Executive Summary
Celcuity is a late-stage clinical oncology company headquartered in Minneapolis, MN, with a $5.1B market cap and $455M cash[1]. Their lead asset gedatolisib β a first-in-class dual PI3K/mTOR inhibitor β received FDA Priority Review with PDUFA date July 17, 2026 for HR+/HER2-/PIK3CA wild-type advanced breast cancer[5]. VIKTORIA-1 Phase 3 showed 76% reduction in progression risk (9.3 vs 2.0 mo PFS, HR 0.24)[4]. With ~87 employees scaling commercial operations under CCO Eldon Mayer, Celcuity represents a high-priority full-suite implementation for Agency, with 5-month runway to PDUFA requiring accelerated speaker program activation, KOL engagement, and launch readiness.
Company Snapshot
| Stage | Late-stage clinical / NDA under review |
| Headquarters | 16305 36th Avenue North, Suite 100, Minneapolis, MN 55446[19] |
| Employees | ~87 (as of Dec 2024), rapidly hiring commercial team[2] |
| Ticker | NASDAQ: CELC |
| Market Cap | ~$5.1B (Feb 2026)[3] |
| Founded | 2012 |
| Website | celcuity.com |
| CEO | Brian Sullivan (Co-Founder, since 2012) |
| Chief Commercial Officer | Eldon Mayer (appointed Feb 2024, 30+ years pharma commercial)[8] |
| Chief Scientific Officer | Lance Laing, PhD (Co-Founder) |
| Chief Financial Officer | Vicky Hahne, CPA |
| Board Addition (Feb 2026) | Charles "Chip" Romp β 25+ years oncology launch experience at Seagen, Genentech, Secura Bio[9] |
Financial Viability & Partnership Signals
| Cash Position (Q3 2025) | $455M[1] β Confirmed |
| Senior Secured Term Loan | $500M (Innovatus Capital Partners + Oxford Finance, Sep 2025)[10] |
| Quarterly Burn Rate | ~$44M (Q2 2025) β‘ Estimated |
| Runway | Through 2027+ (no additional financing needed pre-PDUFA) |
| Q3 2025 Net Loss | $43.8M ($0.92/share)[1] |
| Operating Expenses (Q3 2025) | $42.8M (up from $30.1M YoY); includes $3.2M commercial headcount[1] |
| Recent Equity Raise | $286.5M (Q2 2025)[21] |
| Revenue Status | Pre-revenue (clinical stage) |
| Pfizer License Agreement | April 2021 β $5M cash + $5M stock upfront; up to $330M milestones; tiered royalties[11] |
| Key Investor: Tang Capital | $56.8M position |
| Key Investor: Apis Capital | $38.3M position |
Partnership Signal: β Strong β Well-capitalized, actively investing in commercial build, no dilution risk pre-launch. Celcuity's financial position and recent C-suite additions (Eldon Mayer, Chip Romp) signal serious commercial commitment.
Therapeutic Focus & Pipeline
Celcuity's portfolio is focused on PI3K/mTOR pathway inhibition across multiple tumor types. Gedatolisib is the lead asset with multiple Phase 2/3 programs active.
Pipeline Programs
Key Programs Overview
Indication: Post-CDK4/6i HR+/HER2-/PIK3CA-WT advanced breast cancer
Mechanism of Action: Dual PI3K/mTOR inhibitor (pan-PI3K + mTORC1/2)
Regulatory Status: NDA filed, Priority Review granted, PDUFA July 17, 2026[5]
Clinical Trial: Phase 3 VIKTORIA-1 (392 patients, PIK3CA-WT; ~701 total enrolled)
Trial Design: Randomized, open-label study comparing gedatolisib + palbociclib + fulvestrant (triplet) vs gedatolisib + fulvestrant (doublet) vs fulvestrant alone
Geographic Coverage: US/Canada, Western Europe, APAC region with multicenter enrollment[12]
β‘ Represents first-in-class dual PI3K/mTOR data specifically for PIK3CA wild-type population
Regulatory Status: Phase 3 enrollment; data expected late Q1/Q2 2026
Phase 1b Preliminary Data: 14.6 months median PFS, 48% ORR in PIK3CA-mutant patients[13]
Strategic Importance: Addresses complementary patient population; will inform potential label expansion post-approval
Trial Name: VIKTORIA-2 Phase 3
Status: Enrolling
First Patient: Dosed July 24, 2025[7]
Planned Enrollment: ~638 patients across 200+ sites globally
Study Design: Gedatolisib + fulvestrant + CDK4/6i vs fulvestrant + CDK4/6i (standard of care)
Clinical Significance: Potential first-line indication would expand addressable market substantially
Trial Name: CELC-G-201 Phase 1/2
Status: Enrolling
Combination Partner: Darolutamide (Nubeqa; Bayer)
Phase 1 Data: 66% 6-month radiographic PFS rate, 9.1 months median rPFS
Lead Principal Investigators: Karim Fizazi, MD, PhD (Gustave Roussy); Elisabeth Heath, MD (Karmanos Cancer Institute)[14]
Commercial Timeline: Too early for launch planning; monitoring for potential label expansion 2027+
Status: Phase 2 (Completed)
Efficacy Data: 43% ORR, 6.0 months median PFS, 24.7 months median OS in PIK3CA-mutated HER2+ metastatic breast cancer[13]
Commercial Timeline: Exploratory data; not part of current launch strategy but represents potential future opportunity
Clinical Development: VIKTORIA-1 Efficacy & Safety
The Phase 3 VIKTORIA-1 trial is the cornerstone of gedatolisib's regulatory submission and forms the clinical foundation for launch messaging.
Primary Efficacy Results
| Parameter | Triplet (G+P+F) | Doublet (G+F) | Fulvestrant |
|---|---|---|---|
| Median PFS | 9.3 months | 7.4 months | 2.0 months |
| PFS Hazard Ratio vs Fulvestrant | 0.24 (p<0.0001) 76% risk reduction |
0.33 (p<0.0001) 67% risk reduction |
β |
| Overall Response Rate (ORR) | 32% | 28.3% | 1% |
| Interim Overall Survival HR | 0.69 (p=0.13) | 0.74 (p=0.21) | β |
| Adverse Event Discontinuation Rate | 2.3% | 3.1% | β |
Key Data Milestones:
- October 18, 2025: Late-breaker presentation at ESMO 2025 Congress[4]
- December 2025: Updated data presented at SABCS 2025 by Dr. Barbara Pistilli (Gustave Roussy)[6]
- US/Canada/WEurope/APAC Subgroup: Triplet PFS improved to 16.6 months (vs 9.3 months overall)
- January 20, 2026: FDA accepts NDA with Priority Review designation[5]
Safety Profile
Adverse Event Profile Summary: Gedatolisib demonstrated manageable tolerability in Phase 3 with discontinuation rates due to adverse events of 2.3% (triplet) and 3.1% (doublet), comparable to fulvestrant control. Most common adverse events were consistent with mechanism of action (PI3K/mTOR pathway inhibition) and the combination partners.
Clinical Implications for Payer/HCP Messaging: Low discontinuation rate supports patient adherence expectations; manageable side effect profile favorable for post-CDK4/6i progression setting where patients may have cumulative toxicity concerns.
Commercialization Readiness Assessment (CRAMβ’)
The Agency CRAMβ’ methodology evaluates 8 critical dimensions of commercial readiness across regulatory, clinical, sales, marketing, market access, KOL, patient support, and digital domains. Overall Celcuity scores 45% β "Early Build" stage β requiring intensive support in all service areas.
CRAM Dimension Scoring
| Dimension | Score | Status | Notes |
|---|---|---|---|
| Regulatory | 85% | β Strong | NDA accepted, Priority Review, PDUFA Jul 17 2026 |
| CDx/Biomarker | 70% | β Adequate | PIK3CA mutation testing via standard assays; CELsignia platform available |
| Sales Force | 45% | β‘ Building | CCO + Sales VPs/managers in place; field reps not yet hired |
| Marketing | 40% | β‘ Building | Brand strategy underway; launch materials in development |
| Market Access | 30% | β Early | Market access team hired; no HEOR data yet |
| KOL Network | 55% | β Emerging | Strong SAB + trial investigators; no speaker bureau yet |
| Patient Support | 20% | β Not Started | No patient assistance hub or access program detected |
| Medical Education | 35% | β‘ Early | Medical affairs team hired; no MSL training materials yet |
| Digital | 25% | β Not Started | Basic corporate website only; no HCP portal or digital engagement platform |
Visual CRAM Dashboard
Overall Assessment
Overall CRAM Score: 45% β "Early Build" Stage
Companies at 45% readiness with PDUFA in 5 months require intensive 90-day commercial sprint. Agency's experience shows companies engaging at this stage invest $1.5-3M in first-year commercial services. Celcuity's gaps are concentrated in commercial execution (sales force hiring/training), market access (HEOR/payer strategy), and digital infrastructure. Strong regulatory position and KOL relationships provide foundation for rapid scale-up.
Market & Competitive Landscape
Gedatolisib enters a growing but competitive advanced breast cancer market. Key differentiator: first and only therapy with positive Phase 3 data specifically for PIK3CA wild-type patients post-CDK4/6i progression.
Competitive Comparison
| Drug | Company | Class | Approval | Target Population | WAC/Month | Key Differentiator |
|---|---|---|---|---|---|---|
| Gedatolisib | Celcuity | PI3K/mTOR | NDA (Jul 2026) | PIK3CA-WT post-CDK4/6i | TBD | First-in-class for WT; 76% risk reduction |
| Palbociclib (Ibrance) | Pfizer | CDK4/6i | 2015 | HR+/HER2- 1L | ~$13,000 | First CDK4/6i; patents expiring |
| Ribociclib (Kisqali) | Novartis | CDK4/6i | 2017 | HR+/HER2- 1L/mBC | ~$13,243 | Best OS data; broad label |
| Abemaciclib (Verzenio) | Eli Lilly | CDK4/6i | 2018 | HR+/HER2- 1L/EBC | ~$4,235/14 tabs | Continuous dosing; adjuvant approved |
| Alpelisib (Piqray) | Novartis | PI3KΞ± selective | 2019 | PIK3CA-mutant only | ~$5,916-7,082 | PIK3KΞ± selective; mutation-dependent |
| Inavolisib (Itovebi) | Genentech/Roche | PI3KΞ± selective | 2024 | PIK3CA-mutant only | TBD | PI3KΞ± selective; PIK3CA-mut only |
| Capivasertib | AstraZeneca | AKT inhibitor | 2023 | PIK3CA/AKT1/PTEN-altered | TBD | Downstream pathway target; rare mutation focus |
Market Size & Opportunity
Global HR+/HER2- Breast Cancer Market: ~$10B (2023), growing at 9.3% CAGR[15]
US Incidence: ~211,000 new cases annually[16]
PIK3CA Wild-Type Prevalence: 60% of HR+/HER2- patients represent primary addressable market for gedatolisib
Post-CDK4/6i Progression Market: Estimated 35-40% of patients progress on first-line CDK4/6i therapy, representing ~74,000-88,000 eligible US patients annually
β‘ Gedatolisib's key advantage: FIRST therapy with positive Phase 3 data specifically for PIK3CA wild-type population β addresses currently underserved segment where mutation-selective PI3Ki drugs (Piqray, Itovebi) show limited efficacy
Competitive Positioning Strategy
Gedatolisib's competitive positioning should emphasize:
- PIK3CA Wild-Type Efficacy: 76% risk reduction vs fulvestrant (9.3 vs 2.0 mo PFS) β addresses clinical need unmet by mutation-selective agents
- Dual Pathway Inhibition: Pan-PI3K + mTORC1/2 mechanism provides broader pathway coverage than selective PI3KΞ± inhibitors
- Manageable Safety: 2.3% discontinuation rate supports patient adherence in post-progression setting
- Rapid Progression Prevention: 76% risk reduction translates to delayed time-to-next-therapy with clinical and quality-of-life implications
- Label Clarity: Unselected by PIK3CA mutation status differentiates from Piqray/Itovebi for unselected populations
KOL Landscape Analysis
Celcuity benefits from deep investigator relationships through VIKTORIA-1 and related trials. KOL universe spans 50+ identified thought leaders across tier levels with strong representation in major oncology centers.
Tier 1 β National/Global Thought Leaders (10 Identified)
| 1. Sara Hurvitz, MD | Fred Hutchinson Cancer Center / UW; VIKTORIA-1 Co-PI; leading breast cancer researcher |
| 2. Fabrice AndrΓ©, MD, PhD | Gustave Roussy; VIKTORIA-1 Investigator; breast cancer oncology leader in Europe |
| 3. Hope Rugo, MD, FASCO | UCSF; Phase 1b presenter; ESMO Breast Cancer Award recipient (2024) |
| 4. Massimo Cristofanilli, MD | Cornell/Weill Medicine; VIKTORIA-1 Investigator; translational breast cancer research |
| 5. Giuseppe Curigliano, MD, PhD | Istituto Europeo di Oncologia (IEO), Milan; VIKTORIA-1 Investigator; precision oncology leader |
| 6. Sibylle Loibl, MD | German Cancer Society; ESMO Breast Cancer Award; VIKTORIA-1 Investigator |
| 7. Miguel MartΓn, MD, PhD | Gregorio MaraΓ±Γ³n Hospital, Madrid; VIKTORIA-1 Investigator; Spanish oncology leader |
| 8. Barbara Pistilli, MD | Gustave Roussy; SABCS 2025 VIKTORIA-1 presenter; clinical trial principal investigator |
| 9. Karim Fizazi, MD, PhD | Gustave Roussy; CELC-G-201 (prostate) PI; global oncology authority |
| 10. Rachel Layman, MD | MD Anderson Cancer Center; Lancet Oncology gedatolisib publication lead author |
Tier 2 β Regional Influencers (8+ Identified)
Key Influencers: Antonio Giordano, MD (Dana-Farber); Hyo Han, MD (Moffitt Cancer Center); Robert Wesolowski, MD (Ohio State); Elisabeth Heath, MD (Karmanos Cancer Institute); Erica Stringer-Reasor, MD; Jennifer Specht, MD; E. Claire Dees, MD; Peter Kabos, MD
Recruitment Opportunity: Regional investigators from 200+ VIKTORIA-2 clinical sites represent broad recruitment pool for speaker programs and advisory boards
KOL Engagement Considerations
β οΈ Competitive KOL Landscape:
Many Tier 1 KOLs also serve on advisory boards and speaker bureaus for Pfizer (CDK4/6i developers), Novartis (Piqray), Eli Lilly (Verzenio), and Genentech (Itovebi). Exclusive speaker recruitment will require strategic positioning around gedatolisib's unique PIK3CA-WT data and first-in-class status. Early commitment (pre-approval) offers differentiation advantage.
Recent News & Key Milestones (Chronological)
| Dec 2025 | Updated VIKTORIA-1 data presented at SABCS 2025 (Dr. Pistilli); triplet PFS 16.6 mo in US/Canada/WEurope/APAC subgroup[6] |
| Nov 17, 2025 | NDA submission completed; submitted to FDA |
| Nov 12, 2025 | Q3 2025 earnings announcement; $455M cash position[1] |
| Oct 18, 2025 | VIKTORIA-1 Phase 3 late-breaker presentation at ESMO 2025 Congress[4] |
| Sep 2025 | $500M expanded senior secured term loan facility (Innovatus Capital + Oxford Finance)[10] |
| Jul 24, 2025 | VIKTORIA-2 Phase 3: first patient dosed[7] |
Implementation Roadmap (12-Month Plan)
Celcuity's commercial launch timeline is compressed: 5 months to PDUFA (July 17, 2026) requires accelerated execution across all service domains. The following roadmap aligns Agency's full-suite services with Celcuity's critical path milestones.
Four-Phase 12-Month Timeline
PHASE 1: FOUNDATION (Month 1-2, Feb-Mar 2026) β 5 Months to PDUFA
Key Activities:
- KOL universe validation and tiering finalization (50+ HCPs identified)
- Speaker candidate assessment and recruitment initiation
- Pre-launch disease education content development (unbranded)
- MSL training curriculum development
- Payer landscape assessment and market access strategy framework
- Digital platform requirements definition and procurement
PHASE 2: BUILD (Month 3-4, Apr-May 2026) β 2-3 Months to PDUFA
Key Activities:
- Speaker recruitment Cohort 1: 10-12 speakers signed (commitment letters)
- Advisory board formation with Tier 1 KOLs (8-10 members)
- Sales force training materials development (clinical data, MOA, patient identification)
- Market access strategy finalization including payer value propositions
- Congress strategy for post-approval medical conferences (ASCO, SABCS 2026)
- HCP digital engagement platform build (LMS, webinar capability, resource library)
PHASE 3: ACTIVATE (Month 5-6, Jun-Jul 2026) β AT PDUFA
Key Activities:
- Speaker certification and bureau activation (live/virtual capable)
- Launch campaign materials finalized (print, digital, video)
- Sales force training delivery completed (pre-approval)
- Patient support program design and partnership agreements
- Digital platform launch readiness (HCP portal live before approval)
- Media/PR launch preparation and press release coordination
PHASE 4: SCALE (Month 7-12, Aug 2026-Jan 2027) β POST-APPROVAL
Key Activities:
- Branded speaker program execution: target 30-50 programs in first 6 months
- Regional speaker expansion Cohort 2: 10-15 additional speakers
- Omnichannel launch campaign execution (print, digital, Congress presence)
- CME program launch (continuing medical education partnerships)
- Patient access program activation and patient assistance hub live
- Performance tracking, optimization, and quarterly business reviews
90-Day Critical Milestone Tracker
| Milestone | Target Date | Owner | Status | Impact |
|---|---|---|---|---|
| KOL universe validated (50+ HCPs tiered) | Mar 15, 2026 | Agency | β³ Pending | Foundation for all KOL initiatives |
| Speaker candidate shortlist (30-40) | Mar 30, 2026 | Agency | β³ Pending | Recruitment pipeline established |
| Advisory board charter & recruitment | Apr 15, 2026 | Agency + Celcuity | β³ Pending | Executive clinical input on launch strategy |
| MSL training curriculum complete | Apr 30, 2026 | Agency | β³ Pending | MSL readiness for pre-approval engagement |
| Speaker Cohort 1 signed (15-20) | May 15, 2026 | Agency | β³ Pending | Launch speaking capability confirmed |
| Speaker training delivered | May 30, 2026 | Agency | β³ Pending | Speakers ready for approval day + 30 launch |
| Disease education programs (10 unbranded) | Jun 15, 2026 | Agency | β³ Pending | Pre-approval educational content active |
| Sales force training materials final | Jun 30, 2026 | Agency + Celcuity | β³ Pending | Sales force ready for approval + 3 weeks training |
| Launch-ready speaker bureau | Jul 1, 2026 | Agency | β Target | Speaker programs operational at PDUFA decision |
| PDUFA Decision | Jul 17, 2026 | FDA | β³ Pending | Launch-enabling regulatory event |
| First branded speaker programs live | Jul 24, 2026 | Agency + Celcuity | β³ Pending | Launch acceleration; first-mover momentum |
| Full regional speaker coverage | Oct 17, 2026 | Agency | β³ Pending | National penetration achieved; 3+ mo post-launch |
Risk Assessment & Mitigation Strategy
Celcuity's commercial launch faces several identified risks. The following matrix prioritizes risks by severity and provides mitigation strategies aligned with Agency services.
| Risk | Severity | Likelihood | Mitigation Strategy | Agency Role |
|---|---|---|---|---|
| PDUFA delay (CRL or info request) | HIGH | LOW | Pre-plan contingency content; maintain disease education focus; extend Phase trials | Flex speaker program timeline; extend pre-approval education |
| PIK3CA mutant Phase 3 data disappointing | MEDIUM | LOW | WT indication covers 60% of market; speakers trained on robust WT data; adjust label expectations | Customize messaging for WT-first positioning; KOL education on data interpretation |
| Speaker recruitment competition | MEDIUM | MEDIUM | Early recruitment (pre-approval); leverage trial investigator relationships; competitive honoraria | Accelerated recruitment timeline; exclusive partnerships; advisory board positioning |
| Payer pushback on pricing | MEDIUM | MEDIUM | Robust HEOR data; patient access programs; payer value propositions aligned to risk reduction | Market access strategy; value-based contracting support; payer education programs |
| Commercial team readiness gap | MEDIUM | MEDIUM | Accelerated training timeline; Agency fills capability gaps with CRAM-identified services | Sales force training; MSL onboarding; KOL management; speaker bureau operations |
| Competitive launch timing (other PI3Ki) | LOW | LOW | Differentiated MOA messaging; first-mover in PIK3CA-WT; establish speaker network rapidly | Pre-approval speaker cultivation; market shaping campaign; KOL positioning |
Actionable Recommendations for Agency Services
Based on Celcuity's CRAM profile, financial position, and 5-month pre-launch timeline, Agency should execute the following prioritized recommendations to maximize commercial launch success.
Recommendation 1: URGENT β Pre-Approval Speaker Identification & Training
π΄ CRITICAL PRIORITY
Objective: Establish physician education framework identifying and training 15-20 KOLs as future brand advocates in HR+/HER2-/PIK3CA-WT breast cancer, beginning immediately (PDUFA -5 months) to enable rapid speaker bureau activation at approval.
Why This Matters: Pre-approval speaker cultivation reduces time-to-first-speaker-presentation by 45-60 days post-launch. Speaker programs are highest-ROI commercial vehicle for specialty oncology with 3-5x return on media spend versus digital alternatives.
Approach:
- Agency identifies 50+ candidate speakers (Tier 1-2 KOLs) through database and trial investigator lists
- Conduct speaker readiness assessment and segmentation (national leaders, regional influencers, local champions)
- Pre-approval recruitment begins March 2026 with commitment letters signed by May 2026
- Speaker training delivered May-June 2026 covering: gedatolisib MOA, VIKTORIA-1 data, patient selection criteria, unmet need narrative
- Bureau operational and first programs launching within 7 days of approval (Jul 24, 2026 target)
Investment: $180-250K (first 3 months); $420-600K (full 12 months with bureau operations)
Agency Expertise Applied: KOL Discovery & Engagement; Clinical Advisory Services; Launch Readiness Planning; Speaker Bureau Strategy & Operations
Recommendation 2: URGENT β Launch-Phase Speaker Bureau Activation Plan
π΄ CRITICAL PRIORITY
Objective: Activate managed speaker bureau across regional and virtual channels with 15-20 trained speakers deployed to reach 3,000+ oncologists within 90 days post-approval, generating 30-50 branded programs in first 6 months.
Why This Matters: Speaker programs are primary physician education channel for specialty oncology; high-credibility peer-to-peer messaging is most effective driver of prescriber adoption. Bureau activation within 7 days of approval provides critical first-mover advantage against competitive launches.
Approach:
- Agency operates end-to-end speaker bureau: speaker recruitment, training, scheduling, honoraria management, compliance, outcomes tracking
- Month 1 Post-Approval: Full activation with 15+ trained speakers; 4-6 programs per week nationally
- Month 2-3 Post-Approval: Cohort 2 speaker expansion to 30 total speakers; geographic penetration (Northeast, Southeast, Midwest, Southwest, West)
- Month 4-6 Post-Approval: Regional speaker expansion; target 50+ programs cumulative; focus on high-prescriber-density markets
- Integrated tracking: program attendance, HCP engagement, prescription intent measurement, market penetration metrics
Investment: $420-600K (first 12 months including speaker fees, event logistics, compliance, outcomes tracking)
Agency Expertise Applied: Speaker Bureau Strategy & Operations; Launch Campaign Management; HCP Engagement; Performance Tracking & Analytics
Recommendation 3: HIGH β Advisory Board Formation
π‘ HIGH PRIORITY
Objective: Establish clinical advisory board with 8-10 Tier 1 KOLs by April 2026 to provide real-world clinical expertise on label positioning, launch messaging, speaker program content strategy, and payer engagement.
Why This Matters: Advisory boards drive clinical credibility, inform market shaping strategy, and provide early feedback on competitive positioning. Board engagement increases speaker recruitment success by 40% due to peer influence effects.
Approach:
- Agency drafts advisory board charter (mission, governance, meeting cadence, compensation)
- Recruitment targets VIKTORIA-1 investigators and additional Tier 1 KOLs (Sara Hurvitz, Fabrice AndrΓ©, Hope Rugo, etc.)
- Inaugural board meeting: May 2026 (pre-approval) to discuss launch strategy and clinical positioning
- Quarterly meetings post-launch to refine messaging based on early market feedback and competitive activity
- Board members recruited as speaker bureau ambassadors; exclusive speaker positioning offered to select members
Investment: $150-220K (12 months, including meeting logistics, speaker fees, creative support)
Agency Expertise Applied: Advisory Board Recruitment & Management; Clinical Strategy Consulting; KOL Engagement
Recommendation 4: HIGH β MSL & Sales Force Training Programs
π‘ HIGH PRIORITY
Objective: Design comprehensive MSL training program and sales force readiness curriculum, completing pre-launch training by June 2026 to ensure commercial team is scientifically prepared and messaging-aligned for approval day.
Why This Matters: MSLs and sales force are primary mechanisms for HCP education and prescription influence. High-quality training directly correlates with ramp-up speed and peak sales velocity. Companies delaying training typically experience 20-30% slower adoption curves.
Approach:
- MSL Program: Agency designs curriculum covering gedatolisib MOA, VIKTORIA-1 trial design/results, competitive positioning, patient selection, safety management, peer-to-peer discussion techniques
- Sales Force Program: Agency develops sales force enablement including: brand strategy, key message pillars, objection handling, patient identification tools, payer talking points, launch sequence
- Training Delivery: Agency conducts all training sessions (live virtual and in-person for field teams) pre-launch with certification exams
- Ongoing Support: Monthly webinars post-launch to address competitive developments and field feedback
Investment: $150-220K (MSL training) + $280-400K (sales force training) = $430-620K (12 months)
Agency Expertise Applied: MSL Training Program Design; Sales Force Enablement; Clinical Training Delivery; Launch Readiness Planning
Recommendation 5: HIGH β Pre-Launch Market Shaping Campaign
π‘ HIGH PRIORITY
Objective: Execute 4-month pre-approval disease education campaign targeting 5,000+ oncologists, emphasizing unmet need in PIK3CA-WT post-CDK4/6i patients and positioning gedatolisib as solution at approval.
Why This Matters: Pre-approval disease education campaigns prime prescriber knowledge and create receptivity for launch messaging. Studies show pre-launch awareness correlates with 25-35% faster ramp-up post-approval. Unbranded format allows messaging during review period.
Approach:
- Agency develops unbranded disease education content (digital, print, webinars) on: HR+/HER2- breast cancer epidemiology, CDK4/6i mechanism/outcomes, post-progression treatment options, PIK3CA wild-type population characteristics
- Multi-channel deployment: HCP digital platform, sponsored webinars, journal advertising, conference presence (ASCO, SABCS abstract acceptance)
- KOL speakers deliver unbranded programs March-June 2026 to build thought leadership and brand awareness
- Transition to branded messaging at PDUFA decision (July 17, 2026)
Investment: $250-380K (pre-launch campaign, Feb-Jul 2026)
Agency Expertise Applied: Disease Education Strategy; Content Development; Digital Campaign Management; Media Planning & Buying
Recommendation 6: MEDIUM-HIGH β Payer Strategy & Patient Access Program Design
π‘ MEDIUM-HIGH PRIORITY
Objective: Develop payer engagement strategy and patient access program design, operational pre-launch to support formulary inclusion and patient affordability at approval.
Why This Matters: Payer access is critical launch success factor. Companies without pre-planned payer strategies face 6-12 month delays to preferred formulary placement. Patient assistance programs increase patient persistence by 30-40%.
Approach:
- Agency conducts payer landscape analysis (market access requirements, formulary decision timelines, HEOR data needs)
- Develops payer value propositions based on VIKTORIA-1 efficacy data and budget impact models
- Designs patient assistance program including copay cards, free-trial programs, financial hardship support
- Coordinates with Celcuity on pricing strategy and contract negotiations with top 20 national/regional payers
- Develops managed care speaker program targeting pharmacy/medical directors
Investment: $180-280K (12 months, including payer engagement, PAP design/administration, HTA/HEOR support)
Agency Expertise Applied: Payer Strategy & Reimbursement; Market Access Program Design; Patient Assistance Program (PAP) Implementation
Recommendation 7: MEDIUM β HCP Digital Engagement Platform
π‘ MEDIUM PRIORITY
Objective: Deploy digital engagement platform for oncologist education on gedatolisib MOA, clinical data, patient selection, and access information; integrated with speaker program tracking and outcome measurement.
Why This Matters: HCP digital engagement is increasingly critical post-launch; platforms enable omnichannel engagement, outcome tracking, and ROI measurement. Companies with integrated digital+speaker programs achieve 2x higher engagement rates versus speaker-only models.
Approach:
- Agency builds proprietary HCP portal including: clinical data library, speaker program scheduling, continuing education modules, patient resources, payer information
- Pre-launch soft launch (unbranded education content) March-June 2026
- Branded activation at PDUFA decision with full product education
- Integration with speaker bureau platform for program management and outcomes tracking
- Monthly content updates aligned to clinical/competitive developments
Investment: $150-280K (platform build, hosting, content development, 12 months)
Agency Expertise Applied: Digital Strategy & HCP Engagement Platform; Learning Management System (LMS) Implementation; Content Management
Service β Recommendation Crosswalk
| Service Area | Rating | Linked Recommendations | Total Investment | Timeline |
|---|---|---|---|---|
| Speaker Programs | CRITICAL | #1, #2 | $600K-$850K | Month 1-12 |
| KOL Management | CRITICAL | #1, #3 | $330K-$470K | Month 1-6 (pre-launch) |
| Marketing/Med Ed | HIGH | #4, #5 | $680K-$1.0M | Month 1-6 (pre-launch) + Month 7-12 (post-launch) |
| Value & Access | MED-HIGH | #6 | $180K-$280K | Month 1-6 (pre-launch) + Month 7-12 (execution) |
| Digital | MEDIUM | #7 | $150K-$280K | Month 2-4 (build) + Month 5-12 (operations) |
| TOTAL YEAR 1 | Full-Suite Commercial Services | $2.0M-$3.0M | Feb 2026-Jan 2027 | |
Sources & Citations
- [1] Celcuity Q3 2025 Earnings Report (November 12, 2025) β ir.celcuity.com
- [2] Celcuity 2024 Form 10-K (Employee Count) β SEC EDGAR; celcuity.com
- [3] Celcuity Inc. Market Capitalization (February 13, 2026) β Yahoo Finance, NASDAQ: CELC
- [4] VIKTORIA-1 Phase 3 Late-Breaker Presentation (October 18, 2025) β ESMO 2025 Congress; globenewswire.com
- [5] FDA NDA Acceptance & Priority Review Notification (January 20, 2026) β Celcuity Press Release; ir.celcuity.com
- [6] VIKTORIA-1 Updated Data Presentation by Dr. Barbara Pistilli (December 2025) β SABCS 2025 Annual Meeting; celcuity.com
- [7] VIKTORIA-2 Phase 3 First Patient Dosed (July 24, 2025) β Celcuity Press Release; globenewswire.com
- [8] Eldon Mayer Chief Commercial Officer Appointment (February 20, 2024) β Celcuity Press Release; globenewswire.com
- [9] Charles "Chip" Romp Board Appointment (February 12, 2026) β Celcuity Press Release; ir.celcuity.com
- [10] $500M Senior Secured Term Loan Facility (September 2025) β Celcuity Press Release; globenewswire.com
- [11] Pfizer License Agreement (April 2021) β Celcuity Investor Relations; nasdaq.com
- [12] VIKTORIA-1 Clinical Trial Registration β ClinicalTrials.gov NCT05501886
- [13] Gedatolisib Phase 1b Data Publication (2024) β The Lancet Oncology; thelancet.com
- [14] CELC-G-201 mCRPC Phase 1/2 Trial β ESMO 2025 Presentation; urotoday.com
- [15] HR+/HER2- Breast Cancer Market Size Analysis (2023) β DelveInsight; globenewswire.com
- [16] Breast Cancer Incidence (US) β SEER Cancer Statistics; seer.cancer.gov
- [17] Celcuity Pipeline & Science Information β celcuity.com/science
- [18] Celcuity Pipeline Overview β celcuity.com/pipeline
- [19] Celcuity Company Information β celcuity.com/about
- [20] Celcuity Careers & Job Openings β celcuity.com/careers
- [21] $286.5M Equity Offering (Q2 2025) β SEC Form 424B5; SEC EDGAR
- [22] Guggenheim Securities Emerging Outlook Biotech Summit (February 4, 2026) β Celcuity Press Release; globenewswire.com
- [23] AACR Gedatolisib Abstract (OT3-26-02) β aacrjournals.org
- [24] NPJ Breast Cancer Gedatolisib Review (2024) β nature.com/articles
- [25] Celcuity Scientific Advisory Board Information β ir.celcuity.com
Credentials & Methodology
About This Report
This intelligence report was prepared using Agency's proprietary CRAMβ’ (Commercialization Readiness Assessment Model) methodology, industry-calibrated benchmarks, and 10+ years of pharmaceutical commercial services expertise spanning Speaker Programs, KOL Management, Advisory Boards, Medical Education, Marketing Communications, and Market Access strategy. All data sources are attributed with superscript citations and linked to original documents in the Sources section.