drug
aficamten
Marketedupdated 3mo agoby $CYTK CYTOKINETICS INC
Approvedcommunity read0 votes
🐶 often sniffed alongside
top 3Small molecule drug with a maximum clinical stage of Preapproval (across all indications), with 2 investigational indications.
all catalysts(2)
Trials studying aficamten
- phase3A Study to Evaluate the Effect of Aficamten in Pediatric Patients With Symptomatic Obstructive Hypertrophic Cardiomyopathy (oHCM).
- phase3A Trial to Evaluate the Efficacy and Safety of Aficamten Compared to Placebo in Adults With Symptomatic Non-Obstructive Hypertrophic Cardiomyopathy (nHCM)
- phase3Phase 3 Trial to Evaluate the Efficacy and Safety of Aficamten Compared to Metoprolol Succinate in Adults With Symptomatic oHCM
- phase3Phase 3 Trial to Evaluate the Efficacy and Safety of Aficamten Compared to Placebo in Adults With Symptomatic oHCM
- phase3Open-label Extension Study to Evaluate the Long-term Safety and Tolerability of Aficamten in Adults With HCM
- phase3An Open-Label Study of Aficamten for Chinese Patients With Symptomatic oHCM
- phase1Study to Evaluate the Effect of Aficamten Administration on QT/QTc Interval
Patent cliff
source: FDA Orange Bookfirst barrier falls
Dec 19, 2030
~4.3 years out
Earliest of all listed patents + FDA exclusivities. Generic / biosimilar entry typically only becomes possible AFTER both patent and exclusivity barriers expire.
patents (8)
- Jul 15, 2042method-of-use (U-4371)US 12370179
- Jul 15, 2042method-of-use (U-4371)US 12370179
- Jul 15, 2042method-of-use (U-4371)US 12370179
- Jul 15, 2042method-of-use (U-4371)US 12370179
- Jan 18, 2039compositionUS 10836755
- Jan 18, 2039compositionUS 10836755
- Jan 18, 2039compositionUS 10836755
- Jan 18, 2039compositionUS 10836755
FDA exclusivities (4)
- Dec 19, 2030NCENew Chemical Entity (5y)4.3y
- Dec 19, 2030NCENew Chemical Entity (5y)4.3y
- Dec 19, 2030NCENew Chemical Entity (5y)4.3y
- Dec 19, 2030NCENew Chemical Entity (5y)4.3y
News(10)
- Capricor shares spike on CEO comments; Cytokinetics sues Bristol MyersThe FDA is “willing to review” an updated submission for Capricor’s Duchenne cell therapy, its CEO said. Elsewhere, a heart drug battle spilled into court and Rigel priced the first “Protac” medicine.biopharma_dive · 6d ago
- Braveheart pumps more life into biotech IPO market with $382M expected debutBraveheart Bio has emerged on the Nasdaq with an upsized expected initial public offering—marking the public entrance of the twenty-second biotech this year.biospace · 14d ago
- Braveheart charges past expectations with $382.5M IPO to fund cardio drug from HengruiBraveheart Bio has overcome its own IPO expectations, rallying $382.5 million in an upsized listing to fund its cardiovascular ambitions.fiercebiotech · 14d ago
- Attovia, Braveheart and Vogenx seek more than $500M across trio of IPOsAttovia Therapeutics, Braveheart Bio and Vogenx have set target ranges for their IPOs, positioning the trio to collectively net more than $500 million from public investors.fiercebiotech · 21d ago
- Braveheart, Attovia, Vogenx keep IPOs ballooning with plans to compete in cardiometabolic, immunoBraveheart Bio is looking to take on Bristol Myers Squibb in hypertrophic cardiomyopathy, while Attovia Therapeutics wants to challenge Sanofi and Regeneron’s Dupixent. Vogenx, meanwhile, is lookin…biospace · 1mo ago
- Braveheart, Attovia join next wave of biotech IPOsThe two startups are the third and fourth, respectively, to outline offerings this month and aim to capitalize on momentum that’s already yielded several big-ticket IPOs.biopharma_dive · 1mo ago
- 10 clinical trials to watch in the second half of 2026The biotechnology sector’s upswing accelerated in the first half. Positive results from anticipated trials in lung cancer, Alzheimer’s and multiple autoimmune conditions could add to the momentum.biopharma_dive · 1mo ago
- Edgewise heart drug passes key trial testStill, the results leave somewhat unclear how different the company’s drug is than marketed hypertrophic cardiomyopathy medicines from Bristol Myers Squibb and Cytokinetics.biopharma_dive · 2mo ago
- STAT+: Angelini Pharma buys Catalyst Pharmaceuticals and its rare disease drugs for $4.1BThe Italian firm Angelini Pharma is buying Catalyst Pharmaceuticals, the maker of rare disease drugs, for $4.1 billion.stat · 3mo ago
- STAT+: Novo Nordisk’s less-bad news on its Wegovy pill boosts earnings and share priceVivek Ramaswamy wins GOP primary for Ohio governor, CellCentric raises $220M for myeloma drug, and more biotech newsstat · 3mo ago
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