drug · small molecule
osimertinib mesylate
Marketedupdated 3mo agoby $AZN ASTRAZENECA PLC🔗 ChEMBL
Approvedannual revenue · 2024–2024peak $6.6B
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Small molecule drug with a maximum clinical stage of Approval (across all indications), with an approval for non-small cell lung carcinoma and 1 investigational indication.
indications
investigational
NSCLC
targets
Epidermal growth factor receptor
all catalysts(0)
nothing on the calendar yet
Trials studying osimertinib mesylate
- phase1Study of ONO-7475 in Combination With Osimertinib in EGFR Gene Mutation-positive Non-small Cell Lung Cancer
- phase3A Study Evaluating Furmonertinib Plus Platinum-based Doublet Chemotherapy Versus Osimertinib in Patients With Epidermal Growth Factor Receptor (EGFR) Sensitizing Mutation-Positive Non-squamous Non-Small Cell Lung Cancer (NSCLC) and Brain Metastases
- phase2A Study of SHR-A2102 in Combination With Other Anti-tumor Therapies for Resectable Non-small Cell Lung Cancer
- phase2A Study to Evaluate Safety and Efficacy of WSD0922-FU Combo With Osimertinib for NSCLC
- phase1A Study of APG-1252 Plus Osimertinib(AZD9291) in EGFR TKI Resistant NSCLC Patients
- phase2A Study of BL-B01D1 and BL-B01D1 in Combination With Osimertinib Mesylate Tablets in Patients With Locally Advanced or Metastatic Non-small Cell Lung Cancer
- phase2A Study of BL-B01D1 in Combination With Osimertinib Mesylate Tablets in Patients With Locally Advanced or Metastatic Non-small Cell Lung Cancer
- phase2A Trial of SHR-A2102 With Other Antitumor Therapies in Advanced Solid Tumors
Patent cliff
source: FDA Orange Bookfirst barrier falls
Feb 16, 2027
188 days
Earliest of all listed patents + FDA exclusivities. Generic / biosimilar entry typically only becomes possible AFTER both patent and exclusivity barriers expire.
patents (10)
- Nov 26, 2042method-of-use (U-3823)US 12465608
- Nov 26, 2042method-of-use (U-3823)US 12465608
- Jan 2, 2035formulationUS 10183020
- Jan 2, 2035formulationUS 10183020
- Aug 8, 2032compositionUS 8946235
- Aug 8, 2032compositionUS 8946235
- Jul 25, 2032compositionUS 11524951
- Jul 25, 2032compositionUS 11524951
- Jul 25, 2032compositionUS 9732058
- Jul 25, 2032compositionUS 9732058
FDA exclusivities (6)
- Dec 18, 2027ODE-337Orphan Drug (7y)1.4y
- Dec 18, 2027ODE-337Orphan Drug (7y)1.4y
- Sep 25, 2027I-952Indication (3y)1.1y
- Sep 25, 2027I-952Indication (3y)1.1y
- Feb 16, 2027I-941Indication (3y)188d
- Feb 16, 2027I-941Indication (3y)188d
News(7)
- BlossomHill, Latigo outshine IPO expectations with oversubscribed debutsTwo growing biotechs blasted through their IPO expectations Friday, with Blossom Hill Therapeutics and Latigo Biotherapeutics each raising at least 30% more than expected in their stock market debuts.fiercebiotech · 4d ago
- Latigo laces up for $247M IPO to fund non-opioid pain drug rival to Vertex’s JournavxLatigo Biotherapeutics has fleshed out its plans for an IPO to finance the development of its clinical-stage pipeline of non-opioid pain management drugs.fiercebiotech · 7d ago
- ‘Unlikely’ AstraZeneca-BMS mega-merger would be largest pharma deal everIf AstraZeneca and Bristol Myers Squibb were to successfully become one company, analysts say it could reset the current deal environment, which has picked up greatly in the first half of the year.biospace · 8d ago
- BlossomHill eyes $112M IPO harvest to bankroll potential Tagrisso challengerBlossomHill Therapeutics plans to raise $111.7 million to fund the clinical journey of its potential challenger to Tagrisso.fiercebiotech · 8d ago
- AstraZeneca has no plans to ramp up dealmaking in wake of Wainua failureAstraZeneca remains "very much on track" to hit its 2030 goal of reaching $80 billion in revenue despite the recent late-stage failure of Wainua in ATTR-cardiomyopathy, CEO Pascal Soriot said durin…biospace · 15d ago
- BlossomHill eyes IPO as fertilizer to grow taller in crowded cancer fieldsAnother biotech is squeezing into the crowded IPO waiting room just in time for the weekend. BlossomHill Therapeutics, a San Diego-based oncology outfit focused on small molecules, has filed paperw…fiercebiotech · 25d ago
- Dr Lee on Research Collaborations Studying PD-L1 as a Biomarker in NSCLCJonathan Wennan Lee, MD, MSc, discusses future directions for studying PD-L1 as a predictive biomarker in EGFR-mutated NSCLC.onclive · 3mo ago
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