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  1. pharmadog
  2. ›drugs
  3. ›Wainua
drug · oligonucleotide
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eplontersen sodium

Marketedupdated 3mo ago
by $AZN ASTRAZENECA PLC🔗 ChEMBL
Approved
community read0 votes

🐶 often sniffed alongside

top 2
  • tagApproval20 co-mentions · 5 sources
  • drugWAINUA (AUTOINJECTOR)20 co-mentions · 5 sources

Oligonucleotide drug with a maximum clinical stage of Approval (across all indications), with an approval for familial amyloid neuropathy and polyneuropathy and 1 investigational indication.

targets

Transthyretin mRNA

all catalysts(5)

approval · 5
Dec 21, 2023
approval
$AZN157.56-0.75%
3y ago
WAINUA (AUTOINJECTOR) (EPLONTERSEN SODIUM) — FDA approval
eplontersen sodium
→
Sep 25, 2024
approval
$AZN157.56-0.75%
2y ago
WAINUA (AUTOINJECTOR) (EPLONTERSEN SODIUM) — FDA approval
eplontersen sodium
→
Apr 18, 2025
approval
$AZN157.56-0.75%
1y ago
WAINUA (AUTOINJECTOR) (EPLONTERSEN SODIUM) — FDA approval
eplontersen sodium
→
Dec 17, 2025
approval
$AZN157.56-0.75%
8mo ago
WAINUA (AUTOINJECTOR) (EPLONTERSEN SODIUM) — FDA approval
eplontersen sodium
→
Apr 15, 2026
approval
$AZN157.56-0.75%
4mo ago
WAINUA (AUTOINJECTOR) (EPLONTERSEN SODIUM) — FDA approval
eplontersen sodium
→

Patent cliff

source: FDA Orange Book
first barrier falls
Dec 21, 2028
~2.4 years out

Earliest of all listed patents + FDA exclusivities. Generic / biosimilar entry typically only becomes possible AFTER both patent and exclusivity barriers expire.

patents (4)

  • Aug 25, 2034compositionUS 10683499
  • May 1, 2034compositionUS 9127276
  • May 1, 2034compositionUS 9181549
  • Apr 1, 2026compositionUS 8101743

FDA exclusivities (2)

  • Dec 21, 2030ODE-461Orphan Drug (7y)4.4y
  • Dec 21, 2028NCENew Chemical Entity (5y)2.4y

News(10)

  • BridgeBio continues ATTR ascent as Alnylam’s Amvuttra falls short of expectations
    BridgeBio Pharma’s transthyretin amyloidosis medicine Attruby is off to a strong launch, while Alnylam lowered full-year sales guidance for competitor Amvuttra.
    biospace · 4h ago
  • Intellia finds genetic suspect for liver safety signals with ATTR gene therapy
    In November 2025, one patient died after receiving Intellia Therapeutics’ investigational gene silencer for transthyretin amyloidosis.
    biospace · 5d ago
  • ‘Unlikely’ AstraZeneca-BMS mega-merger would be largest pharma deal ever
    If 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 · 9d ago
  • 5 companies advancing ATTR assets in the wake of Wainua’s fail
    The Phase 3 failure of AstraZeneca and Ionis Pharmaceuticals’ antisense therapy in transthyretin amyloid cardiomyopathy last month left the space reeling—and readjusting. BioSpace looks at five con…
    biospace · 9d ago
  • Alnylam absorbs $10.8B blowback after cutting full-year guidance for TTR franchise
    Alnylam’s revenue cut “may create a near term credibility overhang and could “raise questions on peak sales potential, even if there’s tailwinds in the competitive landscape,” according to Stifel.
    biospace · 12d ago
  • Capricor and Replimune prep for FDA adcomms, Q2 earnings roll on, Sarepta’s new leader, more
    The FDA published briefing documents ahead of advisory committee meetings for therapies from Capricor Therapeutics and Replimune indicate an uphill battle for the biotechs; GSK and AstraZeneca outl…
    biospace · 14d ago
  • AstraZeneca has no plans to ramp up dealmaking in wake of Wainua failure
    AstraZeneca 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 · 16d ago
  • Q2 earnings underway, FDA’s CRL kerfuffle, IPOs full speed ahead in H2
    Second quarter earnings continue to roll with Novartis and Roche reporting this week; Eli Lilly’s AtaiBeckley buy for up to $3.8 billion offers clear “validation” for the fledgling psychedelics spa…
    biospace · 21d ago
  • Royalty Pharma pens $425M deal for slice of sales on AstraZeneca’s ATTR drug
    Royalty Pharma has secured a stake in another transthyretin-mediated amyloidosis drug, this time paying $125 million upfront to Neurimmune for a cut of the sales of its AstraZeneca-partnered med.
    fiercebiotech · 21d ago
  • Wainua flop narrows AstraZeneca’s path to $80B goal ahead of high-risk readouts
    With a Phase 3 failure denting the rare disease drug’s prospects, AstraZeneca has little room for error as it plots a path toward its ambitious 2030 sales target.
    biospace · 21d ago
view all news mentions →
brand
Wainua
trade names
Wainua, Wainua (autoinjector)
generic
eplontersen sodium
MOA
Transthyretin mRNA antisense inhibitor
indication
Familial Amyloid Cardiomyopathy
phase
marketed
Data sources
openFDA · ClinicalTrials.gov · OpenTargets
last refreshed 1h ago
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