The Priority Review
LightNews LightNews
banner
priorityreview.bsky.social
The Priority Review
@priorityreview.bsky.social
2 followers 1 following 38 posts
Life sciences news: regulatory, clinical, and commercial updates for biotech and pharma professionals. thepriorityreview.com
Posts Replies Media Videos
priorityreview.bsky.social
Daraxonrasib, Rasonque, and Atopic Dermatitis: the issue of October 12, 2026

https://thepriorityreview.com/news/issue-week-of-2026-10-12
Daraxonrasib, Rasonque, and Atopic Dermatitis: the issue of October 12, 2026
The week of October 12 to 18, 2026: 45 briefs, 14 stories, led by daraxonrasib, Rasonque, and Atopic Dermatitis.
thepriorityreview.com
October 19, 2026 at 12:00 PM
priorityreview.bsky.social
Vertex posts Phase 3 ELX/TEZ/IVA study results in infants with cystic fibrosis

https://thepriorityreview.com/news/vertex-elx-tez-iva-phase-3-infants-cystic-fibrosis-results
Vertex posts Phase 3 ELX/TEZ/IVA study results in infants with cystic fibrosis
Vertex Pharmaceuticals Incorporated posted results of a Phase 3 open-label study of ELX/TEZ/IVA in cystic fibrosis participants 12 to less than 24 months of age. The study enrolled 67 participants.
thepriorityreview.com
October 19, 2026 at 12:00 AM
priorityreview.bsky.social
ACADIA posts Phase 3 carbetocin nasal spray results in Prader-Willi syndrome

https://thepriorityreview.com/news/acadia-carbetocin-nasal-spray-prader-willi-phase-3-results
ACADIA posts Phase 3 carbetocin nasal spray results in Prader-Willi syndrome
ACADIA Pharmaceuticals Inc. posted results of a 12-week Phase 3 study of carbetocin nasal spray against placebo in hyperphagia in Prader-Willi syndrome. The study enrolled 175 participants.
thepriorityreview.com
October 18, 2026 at 9:00 PM
priorityreview.bsky.social
Lilly posts Phase 3 results for lebrikizumab in atopic dermatitis

https://thepriorityreview.com/news/lilly-lebrikizumab-phase-3-atopic-dermatitis-results
Lilly posts Phase 3 results for lebrikizumab in atopic dermatitis
Eli Lilly’s completed Phase 3 study enrolled 301 participants with moderate-to-severe atopic dermatitis. The registry reports Week 16 EASI-75 response rates across the treatment groups, with results first posted on 2026-10-16.
thepriorityreview.com
October 17, 2026 at 9:00 PM
priorityreview.bsky.social
In the stream for October 16: 12 updates from ClinicalTrials.gov, FDA and the Federal Register

https://thepriorityreview.com/stream/2026-10-16
The stream for Friday, October 16, 2026
12 briefs for Friday, October 16, 2026 from ClinicalTrials.gov, FDA and the Federal Register, each linked to its primary source.
thepriorityreview.com
October 17, 2026 at 12:00 AM
priorityreview.bsky.social
Eli Lilly posts Phase 3 orforglipron results against dapagliflozin

https://thepriorityreview.com/news/eli-lilly-orforglipron-dapagliflozin-phase-3-results
Eli Lilly posts Phase 3 orforglipron results against dapagliflozin
Eli Lilly posted ACHIEVE-2 results on ClinicalTrials.gov on 2026-10-16. The record reports Week 40 blood-sugar and body-weight measures in 962 adults with type 2 diabetes taking metformin.
thepriorityreview.com
October 16, 2026 at 9:00 PM
priorityreview.bsky.social
In the stream for October 15: 13 updates from ClinicalTrials.gov and the Federal Register

https://thepriorityreview.com/stream/2026-10-15
The stream for Thursday, October 15, 2026
13 briefs for Thursday, October 15, 2026 from ClinicalTrials.gov and the Federal Register, each linked to its primary source.
thepriorityreview.com
October 16, 2026 at 12:00 PM
priorityreview.bsky.social
TETON-2 results posted: inhaled treprostinil and lung function in idiopathic pulmonary fibrosis

https://thepriorityreview.com/news/united-therapeutics-teton-2-inhaled-treprostinil-ipf-results
TETON-2 results posted: inhaled treprostinil and lung function in idiopathic pulmonary fibrosis
On October 15, 2026, United Therapeutics' registry entry for the Phase 3 TETON-2 trial posted results. It reports a 95.6 mL difference in FVC change at Week 52 against placebo.
thepriorityreview.com
October 16, 2026 at 12:00 AM
priorityreview.bsky.social
AERIFY-1 results posted: itepekimab and COPD exacerbations in former smokers

https://thepriorityreview.com/news/sanofi-aerify-1-itepekimab-copd-results-posted
AERIFY-1 results posted: itepekimab and COPD exacerbations in former smokers
On October 15, 2026, Sanofi's registry entry for the Phase 3 AERIFY-1 trial posted results. Both itepekimab doses lowered the annualized rate of moderate or severe exacerbations against placebo.
thepriorityreview.com
October 15, 2026 at 9:00 PM
priorityreview.bsky.social
In the stream for October 14: 5 updates from ClinicalTrials.gov and FDA

https://thepriorityreview.com/stream/2026-10-14
The stream for Wednesday, October 14, 2026
5 briefs for Wednesday, October 14, 2026 from ClinicalTrials.gov and FDA, each linked to its primary source.
thepriorityreview.com
October 15, 2026 at 4:00 PM
priorityreview.bsky.social
Roche posts Phase 3 results for obinutuzumab in childhood nephrotic syndrome

https://thepriorityreview.com/news/roche-obinutuzumab-childhood-nephrotic-syndrome-results
Roche posts Phase 3 results for obinutuzumab in childhood nephrotic syndrome
Hoffmann-La Roche posted results on October 14, 2026 for its INShore trial of obinutuzumab against mycophenolate mofetil. The record lists sustained complete remission at Week 52 in 95.5% of 44 participants on obinutuzumab and 73.2% of 41 on mycophenolate mofetil.
thepriorityreview.com
October 15, 2026 at 2:00 PM
priorityreview.bsky.social
FDA expands Anktiva indication to high-grade papillary bladder cancer

https://thepriorityreview.com/news/fda-expands-anktiva-bcg-unresponsive-nmibc-papillary
FDA expands Anktiva indication to high-grade papillary bladder cancer
On October 14, 2026, the FDA approved nogapendekin alfa inbakicept-pmln (Anktiva) with BCG for BCG-unresponsive non-muscle invasive bladder cancer with high-grade papillary-only tumors. The agency extrapolated from earlier data in patients with carcinoma in situ.
thepriorityreview.com
October 15, 2026 at 12:00 PM
priorityreview.bsky.social
In the stream for October 13: 10 updates from ClinicalTrials.gov

https://thepriorityreview.com/stream/2026-10-13
The stream for Tuesday, October 13, 2026
10 briefs for Tuesday, October 13, 2026 from ClinicalTrials.gov, each linked to its primary source.
thepriorityreview.com
October 15, 2026 at 12:00 AM
priorityreview.bsky.social
Lee's Pharmaceutical posts Phase 3 results for ciprofloxacin-fluocinolone ear drops

https://thepriorityreview.com/news/lees-ciprofloxacin-fluocinolone-aoe-results
Lee's Pharmaceutical posts Phase 3 results for ciprofloxacin-fluocinolone ear drops
Lee's Pharmaceutical Limited posted results on October 13, 2026 for a Phase 3 trial of ciprofloxacin 0.3% plus fluocinolone acetonide 0.025% otic solution. The record lists clinical cure for 249 of 295 participants on the combination and 213 of 297 on ciprofloxacin alone.
thepriorityreview.com
October 14, 2026 at 9:00 PM
priorityreview.bsky.social
New Phase 3 trials registered, week of October 12, 2026: 3 industry trials

https://thepriorityreview.com/news/new-phase-3-trials-week-of-2026-10-12
New Phase 3 trials registered, week of October 12, 2026: 5 industry trials
Industry sponsors registered 5 Phase 3 trials on ClinicalTrials.gov so far in the week of October 12 to 18, 2026. They plan to enroll 18,314 participants in all; the largest, GlaxoSmithKline's RZV vaccine trial, plans to enroll 16,390.
thepriorityreview.com
October 14, 2026 at 6:00 PM
priorityreview.bsky.social
Phase 3 results posted, week of October 12, 2026: 2 industry trials

https://thepriorityreview.com/news/phase-3-results-week-of-2026-10-12
Phase 3 results posted, week of October 12, 2026: 4 industry trials
Industry sponsors posted results for 4 Phase 3 trials on ClinicalTrials.gov so far in the week of October 12 to 18, 2026. Together the trials enrolled 786 participants; the largest, Lee's Pharmaceutical's NCT04636957 trial, enrolled 600.
thepriorityreview.com
October 14, 2026 at 4:00 PM
priorityreview.bsky.social
Eli Lilly and Company, Boehringer Ingelheim, and IgA Nephropathy: the issue of September 28, 2026

https://thepriorityreview.com/news/issue-week-of-2026-09-28
Eli Lilly and Company, Boehringer Ingelheim, and IgA Nephropathy: the issue of September 28, 2026
The week of September 28 to October 4, 2026: 29 briefs, 3 stories, led by Eli Lilly and Company, Boehringer Ingelheim, and IgA Nephropathy.
thepriorityreview.com
October 14, 2026 at 2:00 PM
priorityreview.bsky.social
In the stream for October 11: 4 updates

https://thepriorityreview.com/stream/2026-10-11
The stream for Sunday, October 11, 2026
4 briefs for Sunday, October 11, 2026, each linked to its primary source.
thepriorityreview.com
October 14, 2026 at 12:00 PM
priorityreview.bsky.social
FDA approves Hovilpri for immunocompromised adults with unresponsive HSV lesions

https://thepriorityreview.com/news/fda-approves-hovilpri-pritelivir-hsv-immunocompromised
FDA approves Hovilpri for immunocompromised adults with unresponsive HSV lesions
The FDA approved Hovilpri (pritelivir) tablets, its page current as of October 9, 2026, for immunocompromised adults whose herpes simplex lesions did not respond to acyclovir, valacyclovir or famciclovir. In a Phase 3 trial, all lesions healed by 28 days in 63% of patients on Hovilpri.
thepriorityreview.com
October 14, 2026 at 12:00 AM
priorityreview.bsky.social
FDA actions, week of October 12, 2026: 1 rule, 1 notice

https://thepriorityreview.com/news/fda-actions-week-of-2026-10-12
FDA actions, week of October 12, 2026: 1 rule, 1 notice
The FDA published 2 actions so far in the week of October 12 to 18, 2026: 1 final rule in the Federal Register and 1 notice in the Federal Register.
thepriorityreview.com
October 13, 2026 at 9:00 PM
priorityreview.bsky.social
Atezolizumab, ibogaine, and GlaxoSmithKline: the issue of October 5, 2026

https://thepriorityreview.com/news/issue-week-of-2026-10-05
Atezolizumab, ibogaine, and GlaxoSmithKline: the issue of October 5, 2026
The week of October 5 to 11, 2026: 44 briefs, 9 stories, led by atezolizumab, ibogaine, and GlaxoSmithKline.
thepriorityreview.com
October 13, 2026 at 6:00 PM
priorityreview.bsky.social
Roche posts IMpower030 results: atezolizumab before surgery in resectable lung cancer

https://thepriorityreview.com/news/roche-impower030-atezolizumab-nsclc-results
Roche posts IMpower030 results: atezolizumab before surgery in resectable lung cancer
Hoffmann-La Roche posted results for the Phase 3 IMpower030 trial on October 9, 2026. In the Stage IIB-IIIB wild-type group, median event-free survival was 34.92 months on placebo and 62.78 months on atezolizumab, both plus chemotherapy.
thepriorityreview.com
October 13, 2026 at 4:00 PM
priorityreview.bsky.social
Sanofi posts AERIFY-2 itepekimab COPD results: exacerbation rates in former smokers

https://thepriorityreview.com/news/sanofi-itepekimab-aerify-2-copd-results
Sanofi posts AERIFY-2 itepekimab COPD results: exacerbation rates in former smokers
Sanofi and Regeneron Pharmaceuticals posted results for the Phase 3 AERIFY-2 trial of itepekimab in moderate-to-severe COPD on October 9, 2026. In former smokers, the annualized exacerbation rate was 0.879 on placebo and 0.770 on itepekimab every 4 weeks.
thepriorityreview.com
October 13, 2026 at 2:00 PM
priorityreview.bsky.social
Phase 3 results posted, week of September 28, 2026: 8 industry trials

https://thepriorityreview.com/news/phase-3-results-week-of-2026-09-28
Phase 3 results posted, week of September 28, 2026: 8 industry trials
Industry sponsors posted results for 8 Phase 3 trials on ClinicalTrials.gov in the week of September 28 to October 4, 2026. Together the trials enrolled 3,200 participants; the largest, Teva Pharmaceuticals USA's Estradiol trial, enrolled 1,050.
thepriorityreview.com
October 10, 2026 at 12:00 AM
priorityreview.bsky.social
FDA actions, week of September 28, 2026: 1 approval, 1 rule, 3 notices

https://thepriorityreview.com/news/fda-actions-week-of-2026-09-28
FDA actions, week of September 28, 2026: 1 approval, 1 rule, 3 notices
The FDA published 5 actions in the week of September 28 to October 4, 2026: 1 approval announcement, 1 final rule in the Federal Register and 3 notices in the Federal Register.
thepriorityreview.com
October 9, 2026 at 9:00 PM