Last updated
Revenue
R&D Expenses
Operating CF
Total Assets
Total Liabilities
Equity
Shares Out.
D/E Ratio
Dilution Watch
Financials
52W LOW $69.5852W HIGH $95.57
Volume
510.56 K
Value Traded
39.14 M
Short % Float
17.21%
Days to Cover
10.1
-2.66%Week
-2.63%1 Month
-11.73%3 Month
-14.15%6 Month
+134.93%5 Year
-72.32%All Time
Cash Data
- Monthly Burn
- Burn Trend
- Dilution Risk
- SEC Filing
Key Stats
Market Cap
1.62 B
EPS (TTM)
4.72
P/E Ratio
14.99
Ent. Value
1.56 B
Total Shares
22.96 M
Float Shares
20.18 M
Insiders
12.13%
Institutions
101.24%
Upcoming Catalysts
FDA decisions, readouts and PDUFA dates · scored by probability of approval
| Catalyst | Drug / Treatment | Stage | Prob. of Approval | Description | Drug Type | Therapeutic Area | Source |
|---|
PoA blends historical approval base rates, trial design score and FDA review track record.
ANIP Catalyst Timeline
Dated clinical, regulatory and corporate events for ANI Pharmaceuticals, Inc.
Catalyst Timeline
Dated clinical, regulatory & corporate events for ANI Pharmaceuticals, Inc.
539Total events
9Upcoming
149Tier-1 (high impact)
2013 to 2027Coverage
Upcoming catalysts 2
Event history 50
▲Product LaunchPost-Market
Launch of Duloxetine Delayed-Release Capsules 20, 30 and 60 mg in the U.S.
▲Late-BreakerPresentation
SYNCHRONICITY 6- and 24-month data presented as late-breaking oral presentation at AAO 2026
chronic non-infectious uveitis affecting the posterior segment of the eye (chronic NIU-PS)source ↗
▲Secondary Endpoint DataClinical Data
24-month secondary efficacy outcomes showed functional and anatomic changes generally maintained
chronic non-infectious uveitis affecting the posterior segment of the eye (chronic NIU-PS)source ↗
▲Primary Endpoint MetClinical Data
SYNCHRONICITY met both co-primary endpoints (BCVA letter score and CST) at 6 months with statistical significance
chronic non-infectious uveitis affecting the posterior segment of the eye (chronic NIU-PS)source ↗
●Safety Data UpdateClinical Data
SYNCHRONICITY safety data consistent with prior trials of fluocinolone acetonide intravitreal implant
chronic non-infectious uveitis affecting the posterior segment of the eye (chronic NIU-PS)source ↗
◆Poster PresentationPresentation
Post-hoc analyses of rescued vs non-rescued patients from Phase 4 NEW DAY trial presented as on-demand ePoster
Diabetic Macular Edema (DME)source ↗
▲FDA ApprovalFDA Decision
FDA final approval of Everolimus Tablets for Oral Suspension (generic Afinitor Disperz)
▲Quarterly UpdateCorporate
Reaffirming 2026 guidance for total net revenue and adjusted non-GAAP EBITDA
◆Topline ReadoutILUVIENApprovedClinical Data
Announced 6-month topline data from Phase 4 SYNCHRONICITY trial
chronic non-infectious uveitis affecting the posterior segment of the eye (NIU-PS)source ↗
▼Quarterly UpdateCorporate
Revised Cortrophin Gel net revenue guidance to $520-$540 million for 2026
▼IP Litigation RulingIP / Competition
Trial court denied ANI's post-trial motions for new trial and judgment as a matter of law in CG Oncology matter
▲Primary Endpoint MetClinical Data
Co-primary endpoints met: BCVA and CST at 6 months
chronic non-infectious uveitis affecting the posterior segment of the eyesource ↗
▲Topline ReadoutClinical Data
Positive six-month topline data from SYNCHRONICITY trial
chronic non-infectious uveitis affecting the posterior segment of the eyesource ↗
◆Topline ReadoutILUVIENApprovedClinical Data
Phase 4 SYNCHRONICITY trial results to be announced at medical conference in Q3 2026
NIU-PSsource ↗
▲Milestone PaymentCorporate
Additional $2.0 million development milestone revenue expected upon completion of development work
◆Topline ReadoutClinical Data
Six-month topline results from Phase 4 SYNCHRONICITY trial announced
chronic non-infectious uveitis affecting the posterior segment of the eye (chronic NIU-PS)source ↗
▲Milestone PaymentCorporate
Recognized $8.0 million development milestone revenue under Harmony Agreement
▲Product LaunchPost-Market
Organization expansion for gout fully operational
acute gouty arthritis flaressource ↗
◆Oral PresentationPresentation
ANI Pharmaceuticals to present at 2026 Jefferies Global Healthcare Conference
▲Product LaunchPost-Market
Planned expansion of Rare Disease organization by ~90 people for Cortrophin Gel in acute gouty arthritis flares
acute gouty arthritis flaressource ↗
▲PublicationILUVIENApprovedPresentation
NEW DAY clinical trial results published in Ophthalmology
diabetic macular edemasource ↗
▲Product LaunchPost-Market
Launch of Pimozide Tablets 1 mg and 2 mg with 180-day CGT exclusivity
▲Product LaunchPost-Market
Launch of Carbamazepine Extended-Release Capsules 100 mg, 200 mg, 300 mg
▲PublicationILUVIENApprovedPresentation
Publication of NEW DAY trial results in Ophthalmology journal
diabetic macular edemasource ↗
▲Quarterly UpdateCorporate
Expanded Rare Disease organization expected to deploy in mid-2026
acute gouty arthritis flaressource ↗
▲Milestone PaymentCorporate
$10M milestone payment expected upon achievement of development milestones in Q2/Q3 2026
pitolisantsource ↗
▲Quarterly UpdateCorporate
Cortrophin Gel Q1 2026 net revenues $75.1M, up 42.1% YoY
Rare Disease indicationssource ↗
▲Quarterly UpdateILUVIENApprovedCorporate
ILUVIEN Q1 2026 net revenues $19.3M, up 19.5% YoY
diabetic macular edemasource ↗
◆Oral PresentationPresentation
Presentation at Leerink Partners Global Healthcare Conference 2026
▲Quarterly UpdateCorporate
Planned expansion of Rare Disease organization by 90 people for Cortrophin Gel in acute gouty arthritis flares
acute gouty arthritis flaressource ↗
▲Partnership / LicenseCorporate
Harmony Agreement with Harmony Biosciences for pitolisant IP
pitolisantsource ↗
▲Quarterly UpdateCorporate
Cortrophin Gel net revenues $111.4M in Q4 2025, up 87.6% YoY
acute gouty arthritis flaressource ↗
●Management ChangeCorporate
Patrick D. Walsh steps down as Chairman and will retire from Board after 2026 Annual Meeting
◆Oral PresentationPresentation
ANI Pharmaceuticals to present at Jefferies Global Healthcare Conference – London
◆Oral PresentationILUVIENApprovedPresentation
Late-breaking oral presentation of NEW DAY trial results at AAO 2025
diabetic macular edemasource ↗
Past FDA Catalysts and PDUFA Decisions
How ANIP actually traded into and out of each decision
| Date | Drug | Catalyst | Stage | Reaction | Event Move % | Best Trade % |
|---|---|---|---|---|---|---|
| 2025-01-28 | Inzirqo (hydrochlorothiazide) | PDUFA Date Approved | PDUFA |
Reaction: 30 trading days around the event · Event Move: close to close on decision day · Best Trade: peak run-up from entry 10 days before the decision
Drug Pipeline Intelligence
Pipeline Score
Pipeline Value
Commercial Value
Valuation Signal
4
Drugs Scored
rNPV / MCap
Top Drug
Top 75%
Micro Cap(rank 506 of 674)
Percentile Rank
Commercial products (revenue basis: trailing 4 quarters of total revenue (10-K and 10-Q), to Jun 2026; product lines: last four quarters to Jun 2026 (10-K and 10-Q))
| Product | Revenue | Prior period | Change |
|---|---|---|---|
| Cortrophin Gel | |||
| ILUVIEN and YUTIQ |
| Drug | Indication | Phase | PTRS | rNPV | Status | Enroll | Velocity | Design | Est. Completion | ML Signal | Last Change |
|---|---|---|---|---|---|---|---|---|---|---|---|
| Yutiq Small moleculeMarketedNCT05486468 | Uveitis | Approved | RECRUITING | 30 | Dec 1, 2026 | ||||||
| Fluocinolone Acetonide/Medidur Small moleculeMarketedNCT00344968 | Diabetic Macular Edema | Approved | COMPLETED | 1,113 | Dec 1, 2010 | ||||||
| Fluocinolone Acetonide/Medidur Small moleculeNot countedNCT00605423 | Age Related Macular Degeneration | Phase 2 | COMPLETED | 6 | Nov 1, 2011 |
Clinical Trial Results
Readouts, endpoints and source filings for every ANIP program
| Drug Name | Indication | Phase | Date | Trial Results Summary | Title | Source |
|---|---|---|---|---|---|---|
| Fluocinolone Acetonide Intravitreal Implant | chronic non-infectious uveitis affecting the posterior segment of the eye | Phase 4 | 2026-10-12 | mean change BCVA month 6: +3.6 letters gained (p =0.0077); mean BCVA baseline: 62.5; mean BCVA month 6: 65.8; mean change CST month 6: -157.5 microns (p<0.0001); mean CST baseline: 505.7 microns; mean CST month 6: 348.8 microns; mean change BCVA month 24: +5.5 ETDRS letters; mean change CST month 24: -171.2 microns; no recurrence rate: 79.6%; median time to recurrence: 168 days; resolution of macular edema: 48.2% (n= 52/108); vascular leakage baseline: 78.7% (n=85/108); vascular leakage month 24: 55.6% (n=60/108)Read More | ANI Pharmaceuticals Announces Positive Phase 4 Open-Label, Single-Arm SYNCHRONICITY Clinical Trial Results Presented as Late Breaking Oral Presentation at the American Academy of Ophthalmology 2026 Annual MeetingRead More |
Inside Trades
| Insider | Side | Shares | Price | Value | Date |
|---|---|---|---|---|---|
| CAREY STEPHEN P.Officer (SVP & CFO) | Sell | -2,850 166,143 held | $72.87 | 10/29/2026 |
Hedge Fund 13F Activity
Hedge Funds invested in ANIP
| Fund | % of Portfolio | Current MV | Shares Owned | Activity |
|---|---|---|---|---|
| SOLEUS CAPITAL MANAGEMENT, L.P. | 2.5 % (-3.8 %) | 71.83 M | 867.76 K | 5.79% ( 47.52 K) |
Ownership Trends
ANIP Short Interest
Shares sold short, counted twice a month.
17.21%
Short % of Float
of tradable shares sold short
3.5M
Shares Sold Short
-0.6% vs prior count
10.1 Very high
Days to Cover
trading days of normal volume to buy every short share back
343.8K
Avg Daily Volume
the average used for days to cover
Options Data
Option Volume
Open Interest
Call OI
Put OI
Put-Call Ratio
OI 30-day avg
Today vs avg
Option Volume
Call Vol
Put Vol
Put-Call Ratio
Vol 30-day avg
Today vs avg
Option Chain Statistics
| Expiry | Call Vol | Put Vol | Vol P/C | Call OI | Put OI | OI P/C | IV Call | IV Call OI-Wtd | IV Call Vol-Wtd | IV Put | IV Put OI-Wtd | IV Put Vol-Wtd |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 2026-11-20 | ||||||||||||
Real-Time Option Chain
| Calls | Strike | Puts | ||||
|---|---|---|---|---|---|---|
| Last | Vol | OI | Last | Vol | OI | |
| No data available | ||||||
Calls vs Puts by Expiry
CallsPutsLog scale
Competitive positioning
How ANIP ranks across every disease it competes in
Competitive Position is a premium feature
See how ANIP ranks against every competitor across each disease it develops in: phase, best drug, trials and likelihood of approval.
Start free trialANIP News
ANIPANI Pharmaceuticals to Discuss Third Quarter 2026 Financial Results on November 5, 2026 at 8:00 a.m. ET
ANI Pharmaceuticals announced it will release its third quarter 2026 financial results on November 5, 2026, at 8:00 a.m. ET. The event will feature a webcast and conference call led by key executives. The archived webcast will be available for one year on the company's website.
Read more →ANIPANI Pharmaceuticals Announces the Launch of Duloxetine Delayed-Release Capsules
ANI Pharmaceuticals has launched Duloxetine Delayed-Release Capsules in 20, 30, and 60 mg dosages, offering a generic alternative to Cymbalta. This launch aims to provide a stable supply in a limited market, with annual sales for Duloxetine estimated at $247 million. The company emphasizes its commitment to ensuring high-quality products are accessible to patients.
Read more →ANIPANI Pharmaceuticals Announces Positive Phase 4 Open-Label, Single-Arm SYNCHRONICITY Clinical Trial Results Presented as Late Breaking Oral Presentation at the American Academy of Ophthalmology 2026 Annual Meeting
ANI Pharmaceuticals announced positive results from its Phase 4 SYNCHRONICITY trial, demonstrating significant improvements in best corrected visual acuity and central subfield thickness at both 6 and 24 months. The trial involved patients with chronic non-infectious uveitis affecting the posterior segment of the eye. The safety profile was consistent with previous studies, although some patients experienced treatment-related adverse events.
Read more →ANIPANI Pharmaceuticals Announces New Fluocinolone Acetonide Intravitreal Implant Data to be Presented at the American Academy of Ophthalmology 2026 Annual Meeting
ANI Pharmaceuticals announced that data from its Phase 4 SYNCHRONICITY trial will be presented at the American Academy of Ophthalmology 2026 Annual Meeting. The trial focuses on the Fluocinolone Acetonide Intravitreal Implant for treating chronic non-infectious uveitis. Additionally, post-hoc analyses from the NEW DAY trial will also be shared. These presentations aim to highlight the efficacy and safety of the treatments.
Read more →ANIPANI Pharmaceuticals Announces the FDA Approval of Everolimus Tablets for Oral Suspension
ANI Pharmaceuticals has received FDA approval for its Everolimus Tablets for Oral Suspension, available in 2mg, 3mg, and 5mg doses. This approval is part of ANI's strategy to expand its generics portfolio, which is projected to include at least 15 new products this year. The U.S. market for Everolimus is estimated at $123 million annually, indicating significant commercial potential.
Read more →ANIPANI Pharmaceuticals to Present at September Investor Conferences
ANI Pharmaceuticals announced that its CEO and executive team will participate in upcoming investor conferences. The company aims to enhance its visibility and investor relations through these events. ANI focuses on developing innovative therapeutics across multiple therapeutic areas, including rare diseases and generics.
Read more →ANIPANI Pharmaceuticals Appoints Henry Gosebruch to Board of Directors
ANI Pharmaceuticals has appointed Henry Gosebruch to its Board of Directors, effective August 19, 2026. Gosebruch brings over 30 years of experience in corporate strategy and business development, which is expected to enhance ANI's initiatives in the Rare Disease sector. The appointment comes as ANI aims to strengthen its position in the biopharmaceutical market.
Read more →ANIP▼ -5.3%on this news
ANI Pharmaceuticals Reports Record Second Quarter 2026 Financial Results
ANI Pharmaceuticals reported strong financial results for Q2 2026, with net revenues reaching $266.0 million, a 25.9% increase from the previous year. Cortrophin Gel saw significant growth, contributing $117.1 million in revenues, while the company reaffirmed its full-year guidance. However, ILUVIEN revenues declined, impacting overall brand performance. The expansion into the gout market shows promising initial trends.
Read more →ANIPANI Pharmaceuticals to Discuss Second Quarter 2026 Financial Results on August 7, 2026 at 8:00 a.m. ET
ANI Pharmaceuticals will announce its second quarter 2026 financial results on August 7, 2026, at 8:00 a.m. ET. The announcement will be followed by a webcast and conference call hosted by key executives, including the CEO and CFO. The event will provide insights into the company's performance and future strategies.
Read more →ANIPANI Pharmaceuticals Announces Intent to Appeal Rulings in CG Oncology Matter
ANI Pharmaceuticals announced its intent to appeal a trial court's denial of its motion for a new trial regarding unjust enrichment claims against CG Oncology. The company seeks to recover the value of assets sold in 2010 and aims to secure a 5% royalty on future sales of a specific product. ANI's CEO expressed disagreement with the court's decision and commitment to pursue legal avenues.
Read more →ANIPANI Pharmaceuticals Announces Positive Six-Month Topline Data from the Phase 4 Open-Label, Single-Arm SYNCHRONICITY Trial Evaluating Fluocinolone Acetonide Intravitreal Implant in Patients with Chronic Non-Infectious Uveitis
ANI Pharmaceuticals announced positive topline results from its Phase 4 SYNCHRONICITY trial, which evaluated the fluocinolone acetonide intravitreal implant in patients with chronic non-infectious uveitis. The trial met both co-primary endpoints, showing significant improvements in best corrected visual acuity and central subfield thickness at six months. Adverse events were consistent with prior studies, with a notable percentage of patients experiencing treatment-related issues.
Read more →ANIPANI Pharmaceuticals to Present at the 2026 Jefferies Global Healthcare Conference
ANI Pharmaceuticals, Inc. announced that CEO Nikhil Lalwani will participate in a fireside chat at the 2026 Jefferies Global Healthcare Conference. The event will be accessible via a live and archived webcast on the company's website. ANI Pharmaceuticals focuses on developing and commercializing innovative therapeutics across various medical fields.
Read more →ANIPANI Pharmaceuticals Reports First Quarter 2026 Financial Results and Raises 2026 Financial Guidance
ANI Pharmaceuticals reported strong financial results for Q1 2026, with net revenues of $237.5 million, a 20.5% increase from the previous year. The company raised its full-year guidance, expecting total revenues between $1.08 billion and $1.14 billion, driven largely by growth in its Rare Disease segment. Cortrophin Gel showed significant revenue growth, and the company is focused on expanding its market presence.
Read more →ANIPANI Pharmaceuticals to Discuss First Quarter 2026 Financial Results on May 8, 2026, at 8:00 a.m. ET
ANI Pharmaceuticals will release its first quarter 2026 financial results on May 8, 2026. The announcement includes a conference call and webcast hosted by key executives to discuss the results. The company emphasizes its commitment to developing innovative therapeutics and sustainable growth in its Rare Disease business.
Read more →ANIPANI Pharmaceuticals Announces the FDA Approval and Launch of Pimozide Tablets with 180 Day CGT Exclusivity
ANI Pharmaceuticals has announced the FDA approval and launch of Pimozide Tablets, a generic version of Orap®. The launch includes 180-day CGT exclusivity, allowing ANI to enter the market with limited competition. The annual sales for Pimozide Tablets are approximately $3.1 million. The company aims to provide high-quality generic alternatives to patients.
Read more →ANIPANI Pharmaceuticals Announces the Launch of Carbamazepine Extended-Release Capsules
ANI Pharmaceuticals has launched Carbamazepine Extended-Release Capsules in 100 mg, 200 mg, and 300 mg dosages, marking a significant addition to its generics portfolio. This launch aims to enhance patient access to essential medications and is expected to tap into a market with annual sales of around $65 million. The company's commitment to quality and compliance remains a priority.
Read more →ANIPANI Pharmaceuticals Announces FDA Approval and Launch of Isosorbide Mononitrate Tablet
ANI Pharmaceuticals has received FDA approval for its Isosorbide Mononitrate Tablet USP, available in 10 mg and 20 mg dosages. This launch emphasizes the company's commitment to providing high-quality, limited-competition products. ANI's CEO highlighted the importance of this approval in reinforcing their R&D capabilities and operational execution.
Read more →ANIPANI Pharmaceuticals Announces Publication of NEW DAY Clinical Trial Results in Ophthalmology
ANI Pharmaceuticals announced the publication of the NEW DAY clinical trial results for ILUVIEN, a treatment for diabetic macular edema, in the journal Ophthalmology. The trial demonstrated ILUVIEN's efficacy, and the publication underscores ANI's commitment to advancing care for patients with this condition. However, safety information highlights potential risks associated with the treatment.
Read more →ANIPANI Pharmaceuticals Reports Record Fourth Quarter and Full Year 2025 Financial Results and Reaffirms 2026 Financial Guidance
ANI Pharmaceuticals reported record financial results for Q4 and full year 2025, with net revenues of $247.1 million and $883.4 million, respectively. The Rare Disease segment saw substantial growth, particularly with Cortrophin Gel, which is expected to drive future revenue. The company reaffirmed its financial guidance for 2026, anticipating over $1 billion in revenue, with a focus on expanding its Rare Disease business.
Read more →ANIPANI Pharmaceuticals to Present at Upcoming Investor Conferences
ANI Pharmaceuticals announced that CEO Nikhil Lalwani and the executive team will present at upcoming investor conferences. The live and archived webcasts will be available on the company's website, ensuring accessibility for stakeholders. This initiative reflects the company's commitment to engaging with investors and promoting its diverse biopharmaceutical portfolio.
Read more →About ANI Pharmaceuticals, Inc.
Headquarters104 CARNEGIE CENTER DRIVE SUITE 300, PRINCETON, NJ, 08540
Founded1996
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