Cash and Cash Equivalents of $28.4 Million as of June 30, 2026 Providing Runway Through Mid-2027; Company Advances Chemistry, Manufacturing and Controls (CMC) Work Toward NDA Resubmission KANSAS CITY, Kan., Aug. 13, 2026 (GLOBE NEWSWIRE) -- Cingulate Inc.
First lupus nephritis patient dosed in RECLAIM-LN, a Phase 2 potentially registrational trial utilizing FT819, an iPSC-derived, off-the-shelf CAR T-cell therapy; patient was treated as an outpatient with same-day discharge FDA clearance of the FT839 IND application advances the Company’s novel
Planning to submit a Biologics License Application (BLA) for aglatimagene besadenovec (aglatimagene) in localized, intermediate- to high-risk prostate cancer in Q4 2026 Pivotal phase 3 clinical data published in The Lancet Oncology demonstrated a statistically significant improvement in
ROCKVILLE, Md., Aug. 13, 2026 (GLOBE NEWSWIRE) -- Ascentage Pharma Group International (NASDAQ: AAPG; HKEX: 6855) (“Ascentage Pharma” or the “Company”), a global, commercial-stage, integrated biopharmaceutical company engaged in the discovery, development and commercialization of novel,
The number of patients experiencing moderate to severe odynophagia (pain swallowing) in the cohorts analyzed (Cohorts 7-9) was reduced from 62% at baseline to 25% from 24 through to 52 weeks post treatment In the same analysis, 23% of patients reported severe odynophagia at baseline; and no
– Q2 2026 product revenue of €315 million (+105% Y/Y), comprising €252 million for YORVIPATH ®, €55 million for SKYTROFA ®, and €8 million for YUVIWEL ® – Through July 31, more than 220 unique YUVIWEL patient enrollments in the U.S. – Substantial pipeline updates: presented long-term Phase 2 & 3
First patients treated in randomized Phase 2 trial C-1300-02 were alive at Day 28, with improved oxygenation, resolution of ARDS with return to spontaneous breathing and liberation from vasopressor support Clinical recovery and biologic readouts moved in the same direction; serum and
SAN FRANCISCO, Aug. 13, 2026 (GLOBE NEWSWIRE) -- Olema Pharmaceuticals, Inc. (“Olema” or “Olema Oncology”, Nasdaq: OLMA), a clinical-stage biopharmaceutical company focused on the discovery, development, and commercialization of targeted therapies for breast cancer and beyond, today announced the
- Obexelimab BLA submission for the treatment of IgG4-RD accepted by FDA; PDUFA target action date of May 27, 2027 - - New study data confirm bioequivalence of obexelimab single-dose prefilled autoinjector pen compared to prefilled syringes - - Obexelimab global Phase 2 SunStone SLE trial topline
EscharEx ® Phase III VALUE Trial Advancing; Interim Assessment and Enrollment Completion Expected by End of First Quarter 2027 Master Services Agreement Signed with Vericel Under its BARDA Contract for NexoBrid ® Second Quarter Revenue of $3.1 Million; Full-Year 2026 Revenue Guidance of $24–26
Updated data from the MICVO Phase 1 monotherapy study in 2L+ R/M HNSCC on track to be reported in Fall 2026; update to include detailed analyses of patients treated at or below a dose cap Updated data from the MICVO Phase 1/2 combination study with pembrolizumab in 1L R/M HNSCC on track to be
• Initiated Study to Assess the Potential Impact of the Combination of Icovamenib and Low-Dose Semaglutide on Physical Function, Body Weight, Body Composition, Muscle Health, and Metabolic Outcomes SAN CARLOS, Calif., Aug. 13, 2026 (GLOBE NEWSWIRE) -- Biomea Fusion, Inc.
First clinical validation of Axiomer™ RNA editing established through NTCP modulation with positive AX-0810 clinical target engagement data; full Phase 1 dataset to be presented at a medical or scientific conference later this year Multiple clinical milestones, including initial AX-0811 Phase 1 data expected by year-end 2026, followed in H1 2027 by:...
Phase 3 clinical trial of denifanstat in moderate to severe acne patients in the U.S. on track to initiate in second half of 2026 FOSTER CITY, Calif., Aug. 13, 2026 (GLOBE NEWSWIRE) -- Sagimet Biosciences Inc. (Nasdaq: SGMT), a clinical-stage biopharmaceutical company developing novel therapeutics
Total product sales of €64.0 million In-line with expectations; full-year guidance of €135 -150 million reaffirmed Solid cash position of €121.5 million as of end June 2026 Reflects disciplined cash management and proceeds from the recent reserved offering [1] Restructuring program implemented with positive P&L and cash flow impacts expected in the second...
U.S. Food and Drug Administration (FDA) accepted the New Drug Application (NDA) with Priority Review for tinlarebant for the treatment of Stargardt disease type 1 (STGD1); Prescription Drug User Fee Act (PDUFA) target action date of February 12, 2027 Company presented additional positive secondary
PRINCETON, New Jersey, TOKYO, Japan, CAMBRIDGE, Mass., August 12, 2026 — Taiho Oncology, Inc., Taiho Pharmaceutical Co., Ltd., and Cullinan Therapeutics, Inc. (Nasdaq: CGEM) today announced that the REZILIENT3 trial, a global Phase 3 clinical trial evaluating the combination of zipalertinib and
BRANFORD, Conn., Aug. 12, 2026 /PRNewswire/ -- Azitra, Inc. (" Azitra " or the "Company") (NYSE American: AZTR), a clinical stage biopharmaceutical company focused on developing innovative therapies for precision dermatology and high value cosmetic proteins and peptides, today reported financial
- Executed a $15.3 million financing with milestone warrants providing potential for an additional $34.0 million in gross proceeds, supporting continued advancement of ABP-450's development program - Upfront proceeds from financing provide cash runway into the first quarter of 2027 ALISO VIEJO,
NEW YORK, NY, August 12, 2026 — Royalty Pharma plc (Nasdaq: RPRX) today announced an agreement for $100 million in funding to Zealand Pharma in exchange for Zealand Pharma’s economics related to rusfertide (PTG-300), a potential first-in-class therapy for polycythemia vera, a rare and chronic blood disorder....
– Completed enrollment in Phase 2 Seabreeze STAT studies for acute exacerbations in asthma and COPD – – Expect to report topline results from both Phase 2 Seabreeze STAT studies in September 2026 – – Cash runway expected for a period of at least one year from the date of this release – SAN DIEGO,
Phase 3 C-BEYOND Trial Met Primary and Secondary Endpoints, with a Short 8-week Duration for Patients Without Cirrhosis Supporting a Potential Best-in-Class Profile of BEM/RZR for Treatment of HCV C-FORWARD Phase 3 Trial Outside North America on Track with Topline Results Expected Early Q1 2027
Pivotal Phase 2 ALPHA3 Program in 1L Large B-cell Lymphoma (LBCL): Recent Interim Futility Analysis Supports Cemacabtagene Ansegedleucel’s (Cema-Cel) Potential as an Outpatient, MRD-Guided 1L Consolidation Therapy Strong Execution and Increased Investigator Interest Accelerated 2026 Site
– KOMZIFTI ® (ziftomenib) generated $9.1 million in net product revenue, up 57% over 1Q, and approximately 115 new patient starts, up 35% over 1Q – – KOMZIFTI ® achieved majority share of new patient starts in R/R NPM1-m AML menin inhibitor class, establishing leadership after just two full
Topline global pivotal Phase 3 data for firmonertinib in first-line EGFR exon 20 insertion mutant NSCLC expected 2H 2026 ARR-217, a CDH17 targeted ADC for gastrointestinal malignancies, advanced to Phase 1b dose optimization Dosing of first patient with ARR-002, a dual-targeting MUC16/NaPi2b
Sangamo Therapeutics, Inc. (OTCID Basic Market: SGMOQ), a genomic medicine company, today announced that it has successfully concluded a court-supervised auction process under Section 363 of the U.S. Bankruptcy Code to maximize the value of Sangamo’s assets for the benefit of all stakeholders.
Genmab A/S has published its Articles of Association dated August 11, 2026. The Articles of Association can be found on Genmab’s website: https://ir.genmab.com/genmab-news Contact: Marisol Peron, Senior Vice President, Global Communications & Corporate Affairs
WILMETTE, Ill., Aug. 12, 2026 (GLOBE NEWSWIRE) -- Monopar Therapeutics Inc. (“Monopar” or the “Company”) (Nasdaq: MNPR), a clinical‐stage biopharmaceutical company developing innovative treatments for patients with unmet medical needs, today announced second quarter 2026 financial results and provided business updates....
Biologics License Application (BLA) for TA-ERT for the Treatment of MPS IIIB Anticipated in the Fourth Quarter of 2026 TrAnsform Confirmatory Study Required for Potential FDA Accelerated Approval of TA-ERT Expected to Initiate in the Fourth Quarter of 2026 Strengthened Leadership Team with the
Article by CEO Thomas K. Equels calls for proactive evaluation of broad-spectrum antiviral countermeasures before novel viral threats emerge Highlights Company’s investigational drug Ampligen® (rintatolimod) and its potential application as a broad-spectrum prophylactic or early-onset antiviral countermeasure in Ebola and its variants Access the article...
Enrollment in the ongoing Phase 1 dose escalation ACESOT-1051 trial of oral WEE1 inhibitor APR-1051 is accelerating as dose escalation advances Aprea plans to advance APR-1051 in uterine serous carcinoma (USC), and Cyclin E–overexpressing platinum-resistant ovarian cancer (PROC) while also
Company to request a Type B meeting with the FDA to align on a registrational path in a setting with no approved targeted therapy — Study met its primary endpoint: six-month progression-free survival of 48.9% versus a pre-specified 20% benchmark for standard of care (p = 0.0047) — Median overall
Investment Broadens Patient Access to Tralesinidase Alfa Enzyme Replacement Therapy (TA-ERT) for Sanfilippo Syndrome Type B in the TA-ERT Expanded Access Program (EAP) TA-ERT EAP Expected to Initiate in the Fourth Quarter of 2026 SOUTH SAN FRANCISCO, Calif. --(BUSINESS WIRE)--Aug.
Received FDA clearance of IND application for XTX501, a potential best-in-class bispecific PD-1 / masked IL-2 Advancing IND-enabling studies for potential first-in-class multi-specific, masked T cell engager programs targeting CLDN18.2 and PSMA+STEAP1; IND applications anticipated in the second
FDA Accepted D-PLEX₁₀₀ NDA with Priority Review; PDUFA Goal Date of November 28, 2026, Approximately One Quarter Ahead of Previously Communicated Guidance Exclusive U.S. and Canada Commercialization Partnership with Azurity Pharmaceuticals; $30 Million in Upfront and Near-Term Milestones Achieved
Randomized Phase 2 trial in microsatellite stable colorectal cancer (MSS CRC) ongoing, with results expected in 1H 2027; potential registration trial expected in 2027 once recommended dose regimen has been established Data reported at AACR from triple combination therapy in 1L hepatocellular
Initiated global PERFORMA Phase 3 trial in MASH Reported positive topline data from RECLAIM Phase 2 trial in AUD Completed patient enrollment in RESTORE Phase 2 trial in ALD $519 million in cash, cash equivalents and investments as of June 30, 2026 Webcast to be held today at 8:30 a.m.