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) Mon, 01 Jun 2026 06:20:00 -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/SEC+Filings/Form++8-K++++++++MoonLake+Immunotherapeut++For%3A+May+22/26578569.html si-local-file:///var/storage/secattach/20260601/26578569.html http://www.streetinsider.com/SEC+Filings/Form++8-K++++++++MoonLake+Immunotherapeut++For%3A+May+22/26578569.html Mon, 01 Jun 2026 06:20:00 -0400 MLTX O.49004955 http://www.streetinsider.com/SEC+Filings/Form++8-K++++++++MoonLake+Immunotherapeut++For%3A+May+22/26578569.html si-local-file:///var/storage/secattach/20260601/26578569.html http://www.streetinsider.com/SEC+Filings/Form++8-K++++++++MoonLake+Immunotherapeut++For%3A+May+22/26578569.html Mon, 01 Jun 2026 06:20:00 -0400 MLTX O.49004955 http://www.streetinsider.com/SEC+Filings/Form++SCHEDULE+13GA++MoonLake+Immunotherapeut+++++++++++++++Filed+by%3A+Cormorant+Asset+Management%2C+LP/26503292.html si-local-file:///var/storage/secattach/20260515/26503292.html http://www.streetinsider.com/SEC+Filings/Form++SCHEDULE+13GA++MoonLake+Immunotherapeut+++++++++++++++Filed+by%3A+Cormorant+Asset+Management%2C+LP/26503292.html Fri, 15 May 2026 13:26:00 -0400 MLTX O.49004955 http://www.streetinsider.com/SEC+Filings/Form++SCHEDULE+13GA++MoonLake+Immunotherapeut+++++++++++++++Filed+by%3A+Cormorant+Asset+Management%2C+LP/26503292.html si-local-file:///var/storage/secattach/20260515/26503292.html http://www.streetinsider.com/SEC+Filings/Form++SCHEDULE+13GA++MoonLake+Immunotherapeut+++++++++++++++Filed+by%3A+Cormorant+Asset+Management%2C+LP/26503292.html Fri, 15 May 2026 13:26:00 -0400 MLTX O.49004955 http://www.streetinsider.com/SEC+Filings/Form++4++++++++++MoonLake+Immunotherapeut++For%3A+May+11++Filed+by%3A+Bodenstedt+Matthias/26486050.html si-local-file:///var/storage/secattach/20260513/26486050.html http://www.streetinsider.com/SEC+Filings/Form++4++++++++++MoonLake+Immunotherapeut++For%3A+May+11++Filed+by%3A+Bodenstedt+Matthias/26486050.html Wed, 13 May 2026 16:10:00 -0400 MLTX O.49004955 http://www.streetinsider.com/SEC+Filings/Form++4++++++++++MoonLake+Immunotherapeut++For%3A+May+11++Filed+by%3A+Bodenstedt+Matthias/26486050.html si-local-file:///var/storage/secattach/20260513/26486050.html http://www.streetinsider.com/SEC+Filings/Form++4++++++++++MoonLake+Immunotherapeut++For%3A+May+11++Filed+by%3A+Bodenstedt+Matthias/26486050.html Wed, 13 May 2026 16:10:00 -0400 MLTX O.49004955 http://www.streetinsider.com/Analyst+PT+Change/Moonlake+Immunotherapeutics+%28MLTX%29+PT+Raised+to+%2430+at+Needham/26472955.html (Updated - May 12, 2026 7:14 AM EDT) <p>Needham analyst Serge Belanger raised the price target on Moonlake Immunotherapeutics (NASDAQ: MLTX) to $30.00 (from $25.00) while maintaining a Buy rating.</p><p>The analyst commented: "MLTX reported 1Q26 financials and provided an update that focused on BLA filing plans for sonelokimab (SLK) in HS.</p><p>In their last pre-BLA meeting, MLTX aligned with FDA on the submission plans and label strategy discussed at their investor event in late-Feb. The BLA filing (planned for Sept 2026) will include ph 2 MIRA trial results, to establish substantial evidence of effectiveness (SEE), and VELA-TEEN trial data.</p><p>This is a best-case http://www.streetinsider.com/Analyst+PT+Change/Moonlake+Immunotherapeutics+%28MLTX%29+PT+Raised+to+%2430+at+Needham/26472955.html Tue, 12 May 2026 07:14:04 -0400 MLTX http://www.streetinsider.com/Analyst+Comments/Moonlake+Immunotherapeutics+%28MLTX%29+PT+Raised+to+%2430+at+Needham/26472955.html (Updated - May 12, 2026 7:14 AM EDT) <p>Needham analyst Serge Belanger raised the price target on Moonlake Immunotherapeutics (NASDAQ: MLTX) to $30.00 (from $25.00) while maintaining a Buy rating.</p><p>The analyst commented: "MLTX reported 1Q26 financials and provided an update that focused on BLA filing plans for sonelokimab (SLK) in HS.</p><p>In their last pre-BLA meeting, MLTX aligned with FDA on the submission plans and label strategy discussed at their investor event in late-Feb. The BLA filing (planned for Sept 2026) will include ph 2 MIRA trial results, to establish substantial evidence of effectiveness (SEE), and VELA-TEEN trial data.</p><p>This is a best-case http://www.streetinsider.com/Analyst+Comments/Moonlake+Immunotherapeutics+%28MLTX%29+PT+Raised+to+%2430+at+Needham/26472955.html Tue, 12 May 2026 07:14:04 -0400 MLTX http://www.streetinsider.com/SEC+Filings/Form++10-Q+++++++MoonLake+Immunotherapeut++For%3A+Mar+31/26465958.html si-local-file:///var/storage/secattach/20260511/26465958.html http://www.streetinsider.com/SEC+Filings/Form++10-Q+++++++MoonLake+Immunotherapeut++For%3A+Mar+31/26465958.html Mon, 11 May 2026 08:56:00 -0400 MLTX O.49004955 http://www.streetinsider.com/SEC+Filings/Form++10-Q+++++++MoonLake+Immunotherapeut++For%3A+Mar+31/26465958.html si-local-file:///var/storage/secattach/20260511/26465958.html http://www.streetinsider.com/SEC+Filings/Form++10-Q+++++++MoonLake+Immunotherapeut++For%3A+Mar+31/26465958.html Mon, 11 May 2026 08:56:00 -0400 MLTX O.49004955 http://www.streetinsider.com/Analyst+PT+Change/Moonlake+Immunotherapeutics+%28MLTX%29+PT+Raised+to+%2445+at+H.C.+Wainwright/26464710.html (Updated - May 11, 2026 7:12 AM EDT) <p>H.C. Wainwright analyst Raghuram Selvaraju raised the price target on Moonlake Immunotherapeutics (NASDAQ: MLTX) to $45.00 (from $40.00) while maintaining a Buy rating.</p><p>The analyst commented: "Yesterday, MoonLake reported the positive outcome of its final pre-BLA meeting held on April 1, 2026, with the FDA on the program in hidradenitis suppurativa (HS) with its nanobody-based candidate sonelokimab (SLK). MoonLake and the FDA aligned on the submission plans and the label strategy, the approach to include adolescent HS data in the Biologics License Application (BLA), and the safety data strategy. Specifically, the FDA re-confirmed the http://www.streetinsider.com/Analyst+PT+Change/Moonlake+Immunotherapeutics+%28MLTX%29+PT+Raised+to+%2445+at+H.C.+Wainwright/26464710.html Mon, 11 May 2026 07:12:23 -0400 MLTX http://www.streetinsider.com/Analyst+Comments/Moonlake+Immunotherapeutics+%28MLTX%29+PT+Raised+to+%2445+at+H.C.+Wainwright/26464710.html (Updated - May 11, 2026 7:12 AM EDT) <p>H.C. Wainwright analyst Raghuram Selvaraju raised the price target on Moonlake Immunotherapeutics (NASDAQ: MLTX) to $45.00 (from $40.00) while maintaining a Buy rating.</p><p>The analyst commented: "Yesterday, MoonLake reported the positive outcome of its final pre-BLA meeting held on April 1, 2026, with the FDA on the program in hidradenitis suppurativa (HS) with its nanobody-based candidate sonelokimab (SLK). MoonLake and the FDA aligned on the submission plans and the label strategy, the approach to include adolescent HS data in the Biologics License Application (BLA), and the safety data strategy. Specifically, the FDA re-confirmed the http://www.streetinsider.com/Analyst+Comments/Moonlake+Immunotherapeutics+%28MLTX%29+PT+Raised+to+%2445+at+H.C.+Wainwright/26464710.html Mon, 11 May 2026 07:12:23 -0400 MLTX http://www.streetinsider.com/SEC+Filings/Form++8-K++++++++MoonLake+Immunotherapeut++For%3A+May+10/26464940.html si-local-file:///var/storage/secattach/20260511/26464940.html http://www.streetinsider.com/SEC+Filings/Form++8-K++++++++MoonLake+Immunotherapeut++For%3A+May+10/26464940.html Mon, 11 May 2026 07:09:00 -0400 MLTX O.49004955 http://www.streetinsider.com/SEC+Filings/Form++8-K++++++++MoonLake+Immunotherapeut++For%3A+May+10/26464940.html si-local-file:///var/storage/secattach/20260511/26464940.html http://www.streetinsider.com/SEC+Filings/Form++8-K++++++++MoonLake+Immunotherapeut++For%3A+May+10/26464940.html Mon, 11 May 2026 07:09:00 -0400 MLTX O.49004955 http://www.streetinsider.com/Earnings/MoonLake+Immunotherapeutics+%28MLTX%29+Misses+Q1+EPS+by+9c/26464499.html <p>MoonLake Immunotherapeutics (NASDAQ: MLTX) reported Q1 EPS of ($0.98), $0.09 worse than the analyst estimate of ($0.89).</p><p>For earnings history and earnings-related data on MoonLake Immunotherapeutics (MLTX) <a href="http://www.streetinsider.com/ec_earnings.php?q=MLTX">click here</a>.</p> http://www.streetinsider.com/Earnings/MoonLake+Immunotherapeutics+%28MLTX%29+Misses+Q1+EPS+by+9c/26464499.html Mon, 11 May 2026 06:29:26 -0400 MLTX http://www.streetinsider.com/FDA/MoonLake+receives+FDA+alignment+on+sonelokimab+BLA+submission+plans/26463404.html <p>MoonLake Immunotherapeutics (NASDAQ: MLTX) announced the completion of its final pre-biologics license application meeting with the U.S. Food and Drug Administration regarding its drug sonelokimab for hidradenitis suppurativa treatment.</p> <p>The FDA agreed to accept data from the company's MIRA clinical trial to establish substantial evidence of effectiveness and approved the inclusion of adolescent patient data from the VELA-TEEN trial for a proposed label covering patients aged 12 years and above. The agency also aligned with MoonLake's safety data strategy across the MIRA and VELA trials.</p> <p>The proposed label is expected to include a 43% HiSCR75 response rate and a 29 percentage point http://www.streetinsider.com/FDA/MoonLake+receives+FDA+alignment+on+sonelokimab+BLA+submission+plans/26463404.html Sun, 10 May 2026 09:00:22 -0400 A.06822034 A.08429512 A.60012014 MLTX O.00811736 O.20026344 O.48492100 O.49004955 http://www.streetinsider.com/FDA/MoonLake+receives+FDA+alignment+on+sonelokimab+BLA+submission+plans/26463404.html <p>MoonLake Immunotherapeutics (NASDAQ: MLTX) announced the completion of its final pre-biologics license application meeting with the U.S. Food and Drug Administration regarding its drug sonelokimab for hidradenitis suppurativa treatment.</p> <p>The FDA agreed to accept data from the company's MIRA clinical trial to establish substantial evidence of effectiveness and approved the inclusion of adolescent patient data from the VELA-TEEN trial for a proposed label covering patients aged 12 years and above. The agency also aligned with MoonLake's safety data strategy across the MIRA and VELA trials.</p> <p>The proposed label is expected to include a 43% HiSCR75 response rate and a 29 percentage point http://www.streetinsider.com/FDA/MoonLake+receives+FDA+alignment+on+sonelokimab+BLA+submission+plans/26463404.html Sun, 10 May 2026 09:00:22 -0400 A.06822034 A.08429512 A.60012014 MLTX O.00811736 O.20026344 O.48492100 O.49004955 http://www.streetinsider.com/FDA/MoonLake+receives+FDA+alignment+on+sonelokimab+BLA+submission+plans/26463404.html <p>MoonLake Immunotherapeutics (NASDAQ: MLTX) announced the completion of its final pre-biologics license application meeting with the U.S. Food and Drug Administration regarding its drug sonelokimab for hidradenitis suppurativa treatment.</p> <p>The FDA agreed to accept data from the company's MIRA clinical trial to establish substantial evidence of effectiveness and approved the inclusion of adolescent patient data from the VELA-TEEN trial for a proposed label covering patients aged 12 years and above. The agency also aligned with MoonLake's safety data strategy across the MIRA and VELA trials.</p> <p>The proposed label is expected to include a 43% HiSCR75 response rate and a 29 percentage point http://www.streetinsider.com/FDA/MoonLake+receives+FDA+alignment+on+sonelokimab+BLA+submission+plans/26463404.html Sun, 10 May 2026 09:00:22 -0400 A.06822034 A.08429512 A.60012014 MLTX O.00811736 O.20026344 O.48492100 O.49004955 http://www.streetinsider.com/FDA/MoonLake+receives+FDA+alignment+on+sonelokimab+BLA+submission+plans/26463404.html <p>MoonLake Immunotherapeutics (NASDAQ: MLTX) announced the completion of its final pre-biologics license application meeting with the U.S. Food and Drug Administration regarding its drug sonelokimab for hidradenitis suppurativa treatment.</p> <p>The FDA agreed to accept data from the company's MIRA clinical trial to establish substantial evidence of effectiveness and approved the inclusion of adolescent patient data from the VELA-TEEN trial for a proposed label covering patients aged 12 years and above. The agency also aligned with MoonLake's safety data strategy across the MIRA and VELA trials.</p> <p>The proposed label is expected to include a 43% HiSCR75 response rate and a 29 percentage point http://www.streetinsider.com/FDA/MoonLake+receives+FDA+alignment+on+sonelokimab+BLA+submission+plans/26463404.html Sun, 10 May 2026 09:00:22 -0400 A.06822034 A.08429512 A.60012014 MLTX O.00811736 O.20026344 O.48492100 O.49004955 http://www.streetinsider.com/FDA/MoonLake+receives+FDA+alignment+on+sonelokimab+BLA+submission+plans/26463404.html <p>MoonLake Immunotherapeutics (NASDAQ: MLTX) announced the completion of its final pre-biologics license application meeting with the U.S. Food and Drug Administration regarding its drug sonelokimab for hidradenitis suppurativa treatment.</p> <p>The FDA agreed to accept data from the company's MIRA clinical trial to establish substantial evidence of effectiveness and approved the inclusion of adolescent patient data from the VELA-TEEN trial for a proposed label covering patients aged 12 years and above. The agency also aligned with MoonLake's safety data strategy across the MIRA and VELA trials.</p> <p>The proposed label is expected to include a 43% HiSCR75 response rate and a 29 percentage point http://www.streetinsider.com/FDA/MoonLake+receives+FDA+alignment+on+sonelokimab+BLA+submission+plans/26463404.html Sun, 10 May 2026 09:00:22 -0400 A.06822034 A.08429512 A.60012014 MLTX O.00811736 O.20026344 O.48492100 O.49004955 http://www.streetinsider.com/FDA/MoonLake+receives+FDA+alignment+on+sonelokimab+BLA+submission+plans/26463404.html <p>MoonLake Immunotherapeutics (NASDAQ: MLTX) announced the completion of its final pre-biologics license application meeting with the U.S. Food and Drug Administration regarding its drug sonelokimab for hidradenitis suppurativa treatment.</p> <p>The FDA agreed to accept data from the company's MIRA clinical trial to establish substantial evidence of effectiveness and approved the inclusion of adolescent patient data from the VELA-TEEN trial for a proposed label covering patients aged 12 years and above. The agency also aligned with MoonLake's safety data strategy across the MIRA and VELA trials.</p> <p>The proposed label is expected to include a 43% HiSCR75 response rate and a 29 percentage point http://www.streetinsider.com/FDA/MoonLake+receives+FDA+alignment+on+sonelokimab+BLA+submission+plans/26463404.html Sun, 10 May 2026 09:00:22 -0400 A.06822034 A.08429512 A.60012014 MLTX O.00811736 O.20026344 O.48492100 O.49004955 http://www.streetinsider.com/FDA/MoonLake+receives+FDA+alignment+on+sonelokimab+BLA+submission+plans/26463404.html <p>MoonLake Immunotherapeutics (NASDAQ: MLTX) announced the completion of its final pre-biologics license application meeting with the U.S. Food and Drug Administration regarding its drug sonelokimab for hidradenitis suppurativa treatment.</p> <p>The FDA agreed to accept data from the company's MIRA clinical trial to establish substantial evidence of effectiveness and approved the inclusion of adolescent patient data from the VELA-TEEN trial for a proposed label covering patients aged 12 years and above. The agency also aligned with MoonLake's safety data strategy across the MIRA and VELA trials.</p> <p>The proposed label is expected to include a 43% HiSCR75 response rate and a 29 percentage point http://www.streetinsider.com/FDA/MoonLake+receives+FDA+alignment+on+sonelokimab+BLA+submission+plans/26463404.html Sun, 10 May 2026 09:00:22 -0400 A.06822034 A.08429512 A.60012014 MLTX O.00811736 O.20026344 O.48492100 O.49004955 http://www.streetinsider.com/FDA/MoonLake+receives+FDA+alignment+on+sonelokimab+BLA+submission+plans/26463404.html <p>MoonLake Immunotherapeutics (NASDAQ: MLTX) announced the completion of its final pre-biologics license application meeting with the U.S. Food and Drug Administration regarding its drug sonelokimab for hidradenitis suppurativa treatment.</p> <p>The FDA agreed to accept data from the company's MIRA clinical trial to establish substantial evidence of effectiveness and approved the inclusion of adolescent patient data from the VELA-TEEN trial for a proposed label covering patients aged 12 years and above. The agency also aligned with MoonLake's safety data strategy across the MIRA and VELA trials.</p> <p>The proposed label is expected to include a 43% HiSCR75 response rate and a 29 percentage point http://www.streetinsider.com/FDA/MoonLake+receives+FDA+alignment+on+sonelokimab+BLA+submission+plans/26463404.html Sun, 10 May 2026 09:00:22 -0400 A.06822034 A.08429512 A.60012014 MLTX O.00811736 O.20026344 O.48492100 O.49004955 http://www.streetinsider.com/FDA/MoonLake+completes+FDA+pre-BLA+meeting+for+hidradenitis+suppurativa+drug/26463402.html <p>MoonLake Immunotherapeutics (NASDAQ: MLTX) announced completion of its final pre-Biologics License Application meeting with the U.S. Food and Drug Administration for sonelokimab in hidradenitis suppurativa treatment. The company said the FDA agreed to its submission plans and label strategy for the drug.</p> <p>The FDA confirmed acceptance of data from the MIRA clinical trial to establish substantial evidence of effectiveness and agreed to include VELA-TEEN trial data for patients aged 12 years and above in the proposed label. The agency also approved the safety data strategy and approach for the clinical safety section.</p> <p>The proposed label is expected to include the MIRA trial's http://www.streetinsider.com/FDA/MoonLake+completes+FDA+pre-BLA+meeting+for+hidradenitis+suppurativa+drug/26463402.html Sun, 10 May 2026 09:00:19 -0400 A.06822034 A.08429512 A.60012014 MLTX O.00811736 O.20026344 O.48492100 O.49004955 http://www.streetinsider.com/FDA/MoonLake+completes+FDA+pre-BLA+meeting+for+hidradenitis+suppurativa+drug/26463402.html <p>MoonLake Immunotherapeutics (NASDAQ: MLTX) announced completion of its final pre-Biologics License Application meeting with the U.S. Food and Drug Administration for sonelokimab in hidradenitis suppurativa treatment. The company said the FDA agreed to its submission plans and label strategy for the drug.</p> <p>The FDA confirmed acceptance of data from the MIRA clinical trial to establish substantial evidence of effectiveness and agreed to include VELA-TEEN trial data for patients aged 12 years and above in the proposed label. The agency also approved the safety data strategy and approach for the clinical safety section.</p> <p>The proposed label is expected to include the MIRA trial's http://www.streetinsider.com/FDA/MoonLake+completes+FDA+pre-BLA+meeting+for+hidradenitis+suppurativa+drug/26463402.html Sun, 10 May 2026 09:00:19 -0400 A.06822034 A.08429512 A.60012014 MLTX O.00811736 O.20026344 O.48492100 O.49004955