http://www.streetinsider.com Latest StreetInsider.com News Articles en-us Copyright 2026, StreetInsider.com rss@streetinsider.com (SI RSS) rss@streetinsider.com (SI RSS) Tue, 16 Jun 2026 08:30:35 -0400 http://blogs.law.harvard.edu/tech/rss http://www.streetinsider.com/images/rss_logo.gif http://www.streetinsider.com 143 28 0 1 2 3 21 22 23 Saturday Sunday http://www.streetinsider.com/FDA/DIAMEDICA+gets+FDA+feedback+on+DM199+preeclampsia+nonclinical+work/26651026.html <p>DiaMedica Therapeutics Inc. (NASDAQ: DMAC) said it received written feedback from the U.S. Food and Drug Administration regarding additional nonclinical data needed to support continued development of DM199 (rinvecalinase alfa) for the treatment of preeclampsia.</p> <p>According to the company, the FDA indicated that a previously completed rat reproductive toxicity study may be acceptable to support a U.S. investigational new drug (IND) application, provided DiaMedica can demonstrate sufficient evidence of DM199 exposure and enzymatic activity throughout that study, as well as adequate pharmacologic effect in rats to support their use as an appropriate toxicology species.</p> <p>In response, DiaMedica said it is initiating a http://www.streetinsider.com/FDA/DIAMEDICA+gets+FDA+feedback+on+DM199+preeclampsia+nonclinical+work/26651026.html Tue, 16 Jun 2026 08:30:35 -0400 A.06822034 DMAC O.02595765 O.20026344 http://www.streetinsider.com/FDA/DIAMEDICA+gets+FDA+feedback+on+DM199+preeclampsia+nonclinical+work/26651026.html <p>DiaMedica Therapeutics Inc. (NASDAQ: DMAC) said it received written feedback from the U.S. Food and Drug Administration regarding additional nonclinical data needed to support continued development of DM199 (rinvecalinase alfa) for the treatment of preeclampsia.</p> <p>According to the company, the FDA indicated that a previously completed rat reproductive toxicity study may be acceptable to support a U.S. investigational new drug (IND) application, provided DiaMedica can demonstrate sufficient evidence of DM199 exposure and enzymatic activity throughout that study, as well as adequate pharmacologic effect in rats to support their use as an appropriate toxicology species.</p> <p>In response, DiaMedica said it is initiating a http://www.streetinsider.com/FDA/DIAMEDICA+gets+FDA+feedback+on+DM199+preeclampsia+nonclinical+work/26651026.html Tue, 16 Jun 2026 08:30:35 -0400 A.06822034 DMAC O.02595765 O.20026344 http://www.streetinsider.com/FDA/DIAMEDICA+gets+FDA+feedback+on+DM199+preeclampsia+nonclinical+work/26651026.html <p>DiaMedica Therapeutics Inc. (NASDAQ: DMAC) said it received written feedback from the U.S. Food and Drug Administration regarding additional nonclinical data needed to support continued development of DM199 (rinvecalinase alfa) for the treatment of preeclampsia.</p> <p>According to the company, the FDA indicated that a previously completed rat reproductive toxicity study may be acceptable to support a U.S. investigational new drug (IND) application, provided DiaMedica can demonstrate sufficient evidence of DM199 exposure and enzymatic activity throughout that study, as well as adequate pharmacologic effect in rats to support their use as an appropriate toxicology species.</p> <p>In response, DiaMedica said it is initiating a http://www.streetinsider.com/FDA/DIAMEDICA+gets+FDA+feedback+on+DM199+preeclampsia+nonclinical+work/26651026.html Tue, 16 Jun 2026 08:30:35 -0400 A.06822034 DMAC O.02595765 O.20026344 http://www.streetinsider.com/FDA/DIAMEDICA+gets+FDA+feedback+on+DM199+preeclampsia+nonclinical+work/26651026.html <p>DiaMedica Therapeutics Inc. (NASDAQ: DMAC) said it received written feedback from the U.S. Food and Drug Administration regarding additional nonclinical data needed to support continued development of DM199 (rinvecalinase alfa) for the treatment of preeclampsia.</p> <p>According to the company, the FDA indicated that a previously completed rat reproductive toxicity study may be acceptable to support a U.S. investigational new drug (IND) application, provided DiaMedica can demonstrate sufficient evidence of DM199 exposure and enzymatic activity throughout that study, as well as adequate pharmacologic effect in rats to support their use as an appropriate toxicology species.</p> <p>In response, DiaMedica said it is initiating a http://www.streetinsider.com/FDA/DIAMEDICA+gets+FDA+feedback+on+DM199+preeclampsia+nonclinical+work/26651026.html Tue, 16 Jun 2026 08:30:35 -0400 A.06822034 DMAC O.02595765 O.20026344 http://www.streetinsider.com/Press+Releases/DiaMedica+Receives+FDA+Feedback+on+DM199+Preeclampsia+Nonclinical+Program/26650990.html <ul class="bwlistdisc"> <li> <b><i>DiaMedica planning to conduct a rat pharmacokinetic and activity study, which it believes will address FDA-requested data for a preeclampsia IND</i></b> </li> </ul> <p> MINNEAPOLIS--(BUSINESS WIRE)-- DiaMedica Therapeutics Inc. (Nasdaq: DMAC), a clinical-stage biopharmaceutical company, today announced that it has received a written response from the U.S. Food and Drug Administration (FDA) regarding the need for additional nonclinical reproductive toxicity data to support continued development of DM199 (rinvecalinase alfa) for the treatment of preeclampsia (PE). DiaMedica believes, based on the FDA’s feedback, that the previously completed rat reproductive toxicity study may be acceptable to support a U.S. investigational new drug http://www.streetinsider.com/Press+Releases/DiaMedica+Receives+FDA+Feedback+on+DM199+Preeclampsia+Nonclinical+Program/26650990.html Tue, 16 Jun 2026 08:30:00 -0400 A.06822034 DMAC O.02595765 O.20026344 http://www.streetinsider.com/Press+Releases/DiaMedica+Receives+FDA+Feedback+on+DM199+Preeclampsia+Nonclinical+Program/26650990.html <ul class="bwlistdisc"> <li> <b><i>DiaMedica planning to conduct a rat pharmacokinetic and activity study, which it believes will address FDA-requested data for a preeclampsia IND</i></b> </li> </ul> <p> MINNEAPOLIS--(BUSINESS WIRE)-- DiaMedica Therapeutics Inc. (Nasdaq: DMAC), a clinical-stage biopharmaceutical company, today announced that it has received a written response from the U.S. Food and Drug Administration (FDA) regarding the need for additional nonclinical reproductive toxicity data to support continued development of DM199 (rinvecalinase alfa) for the treatment of preeclampsia (PE). DiaMedica believes, based on the FDA’s feedback, that the previously completed rat reproductive toxicity study may be acceptable to support a U.S. investigational new drug http://www.streetinsider.com/Press+Releases/DiaMedica+Receives+FDA+Feedback+on+DM199+Preeclampsia+Nonclinical+Program/26650990.html Tue, 16 Jun 2026 08:30:00 -0400 A.06822034 DMAC O.02595765 O.20026344 http://www.streetinsider.com/Press+Releases/DiaMedica+Receives+FDA+Feedback+on+DM199+Preeclampsia+Nonclinical+Program/26650990.html <ul class="bwlistdisc"> <li> <b><i>DiaMedica planning to conduct a rat pharmacokinetic and activity study, which it believes will address FDA-requested data for a preeclampsia IND</i></b> </li> </ul> <p> MINNEAPOLIS--(BUSINESS WIRE)-- DiaMedica Therapeutics Inc. (Nasdaq: DMAC), a clinical-stage biopharmaceutical company, today announced that it has received a written response from the U.S. Food and Drug Administration (FDA) regarding the need for additional nonclinical reproductive toxicity data to support continued development of DM199 (rinvecalinase alfa) for the treatment of preeclampsia (PE). DiaMedica believes, based on the FDA’s feedback, that the previously completed rat reproductive toxicity study may be acceptable to support a U.S. investigational new drug http://www.streetinsider.com/Press+Releases/DiaMedica+Receives+FDA+Feedback+on+DM199+Preeclampsia+Nonclinical+Program/26650990.html Tue, 16 Jun 2026 08:30:00 -0400 A.06822034 DMAC O.02595765 O.20026344 http://www.streetinsider.com/Press+Releases/DiaMedica+Receives+FDA+Feedback+on+DM199+Preeclampsia+Nonclinical+Program/26650990.html <ul class="bwlistdisc"> <li> <b><i>DiaMedica planning to conduct a rat pharmacokinetic and activity study, which it believes will address FDA-requested data for a preeclampsia IND</i></b> </li> </ul> <p> MINNEAPOLIS--(BUSINESS WIRE)-- DiaMedica Therapeutics Inc. (Nasdaq: DMAC), a clinical-stage biopharmaceutical company, today announced that it has received a written response from the U.S. Food and Drug Administration (FDA) regarding the need for additional nonclinical reproductive toxicity data to support continued development of DM199 (rinvecalinase alfa) for the treatment of preeclampsia (PE). DiaMedica believes, based on the FDA’s feedback, that the previously completed rat reproductive toxicity study may be acceptable to support a U.S. investigational new drug http://www.streetinsider.com/Press+Releases/DiaMedica+Receives+FDA+Feedback+on+DM199+Preeclampsia+Nonclinical+Program/26650990.html Tue, 16 Jun 2026 08:30:00 -0400 A.06822034 DMAC O.02595765 O.20026344 http://www.streetinsider.com/Business+Wire/DiaMedica+Receives+FDA+Feedback+on+DM199+Preeclampsia+Nonclinical+Program/26650990.html <ul class="bwlistdisc"> <li> <b><i>DiaMedica planning to conduct a rat pharmacokinetic and activity study, which it believes will address FDA-requested data for a preeclampsia IND</i></b> </li> </ul> <p> MINNEAPOLIS--(BUSINESS WIRE)-- DiaMedica Therapeutics Inc. (Nasdaq: DMAC), a clinical-stage biopharmaceutical company, today announced that it has received a written response from the U.S. Food and Drug Administration (FDA) regarding the need for additional nonclinical reproductive toxicity data to support continued development of DM199 (rinvecalinase alfa) for the treatment of preeclampsia (PE). DiaMedica believes, based on the FDA’s feedback, that the previously completed rat reproductive toxicity study may be acceptable to support a U.S. investigational new drug http://www.streetinsider.com/Business+Wire/DiaMedica+Receives+FDA+Feedback+on+DM199+Preeclampsia+Nonclinical+Program/26650990.html Tue, 16 Jun 2026 08:30:00 -0400 A.06822034 DMAC O.02595765 O.20026344 http://www.streetinsider.com/Business+Wire/DiaMedica+Receives+FDA+Feedback+on+DM199+Preeclampsia+Nonclinical+Program/26650990.html <ul class="bwlistdisc"> <li> <b><i>DiaMedica planning to conduct a rat pharmacokinetic and activity study, which it believes will address FDA-requested data for a preeclampsia IND</i></b> </li> </ul> <p> MINNEAPOLIS--(BUSINESS WIRE)-- DiaMedica Therapeutics Inc. (Nasdaq: DMAC), a clinical-stage biopharmaceutical company, today announced that it has received a written response from the U.S. Food and Drug Administration (FDA) regarding the need for additional nonclinical reproductive toxicity data to support continued development of DM199 (rinvecalinase alfa) for the treatment of preeclampsia (PE). DiaMedica believes, based on the FDA’s feedback, that the previously completed rat reproductive toxicity study may be acceptable to support a U.S. investigational new drug http://www.streetinsider.com/Business+Wire/DiaMedica+Receives+FDA+Feedback+on+DM199+Preeclampsia+Nonclinical+Program/26650990.html Tue, 16 Jun 2026 08:30:00 -0400 A.06822034 DMAC O.02595765 O.20026344 http://www.streetinsider.com/Business+Wire/DiaMedica+Receives+FDA+Feedback+on+DM199+Preeclampsia+Nonclinical+Program/26650990.html <ul class="bwlistdisc"> <li> <b><i>DiaMedica planning to conduct a rat pharmacokinetic and activity study, which it believes will address FDA-requested data for a preeclampsia IND</i></b> </li> </ul> <p> MINNEAPOLIS--(BUSINESS WIRE)-- DiaMedica Therapeutics Inc. (Nasdaq: DMAC), a clinical-stage biopharmaceutical company, today announced that it has received a written response from the U.S. Food and Drug Administration (FDA) regarding the need for additional nonclinical reproductive toxicity data to support continued development of DM199 (rinvecalinase alfa) for the treatment of preeclampsia (PE). DiaMedica believes, based on the FDA’s feedback, that the previously completed rat reproductive toxicity study may be acceptable to support a U.S. investigational new drug http://www.streetinsider.com/Business+Wire/DiaMedica+Receives+FDA+Feedback+on+DM199+Preeclampsia+Nonclinical+Program/26650990.html Tue, 16 Jun 2026 08:30:00 -0400 A.06822034 DMAC O.02595765 O.20026344 http://www.streetinsider.com/Business+Wire/DiaMedica+Receives+FDA+Feedback+on+DM199+Preeclampsia+Nonclinical+Program/26650990.html <ul class="bwlistdisc"> <li> <b><i>DiaMedica planning to conduct a rat pharmacokinetic and activity study, which it believes will address FDA-requested data for a preeclampsia IND</i></b> </li> </ul> <p> MINNEAPOLIS--(BUSINESS WIRE)-- DiaMedica Therapeutics Inc. (Nasdaq: DMAC), a clinical-stage biopharmaceutical company, today announced that it has received a written response from the U.S. Food and Drug Administration (FDA) regarding the need for additional nonclinical reproductive toxicity data to support continued development of DM199 (rinvecalinase alfa) for the treatment of preeclampsia (PE). DiaMedica believes, based on the FDA’s feedback, that the previously completed rat reproductive toxicity study may be acceptable to support a U.S. investigational new drug http://www.streetinsider.com/Business+Wire/DiaMedica+Receives+FDA+Feedback+on+DM199+Preeclampsia+Nonclinical+Program/26650990.html Tue, 16 Jun 2026 08:30:00 -0400 A.06822034 DMAC O.02595765 O.20026344 http://www.streetinsider.com/SEC+Filings/Form++4++++++++++DiaMedica+Therapeutics++++For%3A+Jun+01++Filed+by%3A+Kuntz+Richard/26600447.html si-local-file:///var/storage/secattach/20260603/26600447.html http://www.streetinsider.com/SEC+Filings/Form++4++++++++++DiaMedica+Therapeutics++++For%3A+Jun+01++Filed+by%3A+Kuntz+Richard/26600447.html Wed, 03 Jun 2026 17:28:00 -0400 DMAC O.02595765 http://www.streetinsider.com/SEC+Filings/Form++4++++++++++DiaMedica+Therapeutics++++For%3A+Jun+01++Filed+by%3A+Kuntz+Richard/26600447.html si-local-file:///var/storage/secattach/20260603/26600447.html http://www.streetinsider.com/SEC+Filings/Form++4++++++++++DiaMedica+Therapeutics++++For%3A+Jun+01++Filed+by%3A+Kuntz+Richard/26600447.html Wed, 03 Jun 2026 17:28:00 -0400 DMAC O.02595765 http://www.streetinsider.com/SEC+Filings/Form++4++++++++++DiaMedica+Therapeutics++++For%3A+Jun+01++Filed+by%3A+Giuffre+Randall+Michael/26600451.html si-local-file:///var/storage/secattach/20260603/26600451.html http://www.streetinsider.com/SEC+Filings/Form++4++++++++++DiaMedica+Therapeutics++++For%3A+Jun+01++Filed+by%3A+Giuffre+Randall+Michael/26600451.html Wed, 03 Jun 2026 17:28:00 -0400 DMAC O.02595765 http://www.streetinsider.com/SEC+Filings/Form++4++++++++++DiaMedica+Therapeutics++++For%3A+Jun+01++Filed+by%3A+Giuffre+Randall+Michael/26600451.html si-local-file:///var/storage/secattach/20260603/26600451.html http://www.streetinsider.com/SEC+Filings/Form++4++++++++++DiaMedica+Therapeutics++++For%3A+Jun+01++Filed+by%3A+Giuffre+Randall+Michael/26600451.html Wed, 03 Jun 2026 17:28:00 -0400 DMAC O.02595765 http://www.streetinsider.com/SEC+Filings/Form++4++++++++++DiaMedica+Therapeutics++++For%3A+Jun+01++Filed+by%3A+Lewis+Tanya/26600433.html si-local-file:///var/storage/secattach/20260603/26600433.html http://www.streetinsider.com/SEC+Filings/Form++4++++++++++DiaMedica+Therapeutics++++For%3A+Jun+01++Filed+by%3A+Lewis+Tanya/26600433.html Wed, 03 Jun 2026 17:27:00 -0400 DMAC O.02595765 http://www.streetinsider.com/SEC+Filings/Form++4++++++++++DiaMedica+Therapeutics++++For%3A+Jun+01++Filed+by%3A+Lewis+Tanya/26600433.html si-local-file:///var/storage/secattach/20260603/26600433.html http://www.streetinsider.com/SEC+Filings/Form++4++++++++++DiaMedica+Therapeutics++++For%3A+Jun+01++Filed+by%3A+Lewis+Tanya/26600433.html Wed, 03 Jun 2026 17:27:00 -0400 DMAC O.02595765 http://www.streetinsider.com/SEC+Filings/Form++4++++++++++DiaMedica+Therapeutics++++For%3A+Jun+01++Filed+by%3A+O%26apos%3BConnor+Daniel+J./26600437.html si-local-file:///var/storage/secattach/20260603/26600437.html http://www.streetinsider.com/SEC+Filings/Form++4++++++++++DiaMedica+Therapeutics++++For%3A+Jun+01++Filed+by%3A+O%26apos%3BConnor+Daniel+J./26600437.html Wed, 03 Jun 2026 17:27:00 -0400 DMAC O.02595765 http://www.streetinsider.com/SEC+Filings/Form++4++++++++++DiaMedica+Therapeutics++++For%3A+Jun+01++Filed+by%3A+O%26apos%3BConnor+Daniel+J./26600437.html si-local-file:///var/storage/secattach/20260603/26600437.html http://www.streetinsider.com/SEC+Filings/Form++4++++++++++DiaMedica+Therapeutics++++For%3A+Jun+01++Filed+by%3A+O%26apos%3BConnor+Daniel+J./26600437.html Wed, 03 Jun 2026 17:27:00 -0400 DMAC O.02595765 http://www.streetinsider.com/SEC+Filings/Form++4++++++++++DiaMedica+Therapeutics++++For%3A+Jun+01++Filed+by%3A+Semba+Charles+Pauling/26600427.html si-local-file:///var/storage/secattach/20260603/26600427.html http://www.streetinsider.com/SEC+Filings/Form++4++++++++++DiaMedica+Therapeutics++++For%3A+Jun+01++Filed+by%3A+Semba+Charles+Pauling/26600427.html Wed, 03 Jun 2026 17:26:00 -0400 DMAC O.02595765 http://www.streetinsider.com/SEC+Filings/Form++4++++++++++DiaMedica+Therapeutics++++For%3A+Jun+01++Filed+by%3A+Semba+Charles+Pauling/26600427.html si-local-file:///var/storage/secattach/20260603/26600427.html http://www.streetinsider.com/SEC+Filings/Form++4++++++++++DiaMedica+Therapeutics++++For%3A+Jun+01++Filed+by%3A+Semba+Charles+Pauling/26600427.html Wed, 03 Jun 2026 17:26:00 -0400 DMAC O.02595765 http://www.streetinsider.com/SEC+Filings/Form++4++++++++++DiaMedica+Therapeutics++++For%3A+Jun+01++Filed+by%3A+Pauls+Dietrich+John/26600394.html si-local-file:///var/storage/secattach/20260603/26600394.html http://www.streetinsider.com/SEC+Filings/Form++4++++++++++DiaMedica+Therapeutics++++For%3A+Jun+01++Filed+by%3A+Pauls+Dietrich+John/26600394.html Wed, 03 Jun 2026 17:24:00 -0400 DMAC O.02595765 http://www.streetinsider.com/SEC+Filings/Form++4++++++++++DiaMedica+Therapeutics++++For%3A+Jun+01++Filed+by%3A+Pauls+Dietrich+John/26600394.html si-local-file:///var/storage/secattach/20260603/26600394.html http://www.streetinsider.com/SEC+Filings/Form++4++++++++++DiaMedica+Therapeutics++++For%3A+Jun+01++Filed+by%3A+Pauls+Dietrich+John/26600394.html Wed, 03 Jun 2026 17:24:00 -0400 DMAC O.02595765 http://www.streetinsider.com/SEC+Filings/Form++4++++++++++DiaMedica+Therapeutics++++For%3A+Jun+01++Filed+by%3A+Parsons+James+T./26600400.html si-local-file:///var/storage/secattach/20260603/26600400.html http://www.streetinsider.com/SEC+Filings/Form++4++++++++++DiaMedica+Therapeutics++++For%3A+Jun+01++Filed+by%3A+Parsons+James+T./26600400.html Wed, 03 Jun 2026 17:24:00 -0400 DMAC O.02595765