Day: May 9, 2024

Cretostimogene Monotherapy Demonstrated 75.2% Complete Response (CR) Rate at Any Time in Bacillus Calmette Guerin (BCG)-Unresponsive, High-Risk Non-Muscle Invasive Bladder Cancer (HR-NMIBC) First Patient Dosed in PIVOT-006 Phase 3 Clinical Trial of Cretostimogene in Intermediate-Risk NMIBC (IR-NMIBC) Final Results from CORE-001 Phase 2 Clinical Trial of Cretostimogene in Combination with Pembrolizumab in BCG-Unresponsive HR-NMIBC will be presented at ASCO 2024Completed Oversubscribed and Upsized $437 Million Initial Public Offering that Extends Expected Runway Through 2027IRVINE, Calif., May 09, 2024 (GLOBE NEWSWIRE) — CG Oncology, Inc. (NASDAQ: CGON), a late-stage clinical biopharmaceutical company focused on developing and commercializing a potential backbone bladder-sparing therapeutic for patients with bladder cancer,...

Presented top-line results from AURORA, the placebo-controlled phase 2 study of bitopertin in erythropoietic porphyrias (EPP), in April 2024 On track to deliver additional analyses from BEACON and AURORA in Q2 2024 Plan to present updated data from the phase 1b/2 study of DISC-0974 in anemia of myelofibrosis (MF), as well as initial single-ascending dose (SAD) data from the phase 1 study of DISC-3405 in healthy volunteers in Q2 2024 Continue to be well-capitalized, ending Q1 2024 with $343M in cash and cash equivalents, which provides runway well into 2026WATERTOWN, Mass., May 09, 2024 (GLOBE NEWSWIRE) — Disc Medicine, Inc. (NASDAQ:IRON), a clinical-stage biopharmaceutical company focused on the discovery, development, and commercialization of novel treatments for patients suffering from serious hematologic diseases, today reported...

Presented positive 72-week data from the Phase 2b ORIGIN clinical trial, setting a new standard in IgAN with no loss of kidney function over the duration of treatment Topline 96-week data from ORIGIN 2 trial expected in Q4 2024 Pivotal Phase 3 ORIGIN 3 trial estimated to complete enrollment for primary endpoint in Q3 2024; topline data expected in 1H 2025 Completed $287.5 million financing, further strengthening the Company’s balance sheetBRISBANE, Calif., May 09, 2024 (GLOBE NEWSWIRE) — Vera Therapeutics, Inc. (Nasdaq: VERA), a late clinical-stage biotechnology company focused on developing and commercializing transformative treatments for patients with serious immunological diseases, today reported its business highlights and financial results for the first quarter ended March 31, 2024. “This quarter, we shared results from...

Design of Phase 2b trial for VYN201 in nonsegmental vitiligo finalized and on track to begin this quarter Phase 2b trial expected to enroll approximately 160 subjects with either active or stable nonsegmental vitiligo and will evaluate VYN201 gel in 1%, 2% and 3% concentrations compared to vehicle for 24 weeks, followed by a 28-week active treatment extension IND clearance received for oral BD2-selective BET inhibitor, VYN202; anticipate first healthy volunteers to be dosed in Phase 1a SAD/MAD trial this quarterBRIDGEWATER, N.J., May 09, 2024 (GLOBE NEWSWIRE) — VYNE Therapeutics Inc. (Nasdaq: VYNE) (“VYNE” or the “Company”), a clinical-stage biopharmaceutical company focused on developing proprietary, innovative and differentiated therapies for the treatment of immuno-inflammatory conditions, today announced financial results...

First patient dosed and continued enrollment in Phase 2 portion of the PYNNACLE trial evaluating rezatapopt as monotherapy in patients with TP53 Y220C and KRAS wild-type advanced solid tumorsPhase 1 data of rezatapopt in advanced ovarian cancer featured in late-breaking oral presentation at 2024 SGO Annual Meeting on Women’s CancerCash, cash equivalents, and marketable securities of $213.1 million as of March 31, 2024, providing expected cash runway to end of 2026PRINCETON, N.J., May 09, 2024 (GLOBE NEWSWIRE) — PMV Pharmaceuticals, Inc. (Nasdaq: PMVP), a precision oncology company pioneering the discovery and development of small molecule, tumor-agnostic therapies targeting p53, today reported financial results for the first quarter ended March 31, 2024, and provided a corporate update. “Dosing the first patient in the...

ATLANTA, May 09, 2024 (GLOBE NEWSWIRE) — Perma-Fix Environmental Services, Inc. (NASDAQ: PESI) (the “Company”) today announced financial results and provided a business update for the first quarter ended March 31, 2024. Mark Duff, President and CEO of the Company, commented, “As previously disclosed, our financial performance in the first quarter of 2024 was impacted by a few temporary headwinds. However, we have seen steady improvement heading into the second quarter and anticipate a strong second half of 2024. The weakness we experienced was due in part to delayed project starts and waste shipments, as well as challenging weather conditions during the first quarter of 2024. However, we used this period for equipment replacement and repairs, program enhancements, and testing to support permit expansion and broader market penetration....

Company maintains solid cash position of $141.6 million SOUTH SAN FRANCISCO, Calif., May 09, 2024 (GLOBE NEWSWIRE) — RAPT Therapeutics, Inc. (Nasdaq: RAPT), a clinical-stage, immunology-based therapeutics company focused on discovering, developing and commercializing oral small molecule therapies for patients with significant unmet needs in inflammatory diseases and oncology, today reported financial results for the first quarter ended March 31, 2024. The Company also announced today that it has decided to close and unblind both its Phase 2b clinical trial of zelnecirnon (RPT193) in atopic dermatitis (“AD”) and its Phase 2a trial of zelnecirnon in asthma. Both clinical trials were placed on clinical hold by the FDA in February 2024 based on a serious adverse event of liver failure requiring transplant in one patient in the AD trial....

— Enrolled over 9,500 patients in Phase 3 PREVAIL global CVOT– — On-track to report topline data from Phase 3 BROOKLYN trial in HeFH in 3Q 2024 and Phase 3 BROADWAY trial in ASCVD in 4Q 2024 — — Dosed first patients in TANDEM, pivotal Phase 3 trial evaluating fixed-dose combination of obicetrapib and ezetimibe; topline data expected in 1Q 2025 — — Company to host R&D event on May 16, 2024, beginning at 9:00 a.m. ET in New York City – — Strong financial position; ending the quarter with $481.1 million in cash — NAARDEN, the Netherlands and MIAMI, May 09, 2024 (GLOBE NEWSWIRE) — NewAmsterdam Pharma Company N.V. (Nasdaq: NAMS or “NewAmsterdam” or the “Company”), a late-stage, clinical biopharmaceutical company developing oral, non-statin medicines for patients at risk of cardiovascular...

– Positive data from the Phase 1 AQUAx study in radiation-induced xerostomia (RIX) presented in an oral session at the American Academy of Oral Medicine 2024 annual meeting (AAOM) April 17-20, 2024 – Received $50 million milestone following initiation of the extension study for the Phase 3 LUMEOS clinical trial for botaretigene sparoparvovec (bota-vec, formerly AAV-RPGR) for the treatment of X-linked retinitis pigmentosa (XLRP) – Clinical development milestones met and remain on track for the rest of the year for AAV-hAQP1 for RIX, bota-vec for XLRP, and AAV-GAD for Parkinson’s disease LONDON and NEW YORK, May 09, 2024 (GLOBE NEWSWIRE) — MeiraGTx Holdings plc (Nasdaq: MGTX), a vertically integrated, clinical stage gene therapy company, today announced financial and operational results for the first quarter ended...