Every investment category must answer the big question, why? For undervalued biotech stocks, it comes down to advantaging a supremely relevant sector without paying full price. Of course, the broader healthcare ecosystem offers a compelling narrative for market participants. As the Covid- 19 pandemic demonstrated, no matter how advanced we become as a society, a microscopic virus can impose devastation. In order to protect individuals and communities at large, enterprises need a way to address diseases: inf ...

FDA confirms the favorable benefit-risk profile of WAKIX Harmony Biosciences focused on continuing to advance its pipeline assets across three rare CNS franchises; anticipates at least one new product or indication launch annually over the next five years PLYMOUTH MEETING, Pa., June 25, 2024 /PRNewswire/ -- Harmony Biosciences Holdings, Inc. (Nasdaq: HRMY), today announced that the U.S. Food and Drug Administration denied the Citizen Petition filed by a short seller claiming that WAKIX is not safe and effec ...

PLYMOUTH MEETING, Pa., June 5, 2024 /PRNewswire/ -- Harmony Biosciences (Nasdaq: HRMY) presented data from its Phase 2 signal detection study showing that pitolisant reduced excessive daytime sleepiness (EDS) and fatigue in adults with Myotonic dystrophy Type 1 (DM1). "More than 80 percent of DM1 patients experience EDS and fatigue, which patient-reported outcomes research has shown to be nearly as debilitating as the primary symptoms of DM1, namely myotonia and muscle weakness,"1 said Kumar Budur, M.D., M. ...

PLYMOUTH MEETING, Pa., May 28, 2024 /PRNewswire/ -- Harmony Biosciences Holdings, Inc. (Nasdaq: HRMY), today announced that Harmony's management team will participate in a fireside chat at the upcoming Goldman Sachs 45th Annual Global Healthcare Conference in Miami Beach, FL on Monday, June 10, 2024, at 9:20 a.m. ET. A webcast of the fireside chat will be available on the investor page of Harmony's website at https://ir.harmonybiosciences.com/. About Harmony Biosciences At Harmony Biosciences, we specialize ...

Growth stocks are attractive to many investors, as above-average financial growth helps these stocks easily grab the market's attention and produce exceptional returns. But finding a growth stock that can live up to its true potential can be a tough task. That's because, these stocks usually carry above-average risk and volatility. In fact, betting on a stock for which the growth story is actually over or nearing its end could lead to significant loss. However, the Zacks Growth Style Score (part of the Zack ...

Investors interested in Medical - Biomedical and Genetics stocks are likely familiar with Harmony Biosciences Holdings, Inc. (HRMY) and Techne (TECH) . But which of these two stocks offers value investors a better bang for their buck right now? We'll need to take a closer look. We have found that the best way to discover great value opportunities is to pair a strong Zacks Rank with a great grade in the Value category of our Style Scores system. The proven Zacks Rank emphasizes companies with positive estima ...

财务数据和关键指标变化 - 公司报告第一季度净收入为1.546亿美元,同比增长30% [2][5][56][57] - 非GAAP调整后净收益为5070万美元,每股0.88美元,同比增长 [59] - 公司预计2024年全年净收入为7亿美元至7.2亿美元 [61] 各条业务线数据和关键指标变化 - WAKIX在成人narcolepsy市场的表现强劲,第一季度销售额同比增长30% [7][25][27][33] - WAKIX患者人数持续增长,第一季度平均患者人数增加约6,300人 [28][33] - WAKIX处方医生群体持续扩大,非oxybate REMS医生群体渗透率超过33% [29][30][31] - WAKIX在oxybate REMS医生群体中的渗透率和处方深度也在持续增加 [31] 各个市场数据和关键指标变化 - 公司未提及具体市场数据和关键指标变化 公司战略和发展方向及行业竞争 - 公司正在积极拓展管线,通过自主研发和业务合作的方式,建立了三大稀有神经系统疾病领域的产品管线 [6][9][10][11][12][14] - 公司正在开发WAKIX的新一代制剂,以改善患者体验、延长专利期,并拓展适应症至儿童narcolepsy和特发性嗜睡症 [8][16][17][36][37][38] - 公司通过收购Epygenix Therapeutics,进军罕见癫痫领域,获得两个新资产作为该领域的基础 [20][21][49][50][51] - 公司未来5年内每年预计至少推出一个新产品或新适应症 [23] - 公司有450多万美元的现金,有能力继续进行业务合作和并购 [15] 管理层对经营环境和未来前景的评论 - 公司对WAKIX在成人narcolepsy市场的长期增长前景充满信心,认为其有10亿美元以上的市场机会 [7][25] - 公司看好新管线项目的发展前景,认为每个项目都有10亿至20亿美元的峰值销售潜力 [10] - 公司认为自身有能力成为领先的以患者为中心的中枢神经系统生物技术公司,为患有未满足医疗需求的患者提供创新治疗,并实现持久的价值创造 [11] 问答环节重要的提问和回答 问题1 **Charles Duncan 提问** 询问WAKIX新一代制剂的预期对患者使用的影响 [74][75] **Jeffrey Dierks 回答** 公司正在开发新一代WAKIX制剂,可以更快达到治疗剂量,预计将改善患者体验 [76][77][78][79][80] 问题2 **Francois Brisebois 提问** 询问Epygenix资产的历史数据是否会公开 [85][86] **Kumar Budur 回答** 公司将适时公开Epygenix资产的相关数据,包括临床前和临床试验数据 [87][88][89][90] 问题3 **David Amsellem 提问** 询问Clemizole与同类竞争品的对比,以及公司在Orexin-2受体激动剂领域的发展计划 [113][114][115][116][117][118][119][120][121] **Kumar Budur 和 Jeffrey Dayno 回答** 公司认为Clemizole有独特的产品特征和优势,在罕见癫痫领域有较大的市场机会。在Orexin-2受体激动剂领域,公司将根据其他竞争品的临床进展情况,灵活确定自身的最佳发展路径 [116][117][118][119][120][121]

Q1 2024 Financial Results April 30, 2024 Forward-Looking Statements This presentation includes forward‐l ...

Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the Quarterly Period Ended March 31, 2024 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Commission File Number: 001-39450 HARMONY BIOSCIENCES HOLDINGS, INC. (Exact name of registrant as specified in its charter) Delaware 82-2 ...

Exhibit 99.1 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 DIVERSIFIES INTO RARE EPILEPSY WAKIX® (pitolisant) Net Revenue of $154.6 Million for First Quarter 2024; ~30% Growth Year-over-Year Supplemental New Drug Application for Pitolisant in Idiopathic Hypersomnia Planned for Second Half 2024 On Track Toward Pediatric Exclusivity to Exten ...