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Mesoblast (MESO) - 2026 Q2 - Earnings Call Transcript
2026-02-26 23:00
Mesoblast (NasdaqGS:MESO) H1 2026 Earnings call February 26, 2026 05:00 PM ET Speaker6Hello, and welcome to the Mesoblast financial results for the half year ended December 31st, 2025. An announcement and presentation have been lodged with the ASX and are also available on the home and investor pages at www.mesoblast.com. At this time, all participants are in listen-only mode. Later, we will conduct a question and answer session and instructions will follow at that time. As a reminder, this conference call ...
X @Forbes
Forbes· 2026-02-01 22:37
A 'Holy Grail' Sleep Apnea Pill Could Be On The Market Next YearThe disease affects as many as 80 million in the U.S. alone. Now Apnimed, the $400 million company behind the first ever pill to treat it, is preparing to file for FDA approval.Read more: https://t.co/Vjs2cq7po3 https://t.co/hNVae5XT6a ...
X @Forbes
Forbes· 2026-01-31 22:37
A 'Holy Grail' Sleep Apnea Pill Could Be On The Market Next YearThe disease affects as many as 80 million in the U.S. alone. Now Apnimed, the $400 million company behind the first ever pill to treat it, is preparing to file for FDA approval.Read more: https://t.co/Vjs2cq7po3 https://t.co/gMbn8cPqYb ...
X @Forbes
Forbes· 2026-01-30 22:37
A 'Holy Grail' Sleep Apnea Pill Could Be On The Market Next YearThe disease affects as many as 80 million in the U.S. alone. Now Apnimed, the $400 million company behind the first ever pill to treat it, is preparing to file for FDA approval.Read more: https://t.co/Vjs2cq7po3 https://t.co/bKYT13oDxj ...
X @Forbes
Forbes· 2026-01-29 22:32
A 'Holy Grail' Sleep Apnea Pill Could Be On The Market Next YearThe disease affects as many as 80 million in the U.S. alone. Now Apnimed, the $400 million company behind the first ever pill to treat it, is preparing to file for FDA approval.Read more: https://t.co/Vjs2cq7po3 https://t.co/qQ2jOoAUGK ...
Is Apellis Pharmaceuticals' FDA Win Just the Beginning?
247Wallst· 2026-01-17 10:36
Core Insights - Apellis Pharmaceuticals (APLS) received FDA approval for EMPAVELI targeting C3 glomerulopathy and IC-MPGN, with the stock trading around $28 at the time of approval [1] Company Summary - The FDA approval of EMPAVELI marks a significant milestone for Apellis Pharmaceuticals, potentially impacting its market position and stock performance [1]
Omeros Corporation (OMER) Discusses FDA Approval and Commercialization Plans for YARTEMLEA in TA-TMA Treatment Transcript
Seeking Alpha· 2026-01-08 02:07
Core Viewpoint - Omeros Corporation is discussing its newly approved drug, YARTEMLEA, and its expectations regarding demand, manufacturing capacity, and commercial sales [2][3]. Group 1: Company Operations - The conference call includes forward-looking statements about Omeros' operations and assets, particularly focusing on YARTEMLEA [2]. - Management's current expectations and beliefs are subject to risks and uncertainties that could lead to actual results differing from projections [3]. Group 2: Drug Approval and Market Expectations - YARTEMLEA has received approval, and the company anticipates significant demand and commercial sales [2]. - The discussion will cover aspects such as reimbursement and development in additional indications for YARTEMLEA [2].
Omeros: Why The Novo Nordisk Deal Is More Important Than FDA Approval (NASDAQ:OMER)
Seeking Alpha· 2025-12-29 07:45
Core Insights - The article emphasizes the importance of conducting independent research before making investment decisions, highlighting the inherent volatility and risks associated with stock investments [2][3]. Group 1 - The content is intended to provide informational insights rather than exhaustive analysis of any featured company [2]. - The predictions and opinions presented are based on a probabilistic approach, indicating that they do not guarantee absolute certainty [2]. - Readers are encouraged to verify the information independently and assess their financial circumstances before investing [2]. Group 2 - The article clarifies that past performance is not indicative of future results, and no specific investment recommendations are provided [3]. - It notes that the views expressed may not reflect those of the platform as a whole, emphasizing the diversity of opinions among analysts [3]. - The authors of the analysis may not be licensed or certified, which could impact the reliability of the insights provided [3].
FDA Lifts Partial Clinical Hold on Tradipitant for Motion Sickness
Prnewswire· 2025-12-04 21:21
Core Insights - The U.S. FDA has lifted the partial clinical hold on Vanda Pharmaceuticals' protocol for tradipitant, allowing for an increase in the maximum number of doses administered in clinical studies [1][4] - This decision follows a formal dispute resolution request by Vanda and an expedited re-review by the FDA, which recognized motion sickness as an acute condition [2][3] - The ongoing review of the New Drug Application (NDA) for tradipitant is on track, with a target action date of December 30, 2025, potentially marking the first new treatment for motion sickness in over 40 years [4] Company Overview - Vanda Pharmaceuticals is a global biopharmaceutical company focused on developing innovative therapies to meet high unmet medical needs [5] - Tradipitant, a neurokinin-1 receptor antagonist licensed from Eli Lilly, is in clinical development for various indications, including motion sickness and nausea prevention [6]
Arrowhead Pharmaceuticals, Inc. (ARWR) Discusses FDA Approval and Commercial Launch Plans for REDEMPLO in Familial Chylomicronemia Syndrome Transcript
Seeking Alpha· 2025-11-19 08:48
Core Viewpoint - Arrowhead Pharmaceuticals has received FDA approval for REDEMPLO, a treatment aimed at reducing triglycerides in adults with familial chylomicronemia syndrome (FCS) [2]. Group 1: FDA Approval - The FDA approval of REDEMPLO is a significant milestone for Arrowhead Pharmaceuticals, as it addresses a critical need for patients suffering from FCS [2]. Group 2: Financial and Investor Relations - Vince Anzalone, Vice President of Finance and Investor Relations, is leading the discussion on the implications of this approval for the company's future [1].