Quarterly archive / January to March 2026

Q1 2026: life-sciences IPOs
and the evidence they disclosed

Drug developers made up most of the quarter, alongside the first direct listing in the cohort and a diabetes-device carve-out. Staff comment letters are released for only some issuers so far

See the 7 issuers
Priced IPOs7
Sector mix6 biotech · 1 device
Median days to price181
Staff letters released2 of 7 issuers

01 / issuers, in pricing order

7 priced offerings

Each record shows the SEC-assigned industry code and why the issuer sits in its sector, the filing timeline from first submission to the final prospectus, and the evidence signals found in the 424B4 text. Signal counts are phrase occurrences, not a quality score

Biotech and pharmaAktis Oncology, Inc.

Clinical-stage targeted radiopharmaceuticals for oncology

Classification basis SEC SIC 2834 (Pharmaceutical Preparations); prospectus business description read and consistent

First submission
Draft (DRS) 11 Oct 2024
Public S-1
19 Dec 2025
S-1/A amendments
2
Priced (424B4)
9 Jan 2026
Days, first submission to pricing
455
Staff letters released
not yet released
  • Clinical evidencePhase 1 5Phase 2 6Phase 3 4Pivotal study 5Topline data 4Clinical hold 7Clinical validation 9
  • Regulatory pathwayIND 46NDA or BLA 49Expedited designation 51
  • Quality and manufacturingcGMP 28Contract manufacturer 41Form 483 or warning letter 3Recall 12
  • Commercial operationsReimbursement 65Medicare or Medicaid 51Payer contracts 50Sales force 4
  • Healthcare complianceHIPAA 17Anti-Kickback Statute 10
  • Financial disclosureEmerging growth company 31Cash runway statement 4

Final prospectus (424B4) ↗First public S-1, 19 Dec 2025 ↗All filings, CIK 2035832 ↗

LSH-2026Q1-35832 · accession 0001193125-26-009078 · checked September 2026 · verified
Biotech and pharma · direct listingPolaryx Therapeutics, Inc.

Clinical-stage therapies for rare pediatric lysosomal storage disorders

Classification basis SEC SIC 2834 (Pharmaceutical Preparations); prospectus business description read and consistent

First submission
Draft (DRS) 5 Aug 2025
Public S-1
21 Nov 2025
S-1/A amendments
2
Priced (424B4)
2 Feb 2026
Days, first submission to pricing
181
Staff letters released
not yet released
  • Clinical evidencePhase 1 3Phase 2 23Phase 3 6Pivotal study 13Topline data 7Clinical hold 6Clinical validation 1
  • Regulatory pathwayIND 63NDA or BLA 49Expedited designation 97
  • Quality and manufacturingcGMP 27Contract manufacturer 31Form 483 or warning letter 3Recall 8
  • Commercial operationsReimbursement 52Medicare or Medicaid 25Payer contracts 26Sales force 3
  • Healthcare complianceHIPAA 14
  • Financial disclosureEmerging growth company 24Cash runway statement 1

Final prospectus (424B4) ↗First public S-1, 21 Nov 2025 ↗All filings, CIK 2075320 ↗

LSH-2026Q1-75320 · accession 0001213900-26-010761 · checked September 2026 · verified
Biotech and pharmaVeradermics, Inc

Late clinical-stage therapeutics for aesthetic and dermatological conditions

Classification basis SEC SIC 2834 (Pharmaceutical Preparations); prospectus business description read and consistent

First submission
Draft (DRS) 27 Oct 2025
Public S-1
9 Jan 2026
S-1/A amendments
1
Priced (424B4)
4 Feb 2026
Days, first submission to pricing
100
Staff letters released
1
  • Clinical evidencePhase 1 13Phase 2 38Phase 3 26Pivotal study 1Topline data 12Clinical hold 4
  • Regulatory pathwayIND 20NDA or BLA 3
  • Quality and manufacturingcGMP 17Contract manufacturer 38Form 483 or warning letter 3Recall 6
  • Commercial operationsReimbursement 55Medicare or Medicaid 46Payer contracts 52Sales force 5
  • Healthcare complianceHIPAA 3Anti-Kickback Statute 4Corporate practice of medicine 1
  • Financial disclosureEmerging growth company 36Cash runway statement 3

Final prospectus (424B4) ↗First public S-1, 9 Jan 2026 ↗First released staff letter ↗All filings, CIK 1827635 ↗

LSH-2026Q1-27635 · accession 0001628280-26-005505 · checked September 2026 · verified
Biotech and pharmaEikon Therapeutics, Inc.

Late-stage clinical biopharmaceutical pipeline across several indications

Classification basis SEC SIC 2836 (Biological Products, (No Diagnostic Substances)); prospectus business description read and consistent

First submission
Draft (DRS) 9 May 2025
Public S-1
9 Jan 2026
S-1/A amendments
1
Priced (424B4)
5 Feb 2026
Days, first submission to pricing
272
Staff letters released
not yet released
  • Clinical evidencePhase 1 24Phase 2 45Phase 3 11Pivotal study 14Topline data 2Clinical hold 13
  • Regulatory pathwayIND 38NDA or BLA 40Expedited designation 32
  • Quality and manufacturingcGMP 20Contract manufacturer 39Form 483 or warning letter 1Recall 10
  • Commercial operationsReimbursement 73Medicare or Medicaid 68Payer contracts 59Sales force 4
  • Healthcare complianceHIPAA 13Anti-Kickback Statute 10
  • Financial disclosureMaterial weakness identified 3Emerging growth company 32Cash runway statement 3

Final prospectus (424B4) ↗First public S-1, 9 Jan 2026 ↗All filings, CIK 1861123 ↗

LSH-2026Q1-61123 · accession 0001193125-26-039375 · checked September 2026 · verified
Biotech and pharmaSpyGlass Pharma, Inc.

Late-stage sustained-release drug delivery for chronic eye conditions

Classification basis SEC SIC 3841 (Surgical & Medical Instruments & Apparatus); reassigned after reading the prospectus business description: the prospectus describes a late-stage biopharmaceutical company delivering approved medicines through sustained-release eye implants, so its evidence path is drug development

First submission
Draft (DRS) 26 Sep 2025
Public S-1
16 Jan 2026
S-1/A amendments
1
Priced (424B4)
6 Feb 2026
Days, first submission to pricing
133
Staff letters released
3
  • Clinical evidencePhase 1 2Phase 2 2Phase 3 44Pivotal study 1Topline data 3Clinical hold 4Clinical validation 1
  • Regulatory pathwayIND 10NDA or BLA 7Expedited designation 12510(k) 2PMA or De Novo 5CE mark or EU MDR/IVDR 1
  • Quality and manufacturingcGMP 21Contract manufacturer 31QSR, QMSR or ISO 13485 4Form 483 or warning letter 5Recall 9
  • Commercial operationsReimbursement 82CPT or HCPCS coding 12Medicare or Medicaid 74Payer contracts 40Sales force 2
  • Healthcare complianceHIPAA 6Anti-Kickback Statute 10
  • Financial disclosureMaterial weakness identified 1Emerging growth company 24Cash runway statement 4

Final prospectus (424B4) ↗First public S-1, 16 Jan 2026 ↗First released staff letter ↗All filings, CIK 1778922 ↗

LSH-2026Q1-78922 · accession 0001628280-26-006068 · checked September 2026 · verified
Biotech and pharmaGenerate Biomedicines, Inc.

Clinical-stage generative-AI protein design and drug development

Classification basis SEC SIC 2834 (Pharmaceutical Preparations); prospectus business description read and consistent

First submission
Draft (DRS) 23 Dec 2025
Public S-1
4 Feb 2026
S-1/A amendments
2
Priced (424B4)
27 Feb 2026
Days, first submission to pricing
66
Staff letters released
not yet released
  • Clinical evidencePhase 1 57Phase 2 14Phase 3 61Pivotal study 5Topline data 3Clinical hold 6
  • Regulatory pathwayIND 42NDA or BLA 55Expedited designation 37510(k) 1
  • Quality and manufacturingcGMP 31Contract manufacturer 65Form 483 or warning letter 5Recall 11
  • Commercial operationsReimbursement 92Medicare or Medicaid 48Payer contracts 53Sales force 3
  • Healthcare complianceHIPAA 8Anti-Kickback Statute 9
  • Financial disclosureAuditor going-concern paragraph 1Emerging growth company 24Cash runway statement 4

Final prospectus (424B4) ↗First public S-1, 4 Feb 2026 ↗All filings, CIK 2100782 ↗

LSH-2026Q1-00782 · accession 0001193125-26-083190 · checked September 2026 · verified
Medical device and diagnosticsMiniMed Group, Inc.

Scaled diabetes management devices, a carve-out from a larger device company

Classification basis SEC SIC 3841 (Surgical & Medical Instruments & Apparatus); prospectus business description read and consistent

First submission
Draft (DRS) 30 May 2025
Public S-1
19 Dec 2025
S-1/A amendments
3
Priced (424B4)
6 Mar 2026
Days, first submission to pricing
280
Staff letters released
not yet released
  • Clinical evidencePivotal study 3Topline data 2
  • Regulatory pathway510(k) 24PMA or De Novo 23CE mark or EU MDR/IVDR 65
  • Quality and manufacturingcGMP 1Contract manufacturer 1QSR, QMSR or ISO 13485 2Form 483 or warning letter 18Recall 37
  • Commercial operationsReimbursement 66CPT or HCPCS coding 1Medicare or Medicaid 25Payer contracts 47Value-based care 1Sales force 9
  • Healthcare complianceHIPAA 13Anti-Kickback Statute 2
  • Financial disclosureDual-class or controlled company 23

Final prospectus (424B4) ↗First public S-1, 19 Dec 2025 ↗All filings, CIK 2062583 ↗

LSH-2026Q1-62583 · accession 0001628280-26-015648 · checked September 2026 · verified

02 / notes and gaps

What this quarter can and cannot show

7 issuers is a small sample. Differences from other quarters may reflect a single company, and nothing here measures total US IPO activity. Offerings by companies that were already SEC reporters, blank-check companies and foreign issuers on Form F-1 are outside the scope

SEC staff comment letters had been released for 2 of 7 issuers when the data was collected. SEC releases correspondence some time after a registration statement goes effective, so empty values are a timing gap, not evidence of a light review. Fields that could not be found are shown as not found and are not estimated