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Harmony Biosciences Holdings, Inc.

$36.84

-1.37 (-3.59%)

C 52Pipeline Score Overvalued Pharma · Commercial
Market Cap
1.75 B
EPS
2.53
P/E Ratio
12.14 $
Value Trade
32.33 M
SEC Financials
Q1 2026
  • Dilution Risk

    5%
  • Revenue

    215.39 M

  • R&D Expenses

    69.38 M

  • Operating CF

    27.76 M


  • Total Assets

    1.27 B

  • Total Liabilities

    361.48 M

  • Equity

    910.35 M

  • D/E Ratio

    12,345

-2.43 %
Week
-6.02 %
1 Month
-11.04 %
3 Month
-9.51 %
6 Month
-7.97 %
5 Year
-24.61 %
All Time
Cash Data
Profitable
  • Cash Position

    640.92 M

  • Monthly Burn

    -

  • Runway

    12,345 mo

  • Burn Trend

    Stable
  • SEC Filing

    May 7, 2026
Overview
Volume
668.82 K
52 Week Range
25.52 - 40.87
% held by Insiders
12.98 %
% held by Institutions
99.85 %
Enterprise Value
1.31 B
Total Shares
57.56 M
Short %
9.76 %
Float Shares
47.26 M
Company Description
HQ: 630 W GERMANTOWN PIKE, PLYMOUT...
Employees:293

locked

Upcoming Catalyst
Catalyst Drug/Treatment Stage Probability of Approval Description Drug Type Therapeutic Area Source
EPX-100 (Clemizole HCl) Dravet Syndrome (DS)
Phase 3

Subscribe to access the data.

Small Molecules
Nervous System
EPX-100 (Clemizole HCl) Dravet Syndrome (DS)
Phase 3

Subscribe to access the data.

Small Molecules
Nervous System
EPX-100 (Clemizole HCl) Dravet Syndrome (DS)
Phase 3

Subscribe to access the data.

Small Molecules
Nervous System
Unlock Upcoming Catalyst data

Catalyst Timeline

Dated clinical, regulatory & corporate events for Harmony Biosciences Holdings, Inc.

166Total events
13Upcoming
50Tier-1 (high impact)
2019 – 2028Coverage

Upcoming catalysts 13

2026
T2Quarterly Update
WAKIX 2026 net revenue guidance of $1.0 - $1.04 billion
WAKIXApprovednarcolepsyapproved
2027
T1Topline Readout
Topline data for pitolisant in sleep inertia in IH expected in 2027
sleep inertia in idiopathic hypersomniaphase 3
2027
T1PDUFA Date
PDUFA for DS
EPX-100Dravet Syndrome
2028
T1PDUFA Date
Anticipated PDUFA date in 2028 for pitolisant in sleep inertia in IH
sleep inertia in idiopathic hypersomniaphase 3
2028
T1PDUFA Date
PDUFA date expected in 2028 for pitolisant high-dose
Pitolisantnarcolepsy
2028
T1PDUFA Date
PDUFA for LGS
EPX-100Lennox-Gastaut Syndrome
TBD
T3Enrollment Update
ARGUS trial currently enrolling
EPX-100Dravet syndromePhase 3
TBD
T2Exclusivity Granted
Potential pediatric exclusivity for WAKIX
WAKIXApprovedpediatric narcolepsy
TBD
T2Patent Granted
Utility patents filed for next-generation formulations out to 2044
Pitolisant
TBD
T2Trial Initiation
Phase 3 registrational trial ongoing for pitolisant GR
PitolisantnarcolepsyPhase 3
TBD
T2Trial Initiation
Phase 3 registrational trial ongoing for pitolisant HD
Pitolisantrare CNS indicationsPhase 3
TBD
T2Trial Initiation
Phase 3 registrational trial ongoing for orexin-2 receptor agonist BP1.15205
BP1.15205CNS disordersPhase 3
TBD
T2Trial Initiation
Phase 3 registrational trial ongoing for EPX-100 in Lennox-Gastaut syndrome
EPX-100Lennox-Gastaut syndromePhase 3

Event history 153

Jun 11, 2026
Poster PresentationPresentation
Poster presentations at 2026 SLEEP Annual Meeting
May 7, 2026
Quarterly UpdateCorporate
Q1 2026 revenue of $215.4 million, 17% YoY growth for WAKIX
Apr 22, 2026
Poster PresentationEPX-100Presentation
Poster presentation of open-label extension data from Phase 3 ARGUS trial at AAN 2026
Dravet syndromesource ↗
Apr 16, 2026
Oral PresentationPresentation
Open-label extension data from Phase 3 ARGUS trial at 2026 AAN Annual Meeting
Apr 15, 2026
Management ChangeCorporate
Appointment of Glenn Reicin as Chief Financial Officer
Apr 14, 2026
Management ChangeCorporate
Appointment of Glenn Reicin as Chief Financial Officer
Apr 13, 2026
Oral PresentationPresentation
Harmony Biosciences to participate in fireside chat at 25th Annual Needham Virtual Healthcare Conference
Apr 2, 2026
Management ChangeCorporate
New executive appointment and board additions
Q2 2026
Topline ReadoutBP1.15205Clinical Data
Orexin-2 agonist BP1.15205 Phase 1 clinical data expected in mid-2026
Mar 10, 2026
Oral PresentationPresentation
Barclays 28th Annual Global Healthcare Conference
Mar 9, 2026
Oral PresentationPresentation
Leerink Partners Global Healthcare Conference
Feb 24, 2026
Quarterly UpdateCorporate
Q4 2025 earnings reported with revenue of $243.8M
Drug Pipeline Intelligence
C52
Pipeline Score
$898M
Pipeline Value
Overvalued
Valuation Signal
9
Drugs Scored
0.5x
rNPV / MCap
Top 79%
Micro Cap
(rank 192 of 911)
Percentile Rank
Harmony Biosciences Holdings, Inc. carries a moderate pipeline score (52/100), with $2.2B risk-adjusted pipeline value, led by OVX836 480µg in Influenza (Phase 2).
Showing 1 of 1 assets
DrugIndicationPhaseNCT IDPTRSrNPVStatusEnrollmentVelocityDesignCompletionML SignalLast Change
OVX836 480µg
Monoclonal antibody
InfluenzaPhase 2NCT0528479954% $1.1B COMPLETED 180 - -Dec 9, 2022 -Oct 31, 2024
Unlock Drug Pipeline Intelligence
Clinical Trial Results
Drug Name Indications Phase Date Trial Results Summary Title Source
ZYN002
Fragile X syndrome
Phase 3
2025-09-24

The RECONNECT Study did not meet the primary endpoint due to a higher than expected placebo response rate.

Read More

HARMONY BIOSCIENCES PROVIDES UPDATE FROM ITS PHASE 3 RECONNECT STUDY OF ZYN002 IN FRAGILE X

Read More
ZYN002
Fragile X syndrome
Phase 3
2025-09-24

The RECONNECT Study did not meet the primary endpoint due to a higher than expected placebo response rate.

Read More

HARMONY BIOSCIENCES PROVIDES UPDATE FROM ITS PHASE 3 RECONNECT STUDY OF ZYN002 IN FRAGILE X

Read More
ZYN002
Fragile X syndrome
Phase 3
2025-09-24

The RECONNECT Study did not meet the primary endpoint due to a higher than expected placebo response rate.

Read More

HARMONY BIOSCIENCES PROVIDES UPDATE FROM ITS PHASE 3 RECONNECT STUDY OF ZYN002 IN FRAGILE X

Read More
Unlock Clinical Trial Results data
Inside Trades
TREND
CORPORATE INSIDERS BOUGHT SHARES WORTH 1.8M IN THE LAST 3 MONTHS
YEARLY INSIDER TRANSACTIONS
Sector Avg.
INSIDERS
SOLD
INSIDERS
BOUGHT
POSITIVE SENTIMENT Based on 22 Insiders Transactions
Unlock Inside Trades data
Hedge Funds
TREND
HEDGE FUNDS INCREASED HOLDINGS BY 200.0K SHARES IN THE LAST QUARTER
Shares Held
2040.00B1530.00B1020.00B510.00B0
Q3
2024
Q4
2024
Q1
2025
Q2
2025
HEDGE FUNDS
SOLD
HEDGE FUNDS
BOUGHT
POSITIVE SENTIMENT Based on 27 hedge funds in the last quarter
18 buying (3 new)·9 selling (1 exited)·2 unchanged
Fund Count
60%
Share Volume
25%
Conviction
15%
HedgeFund Name
( 3 )
% of Portfolio Current MV
-
Shares Owned
-
Activity
Avg Price $0

Example Capital Management

2.5 %
15.00 M
250.00 K

Example Capital Management

2.5 %
15.00 M
250.00 K

Example Capital Management

2.5 %
15.00 M
250.00 K
Unlock Hedge Funds table data
HRMY Institutional Ownership Trends
Current Insider %
5.20%
+0.00%
Current Institutional %
62.40%
+0.00%
Total Ownership
67.60%
Insider + Institutional
Data Points
1
1 Ticker(s)
Option Chain Statistics
ExpirationVolumeOpen InterestImplied Volatility CallsImplied Volatility Puts
CallsPutsPut-Call RatioCallsPutsPut-Call RatioIVOiWaIvVWaIvIVOiWaIvVWaIv
2026-07-17 0.00 0 - - - - - -
2026-07-17 0.00 0 - - - - - -
2026-07-17 0.00 0 - - - - - -
Unlock Option Chain Statistics data
Option Chain
CallsStrikePuts
Last PriceVolumeOpen InterestLast PriceVolumeOpen Interest
No data available
Unlock Option Chain data
Unlock Options Chart data
Open interest
0 600K 1.2M 1.8M Avg OI 1.00 M Open Interest
0 1 2 3 1.1 Put-Call Ratio
Today's Open Interest
1.00 M
Put-Call Ratio
1.1
Put Open Interest
480.00 K
Call Open Interest
520.00 K
Open Interest Avg (30-day)
900,000
Today vs Open Interest Avg (30-day)
11.11%
Option Volume
0 450K 900K 1.4M Avg OV 750.00 K Option Volume
0 1 2 3 0.95 Put-Call Ratio
Today's Volume
750.00 K
Put-Call Ratio
0.95
Put Volume
360.00 K
Call Volume
390.00 K
Volume Avg (30-day)
800,000
Today vs Volume Avg (30-day)
-6.25%
Company News
HRMY
Jun 11, 2026
HRMYConferences/Events

Harmony Biosciences Announces Poster Presentations at 2026 SLEEP Annual Meeting

Harmony Biosciences has announced poster presentations at the upcoming 2026 SLEEP Annual Meeting. The details regarding the specific presentations or topics have not been disclosed in the article. This event is expected to showcase advancements in sleep medicine and related research.

Read more →
HRMY
May 7, 2026
HRMYGeneral

Harmony Biosciences Reports Q1 Financial Results and Confirms 2026 Net Revenue Guidance of Over $1 Billion; Reinforces 2026 Strategic Priorities

Harmony Biosciences reported a Q1 2026 revenue of $215.4 million, marking a 17% year-over-year growth driven by strong demand for WAKIX®. Despite facing market access challenges, the company has reaffirmed its guidance for over $1 billion in net revenue for 2026. This follows a record performance over the last three quarters.

Read more →
HRMY
Apr 23, 2026
HRMYConferences/Events

Harmony Biosciences to Report First Quarter 2026 Financial Results on May 7, 2026

Harmony Biosciences Holdings, Inc. will report its first quarter 2026 financial results on May 7, 2026. The company will host a conference call and webcast at 8:30 a.m. ET to discuss these results. Interested participants can join the call using the provided dial-in numbers and passcode.

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HRMY
Apr 17, 2026
HRMYPhases

Harmony Biosciences to Present Open-Label Extension Data From Phase 3 ARGUS Trial at the 2026 American Academy of Neurology Annual Meeting

Harmony Biosciences announced the presentation of open-label extension data from the Phase 3 ARGUS trial for EPX-100, targeting Dravet syndrome, at the 2026 American Academy of Neurology Annual Meeting. The trial is currently enrolling participants, and details about the trial can be found online. EPX-100 is an oral treatment aimed at modulating serotonin signaling in patients with Dravet syndrome.

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HRMY
Apr 15, 2026
HRMYGeneral

Harmony Biosciences Appoints Glenn Reicin as Chief Financial Officer

Harmony Biosciences has appointed Glenn Reicin as Chief Financial Officer, effective immediately. His extensive experience in the biopharmaceutical sector is expected to support the company's strategic growth and financial strength. Harmony also reaffirmed its revenue guidance of $1.0 to $1.04 billion by 2026, indicating confidence in its future performance.

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HRMY
Apr 2, 2026
HRMYGeneral

Harmony Biosciences Strengthens Executive Team With New Appointment and Announces Additions to Its Board

Harmony Biosciences has announced the strengthening of its executive team through new appointments. This move is expected to enhance the company's leadership structure and strategic direction. Additionally, the company has made additions to its board, signaling a commitment to growth and innovation.

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HRMY
Mar 31, 2026
HRMYConferences/Events

Harmony Biosciences to Participate in 25th Annual Needham Virtual Healthcare Conference

Harmony Biosciences will participate in the 25th Annual Needham Virtual Healthcare Conference on April 13, 2026. The management team will engage in a fireside chat, which will be accessible via a webcast. This event highlights the company's commitment to developing therapies for rare neurological diseases.

Read more →
HRMY
Mar 4, 2026
HRMYConferences/Events

Harmony Biosciences to Participate in Upcoming Investor Conferences

Harmony Biosciences Holdings, Inc. will participate in several upcoming investor conferences, including the Leerink Partners Global Healthcare Conference and the UBS Biotech Summit, both scheduled for March 9, 2026, in Miami, FL, followed by the Barclays 28th Annual Global Healthcare Conference on March 10, 2026. The company is dedicated to developing therapies for patients with rare neurological diseases.

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HRMY
Feb 24, 2026
HRMYGeneral

Harmony Biosciences Reports Strong 2025 Financial Results and Reiterates 2026 Net Revenue Guidance of Over $1 Billion

Harmony Biosciences reported a strong financial performance for 2025, with Q4 revenue reaching $243.8 million, marking a 21% increase year-over-year. The company anticipates WAKIX will exceed $1 billion in revenue in 2026, supported by a robust pipeline of late-stage clinical trials. Harmony's continued growth reflects its strong market position in treating narcolepsy and expanding into additional indications.

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HRMY
Feb 17, 2026
HRMYFDA Updates

Harmony Biosciences Receives U.S. Food and Drug Administration Approval for WAKIX® (pitolisant) for the Treatment of Cataplexy in Pediatric Narcolepsy

Harmony Biosciences has received FDA approval for WAKIX (pitolisant) for treating cataplexy in pediatric narcolepsy patients aged 6 and older. This marks WAKIX as the first FDA-approved non-scheduled treatment option for both pediatric and adult narcolepsy patients. The company plans to pursue pediatric exclusivity and explore additional indications for pitolisant.

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HRMY
Feb 10, 2026
HRMYConferences/Events

Harmony Biosciences to Report Fourth Quarter and Full Year 2025 Financial Results on February 24, 2026

Harmony Biosciences Holdings, Inc. will announce its fourth quarter and full year 2025 financial results on February 24, 2026. The announcement will be made before the U.S. financial markets open, followed by a conference call at 8:30 a.m. ET. This event highlights the company's ongoing commitment to transparency and engagement with investors.

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HRMY
Jan 12, 2026
HRMYGeneral

HARMONY BIOSCIENCES GUIDES TO OVER $1 BILLION IN WAKIX REVENUE IN 2026; ADVANCING ROBUST LATE-STAGE PIPELINE WITH POTENTIAL FOR LONG- TERM VALUE CREATION WAKIX 2025 Preliminary Net Revenue of ~$868 Million; 2026 WAKIX Ne

Harmony Biosciences has projected WAKIX revenue to surpass $1 billion in 2026, supported by preliminary figures indicating approximately $868 million in net revenue for 2025. The company is strengthening its position as a self-sustaining biotech with a robust late-stage pipeline that includes five ongoing Phase 3 clinical trials across various CNS indications. Harmony's strategy includes extending the pitolisant franchise with new formulations aimed at sustaining growth well into the 2040s. The company's commercial success and pipeline developments will be highlighted in an upcoming presentation at the J.P. Morgan Healthcare Conference.

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HRMY
Dec 2, 2025
HRMYPhases

Harmony Biosciences to Present New Open-Label Extension Data from Phase 3 ARGUS Trial at the 2025 American Epilepsy Society Annual Meeting

Harmony Biosciences will present new open-label extension data from its Phase 3 ARGUS trial for EPX-100 at the 2025 American Epilepsy Society Annual Meeting. The trial focuses on the treatment of Dravet syndrome, a severe form of epilepsy. The presentation is scheduled for December 8, 2025, in Atlanta, GA.

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HRMY
Nov 4, 2025
HRMYGeneral

HARMONY BIOSCIENCES REPORTS STRONG Q3 2025 FINANCIAL RESULTS; RECENTLY RAISED 2025 REVENUE GUIDANCE TO $845-$865M WAKIX (pitolisant) Franchise Delivers Net Revenue of $239M in Q3 2025 (+29% YoY Growth) Record Increase in

Harmony Biosciences announced robust financial results for Q3 2025, reporting a net revenue of $239.5M, which marks a 29% increase compared to the same quarter last year. The company raised its 2025 revenue guidance, now targeting between $845 million and $865 million. This growth is attributed to a significant increase in the average number of patients using Wakix, which has also solidified Harmony's financial standing with over $778 million in cash at the quarter's end. Additionally, the company is on track to advance multiple promising programs in its late-stage pipeline, enhancing its prospects in the biotechnology sector.

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HRMY
Oct 23, 2025
HRMYGeneral
▲ +12.7%on this news

HARMONY BIOSCIENCES PREANNOUNCES STRONG Q3 2025 WAKIX PERFORMANCE; RAISES 2025

Harmony Biosciences announced strong preliminary results for Q3 2025, particularly highlighting the performance of its flagship product, WAKIX. The company has raised its revenue guidance for 2025, reflecting confidence in the product's market opportunity. Full financial results will be disclosed on November 4, 2025, with a conference call scheduled for the same day. This positive financial outlook suggests a successful quarter and a promising growth trajectory for Harmony Biosciences.

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HRMY
Sep 24, 2025
HRMYPhases
▼ -16.6%on this news

HARMONY BIOSCIENCES PROVIDES UPDATE FROM ITS PHASE 3 RECONNECT STUDY OF ZYN002 IN FRAGILE X

Harmony Biosciences announced that its Phase 3 RECONNECT Study of ZYN002 for Fragile X syndrome did not meet its primary endpoint due to a higher than expected placebo response. Despite this setback, the company emphasizes the importance of the insights gained from the study and the dedication of all participants. Leadership highlighted the company's intention to analyze the data further while also maintaining confidence in its broader pipeline of therapies aimed at rare neurological diseases.

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HRMY
Aug 5, 2025
HRMYPhases

HARMONY BIOSCIENCES REPORTS STRONG Q2 2025 FINANCIAL RESULTS AND REAFFIRMS 2025 REVENUE GUIDANCE; ON TRACK TO ANNOUNCE FRAGILE X TOPLINE DATA FROM PHASE 3 REGISTRATIONAL TRIAL IN Q3 2025 WAKIX (pitolisant) Franchise Cont

Harmony Biosciences reported a robust financial performance for Q2 2025, highlighting a year-over-year revenue growth of 16% attributed to its WAKIX product. The company reaffirmed its full-year revenue guidance of $820 million to $860 million and is preparing to announce topline data from its Phase 3 trial for ZYN002 targeting Fragile X syndrome in Q3 2025. With a strong cash position, Harmony aims to address significant unmet medical needs while maintaining profitability and growth.

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HRMY
Jun 11, 2025
HRMYPhases

Harmony Biosciences Presents Preclinical Data Demonstrating Significant Wake-Promoting and Cataplexy-Suppressing Effects of BP1.15205 in Narcolepsy at SLEEP 2025 BP1.15205 is a potentially best-in-class OX2R agonist bein

Harmony Biosciences has presented promising preclinical data for BP1.15205, a potentially best-in-class OX2R agonist, at the SLEEP 2025 conference. The data suggest significant wake-promoting and cataplexy-suppressing effects in a transgenic mouse model of narcolepsy. A first-in-human study is anticipated to start in the second half of 2025, with topline clinical data expected in 2026. The results indicate a favorable safety and tolerability profile, which may support the drug's use in treating narcolepsy and other hypersomnolence disorders.

Read more →
HRMY
May 6, 2025
HRMYGeneral
▲ +7%on this news

HARMONY BIOSCIENCES REPORTS STRONG Q1 2025 FINANCIAL RESULTS, HIGHLIGHTS ADVANCEMENT OF ITS PIPELINE AND UPCOMING CATALYSTS, AND REAFFIRMS 2025 REVENUE GUIDANCE WAKIX (pitolisant) Net Revenue of $184.7 Million for First

Harmony Biosciences reported strong financial results for Q1 2025, with net revenue of $184.7 million, reflecting a 20% growth from the previous year. The company also achieved a 19% increase in net income, maintaining four consecutive years of profitability and bolstering its cash reserves to over $600 million. Upcoming catalysts include Phase 3 trial data for ZYN002 in Fragile X syndrome expected in Q3 2025, enhancing the company's potential for significant growth in 2025 and beyond.

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HRMY
Feb 25, 2025
HRMYGeneral
▲ +8.2%on this news

HARMONY BIOSCIENCES REPORTS STRONG 2024 FINANCIAL RESULTS AND REITERATES 2025 NET REVENUE GUIDANCE; HIGHLIGHTS 2025 CATALYSTS IN SLEEP/WAKE AND FRAGILE X SYNDROME DEVELOPMENT PROGRAMS WAKIX (pitolisant) Net Revenue of $2

Harmony Biosciences has reported robust financial performance for 2024, with net revenues reaching $714.7 million, reflecting a 23% increase from the previous year. The company has provided guidance for 2025 WAKIX net revenues, projected between $820 million and $860 million. Plans for advancing their treatment pipeline include initiating Phase 3 trials in narcolepsy later in 2025 and reporting data on ZYN002 for Fragile X syndrome, reinforcing their strategic position in CNS treatments. With significant market opportunities, Harmony is poised for continued growth and innovation in 2025.

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HRMY
Jan 13, 2025
HRMYGeneral
▲ +7.6%on this news

HARMONY BIOSCIENCES REPORTS STRONG 2024 REVENUES, PROVIDES 2025 REVENUE GUIDANCE AND HIGHLIGHTS KEY PIPELINE CATALYSTS WAKIX (pitolisant) Preliminary Net Revenue of ~$201 Million for Fourth Quarter and ~$714 Million for

Harmony Biosciences reported strong preliminary revenues for 2024, with net product revenues of about $714 million, reflecting a 23% growth. The company provided revenue guidance for 2025 between $820 million and $860 million, reinforcing its optimistic outlook. Key catalysts are anticipated throughout 2025, including FDA decisions and pivotal trial initiations, which could further enhance the company’s growth trajectory. The CEO emphasized the potential for long-term revenue exceeding $3 billion, indicating a solid foundation for future expansion.

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HRMY
Oct 29, 2024
HRMYGeneral
▲ +16.1%on this news

HARMONY BIOSCIENCES REPORTS STRONG THIRD QUARTER 2024 FINANCIAL RESULTS AND HIGHLIGHTS CATALYST-RICH, LATE-STAGE PIPELINE POISED TO DELIVER ONE OR MORE NEW LAUNCHES EVERY YEAR OVER NEXT FIVE YEARS WAKIX (pitolisant) Net

Harmony Biosciences reported robust financial results for Q3 2024, achieving $186 million in net revenue and surpassing $2 billion in cumulative sales since WAKIX's launch. The company is on track to submit a supplemental new drug application for pitolisant in Idiopathic Hypersomnia and noted positive outcomes in clinical trials for multiple programs aimed at treating rare CNS disorders. Its pipeline is poised to generate new products yearly over the next five years, reinforcing Harmony's growth strategy and market position in the biopharmaceutical industry.

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HRMY
Oct 1, 2024
HRMYConferences/Events

Copyright © 2024 Harmony Biosciences. All rights reserved. INVESTOR DAY 2024

Harmony Biosciences held its Investor Day 2024, highlighting a robust pipeline with plans for annual product launches over the next five years. The company aims to establish a leadership position in the CNS market, with four development programs entering Phase 3 trials by year-end. Key therapeutic focuses include treating Lennox-Gastaut Syndrome and Dravet Syndrome, addressing severe epilepsy with unmet needs. The event also emphasized the company's commitment to delivering meaningful treatment options that enhance patient outcomes.

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HRMY
Aug 6, 2024
HRMYGeneral
▲ +6.2%on this news

HARMONY BIOSCIENCES REPORTS STRONG SECOND QUARTER 2024 FINANCIAL RESULTS AND ADVANCES PITOLISANT HIGH-DOSE PROGRAM TOWARD EXPECTED PDUFA DATE IN 2028 WAKIX (pitolisant) Net Revenue of $172.8 Million for Second Quarter 20

Harmony Biosciences reported a strong financial performance with a 29% increase in net revenue for Q2 2024, amounting to $172.8 million. The company made significant advancements in its pitolisant high-dose development program, aiming for a PDUFA date in 2028 to extend its product franchise. Additionally, the FDA approved and launched WAKIX for pediatric patients with narcolepsy, marking a notable milestone for the company's product offerings. However, GAAP net income decreased to $11.6 million primarily due to upfront licensing fees related to new development agreements.

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HRMY
Apr 30, 2024
HRMYGeneral
▲ +5.7%on this news

HARMONY BIOSCIENCES REPORTS STRONG FIRST QUARTER FINANCIAL RESULTS AND ACCELERATION OF ITS GROWTH STRATEGY; ADVANCES PITOLISANT FRANCHISE TO EXTEND REVENUE POTENTIAL BEYOND 2040; STRENGHTENS SLEEP/WAKE LEADERSHIP AND DIV

Harmony Biosciences reported a strong first quarter with net revenue reaching $154.6 million, marking a 30% increase year-over-year. The company is advancing its pitolisant franchise, aiming to expand its revenue potential beyond 2040 and enhancing its position in the sleep/wake market through strategic acquisitions and licensing. The firm reiterated its 2024 net product revenue guidance of $700 to $720 million while maintaining a strong financial position with significant cash reserves.

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HRMY
Feb 22, 2024
HRMYGeneral

HARMONY BIOSCIENCES REPORTS FOURTH QUARTER AND FULL YEAR 2023 FINANCIAL RESULTS AND BUSINESS UPDATES WAKIX (pitolisant) Net Revenue of $168.4 Million for Fourth Quarter and $582.0 Million for Full Year 2023; Representing

Harmony Biosciences reported strong financial results for the fourth quarter and full year of 2023, with WAKIX net revenue growing by approximately 31% for the quarter and 33% for the year. The FDA has granted priority review for WAKIX in pediatric narcolepsy, with a PDUFA date set for June 2024. Additionally, the company received orphan drug designation for pitolisant for Prader-Willi Syndrome and plans to initiate a Phase 3 trial in early 2024. However, despite these positive developments, GAAP net income has decreased compared to the previous year.

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HRMY
Jan 8, 2024
HRMYGeneral

HARMONY BIOSCIENCES PRELIMINARY UNAUDITED FOURTH QUARTER AND FULL YEAR 2023 NET PRODUCT REVENUE INCREASES MORE THAN 30 PERCENT; PROVIDES 2024 NET PRODUCT REVENUE GUIDANCE WAKIX (pitolisant) Preliminary Net Revenue of ~$1

Harmony Biosciences has reported preliminary, unaudited net product revenue growth of over 30% for the fourth quarter and full year of 2023, with net revenue reaching approximately $582 million. The company provided a positive outlook for 2024, projecting net product revenue between $700 million and $720 million. CEO Jeffrey M. Dayno emphasized the company's commitment to expanding their product pipeline and leveraging their strong cash position. The results reflect continued growth in user adoption of their flagship product, WAKIX, targeting adult narcolepsy patients.

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HRMY
Nov 8, 2023
HRMYGeneral

HARMONY BIOSCIENCES APPOINTS PETER Anastasiou To Its Board of Directors

Harmony Biosciences has appointed Peter Anastasiou to its Board of Directors. Anastasiou, who has a strong background in neuroscience and business development, previously held key positions at Lundbeck and other notable companies. His appointment is seen as a strategic move to support Harmony's mission of delivering innovative therapies for patients with rare neurological diseases. Anastasiou expressed his enthusiasm for joining the company at this pivotal time, emphasizing the importance of addressing unmet medical needs.

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HRMY
Oct 31, 2023
HRMYGeneral
▲ +19.4%on this news· ran to +32% by day 3

HARMONY BIOSCIENCES REPORTS STRONG THIRD QUARTER 2023 FINANCIAL RESULTS Continued Strong Growth with WAKIX (pitolisant) Net Revenue of $160.3 Million for Third Quarter 2023; Increased ~37% Year-over-Year Average Number o

Harmony Biosciences reported robust third-quarter financial results, with WAKIX generating net revenues of $160.3 million, marking a 37% increase year-over-year. The company experienced substantial growth in patient numbers on WAKIX, rising to approximately 5,800. Harmony also expanded its pipeline through the acquisition of Zynerba Pharmaceuticals. However, the company noted a decrease in GAAP net income compared to the same period last year, partly due to certain financial adjustments.

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HRMY
Oct 13, 2023
HRMYPhases
▼ -30.2%on this news

HARMONY BIOSCIENCES ANNOUNCES TOPLINE DATA FROM PHASE 3 INTUNE STUDY EVALUATING PITOLISANT IN PATIENTS WITH IDIOPATHIC HYPERSOMNIA Pitolisant demonstrated clinically meaningful benefit in patients completing the initial

Harmony Biosciences has announced topline results from the Phase 3 INTUNE study evaluating pitolisant in patients with idiopathic hypersomnia. While the primary endpoint of excessive daytime sleepiness did not show statistical significance, 83% of patients responded favorably in the initial open-label phase. Additional positive trends were noted in secondary endpoints, contributing to optimism regarding further development with the FDA. The study maintained a consistent safety profile for pitolisant.

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HRMY
Oct 11, 2023
HRMYGeneral

HARMONY BIOSCIENCES COMPLETES ACQUISITION OF ZYNERBA PHARMACEUTICALS AND EXPANDS PIPELINE New product in development diversifies portfolio to drive long-term growth Innovative potential new therapeutic option for rare/or

Harmony Biosciences has completed its acquisition of Zynerba Pharmaceuticals, enhancing its portfolio with Zygel, a candidate aimed at treating rare neuropsychiatric disorders such as Fragile X syndrome and 22q11.2 deletion syndrome. Zygel is the first pharmaceutically manufactured synthetic cannabidiol, positioned to serve a significant patient population. The acquisition involved a cash transaction valued at approximately $60 million, supplemented by contingent value rights for potential future payments. This strategic move is expected to drive Harmony's long-term growth by addressing high unmet medical needs in the neuropsychiatric space.

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HRMY
Aug 14, 2023
HRMYGeneral

Execution Version SCHEDULE A Subject Securities Common Shares Company Restricted Stock Awards Company Options Total Shares

Harmony Biosciences Holdings, Inc. has entered into a Tender and Support Agreement with Zynerba Pharmaceuticals, initiating a merger process. Under this agreement, Xylophone Acquisition Corp. will begin a tender offer for all outstanding shares of Zynerba Pharmaceuticals' common stock. The merger aims to strengthen Harmony Biosciences' position in the biopharma sector by integrating Zynerba's assets. Stockholders of Zynerba will adhere to specific transaction terms and restrictions during the support period outlined in the agreement.

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HRMY
Aug 1, 2023
HRMYGeneral

HARMONY BIOSCIENCES REPORTS SECOND QUARTER 2023 FINANCIAL RESULTS AND BUSINESS UPDATES WAKIX (pitolisant) Net Revenue Increased ~25% Year-over-Year to $134.2 Million for Second Quarter 2023 Average Number of Patients on

Harmony Biosciences reported strong financial results for Q2 2023, with net revenues of $134.2 million, marking a 25% increase year-over-year. The average number of patients on WAKIX rose by approximately 350, totaling about 5,600 by quarter-end. The company completed enrollment in its Phase 3 study for idiopathic hypersomnia and plans to initiate another Phase 3 study for Prader-Willi syndrome. These developments reflect sustained momentum and growth potential within the company's core business operations.

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HRMY
Jul 27, 2023
HRMYGeneral

HARMONY BIOSCIENCES ENTERS INTO $185 MILLION TERM LOAN FACILITY Financing further strengthens balance sheet Use of net proceeds and existing cash to repay existing debt Reduces annual interest expense by approximately $6

Harmony Biosciences has secured a $185 million term loan facility aimed at repaying a portion of its existing $196.5 million debt. This financing is expected to strengthen the company's balance sheet and enhance financial flexibility, potentially paving the way for growth. The loan will also reduce Harmony's annual interest expenses by about $6 million, which could have a positive impact on profitability. The facility was arranged by JPMorgan Chase Bank, which will serve as the administrative agent.

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HRMY
May 2, 2023
HRMYGeneral

HARMONY BIOSCIENCES REPORTS FIRST QUARTER 2023 FINANCIAL RESULTS AND BUSINESS UPDATES WAKIX (pitolisant) Net Revenue Increased ~40% Year-over-Year to $119.1 Million for First Quarter 2023 Average Number of Patients on WA

Harmony Biosciences reported robust financial results for Q1 2023, highlighting a 40% year-over-year increase in net revenue, reaching $119.1 million. The average number of patients on WAKIX also grew by approximately 1,200 year-over-year, with a total of around 5,200 patients by the end of the quarter. Additionally, the cumulative net revenue for WAKIX surpassed $1 billion, marking a significant milestone. The company plans to unveil topline data from its Phase 3 Idiopathic Hypersomnia study in Q4 2023, emphasizing its strong growth trajectory.

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HRMY
Apr 24, 2023
HRMYGeneral

HARMONY BIOSCIENCES ANNOUNCES J EFFREY M. DAYNO, M.D. APPOINTED PRESIDENT & CHIEF EXECUTIVE OFFICER Dr. Dayno joins Harmony Biosciences Board of Directors

Harmony Biosciences has appointed Dr. Jeffrey M. Dayno as President and Chief Executive Officer. Dr. Dayno, who has been with the company since its inception and served as Interim CEO, is recognized for his leadership and expertise in neuroscience. He aims to expand the company's key product, WAKIX, in narcolepsy and pursue new indications while advancing the company's pipeline. The Board expressed strong confidence in Dr. Dayno's vision for future growth.

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HRMY
Mar 30, 2023
HRMYGeneral

Harmony Biosciences Holdings: Company Investigated by the Portnoy Law Firm

Harmony Biosciences Holdings, Inc. is currently under investigation by the Portnoy Law Firm for possible securities fraud, following a report by Scorpion Capital. The report alleges that there were fatalities during clinical trials of the company's drug Wakix and that essential information was concealed from the FDA. This has led to a decrease in the company's share value. Investors who suffered losses are encouraged to contact the law firm for assistance in recovering their investments.

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HRMY
Mar 29, 2023
HRMYPhases
▲ +8.3%on this newsshared move

the forward-looking statements made in this press release. Any such forward-looking statements represent management's estimates as of the date of this press release. While we may elect to update such forward-looking stat

Harmony Biosciences announced an accelerated timeline for its Phase 3 INTUNE study evaluating pitolisant in patients with idiopathic hypersomnia. Enrollment is ahead of schedule, with expected completion by the second quarter of 2023 and topline data anticipated in the fourth quarter. The study aims to assess the safety and efficacy of pitolisant in reducing excessive daytime sleepiness associated with idiopathic hypersomnia. The trial demonstrates strong interest from both the patient community and clinical investigators, reflecting an unmet medical need in this area.

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HRMY
Mar 28, 2023
HRMYGeneral
▼ -25.8%on this newsshared move

Harmony Biosciences Holdings Shareholder News: Johnson Fistel Urges Investors with Losses to Reach Out Regarding Class Action Investigation - HRMY

Johnson Fistel, LLP is investigating Harmony Biosciences Holdings regarding potential violations of securities laws. The investigation stems from claims that the company misrepresented material information and that its drug, Wakix, presents serious health risks. Allegations suggest the company engaged in unethical practices, leading to significant losses for its investors. Following these revelations, Harmony's stock price experienced a substantial drop of over 27% in intraday trading.

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HRMY
Feb 21, 2023
HRMYGeneral
▼ -11.1%on this news

HARMONY BIOSCIENCES REPORTS FOURTH QUARTER AND FULL YEAR 2022 FINANCIAL RESULTS AND BUSINESS UPDATES WAKIX (pitolisant) Net Revenue Increased ~41% Year-over-Year to $128.3 Million for Fourth Quarter 2022; ~43% to $437.9

Harmony Biosciences reported its fourth quarter and full year financial results for 2022, with notable net revenue growth of around 41% to $128.3 million in Q4 and an increase of approximately 43% to $437.9 million for the full year. The company achieved a net income of $181.5 million, partly due to a significant tax benefit. Harmony also highlighted the growth in the number of patients using WAKIX and ongoing success in their clinical development. However, concerns about the medication's mechanism and safety remain relevant.

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HRMY
Jan 6, 2023
HRMYGeneral

HARMONY BIOSCIENCES APPOINTS JEFFREY DAYNO

Harmony Biosciences has appointed Jeffrey Dayno, MD, as the interim CEO following the departure of John Jacobs. Dr. Dayno, previously the Chief Medical Officer, is expected to lead the company while continuing to execute its strategic growth plan focused on narcolepsy and business development. Jeff Aronin, the founder and Board chairman, will guide the transition and has expressed confidence in Dayno's leadership. The company aims to maintain its commitment to developing treatments for rare neurological diseases.

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HRMY
Nov 1, 2022
HRMYGeneral
▲ +14%on this news

HARMONY BIOSCIENCES REPORTS THIRD QUARTER 2022 FINANCIAL RESULTS AND BUSINESS UPDATES WAKIX (pitolisant) Net Revenue of $117.2 Million for Third Quarter 2022 Increase of ~45% vs. the Same Period in 2021 Average Number of

HARMONY BIOSCIENCES REPORTS THIRD QUARTER 2022 FINANCIAL RESULTS AND BUSINESS UPDATES WAKIX (pitolisant) Net Revenue of $117.2 Million for Third Quarter 2022 Increase of ~45% vs. the Same Period in 2021 Average Number of Patients on WAKIX Increased to ~4,600 Prader-Willi Syndr

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HRMY
Aug 2, 2022
HRMYGeneral
▲ +12.6%on this news

HARMONY BIOSCIENCES REPORTS SECOND QUARTER 2022 FINANCIAL RESULTS AND BUSINESS UPDATES WAKIX (pitolisant) Net Revenue of $107.0 Million for Second Quarter 2022 Increase of 45% vs. the Same Period in 2021 Average Number o

HARMONY BIOSCIENCES REPORTS SECOND QUARTER 2022 FINANCIAL RESULTS AND BUSINESS UPDATES WAKIX (pitolisant) Net Revenue of $107.0 Million for Second Quarter 2022 Increase of 45% vs. the Same Period in 2021 Average Number of Patients on WAKIX Increased to ~4,300 Signs New Agreeme

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HRMY
May 3, 2022
HRMYGeneral
▼ -17.6%on this news

HARMONY BIOSCIENCES REPORTS FIRST QUARTER 2022 FINANCIAL RESULTS AND BUSINESS UPDATES WAKIX (pitolisant) Net Revenue of $85.3 Million for First Quarter 2022 Increase of 43% vs. the Same Period in 2021 WAKIX Surpasses $50

HARMONY BIOSCIENCES REPORTS FIRST QUARTER 2022 FINANCIAL RESULTS AND BUSINESS UPDATES WAKIX (pitolisant) Net Revenue of $85.3 Million for First Quarter 2022 Increase of 43% vs. the Same Period in 2021 WAKIX Surpasses $500 Million in Cumulative Net Revenue Since Launch Initiate

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HRMY
Feb 28, 2022
HRMYGeneral
▲ +5.4%on this news

HARMONY BIOSCIENCES REPORTS FOURTH QUARTER AND FULL YEAR 2021 FINANCIAL RESULTS AND BUSINESS UPDATES WAKIX (pitolisant) Net Revenue Increased 62% Year-over-Year to $91.2 Million for Fourth Quarter 2021 and 91% to $305.4

HARMONY BIOSCIENCES REPORTS FOURTH QUARTER AND FULL YEAR 2021 FINANCIAL RESULTS AND BUSINESS UPDATES WAKIX (pitolisant) Net Revenue Increased 62% Year-over-Year to $91.2 Million for Fourth Quarter 2021 and 91% to $305.4 Million for Full Year Achieved First Full Year of Profitab

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HRMY
Nov 9, 2021
HRMYGeneral

HARMONY BIOSCIENCES REPORTS THIRD QUARTER 2021 FINANCIAL RESULTS AND BUSINESS UPDATES WAKIX (pitolisant) Net Revenue of $80.7 Million for Third Quarter 2021 Increase of 77% vs. the Same Period in 2020 Average Number of P

HARMONY BIOSCIENCES REPORTS THIRD QUARTER 2021 FINANCIAL RESULTS AND BUSINESS UPDATES WAKIX (pitolisant) Net Revenue of $80.7 Million for Third Quarter 2021 Increase of 77% vs. the Same Period in 2020 Average Number of Patients on WAKIX Increased to ~3,500 Announced Inclusion

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HRMY
Aug 10, 2021
HRMYConferences/Events
▲ +12.7%on this news

Conference Call Transcript Harmony Biosciences Holdings, Inc. Earnings Conference Call Second Quarter 2021

Conference Call Transcript Earnings Conference Call Second Quarter 2021 August 10, 2021 // 8:30 am (ET) Good day, and thank you for standing by. Welcome to the Second Quarter 2021 Financial and Business Update Conference Call. At this time, all participant lines are in a list

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HRMY
May 11, 2021
HRMYConferences/Events

HARMONY BIOSCIENCES REPORTS FIRST QUARTER 2021 RESULTS AND BUSINESS UPDATES WAKIX (pitolisant) Total Revenue of $59.7 Million for First Quarter 2021 Achieves Profitability with $7.4 Million Net Income Conference Call and

HARMONY BIOSCIENCES REPORTS FIRST QUARTER 2021 RESULTS AND WAKIX (pitolisant) Total Revenue of $59.7 Million for First Quarter 2021 Achieves Profitability with $7.4 Million Net Income Conference Call and Webcast to be Held Today at 8:30 a.m. ET PLYMOUTH MEETING, PA, May 11, 2

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HRMY
Mar 25, 2021
HRMYGeneral

HARMONY BIOSCIENCES REPORTS FOURTH QUARTER AND FULL-YEAR 2020 FINANCIAL RESULTS AND BUSINESS UPDATES WAKIX (pitolisant) Total Revenue of $160 Million for Full-Year 2020 ; $56 Million for Fourth Quarter 2020 Clinical Util

HARMONY BIOSCIENCES REPORTS FOURTH QUARTER AND FULL-YEAR 2020 FINANCIAL RESULTS AND BUSINESS UPDATES WAKIX (pitolisant) Total Revenue of $160 Million for Full-Year 2020; $56 Million for Fourth Quarter 2020 Clinical Utility of WAKIX was Expanded with Additional Approval for Tr

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HRMY
Dec 17, 2020
HRMYGeneral

HARMONY BIOSCIENCES TO BE ADDED TO RUSSELL 2000 AND RUSSELL 3000 INDEXES PLYMOUTH MEETING, PA and CHICAGO, IL

HARMONY BIOSCIENCES TO BE ADDED TO RUSSELL 2000 AND RUSSELL 3000 INDEXES PLYMOUTH MEETING, PA and CHICAGO, IL, December 17, 2020 Harmony Biosciences Holdings, Inc. ( Harmony ) (Nasdaq: HRMY), a pharmaceutical company dedicated to developing and commercializing innovative thera

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HRMY
Dec 15, 2020
HRMYPhases

HARMONY BIOSCIENCES ENROLLS FIRST PATIENT IN PHASE 2 TRIAL EVALUATING PITOLISANT FOR EXCESSIVE DAYTIME SLEEPINESS IN PATIENTS WITH PRADER-WILLI SYNDROME PLYMOUTH MEETING, PA and CHICAGO, IL

HARMONY BIOSCIENCES ENROLLS FIRST PATIENT IN PHASE 2 TRIAL EVALUATING PITOLISANT FOR EXCESSIVE DAYTIME SLEEPINESS IN PATIENTS WITH PRADER-WILLI PLYMOUTH MEETING, PA and CHICAGO, IL, December 15, 2020 Harmony Biosciences Holdings, Inc. ( Harmony ) (Nasdaq: HRMY), a pharmaceutic

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HRMY
Nov 12, 2020
HRMYGeneral

HARMONY BIOSCIENCES REPORTS THIRD QUARTER 2020 FINANCIAL RESULTS AND BUSINESS UPDATES WAKIX (pitolisant) Total Revenue of $45.6 Million for Third Quarter of 2020 Differentiated Product Profile Aligns with Unmet Medical N

HARMONY BIOSCIENCES REPORTS THIRD QUARTER 2020 FINANCIAL RESULTS AND BUSINESS UPDATES WAKIX (pitolisant) Total Revenue of $45.6 Million for Third Quarter of 2020 Differentiated Product Profile Aligns with Unmet Medical Need On Track to Initiate Phase 2 Trial in Patients with

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HRMY
Nov 11, 2020
HRMYGeneral

HARMONY BIOSCIENCES APPOINTS MARK GRAF AND ERIC MOTLEY TO ITS BOARD OF DIRECTORS PLYMOUTH MEETING, PA and CHICAGO, IL

HARMONY BIOSCIENCES APPOINTS MARK GRAF AND ERIC MOTLEY TO ITS BOARD OF DIRECTORS PLYMOUTH MEETING, PA and CHICAGO, IL, November 11, 2020 Harmony Biosciences Holdings, Inc. ( Harmony ) (Nasdaq: HRMY), a pharmaceutical company dedicated to developing and commercializing innovati

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HRMY
Oct 14, 2020
HRMYFDA Updates

HARMONY BIOSCIENCES RECEIVES FDA APPROVAL FOR EXPANDED USE OF WAKIX (PITOLISANT) FOR THE TREATMENT OF CATAPLEXY IN ADULT PATIENTS WITH NARCOLEPSY WAKIX is the first and only non-scheduled treatment approved for excessive

HARMONY BIOSCIENCES RECEIVES FDA APPROVAL FOR EXPANDED USE OF WAKIX (PITOLISANT) FOR THE TREATMENT OF CATAPLEXY IN ADULT PATIENTS WITH NARCOLEPSY WAKIX is the first and only non-scheduled treatment approved for excessive daytime sleepiness or cataplexy in adult patients with n

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