Regulatory Approval

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aixbt· 2025-07-06 15:25
so TON's pushing a "stake $100k for UAE golden visa" narrative with zero regulatory approvalCZ already called BS. no updates on any UAE gov sites. VARA, ADGM, SCA all require staking licenses that TON Foundation doesn't havethe setup:• lock $100k in TON for 3 years• pay $35k non refundable "processing fee"• get maybe a visa applicationsame ecosystem that just had a $2M telegram gifts rug yesterday btwstop believing influencer threads about token utility bypassing financial regulations. demand actual license ...
Gossamer Bio (GOSS) Earnings Call Presentation
2025-07-04 14:12
Seralutinib Partnership with Chiesi - Chiesi will provide a $160 million immediate development reimbursement to Gossamer[13] - Gossamer and Chiesi will split US profits 50/50, with mid-to-high teens royalties to Gossamer ex-US[13] - Regulatory milestones could reach up to $146 million, and sales milestones up to $180 million[13] - R&D costs will be split 50/50 worldwide, with Gossamer leading global development and US commercialization of PAH & PH-ILD[13] - Gossamer has a pro forma cash position of approximately $396 million[20, 38] Seralutinib in PAH - Seralutinib is in an ongoing registrational Phase 3 trial for PAH, with topline results expected in Q4 2025[13, 24, 26] - The PROSERA Phase 3 study is a double-blind, placebo-controlled trial with 175 patients per arm[26] - The US has approximately 30,000 to 50,000 PAH patients, with a 5-year survival rate of 57%[13, 22, 23, 35] Seralutinib in PH-ILD - The US has approximately 60,000 to 100,000 PH-ILD patients[13, 29, 35] - The median 5-year survival for PH-ILD patients is 23%[13, 35] - A Phase 3 study in PH-ILD is expected to begin in mid-2025[13, 20] - Only one therapy is approved for PH-ILD in the US[29, 30, 35]
Update on closing timetable for sale of MacGregor
Globenewswire· 2025-07-01 09:15
Core Points - Hiab Corporation announced an update on the closing timetable for the sale of its MacGregor business to funds managed by Triton, with the transaction subject to regulatory approvals [1] - Regulatory approvals have been obtained from various jurisdictions, including the European Union, but approval from the Chinese State Administration for Market Regulation (SAMR) is still pending [2] - The closing of the transaction is now expected by 1 October 2025, which is later than the initially expected date of 1 July 2025 [2] - MacGregor has been reported as part of discontinued operations since the fourth quarter of 2024, and the updated closing timetable is not expected to have a significant financial impact on the company [3] Company Overview - Hiab is a leading provider of smart and sustainable on-road load handling solutions, with a commitment to delivering the best customer experience [3] - The company has a global presence with an extensive network of 3,000 own and partner sales and service locations, enabling delivery to over 100 countries [3] - Hiab's continuing operations sales in 2024 totaled approximately EUR 1.6 billion, and the company employs over 4,000 people [3]
Edgewise Therapeutics (EWTX) Earnings Call Presentation
2025-06-26 12:37
Sevasemten Update June 26, 2025 Forward Looking Statement This presentation contains forward-looking statements as that term is defined in Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. Statements in this press release that are not purely historical are forward-looking statements. Such forward-looking statements include, among other things, statements regarding the potential of, and expectations regarding sevasemten, statements regarding the potential marke ...
American Water Works pany(AWK) - 2016 Q4 - Earnings Call Presentation
2025-06-26 12:37
2016 Fourth Quarter Earnings Conference Call February 22, 2017 1 Forward-Looking Statements Ed Vallejo Vice President Financial Planning and Investor Relations February 2017 NYSE: AWK www.amwater.com 2 Forward-Looking Statements and Other Information Certain statements in this presentation including, without limitation, 2017 earnings guidance, future earnings growth, the outcome of pending acquisition activity, the amount of future capital investments, adjusted O&M efficiency ratio targets, and estimated ou ...
CytoSorbents(CTSO) - 2024 Q2 - Earnings Call Presentation
2025-06-23 07:47
The Unrecognized Faces of Critical Illness CytoSorbents Corporation Nasdaq: CTSO Q2 2024 Earnings Conference Call August 13, 2024 Conference Call Participants Moderator: Eric Ribner LifeSci Advisors Christian Steiner, MD Executive VP Sales & Marketing Managing Director CytoSorbents Europe GmbH Christopher Cramer, MS, MBA Senior VP Business Development 2 Phillip Chan, MD, PhD Chief Executive Officer Vincent Capponi, MS President and Chief Operating Officer Kathleen Bloch, MBA, CPA Chief Financial Officer Eft ...
Inventiva Announces the Appointment of Renée Aguiar-Lucander to its Board of Directors
Globenewswire· 2025-06-10 20:00
Daix (France), New York City (New York, United States), June 10, 2025 – Inventiva (Euronext Paris and Nasdaq: IVA) (“Inventiva” or the “Company”), a clinical-stage biopharmaceutical company focused on the development of oral therapies for the treatment of metabolic dysfunction-associated steatohepatitis (“MASH”), today announced the appointment of Renée Aguiar-Lucander to its Board of Directors. The appointment was approved by shareholders at the recent Company’s Annual General Meeting. Mark Pruzanski, Chai ...
Vaxcyte (PCVX) Conference Transcript
2025-06-05 14:55
Vaxcyte (PCVX) Conference June 05, 2025 09:55 AM ET Speaker0 Alright. Welcome, everyone, to twenty twenty five Jefferies Global Healthcare Conference. My name is Roger Song, one of the senior analysts covering mid cap biotech in The US. It's my pleasure to introduce next presenting company, Backside. So we have a whole crew here. We're gonna have a fireside chat with the CEO, Grant, president and CFO, Andrew, and then COO, Jim. Good morning, gentlemen. Speaker1 Good morning, Roger. Good morning. Speaker0 Aw ...
PTC Therapeutics (PTCT) FY Earnings Call Presentation
2025-06-03 14:54
PTC Therapeutics June 2025 Matthew B. Klein, MD CEO Pam and Kelsey living with PKU 1 Corporate Presentation – June 2025 Forward Looking Statements This presentation contains forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995. All statements contained in this presentation, other than statements of historic fact, are forward-looking statements, including statements regarding: the future expectations, plans and prospects for PTC, including with respect to the ...
Boston Scientific Scraps This Aortic Valve, Sticks To 2025 Outlook
Benzinga· 2025-05-28 19:40
Boston Scientific Corporation BSX is pulling the plug on its ACURATE neo2 and Prime aortic valve systems.What Happened: The medical technology giant halted global sales and abandoned regulatory pursuits—including a long-sought FDA approval—after escalating demands from health authorities rendered the effort too costly. Despite the setback, the Marlborough, Massachusetts-based company signaled confidence in its broader portfolio, affirming that it remains on track to hit its financial targets for the quarter ...