SAN DIEGO, Sept. 28, 2026 (GLOBE NEWSWIRE) -- Belite Bio, Inc (NASDAQ: BLTE) (“Belite Bio ® ” or the “Company”), a clinical-stage drug development company focused on advancing novel therapeutics targeting degenerative retinal diseases that have significant unmet medical needs, today announced that
RAMP 201 study supported FDA Accelerated Approval of AVMAPKI FAKZYNJA CO-PACK for treatment of KRAS-mutated recurrent LGSOC following prior systemic therapy Across patients with KRAS wild-type and KRAS-mutated recurrent LGSOC, the combination had a median duration of response of 31.1 months, median
November 17 meeting will address Phase 2 study design and potential regulatory pathways CALABASAS, Calif., Sept. 28, 2026 (GLOBE NEWSWIRE) -- NeOnc Technologies Holdings, Inc. (Nasdaq: NTHI) (“NeOnc” or the “Company”), a clinical-stage biopharmaceutical company developing therapies for central
Achieved 40.3% ORR with evorpacept plus trastuzumab, ramucirumab and paclitaxel versus 26.6% for control, with response rates increasing to 63.6% versus 23.1% among patients with high CD47 expression and retained HER2-positive disease Subgroup analyses support CD47 expression as a predictive
4D-150 is advancing into Phase 3 development for DME, a second multi-billion-dollar retinal disease market with significant unmet need First patients have been enrolled in 4SIGHT global Phase 3 trial (N=514) evaluating 4D-150 in a treatment-naïve DME population Updated 2-year data from SPECTRA
New data to be presented from the REZOLVE-AA study at EADV, including 6-month off-treatment data for patients with severe-to-very-severe alopecia areata Company to host conference call with investors and analysts on October 1, 2026 at 8:00 AM ET / 2:00 PM CET SAN FRANCISCO, Sept.
Study advances development of Lantheus' investigational GRPR-targeted PET imaging program for prostate cancer BEDFORD, Mass., Sept. 28, 2026 (GLOBE NEWSWIRE) -- Lantheus Holdings, Inc. ("Lantheus" or the "Company") (NASDAQ: LNTH), the leading radiopharmaceutical-focused company committed to
DURHAM, N.C., Sept. 28, 2026 (GLOBE NEWSWIRE) -- Humacyte, Inc. (Nasdaq: HUMA), a commercial-stage biotechnology platform company developing universally implantable, bioengineered human tissues at commercial scale, today announced the addition of life science industry veterans Scott Coward and Paul
Dr. Houvras brings over two decades of executive leadership across premier industry and academic research institutions in clinical development, translational medicine and immuno-oncology WALTHAM, Mass., Sept. 28, 2026 (GLOBE NEWSWIRE) -- Xilio Therapeutics, Inc.
NDA submission completed following positive Phase 3 SELVA results; potential U.S. commercial launch in the first half of 2027, if approved QTORIN™ rapamycin has the potential to become the first FDA-approved therapy and establish a new standard of care for an estimated more than 30,000 pediatric
Oral presentation selected: Phase 1 findings from the ongoing BHV1530-101 study will be featured in an oral presentation at the 38th EORTC-NCI-AACR Symposium on Molecular Targets and Cancer Therapeutics (ENA 2026), a leading international forum for early-phase oncology drug development.
– ARV-6723 is an investigational, oral PROTAC designed to degrade HPK1, a negative regulator of immune activation, in advanced solid tumors – NEW HAVEN, Conn., Sept. 28, 2026 (GLOBE NEWSWIRE) -- Arvinas, Inc. (Nasdaq: ARVN), a clinical-stage biotechnology company creating a new class of drugs based
BOSTON, Sept. 28, 2026 (GLOBE NEWSWIRE) -- Tiziana Life Sciences, Ltd. (Nasdaq: TLSA) (“Tiziana” or the “Company”), a biotechnology company developing breakthrough immunomodulation therapies with its lead development candidate, intranasal foralumab, a fully human, anti-CD3 monoclonal antibody,
FOSTER CITY, Calif., Sept. 28, 2026 (GLOBE NEWSWIRE) -- Sagimet Biosciences Inc. (Nasdaq: SGMT), a clinical-stage biopharmaceutical company developing novel therapeutics targeting dysfunctional metabolic and fibrotic pathways, today announced that it will host a virtual key opinion leader (KOL)
Funding from Gates Foundation supports continued advancement of boron-based LeuRS inhibitors for the treatment of tuberculosis MENLO PARK, Calif. --(BUSINESS WIRE)--Sep. 28, 2026-- AN2 Therapeutics, Inc. (Nasdaq: ANTX), a clinical stage pharmaceutical company focused on the discovery and
Eton Pharmaceuticals now holds exclusive commercialization rights for IMPAVIDO in the United States Eton has integrated full Eton Cares ® patient support, including $0 co-pay for eligible commercially insured patients and expanded patient assistance programs Centralized distribution through Anovo
Through this commitment, Lilly aims to expand access to its innovative diabetes and obesity medicines to as many people in resource-limited settings, including low- and middle-income countries (LMICs), as in high-income countries, before 2040 Key highlights: Lilly today launched the Lilly Change
RAHWAY, N.J.–(BUSINESS WIRE)– Merck (NYSE: MRK), known as MSD outside of the United States and Canada, and SciBrunch Therapeutics Co., Ltd. (“SciBrunch”), today announced that they have entered into an exclusive global license agreement for SPR2015, an investigational preclinical oral KRAS G12D (ON) inhibitor....
- Prula-cel shown to be generally well tolerated with no CRS greater than Grade 2 and no IEC-HS or ICANS - -At 12-months, 54% of evaluable patients achieved DORIS remission and 50% of patients achieved CRR- -All patients discontinued immunosuppressants – - All but one patient tapered background
Zenkuda (tarcocimab tedromer) met the primary endpoint (p-value of 0.0007) demonstrating meaningful vision gains as well as rapid and sustained retinal drying with the majority of patients (54%) on 6-month dosing, establishing a first-line benchmark in wet age-related macular degeneration (wAMD)
Acquisition diversifies durable cash flows and advances Zymeworks’ strategy to build a productive R&D company with a growing portfolio of revenue-generating assets YUPELRI ® expected to contribute immediately accretive revenue and cash flow to Zymeworks with base case mid-teens IRR Zymeworks to
MN-001 showed statistically significant increases in HDL-C and HDL-P and significant early reduction in triglyceride, a reduction in body weight and a numerical improvement in liver fat LA JOLLA, Calif., Sept. 28, 2026 (GLOBE NEWSWIRE) -- MediciNova, Inc., a biopharmaceutical company traded on the
-Once-daily oral ALK2 inhibitor approved to reduce the volume of total new heterotopic ossification in patients aged 12 years and older with FOP -Atebrioz expected to be available in the United States in October through Mirum Access Plus (MAP), with eligible patients paying as little as $0 per
Kodiak Sciences to Host Webcast on Monday, September 28 at 8:30 AM Eastern Time PALO ALTO, Calif., Sept. 25, 2026 /PRNewswire/ -- Kodiak Sciences Inc. (Nasdaq: KOD), a precommercial retina-focused biotechnology company committed to researching, developing and commercializing transformative
FDA approval supported by data from BRAVE-AA-PEDS, the first and largest Phase 3 study specifically designed to evaluate pediatric patients with severe alopecia areata (AA) Treatment with Olumiant resulted in substantial scalp hair regrowth, as well as improvements in eyebrows and eyelashes
EMERYVILLE, Calif., Sept. 25, 2026 (GLOBE NEWSWIRE) -- BioAge Labs, Inc. (NASDAQ: BIOA) ("BioAge", "the Company"), a clinical-stage biotechnology company developing therapeutic product candidates for cardiometabolic diseases by targeting the biology of human aging, today announced that the Company
RAHWAY, N.J.–(BUSINESS WIRE)– The Biologics License Application (BLA) seeking accelerated approval in the U.S. for Daiichi Sankyo (TSE: 4568) and Merck's (NYSE: MRK), known as MSD outside of the United States and Canada, ifinatamab deruxtecan (I-DXd) for the treatment of adult patients with extensive-stage small cell lung cancer (ES-SCLC) with disease...
SAN FRANCISCO, Sept. 25, 2026 /PRNewswire/ -- Nektar Therapeutics (NASDAQ: NKTR) today announced that, on September 18, 2026, the Organization and Compensation Committee of Nektar's Board of Directors granted non-qualified stock options to purchase an aggregate of 58,600 shares of its common stock
REDWOOD CITY, Calif. --(BUSINESS WIRE)--Sep. 25, 2026-- Adicet Bio, Inc. (Nasdaq: ACET), a clinical-stage biotechnology company discovering and developing allogeneic gamma delta CAR-T cell and in vivo CAR-T therapies for autoimmune diseases, hematologic malignancies and solid tumors, today
CAMBRIDGE, Mass. --(BUSINESS WIRE)--Sep. 25, 2026-- Sarepta Therapeutics, Inc. (NASDAQ:SRPT), the leader in precision genetic medicine for rare diseases, will present new data from its portfolio of treatments for Duchenne muscular dystrophy at the 31 st Annual Congress of the World Muscle Society
Ocugen will provide its investigational modifier gene therapy OCU400 through an expanded access program (EAP), with the goal of enabling the first patient to be treated for retinitis pigmentosa (RP) within 90 days, following full approval by the Longevity and Regenerative Therapies Board (LARTA
$15.0 Million Award to Support Advancement of RECLAIM-LN, a Phase 2 Potentially Registrational Trial of FT819 Off-the-Shelf CAR T-Cell Therapy in Lupus Nephritis CLIN2 Grant is a highly competitive award from CIRM to fund advancing clinical trials for stem cell and gene therapies that have the
Approval based on results from the Phase 3 LITESPARK-011 trial evaluating WELIREG in combination with LENVIMA compared to cabozantinib for the treatment of patients with advanced ccRCC following treatment with a PD-1/PD-L1 inhibitor WELIREG plus LENVIMA is the first approved combination of a HIF-2 alpha inhibitor and a multi-targeted VEGFR-TKI for these...
Majority of Dose Level 3 participants with NPDR demonstrated a > 2-step DRSS improvement at 3 years post-one-time, in-office sura-vec gene therapy treatment, with no vision-threatening events and no additional treatment for diabetic retinopathy No IOI observed with short-course prophylactic topical
Promising early results reported from full cohort analysis of the completed dose-escalation and expansion phases of a Phase 1 study evaluating JNJ-1900 (NBTXR3) for patients with inoperable, locoregionally recurrent non-small cell lung cancer (“NSCLC”) amenable to re-irradiation Strengthened
TARRYTOWN, N.Y., Sept. 24, 2026 (GLOBE NEWSWIRE) -- Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) today announced that it will report its third quarter 2026 financial and operating results on Friday, October 30, 2026, before the U.S. financial markets open.
REDWOOD CITY, Calif., Sept. 24, 2026 (GLOBE NEWSWIRE) -- Rezolute, Inc. (Nasdaq: RZLT) (“Rezolute” or the “Company”), a late-stage ultra-rare rare disease company focused on treating refra...
Company Announcement COPENHAGEN, Denmark; September 24, 2026 – Genmab A/S (Nasdaq: GMAB) announced today that the Board of Directors decided to grant 13,794 restricted stock units and 13,331 warrants to employees of the Company and the Company's subsidiaries.