Harmony Biosciences Holdings, Inc.
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Truist Securities Downgrades Harmony Biosciences Holdings, Inc. (HRMY) to Hold After Patent Trial Developments
Yahoo Finance· 2026-02-26 13:57
Core Insights - Harmony Biosciences Holdings, Inc. (NASDAQ:HRMY) is recognized as one of the best investment stocks for 2026, indicating strong future potential in the market [1][2]. Company Developments - Truist Securities downgraded HRMY from Buy to Hold due to concerns raised during a patent trial against AET Pharma, suggesting a potential negative outcome for Harmony's case and highlighting risks for the Wakix franchise, with generic competition expected before 2029 [3][8]. - On February 17, the U.S. FDA approved Harmony's supplemental New Drug Application for WAKIX (pitolisant) tablets, allowing treatment for cataplexy in children aged six and older, marking it as the first FDA-approved non-scheduled therapy for narcolepsy [4][5]. Industry Context - Harmony Biosciences focuses on developing therapies for rare neurological disorders, particularly innovative treatments for narcolepsy and other sleep-related diseases, positioning itself within a niche but critical segment of the biopharmaceutical industry [5].
IOVA Beats on Q4 Earnings & Sales, Stock Soars on Pipeline Progress
ZACKS· 2026-02-25 17:06
Key Takeaways Iovance reported a Q4 loss of 18 cents per share on $87M in revenues, topping estimates.IOVA's Amtagvi sales rose 33% to $65M, lifting gross margin to 50% after restructuring.IOVA shares jumped 31% on 50% ORR data in sarcoma and a new study plan.Iovance Biotherapeutics (IOVA) incurred a fourth-quarter 2025 loss of 18 cents per share, narrower than the Zacks Consensus Estimate of a loss of 22 cents. In the year-ago quarter, the company reported a loss per share of 26 cents.Total revenues for th ...
BEAM's Q4 Loss Narrower Than Expected, Revenues Rise Y/Y
ZACKS· 2026-02-25 17:06
Key Takeaways BEAM reported Q4 loss of 10 cents per share as revenues jumped to $114.1 million, beating estimates.BEAM secured a $500M non-dilutive credit facility to support risto-cel launch in SCD.BEAM plans risto-cel BLA by the end of 2026. Its cash runway now extends into mid-2029.Beam Therapeutics (BEAM) incurred a loss of 10 cents per share in the fourth quarter of 2025 (excluding gain on sale of equity method investment), narrower than the Zacks Consensus Estimate of a loss of $1.13. The company had ...
RXRX Q4 Loss Narrower Than Expected, Revenues Increase Y/Y, Stock Up
ZACKS· 2026-02-25 16:26
Key Takeaways RXRX reported a Q4 loss of 21 cents per share, beating estimates and narrowing from last year.Recursion revenues rose to $35.5M on a $30M Roche milestone payment and contributions from Sanofi.Recursion Pharmaceuticals ended 2025 with $753.9M in cash, funding operations into early 2028.Recursion Pharmaceuticals (RXRX) reported a loss of 21 cents per share in the fourth quarter of 2025, narrower than the Zacks Consensus Estimate of a loss of 28 cents. The company had incurred a loss of 53 cents ...
Corcept's Q4 Earnings and Revenues Fall Short of Estimates
ZACKS· 2026-02-25 15:15
Key Takeaways CORT posted Q4 EPS of 20 cents, missing estimates. Revenues rose 11% Y/Y to $202.1M in Q4 2025.CORT expects 2026 revenues of $900M-$1B. FDA decision on relacorilant in ovarian cancer is due in July 2026.Corcept received the FDA's CRL for relacorilant in Cushing's syndrome and is engaging in the next steps.Corcept Therapeutics (CORT) reported fourth-quarter 2025 earnings of 20 cents per share, which missed the Zacks Consensus Estimate of 27 cents. The company had reported earnings of 26 cents p ...
Repligen's Q4 Earnings Beat Estimates, Revenues Surge Y/Y
ZACKS· 2026-02-25 15:11
Key Takeaways Repligen posted Q4 2025 EPS of 49 cents, beating estimates. Revenues rose 18% Y/Y to $198M.Repligen delivered 14% organic growth in Q4 2025, with Proteins and Process Analytics up over 30%.Repligen guides 2026 revenues of $810-$840M and estimates EPS to be in the band of $1.93-$2.01.Repligen Corporation (RGEN) reported fourth-quarter 2025 adjusted earnings per share of 49 cents, which came ahead of the Zacks Consensus Estimate and the year-ago adjusted earnings of 44 cents per share.Total reve ...
Apellis Q4 Loss Wider Than Expected, Revenues Decline Y/Y
ZACKS· 2026-02-25 14:56
Core Insights - Apellis Pharmaceuticals reported a fourth-quarter 2025 loss of 47 cents per share, which was wider than the Zacks Consensus Estimate of a loss of 39 cents, compared to a loss of 29 cents in the same quarter last year [1][7] Financial Performance - Total revenues for the fourth quarter were $199.9 million, exceeding the Zacks Consensus Estimate of $194 million, but down 6% year-over-year from $212.5 million in the previous year [2] - Revenues included product sales from Empaveli and Syfovre, along with licensing and other revenues from a collaboration agreement with Sobi [3] - Syfovre sales were $155.2 million, an 8% decline year-over-year, although it slightly surpassed the Zacks Consensus Estimate of $154.2 million [4] - Empaveli recorded sales of $35.1 million, a 50% increase from the previous year, driven by early launch momentum in C3G and IC-MPGN, and also beat the Zacks Consensus Estimate of $28.5 million [9] Market Position and Product Performance - Syfovre holds approximately 60% market share in geographic atrophy treatment, with total injections growing about 17% year-over-year despite the revenue decline attributed to increased use of free goods [5] - Apellis delivered over 89,000 commercial vials and nearly 13,000 samples of Syfovre to doctors in the reported quarter [5] Cost Management - Research and development expenses decreased by 3% year-over-year to $74.2 million, attributed to lower program-specific external costs and personnel costs [10] - Selling, general, and administrative expenses rose by 21% year-over-year to $147.1 million, driven by higher professional fees and personnel costs [11] Cash Position - As of December 31, 2025, Apellis had cash, cash equivalents, and marketable securities totaling $466.2 million, down from $479.2 million as of September 30, 2025, with expectations that this will fund operations to profitability [12] Annual Performance - For the full year 2025, Apellis reported total revenues of $1.0 billion, a 28% increase year-over-year, surpassing the Zacks Consensus Estimate of $998.3 million, which included a one-time $275 million upfront payment from a royalty repurchase agreement [14] - The company reported earnings per share of 20 cents for 2025, compared to a loss of $1.60 per share in 2024, although it missed the Zacks Consensus Estimate of 24 cents [14] Pipeline Developments - Apellis has initiated two pivotal phase III studies of Empaveli for focal segmental glomerulosclerosis and delayed graft function, both of which are rare kidney diseases with no approved therapies [16] - A mid-stage multi-dose study of siRNA candidate APL-3007 in combination with Syfovre is ongoing, with top-line data expected in 2027 [17]
AXSM Q4 Loss Wider Than Expected, Revenues Surge Y/Y on Auvelity Sales
ZACKS· 2026-02-24 18:11
Key Takeaways AXSM reported a Q4 loss of 71 cents, missing estimates even as revenues rose 65% to $196M.Auvelity sales climbed 68% Y/Y to $155.1M, with prescriptions up 42% year over year in Q425.Axsome's Sunosi sales rose 40% Y/Y, while newly launched Symbravo generated $4.1M in Q4.Axsome Therapeutics (AXSM) incurred a loss of 71 cents per share in the fourth quarter of 2025, wider than the Zacks Consensus Estimate of a loss of 70 cents. The company had incurred a loss of 96 cents per share in the year-ago ...
BMRN Beats on Q4 Earnings, to Withdraw Roctavian From Market
ZACKS· 2026-02-24 17:36
Key Takeaways BioMarin reported Q4 EPS of 46 cents, beating estimates while revenues rose 17% Y/Y to $875M.Voxzogo sales jumped 31% to $273M in Q4, while BioMarin's enzyme therapies sales rose 13%.BioMarin will withdraw Roctavian after failing to find a buyer, recording a $119.2M charge in Q4.BioMarin Pharmaceutical (BMRN) reported fourth-quarter 2025 adjusted earnings per share of 46 cents, beating the Zacks Consensus Estimate of 25 cents. However, earnings declined 50% year over year, largely due to a $11 ...
Amicus' Q4 Earnings Miss, Higher Product Sales Drive Y/Y Revenues
ZACKS· 2026-02-23 17:15
Key Takeaways FOLD reported Q4 EPS of 10 cents, missing estimates, as revenues rose 24% Y/Y to $185.2M.Amicus saw Galafold sales rise 14% and Pombiliti plus Opfolda jump 51% Y/Y at constant exchange rates.BioMarin will acquire Amicus for $14.50 per share in a $4.8B cash deal set to close in Q2 2026.Amicus Therapeutics (FOLD) reported adjusted earnings of 10 cents per share for the fourth quarter of 2025, which missed the Zacks Consensus Estimate of 13 cents. The company had reported adjusted earnings of 9 c ...