Call Scheduled for Friday, November 15 at 11:30 AM EST Northvale, New Jersey--(Newsfile Corp. - November 14, 2024) - Elite Pharmaceuticals, Inc. (OTCQB: ELTP) ("Elite" or the "Company"), a specialty pharmaceutical company engaged in the development, manufacture, and distribution of niche generic products, announced results for the three months ended September 30, 2024, which is the second quarter of the Company's fiscal...Read more
PARIS, France, November 14, 2024, 10:00 p.m. CET – Abivax SA (Euronext Paris: FR0012333284 – ABVX / Nasdaq – ABVX) (“Abivax” or the “Company”), a clinical-stage biotechnology company focused on developing therapeutics that harness the body’s natural regulatory mechanisms to modulate the inflammatory response in patients with chronic inflammatory diseases, announces today its key financial information for the quarter ended September 30,...Read more
Topline Real-World Evidence (RWE) Comparability and Outcomes Data for ANX005 in Guillain-Barré Syndrome (GBS) Expected by Year-End 2024; Biologics License Application (BLA) Submission Targeted for First Half 2025 Ongoing Enrollment in Phase 3 ARCHER II Trial for ANX007 in Geographic Atrophy (GA); Topline Data Expected Second Half 2026 Proof-of-Concept Study with First-in-Kind Oral C1s Inhibitor ANX1502 Transitioned to an Enhanced...Read more
Phase 2b clinical trial of GH001 in patients with treatment-resistant depression completed enrolment of the double-blind phase in Q3 2024 Phase 1 clinical trial to evaluate proprietary aerosol delivery device in healthy volunteers is ongoing in the UK Cash, cash equivalents, other financial assets and marketable securities of $193.8 million DUBLIN, Nov. 14, 2024 (GLOBE NEWSWIRE) -- GH Research PLC (Nasdaq: GHRS), a clinical-stage...Read more
The PIK3CA wild-type cohort of the Phase 3 VIKTORIA-1 trial is 100% enrolled; expect to report topline data for this cohort in late Q1 2025 or Q2 2025 Approximately $264 million in cash, cash equivalents and investments at end of Q3 2024 expected to fund current clinical development program activities through 2026 Management to host webcast and conference call today, November 14, 2024, at 4:30 p.m. ET MINNEAPOLIS, Nov. 14, 2024...Read more
Revenue of $19.4 million and Adjusted EBITDA of $3.7 million for the quarter Beverly, Massachusetts and Toronto, Ontario--(Newsfile Corp. - November 14, 2024) - Hamilton Thorne Ltd. (TSX: HTL), a leading provider of precision instruments, laboratory equipment, consumables, software, and services to the Assisted Reproductive Technologies (ART), research, and cell biology markets, today reported unaudited condensed interim financial...Read more
Highlights successful Evie Ring back-in-stock execution Updates status of EvieMED 510(k) application review Focuses on launch of EvieMED and securing B2B opportunities Conference Call at 2:00 PM PT/ 5:00 PM ET Today PLEASANTON, Calif., Nov. 14, 2024 /PRNewswire/ -- Movano Health (Nasdaq: MOVE), a pioneer in health technology, reported third quarter 2024 results and provided a business update. The Company continues to remain...Read more
PALO ALTO, Calif., Nov. 14, 2024 /PRNewswire/ -- Kodiak Sciences Inc. (Nasdaq: KOD), today reported business highlights and financial results for the quarter ended September 30, 2024. "In the third quarter we hosted an Investor R&D Day in New York," said Victor Perlroth, M.D., Chief Executive Officer of Kodiak Sciences. "The Investor R&D Day webcast and presentation provide a comprehensive and up-to-date overview of where we...Read more
Completed pre-BLA meeting with FDA with full alignment on content of BLA, including CMC module, and path for fourth quarter 2024 rolling BLA submission for PRGN-2012† in RRP under accelerated approval pathway Commercial and manufacturing readiness campaign underway for PRGN-2012 in anticipation of a potential 2025 launch Confirmatory clinical trial for PRGN-2012 in RRP was initiated in accordance with guidance from...Read more
FDA accepts BLA resubmission of pz-cel in recessive dystrophic epidermolysis bullosa and sets PDUFA target action date of April 29, 2025 Company makes significant progress toward potential commercialization of pz-cel in 2025; Builds momentum with payor discussions and target treatment centers CLEVELAND, Nov. 14, 2024 (GLOBE NEWSWIRE) -- Abeona Therapeutics Inc. (Nasdaq: ABEO) today reported financial results for the third quarter...Read more
SAN DIEGO, Nov. 14, 2024 /PRNewswire/ -- Inhibrx Biosciences, Inc. (Nasdaq: INBX) ("Inhibrx Biosciences" or the "Company") today reported financial results for the third quarter of 2024. Following the completion of the sale of INBRX-101 by Inhibrx, Inc. (the "Former Parent") to Sanofi S.A. and the Former Parent's concurrent spin-off of the Inhibrx Biosciences business in May 2024, the biopharmaceutical company now has two programs in...Read more
Target enrollment in the chronic cohort of our Phase 1b/2a clinical trial of NVG-291 in individuals with spinal cord injury (SCI) is approaching completion NVG-300 preclinical test-of-concept studies in ischemic stroke, amyotrophic lateral sclerosis (ALS) and SCI underway Vancouver, British Columbia--(Newsfile Corp. - November 14, 2024) - NervGen Pharma Corp. (TSXV: NGEN) (OTCQB: NGENF), a clinical-stage biotech company...Read more
NAVIGATE trial on track for top-line results in December 2024 NORCROSS, Ga., Nov. 14, 2024 (GLOBE NEWSWIRE) -- Galectin Therapeutics, Inc. (NASDAQ: GALT), the leading developer of therapeutics that target galectin proteins, today reported financial results and provided a business update for the quarter ended September 30, 2024. Joel Lewis, Chief Executive Officer and President of Galectin Therapeutics, said “This past quarter, we...Read more
Revenues of $8.8 million compare with $3.9 million in the prior-year quarter, adjusted EBITDA (a non-GAAP measure) of $1.6 million compares with negative $1.7 million a year ago Signed a Fair Deal Agreement with Platinum Dermatology, a leading dermatology network with 130 clinics across the U.S. Conference call begins at 4:30 p.m. Eastern time today BOCA RATON, Fla., Nov. 14, 2024 (GLOBE NEWSWIRE) -- Sensus Healthcare, Inc....Read more
Denifanstat received Breakthrough Therapy designation from FDA for MASH Results from Phase 2b FASCINATE-2 study of denifanstat published in The Lancet Gastroenterology & Hepatology Successful completion of end-of-Phase 2 interactions with FDA on the development of denifanstat for MASH; Phase 3 program initiation expected by end of 2024 Anticipated cash runway through 2025, with cash, cash equivalents and marketable securities...Read more
On track for topline disease-free survival data from the phase 3 randomized controlled clinical trial of CAN-2409 in localized intermediate/high risk prostate cancer, expected in Q4 2024 On track for topline progression-free survival data from the phase 2b randomized controlled clinical trial of CAN-2409 in the active surveillance population with localized low/intermediate risk prostate cancer, expected in Q4 2024 Presented...Read more
Over 100 EluPro VAC Submissions and 19% SimpliDerm Growth Drive Momentum into 2025 SILVER SPRING, Md., Nov. 14, 2024 (GLOBE NEWSWIRE) -- Elutia Inc. (Nasdaq: ELUT) (“Elutia” or the “Company”), a pioneer in drug-eluting biomatrix products, today provided a business update and financial results for the third quarter ended September 30, 2024. Business Highlights: First Commercial Use: Announced the first patient implant of EluPro,...Read more
Reported Q3 and nine-month revenues of $7.3 million and $21.2 million respectively, up 42% and 66% year-over-year Provided 2025 guidance with expectations of over 50% annual sales growth, 20%+ reduction in operating expenses, positive full-year EBITDA, and positive cash flow in H2 2025 Launched TriNav® LV Infusion System and TriGuide™ Guiding Catheter for larger vessels and complex cases, expanding the TriNav system’s full access to the...Read more
OpRegen® Granted Regenerative Medicine Advanced Therapy (RMAT) Designation From FDA ReSonance™ (ANP1) Preclinical Results Presented at 59th Annual Inner Ear Biology Workshop Added to 2024 Russell 3000® Index CARLSBAD, Calif. / Nov 14, 2024 / Business Wire / Lineage Cell Therapeutics, Inc. (NYSE American and TASE: LCTX), a clinical-stage biotechnology company developing allogeneic cell therapies for unmet medical needs, today reported...Read more
New immunology data for INO-3107 supporting proposed mechanism of action presented at several recent conferences Data showed ability of INO-3107 to induce an antigen-specific cytotoxic T cell response against HPV-6 and HPV-11 and drive recruitment of T cells into airway tissues and papilloma Data showed INO-3107 induced expansion of new clonal T cells that infiltrate airway tissues and correspond with reduction of...Read more
MARLBOROUGH, Mass., Nov. 14, 2024 (GLOBE NEWSWIRE) -- Akoya Biosciences, Inc. (Nasdaq: AKYA) (“Akoya”), The Spatial Biology Company®, today announced its financial results for the third quarter ending September 30, 2024. “Our third-quarter results came in below expectations, largely due to ongoing capital equipment purchase constraints seen across the life science tools market. We remain optimistic about the long-term growth outlook of...Read more
Positive 270-day Interim Clinical Study Data for the First Subject and Positive 180-day Interim Clinical Study Data for the Second Subject Treated with the Low-Dose of BB-301 in the Phase 1b/2a Clinical Treatment Study Reported in October as a Late-Breaking Oral Presentation at the 29th Annual Congress of the World Muscle Society Third Subject Safely Treated with the Low-Dose of BB-301 in October 2024, and Fourth Subject Expected to...Read more
Conference call planned for later in Q4 2024 to provide updates on NurOwn® program NEW YORK, Nov. 14, 2024 /PRNewswire/ -- BrainStorm Cell Therapeutics Inc. (NASDAQ: BCLI), a leading developer of adult stem cell therapeutics for neurodegenerative diseases, today announced financial results for the third quarter ended September 30, 2024 and provided a corporate update. "BrainStorm's primary focus continues to be preparing for...Read more
Clinical data from the RESET-Myositis™ and RESET-SLE™ trials, along with initial clinical data from the RESET-SSc™ trial, to be presented this weekend in oral and poster presentations at ACR Convergence 2024 16 patients enrolled with 10 patients dosed as of November 12 across the RESET™ clinical development program; 40 U.S. clinical sites actively recruiting patients Data permitting, anticipate meeting with the FDA in...Read more
WESTLAKE VILLAGE, Calif., Nov. 14, 2024 (GLOBE NEWSWIRE) -- Genelux Corporation (NASDAQ: GNLX), a late clinical-stage immuno-oncology company, today announced financial results for the third quarter of 2024 and provided general business updates. The Company initiated its second lung cancer trial, a US-based, Phase 2 trial (VIRO-25) treating patients with recurrent advanced or metastatic non-small cell lung cancer (NSCLC) with Olvi-Vec,...Read more
Q3 2024 PEMGARDA™ (pemivibart) net product revenue of $9.3 million; Invivyd ended Q3 2024 with $106.9 million in cash and cash equivalents Targets near-term (1H 2025) profitability with existing cash and cash equivalents, anticipated growth of net product revenue, and various operational efficiency improvements PEMGARDA Fact Sheet updated to properly reflect neutralization activity of PEMGARDA against current circulating variants...Read more
PRINCETON, N.J., Nov. 14, 2024 (GLOBE NEWSWIRE) -- PDS Biotechnology Corporation (Nasdaq: PDSB) (“PDS Biotech” or the “Company”), a late-stage immunotherapy company focused on transforming how the immune system targets and kills cancers and the development of infectious disease vaccines, today provided a business update and reported financial results for the third quarter of 2024. “Since our last update in August, we have been actively...Read more
Conference call to discuss financial and operational results scheduled for Friday, November 15 at 8:30 a.m. U.S. Eastern Time HENDERSON, Nev. , Nov. 14, 2024 /PRNewswire/ -- VolitionRx Limited (NYSE AMERICAN: VNRX) ("Volition"), a multi-national epigenetics company, today announces financial results and a business update for the third quarter of 2024. Volition management will host a conference call tomorrow, November 15 at...Read more
Givastomig data presented at ESMO 2024 and SITC 2024 highlights encouraging monotherapy data On track to dose first patient in randomized Phase 2 study of uliledlimab in first-line mNSCLC in 1H 2025 Appointed Dr. Sean Fu as permanent CEO effective November 1, 2024 Estimated cash runway into 2027, based on $184.4 million in cash and cash equivalents, and short-term investments as of September 30, 2024 ROCKVILLE, Md., Nov. 14,...Read more
Phase 3 PIVOT-PO trial of tebipenem HBr remains on track to complete enrollment in 2H 2025 Reiterate cash runway into mid-2026; Q3 2024 ending cash balance of $76.3M CAMBRIDGE, Mass., Nov. 14, 2024 (GLOBE NEWSWIRE) -- Spero Therapeutics, Inc. (Nasdaq: SPRO), a multi-asset clinical-stage biopharmaceutical company, focused on identifying and developing novel treatments for rare diseases and multi-drug resistant (MDR) bacterial...Read more
Completed two equity offerings with total gross proceeds of approximately $20.0 million; cash runway extended into 3Q 2025 Announced new preclinical pharmacokinetic data supporting transenteric delivery of GLP-1 incretin triagonist Phase 1 study for RT-114, an oral GLP-1/GLP-2 dual agonist for the treatment of obesity, expected to initiate in 2025 SAN JOSE, Calif., Nov. 14, 2024 (GLOBE NEWSWIRE) -- Rani...Read more
Conference Call/Webcast Today at 5 pm ET TORONTO and DALLAS, Nov. 14, 2024 /CNW/ - Perimeter Medical Imaging AI, Inc. (TSXV: PINK) (OTC: PYNKF) ("Perimeter" or the "Company"), a commercial-stage medical technology company, today reported financial results for its third quarter ended September 30, 2024 and provided a corporate update. Business Highlights The Company continues to gain positive commercial market...Read more
74 patient starts completed or scheduled to date in 2024 across bluebird’s commercial portfolio Third quarter 2024 net revenue of $10.6 million reflects quarter-to-quarter fluctuations in drug product infusions; anticipate at least $25 million of net revenue in the fourth quarter Management to host conference call today, November 14, 2024 at 8:00 am ET SOMERVILLE, Mass. / Nov 14, 2024 / Business Wire / bluebird bio,...Read more
Testing in advanced animal model planned in Q4 for smaller, 00-size BioJet device with largest capacity of any ingestible injectable Company granted extension until December 9 to regain compliance with Nasdaq listing requirements for market value of securities SAN DIEGO, Nov. 14, 2024 (GLOBE NEWSWIRE) -- Biora Therapeutics, Inc. (Nasdaq: BIOR), the biotech company reimagining therapeutic delivery, today provided a corporate update...Read more
Announced promising safety and positive biomarker data from Cohort 2 (5mg BID) of the Phase 1b clinical trial of LTI-03 in idiopathic pulmonary fibrosis (IPF) patients demonstrating dose dependent effects in five biomarkers evaluated compared to low dose LTI-03 Data from Cohort 2 of the Phase 1b clinical trial confirms results from Cohort 1, with four biomarkers achieving statistical significance in the combined Cohort 1 and Cohort 2...Read more
Reports 57% increase in international dental sales for the third quarter of 2024 Advances commercial rollout of CompuFlo® Epidural System across additional pain management clinics following Medicare price assignment in multiple U.S. states ROSELAND, N.J., Nov. 14, 2024 (GLOBE NEWSWIRE) -- Milestone Scientific Inc. (NYSE: MLSS), a leading developer of computerized drug delivery instruments that provide painless and precise...Read more
BOSTON, Nov. 14, 2024 (GLOBE NEWSWIRE) -- Cue Biopharma, Inc. (Nasdaq: CUE), a clinical-stage biopharmaceutical company developing a novel class of therapeutic biologics to selectively engage and modulate disease-specific T cells for the treatment of cancer and autoimmune disease, today provided a business and financial update for the third quarter of 2024. Recent Business Highlights Presented positive updated data from the Phase...Read more
Lucid reports record quarterly EsoGuard® revenue and completes clinical evidence package for imminent submission to formally seek Medicare coverage Veris Health completes pilot program with The Ohio State's James Cancer Hospital and continues pursuit of financing to relaunch development of implantable monitor Ongoing initiatives position PAVmed to preserve Nasdaq listing Conference call and webcast to be held today, November 14th...Read more
Announced development of SL-325, a first-in-class antagonist antibody to DR3, the receptor for TL1A; IND filing expected in Q3'2025 Cash balance of approximately $90M as of September 30, 2024; expected to fund operations into 2027 AUSTIN, TX and DURHAM, NC, Nov. 14, 2024 (GLOBE NEWSWIRE) -- Shattuck Labs, Inc. (Shattuck) (Nasdaq: STTK), a biotechnology company pioneering the development of novel therapeutics...Read more
Cash position of $86.1 million as of September 30, 2024, not including cash R&D tax credit of $12.8 million received in October 2024 LONDON, Nov. 14, 2024 (GLOBE NEWSWIRE) -- Achilles Therapeutics plc (NASDAQ: ACHL) today announced its financial results for the third quarter ended September 30, 2024, and recent corporate updates. Corporate Updates Following the discontinuation of its TIL-based cNeT...Read more
WHITE BEAR LAKE, Minn., Nov. 14, 2024 (GLOBE NEWSWIRE) -- Envoy Medical®, Inc. (“Envoy Medical”) (Nasdaq: COCH), a revolutionary hearing health company focused on fully implanted hearing devices, today announces its corporate and financial results for the third quarter ended September 30, 2024, as well as other subsequent events. “The progress and accomplishments of late have been extremely important to Envoy Medical as they have set the...Read more
Vancouver, British Columbia--(Newsfile Corp. - November 14, 2024) - InMed Pharmaceuticals Inc. (NASDAQ: INM) ("InMed" or the "Company"), a pharmaceutical company focused on developing a pipeline of proprietary small molecule drug candidates for diseases with high unmet medical needs, today reports financial results for the first quarter of the fiscal year 2025 which ended September 30, 2024. The Company's full financial statements and...Read more
Established clinical proof-of-mechanism and validation of epigenomic controllers as potential new class of medicines from completed Phase 1 MYCHELANGELO™ I trial for c-MYC in HCC; Company exploring strategic partnership opportunities for Phase 2 development of OTX-2002 Company is focusing capital resources on three prioritized programs that reflect Omega’s unique value proposition to enable precision epigenomic control for potential...Read more
AFM24 combination with atezolizumab: The non-small cell lung cancer (NSCLC) EGFR wild-type (EGFRwt) cohort completed enrollment: Objective response rate (ORR) and safety data to be presented on a Company conference call on December 17, 2024. Acimtamig (AFM13) combination with AlloNK® (AB-101): Updated clinical data from the four cohorts of the run-in phase to be presented in a poster session at ASH 2024. AFM28 monotherapy phase 1...Read more
BETHESDA, Md., Nov. 14, 2024 (GLOBE NEWSWIRE) -- Gain Therapeutics, Inc. (Nasdaq: GANX) (“Gain”, or the “Company”), a clinical-stage biotechnology company leading the discovery and development of the next generation of allosteric small molecule therapies, today reports financial results for the quarter ended September 30, 2024, and provides a corporate update. “The third quarter of 2024 marked substantial progress for Gain and the...Read more
108 patients have completed 1-year of treatment in 1-year open-label extension (OLE) trial Vocal biomarker speech latency data from RECOVER trial reinforce brilaroxazine’s improvement on negative symptoms and other key symptom domains of schizophrenia Topline data from OLE trial expected in December 2024 CUPERTINO, Calif., Nov. 14, 2024 (GLOBE NEWSWIRE) -- Reviva Pharmaceuticals Holdings, Inc. (NASDAQ: RVPH) (“Reviva” or the...Read more
ORLYNVAHTM Approved by FDA on October 25, 2024 Company to Host Conference Call Today at 8:30 a.m. EDT DUBLIN and CHICAGO, Nov. 14, 2024 (GLOBE NEWSWIRE) -- Iterum Therapeutics plc (Nasdaq: ITRM), (Iterum), a company focused on delivering next generation oral and IV antibiotics to treat infections caused by multi-drug resistant pathogens in both community and hospital settings, today reported financial results for the third quarter...Read more
MIAMI, Nov. 14, 2024 (GLOBE NEWSWIRE) -- MSP Recovery, Inc. d/b/a LifeWallet (NASDAQ: LIFW) (“LifeWallet,” or the “Company”), a Medicare, Medicaid, commercial, and secondary payer reimbursement recovery and technology leader, today announced financial results for the quarter ended September 30, 2024. LifeWallet Chief Executive Officer, John H. Ruiz, said, “From additional settlements to the processing of additional claims data, we...Read more
Emrosi approved by FDA on November 4 for the treatment of inflammatory lesions of rosacea in adults Cosibelimab PDUFA goal date of December 28 for potential approval to treat metastatic or locally advanced cutaneous squamous cell carcinoma MIAMI, Nov. 14, 2024 (GLOBE NEWSWIRE) -- Fortress Biotech, Inc. (Nasdaq: FBIO) (“Fortress”), an innovative biopharmaceutical company focused on acquiring and advancing assets to enhance long-term...Read more
NEW YORK and MELBOURNE, Australia, Nov. 14, 2024 (GLOBE NEWSWIRE) -- Incannex Healthcare Inc. (Nasdaq: IXHL), (Incannex), a clinical-stage biopharmaceutical company developing innovative medicines for people with chronic diseases and significant unmet medical needs, today reported fiscal first quarter financial results and provided business highlights for the quarter ended September 30, 2024. “The first quarter reflects ongoing progress...Read more
Near-Term Revenue Potential with Commercialization Plan for FDA-Cleared RenovoCath® Delivery System in Both Direct and Commercial Partner Channels Renowned Clinical Oncology Sites Participating in Ongoing Pivotal Phase III TIGeR-PaC Clinical Trial; Trial Moving Towards Next Interim Analysis and Full Enrollment As of September 30, 2024, the Company had $9.6 million in Cash, Sufficient to Fund Operations to Achieve Next Interim Read-Out...Read more
Presented full dataset from first-in-human Phase 1a clinical trial demonstrating PMN310 was generally well-tolerated with monthly dosing and that PMN310 demonstrated CSF levels indicative of potential target engagement in patients with Alzheimer’s disease On track to initiate Phase 1b clinical trial in patients with Alzheimer’s disease by end of 2024 CAMBRIDGE, Massachusetts and TORONTO, Ontario, Nov. 14, 2024 (GLOBE NEWSWIRE) --...Read more
Conference Call and Webcast Today at 4:30 p.m. ET Development Program Highlights and Anticipated Milestones Ovaprene® hormone-free monthly intravaginal contraceptive candidate – pivotal Phase 3 contraceptive efficacy study recruiting across the United States; foundation grant announced yesterday will provide funding to allow Daré to expand the number of clinical sites to accelerate the development timeline Sildenafil Cream,...Read more
NEW YORK, Nov. 14, 2024 (GLOBE NEWSWIRE) -- MiNK Therapeutics, Inc. (NASDAQ: INKT), a clinical-stage biopharmaceutical company pioneering the discovery, development, and commercialization of allogeneic, off-the-shelf, invariant natural killer T (iNKT) cell therapies to treat cancer and other immune-mediated diseases, today announced results for the third quarter 2024. MiNK will host a conference call and webcast at 8:30 a.m....Read more
MIRAMAR, Fla., Nov. 14, 2024 (GLOBE NEWSWIRE) -- HCW Biologics Inc. (the “Company” or “HCW Biologics”) (NASDAQ: HCWB), a clinical-stage biopharmaceutical company focused on discovering and developing novel immunotherapies to lengthen healthspan by disrupting the link between inflammation and age-related diseases, today reported financial results and recent business highlights for its third quarter ended September 30, 2024. Dr. Hing...Read more
Terns Pharmaceuticals is a clinical-stage biopharmaceutical company developing a portfolio of small-molecule product candidates to address serious diseases, including oncology and obesity. Terns’ pipeline contains three clinical stage development programs including GLP-1 receptor...
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