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2026
Pharma News, 2026
MAIA Biotech Advances Ateganosine with Fast Track and Phase 3 NSCLC Trial
MAIA Biotechnology advances its lead cancer drug ateganosine (THIO) into Phase 3 trials for NSCLC, backed by Fast Track status and strong interim data.
ImmunityBio Wins Macau Approval for Anktiva Combo Therapy in Bladder Cancer
ImmunityBio receives Macau approval for Anktiva in combination with BCG to treat adult patients with BCG-unresponsive non-muscle invasive bladder cancer.
MIRA’s Mira-55 Shows No THC-Like CNS Side Effects in Preclinical Trials
MIRA Pharmaceuticals reports positive preclinical data for Mira-55, demonstrating pain relief potential without THC-like CNS side effects or opioid risks.
J&J Wins FDA Approval for Icotyde to Enter Plaque Psoriasis Pill Market
The FDA has approved J&J's Icotyde (icotrokinra), the first oral peptide for moderate-to-severe plaque psoriasis in adults and pediatric patients 12+.
Omega Therapeutics Stock Jumps on Positive OP-101 Preclinical Cancer Data
Omega Therapeutics stock climbs as preclinical data for its lead epigenomic medicine, OP-101, shows up to 70% tumor reduction in solid cancer models.
Caliway to Present Preclinical Data on CBL-514 with GLP-1R at ECO 2026
Caliway will present preclinical data on CBL-514 combined with GLP-1R therapy at ECO 2026, showcasing a novel approach to tackle obesity and weight regain.
Shionogi Enrols First Patients in Esprit Trial for Pompe Disease Therapy
Shionogi has enrolled the first patients in its Phase II Esprit trial evaluating S-606001, a novel oral substrate reduction therapy for Pompe disease.
Roche Halts Phase III Plans for Emugrobart in Muscle Wasting Diseases
Roche drops Phase III development of anti-myostatin antibody emugrobart for FSHD and SMA due to lack of efficacy, while shifting focus to obesity trials.
Arvinas Reports Strong Phase 1 Results for ARV-102 in Parkinson’s Disease
Arvinas announces encouraging phase 1 data for its PROTAC degrader ARV-102, showing over 50% LRRK2 degradation in Parkinson's disease patients' CSF.
FDA Issues CRL to Aldeyra’s Reproxalap Application for Dry Eye Disease
The FDA issued a Complete Response Letter to Aldeyra Therapeutics for its reproxalap NDA to treat dry eye disease, citing a lack of efficacy evidence.
Nia Therapeutics Wins FDA Breakthrough Nod for Memory Loss Neuromod System
Nia Therapeutics' Smart Neurostimulation System receives FDA breakthrough designation to treat episodic memory loss in adults with traumatic brain injury.
Hoth Therapeutics Applies AI in Development of HT-KIT for Rare Cancers
Hoth Therapeutics is leveraging AI to advance its targeted antisense oligonucleotide HT-KIT for KIT-driven cancers toward IND submission and Phase I trials.
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