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RZLT: two statements about the upLIFT readout

Which study is this?

Drug
ersodetug [source]
Study
upLIFT [source]
Patient population
tumor hyperinsulinism [source]
study of ersodetug in tumor HI (upLIFT)

Source: 8-K, Exhibit 99.1, filed . Exhibit 99.1 → opening paragraph beginning “REDWOOD CITY, Calif., October 14, 2026”.

Study context and document locations: founder confirmed .

Comparison scope: company-stated timing for upLIFT in tumor HI. Other ersodetug studies are outside this comparison.

10-K, filed Sep 24, 2026

before the end of 2026

8-K, filed Oct 14, 2026

mid-December 2026

An earlier 10-Q (filed May 12, 2026) said second half of calendar 2026. Full history on the record page.

Quote matches the filingⓘ · data as of

Read the statements and sources
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Latest wording change: “November 1, 2026” → “February 1, 2027” · AGIO · Company press release · SEC filing pending filed Oct 30, 2026

Recently changed: AGIO ARGX RZLT BNTC MBRX Full calendar →

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10Days until stated date

November 10, 2026

NRXP

NRX Pharmaceuticals, Inc.

KETAFREE (preservative-free ketamine) · not stated in the cited filing

GDUFA goal date (company stated)

Company-stated FDA target action date for KETAFREE (preservative-free ketamine) (ANDA): November 10, 2026.

Quote matches the filingⓘ
SEC ↗
The acknowledgement letter revised the GDUFA goal date to November 10, 2026, citing that theDetails

NRX Pharmaceuticals, Inc. (NRXP) · KETAFREE (preservative-free ketamine) · not stated in the cited filing

Stage: Not stated

Public float: Unknown (no public float found in SEC filings)

GDUFA goal date (company stated):

The acknowledgement letter revised the GDUFA goal date to November 10, 2026, citing that the reclassified amendment will not require a substantial expenditure of FDA resources.

SEC Form 8-K · Filed: · Accession: 0001437749-26-030492 · Last checked: · Quote matches the filingⓘ

founder confirmed 2026-10-30 · AI quote review: machine_extracted_quote_verified

Earlier SEC statements (1)
  1. · “The KETAFREE™ ANDA was refiled in September 2025, and the Company received a letter in November 2025 with a notice that FDA had received the file and assigning a summer 2026 decision date under the Generic Drug User Fee Act (GDUFA).” · SEC filing
What these terms mean
8-K
A Form 8-K is a report a company files with the SEC to announce a significant event between its regular reports.
10-Q
A Form 10-Q is a company’s quarterly report to the SEC, with unaudited financial statements.
10-K
A Form 10-K is a company’s annual report to the SEC, with audited financial statements.
Topline
Topline results are the main summary results of a clinical trial, released before the full data.
PDUFA
A PDUFA date is the target date by which the FDA aims to decide on a drug or biologic application.
NDA / BLA
A New Drug Application (NDA) or Biologics License Application (BLA) asks the FDA to approve a drug or biologic for sale.
1H / 2H
1H means January–June and 2H means July–December of the stated year, unless the company uses a different fiscal year.
Q1–Q4
Q1–Q4 (also written 1Q–4Q) are quarters of the year: Q1 is January–March, Q2 April–June, Q3 July–September and Q4 October–December, unless the company uses a different fiscal year.

Latest wording changes

Source wording changes in the last 30 days.

  1. AGIOmitapivat Checked by founder

    Earlier wording: “November 1, 2026” → “February 1, 2027”

    8-K · Filed · Company press release · SEC filing pending · Published · See this change

  2. ARGXempasiprubart Quote matches the filingⓘ

    Earlier wording: “fourth quarter of 2026” → “in December 2026”

    EX-99.1 · Filed · 6-K · Filed · See this change

  3. RZLTersodetug Quote matches the filingⓘ

    Earlier wording: “before the end of 2026” → “mid-December 2026”

    10-K · Filed · 8-K · Filed · See this change

  4. BNTCBB-301 Quote matches the filingⓘ

    Earlier wording: “2H-2026” → “October 27-30, 2026”

    EX-99.1 · Filed · EX-99.1 · Filed · See this change

Calendar

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○ Quote matches the filing · ✓ Checked by founder.

Showing up to 20 programs. All records, original quotations and SEC links →

November 2026 · Dates the companies stated

  1. ICCCImmuCell · Unaudited financial results for the quarter and nine months ended September 30, 2026Financial results Quote matches the filingⓘSEC ↗

    13 days left

    Company-stated date for Unaudited financial results for the quarter and nine months ended September 30, 2026: November 13, 2026.

    The Company is planning to host a conference call on Friday, November 13, 2026, at 9:00 AM ET toDetails

    IMMUCELL CORP /DE/ (ICCC) · Unaudited financial results for the quarter and nine months ended September 30, 2026

    Stage: Not stated

    Public float (as of ): $50M (SEC filing) · Under $500M

    Date the company stated:

    The Company is planning to host a conference call on Friday, November 13, 2026, at 9:00 AM ET to discuss the unaudited financial results for the quarter and nine months ended September 30, 2026.

    SEC Form 8-K · Filed: · Accession: 0001437749-26-032465 · Last checked: · Quote matches the filingⓘ

  2. CYTKCytokinetics · aficamtenPDUFA target date (company stated) Quote matches the filingⓘSEC ↗

    14 days left

    Company-stated FDA target action date for aficamten: November 14, 2026.

    The FDA assigned a standard review classification to the sNDA with a PDUFA date of November 14, 2026Details

    CYTOKINETICS INC (CYTK) · aficamten

    Stage: PDUFASEC filing · “PDUFA date”

    Public float (as of ): $2.5B (SEC filing) · Over $2B

    PDUFA target date (company stated):

    The FDA assigned a standard review classification to the sNDA with a PDUFA date of November 14, 2026.

    SEC Form 10-Q · Filed: · Accession: 0001193125-26-338217 · Last checked: · Quote matches the filingⓘ

  3. NTHINeOnc Technologies Holdings · NEO212FDA meeting Meeting date, not a results announcement Quote matches the filingⓘSEC ↗

    17 days left

    Company-stated date for NEO212: November 17, 2026.

    On September 28, 2026, NeOnc Technologies Holdings, Inc. (the “Company”) issued a press release announcing that it is scheduled to meet with the U.S. Food and Drug Administration on November 17, 2026Details

    NEONC TECHNOLOGIES HOLDINGS, INC. (NTHI) · NEO212

    Stage: Phase 1SEC filing · “Phase 1”

    Public float (as of ): $67M (SEC filing) · Under $500M

    Date the company stated:

    On September 28, 2026, NeOnc Technologies Holdings, Inc. (the “Company”) issued a press release announcing that it is scheduled to meet with the U.S. Food and Drug Administration on November 17, 2026, for an in-person End-of-Phase 1 Type B meeting concerning NEO212.

    SEC Form 8-K · Filed: · Accession: 0001829126-26-010493 · Last checked: · Quote matches the filingⓘ

  4. SVRASavara · molgramostimPDUFA target date (company stated) Quote matches the filingⓘSEC ↗

    22 days left

    Company-stated FDA target action date for molgramostim: November 22, 2026.

    Prescription Drug User Fee Act ("PDUFA") target action date to November 22, 2026.Details

    Savara Inc (SVRA) · molgramostim

    Stage: PDUFASEC filing · “PDUFA") target action date”

    Public float (as of ): $544M (SEC filing) · $500M–$2B

    PDUFA target date (company stated):

    Prescription Drug User Fee Act ("PDUFA") target action date to November 22, 2026.

    SEC Form 10-Q · Filed: · Accession: 0001193125-26-344585 · Last checked: · Quote matches the filingⓘ

  5. SNYSanofi · venglustat · type 3 Gaucher disease (GD3)FDA goal date (company stated) Quote matches the filingⓘSEC ↗

    25 days left

    Company-stated FDA target action date for venglustat (NDA): November 25, 2026.

    The target action date for the FDA decision is November 25, 2026.Details

    Sanofi (SNY) · venglustat · type 3 Gaucher disease (GD3)

    Stage: PDUFASEC filing · “target action date”

    Public float: Unknown (no public float found in SEC filings)

    FDA goal date (company stated):

    The target action date for the FDA decision is November 25, 2026.

    SEC Form 6-K · Filed: · Accession: 0001121404-26-000008 · Last checked: · Quote matches the filingⓘ

    founder confirmed 2026-10-30 · AI quote review: machine_extracted_quote_verified

    Earlier SEC statements (1)
    1. · “The target action date for the FDA decision is November 25, 2026.” · SEC filing
  6. PYPDPolyPid · D-PLEX100 · Prevention of surgical site infections in patients undergoing abdominal colorectal surgeryPDUFA target date (company stated) Quote matches the filingⓘSEC ↗

    28 days left

    Company-stated FDA target action date for D-PLEX100 (NDA): November 28, 2026.

    PolyPid’s management will also review the Company’s plans to maximize the value of D-PLEX₁₀₀, for which a New Drug Application (“NDA”) is under FDA Priority Review with a PDUFA goal date of November 28, 2026Details

    PolyPid Ltd. (PYPD) · D-PLEX100 · Prevention of surgical site infections in patients undergoing abdominal colorectal surgery

    Stage: PDUFASEC filing · “PDUFA goal date”

    Public float: Unknown (no public float found in SEC filings)

    PDUFA target date (company stated):

    PolyPid’s management will also review the Company’s plans to maximize the value of D-PLEX₁₀₀, for which a New Drug Application (“NDA”) is under FDA Priority Review with a PDUFA goal date of November 28, 2026, including potential label expansion beyond colorectal surgery and potential geographic expansion.

    SEC Form 6-K · Filed: · Accession: 0001213900-26-113107 · Last checked: · Quote matches the filingⓘ

    founder confirmed 2026-10-30 · AI quote review: machine_extracted_quote_verified

    Earlier SEC statements (1)
    1. · “The Company anticipates a potential FDA decision in the first quarter of 2027 under the Prescription Drug User Fee Act (“PDUFA”) review timeline.” · SEC filing
  7. COGTCogent Biosciences · bezuclastinib and sunitinib · GIST after prior imatinibPDUFA target date (company stated) Quote matches the filingⓘSEC ↗

    30 days left

    Company-stated FDA target action date for bezuclastinib and sunitinib: November 30, 2026.

    PDUFA target action date of November 30, 2026Details

    Cogent Biosciences, Inc. (COGT) · bezuclastinib and sunitinib · GIST after prior imatinib

    Stage: PDUFASEC filing · “PDUFA target action date”

    Public float (as of ): $772M (SEC filing) · $500M–$2B

    PDUFA target date (company stated):

    PDUFA target action date of November 30, 2026

    SEC Form filing · Filed: · Accession: 0001193125-26-342393 · Last checked: · Quote matches the filingⓘ

    Earlier SEC statements (1)
    1. · “PDUFA date of November 30, 2026” · SEC filing
  8. VRTXVertex Pharmaceuticals · povetacicept · IgA nephropathy in adultsPDUFA target date (company stated) Quote matches the filingⓘSEC ↗

    30 days left

    Company-stated FDA target action date for povetacicept: November 30, 2026.

    PDUFA target action date of November 30, 2026Details

    VERTEX PHARMACEUTICALS INC / MA (VRTX) · povetacicept · IgA nephropathy in adults

    Stage: PDUFASEC filing · “PDUFA target action date”

    Public float (as of ): $113.4B (SEC filing) · Over $2B

    PDUFA target date (company stated):

    PDUFA target action date of November 30, 2026

    SEC Form filing · Filed: · Accession: 0000875320-26-000259 · Last checked: · Quote matches the filingⓘ

    Earlier SEC statements (1)
    1. · “PDUFA target action date of November 30, 2026” · SEC filing

December 2026 · Dates the companies stated

  1. EXELExelixis · zanzalintinib and atezolizumab · previously treated metastatic colorectal cancerPDUFA target date (company stated) Quote matches the filingⓘSEC ↗

    33 days left

    Company-stated FDA target action date for zanzalintinib and atezolizumab: December 3, 2026.

    Prescription Drug User Fee Act (PDUFA) target action date of December 3, 2026Details

    EXELIXIS, INC. (EXEL) · zanzalintinib and atezolizumab · previously treated metastatic colorectal cancer

    Stage: PDUFASEC filing · “PDUFA) target action date”

    Public float (as of ): $9.4B (SEC filing) · Over $2B

    PDUFA target date (company stated):

    Prescription Drug User Fee Act (PDUFA) target action date of December 3, 2026

    SEC Form filing · Filed: · Accession: 0000939767-26-000098 · Last checked: · Quote matches the filingⓘ

    Earlier SEC statements (6)
    1. · “Prescription Drug User Fee Act (PDUFA) target action date of December 3, 2026” · SEC filing
    2. · “Prescription Drug User Fee Act (PDUFA) target action date of December 3, 2026” · SEC filing
    3. · “PDUFA target action date of December 3, 2026” · SEC filing
    4. · “target action date of December 3, 2026” · SEC filing
    5. · “Prescription Drug User Fee Act (PDUFA) target action date of December 3, 2026” · SEC filing
    6. · “Prescription Drug User Fee Act (PDUFA) target action date of December 3, 2026” · SEC filing
  2. ANABAnaptysBio · imsidolimab · generalized pustular psoriasisPDUFA target date (company stated) Quote matches the filingⓘSEC ↗

    42 days left

    Company-stated FDA target action date for imsidolimab: December 12, 2026.

    target action date of December 12, 2026Details

    ANAPTYSBIO, INC (ANAB) · imsidolimab · generalized pustular psoriasis

    Stage: PDUFASEC filing · “target action date”

    Public float (as of ): $432M (SEC filing) · Under $500M

    PDUFA target date (company stated):

    target action date of December 12, 2026

    SEC Form filing · Filed: · Accession: 0001193125-26-219515 · Last checked: · Quote matches the filingⓘ

    Earlier SEC statements (3)
    1. · “target action date (PDUFA) of Dec. 12, 2026” · SEC filing
    2. · “target action date of December 12, 2026” · SEC filing
    3. · “target action date of Dec. 12, 2026” · SEC filing
  3. CORTCorcept Therapeutics · relacorilant · Cushing’s syndromePDUFA target date (company stated) Quote matches the filingⓘSEC ↗

    47 days left

    Company-stated FDA target action date for relacorilant (NDA (resubmission)): December 17, 2026.

    Relacorilant for patients with Cushing’s syndrome – New Drug Application for relacorilant resubmitted with a Prescription Drug User Fee Act (PDUFA) date of December 17, 2026Details

    CORCEPT THERAPEUTICS INC (CORT) · relacorilant · Cushing’s syndrome

    Stage: PDUFASEC filing · “PDUFA) date”

    Public float: Unknown (no public float found in SEC filings)

    PDUFA target date (company stated):

    Relacorilant for patients with Cushing’s syndrome – New Drug Application for relacorilant resubmitted with a Prescription Drug User Fee Act (PDUFA) date of December 17, 2026

    SEC Form 8-K · Filed: · Accession: 0001628280-26-050607 · Last checked: · Quote matches the filingⓘ

    founder confirmed 2026-10-30 · AI quote review: machine_extracted_quote_verified

    Earlier SEC statements (1)
    1. · “Corcept expects the resubmission to receive a six-month review.” · SEC filing
  4. MLYSMineralys Therapeutics · lorundrostatPDUFA target date (company stated) Quote matches the filingⓘSEC ↗

    52 days left

    Company-stated FDA target action date for lorundrostat: December 22, 2026.

    The FDA accepted the NDA submission and provided us with a Prescription Drug User Fee Act (PDUFA) target date of December 22, 2026Details

    Mineralys Therapeutics, Inc. (MLYS) · lorundrostat

    Stage: PDUFASEC filing · “PDUFA) target date”

    Public float (as of ): $676M (SEC filing) · $500M–$2B

    PDUFA target date (company stated):

    The FDA accepted the NDA submission and provided us with a Prescription Drug User Fee Act (PDUFA) target date of December 22, 2026 for lorundrostat.

    SEC Form 10-Q · Filed: · Accession: 0001933414-26-000114 · Last checked: · Quote matches the filingⓘ

    Earlier SEC statements (6)
    1. · “The FDA accepted the NDA submission and provided us with a Prescription Drug User Fee Act (PDUFA) target date of December 22, 2026 for lorundrostat.” · SEC filing
    2. · “The FDA accepted the NDA submission and provided the Company with a Prescription Drug User Fee Act target date of December 22, 2026 for lorundrostat.” · SEC filing
    3. · “Food and Drug Administration (FDA) accepted the NDA for lorundrostat for the treatment of hypertension in combination with other antihypertensive drugs and assigned a Prescription Drug User Fee Act (PDUFA) target date of December 22, 2026.” · SEC filing
    4. · “The FDA accepted the NDA submission and provided us with a Prescription Drug User Fee Act (PDUFA) target action date of December 22, 2026.” · SEC filing
    5. · “The FDA accepted the NDA submission and provided us with a PDUFA target action date of December 22, 2026.” · SEC filing
    6. · “The FDA accepted the NDA submission and provided the Company with a Prescription Drug User Fee Act target action date of December 22, 2026.” · SEC filing
  5. GILDGilead Sciences · anito-cel · relapsed or refractory multiple myeloma after at least three prior therapiesPDUFA target date (company stated) Quote matches the filingⓘSEC ↗

    53 days left

    Company-stated FDA target action date for anito-cel: December 23, 2026.

    PDUFA target action date of December 23, 2026Details

    GILEAD SCIENCES, INC. (GILD) · anito-cel · relapsed or refractory multiple myeloma after at least three prior therapies

    Stage: PDUFASEC filing · “PDUFA target action date”

    Public float (as of ): $103.2B (SEC filing) · Over $2B

    PDUFA target date (company stated):

    PDUFA target action date of December 23, 2026

    SEC Form filing · Filed: · Accession: 0000882095-26-000031 · Last checked: · Quote matches the filingⓘ

    Earlier SEC statements (3)
    1. · “PDUFA target action date of December 23, 2026” · SEC filing
    2. · “PDUFA target action date of December 23, 2026” · SEC filing
    3. · “Prescription Drug User Fee Act (PDUFA) action date of December 23, 2026” · SEC filing
  6. PRAXPraxis Precision Medicines · relutrigine · SCN2A and SCN8A developmental and epileptic encephalopathiesPDUFA target date (company stated) Quote matches the filingⓘSEC ↗

    57 days left

    Company-stated FDA target action date for relutrigine: December 27, 2026.

    PDUFA target action date of December 27, 2026Details

    Praxis Precision Medicines, Inc. (PRAX) · relutrigine · SCN2A and SCN8A developmental and epileptic encephalopathies

    Stage: PDUFASEC filing · “PDUFA target action date”

    Public float (as of ): $883M (SEC filing) · $500M–$2B

    PDUFA target date (company stated):

    PDUFA target action date of December 27, 2026

    SEC Form filing · Filed: · Accession: 0001689548-26-000082 · Last checked: · Quote matches the filingⓘ

    Earlier SEC statements (7)
    1. · “PDUFA action date of September 27, 2026” · SEC filing
    2. · “PDUFA action date of December 27, 2026” · SEC filing
    3. · “PDUFA date of December 27, 2026” · SEC filing
    4. · “PDUFA target action date from September 27, 2026” · SEC filing
    5. · “PDUFA target action date of September 27, 2026” · SEC filing
    6. · “PDUFA action date of September 27, 2026” · SEC filing
    7. · “target action date under the Prescription Drug User Fee Act of September 27, 2026” · SEC filing
  7. VTRSViatris · MR-107A-02 (fast-acting meloxicam) · moderate-to-severe acute painPDUFA target date (company stated) Quote matches the filingⓘSEC ↗

    57 days left

    Company-stated FDA target action date for MR-107A-02 (fast-acting meloxicam) (NDA): December 27, 2026.

    The FDA has assigned a PDUFA goal date of December 27, 2026.Details

    Viatris Inc (VTRS) · MR-107A-02 (fast-acting meloxicam) · moderate-to-severe acute pain

    Stage: PDUFASEC filing · “PDUFA goal date”

    Public float: Unknown (no public float found in SEC filings)

    PDUFA target date (company stated):

    The FDA has assigned a PDUFA goal date of December 27, 2026.

    SEC Form 8-K · Filed: · Accession: 0001792044-26-000037 · Last checked: · Quote matches the filingⓘ

    founder confirmed 2026-10-30 · AI quote review: machine_extracted_quote_verified

  8. COGTCogent Biosciences · bezuclastinib · nonadvanced systemic mastocytosisPDUFA target date (company stated) Quote matches the filingⓘSEC ↗

    60 days left

    Company-stated FDA target action date for bezuclastinib: December 30, 2026.

    Prescription Drug User Fee Act ("PDUFA") target action date of December 30, 2026Details

    Cogent Biosciences, Inc. (COGT) · bezuclastinib · nonadvanced systemic mastocytosis

    Stage: PDUFASEC filing · “PDUFA") target action date”

    Public float (as of ): $772M (SEC filing) · $500M–$2B

    PDUFA target date (company stated):

    Prescription Drug User Fee Act ("PDUFA") target action date of December 30, 2026

    SEC Form filing · Filed: · Accession: 0001193125-26-342393 · Last checked: · Quote matches the filingⓘ

    Earlier SEC statements (3)
    1. · “PDUFA date of December 30, 2026” · SEC filing
    2. · “Prescription Drug User Fee Act ("PDUFA") target action date of December 30, 2026” · SEC filing
    3. · “Prescription Drug User Fee Act (PDUFA) target action date of December 30, 2026” · SEC filing

January 2027 · Dates the companies stated

  1. NUVBNuvation Bio · taletrectinib / IBTROZIPDUFA target date (company stated) Quote matches the filingⓘSEC ↗

    65 days left

    Company-stated FDA target action date for taletrectinib / IBTROZI: January 4, 2027.

    supplemental New Drug Application (sNDA) for IBTROZI with updated efficacy data in TKI-naïve and TKI-pretreated advanced ROS1+ NSCLC, with a target action date of January 4, 2027Details

    Nuvation Bio Inc. (NUVB) · taletrectinib / IBTROZI

    Stage: PDUFASEC filing · “target action date”

    Public float (as of ): $496M (SEC filing) · Under $500M

    PDUFA target date (company stated):

    supplemental New Drug Application (sNDA) for IBTROZI with updated efficacy data in TKI-naïve and TKI-pretreated advanced ROS1+ NSCLC, with a target action date of January 4, 2027.

    ClinicalTrials.gov NCT04395677 · NCT stated in SEC filing

    ClinicalTrials.gov NCT04919811 · NCT stated in SEC filing

    SEC Form 8-K · Filed: · Accession: 0001193125-26-336751 · Last checked: · Quote matches the filingⓘ

  2. DYNDyne Therapeutics · zeleciment rostudirsen (DYNE-251) · Duchenne muscular dystrophy amenable to exon 51 skippingPDUFA target date (company stated) Quote matches the filingⓘSEC ↗

    82 days left

    Company-stated FDA target action date for zeleciment rostudirsen (DYNE-251): January 21, 2027.

    PDUFA target action date set for January 21, 2027Details

    Dyne Therapeutics, Inc. (DYN) · zeleciment rostudirsen (DYNE-251) · Duchenne muscular dystrophy amenable to exon 51 skipping

    Stage: PDUFASEC filing · “PDUFA target action date”

    Public float (as of ): $948M (SEC filing) · $500M–$2B

    PDUFA target date (company stated):

    PDUFA target action date set for January 21, 2027

    SEC Form filing · Filed: · Accession: 0001193125-26-323940 · Last checked: · Quote matches the filingⓘ

    Earlier SEC statements (3)
    1. · “Prescription Drug User Fee Act (PDUFA) target action date set for January 21, 2027” · SEC filing
    2. · “Prescription Drug User Fee Act, or PDUFA, target action date of January 21, 2027” · SEC filing
    3. · “Prescription Drug User Fee Act target action date of January 21, 2027” · SEC filing
  3. INSMInsmed · ARIKAYCE (amikacin liposome inhalation suspension) · Mycobacterium avium complex lung disease, as part of a combination antibacterial drug regimenFDA goal date (company stated) Quote matches the filingⓘSEC ↗

    89 days left

    Company-stated FDA target action date for ARIKAYCE (amikacin liposome inhalation suspension) (sNDA): January 28, 2027.

    The FDA granted Priority Review to the sNDA and set a target action date of January 28, 2027,Details

    INSMED Inc (INSM) · ARIKAYCE (amikacin liposome inhalation suspension) · Mycobacterium avium complex lung disease, as part of a combination antibacterial drug regimen

    Stage: PDUFASEC filing · “target action date of January 28, 2027, under the Prescription Drug User Fee Act (PDUFA”

    Public float: Unknown (no public float found in SEC filings)

    FDA goal date (company stated):

    In September 2026, the U.S. Food and Drug Administration (FDA) accepted Insmed’s Supplemental New Drug Application (sNDA) for review of ARIKAYCE for the treatment of Mycobacterium avium complex (MAC) lung disease as part of a combination antibacterial drug regimen. The FDA granted Priority Review to the sNDA and set a target action date of January 28, 2027, under the Prescription Drug User Fee Act (PDUFA).

    SEC Form 8-K · Filed: · Accession: 0001140361-26-041097 · Last checked: · Quote matches the filingⓘ

    founder confirmed 2026-10-30 · AI quote review: machine_extracted_quote_verified

  4. PRAXPraxis Precision Medicines · ulixacaltamide · essential tremorPDUFA target date (company stated) Quote matches the filingⓘSEC ↗

    90 days left

    Company-stated FDA target action date for ulixacaltamide: January 29, 2027.

    target action date under the Prescription Drug User Fee Act, or PDUFA, of January 29, 2027Details

    Praxis Precision Medicines, Inc. (PRAX) · ulixacaltamide · essential tremor

    Stage: PDUFASEC filing · “target action date under the Prescription Drug User Fee Act, or PDUFA”

    Public float (as of ): $883M (SEC filing) · $500M–$2B

    PDUFA target date (company stated):

    target action date under the Prescription Drug User Fee Act, or PDUFA, of January 29, 2027

    SEC Form filing · Filed: · Accession: 0001689548-26-000083 · Last checked: · Quote matches the filingⓘ

    Earlier SEC statements (5)
    1. · “PDUFA date of January 29, 2027” · SEC filing
    2. · “target action date under the Prescription Drug User Fee Act (PDUFA) of January 29, 2027” · SEC filing
    3. · “PDUFA target action date of January 29, 2027” · SEC filing
    4. · “target action date under the Prescription Drug User Fee Act, or PDUFA, of January 29, 2027” · SEC filing
    5. · “target action date under the Prescription Drug User Fee Act of January 29, 2027” · SEC filing

Open the calendar →

How ORION works

  1. The earliest statement we found. The original sentence, the time window as written, the filing it came from and its date.
  2. Changes since. Later filings that restate or move the timing, kept beside the earlier wording.
  3. What is confirmed today. The disclosure found, the filings and releases read, and the date they were checked.

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