|Over a week ago |
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DiaMedica Therapeutics reports Q1 EPS (20c), consensus (16c) » 16:3005/1505/15/23
DiaMedica plans to file a…
DiaMedica plans to file a clinical hold response with the U.S. Food and Drug Administration (FDA) by the end of the week. This request for lifting the clinical hold will include the submission of requested additional supporting data to address prior issues that led to the clinical hold in July 2022. DiaMedica has completed supplemental in-use studies as requested by the FDA. These studies, performed at an independent laboratory, were conducted in two parts. Part 1 simulated actual use of DM199 administration in a hospital setting and Part 2 evaluated worst-case scenarios such as varying storage durations, temperature(s) and light exposure to DM199. DiaMedica believes data from Part 1 confirmed its conclusions from prior testing that the intravenous (IV) dose administered in the ReMEDy2 study was higher than planned due to the change in IV bag materials and was the cause of the hypotension. Accordingly, a dose revision in ReMEDy2 from 1.0 microgram/kg to 0.5 microgram/kg should avoid or minimize the risk of clinically significant hypotension while still reaching what we believe will be a therapeutic blood concentration level. Additionally, results from part 2 of the in-use study were substantially consistent with Part 1 indicating that no special handling instructions should be required. These results are also similar to the Company's IV bag study completed in the fall of 2022. The Company further notes that there are no proposed changes to the ensuing three weeks of subcutaneous dosing under the study protocol. "With the pending submission of our request to lift the clinical hold, we are optimistic that we have fully identified the cause for last year's unexpected hypotensive events and have provided the FDA with adequate data to support our position and allow the FDA to lift the clinical hold," commented Rick Pauls, DiaMedica's Chief Executive Officer. "We look forward to receiving the FDA's response and hope to then be able to resume our work advancing the science of stroke care."
|Over a month ago|
Fly Insider: Better Therapeutics, AMD among week's notable insider transactions » 14:5504/1704/17/23
BTTX, ALOT, DMAC, SMPL, AMD, AAPL, FDX, COIN
Welcome to "Fly Insider,"…
DiaMedica Therapeutics appoints David Wambeke CBO » 08:4304/1104/11/23
DiaMedica Therapeutics …
DiaMedica Therapeutics announced the appointment of David Wambeke, as Chief Business Officer CBO . In this position, he will lead business development, including financing and partnering strategies, and acceleration of prioritized development programs, as well as other business operations.
DiaMedica Therapeutics reports FY22 EPS (52c), consensus (52c) » 16:3103/2803/28/23
"With the completion…
"With the completion of the in-use study at hand, we look forward to continuing to work with the FDA to confirm that we have addressed all issues of the clinical hold and then prepare our complete response requesting a lifting of the clinical hold," commented Rick Pauls, DiaMedica's Chief Executive Officer. "We believe that we've addressed the issues raised by the FDA and are optimistic that the results of the in-use study will fully and finally confirm the cause of the hypotensive events."
DiaMedica Therapeutics says does not hold deposits at Silicon Valley Bank » 16:5303/1003/10/23
In a regulatory 8-K…
In a regulatory 8-K filing, the company states: "On March 10, 2023, DiaMedica Therapeutics Inc. announced that it does not hold cash deposits or securities at Silicon Valley Bank."
|Over a quarter ago|
DiaMedica Therapeutics reports Q3 EPS (12c), consensus (15c) » 16:3611/0911/09/22
DiaMedica reported total…
DiaMedica reported total cash, cash equivalents and investments of $36.1 million, current liabilities of $1.5 million and working capital of $34.9 million as of September 30, 2022, compared to total cash, cash equivalents and investments of $45.1 million, $1.5 million in current liabilities and $43.9 million in working capital as of December 31, 2021. The decreases in cash and investments and in working capital were due primarily to cash used to fund operating activities during the nine months ended September 30, 2022.
DiaMedica Therapeutics provides update on ReMEDy2 trial » 16:3610/2610/26/22
DiaMedica Therapeutics announced that the Company has received further guidance from the U.S. Food and Drug Administration (FDA) regarding the clinical hold on its ReMEDy2 Phase 2/3 trial for the treatment of acute ischemic stroke (AIS). The FDA stated it is maintaining its clinical hold at this time and that additional non-clinical data related to the materials used by a hospital in the IV infusion process is needed to resolve the clinical hold. In response to the FDA's clinical hold letter in July 2022 related to three serious adverse event cases of transient acute hypotension during intravenous infusion of DM199, the Company previously submitted to the FDA supporting in vitro data that the etiology (cause) is likely related to switching the type of intravenous (IV) bag used in the prior ReMEDy 1 trial, where no hypotensive episodes were reported, versus the current ReMEDy 2 trial. Hypotension is a known response to DM199 treatment. Significant differences in protein binding were observed between the two types of IV bags used in the studies that the Company believes altered the total amount of drug being administered. Following review of this data, the FDA requested an additional in-use in vitro stability study of the IV administration of DM199 which includes the IV tubing and mechanical infusion pump to further rule out any etiology other than IV bag protein binding. Preparations for these in vitro studies are already underway and the Company will request a Type A FDA meeting to confirm the study design and obtain additional guidance towards lifting the clinical hold and resuming the ReMEDy2 trial. The Company plans to provide an update on the timing of completion of the in-use in-vitro study and data submission following consultation with the FDA. Rick Pauls, DiaMedica's Chief Executive Officer, commented "Patient safety remains our top priority. We believe that we now have a clear path to resolving the clinical hold and we are highly focused on resuming the ReMEDy2 trial as quickly as possible."
DiaMedica Therapeutics reports Q2 EPS (13c), consensus (18c) » 17:2208/1008/10/22
DiaMedica reported total…
DiaMedica reported total cash and investments of $38.4M, current liabilities of $1.5M and working capital of $37.6M as of June 30, 2022, compared to total cash and investments of $45.1M, $1.5M in current liabilities and $43.9M in working capital as of December 31, 2021.
Fly Intel: Pre-market Movers » 08:5507/0707/07/22
SGEN, EDR, LAMR, GME, SPCE, ENSV, HELE, MRK, CNSL, DMAC, BA, CTMX
Check out this morning's…
DiaMedica Therapeutics price target lowered to $8 from $14 at Lake Street » 08:4407/0707/07/22
Lake Street analyst…
Lake Street analyst Thomas Flaten lowered the firm's price target on DiaMedica Therapeutics to $8 from $14 and keeps a Buy rating on the shares after the company announced the FDA has placed a clinical hold on the ReMEDy2 stroke study. While "not positive," he believes the issue leading to the hold may be resolved in short order and that the company should then be able to restart enrollment, said Flaten, who expresses confidence that there will not be a significant delay to the interim analysis readout.