Company guidance, FDA catalysts, dilution risk and cash runway, built from SEC, FDA and ClinicalTrials.gov filings and updated every day.
$667.8MCash, Jun 2026
+1%Share Count, 1 Year
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💊 Upcoming FDA Decisions
PDUFA Date
Drug
Indication
Type
PoA
2027-04-01
—
NDA
66%
PoA = estimated probability of approval: base rates calibrated against BioRadar's verified FDA outcomes, adjusted for application type, modality, therapy area and cash runway. Not investment advice. See the full PDUFA calendar →
📣 What HRMY Says Is Next
in 2027 · “PITOLISANT GR – NDA ACCEPTED FOR FULL REVIEW PDUFA date anticipated April 1, 2027 PITOLISANT HD – ONGOING PHASE 3 REGISTRATIONAL STUDIES IN NARCOLEPSY AND IH TLD expected in 2027; Anticipated PDUFA in 2028 UTILITY PATENTS FILED FOR BOTH GR AND HD Potential to extend the pitolisant franchise into the 2040s PITOLISANT PHASE 3 STUDY IN PWS: RECRUITMENT ONGOING TLD expected in mid-2027; Anticipated PDUFA in 2028 AMORPHOUS FORM OF PITOLISANT”
Company press release, Aug 4, 2026 · SEC filing
Q4 · “BP-205 MAD DATA IN HEALTHY VOLUNTEERS EXPECTED IN Q4 BP-205 IND OPEN IN US INITIATING PHASE 1B STUDY IN SLEEP-DEPRIVED HEALTHY VOLUNTEERS IN Q3 Data expected early 2027 INITIATING PHASE 2 TRIALS FOR BP-205 IN MULTIPLE CNS INDICATIONS IN MID-2027 Multiple Phase 2 Studies in Mid-2027 Next-Generation Pitolisant Programs 13 Harmony Biosciences | Q2 2026 Financial Results & Business Update | All rights reserved.”
Company press release, Aug 4, 2026 · SEC filing
in 2026 · “Investing in robust Phase 2 development program toward multiple CNS Indications Value Inflection: On Track For >$1B Net Revenue in 2026 & Multiple BP-205 Data Catalysts Ahead GROWING ADVANCING 3 Harmony Biosciences | Q2 2026 Financial Results & Business Update | All rights reserved.”
Company press release, Aug 4, 2026 · SEC filing
Quoted word for word from the company's press releases filed with the SEC. Timing is the company's own guidance, not a BioRadar estimate.
💰 Cash Runway & Dilution Risk
HRMY reported $667.8M in cash and short-term investments (as of Jun 30, 2026) and its operations are currently cash-flow neutral or positive.
Dilution pressure:8 · Low
No operating cash burn in latest filings
FDA decision in 180 days +8
Recent financing filings on SEC EDGAR:
Feb 25, 2025 · Shelf registration with ATM program, up to $200M · S-3ASR
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Data: SEC EDGAR, FDA, ClinicalTrials.gov, Yahoo Finance • Informational purposes only, not investment advice. • All tracked stocks A–Z
This data is for informational purposes only, not investment advice. BioRadar does not provide buy/sell recommendations. Past performance does not guarantee future results. Always do your own due diligence.