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Pipeline (17 active programs)

Technology platforms

Discontinued (2)

• cannabidiol — Fragile X Syndrome · Phase 3 RECONNECT study did not meet the primary endpoint; ZYN002 program in FXS is being phased out
• cannabidiol — 22q Deletion Syndrome · No longer pursuing an indication for 22q deletion syndrome

Capital (as filed)

Cash

$647M cash and cash equivalents · Sep 30, 2026 (10-Q)

Short-term investments

$124M Sep 30, 2026

Long-term investments

$280M Sep 30, 2026

Operating cash flow

$76.7M quarter Jun 30, 2026 → Sep 30, 2026, year-to-date difference (10-Q)

As stated in coverage

$1.05B cash per the update of Nov 4, 2026 — the company's own words as read there, not the filed figure

Cash, investments and operating cash flow are the company's own XBRL facts as filed with the SEC, each shown with its period end and tag. As-stated figures come from the company's own words as read in Biotech Distilled coverage, dated, and routinely count securities and planned financing that a balance sheet does not. Offering rows are the SEC cover pages as filed. Not investment advice. Figures as of Nov 7, 2026.

Biotech Distilled coverage (3)

• 2026-11-05 UPDATE: Harmony Biosciences (HRMY) - Clean Drug, Leakier Margins, Later Verdict 🔒 Paid
• 2026-10-12 UPDATE: Harmony Biosciences (HRMY) - The Hand-Off Before the Hearing 🔒 Paid
• 2026-09-11 Harmony Biosciences (HRMY) — Scientific Deep Dive for WAKIX, the Next-Generation Pitolisant Franchise, BP-205 and Pipeline Products 🔒 Paid

Articles open on Substack. Some are subscriber-only; those marked ★ Distilled Pro are for Distilled Pro members.

Verdict history (3 calls)

Every verdict Biotech Distilled has published on Harmony Biosciences, oldest first — the full history, never a selection. How calls are scored: the track record.

1. 2026-09-11 Watch Harmony Biosciences (HRMY) — Scientific Deep Dive for WAKIX, the Next-Generation Pitolisant Franchise, BP-205 and Pipeline Products A genuinely cheap and profitable business wrapped around a legal binary that the market has stopped pricing — with oral argument on October 22 that could compress the terminal value of 100% of current revenue, the stock at near-52-week highs is not the right entry point.
2. 2026-10-12 Watch UPDATE: Harmony Biosciences (HRMY) - The Hand-Off Before the Hearing CEO change adds uncertainty without resolving anything; a favorable ruling on the '197 patent remains the only catalyst that would justify a re-rating, and that ruling has not happened.
3. 2026-11-05 Watch UPDATE: Harmony Biosciences (HRMY) - Clean Drug, Leakier Margins, Later Verdict BP-205 MAD data passed safety checks but showed no efficacy signal, the Delaware ruling is now pushed to February 2027, growth slowed to 12%, and royalties are taking a larger share of revenue — the binary remains unresolved.

Every verdict Biotech Distilled has published on this company, in order, with the post it came from — the full history, never a selection. Position figures are the same ones shown on /track-record, computed by the same method. Editorial opinion, not investment advice.

Timing, in the company's words (9 quotes from 4 filings)

Sentences quoted verbatim from the company's SEC filings, newest filing first. Each sits under the filing it appeared in; the "matched to" tag names the calendar row it was read for.

• 2026-11-04 10-Q in filings ↓

  • “In November 2026, we announced topline data from the Phase 1 MAD study, which reinforced the favorable safety, tolerability and PK profile observed in the SAD portion of the study, with no liver or visual adverse events reported and no clinically significant cardiovascular events or electrocardiogram abnormalities recorded.”

    matched to BP-205 · interim data · read as November 2026

  • “In June 2026, a New Drug Application (“NDA”) for Pitolisant GR was submitted to the FDA, which was subsequently accepted for full review with a target Prescription Drug User Fee Act date of April 1, 2027. ​ Along with nurturing the growth of our original pipeline, our innovation strategy includes targeted business development that strengthens our foundation and strategically extends our patient reach as we look to expand our portfolio to new diseases beyond histaminergic science.”

    matched to Pitolisant GR · regulatory decision · read as April 1, 2027
• 2026-11-04 8-K in filings ↓

  • “Preliminary injunction hearing scheduled for January 26, 2027; ruling expected by February 14, ahead of the 30-month stay $0.87 $0.81 Q3 2025 Q3 2026 $2.32 $2.63 9M 2025 9M 2026 Financial Summary Q3 2026 18”

    matched to '920 patent case · interim data · read as January 26, 2027

  • “PITOLISANT GR – NDA UNDER FDA REVIEW; ON TRACK TO LAUNCH IN 1H 2027 PDUFA date 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 (TEMPO): ON TRACK FOR PEDIATRIC EXCLUSIVITY TLD expected in mid-2027; Anticipated PDUFA in 2028 AMORPHOUS FORM OF PITOLISANT”

    matched to Pitolisant GR · regulatory decision · read as April 1, 2027
• 2026-08-04 10-Q in filings ↓

  • “In August 2026, we announced Phase 1 clinical PK data from the SAD study for BP-205, which demonstrated favorable PK, safety, and tolerability profiles.”

    matched to BP-205 · interim data · read as August 2026 / matched to BP-205 · trial initiation · read as August 2026

  • “We anticipate topline data from the TEMPO study in mid-2027. ​ Pitolisant gastro-resistant (“Pitolisant GR”) and Pitolisant high dose (“Pitolisant HD”) ​ We are developing two new formulations of pitolisant through a license agreement with Bioprojet: Pitolisant GR and Pitolisant HD.”

    matched to Pitolisant (TEMPO, PWS) · regulatory decision · read as mid-2027

  • “In June 2026, we submitted a New Drug Application (“NDA”) for Pitolisant GR to the FDA, which was subsequently accepted for full review with a target Prescription Drug User Fee Act (“PDUFA”) date of April 1, 2027.”

    matched to Pitolisant GR · regulatory decision · read as April 1, 2027

  • “Oral arguments are scheduled for October 22, 2026.”

    matched to WAKIX (litigation) · other · read as October 22, 2026
• 2026-08-04 8-K in filings ↓

  • “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”

    matched to Pitolisant GR · regulatory decision · read as April 1, 2027

Timing sentences quoted from the company's own SEC filings, each under the filing it appeared in. The 'matched to' tag is the calendar row the sentence was read for; the filing is the source. Not investment advice.

Filings & releases (19)

SEC filings from EDGAR and press releases captured from the company's investor-relations site, newest first. Releases captured from Sep 21, 2026; filings from March 2026. Summaries come from the BD update that read the document; "BD extracted" counts point at the pipeline table above. All companies →

• Nov 4, 2026ReleaseHarmony Biosciences Reports Q3 Financial Results on Track to Achieve More Than $1 Billion WAKIX Net Revenue and Announces Strong Multiple-Ascending Dose Data for Its Orexin Agonist BP-205, Supporting→ BD updateSummary on the 8-K
• Nov 4, 20268-KCurrent report: results of operations, Reg FD disclosure · EX-99.1→ BD updateHarmony's Q3 earnings and BP-205 MAD data land on the same day — the first repeated-dose safety look at its orexin agonist clears the critical liver/cardiac bar, while WAKIX hits $269M (+12%) and a new legal calendar accelerates the patent-cliff timeline into early 2027.
• Nov 4, 202610-QQuarterly report→ BD updateSummary on the 8-K
• Oct 30, 20268-K/ACurrent report (amended): officer / director change
• Oct 20, 2026ReleaseHarmony Biosciences to Report Third Quarter 2026 Financial Results on November 4, 2026
• Oct 13, 20268-KCurrent report: officer / director change, Reg FD disclosure · EX-99.1
• Oct 12, 2026ReleaseHarmony Biosciences Announces Planned CEO Transition to Support Next Phase of Growth→ BD updateJeffrey Dayno is out as CEO at year-end, replaced by COO Peter Anastasiou — announced today, ten days before the October 22 oral argument that the prior writeup called "the single most consequential date in the story." The stock fell 5.1% on the news, and the pattern of executive turnover at Harmony is now two-for-two in six months.
• Oct 1, 2026ReleaseHarmony Biosciences Announces Poster Presentation at the 17th European Narcolepsy Days
• Sep 21, 2026ReleaseHarmony Biosciences Recognizes World Narcolepsy Day 2026, Reflecting on Nearly a Decade of Commitment to the Sleep Community
• Aug 4, 20268-KCurrent report: results of operations, Reg FD disclosure · EX-99.1
• Aug 4, 202610-QQuarterly report
• Jul 16, 20268-KCurrent report: results of operations, officer / director change, Reg FD disclosure · EX-99.1
• May 14, 20268-KCurrent report: shareholder vote
• May 7, 20268-KCurrent report: results of operations, Reg FD disclosure · EX-99.1
• May 7, 202610-QQuarterly report
• Apr 14, 20268-KCurrent report: officer / director change, Reg FD disclosure · EX-99.1
• Apr 3, 2026DEFA14AProxy soliciting material
• Apr 3, 2026DEF 14AProxy statement
• Apr 2, 20268-KCurrent report: officer / director change, Reg FD disclosure · EX-99.1