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AN2 Therapeutics (Nasdaq: ANTX) posts strong early Chagas trial data

Filing Impact
(Moderate)
Filing Sentiment
(Neutral)
Form Type
8-K

Rhea-AI Filing Summary

AN2 Therapeutics reported positive early-stage data for its oral CPSF3 inhibitor AN2-502998 targeting chronic Chagas disease. A 28-day nonhuman primate study showed parasite elimination at exposures planned for humans, and a Phase 1 first-in-human trial in healthy volunteers found a favorable safety and tolerability profile with no dose-limiting toxicities. The company plans to advance AN2-502998 into a Phase 2 proof-of-concept study in collaboration with DNDi and highlights that Chagas disease affects over 300,000 people in the U.S. and about 10 million globally, with no FDA-approved treatments for adults. AN2 also notes that, if approved, AN2-502998 could qualify for an FDA Tropical Disease Priority Review Voucher and views Chagas disease as a potential multi-billion-dollar global market.

Positive

  • Enabling efficacy and safety data for AN2-502998 – 28-day treatment eliminated T. cruzi parasites in 100% of naturally infected nonhuman primates at target human exposure levels, and a Phase 1 first-in-human study showed a favorable safety and tolerability profile with no dose-limiting toxicities, supporting advancement to Phase 2.

Negative

  • None.

Insights

Positive early data de-risks AN2-502998 and supports moving into Phase 2.

AN2 Therapeutics released enabling data for AN2-502998 in chronic Chagas disease. A 28-day nonhuman primate study achieved parasite elimination in 100% of animals at exposures planned for humans, while a Phase 1 first-in-human trial showed a favorable safety profile without dose-limiting toxicities.

Chagas disease has an estimated 10 million infected people worldwide and no FDA-approved adult treatments, and AN2 views it as a potential multi-billion-dollar market. If ultimately approved, AN2-502998 could qualify for an FDA Tropical Disease Priority Review Voucher, which may carry additional economic value.

The company expects to initiate a Phase 2 proof-of-concept study in collaboration with DNDi, leveraging that group’s presence in endemic regions. Actual outcomes will depend on Phase 2 efficacy and safety results and on future regulatory decisions, as emphasized in the forward-looking statements and risk factors sections.

Item 7.01 Regulation FD Disclosure Disclosure
Material non-public information disclosed under Regulation Fair Disclosure, often investor presentations or guidance.
Item 8.01 Other Events Other
Voluntary disclosure of events the company deems important to shareholders but not covered by other items.
Item 9.01 Financial Statements and Exhibits Exhibits
Financial statements, pro forma financial information, and exhibit attachments filed with this report.
NHP treatment duration 28 days Duration of AN2-502998 dosing in nonhuman primate efficacy study
NHP parasite elimination rate 100% Nonhuman primates naturally infected with T. cruzi after 28-day AN2-502998 treatment
Phase 1 multiple dosing period 10 days Duration of multiple ascending oral doses in healthy adult volunteers
Estimated infections in U.S. Over 300,000 people Estimated number of people infected with Chagas disease in the United States
Estimated global infections About 10 million Estimated number of people infected with Chagas disease worldwide
Cardiac complication rate Approximately 20-30% Share of chronically infected people developing serious cardiac damage
Planned Phase 2 studies Three Phase 2 studies Number of Phase 2 studies AN2 expects to be active in 2026 across its pipeline
Phase 1 First-in-Human (FIH) study medical
"The Phase 1 FIH study (NCT07024589) evaluated single ascending oral doses of AN2-502998"
CPSF3 inhibitor medical
"oral CPSF3 inhibitor, AN2-502998, for the treatment of chronic Chagas disease"
Tropical Disease Priority Review Voucher regulatory
"AN2-502998, if approved, would also be eligible for an FDA Tropical Disease Priority Review Voucher"
boron chemistry platform technical
"developing novel small molecule therapeutics derived from its boron chemistry platform"
Drugs for Neglected Diseases initiative (DNDi) medical
"AN2 Therapeutics is advancing AN2-502998 into Phase 2 clinical study in collaboration with DNDi"
nonhuman primate (NHP) study medical
"28-Day Nonhuman Primate (NHP) Study The NHP efficacy study evaluated AN2-502998"
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false 0001880438 0001880438 2026-06-04 2026-06-04
 
 

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

 

 

FORM 8-K

 

 

CURRENT REPORT

Pursuant to Section 13 OR 15(d)

of the Securities Exchange Act of 1934

Date of Report (Date of earliest event reported): June 4, 2026

 

 

AN2 THERAPEUTICS, INC.

(Exact name of registrant as specified in its charter)

 

 

 

Delaware   001-41331   82-0606654
(State or other jurisdiction
of incorporation)
 

(Commission

File Number)

  (IRS Employer
Identification No.)

1300 El Camino Real, Suite 100

Menlo Park, California 94025

(Address of principal executive offices) (Zip Code)

Registrant’s telephone number, including area code: (650) 331-9090

Not Applicable

(Former name or former address, if changed since last report)

 

 

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:

 

Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

 

Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

 

Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

 

Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

Securities registered pursuant to Section 12(b) of the Act:

 

Title of each class

 

Trading
Symbol(s)

 

Name of each exchange

on which registered

Common Stock, $0.00001 par value   ANTX   The Nasdaq Global Select Market

Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§ 230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§ 240.12b-2 of this chapter).

Emerging growth company

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act.

 

 
 


Item 7.01.

Regulation FD Disclosure.

On June 4, 2026, AN2 Therapeutics, Inc. (the “Company” or “AN2”) announced positive results from two studies evaluating the Company’s oral CPSF3 inhibitor, AN2-502998, for the treatment of chronic Chagas disease (American trypanosomiasis) caused by infection with the parasite T. cruzi. A copy of the press release is furnished as Exhibit 99.1 to this Current Report on Form 8-K.

The information set forth in this Item 7.01 and in the press release attached hereto as Exhibit 99.1 is deemed to be “furnished” and shall not be deemed to be “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liabilities of that Section. The information set forth in this Item 7.01, including Exhibit 99.1, shall not be deemed incorporated by reference into any filing under the Exchange Act or the Securities Act of 1933, as amended, except to the extent that the Company specifically incorporates it by reference.

 

Item 8.01.

Other Events.

Key Findings: 28-Day Nonhuman Primate (NHP) Study

The NHP efficacy study evaluated AN2-502998 administered for 28 days in macaques with naturally-acquired, chronic T. cruzi infection, contracted via triatomine (kissing bug) vectors in their natural habitats, the same vector that transmits the parasite to humans. The Chagas disease vector is increasingly prevalent across the southern half of the U.S. The Company believes that efficacy in naturally infected NHPs is the most clinically relevant predictor of efficacy for human chronic Chagas disease.

 

 

100% of treated animals achieved parasite elimination at target exposures attainable in humans.

 

 

Elimination of parasitemia in treated animals was durable and maintained through four months following the end of treatment.

 

 

Parasitemia was evaluated using an enhanced PCR method with improved sensitivity and robustness.

 

 

AN2-502998 was well tolerated with no drug-related adverse events.

 

 

AN2-502998 is the only compound to have demonstrated curative activity in NHPs with long-term, naturally acquired T. cruzi infection.

Key Findings: Phase 1 First-in-Human Study

The Phase 1 FIH study (NCT07024589) evaluated single ascending oral doses of AN2-502998 and then multiple ascending doses administered over 10 days in healthy adult volunteers:

 

 

AN2-502998 was generally well tolerated with no dose-limiting toxicities.

 

 

Human PK was well characterized; plasma exposures at or above NHP efficacy thresholds were achieved.

Overview of Chagas Disease

Chagas disease (also known as American trypanosomiasis) is caused by the parasite T. cruzi. Over 300,000 people are estimated to be infected in the U.S., 200,000 across Europe and Japan, and about 10 million worldwide. Left untreated, chronic T. cruzi infection is lifelong and can be life threatening. The parasite T. cruzi silently damages the heart and digestive system, with approximately 20-30% of people developing serious cardiac damage resulting in heart failure, stroke, or sudden death. There are no FDA-approved treatments for adults with Chagas disease.


Chagas Disease Opportunity

The Company believes that Chagas disease represents a potential multi-billion-dollar global market opportunity globally, given its large and readily treatable patient population. Well-established risk profiles including country of birth, travel history, and exposure to triatomine vectors enable targeted, cost-effective screening, and low-cost diagnostics are widely available. The commercial profile of Chagas disease therapeutics shares key structural characteristics with that of other large infectious disease markets, most notably hepatitis C, for which accessible diagnostics, defined risk populations, high urgency to treat, and broad insurance coverage transformed a historically underdiagnosed condition into a substantial market. In parallel, through its work with the Drugs for Neglected Diseases initiative (“DNDi”), the Company is committed to ensuring global access to AN2-502998, should it eventually be approved, in Chagas-endemic developing regions. AN2-502998, if approved, would also be eligible for an FDA Tropical Disease Priority Review Voucher.

Forward-Looking Statements

This Current Report on Form 8-K contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. In some cases, you can identify forward-looking statements by terms such as “may,” “will,” “should,” “would,” “expect,” “plan,” “anticipate,” “could,” “intend,” “target,” “project,” “believe,” “estimate,” “predict,” “potential,” or “continue,” or the negative of these terms or other similar expressions. Forward-looking statements expressed or implied in this report include, but are not limited to, statements regarding: NHP study data as a predictor of efficacy outcomes in human trials; market size and sales potential; the commercial profile of Chagas disease therapeutics; advancement of AN2-502998 into Phase 2 in collaboration with DNDi; the predictivity of data; eligibility for priority review; and other statements that are not historical fact. These statements are based on AN2’s current estimates, expectations, plans, objectives, and intentions, are not guarantees of future performance, and inherently involve significant risks and uncertainties. Actual results and the timing of events could differ materially from those anticipated in such forward-looking statements as a result of these risks and uncertainties, which include, but are not limited to, risks and uncertainties related to: AN2’s ability to implement its plans for its internal boron chemistry platform and pipeline programs; timely enrollment of patients in AN2’s clinical trials and investigator-initiated clinical trials; AN2’s ability to procure sufficient supply of its product candidates for its clinical trials; the potential for results from clinical trials to differ from preclinical, early clinical, preliminary, or expected results; the ability of particular preclinical models in non-human primates to predict safety and efficacy in humans; significant adverse events, toxicities, or other undesirable side effects associated with AN2’s product candidates; the significant uncertainty associated with AN2’s product candidates ever receiving any regulatory approvals; AN2’s ability to obtain, maintain, or protect intellectual property rights related to its current and future product candidates; implementation of AN2’s strategic plans for its business and product candidates; the sufficiency of AN2’s capital resources and need for additional capital to achieve its goals; global macroeconomic conditions and global conflicts and other risks, including those described under the heading “Risk Factors” in AN2’s Annual Reports on Form 10-K, Quarterly Reports on Form 10-Q and other reports filed with the U.S. Securities and Exchange Commission (“SEC”). These filings, when made, are available on the investor relations section of AN2’s website at www.an2therapeutics.com and on the SEC’s website at www.sec.gov. Forward-looking statements contained in this report are made as of this date, and AN2 undertakes no duty to update such information except as required under applicable law.

 

Item 9.01

Financial Statements and Exhibits.

 

Exhibit No.   

Description

99.1    Press release of AN2 Therapeutics, Inc. dated June 4, 2026.
104    Cover Page Interactive Data File (embedded within the Inline XBRL document)


SIGNATURES

Pursuant to the requirements of the Securities Exchange Act of 1934, the Registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.

 

Dated: June 4, 2026     AN2 Therapeutics, Inc.
    By:  

/s/ Joshua Eizen

      Joshua Eizen
      Chief Legal Officer and Chief Operating Officer

Exhibit 99.1

AN2 Therapeutics Reports Positive Enabling Data Supporting Advancement of

Oral AN2-502998 to Phase 2 Study for Chronic Chagas Disease

Parasite elimination achieved with 28-day treatment in 100% of nonhuman primates (NHPs)

naturally infected with Trypanosoma cruzi (T. cruzi) at target exposures planned in humans

Phase 1 First-In-Human (FIH) study showed favorable safety and tolerability profile; no dose-limiting toxicities

Significant U.S. commercial opportunity, including Priority Review Voucher eligibility upon approval

Menlo Park, CA – June 4, 2026 – AN2 Therapeutics, Inc. (Nasdaq: ANTX) a clinical-stage biopharmaceutical company developing novel small molecule therapeutics derived from its boron chemistry platform, today announced positive results from two studies evaluating the Company’s oral CPSF3 inhibitor, AN2-502998, for the treatment of chronic Chagas disease (American trypanosomiasis) caused by infection with the parasite T. cruzi.

Key findings from the two studies:

 

   

In NHPs with naturally acquired, chronic T. cruzi parasite infection, 28 days of AN2-502998 treatment resulted in 100% parasitic elimination at target exposures attainable in humans, through four months following the end of treatment.

 

   

In the Phase 1 FIH study, AN2-502998 was generally well tolerated at exposure levels consistent with NHP efficacy thresholds, with no dose-limiting toxicities.

“Results from these studies converge on the picture we were hoping to see: efficacy in NHPs at an exposure level achievable in humans, with an excellent safety profile as shown in the FIH study. Notably, parasites were eliminated after one month of treatment in NHPs with the same naturally acquired, chronic infection that we see in humans,” said Eric Easom, Co-founder, Chairman, President and CEO of AN2 Therapeutics. “Together, these data support our goal of making AN2-502998 the first FDA-approved therapy for chronic Chagas disease in adults.”

Easom continued, “We believe an oral therapy capable of delivering high rates of parasitic cure after just one month of treatment could enable large-scale test-and-treat campaigns against this often lethal disease, which affects over 300,000 people in the U.S. and approximately 10 million globally. We look forward to initiating a Phase 2 proof-of-concept study late this year.”


“Chagas disease is hiding in plain sight. We have simple, inexpensive serologic tests, and we know exactly which populations are at risk, no different from where we were with hepatitis C or HIV before systematic screening became standard of care,” said Dr. David Hamer, Professor of Global Health and Medicine, Boston University Schools of Public Health and Medicine. “The patients are there; it’s a matter of clinical awareness and systematic screening. What has been missing is an effective, well-tolerated treatment that physicians and patients can rely on for adults with chronic Chagas disease, who represent the vast majority of patients. It is genuinely encouraging to see serious drug development in this space - chronic Chagas disease represents one of the highest unmet needs in infectious disease, and these data suggest we may finally be moving toward a meaningful therapeutic option for patients who have had too few for too long.”

Overview of Chagas Disease

Chagas disease (also known as American trypanosomiasis) is caused by the parasite T. cruzi. Over 300,000 people are estimated to be infected in the U.S., 200,000 across Europe and Japan, and about 10 million worldwide. Left untreated, chronic T. cruzi infection is lifelong and can be life threatening. The parasite T. cruzi silently damages the heart and digestive system, with ~20-30% of people developing serious cardiac damage resulting in heart failure, stroke, or sudden death. There are no FDA-approved treatments for adults with Chagas disease.

Chagas Disease Opportunity

The Company believes that Chagas disease represents a potential multi-billion-dollar global market opportunity globally, given its large and readily treatable patient population. Well-established risk profiles including country of birth, travel history, and exposure to triatomine vectors enable targeted, cost-effective screening, and low-cost diagnostics are widely available. The commercial profile of Chagas disease therapeutics shares key structural characteristics with that of other large infectious disease markets, most notably hepatitis C, for which accessible diagnostics, defined risk populations, high urgency to treat, and broad insurance coverage transformed a historically underdiagnosed condition into a substantial market. In parallel, through its work with the Drugs for Neglected Diseases initiative (DNDi), the Company is committed to ensuring global access to AN2-502998, should it eventually be approved, in Chagas-endemic developing regions. AN2-502998, if approved, would also be eligible for an FDA Tropical Disease Priority Review Voucher.

Key Findings: 28-Day Nonhuman Primate (NHP) Study

The NHP efficacy study evaluated AN2-502998 administered for 28 days in macaques with naturally-acquired, chronic T. cruzi infection, contracted via triatomine (kissing bug) vectors in their natural habitats, the same vector that transmits the parasite to humans. The Chagas disease vector is increasingly prevalent across the southern half of the U.S. The Company believes that efficacy in naturally infected NHPs is the most clinically relevant predictor of efficacy for human chronic Chagas disease.

 

   

100% of treated animals achieved parasite elimination at target exposures attainable in humans.


   

Elimination of parasitemia in treated animals was durable and maintained through four months following the end of treatment.

 

   

Parasitemia was evaluated using an enhanced PCR method with improved sensitivity and robustness.

 

   

AN2-502998 was well tolerated with no drug-related adverse events.

 

   

AN2-502998 is the only compound to have demonstrated curative activity in NHPs with long-term, naturally acquired T. cruzi infection.

Key Findings: Phase 1 First-in-Human Study

The Phase 1 FIH study (NCT07024589) evaluated single ascending oral doses of AN2-502998 and then multiple ascending doses administered over 10 days in healthy adult volunteers:

 

   

AN2-502998 was generally well tolerated with no dose-limiting toxicities.

 

   

Human PK was well characterized; plasma exposures at or above NHP efficacy thresholds were achieved.

About AN2-502998

AN2-502998 is a boron-based small molecule therapeutic candidate from the benzoxaborole class, which has a broad therapeutic profile and includes two FDA-approved drugs (crisaborole and tavaborole). AN2-502998 is an orally active inhibitor of CPSF3 in T. cruzi. CPSF3 is an essential enzyme involved in messenger RNA processing, is clinically validated, and the same target as acoziborole that was recently approved by the EMA for the treatment of human African trypanosomiasis (HAT), caused by a related trypanosome parasite.

AN2 Therapeutics is advancing AN2-502998 into Phase 2 clinical study in collaboration with DNDi, a non-profit research and development organization whose medical expertise, established presence in Chagas-endemic regions, and commitment to delivering accessible treatments for neglected diseases provides a critical foundation for both the timely execution of clinical development and ensuring broad global access upon approval. The program also benefits from ongoing collaboration with the University of Georgia Research Foundation and the laboratory of Prof. Rick Tarleton, whose pioneering work in T. cruzi biology has been instrumental in advancing the scientific understanding of Chagas disease.

About AN2 Therapeutics

AN2 Therapeutics, Inc. is a clinical stage biopharmaceutical company focused on the discovery and development of novel small-molecule therapeutics derived from our boron chemistry platform. Our development pipeline spans hematologic diseases, infectious diseases, and oncology with three Phase 2 studies expected to be active in 2026, two preclinical oncology candidates, as well as advanced research programs focused on targets in oncology, bone disorders, and infectious diseases. We are committed to delivering high-impact drugs to patients that address critical unmet needs and improve health outcomes.


Forward-Looking Statements

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. In some cases, you can identify forward-looking statements by terms such as “may,” “will,” “should,” “would,” “expect,” “plan,” “anticipate,” “could,” “intend,” “target,” “project,” “believe,” “estimate,” “predict,” “potential,” or “continue,” or the negative of these terms or other similar expressions. Forward-looking statements expressed or implied in this press release include, but are not limited to, statements regarding: the potential of the Company’s boron chemistry platform and advancement of the Company’s development programs; NHP study data as a predictor of efficacy outcomes in human trials; market size and sales potential; the commercial profile of Chagas disease therapeutics; advancement of AN2-502998 into Phase 2 in collaboration with DNDi and other ongoing collaborations; expectations regarding the Company’s clinical trials; the predictivity of data; and other statements that are not historical fact. These statements are based on AN2’s current estimates, expectations, plans, objectives, and intentions, are not guarantees of future performance, and inherently involve significant risks and uncertainties. Actual results and the timing of events could differ materially from those anticipated in such forward-looking statements as a result of these risks and uncertainties, which include, but are not limited to, risks and uncertainties related to: AN2’s ability to implement its plans for its internal boron chemistry platform and pipeline programs; timely enrollment of patients in AN2’s clinical trials and investigator-initiated clinical trials; AN2’s ability to procure sufficient supply of its product candidates for its clinical trials; the potential for results from clinical trials to differ from preclinical, early clinical, preliminary, or expected results; the ability of particular preclinical models in non-human primates to predict safety and efficacy in humans; significant adverse events, toxicities, or other undesirable side effects associated with AN2’s product candidates; the significant uncertainty associated with AN2’s product candidates ever receiving any regulatory approvals; AN2’s ability to obtain, maintain, or protect intellectual property rights related to its current and future product candidates; implementation of AN2’s strategic plans for its business and product candidates; the sufficiency of AN2’s capital resources and need for additional capital to achieve its goals; global macroeconomic conditions and global conflicts and other risks, including those described under the heading “Risk Factors” in AN2’s Annual Reports on Form 10-K, Quarterly Reports on Form 10-Q and other reports filed with the U.S. Securities and Exchange Commission (SEC). These filings, when made, are available on the investor relations section of AN2’s website at www.an2therapeutics.com and on the SEC’s website at www.sec.gov. Forward-looking statements contained in this press release are made as of this date, and AN2 undertakes no duty to update such information except as required under applicable law.

COMPANY CONTACT:

Lucy O. Day

Chief Financial Officer

l.day@an2therapeutics.com

INVESTOR AND MEDIA CONTACT:

Anne Bowdidge

ir@an2therapeutics.com

FAQ

What did AN2 Therapeutics (ANTX) announce about its Chagas disease drug AN2-502998?

AN2 Therapeutics announced positive early data for AN2-502998 in chronic Chagas disease, including parasite elimination in nonhuman primates after 28 days of treatment and a Phase 1 study showing favorable safety and tolerability, supporting advancement into a planned Phase 2 proof-of-concept trial.

How effective was AN2-502998 in nonhuman primate studies reported by AN2 Therapeutics (ANTX)?

In a 28-day nonhuman primate study, AN2-502998 achieved parasite elimination in 100% of macaques naturally infected with T. cruzi at exposure levels planned for humans. AN2 considers efficacy in naturally infected primates an important predictor for potential chronic Chagas disease efficacy in people.

What were the key safety findings from the Phase 1 study of AN2-502998 by AN2 Therapeutics (ANTX)?

The Phase 1 first-in-human study of AN2-502998 in healthy adults showed a favorable safety and tolerability profile with no dose-limiting toxicities. The trial evaluated single ascending oral doses followed by multiple ascending doses over 10 days, supporting progression to Phase 2 evaluation.

How large is the potential market for AN2 Therapeutics’ (ANTX) Chagas disease treatment?

AN2 believes chronic Chagas disease represents a potential multi-billion-dollar global market, with about 300,000 people estimated infected in the U.S., 200,000 across Europe and Japan, and roughly 10 million worldwide, all amid a lack of FDA-approved treatments for adults with the disease.

Why is AN2-502998 potentially important for patients with chronic Chagas disease?

AN2-502998 could become the first FDA-approved therapy for adults with chronic Chagas disease if successful. AN2 aims for an oral, one-month treatment capable of high parasitic cure rates, which could support large-scale test-and-treat campaigns and address a major unmet medical need.

What collaborations support AN2 Therapeutics’ (ANTX) Chagas program and future access plans?

AN2 plans to advance AN2-502998 into Phase 2 with DNDi, a non-profit focused on neglected diseases, and collaborates with the University of Georgia Research Foundation. The company states it is committed to ensuring global access in Chagas-endemic regions if the drug is eventually approved.

Could AN2-502998 qualify AN2 Therapeutics (ANTX) for an FDA Priority Review Voucher?

AN2 notes that AN2-502998, if approved, would be eligible for an FDA Tropical Disease Priority Review Voucher. Such vouchers can be valuable assets, as they provide expedited review for a future application and can potentially be sold or transferred under current FDA programs.

Filing Exhibits & Attachments

4 documents