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, 15 Sep 2026 07:30:00 -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/Press+Releases/Knight+Therapeutics+Announces+Regulatory+Submission+of+GEMTESA%C2%AE+in+Canada/27061127.html <p align="justify">MONTREAL, Sept. 15, 2026 (GLOBE NEWSWIRE) -- Knight Therapeutics Inc. (&quot;Knight&quot;) (TSX: GUD), a pan-American (ex-US) pharmaceutical company, announced today that Knight’s New Drug Submission (NDS) for GEMTESA® (vibegron), proposed for the treatment of overactive bladder (OAB) with symptoms of urge urinary incontinence, urgency, and urinary frequency in adults, and OAB with symptoms of urge urinary incontinence, urgency, urinary frequency, and nocturia in adult males on pharmacological therapy for benign prostatic hyperplasia (BPH), has been accepted for review by Health Canada.</p> <p align="justify">&quot;For patients living with overactive bladder, and for adult males managing OAB alongside BPH, http://www.streetinsider.com/Press+Releases/Knight+Therapeutics+Announces+Regulatory+Submission+of+GEMTESA%C2%AE+in+Canada/27061127.html Tue, 15 Sep 2026 07:30:00 -0400 GUD http://www.streetinsider.com/Globe+Newswire/Knight+Therapeutics+Announces+Regulatory+Submission+of+GEMTESA%C2%AE+in+Canada/27061127.html <p align="justify">MONTREAL, Sept. 15, 2026 (GLOBE NEWSWIRE) -- Knight Therapeutics Inc. (&quot;Knight&quot;) (TSX: GUD), a pan-American (ex-US) pharmaceutical company, announced today that Knight’s New Drug Submission (NDS) for GEMTESA® (vibegron), proposed for the treatment of overactive bladder (OAB) with symptoms of urge urinary incontinence, urgency, and urinary frequency in adults, and OAB with symptoms of urge urinary incontinence, urgency, urinary frequency, and nocturia in adult males on pharmacological therapy for benign prostatic hyperplasia (BPH), has been accepted for review by Health Canada.</p> <p align="justify">&quot;For patients living with overactive bladder, and for adult males managing OAB alongside BPH, http://www.streetinsider.com/Globe+Newswire/Knight+Therapeutics+Announces+Regulatory+Submission+of+GEMTESA%C2%AE+in+Canada/27061127.html Tue, 15 Sep 2026 07:30:00 -0400 GUD http://www.streetinsider.com/Press+Releases/Knight+Therapeutics+Announces+Regulatory+Approval+of+TAVALISSE%C2%AE+in+Colombia/27014059.html <p align="justify">MONTREAL, Sept. 01, 2026 (GLOBE NEWSWIRE) -- Knight Therapeutics Inc. (&quot;Knight&quot;) (TSX: GUD), a pan-American (ex-US) pharmaceutical company, announced today that it has received regulatory approval from INVIMA, the Colombian health regulatory agency, for TAVALISSE® (fostamatinib disodium hexahydrate) for the treatment of adult patients with chronic immune thrombocytopenia (ITP) who have had an insufficient response, loss of response, or intolerance to prior treatment with corticosteroids and intravenous immunoglobulin.1</p> <p align="justify">“We are pleased to receive regulatory approval of TAVALISSE in Colombia, providing an important new therapeutic option http://www.streetinsider.com/Press+Releases/Knight+Therapeutics+Announces+Regulatory+Approval+of+TAVALISSE%C2%AE+in+Colombia/27014059.html Tue, 01 Sep 2026 18:00:00 -0400 GUD http://www.streetinsider.com/Globe+Newswire/Knight+Therapeutics+Announces+Regulatory+Approval+of+TAVALISSE%C2%AE+in+Colombia/27014059.html <p align="justify">MONTREAL, Sept. 01, 2026 (GLOBE NEWSWIRE) -- Knight Therapeutics Inc. (&quot;Knight&quot;) (TSX: GUD), a pan-American (ex-US) pharmaceutical company, announced today that it has received regulatory approval from INVIMA, the Colombian health regulatory agency, for TAVALISSE® (fostamatinib disodium hexahydrate) for the treatment of adult patients with chronic immune thrombocytopenia (ITP) who have had an insufficient response, loss of response, or intolerance to prior treatment with corticosteroids and intravenous immunoglobulin.1</p> <p align="justify">“We are pleased to receive regulatory approval of TAVALISSE in Colombia, providing an important new therapeutic option http://www.streetinsider.com/Globe+Newswire/Knight+Therapeutics+Announces+Regulatory+Approval+of+TAVALISSE%C2%AE+in+Colombia/27014059.html Tue, 01 Sep 2026 18:00:00 -0400 GUD http://www.streetinsider.com/Press+Releases/Knight+Therapeutics+Announces+Supplemental+Regulatory+Submission+for+MINJUVI%C2%AE+%28tafasitamab%29+in+Brazil/26991515.html <p align="justify">MONTREAL, Aug. 27, 2026 (GLOBE NEWSWIRE) -- Knight Therapeutics Inc. (&quot;Knight&quot;) (TSX: GUD), a pan-American (ex-US) pharmaceutical company, announced today that it has submitted a supplemental application to ANVISA, the Brazilian health regulatory agency, seeking approval for an additional indication for MINJUVI® (tafasitamab) in combination with lenalidomide added to R-CHOP (rituximab, cyclophosphamide, doxorubicin, vincristine and prednisone; Tafa-Len-R-CHOP) as a first-line treatment for adults with previously untreated diffuse large B-cell lymphoma (DLBCL) or high-grade B-cell lymphoma (HGBL). The supplemental application for the additional indication was selected for review under Project Orbis.</p> <p align="justify">“This supplemental submission to ANVISA http://www.streetinsider.com/Press+Releases/Knight+Therapeutics+Announces+Supplemental+Regulatory+Submission+for+MINJUVI%C2%AE+%28tafasitamab%29+in+Brazil/26991515.html Thu, 27 Aug 2026 18:00:00 -0400 A.08439236 A.17568957 GUD INCY O.00059377 O.00160346 O.04889877 O.17511696 http://www.streetinsider.com/Press+Releases/Knight+Therapeutics+Announces+Supplemental+Regulatory+Submission+for+MINJUVI%C2%AE+%28tafasitamab%29+in+Brazil/26991515.html <p align="justify">MONTREAL, Aug. 27, 2026 (GLOBE NEWSWIRE) -- Knight Therapeutics Inc. (&quot;Knight&quot;) (TSX: GUD), a pan-American (ex-US) pharmaceutical company, announced today that it has submitted a supplemental application to ANVISA, the Brazilian health regulatory agency, seeking approval for an additional indication for MINJUVI® (tafasitamab) in combination with lenalidomide added to R-CHOP (rituximab, cyclophosphamide, doxorubicin, vincristine and prednisone; Tafa-Len-R-CHOP) as a first-line treatment for adults with previously untreated diffuse large B-cell lymphoma (DLBCL) or high-grade B-cell lymphoma (HGBL). The supplemental application for the additional indication was selected for review under Project Orbis.</p> <p align="justify">“This supplemental submission to ANVISA http://www.streetinsider.com/Press+Releases/Knight+Therapeutics+Announces+Supplemental+Regulatory+Submission+for+MINJUVI%C2%AE+%28tafasitamab%29+in+Brazil/26991515.html Thu, 27 Aug 2026 18:00:00 -0400 A.08439236 A.17568957 GUD INCY O.00059377 O.00160346 O.04889877 O.17511696 http://www.streetinsider.com/Press+Releases/Knight+Therapeutics+Announces+Supplemental+Regulatory+Submission+for+MINJUVI%C2%AE+%28tafasitamab%29+in+Brazil/26991515.html <p align="justify">MONTREAL, Aug. 27, 2026 (GLOBE NEWSWIRE) -- Knight Therapeutics Inc. (&quot;Knight&quot;) (TSX: GUD), a pan-American (ex-US) pharmaceutical company, announced today that it has submitted a supplemental application to ANVISA, the Brazilian health regulatory agency, seeking approval for an additional indication for MINJUVI® (tafasitamab) in combination with lenalidomide added to R-CHOP (rituximab, cyclophosphamide, doxorubicin, vincristine and prednisone; Tafa-Len-R-CHOP) as a first-line treatment for adults with previously untreated diffuse large B-cell lymphoma (DLBCL) or high-grade B-cell lymphoma (HGBL). The supplemental application for the additional indication was selected for review under Project Orbis.</p> <p align="justify">“This supplemental submission to ANVISA http://www.streetinsider.com/Press+Releases/Knight+Therapeutics+Announces+Supplemental+Regulatory+Submission+for+MINJUVI%C2%AE+%28tafasitamab%29+in+Brazil/26991515.html Thu, 27 Aug 2026 18:00:00 -0400 A.08439236 A.17568957 GUD INCY O.00059377 O.00160346 O.04889877 O.17511696 http://www.streetinsider.com/Press+Releases/Knight+Therapeutics+Announces+Supplemental+Regulatory+Submission+for+MINJUVI%C2%AE+%28tafasitamab%29+in+Brazil/26991515.html <p align="justify">MONTREAL, Aug. 27, 2026 (GLOBE NEWSWIRE) -- Knight Therapeutics Inc. (&quot;Knight&quot;) (TSX: GUD), a pan-American (ex-US) pharmaceutical company, announced today that it has submitted a supplemental application to ANVISA, the Brazilian health regulatory agency, seeking approval for an additional indication for MINJUVI® (tafasitamab) in combination with lenalidomide added to R-CHOP (rituximab, cyclophosphamide, doxorubicin, vincristine and prednisone; Tafa-Len-R-CHOP) as a first-line treatment for adults with previously untreated diffuse large B-cell lymphoma (DLBCL) or high-grade B-cell lymphoma (HGBL). The supplemental application for the additional indication was selected for review under Project Orbis.</p> <p align="justify">“This supplemental submission to ANVISA http://www.streetinsider.com/Press+Releases/Knight+Therapeutics+Announces+Supplemental+Regulatory+Submission+for+MINJUVI%C2%AE+%28tafasitamab%29+in+Brazil/26991515.html Thu, 27 Aug 2026 18:00:00 -0400 A.08439236 A.17568957 GUD INCY O.00059377 O.00160346 O.04889877 O.17511696 http://www.streetinsider.com/Press+Releases/Knight+Therapeutics+Announces+Supplemental+Regulatory+Submission+for+MINJUVI%C2%AE+%28tafasitamab%29+in+Brazil/26991515.html <p align="justify">MONTREAL, Aug. 27, 2026 (GLOBE NEWSWIRE) -- Knight Therapeutics Inc. (&quot;Knight&quot;) (TSX: GUD), a pan-American (ex-US) pharmaceutical company, announced today that it has submitted a supplemental application to ANVISA, the Brazilian health regulatory agency, seeking approval for an additional indication for MINJUVI® (tafasitamab) in combination with lenalidomide added to R-CHOP (rituximab, cyclophosphamide, doxorubicin, vincristine and prednisone; Tafa-Len-R-CHOP) as a first-line treatment for adults with previously untreated diffuse large B-cell lymphoma (DLBCL) or high-grade B-cell lymphoma (HGBL). The supplemental application for the additional indication was selected for review under Project Orbis.</p> <p align="justify">“This supplemental submission to ANVISA http://www.streetinsider.com/Press+Releases/Knight+Therapeutics+Announces+Supplemental+Regulatory+Submission+for+MINJUVI%C2%AE+%28tafasitamab%29+in+Brazil/26991515.html Thu, 27 Aug 2026 18:00:00 -0400 A.08439236 A.17568957 GUD INCY O.00059377 O.00160346 O.04889877 O.17511696 http://www.streetinsider.com/Press+Releases/Knight+Therapeutics+Announces+Supplemental+Regulatory+Submission+for+MINJUVI%C2%AE+%28tafasitamab%29+in+Brazil/26991515.html <p align="justify">MONTREAL, Aug. 27, 2026 (GLOBE NEWSWIRE) -- Knight Therapeutics Inc. (&quot;Knight&quot;) (TSX: GUD), a pan-American (ex-US) pharmaceutical company, announced today that it has submitted a supplemental application to ANVISA, the Brazilian health regulatory agency, seeking approval for an additional indication for MINJUVI® (tafasitamab) in combination with lenalidomide added to R-CHOP (rituximab, cyclophosphamide, doxorubicin, vincristine and prednisone; Tafa-Len-R-CHOP) as a first-line treatment for adults with previously untreated diffuse large B-cell lymphoma (DLBCL) or high-grade B-cell lymphoma (HGBL). The supplemental application for the additional indication was selected for review under Project Orbis.</p> <p align="justify">“This supplemental submission to ANVISA http://www.streetinsider.com/Press+Releases/Knight+Therapeutics+Announces+Supplemental+Regulatory+Submission+for+MINJUVI%C2%AE+%28tafasitamab%29+in+Brazil/26991515.html Thu, 27 Aug 2026 18:00:00 -0400 A.08439236 A.17568957 GUD INCY O.00059377 O.00160346 O.04889877 O.17511696 http://www.streetinsider.com/Press+Releases/Knight+Therapeutics+Announces+Supplemental+Regulatory+Submission+for+MINJUVI%C2%AE+%28tafasitamab%29+in+Brazil/26991515.html <p align="justify">MONTREAL, Aug. 27, 2026 (GLOBE NEWSWIRE) -- Knight Therapeutics Inc. (&quot;Knight&quot;) (TSX: GUD), a pan-American (ex-US) pharmaceutical company, announced today that it has submitted a supplemental application to ANVISA, the Brazilian health regulatory agency, seeking approval for an additional indication for MINJUVI® (tafasitamab) in combination with lenalidomide added to R-CHOP (rituximab, cyclophosphamide, doxorubicin, vincristine and prednisone; Tafa-Len-R-CHOP) as a first-line treatment for adults with previously untreated diffuse large B-cell lymphoma (DLBCL) or high-grade B-cell lymphoma (HGBL). The supplemental application for the additional indication was selected for review under Project Orbis.</p> <p align="justify">“This supplemental submission to ANVISA http://www.streetinsider.com/Press+Releases/Knight+Therapeutics+Announces+Supplemental+Regulatory+Submission+for+MINJUVI%C2%AE+%28tafasitamab%29+in+Brazil/26991515.html Thu, 27 Aug 2026 18:00:00 -0400 A.08439236 A.17568957 GUD INCY O.00059377 O.00160346 O.04889877 O.17511696 http://www.streetinsider.com/Press+Releases/Knight+Therapeutics+Announces+Supplemental+Regulatory+Submission+for+MINJUVI%C2%AE+%28tafasitamab%29+in+Brazil/26991515.html <p align="justify">MONTREAL, Aug. 27, 2026 (GLOBE NEWSWIRE) -- Knight Therapeutics Inc. (&quot;Knight&quot;) (TSX: GUD), a pan-American (ex-US) pharmaceutical company, announced today that it has submitted a supplemental application to ANVISA, the Brazilian health regulatory agency, seeking approval for an additional indication for MINJUVI® (tafasitamab) in combination with lenalidomide added to R-CHOP (rituximab, cyclophosphamide, doxorubicin, vincristine and prednisone; Tafa-Len-R-CHOP) as a first-line treatment for adults with previously untreated diffuse large B-cell lymphoma (DLBCL) or high-grade B-cell lymphoma (HGBL). The supplemental application for the additional indication was selected for review under Project Orbis.</p> <p align="justify">“This supplemental submission to ANVISA http://www.streetinsider.com/Press+Releases/Knight+Therapeutics+Announces+Supplemental+Regulatory+Submission+for+MINJUVI%C2%AE+%28tafasitamab%29+in+Brazil/26991515.html Thu, 27 Aug 2026 18:00:00 -0400 A.08439236 A.17568957 GUD INCY O.00059377 O.00160346 O.04889877 O.17511696 http://www.streetinsider.com/Globe+Newswire/Knight+Therapeutics+Announces+Supplemental+Regulatory+Submission+for+MINJUVI%C2%AE+%28tafasitamab%29+in+Brazil/26991515.html <p align="justify">MONTREAL, Aug. 27, 2026 (GLOBE NEWSWIRE) -- Knight Therapeutics Inc. (&quot;Knight&quot;) (TSX: GUD), a pan-American (ex-US) pharmaceutical company, announced today that it has submitted a supplemental application to ANVISA, the Brazilian health regulatory agency, seeking approval for an additional indication for MINJUVI® (tafasitamab) in combination with lenalidomide added to R-CHOP (rituximab, cyclophosphamide, doxorubicin, vincristine and prednisone; Tafa-Len-R-CHOP) as a first-line treatment for adults with previously untreated diffuse large B-cell lymphoma (DLBCL) or high-grade B-cell lymphoma (HGBL). The supplemental application for the additional indication was selected for review under Project Orbis.</p> <p align="justify">“This supplemental submission to ANVISA http://www.streetinsider.com/Globe+Newswire/Knight+Therapeutics+Announces+Supplemental+Regulatory+Submission+for+MINJUVI%C2%AE+%28tafasitamab%29+in+Brazil/26991515.html Thu, 27 Aug 2026 18:00:00 -0400 A.08439236 A.17568957 GUD INCY O.00059377 O.00160346 O.04889877 O.17511696 http://www.streetinsider.com/Globe+Newswire/Knight+Therapeutics+Announces+Supplemental+Regulatory+Submission+for+MINJUVI%C2%AE+%28tafasitamab%29+in+Brazil/26991515.html <p align="justify">MONTREAL, Aug. 27, 2026 (GLOBE NEWSWIRE) -- Knight Therapeutics Inc. (&quot;Knight&quot;) (TSX: GUD), a pan-American (ex-US) pharmaceutical company, announced today that it has submitted a supplemental application to ANVISA, the Brazilian health regulatory agency, seeking approval for an additional indication for MINJUVI® (tafasitamab) in combination with lenalidomide added to R-CHOP (rituximab, cyclophosphamide, doxorubicin, vincristine and prednisone; Tafa-Len-R-CHOP) as a first-line treatment for adults with previously untreated diffuse large B-cell lymphoma (DLBCL) or high-grade B-cell lymphoma (HGBL). The supplemental application for the additional indication was selected for review under Project Orbis.</p> <p align="justify">“This supplemental submission to ANVISA http://www.streetinsider.com/Globe+Newswire/Knight+Therapeutics+Announces+Supplemental+Regulatory+Submission+for+MINJUVI%C2%AE+%28tafasitamab%29+in+Brazil/26991515.html Thu, 27 Aug 2026 18:00:00 -0400 A.08439236 A.17568957 GUD INCY O.00059377 O.00160346 O.04889877 O.17511696 http://www.streetinsider.com/Globe+Newswire/Knight+Therapeutics+Announces+Supplemental+Regulatory+Submission+for+MINJUVI%C2%AE+%28tafasitamab%29+in+Brazil/26991515.html <p align="justify">MONTREAL, Aug. 27, 2026 (GLOBE NEWSWIRE) -- Knight Therapeutics Inc. (&quot;Knight&quot;) (TSX: GUD), a pan-American (ex-US) pharmaceutical company, announced today that it has submitted a supplemental application to ANVISA, the Brazilian health regulatory agency, seeking approval for an additional indication for MINJUVI® (tafasitamab) in combination with lenalidomide added to R-CHOP (rituximab, cyclophosphamide, doxorubicin, vincristine and prednisone; Tafa-Len-R-CHOP) as a first-line treatment for adults with previously untreated diffuse large B-cell lymphoma (DLBCL) or high-grade B-cell lymphoma (HGBL). The supplemental application for the additional indication was selected for review under Project Orbis.</p> <p align="justify">“This supplemental submission to ANVISA http://www.streetinsider.com/Globe+Newswire/Knight+Therapeutics+Announces+Supplemental+Regulatory+Submission+for+MINJUVI%C2%AE+%28tafasitamab%29+in+Brazil/26991515.html Thu, 27 Aug 2026 18:00:00 -0400 A.08439236 A.17568957 GUD INCY O.00059377 O.00160346 O.04889877 O.17511696 http://www.streetinsider.com/Globe+Newswire/Knight+Therapeutics+Announces+Supplemental+Regulatory+Submission+for+MINJUVI%C2%AE+%28tafasitamab%29+in+Brazil/26991515.html <p align="justify">MONTREAL, Aug. 27, 2026 (GLOBE NEWSWIRE) -- Knight Therapeutics Inc. (&quot;Knight&quot;) (TSX: GUD), a pan-American (ex-US) pharmaceutical company, announced today that it has submitted a supplemental application to ANVISA, the Brazilian health regulatory agency, seeking approval for an additional indication for MINJUVI® (tafasitamab) in combination with lenalidomide added to R-CHOP (rituximab, cyclophosphamide, doxorubicin, vincristine and prednisone; Tafa-Len-R-CHOP) as a first-line treatment for adults with previously untreated diffuse large B-cell lymphoma (DLBCL) or high-grade B-cell lymphoma (HGBL). The supplemental application for the additional indication was selected for review under Project Orbis.</p> <p align="justify">“This supplemental submission to ANVISA http://www.streetinsider.com/Globe+Newswire/Knight+Therapeutics+Announces+Supplemental+Regulatory+Submission+for+MINJUVI%C2%AE+%28tafasitamab%29+in+Brazil/26991515.html Thu, 27 Aug 2026 18:00:00 -0400 A.08439236 A.17568957 GUD INCY O.00059377 O.00160346 O.04889877 O.17511696 http://www.streetinsider.com/Globe+Newswire/Knight+Therapeutics+Announces+Supplemental+Regulatory+Submission+for+MINJUVI%C2%AE+%28tafasitamab%29+in+Brazil/26991515.html <p align="justify">MONTREAL, Aug. 27, 2026 (GLOBE NEWSWIRE) -- Knight Therapeutics Inc. (&quot;Knight&quot;) (TSX: GUD), a pan-American (ex-US) pharmaceutical company, announced today that it has submitted a supplemental application to ANVISA, the Brazilian health regulatory agency, seeking approval for an additional indication for MINJUVI® (tafasitamab) in combination with lenalidomide added to R-CHOP (rituximab, cyclophosphamide, doxorubicin, vincristine and prednisone; Tafa-Len-R-CHOP) as a first-line treatment for adults with previously untreated diffuse large B-cell lymphoma (DLBCL) or high-grade B-cell lymphoma (HGBL). The supplemental application for the additional indication was selected for review under Project Orbis.</p> <p align="justify">“This supplemental submission to ANVISA http://www.streetinsider.com/Globe+Newswire/Knight+Therapeutics+Announces+Supplemental+Regulatory+Submission+for+MINJUVI%C2%AE+%28tafasitamab%29+in+Brazil/26991515.html Thu, 27 Aug 2026 18:00:00 -0400 A.08439236 A.17568957 GUD INCY O.00059377 O.00160346 O.04889877 O.17511696 http://www.streetinsider.com/Globe+Newswire/Knight+Therapeutics+Announces+Supplemental+Regulatory+Submission+for+MINJUVI%C2%AE+%28tafasitamab%29+in+Brazil/26991515.html <p align="justify">MONTREAL, Aug. 27, 2026 (GLOBE NEWSWIRE) -- Knight Therapeutics Inc. (&quot;Knight&quot;) (TSX: GUD), a pan-American (ex-US) pharmaceutical company, announced today that it has submitted a supplemental application to ANVISA, the Brazilian health regulatory agency, seeking approval for an additional indication for MINJUVI® (tafasitamab) in combination with lenalidomide added to R-CHOP (rituximab, cyclophosphamide, doxorubicin, vincristine and prednisone; Tafa-Len-R-CHOP) as a first-line treatment for adults with previously untreated diffuse large B-cell lymphoma (DLBCL) or high-grade B-cell lymphoma (HGBL). The supplemental application for the additional indication was selected for review under Project Orbis.</p> <p align="justify">“This supplemental submission to ANVISA http://www.streetinsider.com/Globe+Newswire/Knight+Therapeutics+Announces+Supplemental+Regulatory+Submission+for+MINJUVI%C2%AE+%28tafasitamab%29+in+Brazil/26991515.html Thu, 27 Aug 2026 18:00:00 -0400 A.08439236 A.17568957 GUD INCY O.00059377 O.00160346 O.04889877 O.17511696 http://www.streetinsider.com/Globe+Newswire/Knight+Therapeutics+Announces+Supplemental+Regulatory+Submission+for+MINJUVI%C2%AE+%28tafasitamab%29+in+Brazil/26991515.html <p align="justify">MONTREAL, Aug. 27, 2026 (GLOBE NEWSWIRE) -- Knight Therapeutics Inc. (&quot;Knight&quot;) (TSX: GUD), a pan-American (ex-US) pharmaceutical company, announced today that it has submitted a supplemental application to ANVISA, the Brazilian health regulatory agency, seeking approval for an additional indication for MINJUVI® (tafasitamab) in combination with lenalidomide added to R-CHOP (rituximab, cyclophosphamide, doxorubicin, vincristine and prednisone; Tafa-Len-R-CHOP) as a first-line treatment for adults with previously untreated diffuse large B-cell lymphoma (DLBCL) or high-grade B-cell lymphoma (HGBL). The supplemental application for the additional indication was selected for review under Project Orbis.</p> <p align="justify">“This supplemental submission to ANVISA http://www.streetinsider.com/Globe+Newswire/Knight+Therapeutics+Announces+Supplemental+Regulatory+Submission+for+MINJUVI%C2%AE+%28tafasitamab%29+in+Brazil/26991515.html Thu, 27 Aug 2026 18:00:00 -0400 A.08439236 A.17568957 GUD INCY O.00059377 O.00160346 O.04889877 O.17511696 http://www.streetinsider.com/Globe+Newswire/Knight+Therapeutics+Announces+Supplemental+Regulatory+Submission+for+MINJUVI%C2%AE+%28tafasitamab%29+in+Brazil/26991515.html <p align="justify">MONTREAL, Aug. 27, 2026 (GLOBE NEWSWIRE) -- Knight Therapeutics Inc. (&quot;Knight&quot;) (TSX: GUD), a pan-American (ex-US) pharmaceutical company, announced today that it has submitted a supplemental application to ANVISA, the Brazilian health regulatory agency, seeking approval for an additional indication for MINJUVI® (tafasitamab) in combination with lenalidomide added to R-CHOP (rituximab, cyclophosphamide, doxorubicin, vincristine and prednisone; Tafa-Len-R-CHOP) as a first-line treatment for adults with previously untreated diffuse large B-cell lymphoma (DLBCL) or high-grade B-cell lymphoma (HGBL). The supplemental application for the additional indication was selected for review under Project Orbis.</p> <p align="justify">“This supplemental submission to ANVISA http://www.streetinsider.com/Globe+Newswire/Knight+Therapeutics+Announces+Supplemental+Regulatory+Submission+for+MINJUVI%C2%AE+%28tafasitamab%29+in+Brazil/26991515.html Thu, 27 Aug 2026 18:00:00 -0400 A.08439236 A.17568957 GUD INCY O.00059377 O.00160346 O.04889877 O.17511696 http://www.streetinsider.com/Press+Releases/Knight+Therapeutics+Announces+Launch+of+WYNZORA%C2%AE+in+Canada/26952874.html <p align="justify">MONTREAL, Aug. 20, 2026 (GLOBE NEWSWIRE) -- Knight Therapeutics Inc. (&quot;Knight&quot;) (TSX: GUD), a pan-American (ex-US) pharmaceutical company, announced today the launch of WYNZORA®, a uniform white aqueous cream containing 0.05 mg/g of calcipotriol (CAL) and 0.5 mg/g of betamethasone dipropionate (BDP), in Canada. WYNZORA® is indicated for the topical treatment of psoriasis vulgaris in adults and adolescents aged 12 and older.1</p> <p align="justify">“The launch of WYNZORA® in Canada reflects our commitment to continuing to grow our Canadian platform and bring innovative treatment options to patients. WYNZORA®&apos;s unique aqueous cream formulation, enabled by PAD Technology™, offers http://www.streetinsider.com/Press+Releases/Knight+Therapeutics+Announces+Launch+of+WYNZORA%C2%AE+in+Canada/26952874.html Thu, 20 Aug 2026 07:30:00 -0400 A.17150087 A.50214844 GUD O.01764452 O.17511696 O.34929518 http://www.streetinsider.com/Press+Releases/Knight+Therapeutics+Announces+Launch+of+WYNZORA%C2%AE+in+Canada/26952874.html <p align="justify">MONTREAL, Aug. 20, 2026 (GLOBE NEWSWIRE) -- Knight Therapeutics Inc. (&quot;Knight&quot;) (TSX: GUD), a pan-American (ex-US) pharmaceutical company, announced today the launch of WYNZORA®, a uniform white aqueous cream containing 0.05 mg/g of calcipotriol (CAL) and 0.5 mg/g of betamethasone dipropionate (BDP), in Canada. WYNZORA® is indicated for the topical treatment of psoriasis vulgaris in adults and adolescents aged 12 and older.1</p> <p align="justify">“The launch of WYNZORA® in Canada reflects our commitment to continuing to grow our Canadian platform and bring innovative treatment options to patients. WYNZORA®&apos;s unique aqueous cream formulation, enabled by PAD Technology™, offers http://www.streetinsider.com/Press+Releases/Knight+Therapeutics+Announces+Launch+of+WYNZORA%C2%AE+in+Canada/26952874.html Thu, 20 Aug 2026 07:30:00 -0400 A.17150087 A.50214844 GUD O.01764452 O.17511696 O.34929518 http://www.streetinsider.com/Press+Releases/Knight+Therapeutics+Announces+Launch+of+WYNZORA%C2%AE+in+Canada/26952874.html <p align="justify">MONTREAL, Aug. 20, 2026 (GLOBE NEWSWIRE) -- Knight Therapeutics Inc. (&quot;Knight&quot;) (TSX: GUD), a pan-American (ex-US) pharmaceutical company, announced today the launch of WYNZORA®, a uniform white aqueous cream containing 0.05 mg/g of calcipotriol (CAL) and 0.5 mg/g of betamethasone dipropionate (BDP), in Canada. WYNZORA® is indicated for the topical treatment of psoriasis vulgaris in adults and adolescents aged 12 and older.1</p> <p align="justify">“The launch of WYNZORA® in Canada reflects our commitment to continuing to grow our Canadian platform and bring innovative treatment options to patients. WYNZORA®&apos;s unique aqueous cream formulation, enabled by PAD Technology™, offers http://www.streetinsider.com/Press+Releases/Knight+Therapeutics+Announces+Launch+of+WYNZORA%C2%AE+in+Canada/26952874.html Thu, 20 Aug 2026 07:30:00 -0400 A.17150087 A.50214844 GUD O.01764452 O.17511696 O.34929518 http://www.streetinsider.com/Press+Releases/Knight+Therapeutics+Announces+Launch+of+WYNZORA%C2%AE+in+Canada/26952874.html <p align="justify">MONTREAL, Aug. 20, 2026 (GLOBE NEWSWIRE) -- Knight Therapeutics Inc. (&quot;Knight&quot;) (TSX: GUD), a pan-American (ex-US) pharmaceutical company, announced today the launch of WYNZORA®, a uniform white aqueous cream containing 0.05 mg/g of calcipotriol (CAL) and 0.5 mg/g of betamethasone dipropionate (BDP), in Canada. WYNZORA® is indicated for the topical treatment of psoriasis vulgaris in adults and adolescents aged 12 and older.1</p> <p align="justify">“The launch of WYNZORA® in Canada reflects our commitment to continuing to grow our Canadian platform and bring innovative treatment options to patients. WYNZORA®&apos;s unique aqueous cream formulation, enabled by PAD Technology™, offers http://www.streetinsider.com/Press+Releases/Knight+Therapeutics+Announces+Launch+of+WYNZORA%C2%AE+in+Canada/26952874.html Thu, 20 Aug 2026 07:30:00 -0400 A.17150087 A.50214844 GUD O.01764452 O.17511696 O.34929518 http://www.streetinsider.com/Press+Releases/Knight+Therapeutics+Announces+Launch+of+WYNZORA%C2%AE+in+Canada/26952874.html <p align="justify">MONTREAL, Aug. 20, 2026 (GLOBE NEWSWIRE) -- Knight Therapeutics Inc. (&quot;Knight&quot;) (TSX: GUD), a pan-American (ex-US) pharmaceutical company, announced today the launch of WYNZORA®, a uniform white aqueous cream containing 0.05 mg/g of calcipotriol (CAL) and 0.5 mg/g of betamethasone dipropionate (BDP), in Canada. WYNZORA® is indicated for the topical treatment of psoriasis vulgaris in adults and adolescents aged 12 and older.1</p> <p align="justify">“The launch of WYNZORA® in Canada reflects our commitment to continuing to grow our Canadian platform and bring innovative treatment options to patients. WYNZORA®&apos;s unique aqueous cream formulation, enabled by PAD Technology™, offers http://www.streetinsider.com/Press+Releases/Knight+Therapeutics+Announces+Launch+of+WYNZORA%C2%AE+in+Canada/26952874.html Thu, 20 Aug 2026 07:30:00 -0400 A.17150087 A.50214844 GUD O.01764452 O.17511696 O.34929518