With the writing apparently on the wall, PTC Therapeutics has called off its latest bid for FDA approval of its Duchenne muscular dystrophy (DMD) drug Translarna. Late Thursday, PTC revealed that it withdrew its FDA application for Translarna in nonsense mutation DMD after receiving feedback on its filing from the regulator. "FDA shared that based on its review to date, the data in the [New Drug Application] submission are unlikely to meet the Agency's threshold of substantial evidence of effe

Novel intravenous anti-inflammatory candidate advances to Phase I evaluation to assess safety, tolerability, and pharmacokinetics. February 11, 2026-- Isosceles Pharmaceuticals today announced that its patented investigational candidate, IPI201, has been accepted to proceed into a Phase I first-in-human clinical trial, marking a milestone in the company’s development pipeline. The study is expected to initiate first patient, first dose in April, beginning with dosing in healthy volunteers. IPI

Study to be conducted by PharmaLegacy, a leading Contract Research Organization February 11, 2026 -- Vidac Pharma Holding Plc., a clinical-stage biopharmaceutical company developing first-in-class therapies targeting the HK2/VDAC metabolic checkpoint, today announced the initiation of an in vivo pre-clinical program in psoriasis, marking the first formal evaluation of its proprietary technology platform outside oncology. The study will be conducted by PharmaLegacy, a highly reputable Contract

Prescription Drug User Fee Act (PDUFA) target action date set for September 28, 2026 If approved, Ameluz® would be the first and only PDT photosensitizer indicated for the treatment of superficial Basal Cell Carcinoma (sBCC) in the US BCC is the most common skin cancer in the US with 3.6 million cases diagnosed annually1 Feb. 11, 2026 -- Biofrontera Inc. (Nasdaq: BFRI) (“Biofrontera” or the “Company”), a biopharmaceutical company specializing in the commercialization and development of photod

First dose at HOAG Health in FAPI-PRO trial for Pancreatic Ductal Adenocarcinoma A parallel trial focused on gastroesophageal cancers, FAPI-GO, dosed its first patient December 2025 Feb. 11, 2026 -- SOFIE Biosciences, an established U.S. manufacturer and developer of radiopharmaceuticals, today announced that the first patient has been dosed in the second of its two Phase 3 clinical trials evaluating [18F]FAPI-74, a fluorine-18 labeled radiopharmaceutical targeting Fibroblast Activation Protein

• World’s first clinical study of a fully standardised, multi-alkaloid DMT–harmala formulation designed for regulated medical use • Acute effect scores on MEQ-30 and 5D-ASC exceeded those reported in prior psilocybin and LSD studies using these standardised measures • Psychedelic effects were strongly associated with persisting psychological benefits, including enhanced wellbeing and more positive life attitudes. • Results support advancement of Neurala’s proprietary second-generation product ca

AstraZeneca is moving its oral, once-daily GLP-1 receptor agonist elecoglipron (AZD5004) into Phase III development for obesity and type 2 diabetes in the hopes of adding another drug to its growing portfolio of blockbusters. The company — alongside announcing its latest financial results on Tuesday — noted that it currently has 16 blockbuster medicines on its hands and is hoping to expand this to over 25 by the end of the decade. In 2024, when AstraZeneca set out its target of growing annual r

Upstream Bio on Wednesday said its TSLP-targeting drug met its goal in a mid-stage trial in severe asthma, which is a step forward in its bid to challenge Dupixent and Tezspire down the line. The biotech’s verekitug, given at a 100 mg dose every three months, reduced the rate of yearly asthma flare-ups by 56% versus placebo in the study’s primary endpoint. The result was statistically significant, with a p-value of less than 0.0003. In the less frequent regimen, a 400 mg dose once every six mo

Feb. 11, 2026 -- Akeso, Inc. (9926.HK) is pleased to announce that the National Medical Products Administration has approved the initiation of Phase II clinical trials for AK139, a first-in-class IL-4Rα/ST2-targeting bispecific antibody, across seven indications. These indications include chronic obstructive pulmonary disease (COPD), severe bronchial asthma, chronic spontaneous urticaria, allergic rhinitis, chronic rhinosinusitis with nasal polyps, moderate-to-severe atopic dermatitis, and prur

Feb. 9, 2026 -- MerryLife Biomedical Inc., a clinical-stage biotechnology company focused on neurodegenerative diseases, today announced positive Phase 1 results for TML-6, its investigational oral therapy for Alzheimer's disease (AD). The study demonstrated that TML-6 was generally well tolerated with a favorable safety profile, supporting its continued clinical development. TML-6 is designed to modulate the autolysosomal system and interconnected cellular pathways involved in protein clearanc