Alvotech
ALVO evidence brief
What we can confirm
- Market Cap:
- $1.86B
What it means
What to watch
Prepared research question
What matters most for ALVO—catalysts, financial risk and supporting evidence?
Traceable citations · Unknowns marked
BioSniper AI · ALVO
Alvotech is a global biotechnology company specializing in the development and manufacture of biosimilar medicines, with a pipeline targeting blockbuster biologics and a recent return to profitability.
Key risk: FDA CRLs on key candidates
Market Cap
$1.86B
Cash Runway
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Lead Asset
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Next Catalyst
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Financial data as of Dec 31, 2025.
Tracking 2 clinical trials for Alvotech.
Alvotech is a global biotechnology company specializing in the development and manufacture of biosimilar medicines, with a pipeline targeting blockbuster biologics and a recent return to profitability.
- Cash & equivalents of $172.4M as of 2025-12-31 [sec].
- Reported net income of US$27.92 million for full-year 2025, swinging from a prior-year net loss of US$231.86 million [news · published 2026-03-20].
- FDA accepted for review BLAs for AVT16 (interchangeable biosimilar to Entyvio lyophilized vial) and AVT80 (interchangeable biosimilar to Entyvio prefilled syringe/autoinjector) [sec · filed 2026-06-08] [news · published 2026-08-31].
- Received Complete Response Letters (CRLs) from the FDA in Q4 2025 for AVT05, AVT06, and AVT03 [sec · filed 2026-06-17].
- Partnership with Teva for commercialization of AVT16 and signed supply/commercialization agreements with Sandoz for Canada, Australia, and New Zealand [sec · filed 2026-06-08] [news · published 2026-02-16].
What works
- Returned to profitability in 2025 with net income of US$27.92 million, compared to a net loss of US$231.86 million the prior year [news · published 2026-03-20].
- Broad pipeline of over 30 biosimilar candidates, with multiple BLAs accepted for FDA review (AVT16, AVT80) and new clinical trials starting (AVT29, AVT32) [sec · filed 2026-06-08] [news · published 2026-08-31] [catalyst].
- Established commercialization partnerships with Teva and Sandoz, expanding market reach across the U.S., Canada, Australia, and New Zealand [sec · filed 2026-06-08] [news · published 2026-02-16].
What to weigh
- Received Complete Response Letters (CRLs) from the FDA in Q4 2025 for three key biosimilar candidates (AVT05, AVT06, AVT03), indicating regulatory hurdles [sec · filed 2026-06-17].
- Missed H1 2026 earnings expectations, leading to a hold rating from some analysts [news · published 2026-08-20].
- Relies on third-party partners for commercialization and faces risks from macroeconomic conditions, geopolitical tensions, and regulatory delays [sec_mda · as of 2026-03-31].
From the filings
Quoted directly from source documents.
FDA accepted BLA for AVT16 (interchangeable biosimilar to Entyvio vial).
“A") for AVT16, a proposed interchangeable biosimilar to Entyvio® (vedolizumab) lyophilized vial for intravenous administration, has been accepted for review by the U.S. Food and Drug Administration.”
SEC filings · June 8, 2026
Received CRLs from FDA for AVT05, AVT06, and AVT03 in Q4 2025.
“In the fourth quarter of 2025, we and our partner received CRLs from the FDA regarding, respectively, the BLAs for AVT05, AVT06, and AVT03.”
SEC filings · June 17, 2026
Returned to profitability in 2025.
“Alvotech recently reported full-year 2025 results, swinging to net income of US$27.92 million from a prior-year net loss of US$231.86 million”
News · March 20, 2026
Catalyst timeline
- 2026-04-22 · Phase3_Start: AVT29 vs Eylea HD for diabetic macular edema — A randomized, double-masked, parallel-group, multicenter study to evaluate efficacy and safety.
- 2026-08-10 · Phase1_Start: AVT32 vs Keytruda for adjuvant melanoma treatment — A multicenter, randomized, double-blind, 2-treatment arm study to assess comparative pharmacokinetics, efficacy, safety, and immunogenicity.
Risks & what to watch (3)›
Key risks
- FDA CRLs on key candidates — CRLs received for AVT05, AVT06, and AVT03 in Q4 2025, delaying potential approvals [sec · filed 2026-06-17].
- Missed H1 2026 earnings — Missed H1 2026 earnings expectations, leading to a hold rating from analysts [news · published 2026-08-20].
- Dependence on partnerships — Relies on third-party partners for commercialization and faces risks from macroeconomic/geopolitical conditions [sec_mda · as of 2026-03-31].
What to watch
- FDA review outcomes for AVT16 and AVT80 BLAs, expected within six months of submission [sec · filed 2026-06-08] [news · published 2026-08-31].
- Resubmission plans and FDA feedback for AVT05, AVT06, and AVT03 following CRLs [sec · filed 2026-06-17].
- Phase 3 trial for AVT29 (biosimilar to Eylea HD) starting 2026-04-22 and Phase 1 trial for AVT32 (biosimilar to Keytruda) starting 2026-08-10 [catalyst].
- Financial performance in H2 2026 and ability to sustain profitability after returning to net income in 2025 [news · published 2026-03-20].
Sources: Catalysts · News · SEC filings · SEC MD&A · Generated October 10, 2026 · How we verify sources →
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Evidence & data
Regulatory
Financials
Institutional Holdings
Source: SEC Form 13F · as of Mar 2026Institutional holders
57
Total value held
$52.2M
| Holder | Shares | Value |
|---|---|---|
| vanguard capital management llc | 3,410,447 | $11.8M |
| bracebridge capital, llc | 2,705,304 | $9.3M |
| millennium management llc | 2,122,596 | $7.3M |
| littlejohn & co llc | 1,318,534 | $4.5M |
| blackrock, inc. | 1,245,195 | $4.3M |
| vanguard fiduciary trust co | 974,228 | $3.4M |
| legal & general group plc | 504,460 | $1.7M |
| jpmorgan chase & co | 504,201 | $1.7M |
| geode capital management, llc | 324,199 | $1.1M |
| ubs group ag | 322,157 | $1.1M |
Showing top 10 of 57 institutional holders of Alvotech. Open the full 13F history after sign-in.
Short Interest
as of Apr 28, 2026- % of float
- 2.3%
- Days to cover
- 5.0
- Shares short
- 2,701,400
- Daily short volume
- -
Short percent of float and days-to-cover reflect reported short positioning. Daily short volume is the exchange-reported short share of a single day's trading volume and is noisier. See the most-shorted biotech ranking →
ALVO short interestFrequently asked questions
What is the AI investment thesis for Alvotech?
Alvotech is a global biotechnology company specializing in the development and manufacture of biosimilar medicines, with a pipeline targeting blockbuster biologics and a recent return to profitability.
Who is the CEO of Alvotech?
Ms. Lisa Graver is the chief executive officer of Alvotech (ALVO).
Where is Alvotech headquartered?
Alvotech (ALVO) is headquartered in Luxembourg, Luxembourg.
What therapeutic areas does Alvotech focus on?
Alvotech develops therapies across Oncology, Immunology, Ophthalmology.
The AI overview and BioSniper Score are neutral, data-derived signals built from public SEC filings, ClinicalTrials.gov and FDA records — not investment advice.