Expanded and advanced oncology pipeline to 20 programs in 24 ongoing clinical trials including five ongoing randomized Phase 2 clinical trials; multiple trials with registrational potential expected to be initiated in 2023 and 2024 Announced licensing agreement with OncoC4 to complement the Company’s oncology portfolio with clinical stage next-generation immune checkpoint modulator; a randomized Phase 3 trial planned to start in...Read more
Data to be presented at AACR demonstrate significant SP-3164 anticancer activity in both non-Hodgkin Lymphoma and Multiple Myeloma cell lines and animal models Targeted protein degrader SP-3164 on track for IND submission in first half of 2023 with clinical trial to begin in second half of 2023 HOUSTON, March 27, 2023 (GLOBE NEWSWIRE) -- Salarius Pharmaceuticals, Inc. (Nasdaq: SLRX), a clinical-stage biopharmaceutical company using...Read more
Signed Strategic Collaboration Agreement with Lantheus Holdings Inc. for POINT's PNT2002 and PNT2003 product candidates Completed enrollment for randomization phase of PNT2002's phase 3 SPLASH registrational trial, with top line data expected in the second half of 2023 INDIANAPOLIS, March 27, 2023 (GLOBE NEWSWIRE) -- POINT Biopharma Global Inc. (NASDAQ: PNT) (the “Company” or “POINT”), a company accelerating the discovery,...Read more
Fast Track Designation granted to TNG462, next-generation MTA-Cooperative PRMT5 inhibitor Adam Crystal, M.D., Ph.D. appointed President of Research and Development BOSTON, March 27, 2023 (GLOBE NEWSWIRE) -- Tango Therapeutics, Inc. (NASDAQ: TNGX), a clinical-stage biotechnology company committed to discovering and delivering the next generation of precision cancer medicines, reported its financial results for the fourth...Read more
CAPE CANAVERAL, Fla., March 27, 2023 (GLOBE NEWSWIRE) -- Vaxxinity, Inc. (Nasdaq: VAXX), a U.S. company pioneering the development of a new class of immunotherapeutic vaccines, today reported financial results for the fourth quarter and full year ended December 31, 2022. “We are grateful for and proud of our accomplishments in our first full year as a public company, and remain on track to continue to hit our milestones in 2023 as we...Read more
IRVINE, Calif., March 27, 2023 (GLOBE NEWSWIRE) -- Reneo Pharmaceuticals, Inc. (Nasdaq: RPHM), a clinical-stage pharmaceutical company focused on the development and commercialization of therapies for patients with rare genetic mitochondrial diseases, today reported financial results for the quarter and year ended December 31, 2022 and provided a business update. 2022 and Recent Highlights Achieved the target enrollment of 200...Read more
Phase 3 trial of mavacamten in Chinese patients with symptomatic obstructive hypertrophic cardiomyopathy (oHCM) ongoing, with data expected mid-year 2023 Phase 3 registrational trial of TP-03 in Chinese patients with Demodex blepharitis ongoing, with data expected in the fourth quarter of 2023 Entered into commercial agreement with Pfizer, with Pfizer opting into LianBio rights to RSV therapeutic candidate sisunatovir in LianBio...Read more
Company reports on productive interactions with FDA and preparations for launch of omidubicel, if approved, in advance of May 1 PDUFA date Company outlines strategic restructuring, plans to prioritize omidubicel launch and reduce operating expenses to extend cash runway Company to explore strategic options to support a broader launch of omidubicel, including potential US and global partnerships with pharmaceutical companies Company...Read more
INTERCEPT-AD, a Phase 1 clinical trial of ACU193 in patients with early Alzheimer’s disease, completed enrollment in February 2023 Topline data expected in the third quarter of 2023 Cash, cash equivalents and marketable securities of $193.4 million as of Dec. 31, 2022 expected to be sufficient to support clinical and operational goals through 2025 Company to host conference call and webcast today at 8:00 a.m....Read more
SAN FRANCISCO, March 27, 2023 (GLOBE NEWSWIRE) -- Augmedix (Nasdaq: AUGX), a leading provider of ambient medical documentation and data solutions delivered remotely to healthcare systems, physician practices, hospitals, and telemedicine practitioners, today reported financial results for the three and 12 months ended December 31, 2022. “We finished 2022 with our best-ever fourth quarter in terms of bookings, with sales momentum...Read more
NEW YORK, March 27, 2023 /PRNewswire/ -- Delcath Systems, Inc. (Nasdaq: DCTH), an interventional oncology company focused on the treatment of primary and metastatic cancers of the liver, today reported business highlights and financial results for the fourth quarter and full year ended December 31, 2022. Recent Business Highlights During and since the fourth quarter, Delcath Systems, Inc. (Delcath or the Company): Received an...Read more
Viewbix is a subsidiary of Gix Internet whose results are consolidated with Medigus’ financial statements Tel Aviv, Israel, March 27, 2023 (GLOBE NEWSWIRE) -- Medigus Ltd. (Nasdaq: MDGS), a technology company engaged in advanced medical solutions, innovative internet technologies and electric vehicle and charging solutions, announced today that Viewbix Inc. (henceforth “Viewbix”) (OTC: VBIX), 76% owned by Medigus’ subsidiary Gix...Read more
TORONTO, March 27, 2023 (GLOBE NEWSWIRE) -- Venus Concept Inc. (“Venus Concept” or the “Company”) (NASDAQ: VERO), a global medical aesthetic technology leader, announced financial results for the three and twelve months ended December 31, 2022. Fourth Quarter 2022 Summary & Recent Highlights: Total revenue of $24.3 million, down $8.3 million, or 26%, year-over-year; up $2.7 million, or 13% quarter-over-quarter. U.S. revenue...Read more
Prescription product net revenue was approximately $11.9 million for the year ended December 31, 2022 versus approximately $4.3 million for the year ended December 31, 2021, an increase of 178.7%. Prescription product net revenue of approximately $3.3 million in Q4 2022 increased 3.4% over Q3 2022 and increased approximately 57% over prescription product net revenue in Q4 2021. As of March 24, 2023, the filing date of Jaguar's annual...Read more
HOUSTON, March 27, 2023 (GLOBE NEWSWIRE) -- Nexalin Technology, Inc. (the “Company” or “Nexalin”) (Nasdaq: NXL; NXLIW) today provided a business update for the year ended December 31, 2022. Mark White, CEO of Nexalin Technology stated, “Nexalin has made significant progress towards commencing clinical trials of our Gen-2 and Gen-3 neurostimulation devices in the United States. Nexalin’s enhanced neurostimulation devices combine...Read more
Enrollment Nearing Completion in Human Acellular Vessel™ (HAV™) Phase 2/3 Trial in Vascular Trauma and Phase 3 Trial in Arteriovenous (AV) Access in Hemodialysis Patients Multiple publications and scientific meeting presentations highlighting clinical and preclinical HAV results Conference call and live webcast at 8:00 a.m. ET today DURHAM, N.C., March 24, 2023 (GLOBE NEWSWIRE) -- Humacyte, Inc. (Nasdaq: HUMA), a clinical-stage...Read more
atai’s development candidates, such as RL-007 and GRX-917, all represent significant opportunities to address unmet medical needs of patients living with mental health conditions Continued operational progress on robust clinical pipeline, with multiple phase 1 and phase 2 proof-of-concept datasets expected in the next two years $273 million in cash, cash equivalents and short-term investments at end of 2022 and access to a term loan...Read more
TREK-AD Phase 2b study of eblasakimab fully enrolled, topline data readout expected early July 2023 Phase 2 proof-of-concept trial of farudodstat in alopecia areata expected to commence in the second quarter of 2023 with topline data readout expected in the first quarter of 2024 Expected cash runway extended through at least the second quarter of 2024 with recent $20 million in financing, with potential to receive up an additional $80...Read more
OXFORD, United Kingdom, March 24, 2023 (GLOBE NEWSWIRE) -- Vaccitech plc (NASDAQ: VACC) (the Company, we or us), a clinical-stage biopharmaceutical company engaged in the discovery and development of novel immunotherapeutics and vaccines for the treatment and prevention of infectious diseases, autoimmunity and cancer, today announced its financial results for year end 2022 and an overview of the Company’s progress. “2022 represented an...Read more
Reports significant enhancements to accelerate Tigris patient enrollment including appointment of new Contract Research Organization Management to host Investor Day on April 6, 2023 TORONTO, March 24, 2023 (GLOBE NEWSWIRE) -- Spectral Medical Inc. (“Spectral” or the “Company”) (TSX: EDT), a late-stage theranostic company advancing therapeutic options for sepsis and septic shock, today announced its financial results for the fourth...Read more
Trudhesa® Achieved nTRx of Over 58.4K in 2022; nTRx Increased by 19.4% in Q4 vs. Q3 2022 Net Product Revenue Finished Year at $12.7 Million; Increased 62% in Q4 vs. Q3 2022 to $5 Million Impel to Host Investor Conference Call Today at 8:30 a.m. ET SEATTLE, March 24, 2023 (GLOBE NEWSWIRE) -- Impel Pharmaceuticals Inc. (NASDAQ: IMPL), a commercial-stage pharmaceutical company with a mission to develop transformative therapies for...Read more
CAMBRIDGE, Mass., March 24, 2023 /PRNewswire/ -- Leap Therapeutics, Inc. (Nasdaq:LPTX), a biotechnology company focused on developing targeted and immuno-oncology therapeutics, today reported financial results for the fourth quarter and year ended December 31, 2022. Leap Highlights: Acquired Flame Biosciences, adding FL-301, a clinical stage anti-Claudin18.2 antibody, and preclinical antibody programs targeting Claudin18.2/CD137...Read more
Reprioritized product portfolio to focus on IV-administered, self-amplifying RNA medicines On track to submit IND for ONCR-021 in mid-2023 Preclinical data featured in Nature Communications support self-amplifying RNA platform and promise of repeat IV-administration Ended the quarter with $62.2 million in cash, cash equivalents and investments to support next-generation RNA therapeutics pipeline ANDOVER, Mass., March 24, 2023...Read more
-Q4 Revenue Exceeds $5 Million for 2nd Time in 2022; Q4 Net Income Increases 12% to $0.25 Million or $0.04 per share- -2022 Revenue Reaches Nearly $20 Million; 2022 Net Income Increases 6-Fold Compared to 2021 to $1.3 Million or $0.21 per share- -Conference Call Friday March 24th at 1:00pm ET / 10:00am PT- SAN FRANCISCO, CA, March 24, 2023 (GLOBE NEWSWIRE) -- via NewMediaWire – American Shared Hospital Services (NYSE...Read more
Acquired exclusive license for oral, brain-penetrant, dual TYK2/JAK1 inhibitor for immune-mediated brain disorders in March 2023 covering global (ex-China) rights; Phase 1 clinical trial initiation anticipated in 2023 Completed Phase 1 SAD/MAD study with BHV-7000 from our Kv7 ion channel activator platform and reported preliminary safety and tolerability data Commenced enrollment in pivotal Phase 3 study with our myostatin targeting...Read more
Phase 2 trials of VTX958 (TYK2 inhibitor) are ongoing in plaque psoriasis, Crohn’s disease and psoriatic arthritis, with topline Phase 2 data in plaque psoriasis expected in Q4 2023 The Phase 2 trial of VTX002 (S1P1R modulator) in ulcerative colitis (UC) is on track to complete enrollment by mid-2023, with topline data expected in H2 2023 Initiated a Phase 2 proof-of-mechanism trial of VTX2735 (peripheral NLRP3 inhibitor) in patients...Read more
DUBLIN, Ireland, March 23, 2023 (GLOBE NEWSWIRE) -- Trinity Biotech plc (Nasdaq: TRIB), a leading developer and manufacturer of diagnostic products for the point-of-care and clinical laboratory markets, today announced results for the quarter ended December 31, 2022 and fiscal year 2022. Summary Highlights Revenue: Total revenues for fiscal year 2022 and Q4, 2022 were $74.8m and $18.0m respectively. Excluding our Covid focused PCR...Read more
New Drug Application and Marketing Authorization Application for neffy® Currently Under Review with the FDA and EMA; FDA PDUFA Target Action Date Anticipated in Mid-2023 Strong Financial Position with $274.4 Million in Cash, Cash Equivalents and Short-term Investments to Support Operating Runway for the Next Three Years SAN DIEGO, March 23, 2023 (GLOBE NEWSWIRE) -- ARS Pharmaceuticals, Inc. (Nasdaq: SPRY), a biopharmaceutical...Read more
4Q2022 Total Revenues of $50 Million, a 90% Y-o-Y Increase 4Q2022 Gross Profit of $14 Million, an $11 Million Y-o-Y Increase FY 2023 Total Revenue Expected to Exceed $210 Million First-Time Positive EBITDA Expected No Later than Second Half of 2023 Conference Call Scheduled for Today at 4:30 p.m. ET RAMSEY, N.J. and BOCA RATON, Fla., March 23, 2023 (GLOBE NEWSWIRE) -- ADMA Biologics, Inc. (Nasdaq: ADMA) (“ADMA” or the “Company”),...Read more
Signed exclusive worldwide license for pan-RAF inhibitor naporafenib and completed concurrent $100 million equity offering Multiple clinical data readouts planned in 2023, including for HERKULES-2, HERKULES-3, FLAGSHP-1, and THUNDERBBOLT-1 trials for ERAS-007, ERAS-601, and ERAS-801 Dosing of the first patient in Phase 1b SEACRAFT-1 trial for naporafenib in RAS Q61X tissue agnostic solid tumors planned for H2 2023, and the dosing of...Read more
2022 and Recent Highlights: Full-year 2022 revenues of $88.6 million, up 22% over full-year 2021 revenues of $72.5 million Sold all non-ophthalmology assets, making Harrow a pure-play ophthalmic pharmaceutical company FDA approval of IHEEZO™ topical ocular anesthetic CMS issuance of Permanent J-Code (J2403) and Pass-Through Reimbursement Status for IHEEZO Acquired U.S. commercial rights to ILEVRO®, NEVANAC®, VIGAMOX®, MAXIDEX®, and...Read more
Dosing of first patient in VIKTORIA-1 in the fourth quarter triggered closing of $100 million PIPE financing and drawdown of $20 million term loan tranche, which extends cash runway through 2025 Updated clinical data from the Phase 1b advanced breast cancer trial with gedatolisib was presented at SABCS in December - median PFS was 42.3 months in treatment naïve advanced breast cancer patients Preclinical data reporting therapeutic...Read more
RUBY-3, a basket study of povetacicept in autoimmune glomerulonephritis, has initiated patient enrollment; RUBY-4, a basket study of povetacicept in autoimmune cytopenias, targets initiation in Q2 2023 Initial data from both basket studies are anticipated by the end of 2023 SEATTLE / Mar 23, 2023 / Business Wire / Alpine Immune Sciences, Inc. (NASDAQ: ALPN), a leading clinical-stage immunotherapy company focused on developing...Read more
Initial clinical data supports founding vision that engineered hematopoietic stem cells can enable treatment options after AML transplant Additional trem-cel data expected by year-end 2023; VCAR33ALLO on track for IND submission in first half of 2023 $116M financing extends expected cash runway into Q1 2025 CAMBRIDGE, Mass., March 23, 2023 (GLOBE NEWSWIRE) -- Vor Bio (Nasdaq: VOR), a clinical-stage cell and genome engineering...Read more
BOSTON, March 23, 2023 (GLOBE NEWSWIRE) -- PepGen Inc. (Nasdaq: PEPG), a clinical-stage biotechnology company advancing the next generation of oligonucleotide therapies with the goal of transforming the treatment of severe neuromuscular and neurological diseases, today reported financial results for the fourth quarter and full year ended December 31, 2022 and highlighted recent corporate developments. “2022 was a truly...Read more
OXFORD, U.K. / Mar 23, 2023 / Business Wire / Recent developments in the Exscientia's (Nasdaq: EXAI) pipeline, collaborations, and operations as well as financial results for the fourth quarter and full year 2022 are summarised below. Exscientia will host a conference call today, March 23, at 12:30 p.m. GMT / 8:30 a.m. EDT. "2022 was marked by significant milestones for Exscientia, including signing a groundbreaking strategic...Read more
Annual Net Product Sales Across the Company Grew 25% to $107.7 million in 2022, Compared to Annual Net Product Sales in 2021 APONVIE™ Commercially Launched on March 6, 2023 ZYNRELEF® Net Product Sales for Fourth Quarter of 2022 Increased 44% Over Prior Quarter to $3.9 Million Oncology Care Franchise Net Product Sales for 2022 Grew 17% Over Prior Year to $97.5 Million SAN DIEGO, March 23, 2023 /PRNewswire/ -- Heron...Read more
Advancing VYD222 into clinical development based on in vitro data demonstrating neutralizing activity against multiple important variants of concern, including XBB.1.5 Anticipate near-term designation of an additional monoclonal antibody against SARS-CoV-2 with complementary binding properties to VYD222 for development Well capitalized with $372 million in cash, cash equivalents and marketable securities expected to support operating...Read more
MONTREAL, March 23, 2023 (GLOBE NEWSWIRE) -- Knight Therapeutics Inc. (TSX: GUD) ("Knight" or “the Company”), a leading Pan-American (ex-US) specialty pharmaceutical company, today reported financial results for its fourth quarter and year ended December 31, 2022. All currency amounts are in thousands except for share and per share amounts. All currencies are Canadian unless otherwise specified. Financial information as at and for the...Read more
Sanofi collaboration for Natural Killer cell engager therapeutics expanded to B7-H3 ANKET® program and two additional targets, with €25 million payment Encouraging preliminary TELLOMAK Phase 2 efficacy data for lacutamab in advanced cutaneous T cell lymphoma in Sézary syndrome and mycosis fungoides First patient dosed in monalizumab PACIFIC-9 Phase 3 lung cancer clinical trial with $50M payment from AstraZeneca Cash position of €136.6...Read more
Progress in Three Phase 3 Trials in Areas of High Unmet Clinical Need, Including Positive Sorbitol Reduction Data from the Ongoing Phase 3 INSPIRE Trial in Sorbitol Dehydrogenase (SORD) Deficiency On Track to Report Additional Phase 3 Data Across Multiple Programs in 2023 NEW YORK, March 23, 2023 (GLOBE NEWSWIRE) -- Applied Therapeutics, Inc. (Nasdaq: APLT), a clinical-stage biopharmaceutical company developing a pipeline of novel...Read more
AFM13 combination with AB-101 NK cells: On track for IND filing in H1 2023 and initiation of clinical study in 2023 AFM13 monotherapy REDIRECT data: Oral presentation at the AACR annual meeting AFM24: Data from the three ongoing studies expected to be presented at scientific conferences in Q2 or Q3 of 2023 AFM28: Clinical phase 1 study is open and recruiting; clinical trial applications now approved in four European countries...Read more
SAN DIEGO, March 23, 2023 (GLOBE NEWSWIRE) -- Cidara Therapeutics, Inc. (Nasdaq: CDTX), a biotechnology company developing long-acting therapeutics designed to help improve the standard of care for patients facing serious diseases, today reported financial results for the three months and full year ended December 31, 2022 and provided an update on its corporate activities and product pipeline. “We have completed a transformational...Read more
CORAL GABLES, Fla., March 23, 2023 /PRNewswire/ -- Relmada Therapeutics, Inc. (Nasdaq: RLMD), a late-stage biotechnology company addressing diseases of the central nervous system (CNS), today provided a corporate update and announced preliminary and unaudited financial results for the fourth quarter and full-year ended December 31, 2022. The Company will host a conference call today, Thursday, March 23, at 4:30 PM Eastern...Read more
Recent Highlights: Net revenues of $12.9 million in the fourth quarter of 2022, compared to $10.1 million in the fourth quarter of 2021 and $7.9 million in the third quarter of 2022 Gross systems shipped of 8,863, compared to 7,767 in the fourth quarter of 2021 GAAP operating loss $23.9 million in the fourth quarter of 2022, compared to $45.2 million in the fourth quarter of 2021 and $26.0 million in the third quarter of 2022 Cash...Read more
Cleared dose-limiting toxicity (DLT) observation period with more frequent, dose-intensive regimen of CAB-AXL BA3011; anticipated leiomyosarcoma (LMS) cohort readout in 2H23 Initiated the potentially registrational Phase 2, part 2 BA3011 Undifferentiated Pleomorphic Sarcoma (UPS) study in 1H23 including more frequent, dose-intensive regimens On track for submitting a meeting request to the Food & Drug Administration (FDA) for the...Read more
Company expects completion of IND-enabling studies of GT-02287 in H1 2023 Submission of dossier to start Phase 1 clinical trial of GT-02287 in GBA1 Parkinson’s Disease expected by mid-year 2023 $22.1 million in cash and cash equivalents and marketable securities as of December 31, 2022 €1.2 million non-dilutive grant awarded to Company-led consortium to advance research program in Alpha-1 Antitrypsin Deficiency BETHESDA,...Read more
VICTORIA, BC, March 23, 2023 /CNW/ - Eupraxia Pharmaceuticals Inc. ("Eupraxia" or the "Company") (TSX: EPRX), a Phase 2 clinical-stage biotechnology company with an innovative drug delivery technology platform, today announced its audited financial results (prepared in accordance with International Financial Reporting Standards or "IFRS") and operational highlights for the fourth quarter and year ended December 31, 2022. All amounts...Read more
On track to complete enrollment in Phase 2/3 LIFT-AD trial of fosgonimeton for mild-to-moderate Alzheimer’s disease in mid-2023 with topline data in early 2024 Continuing to advance development of ATH-1105 as a potential clinical candidate for amyotrophic lateral sclerosis Strong balance sheet to support innovative clinical development pipeline in neurodegenerative diseases through key inflection points BOTHELL, Wash., March 23,...Read more
Initial data from Phase 1 combination with capecitabine in advanced ovarian cancer are expected in mid-2023 Dose for the Phase 1 combination trials identified as 400mg daily Ended 2022 with approximately $147 million in cash; Projected cash runway into 2026 LEXINGTON, Mass. / Mar 23, 2023 / Business Wire / Cyteir Therapeutics, Inc. (“Cyteir”) (Nasdaq: CYT), a clinical stage oncology company, today reported financial results for the...Read more
APTIVATE Expansion Trial of Tuspetinib as Single Agent in Relapsed/Refractory AML Patients is Up and Running; Initiated Enrollment of Combination Treatment Arm with Venetoclax RAS Mutated AML Clinically Sensitive to Tuspetinib Continuous Dosing of G3 Formulation of Luxeptinib Ongoing Conference Call and Webcast at 5:00 pm ET Today SAN DIEGO and TORONTO, March 23, 2023 (GLOBE NEWSWIRE) -- Aptose Biosciences Inc. (“Aptose” or the...Read more
Completed the acquisition of AavantiBio, creating a precision genetic medicines company with a focus on cardiac and neuromuscular diseases; Closed concurrent $75 million private placement Company remains on track to submit IND for SGT 003, a next-generation gene therapy for patients with Duchenne; Anticipated dosing in late – 2023, subject to IND clearance Company ends 2022 with approximately $213.7 million in cash and...Read more
TCR² and Adaptimmune announce strategic combination to create a preeminent cell therapy company focused on treating solid tumors Following the expected Q2 2023 closing of the all-stock transaction, the combined company's cash runway is expected to extend into 2026 CAMBRIDGE, Mass., March 23, 2023 (GLOBE NEWSWIRE) -- TCR² Therapeutics Inc. (Nasdaq: TCRR) (TCR² or the Company), a clinical-stage cell therapy company with a...Read more
Following positive regulatory feedback, plan to initiate registrational global Phase 2/3 clinical trial for Gaucher disease type 3 (GD3) in second half 2023, subject to regulatory alignment Patient dosing completed in collaborator-sponsored Phase 1/2 clinical trial for cystinosis; plan to initiate late-stage clinical trial activities in second half 2023, subject to regulatory alignment; expect to provide clinical and regulatory update at...Read more
Initial first-in-human clinical data for IL-2 INDUKINE WTX-124 monotherapy expected in 4Q 2023 from Phase 1/1b clinical trial in advanced or metastatic solid tumors Dosed first patient in Phase 1 clinical trial evaluating IL-12 INDUKINE WTX-330 in patients with advanced or metastatic solid tumors or lymphoma Nominated WTX-712, a conditionally active IL-21 INDUKINE molecule targeting oncology indications; preclinical data...Read more
Enrollment progressing in Phase 1b Multiple-Ascending Dose (MAD) study of RGLS8429 in patients with Autosomal Dominant Polycystic Kidney Disease (ADPKD) Top-line data in the first cohort of RGLS8429-treated ADPKD patients anticipated in second half of 2023 Expansion of team with key leadership appointments in clinical development, regulatory and clinical operations SAN DIEGO, March 23, 2023 /PRNewswire/ -- Regulus Therapeutics...Read more
Starting in 2023, Celyad Oncology is now entirely focused on its new business strategy with one clear objective: help to overcome the current limitations of CAR-T approaches. It plans to do this via (i) strengthening of its research focus centered around NKG2D, B7-H6 and shRNA platforms; (ii) maximizing the value of its IP estate and (iii) driving innovation through strategic collaborations. MONT-SAINT-GUIBERT, Belgium, March 23, 2023...Read more
2022 marked by continued execution and growing body of positive data across clinical and preclinical development programs Sufficient capital to fund operations into the third quarter of 2024 Company to host conference call and webcast today at 8:30 AM ET HOUSTON, March 23, 2023 /PRNewswire/ -- Moleculin Biotech, Inc., (Nasdaq: MBRX) ("Moleculin" or the "Company"), a clinical stage pharmaceutical company with a growing pipeline,...Read more
Completed enrollment of CT1812 Phase 2 SEQUEL study for mild-to-moderate Alzheimer's disease Received FDA clearance for Phase 2 START Study of CT1812 in early Alzheimer’s disease Received FDA clearance for IND for Phase 2 study of CT1812 in 240 patients with geographic atrophy secondary to dry AMD Secured equity commitment of up to an additional $35M enabling potential access to capital Connecting with neuroscience community...Read more
Phase 2 topline data readout for prevention of post-surgical abdominal adhesions on track for Q2 2023 Strong balance sheet with sufficient cash expected to fund operations into mid-2024 Carlsbad, CA, March 23, 2023 (GLOBE NEWSWIRE) -- Palisade Bio, Inc. (Nasdaq: PALI) (“Palisade” or the “Company”), a biopharmaceutical company advancing therapies for acute and chronic gastrointestinal (GI) complications, today reported its...Read more
Company ended the year with $50.6 million in cash, expected to fund operations through 2024 and into 2025 Executing strategy to streamline advancement of development programs, build upon growing body of data across pipeline, and progress towards go/no-go decision milestones Ongoing efforts to accelerate recruitment for our DETECT trial and establish partnering rights to Macrilen™ in the U.S. and Canada TORONTO, ONTARIO, March 23,...Read more
SOMERVILLE, Mass., March 23, 2023 (GLOBE NEWSWIRE) -- Finch Therapeutics Group, Inc. (“Finch”, “Finch Therapeutics” or the “Company”) (Nasdaq: FNCH), a microbiome technology company with a portfolio of intellectual property and microbiome assets, today reported fourth quarter and full year 2022 financial results and provided business updates. “We believe that Finch has made significant progress towards restructuring the business to...Read more
Validive® Phase 2b/3 VOICE Trial Anticipates Go/No-Go Interim Readout by End of Next Week Camsirubicin Phase 1b Dose-Escalation Trial Now Enrolling 5th Dose-Level Cohort (650 mg/m2) WILMETTE, Ill., March 23, 2023 (GLOBE NEWSWIRE) -- Monopar Therapeutics Inc. (Monopar or the Company) (Nasdaq: MNPR), a clinical-stage biopharmaceutical company focused on developing proprietary therapeutics designed to extend life or improve the quality...Read more
Encinitas, California--(Newsfile Corp. - March 23, 2023) - Kiora Pharmaceuticals, Inc. (NASDAQ: KPRX), ("Kiora" or the "Company") today is providing a business update and reporting financial results for the year ended December 31, 2022. CEO Commentary "In 2022, we advanced our pipeline of three differentiated assets across rare, orphan and underserved eye disease indications," said Brian M. Strem, Ph.D., President and Chief Executive...Read more
Year marked by transformational strategic license of the DNase oncology platform and shift in focus to treatment of locally advanced or metastatic solid tumors DNase program progressing towards Phase 1 clinical development Closed the year with $13.1 million of cash expected to fund operations and drive pipeline development FRAMINGHAM, MA / ACCESSWIRE / March 23, 2023 / Xenetic Biosciences, Inc. (NASDAQ:XBIO) ("Xenetic" or the...Read more
On Track to Initiate Phase 2 Proof-of-Concept Trial in Ulcerative Colitis for NX-13 in the Second Quarter of 2023 and Report Topline Results by the Fourth Quarter of 2024 Projected Cash Runway into First Half of 2025 NEW YORK, March 23, 2023 (GLOBE NEWSWIRE) -- Landos Biopharma, Inc. (NASDAQ: LABP), a clinical-stage biopharmaceutical company developing novel, oral medicines for patients with autoimmune diseases, today provided a...Read more
Company Expands Ongoing Clinical Trials and the Breadth and Capacity of Its Novel Vaccine Platform Technology ATLANTA, GA, March 23, 2023 (GLOBE NEWSWIRE) -- via NewMediaWire - GeoVax Labs, Inc. (Nasdaq: GOVX), a biotechnology company developing immunotherapies and vaccines against cancers and infectious diseases, today announced its financial results and key operational accomplishments for the year ended December 31,...Read more
TORONTO, March 23, 2023 (GLOBE NEWSWIRE) -- Vitalhub Corp. (the “Company” or “Vitalhub”) (TSX:VHI) (OTCQX:VHIBF) announced today it has filed its Consolidated Financial Statements and Management’s Discussion and Analysis report for the year ended December 31, 2022, with the Canadian securities authorities. These documents may be viewed under the Company’s profile at www.sedar.com. “Our record fourth-quarter revenue capped off fiscal 2022...Read more
$71.0 million cash balance at the end of 2022 expected to provide cash runway into 2025 Acquired Bioniz Therapeutics, including two first-in-class clinical-stage assets, EQ101 and EQ102, and proprietary product discovery platform Initiated Phase 2 clinical study of EQ101 in alopecia areata and first-in-human clinical study of EQ102 Entered into strategic partnership and an option and asset purchase agreement with Ono Pharmaceutical for...Read more
WILMINGTON, Del. / Mar 22, 2023 / Business Wire / Phreesia, Inc. (NYSE: PHR) (“Phreesia” or the "Company") announced financial results today for the fiscal fourth quarter and fiscal year ended January 31, 2023. "There were many accomplishments and milestones achieved during Phreesia’s 18th year and fourth as a public company. We experienced challenges, opportunities and successes, and we greatly appreciate the hard work of our team members...Read more
ALPHA-STAR Phase 1b/2 Trial in People with HAE Underway with Initial Proof-of-Concept Results Anticipated Mid-2024 Phase 1a Results Support STAR-0215’s Target Profile as a Long-Acting Plasma Kallikrein Inhibitor with Estimated Half-Life of up to 117 Days Ended 4Q 2022 with Cash, Cash Equivalents, and Short-term Investments of $226M, Expected Cash Runway Through H1 2025 Webcast Today at 8:30am ET BOSTON / Mar...Read more
Initiated patient dosing with TYRA-300 in SURF301 oncology study Expanded pipeline beyond oncology into genetically defined conditions with TYRA-300 for achondroplasia Cleared IND for TYRA-200 Phase 1 study; first patient dosed expected in 2H 2023 Well-capitalized with cash and cash equivalents of $251.2 million as of YE 2022 CARLSBAD, Calif., March 22, 2023 /PRNewswire/ -- Tyra Biosciences, Inc. (Nasdaq: TYRA), a...Read more
Announced launch and commercial availability of FUROSCIX® (furosemide injection), the first and only self-administered, subcutaneous loop diuretic for the at-home treatment of congestion in chronic heart failure Ended Q4 with cash, cash equivalents, restricted cash and investments of $118.4M Company to host investor conference call and webcast today, Wednesday, March 22, at 4:30pm ET BURLINGTON, Mass., March 22, 2023 (GLOBE...Read more
Completed all 115 implants in the DREAM U.S. pivotal study Mont-Saint-Guibert, Belgium – March 22, 2023 09:05pm CET / 4:05pm ET – Nyxoah SA (Euronext Brussels/Nasdaq: NYXH) (“Nyxoah” or the “Company”), a medical technology company focused on the development and commercialization of innovative solutions to treat Obstructive Sleep Apnea (OSA), today reported financial and operating results for the fourth quarter and full year...Read more
SALT LAKE CITY, March 22, 2023 /PRNewswire/ -- Sera Prognostics Inc., The Pregnancy Company® (Nasdaq: SERA), focused on improving maternal and neonatal health by providing innovative pregnancy biomarker information to doctors and patients, today announced financial results for the fourth quarter and full year 2022 ended December 31, 2022. Recent Highlights: Announced positive top-line results from the AVERT PRETERM TRIAL (Serum...Read more
Anticipates initiating first Phase 2 clinical study in RT-102 in 2H of 2023 Announced topline results from the Phase 1 repeat-dose study of RT-102 for the treatment of osteoporosis Received preliminary feedback from FDA on RT-102 development plans; 505(b)(2) pathway for RT-102 could be suitable Announced partnership with Celltrion on development of RT-111, a RaniPill GO capsule containing an ustekinumab biosimilar Conference call...Read more
Achieved clinical validation of PRISM platform in 2022 – demonstrated ability to potently and durably engage RNA targets and translate preclinical data to the clinic Extended leadership in RNA editing and advanced WVE-006 for AATD – first-in-class RNA editing candidate transitioning to clinical development in 2023 Initiating Part B of WVE-N531 study in exon 53-amenable DMD to assess dystrophin after...Read more
First launch quarter for ROLVEDON™ (eflapegrastim-xnst) injection Q4 and full year net sales of $10.1 million Management to host webcast and conference call today at 8:30 a.m. ET / 5:30 a.m. PT BOSTON / Mar 22, 2023 / Business Wire / Spectrum Pharmaceuticals, Inc. (NasdaqGS: SPPI), a biopharmaceutical company focused on novel and targeted oncology therapies, announced today financial results for the three-month...Read more
Following safety data review by the DMC, enrollment is now open for the second cohort of its Phase 1b study of PH-762 for the treatment of advanced melanoma Received confirmation from the FDA that the planned Phase 1 clinical trial in patients with advanced solid tumors, in collaboration with Phio's development partner AgonOx, may proceed Newly integrated management and clinical teams continue to make significant advancements across...Read more
Prioritization of core inhibitor candidate ABI-4334 and pausing of core inhibitor candidate ABI-H3733 based on data to date from ongoing clinical Phase 1 studies of both candidates and chronic toxicology observation for ABI-H3733 Phase 1a complete clinical data for all ABI-4334 dose cohorts expected in April 2023 Advancing expanded research portfolio, with additional development candidate nomination anticipated in 2023 and IND/CTA...Read more
SEATTLE, March 22, 2023 (GLOBE NEWSWIRE) -- Atossa Therapeutics, Inc. (Nasdaq: ATOS), a clinical stage biopharmaceutical company developing innovative proprietary medicines to address significant unmet needs in cancer, today announced financial results for the fiscal quarter and fiscal year ended December 31, 2022 and provided an update on recent company developments. Key developments from Q4 2022 and year to date include: Initiation...Read more
Major progress in development of vilobelimab Phase III study in PG announced following detailed feedback and recommendations from the U.S. Food and Drug Administration (FDA); clinical trial protocol submitted; first patient expected around mid-2023 Fast Track and Orphan Drug designations granted for treatment of pyoderma gangrenosum (PG) in the United States and Orphan Drug designation granted in Europe Encouraging results from...Read more
Preliminary data from two Phase 1 trials anticipated late 2023 to early 2024 First subject dosed in Phase 1 trial of PYX-201; clinical sites being activated and patient screening underway in Phase 1 trial of PYX-106 Strong balance sheet with $180.7 million in cash (including restricted cash) and no debt as of year-end 2022 supports operations into 1H 2025 CAMBRIDGE, Mass., March 22, 2023 (GLOBE NEWSWIRE) -- Pyxis Oncology, Inc....Read more
Founding CEO, Axel Bolte, MSc, MBA, to retire; Douglas A. Treco, Ph.D., to succeed as CEO Matthew Winton, Ph.D., appointed COO Upcoming clinical and regulatory milestones remain on track with previous guidance Current cash, cash equivalents and short-term investments anticipated to fund cash flow requirement into the fourth quarter of 2024 BOSTON, March 22, 2023 (GLOBE NEWSWIRE) -- Inozyme Pharma, Inc....Read more
SENTI-202 on track to submit an Investigational New Drug (IND) application in second half of 2023 for treatment of CD33 and/or FLT3 expressing hematologic malignancies including AML and MDS - Preclinical data from multiple Gene Circuit enhanced CAR NK programs to be presented at American Association for Cancer Research (AACR) Annual Meeting in April 2023 - Cash, cash equivalents, and short-term investments of $98.6 million as of...Read more
2022 total revenue of $8.2 million, an increase of 20% year-over-year 2022 total OvaSuiteSM volume of 21,423 units, an increase 23% year-over-year Fourth quarter 2022 cash utilization of $7.1 million Conference Call and Webcast scheduled for today at 4:30 pm Eastern Time AUSTIN, Texas, March 22, 2023 (GLOBE NEWSWIRE) -- Aspira Women’s Health Inc. (“Aspira”) (Nasdaq: AWH), a bio-analytical based women’s health company focused on...Read more
Achieved consolidated Adjusted EBITDA profitability for first-time in LifeMD history Full Year 2022 consolidated revenue of $119.0 million, up 28% from the same year-ago period. Fourth quarter 2022 consolidated revenue of $28.1 million up 3% from the same year-ago period. This figure was impacted by a $2.9 million deferral of telehealth shipments. Adjusted EPS of $0.02, 107% improvement versus the prior year. Subsequent to year end,...Read more
REDWOOD CITY, Calif., March 22, 2023 (GLOBE NEWSWIRE) -- Talis Biomedical Corporation (Nasdaq: TLIS), a diagnostic company dedicated to advancing health equity and outcomes through the delivery of accurate infectious disease testing in the moment of need, at the point of care, today reported financial results for the fourth quarter and full year ended December 31, 2022. In 2022, Talis renewed its focus on the women’s and sexual health...Read more
CAMBRIDGE, Mass., March 22, 2023 /PRNewswire/ -- NeuroSense Therapeutics Ltd. (Nasdaq: NRSN) ("NeuroSense"), a company developing treatments for severe neurodegenerative diseases, announced today that its annual report on Form 20-F, containing audited consolidated financial statements for the year ended December 31, 2022, as filed with the Securities and Exchange Commission, is available through its website...Read more
Enrolled first patient in SZN-043 Ph 1a clinical trial in chronic liver disease with data expected by the end of 2023 Expect to begin SZN-043 Ph1b clinical trial in severe alcoholic hepatitis in 2024 with proof-of-concept data expected in the second half of 2024 Expect to reinitiate SZN-1326 Ph1a clinical trial in healthy volunteers by mid-2023 with data expected by the end of 2023 Anticipate potential proof-of-concept data for...Read more
Compass Therapeutics is a clinical-stage, oncology-focused biopharmaceutical company developing proprietary antibody-based therapeutics to treat multiple human diseases. The company's scientific focus is on the relationship between angiogenesis, the immune system, and tumor growth...
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