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Biotech catalyst, news and analysis PDUFA tracker

Merlintrader Trading Pub
Biotech catalyst, news and analysis PDUFA tracker
AI transparency: articles and reports are produced with the help of artificial intelligence and checked through a process that does not constitute specialist validation. They may contain errors: verify relevant information with independent sources. Read the full disclaimer.
Nov 12, 2026
INBX update: CTOS presentations ahead; ozekibart remains under FDA review
NASDAQ: $INBXBiotech · OncologyRegulatory, hepatic-safety and financing risk
INBX Stock Hub: Inhibrx News, Ozekibart and Ordastobart
Inhibrx has an accepted ozekibart BLA with an April 14, 2027 PDUFA date. Ordastobart showed a response signal in HexAgon-HN, alongside substantial treatment-related toxicity. Latest published accounts are Q2 2026: $133.344M June cash; the later corporate presentation reported $219.5M on August 6. Neither drug is approved. Q2 2026 Form 10-Q · August 13 Corporate presentation furnished September 28, 2026 FDA BLA acceptance and PDUFA announcement · June 15, 2026 HexAgon primary-analysis presentation · September 2026
Research Library · Biotech
Inhibrx: Ozekibart, Ordastobart and the Financing Path
An accepted BLA, randomized oncology data and debt-funded development · November 12, 2026
Next catalyst · Announced scientific presentation
November 19, 2026 · CTOS Ewing sarcoma poster
The Seoul poster session is scheduled for 17:30–18:30 KST, equivalent to November 19 at 03:30–04:30 in New York. It concerns ozekibart with irinotecan and temozolomide. The ChonDRAgon oral session follows on November 20 at 11:00–12:30 KST, equivalent to November 19 at 21:00–22:30 New York. Scientific conference schedule · October 13, 2026
ESMO on October 25, MSTS on October 29 and BCOG on November 5–6 are past events. The next fixed regulatory date is the April 14, 2027 PDUFA goal; approval is not assured. Scientific conference schedule · October 13, 2026 BCOG colorectal abstract · November 5–6, 2026 FDA BLA acceptance and PDUFA announcement · June 15, 2026
INBX stock data: financial position and capital
REFERENCE CLOSE
$90.59
November 11 regular session
COMMON-STOCK VALUE
$1.333B
Calculated using August 7 common shares
LATEST REPORTED CASH
$133.344M
June 30 balance sheet · Q2 accounts
LATER CASH DISCLOSURE
$219.5M
Corporate presentation · August 6
Q2 NET LOSS
$36.650M
Three months ended June 30
OPERATING CASH USED
$67.943M
Six months ended June 30
COMMON SHARES
14.718M
August 7 · excludes 991,849 pre-funded
OZEKIBART PDUFA
April 14, 2027
FDA target date · approval not assured
The July Oxford amendment funded another $100M after the June balance-sheet date. The up-to-$500M facility comprises $275M nominal principal funded across tranches and up to $225M at lenders’ sole discretion; it is not $500M of cash. The August 6 cash figure already follows the July funding. Q2 2026 Form 10-Q · August 13 Corporate presentation furnished September 28, 2026
INBX stock: a PDUFA date with significant safety and financing risks
Ozekibart had one treatment-related hepatic death early in ChonDRAgon before mitigation measures. HexAgon’s safety population recorded grade ≥3 related adverse events in 15/31 combination patients versus 4/34 controls, and treatment discontinuation in 11/31 versus 5/34. ChonDRAgon topline results · October 23, 2025 HexAgon primary-analysis presentation · September 2026
▲ The constructive case
Ozekibart met the randomized ChonDRAgon PFS endpoint and is under FDA review. Ordastobart produced a higher confirmed response rate than pembrolizumab alone in the Phase 2 HexAgon analysis, particularly in the small HPV-positive subgroup. Additional follow-up and expansion cohorts can test durability and reproducibility. FDA BLA acceptance and PDUFA announcement · June 15, 2026 HexAgon-HN primary results · September 8, 2026
▼ The cautious case
BLA acceptance leaves clinical, hepatic-safety, manufacturing and labeling questions for review. The ordastobart subgroup is small and toxicity is material. Inhibrx remains precommercial, with recurring losses, debt covenants, future financing needs and potential dilution. Q2 2026 Form 10-Q · August 13 HexAgon primary-analysis presentation · September 2026
Latest INBX news
Nov 12, 2026
INBX update: CTOS presentations ahead; ozekibart remains under FDA review
As of November 12, Inhibrx's October 13 conference announcement lists a CTOS ozekibart poster on November 19 and a ChonDRAgon oral session on November 20 in Seoul. The oral session is November 19 at 21:00 in New York. FDA accepted the ozekibart BLA in June and set an April 14, 2027 PDUFA date; acceptance is not approval. The latest published financial statements cover June 30, with $133.344M cash and equivalents. The later $219.5M figure in the corporate presentation is dated August 6 and already includes the July debt draw.
INBX stock catalysts: CTOS, ozekibart review and ordastobart expansion
- November 19, 2026 — CTOS Ewing poster, 17:30–18:30 KST / 03:30–04:30 New York. Scientific conference schedule · October 13, 2026 Announced scientific event
- November 20 Seoul / November 19 New York — CTOS ChonDRAgon oral, 11:00–12:30 KST / 21:00–22:30 New York on the preceding date. Scientific conference schedule · October 13, 2026 Announced scientific event
- Q4 2026 — FDA discussion planned on CRC registrational development and potential accelerated pathways. Q2 2026 Form 10-Q · August 13 Company timing window
- Q1 2027 — Interim data from additional CRC combination cohorts. Q2 2026 Form 10-Q · August 13 Company forecast
- April 14, 2027 — Ozekibart PDUFA goal for unresectable or metastatic conventional chondrosarcoma. FDA BLA acceptance and PDUFA announcement · June 15, 2026 FDA target action date
- Mid-2027 — Initial ordastobart perioperative NSCLC results. HexAgon-HN primary results · September 8, 2026 Company forecast, no exact day
- H2 2027 — Ordastobart Phase 2 expansion data and Phase 3 initiation in the corporate roadmap. Corporate presentation furnished September 28, 2026 Development targets dependent on progress
CTOS follows earlier topline results; the scheduled ChonDRAgon session concerns subgroup analysis and updated PFS. Registry completion dates are trial-operational estimates, not promised public readout dates. Scientific conference schedule · October 13, 2026 NCT04950075 · trial registry NCT06295731 · trial registry
Ozekibart: ChonDRAgon and additional combination cohorts
In 206 randomized patients, ChonDRAgon reported median PFS of 5.52 versus 2.66 months, stratified HR 0.479 (95% CI 0.33–0.68), P<0.0001. The accepted BLA concerns conventional chondrosarcoma, not CRC or Ewing sarcoma. ChonDRAgon topline results · October 23, 2025 FDA BLA acceptance and PDUFA announcement · June 15, 2026
The BCOG abstract used an April 10 cutoff: 50 treated CRC patients, 45 evaluable, 20% ORR and 86.7% disease control. It also reported two patients with ozekibart-related grade ≥3 hepatic adverse events. These uncontrolled combination results do not isolate the drug’s contribution. BCOG colorectal abstract · November 5–6, 2026
Ordastobart and HexAgon-HN: response versus tolerability
At the August 19 cutoff, 63 efficacy-evaluable patients had cORR of 48.3% (29 combination patients) versus 26.5% (34 controls). HPV-positive subgroup results were 80.0% in ten versus 33.3% in nine; those small denominators limit precision. HexAgon-HN primary results · September 8, 2026
The safety denominators were 31 and 34. Grade ≥3 related adverse events affected 48.4% versus 11.8%, and discontinuation 35.5% versus 14.7%. The planned expansion adds approximately 50 HPV-positive OPSCC patients with CPS ≥1, broader than the original CPS ≥20 criterion. Accelerated approval remains a development ambition. HexAgon-HN primary results · September 8, 2026 HexAgon primary-analysis presentation · September 2026
Merlintrader Health Score · INBX
3.10out of 5
Weighted calculation: 2.5 × 30% + 4.0 × 30% + 2.5 × 20% + 3.0 × 10% + 3.5 × 10% = 3.10 out of 5. Editorial assessment dated November 12, 2026. Weights: financial position 30%, catalysts 30%, dilution 20%, trading liquidity 10%, execution 10%. Not an investment recommendation or probability of approval.
INBX red flags
- No approved commercial product; the April 2027 FDA date is a target, not an approval. FDA BLA acceptance and PDUFA announcement · June 15, 2026
- Hepatic risk includes an early treatment-related death in ChonDRAgon and two grade ≥3 related hepatic events in the CRC abstract. ChonDRAgon topline results · October 23, 2025 BCOG colorectal abstract · November 5–6, 2026
- HexAgon treatment-related severe toxicity and discontinuation were higher in the combination arm. HexAgon primary-analysis presentation · September 2026
- The $225M undrawn Oxford component requires lenders’ discretion; debt is not unrestricted equity funding. Q2 2026 Form 10-Q · August 13
- Latest published accounts are Q2; June and August cash disclosures have different dates. Q2 2026 Form 10-Q · August 13 Corporate presentation furnished September 28, 2026
- Pre-funded warrants, options, lender warrants and future capital needs expand dilution exposure. Q2 2026 Form 10-Q · August 13
INBX Stock FAQ: Inhibrx Questions Answered
What is the next INBX stock catalyst for Inhibrx?
As of November 12, 2026, the next announced scientific event is the November 19 CTOS Ewing sarcoma poster, at 17:30–18:30 KST / 03:30–04:30 New York. The ChonDRAgon oral session is November 20 in Seoul, equivalent to November 19 at 21:00–22:30 New York. Scientific conference schedule · October 13, 2026
Is Inhibrx ozekibart FDA-approved, and what is the INBX PDUFA date?
As of November 12, 2026, ozekibart is not FDA-approved; its BLA was accepted for filing with an April 14, 2027 PDUFA goal. The application concerns unresectable or metastatic conventional chondrosarcoma. Acceptance starts substantive review and does not guarantee approval. FDA BLA acceptance and PDUFA announcement · June 15, 2026
How much cash does Inhibrx have for INBX development?
At June 30, 2026, Inhibrx reported $133.344M cash and equivalents. A later corporate presentation reported $219.5M on August 6 after July debt funding. The up-to-$500M Oxford facility is not cash on hand: $225M remains subject to lenders’ sole discretion. Q2 2026 Form 10-Q · August 13 Corporate presentation furnished September 28, 2026
What are the main INBX share dilution risks at Inhibrx?
At June 30, 2026, Inhibrx had 991,849 pre-funded warrants, approximately 3.437M options and 162,259 Oxford warrants, besides common stock. July added 21,457 lender warrants. The 14,717,660 August 7 common-share count excludes those securities; future capital raising can create further dilution. Q2 2026 Form 10-Q · August 13
What are the latest Inhibrx earnings for INBX stock?
As of November 12, 2026, Inhibrx had not announced Q3 2026 results. Its latest published quarter was Q2, released August 13: no revenue, a $36.650M net loss and $133.344M June cash. Operating cash use was $67.943M for the first six months. Q2 2026 Form 10-Q · August 13 Q2 financial results · August 13, 2026 Company news releases
What does Inhibrx Biosciences do, and how is INBX linked to Sanofi?
As of November 12, 2026, Inhibrx Biosciences develops engineered multivalent oncology antibodies, principally ozekibart and ordastobart. The standalone company was separated in May 2024; the INBRX-101 business went to the Sanofi-controlled former parent. The current listed company has SEC CIK 2007919. 2025 Form 10-K · March 19, 2026
What did Inhibrx report for INBX ordastobart in HexAgon-HN?
On September 8, 2026, Inhibrx reported cORR of 48.3% versus 26.5% among 29 and 34 evaluable patients. The HPV-positive subgroup had only ten and nine patients. In the separate safety population, grade ≥3 related events occurred in 15/31 combination patients versus 4/34 controls. HexAgon-HN primary results · September 8, 2026 HexAgon primary-analysis presentation · September 2026
What is the main clinical safety risk for INBX ozekibart?
As of November 12, 2026, hepatic toxicity remains a central ozekibart risk. ChonDRAgon had one early treatment-related hepatic death before mitigation measures. The November BCOG abstract, using an April cutoff, also reported two patients with ozekibart-related grade ≥3 hepatic events in the CRC cohort. ChonDRAgon topline results · October 23, 2025 BCOG colorectal abstract · November 5–6, 2026
Primary sources
- Q2 2026 Form 10-Q · August 13
- FDA BLA acceptance and PDUFA announcement · June 15, 2026
- HexAgon-HN primary results · September 8, 2026
- HexAgon primary-analysis presentation · September 2026
- BCOG colorectal abstract · November 5–6, 2026
- Scientific conference schedule · October 13, 2026
- Oxford financing amendment · July 16, 2026
- NCT04950075 · trial registry
- NCT06295731 · trial registry
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