Daraxonrasib, Rasonque, and Atopic Dermatitis: the issue of October 12, 2026

The week of October 12 to 18, 2026 on The Priority Review: 45 briefs and 14 stories, led by daraxonrasib, Rasonque, and Atopic Dermatitis. Every line links its page.

Stories this week

ACADIA posts Phase 3 carbetocin nasal spray results in Prader-Willi syndrome (written story)
AERIFY-1 results posted: itepekimab and COPD exacerbations in former smokers (written story)
Eli Lilly posts Phase 3 orforglipron results against dapagliflozin (written story)
FDA expands Anktiva indication to high-grade papillary bladder cancer (written story)
Lee's Pharmaceutical posts Phase 3 results for ciprofloxacin-fluocinolone ear drops (written story)
Lilly posts Phase 3 results for lebrikizumab in atopic dermatitis (written story)
Roche posts IMpower030 results: atezolizumab before surgery in resectable lung cancer (written story)
Roche posts Phase 3 results for obinutuzumab in childhood nephrotic syndrome (written story)
Sanofi posts AERIFY-2 itepekimab COPD results: exacerbation rates in former smokers (written story)
TETON-2 results posted: inhaled treprostinil and lung function in idiopathic pulmonary fibrosis (written story)
Vertex posts Phase 3 ELX/TEZ/IVA study results in infants with cystic fibrosis (written story)
FDA actions, week of October 12, 2026: 2 approvals, 1 rule, 3 notices, 1 announcement (weekly data page)
New Phase 3 trials registered, week of October 12, 2026: 10 industry trials (weekly data page)
Phase 3 results posted, week of October 12, 2026: 11 industry trials (weekly data page)

Terms this week

pathological complete response – no viable tumor cells found in the primary tumor and all sampled lymph nodes when the tumor is removed in surgery. This is how the trial record defines the rate it reports. (Trial registry record: A Study of Neoadjuvant Atezolizumab Plus Chemotherapy Versus Placebo Plus Chemotherapy in Patients With Resectable Stage II, IIIA, or Select IIIB Non-Small Cell Lung Cancer (IMpower030))
exacerbation – a sudden worsening of symptoms, also called a flare-up. The NHLBI defines it as an increase in how severe a disease is, or its signs and symptoms. (NHLBI, NIH: COPD - Symptoms)
otitis externa – inflammation, irritation, or infection of the outer ear and ear canal, also called swimmer's ear. MedlinePlus says the infection can be sudden and short-term (acute) or long-term (chronic). (MedlinePlus: Swimmer's ear)
bladder cancer – cancer that occurs in the lining of the bladder, a hollow organ in the lower abdomen that stores urine. MedlinePlus lists surgery, radiation therapy, chemotherapy and biologic therapy among the treatments. (MedlinePlus: Bladder Cancer)
nephrotic syndrome – a group of symptoms and abnormal test results that include protein in the urine, low blood protein levels, high cholesterol, increased blood clot risk and bodily swelling. It is caused by disorders that damage the kidneys. (MedlinePlus: Nephrotic syndrome)
COPD – a lung disease in which less air flows in and out of the airways. MedlinePlus says its two main types are emphysema and chronic bronchitis. (MedlinePlus: COPD)
idiopathic pulmonary fibrosis – a lung disease in which deep lung tissue becomes scarred, thick and stiff, and for which no cause can be found. MedlinePlus says there is no cure. (MedlinePlus: Pulmonary Fibrosis)
HbA1c – HbA1c is the glycosylated fraction of hemoglobin A. It is measured to reflect average plasma glucose concentration over a prolonged period of time. (ClinicalTrials.gov: NCT06192108)
EASI-75 – An EASI-75 responder is a participant with a reduction of 75% or more from baseline in the EASI score. (ClinicalTrials.gov: NCT06280716)
hyperphagia – chronic overeating that results from an extreme hunger beginning in childhood in people with Prader-Willi syndrome. (MedlinePlus Genetics: Prader-Willi syndrome)
cystic fibrosis – an inherited disease characterized by the buildup of thick, sticky mucus. Mutations in the CFTR gene cause cystic fibrosis. (MedlinePlus Genetics: Cystic fibrosis)

Approvals briefs

FDA approves Brytly, a nonprescription eye drop for eye redness. The FDA approved Brytly, apraclonidine ophthalmic solution 0.125%, for relief of eye redness due to minor irritations. The approval is the first nonprescription eye drop containing apraclonidine and is available to adults and children 12 years of age and older. Source: FDA approval page, October 16, 2026.
CHMP adopts positive opinion on Fovlussea. The Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion on 15 October 2026, recommending a marketing authorisation for Fovlussea, a ranibizumab biosimilar for several retinal conditions. The applicant is Accord Healthcare S.L.U., and the product will be available as a 10 mg/ml solution for injection. Source: Source record, October 16, 2026.
CHMP recommends marketing authorisation for Neuzafy. On 15 October 2026 the Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion, recommending the granting of a marketing authorisation for Neuzafy, a filgrastim biosimilar. The applicant is CuraTeQ Biologics (Malta) Limited and Neuzafy will be available as 30 MU/0.5 ml and 48 MU/0.5 ml solutions for injection/infusion. Source: Source record, October 16, 2026.
CHMP adopts positive opinion on Yuviwel for achondroplasia. The Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion on 15 October 2026, recommending marketing authorisation for Yuviwel (navepegritide) for children 2 years and older with achondroplasia. The opinion notes that Yuviwel improves annualised growth velocity by 1.49 cm versus placebo in a 52-week trial. Source: Source record, October 16, 2026.
CHMP recommends marketing authorisation for Kizfizo. The Committee for Medicinal Products for Human Use adopted a positive opinion on 15 October 2026, recommending a marketing authorisation for Kizfizo, a 40 mg/ml oral suspension of temozolomide, for newly diagnosed glioblastoma multiforme in adults and for recurrent or progressing malignant glioma in adults and children from the age of one year. The applicant is Orphelia Pharma and the product is designated an orphan medicine. Source: Source record, October 16, 2026.
CHMP adopts positive opinion on Rasonque for metastatic pancreatic cancer. The Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion on 15 October 2026, recommending marketing authorisation for Rasonque, a daraxonrasib monotherapy for adult patients with metastatic pancreatic adenocarcinoma who have received at least one prior systemic therapy. The product will be available as 100 mg and 150 mg film-coated tablets and is designated as an orphan medicine. Source: Source record, October 15, 2026.

2 more briefs in Approvals.

Clinical trials briefs

AbbVie announces data to be presented at 2026 ESMO Congress. AbbVie today announced that new and updated data from its broad solid tumor portfolio will be presented at the 2026 European Society for Medical Oncology Congress in Madrid, Spain. The presentations cover investigational assets such as Temab-A, ABBV-706, ABBV-969, ABBV-1480, alveltamig, EmrelisTM and Elahere. Source: Source record, October 18, 2026.
Nektar posts results of Phase 2/3 NKTR-255 trial in relapsed/refractory large B-cell lymphoma. Results for the study were first posted on ClinicalTrials.gov on October 16, 2026. The terminated study enrolled 15 participants and had a primary completion date of May 22, 2024. Source: Source record, October 16, 2026.
Eli Lilly posts results of Phase 3 orforglipron vs dapagliflozin study. The company posted results for the ACHIEVE-2 study, a Phase 3, randomized, open-label trial that enrolled 962 participants with type 2 diabetes. The study compared once-daily oral orforglipron (LY3502970) with dapagliflozin and completed primary data collection on September 26, 2025. Source: Source record, October 16, 2026.
Eli Lilly posts results of Phase 3 lebrikizumab trial in atopic dermatitis. Results for the Phase 3 trial of lebrikizumab with or without topical corticosteroid treatment in participants with moderate-to-severe atopic dermatitis were first posted on ClinicalTrials.gov on October 16, 2026. The completed study enrolled 301 participants and began on April 24, 2024. Source: Source record, October 16, 2026.
AstraZeneca registers Phase 3 trial of durvalumab and FLOT in Chinese gastric cancer patients. The study, titled MATTERHORN-CN, plans to enroll 140 participants and plans to start on November 30, 2026. It compares neoadjuvant-adjuvant durvalumab plus FLOT chemotherapy to placebo plus FLOT in resectable gastric and gastroesophageal junction cancer. Source: Source record, October 16, 2026.
Vertex posts results of Phase 3 ELX/TEZ/IVA study in infants. Vertex Pharmaceuticals Incorporated posted results of a completed Phase 3, open-label study evaluating the pharmacokinetics, safety, tolerability, pharmacodynamics, and efficacy of ELX/TEZ/IVA in cystic fibrosis participants 12 to less than 24 months of age. The study enrolled 67 participants and began on June 27, 2023, with primary completion on September 4, 2025. Source: Source record, October 15, 2026.

17 more briefs in Clinical trials.

Regulation briefs

FDA announces support for forward compatibility of eCTD 4.0. The FDA's Center for Drug Evaluation and Research and Center for Biologics Evaluation and Research announced support for forward compatibility of Electronic Common Technical Document (eCTD) Version 4.0. This notice informs stakeholders that submissions based on eCTD 4.0 are supported for forward compatibility. Source: Federal Register notice, October 16, 2026.
FDA authorizes emergency use of four animal drugs for New World screwworm. The FDA issued four Emergency Use Authorizations for products requested by Elanco US Inc., Zoetis Inc., Bimeda Animal Health Ltd., and Sergeant's Pet Care Products LLC to prevent infestations caused by New World screwworm larvae in various animals. The authorizations follow a HHS determination on August 18, 2025 that circumstances justify emergency use. Source: Federal Register notice, October 15, 2026.
FDA launches Rare Disease Framework Initiative to gather public feedback. The FDA announced the Rare Disease Framework Initiative on October 14, 2026, aiming to create a fit-for-purpose framework for rare disease drug development. It will host an October 28 meeting at its White Oak campus to solicit feedback from patients, advocates, and industry. Source: FDA press announcement, October 14, 2026.
FDA final rule permits salt substitutes in standardized foods. The rule, effective December 14, 2026, amends FDA's standards of identity to permit the use of salt substitutes in standardized foods. The change is intended to reduce sodium content in these foods. Source: Federal Register rule, October 13, 2026.
FDA finalizes guidance on post-approval manufacturing changes to biosimilars. FDA announced the availability of a final guidance titled "Postapproval Manufacturing Changes to Biosimilar and Interchangeable Biosimilar Products: Questions and Answers." The guidance supersedes the draft issued July 23 2024 and withdraws Q&A I.20 from the Q&A biosimilar development guidance. Source: Federal Register notice, October 13, 2026.
Medtronic announces preliminary results of MiniMed exchange offer. Medtronic says its exchange offer to swap MiniMed shares for Medtronic ordinary shares was oversubscribed, with 298,024,452 Medtronic shares tendered. Medtronic intends to accept 55,032,401 shares for 252,813,348 MiniMed shares, estimating about 18.3% of tendered shares will be exchanged. Source: Source record, October 12, 2026.

Policy briefs

CMS, SBA, Take Command discuss CHOICE Arrangements for Ohio small businesses. The Centers for Medicare & Medicaid Services, the Small Business Administration, and Take Command met to explore CHOICE Arrangements, a tax-advantaged contribution model that lets Ohio employers replace traditional group plans with individual coverage options. CMS Administrator Dr. Mehmet Oz said CHOICE Arrangements help Ohio employers better manage healthcare costs while empowering workers to choose coverage that meets their individual needs. Source: Source record, October 16, 2026.
Actinium Pharmaceuticals names Sean Maenpaa senior vice president of business development. The appointment takes effect on October 12, 2026, and the new executive will lead partnering, licensing and strategic transactions across Actinium's targeted radiotherapy pipeline. He brings more than two decades of oncology business development experience, including senior roles at Bayer, Clovis Oncology, Telix Pharmaceuticals and BWXT Medical. Source: Source record, October 16, 2026.
$78 million for rural Texas health workforce and chronic disease prevention. The Trump Administration announced $78 million in Rural Health Transformation Program funding to 216 rural healthcare providers through the Rural Texas Strong initiative. The investment will support chronic disease prevention, workforce recruitment and retention, and upgrades to medical equipment and facilities across Texas. Source: Source record, October 15, 2026.
MiniMed completes separation from Medtronic. MiniMed announced on Oct. 15, 2026 that it has completed its separation from Medtronic, becoming a fully independent company. Medtronic accepted 55,032,401 Medtronic ordinary shares in exchange for 252,813,348 shares of MiniMed common stock, a 5.4x subscribed offer. Source: Source record, October 15, 2026.
CMS announces $2.3 million RHTP funding for Missouri rural healthcare. The Trump Administration announced more than $2.3 million in Rural Health Transformation Program funding to Missouri, allocating $1.46 million for workforce recruitment and retention and $879,000 to launch a certified nurse midwife training program. The investment aims to expand childcare support for rural healthcare workers and increase maternal care access across the state. Source: Source record, October 13, 2026.
Paragon Labs expands leadership with former Apogee executives. Paragon Labs announced that former senior leaders from Apogee Therapeutics have joined its team, led by Michael Henderson, M.D., to support clinical development of Paragon-discovered assets. The move follows Apogee's 2026 acquisition by AbbVie for over $10.9 billion. Source: Source record, October 13, 2026.

2 more briefs in Policy.

How this issue is made

Code builds this page every Monday from the week's published briefs and stories, listed above. The three topics in the title are the names the briefs tag most often that week. No model writes this page.