Saturday, May 20, 2017 8:30:30 AM
It has reported that GALT is due out with its topline NASH (Nonalcoholic Steatohepatitis) CX trial results in December this year. The company has hinted at the possibility of a Breakthrough Therapy designation if they meet their regulatory endpoints on Hepatic Venous Pressure Gradient (HVPG) and Fibrosis. There seems to be a feeling that there may be a pathway toward provisional approval as they outlined their plans to break the patient groups up into subsets for a follow on phase 3 trial. My understanding is that a few points of improvement in HVPG may result in provisional approval.
The company will need the cash to ramp up and market if it obtains provisional approval. Again, this is absolutely pure speculation, but I cannot think of any other reason for this large offering.
Recent GALT News
- Form 8-K - Current report • Edgar (US Regulatory) • 09/09/2024 12:00:45 PM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 08/26/2024 12:08:18 PM
- Form 8-K - Current report • Edgar (US Regulatory) • 08/13/2024 11:55:19 AM
- Form 10-Q - Quarterly report [Sections 13 or 15(d)] • Edgar (US Regulatory) • 08/13/2024 11:50:29 AM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 08/05/2024 12:41:21 PM
- Form 3 - Initial statement of beneficial ownership of securities • Edgar (US Regulatory) • 08/05/2024 12:38:45 PM
- Form 8-K - Current report • Edgar (US Regulatory) • 08/01/2024 11:50:32 AM
- Form 4/A - Statement of changes in beneficial ownership of securities: [Amend] • Edgar (US Regulatory) • 07/23/2024 01:43:32 PM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 07/23/2024 01:38:41 PM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 06/20/2024 05:55:08 PM
- Form 8-K - Current report • Edgar (US Regulatory) • 05/15/2024 11:55:18 AM
- Form 10-Q - Quarterly report [Sections 13 or 15(d)] • Edgar (US Regulatory) • 05/15/2024 11:50:43 AM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 03/04/2024 05:50:30 PM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 02/07/2024 09:55:59 PM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 02/07/2024 09:53:47 PM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 02/07/2024 09:52:32 PM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 02/07/2024 09:51:03 PM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 02/07/2024 09:50:02 PM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 02/07/2024 09:48:42 PM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 02/07/2024 09:47:36 PM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 02/07/2024 09:46:30 PM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 02/07/2024 09:44:42 PM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 02/07/2024 09:43:19 PM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 02/07/2024 09:40:46 PM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 01/16/2024 04:23:48 PM
VHAI - Vocodia Partners with Leading Political Super PACs to Revolutionize Fundraising Efforts • VHAI • Sep 19, 2024 11:48 AM
Dear Cashmere Group Holding Co. AKA Swifty Global Signs Binding Letter of Intent to be Acquired by Signing Day Sports • DRCR • Sep 19, 2024 10:26 AM
HealthLynked Launches Virtual Urgent Care Through Partnership with Lyric Health. • HLYK • Sep 19, 2024 8:00 AM
Element79 Gold Corp. Appoints Kevin Arias as Advisor to the Board of Directors, Strengthening Strategic Leadership • ELMGF • Sep 18, 2024 10:29 AM
Mawson Finland Limited Further Expands the Known Mineralized Zones at Rajapalot: Palokas step-out drills 7 metres @ 9.1 g/t gold & 706 ppm cobalt • MFL • Sep 17, 2024 9:02 AM
PickleJar Announces Integration With OptCulture to Deliver Holistic Fan Experiences at Venue Point of Sale • PKLE • Sep 17, 2024 8:00 AM