ICoN-1 study presentation planned November 1 at NTM Symposium Australia Study is cleared by health authorities to proceed in Australia, U.S., Japan and South Korea, with Taiwan anticipated by end of year DANBURY, Conn., Oct. 30, 2024 (GLOBE NEWSWIRE) -- MannKind Corporation (Nasdaq: MNKD), a company focused on the development and commercialization of innovative inhaled therapeutic products and devices for patients with endocrine and orphan lung diseases, announced today that it has initiated its first site ...

Looking for a stock that has been consistently beating earnings estimates and might be well positioned to keep the streak alive in its next quarterly report? MannKind (MNKD) , which belongs to the Zacks Medical - Biomedical and Genetics industry, could be a great candidate to consider.This biopharmaceutical company has seen a nice streak of beating earnings estimates, especially when looking at the previous two reports. The average surprise for the last two quarters was 275%.For the last reported quarter, M ...

MannKind (MNKD) reached a significant support level, and could be a good pick for investors from a technical perspective. Recently, MNKD broke through the 20-day moving average, which suggests a short-term bullish trend.A well-liked tool among traders, the 20-day simple moving average offers a look back at a stock's price over a 20-day period. This is very beneficial to short-term traders, as it smooths out short-term price trends and gives more trend reversal signals than longer-term moving averages.Simila ...

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30-week results from the Phase 4 INHALE-3 study expand upon the positive 17-week data presented earlier this year at the American Diabetes Association’s 84th Scientific SessionsSwitching to, or remaining on Afrezza allowed twice as many people to get to goal during the extension phase DANBURY, Conn. and WESTLAKE VILLAGE, Calif., Sept. 30, 2024 (GLOBE NEWSWIRE) --  MannKind Corporation (Nasdaq: MNKD), a company focused on the development and commercialization of inhaled therapeutic products and devices for p ...

Clearance to proceed also received from health authorities in South Korea and Australia, with Taiwan expected in 4Q 2024First U.S. patient randomized DANBURY, Conn., Sept. 18, 2024 (GLOBE NEWSWIRE) -- MannKind Corporation (Nasdaq: MNKD), a company focused on the development and commercialization of innovative inhaled therapeutic products and devices for patients with endocrine and orphan lung diseases, announced today that it has received clearance from Japan’s Pharmaceuticals and Medical Devices Agency (PM ...

DANBURY, Conn. and WESTLAKE VILLAGE, Calif., Sept. 10, 2024 (GLOBE NEWSWIRE) -- MannKind Corporation (Nasdaq: MNKD), a company focused on the development and commercialization of innovative inhaled therapeutic products and devices for patients with endocrine and orphan lung diseases, announced today that Chief Financial Officer Chris Prentiss and Dr. Wasim Fares Therapeutic Area Head, Orphan Lung Diseases, will share updates during a fireside chat at the 2024 Cantor Fitzgerald Global Healthcare Conference i ...

DANBURY, Conn. and WESTLAKE VILLAGE, Calif., Aug. 27, 2024 (GLOBE NEWSWIRE) -- MannKind Corporation (Nasdaq: MNKD), a company focused on the development and commercialization of innovative inhaled therapeutic products and devices for patients with endocrine and orphan lung diseases, announced today that Chief Executive Officer Michael Castagna, PharmD, and Chief Financial Officer Chris Prentiss will share updates during fireside chats at three upcoming investor conferences: 2024 Wells Fargo Healthcare Confe ...

DANBURY, Conn. and WESTLAKE VILLAGE, Calif., Aug. 14, 2024 (GLOBE NEWSWIRE) -- MannKind Corporation (Nasdaq: MNKD), a company focused on the development and commercialization of innovative inhaled therapeutic products and devices for patients with endocrine and orphan lung diseases, announced today that Kent Kresa has decided to retire from MannKind’s Board of Directors effective September 30, 2024. In addition, the Board of Directors has appointed Steven B. Binder to the Board, also effective September 30, ...

财务数据和关键指标变化 - 第二季度总收入为7200万美元,较上年同期增长49% [20][21] - 前6个月总收入为1.39亿美元,较上年同期增长55% [20][21] - Tyvaso DPI特许权使用费收入为2600万美元,较上年同期增长34% [21] - 前6个月Tyvaso DPI特许权使用费收入为4800万美元,较上年同期增长57% [21] - Afrezza净收入为1600万美元,较上年同期增长20% [21] - 前6个月Afrezza净收入为3100万美元,较上年同期增长18% [21] - V-GO收入下降7%至400万美元 [22] - 前6个月V-GO收入下降11%至900万美元 [22] - 第二季度GAAP净亏损200万美元,非GAAP净利润1400万美元 [22][23] - 前6个月GAAP净利润900万美元,非GAAP净利润2900万美元 [23][24] - 第二季度末现金及投资262百万美元 [25][26] 各条业务线数据和关键指标变化 - Tyvaso DPI特许权使用费和制造收入持续增长 [7][21] - Afrezza处方量增长,第二季度新开处方量增长8%,总处方量增长5% [16] - V-GO业务已被降低优先级,收入下降 [16] 各个市场数据和关键指标变化 - 无具体披露 公司战略和发展方向及行业竞争 - 正在推进clofazimine吸入制剂的III期临床试验,预计将成为NTM治疗领域的新选择 [10][13][14] - 正在开发nintedanib吸入制剂,作为IPF治疗的新选择,希望能提高耐受性 [15] - 正在推进Afrezza在儿童人群的INHALE-1试验,为未来拓展新适应症做准备 [18][19] - 正在整合研发团队,搬迁到新的研发中心,以支持未来的研发计划 [32] - 正在积极推动Tyvaso DPI在全球市场的拓展,为公司带来持续的收入增长 [27][33] 管理层对经营环境和未来前景的评论 - 对公司管线的临床试验结果和商业化前景充满信心 [27][29][30][31][34] - 认为公司目前的估值没有充分反映管线的价值 [30][31] - 对Afrezza未来的持续增长前景保持乐观 [19] 其他重要信息 - 公司已完成对Mann Group和Mid-Cap贷款的提前偿还,资产负债表更加健康 [22][25][26] - 正在考虑为clofazimine吸入制剂开设扩大接入计划,以更早惠及患者 [56] 问答环节重要的提问和回答 问题1 **Olivia Brayer 提问** - 公司管线产品的知识产权保护和收入前景 [37][38][40][41] - 201项目(nintedanib吸入制剂)四季度数据的具体情况 [41][42][43] **Michael Castagna 回答** - 公司主要产品的知识产权保护可延续至2030年代中后期 [40] - 201项目第一阶段单剂量试验结果良好,计划进入多剂量试验,并与FDA商讨II/III期试验设计 [42][43] 问题2 **Thomas Smith 提问** - clofazimine吸入制剂III期试验的统计学假设和中期分析设计 [45][46][47][48][49] - INHALE-3试验数据对Afrezza销售的影响 [50][51][52] **Michael Castagna 回答** - clofazimine III期试验设计了90%的统计学功效,中期分析将评估是否需要扩大样本量,但不会有提前停止的条件 [48][49] - INHALE-3试验数据受到正面反馈,预计将在2025年对Afrezza销售产生积极影响,尤其是儿童适应症获批后 [51][52] 问题3 **Gregory Renza 提问** - clofazimine吸入制剂III期试验的站点激活和患者入组进展情况 [54][55] - 是否考虑为该产品开设扩大接入计划 [56] **Michael Castagna 回答** - 试验站点激活和患者入组进展顺利,预计9月份会加快 [55] - 正在考虑是否可以与FDA商讨开设扩大接入计划,以更早惠及无法入组试验的患者 [56]