– No changes in protocol recommended for LUGANO and LUCIA clinical trials – – Masked safety data continues to show no safety signals, consistent with previous clinical trials for DURAVYU – – On track to report topline 56-week data for LUGANO in mid-2026 with LUCIA data to closely follow – WATERTOWN, Mass., Nov. 19, 2025 (GLOBE NEWSWIRE) -- EyePoint Pharmaceuticals, Inc. (Nasdaq: EYPT), a company committed to developing and commercializing innovative therapeutics to improve the lives of pati

80% of patients that completed treatment and 100% of patients that completed the eight-week response assessment achieved clinical success Clinical success achieved with one or two doses of TARA-002 in 88% of patients TARA-002 demonstrated favorable safety and tolerability profile with no serious adverse events reported Company to host conference call and webcast featuring Key Opinion Leader Dr. Jesse Jones at 8:30 a.m. ET Nov. 19, 2025 -- Protara Therapeutics, Inc. (Nasdaq: TARA), a clinical-s

The Phase 2 study is designed to address regulatory approval considerations by comparing bioavailability and pharmacokinetics of NS002 against EpiPen Previous clinical study demonstrated NS002 can achieve faster and higher absorption of epinephrine compared to an autoinjector Dosing of the first participant in the Phase 2 study in Canada reflects the successful initiation of the Company’s needle-free epinephrine delivery program for anaphylaxis treatment Interim results are expected in the first

RAD 402 is a humanized IgG1 internalized by prostate cells, binding KLK3 with high affinity Tb-161 antitumor activity driven by the dual emission of beta particles and Auger electrons Nov. 18, 2025 -- Radiopharm Theranostics (ASX:RAD, “Radiopharm” or the “Company”), a clinical-stage biopharmaceutical company focused on developing innovative oncology radiopharmaceuticals for areas of high unmet medical need, today announced that it has been granted Bellberry Human Research Ethics Committee (HREC

Nov. 17, 2025 -- Medicus Pharma Ltd. (NASDAQ: MDCX) ("Medicus" or the "Company"), a biotech/life sciences company focused on advancing the clinical development programs of novel and potentially disruptive therapeutics assets, is pleased to announce that it has submitted an FDA Commissioner’s national priority voucher (CNPV) application on behalf of Skinject (SKNJCT-003) evaluating Doxorubicin Microneedle Array (D-MNA) to non-invasively treat basal cell carcinoma (BCC) of the skin. The submissio

TONMYA is now available by prescription and available for pharmacy ordering nationwide TONMYA is the first FDA-approved treatment for fibromyalgia in more than 15 years TONMYA is a unique, non-opioid, once-daily bedtime analgesic that significantly reduces fibromyalgia pain and is generally well-tolerated Nov. 17, 2025 -- Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP) (“Tonix” or the “Company”), a fully integrated, commercial biotechnology company, announced today that TONMYATM (cyclobenza

-- STENOVA trial achieves primary endpoint in 103 study participants after 12 weeks of treatment -- -- Pharmacokinetic results confirm gut-restricted profile of ontunisertib in FSCD patients -- -- Positive efficacy signals observed for several exploratory clinical endpoints -- -- Ongoing open-label extension study supports longer-term safety and tolerability profile observed to date -- November 17, 2025 – Agomab Therapeutics NV (‘Agomab’) today announced positive data from 103 participants comp

-- Preclinical data with TK-6302 has shown best-in-class anti-tumor efficacy, demonstrating its potential to elicit deep and durable responses in diverse solid tumor indications with high unmet need -- Following CTA approval, Phase 1 ATLAS trial planned to begin in 2026 Nov. 17, 2025 -- T-knife Therapeutics, Inc., a biopharmaceutical company developing next-generation T cell therapies to fight cancer, today announced the filing of a Clinical Trial Application (CTA) to begin the Phase 1 ATLAS t

FDA grants Fast Track designation to DPTX3186, Dewpoint’s first in class condensate modulator for gastric cancer Designation provides increased FDA engagement, rolling review eligibility, and potential for accelerated development Follows recent IND opening, and Orphan Drug Designation, as Dewpoint prepares to initiate a Phase 1a/2a clinical trial this year Nov. 17, 2025 -- Dewpoint Therapeutics announced today that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation

Sanofi’s Teizeild recommended for EU approval by the CHMP for patients with stage 2 type 1 diabetes Recommendation based on the TN-10 study, demonstrating Teizeild’s ability to delay the onset of stage 3 type 1 diabetes (T1D), compared to placebo, in adults and children with stage 2 T1D If approved, Teizeild would become the first disease-modifying T1D therapy in the EU November 14, 2025. The European Medicines Agency (EMA)’s Committee for Medicinal Products for Human Use (CHMP) has adopted a p