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) Wed, 22 Jul 2026 16:30:32 -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/FDA+grants+priority+review+for+Pfizer%27s+Talzenna+and+Xtandi+combo+in+prostate+cancer/26802128.html <p>Pfizer Inc. (NYSE: PFE) announced that the U.S. Food and Drug Administration has accepted for priority review a supplemental New Drug Application for Talzenna (talazoparib) in combination with Xtandi (enzalutamide) for men with homologous recombination repair (HRR) gene-altered metastatic castration-sensitive prostate cancer (mCSPC).</p> <p>The FDA has set a Prescription Drug User Fee Act action date in the last quarter of 2026. The combination is currently approved in the U.S. for HRR gene-mutated metastatic castration-resistant prostate cancer (mCRPC). If approved, the application would expand its use to mCSPC, an earlier stage of disease.</p> <p>The application is supported by data from the Phase 3 http://www.streetinsider.com/FDA/FDA+grants+priority+review+for+Pfizer%27s+Talzenna+and+Xtandi+combo+in+prostate+cancer/26802128.html Wed, 22 Jul 2026 16:30:32 -0400 4503 A.06822034 A.31066700 A.60012004 O.00000313 O.01115933 O.01304637 O.20026344 O.22422661 PFE http://www.streetinsider.com/FDA/FDA+grants+priority+review+for+Pfizer%27s+Talzenna+and+Xtandi+combo+in+prostate+cancer/26802128.html <p>Pfizer Inc. (NYSE: PFE) announced that the U.S. Food and Drug Administration has accepted for priority review a supplemental New Drug Application for Talzenna (talazoparib) in combination with Xtandi (enzalutamide) for men with homologous recombination repair (HRR) gene-altered metastatic castration-sensitive prostate cancer (mCSPC).</p> <p>The FDA has set a Prescription Drug User Fee Act action date in the last quarter of 2026. The combination is currently approved in the U.S. for HRR gene-mutated metastatic castration-resistant prostate cancer (mCRPC). If approved, the application would expand its use to mCSPC, an earlier stage of disease.</p> <p>The application is supported by data from the Phase 3 http://www.streetinsider.com/FDA/FDA+grants+priority+review+for+Pfizer%27s+Talzenna+and+Xtandi+combo+in+prostate+cancer/26802128.html Wed, 22 Jul 2026 16:30:32 -0400 4503 A.06822034 A.31066700 A.60012004 O.00000313 O.01115933 O.01304637 O.20026344 O.22422661 PFE http://www.streetinsider.com/FDA/FDA+grants+priority+review+for+Pfizer%27s+Talzenna+and+Xtandi+combo+in+prostate+cancer/26802128.html <p>Pfizer Inc. (NYSE: PFE) announced that the U.S. Food and Drug Administration has accepted for priority review a supplemental New Drug Application for Talzenna (talazoparib) in combination with Xtandi (enzalutamide) for men with homologous recombination repair (HRR) gene-altered metastatic castration-sensitive prostate cancer (mCSPC).</p> <p>The FDA has set a Prescription Drug User Fee Act action date in the last quarter of 2026. The combination is currently approved in the U.S. for HRR gene-mutated metastatic castration-resistant prostate cancer (mCRPC). If approved, the application would expand its use to mCSPC, an earlier stage of disease.</p> <p>The application is supported by data from the Phase 3 http://www.streetinsider.com/FDA/FDA+grants+priority+review+for+Pfizer%27s+Talzenna+and+Xtandi+combo+in+prostate+cancer/26802128.html Wed, 22 Jul 2026 16:30:32 -0400 4503 A.06822034 A.31066700 A.60012004 O.00000313 O.01115933 O.01304637 O.20026344 O.22422661 PFE http://www.streetinsider.com/FDA/FDA+grants+priority+review+for+Pfizer%27s+Talzenna+and+Xtandi+combo+in+prostate+cancer/26802128.html <p>Pfizer Inc. (NYSE: PFE) announced that the U.S. Food and Drug Administration has accepted for priority review a supplemental New Drug Application for Talzenna (talazoparib) in combination with Xtandi (enzalutamide) for men with homologous recombination repair (HRR) gene-altered metastatic castration-sensitive prostate cancer (mCSPC).</p> <p>The FDA has set a Prescription Drug User Fee Act action date in the last quarter of 2026. The combination is currently approved in the U.S. for HRR gene-mutated metastatic castration-resistant prostate cancer (mCRPC). If approved, the application would expand its use to mCSPC, an earlier stage of disease.</p> <p>The application is supported by data from the Phase 3 http://www.streetinsider.com/FDA/FDA+grants+priority+review+for+Pfizer%27s+Talzenna+and+Xtandi+combo+in+prostate+cancer/26802128.html Wed, 22 Jul 2026 16:30:32 -0400 4503 A.06822034 A.31066700 A.60012004 O.00000313 O.01115933 O.01304637 O.20026344 O.22422661 PFE http://www.streetinsider.com/FDA/FDA+grants+priority+review+for+Pfizer%27s+Talzenna+and+Xtandi+combo+in+prostate+cancer/26802128.html <p>Pfizer Inc. (NYSE: PFE) announced that the U.S. Food and Drug Administration has accepted for priority review a supplemental New Drug Application for Talzenna (talazoparib) in combination with Xtandi (enzalutamide) for men with homologous recombination repair (HRR) gene-altered metastatic castration-sensitive prostate cancer (mCSPC).</p> <p>The FDA has set a Prescription Drug User Fee Act action date in the last quarter of 2026. The combination is currently approved in the U.S. for HRR gene-mutated metastatic castration-resistant prostate cancer (mCRPC). If approved, the application would expand its use to mCSPC, an earlier stage of disease.</p> <p>The application is supported by data from the Phase 3 http://www.streetinsider.com/FDA/FDA+grants+priority+review+for+Pfizer%27s+Talzenna+and+Xtandi+combo+in+prostate+cancer/26802128.html Wed, 22 Jul 2026 16:30:32 -0400 4503 A.06822034 A.31066700 A.60012004 O.00000313 O.01115933 O.01304637 O.20026344 O.22422661 PFE http://www.streetinsider.com/FDA/FDA+grants+priority+review+for+Pfizer%27s+Talzenna+and+Xtandi+combo+in+prostate+cancer/26802128.html <p>Pfizer Inc. (NYSE: PFE) announced that the U.S. Food and Drug Administration has accepted for priority review a supplemental New Drug Application for Talzenna (talazoparib) in combination with Xtandi (enzalutamide) for men with homologous recombination repair (HRR) gene-altered metastatic castration-sensitive prostate cancer (mCSPC).</p> <p>The FDA has set a Prescription Drug User Fee Act action date in the last quarter of 2026. The combination is currently approved in the U.S. for HRR gene-mutated metastatic castration-resistant prostate cancer (mCRPC). If approved, the application would expand its use to mCSPC, an earlier stage of disease.</p> <p>The application is supported by data from the Phase 3 http://www.streetinsider.com/FDA/FDA+grants+priority+review+for+Pfizer%27s+Talzenna+and+Xtandi+combo+in+prostate+cancer/26802128.html Wed, 22 Jul 2026 16:30:32 -0400 4503 A.06822034 A.31066700 A.60012004 O.00000313 O.01115933 O.01304637 O.20026344 O.22422661 PFE http://www.streetinsider.com/FDA/FDA+grants+priority+review+for+Pfizer%27s+Talzenna+and+Xtandi+combo+in+prostate+cancer/26802128.html <p>Pfizer Inc. (NYSE: PFE) announced that the U.S. Food and Drug Administration has accepted for priority review a supplemental New Drug Application for Talzenna (talazoparib) in combination with Xtandi (enzalutamide) for men with homologous recombination repair (HRR) gene-altered metastatic castration-sensitive prostate cancer (mCSPC).</p> <p>The FDA has set a Prescription Drug User Fee Act action date in the last quarter of 2026. The combination is currently approved in the U.S. for HRR gene-mutated metastatic castration-resistant prostate cancer (mCRPC). If approved, the application would expand its use to mCSPC, an earlier stage of disease.</p> <p>The application is supported by data from the Phase 3 http://www.streetinsider.com/FDA/FDA+grants+priority+review+for+Pfizer%27s+Talzenna+and+Xtandi+combo+in+prostate+cancer/26802128.html Wed, 22 Jul 2026 16:30:32 -0400 4503 A.06822034 A.31066700 A.60012004 O.00000313 O.01115933 O.01304637 O.20026344 O.22422661 PFE http://www.streetinsider.com/FDA/FDA+grants+priority+review+for+Pfizer%27s+Talzenna+and+Xtandi+combo+in+prostate+cancer/26802128.html <p>Pfizer Inc. (NYSE: PFE) announced that the U.S. Food and Drug Administration has accepted for priority review a supplemental New Drug Application for Talzenna (talazoparib) in combination with Xtandi (enzalutamide) for men with homologous recombination repair (HRR) gene-altered metastatic castration-sensitive prostate cancer (mCSPC).</p> <p>The FDA has set a Prescription Drug User Fee Act action date in the last quarter of 2026. The combination is currently approved in the U.S. for HRR gene-mutated metastatic castration-resistant prostate cancer (mCRPC). If approved, the application would expand its use to mCSPC, an earlier stage of disease.</p> <p>The application is supported by data from the Phase 3 http://www.streetinsider.com/FDA/FDA+grants+priority+review+for+Pfizer%27s+Talzenna+and+Xtandi+combo+in+prostate+cancer/26802128.html Wed, 22 Jul 2026 16:30:32 -0400 4503 A.06822034 A.31066700 A.60012004 O.00000313 O.01115933 O.01304637 O.20026344 O.22422661 PFE http://www.streetinsider.com/FDA/FDA+grants+priority+review+for+Pfizer%27s+Talzenna+and+Xtandi+combo+in+prostate+cancer/26802128.html <p>Pfizer Inc. (NYSE: PFE) announced that the U.S. Food and Drug Administration has accepted for priority review a supplemental New Drug Application for Talzenna (talazoparib) in combination with Xtandi (enzalutamide) for men with homologous recombination repair (HRR) gene-altered metastatic castration-sensitive prostate cancer (mCSPC).</p> <p>The FDA has set a Prescription Drug User Fee Act action date in the last quarter of 2026. The combination is currently approved in the U.S. for HRR gene-mutated metastatic castration-resistant prostate cancer (mCRPC). If approved, the application would expand its use to mCSPC, an earlier stage of disease.</p> <p>The application is supported by data from the Phase 3 http://www.streetinsider.com/FDA/FDA+grants+priority+review+for+Pfizer%27s+Talzenna+and+Xtandi+combo+in+prostate+cancer/26802128.html Wed, 22 Jul 2026 16:30:32 -0400 4503 A.06822034 A.31066700 A.60012004 O.00000313 O.01115933 O.01304637 O.20026344 O.22422661 PFE http://www.streetinsider.com/FDA/FDA+grants+priority+review+for+Pfizer%27s+Talzenna+and+Xtandi+combo+in+prostate+cancer/26802128.html <p>Pfizer Inc. (NYSE: PFE) announced that the U.S. Food and Drug Administration has accepted for priority review a supplemental New Drug Application for Talzenna (talazoparib) in combination with Xtandi (enzalutamide) for men with homologous recombination repair (HRR) gene-altered metastatic castration-sensitive prostate cancer (mCSPC).</p> <p>The FDA has set a Prescription Drug User Fee Act action date in the last quarter of 2026. The combination is currently approved in the U.S. for HRR gene-mutated metastatic castration-resistant prostate cancer (mCRPC). If approved, the application would expand its use to mCSPC, an earlier stage of disease.</p> <p>The application is supported by data from the Phase 3 http://www.streetinsider.com/FDA/FDA+grants+priority+review+for+Pfizer%27s+Talzenna+and+Xtandi+combo+in+prostate+cancer/26802128.html Wed, 22 Jul 2026 16:30:32 -0400 4503 A.06822034 A.31066700 A.60012004 O.00000313 O.01115933 O.01304637 O.20026344 O.22422661 PFE http://www.streetinsider.com/Press+Releases/FDA+Grants+Priority+Review+for+Pfizer%E2%80%99s+TALZENNA+Plus+XTANDI+for+the+Treatment+of+Metastatic+Prostate+Cancer/26802114.html <ul class="bwlistdisc"> <li> <i>Supplemental application aims to expand use to men with HRR gene-mutated metastatic castration-sensitive prostate cancer</i> </li> <li> <i>Filing supported by Phase 3 TALAPRO-3 data demonstrating greater than 50% improvement in radiographic progression-free survival, with consistent benefit across BRCA and non-BRCA HRR gene alterations</i> </li> </ul> <p> NEW YORK--(BUSINESS WIRE)-- <a target="_blank" rel="nofollow" href="https://cts.businesswire.com/ct/CT?id=smartlink&amp;url=http%3A%2F%2Fwww.pfizer.com%2F&amp;esheet=54575233&amp;newsitemid=20260722156396&amp;lan=en-US&amp;anchor=Pfizer+Inc.&amp;index=1&amp;md5=4c9ea455a32c52bc7f26de89190150de" shape="rect">Pfizer Inc. </a>(NYSE: PFE) today announced that the U.S. Food and Drug Administration (FDA) accepted for Priority Review a supplemental New Drug Application (sNDA) for TALZENNA<b>®</b> (talazoparib), an oral poly ADP-ribose polymerase (PARP) inhibitor, in combination with XTANDI<b>®</b> (enzalutamide), an androgen receptor pathway inhibitor (ARPI), in men with homologous recombination http://www.streetinsider.com/Press+Releases/FDA+Grants+Priority+Review+for+Pfizer%E2%80%99s+TALZENNA+Plus+XTANDI+for+the+Treatment+of+Metastatic+Prostate+Cancer/26802114.html Wed, 22 Jul 2026 16:30:00 -0400 4503 A.06822034 A.31066700 A.60012004 O.00000313 O.01115933 O.01304637 O.20026344 O.22422661 PFE http://www.streetinsider.com/Press+Releases/FDA+Grants+Priority+Review+for+Pfizer%E2%80%99s+TALZENNA+Plus+XTANDI+for+the+Treatment+of+Metastatic+Prostate+Cancer/26802114.html <ul class="bwlistdisc"> <li> <i>Supplemental application aims to expand use to men with HRR gene-mutated metastatic castration-sensitive prostate cancer</i> </li> <li> <i>Filing supported by Phase 3 TALAPRO-3 data demonstrating greater than 50% improvement in radiographic progression-free survival, with consistent benefit across BRCA and non-BRCA HRR gene alterations</i> </li> </ul> <p> NEW YORK--(BUSINESS WIRE)-- <a target="_blank" rel="nofollow" href="https://cts.businesswire.com/ct/CT?id=smartlink&amp;url=http%3A%2F%2Fwww.pfizer.com%2F&amp;esheet=54575233&amp;newsitemid=20260722156396&amp;lan=en-US&amp;anchor=Pfizer+Inc.&amp;index=1&amp;md5=4c9ea455a32c52bc7f26de89190150de" shape="rect">Pfizer Inc. </a>(NYSE: PFE) today announced that the U.S. Food and Drug Administration (FDA) accepted for Priority Review a supplemental New Drug Application (sNDA) for TALZENNA<b>®</b> (talazoparib), an oral poly ADP-ribose polymerase (PARP) inhibitor, in combination with XTANDI<b>®</b> (enzalutamide), an androgen receptor pathway inhibitor (ARPI), in men with homologous recombination http://www.streetinsider.com/Press+Releases/FDA+Grants+Priority+Review+for+Pfizer%E2%80%99s+TALZENNA+Plus+XTANDI+for+the+Treatment+of+Metastatic+Prostate+Cancer/26802114.html Wed, 22 Jul 2026 16:30:00 -0400 4503 A.06822034 A.31066700 A.60012004 O.00000313 O.01115933 O.01304637 O.20026344 O.22422661 PFE http://www.streetinsider.com/Press+Releases/FDA+Grants+Priority+Review+for+Pfizer%E2%80%99s+TALZENNA+Plus+XTANDI+for+the+Treatment+of+Metastatic+Prostate+Cancer/26802114.html <ul class="bwlistdisc"> <li> <i>Supplemental application aims to expand use to men with HRR gene-mutated metastatic castration-sensitive prostate cancer</i> </li> <li> <i>Filing supported by Phase 3 TALAPRO-3 data demonstrating greater than 50% improvement in radiographic progression-free survival, with consistent benefit across BRCA and non-BRCA HRR gene alterations</i> </li> </ul> <p> NEW YORK--(BUSINESS WIRE)-- <a target="_blank" rel="nofollow" href="https://cts.businesswire.com/ct/CT?id=smartlink&amp;url=http%3A%2F%2Fwww.pfizer.com%2F&amp;esheet=54575233&amp;newsitemid=20260722156396&amp;lan=en-US&amp;anchor=Pfizer+Inc.&amp;index=1&amp;md5=4c9ea455a32c52bc7f26de89190150de" shape="rect">Pfizer Inc. </a>(NYSE: PFE) today announced that the U.S. Food and Drug Administration (FDA) accepted for Priority Review a supplemental New Drug Application (sNDA) for TALZENNA<b>®</b> (talazoparib), an oral poly ADP-ribose polymerase (PARP) inhibitor, in combination with XTANDI<b>®</b> (enzalutamide), an androgen receptor pathway inhibitor (ARPI), in men with homologous recombination http://www.streetinsider.com/Press+Releases/FDA+Grants+Priority+Review+for+Pfizer%E2%80%99s+TALZENNA+Plus+XTANDI+for+the+Treatment+of+Metastatic+Prostate+Cancer/26802114.html Wed, 22 Jul 2026 16:30:00 -0400 4503 A.06822034 A.31066700 A.60012004 O.00000313 O.01115933 O.01304637 O.20026344 O.22422661 PFE http://www.streetinsider.com/Press+Releases/FDA+Grants+Priority+Review+for+Pfizer%E2%80%99s+TALZENNA+Plus+XTANDI+for+the+Treatment+of+Metastatic+Prostate+Cancer/26802114.html <ul class="bwlistdisc"> <li> <i>Supplemental application aims to expand use to men with HRR gene-mutated metastatic castration-sensitive prostate cancer</i> </li> <li> <i>Filing supported by Phase 3 TALAPRO-3 data demonstrating greater than 50% improvement in radiographic progression-free survival, with consistent benefit across BRCA and non-BRCA HRR gene alterations</i> </li> </ul> <p> NEW YORK--(BUSINESS WIRE)-- <a target="_blank" rel="nofollow" href="https://cts.businesswire.com/ct/CT?id=smartlink&amp;url=http%3A%2F%2Fwww.pfizer.com%2F&amp;esheet=54575233&amp;newsitemid=20260722156396&amp;lan=en-US&amp;anchor=Pfizer+Inc.&amp;index=1&amp;md5=4c9ea455a32c52bc7f26de89190150de" shape="rect">Pfizer Inc. </a>(NYSE: PFE) today announced that the U.S. Food and Drug Administration (FDA) accepted for Priority Review a supplemental New Drug Application (sNDA) for TALZENNA<b>®</b> (talazoparib), an oral poly ADP-ribose polymerase (PARP) inhibitor, in combination with XTANDI<b>®</b> (enzalutamide), an androgen receptor pathway inhibitor (ARPI), in men with homologous recombination http://www.streetinsider.com/Press+Releases/FDA+Grants+Priority+Review+for+Pfizer%E2%80%99s+TALZENNA+Plus+XTANDI+for+the+Treatment+of+Metastatic+Prostate+Cancer/26802114.html Wed, 22 Jul 2026 16:30:00 -0400 4503 A.06822034 A.31066700 A.60012004 O.00000313 O.01115933 O.01304637 O.20026344 O.22422661 PFE http://www.streetinsider.com/Press+Releases/FDA+Grants+Priority+Review+for+Pfizer%E2%80%99s+TALZENNA+Plus+XTANDI+for+the+Treatment+of+Metastatic+Prostate+Cancer/26802114.html <ul class="bwlistdisc"> <li> <i>Supplemental application aims to expand use to men with HRR gene-mutated metastatic castration-sensitive prostate cancer</i> </li> <li> <i>Filing supported by Phase 3 TALAPRO-3 data demonstrating greater than 50% improvement in radiographic progression-free survival, with consistent benefit across BRCA and non-BRCA HRR gene alterations</i> </li> </ul> <p> NEW YORK--(BUSINESS WIRE)-- <a target="_blank" rel="nofollow" href="https://cts.businesswire.com/ct/CT?id=smartlink&amp;url=http%3A%2F%2Fwww.pfizer.com%2F&amp;esheet=54575233&amp;newsitemid=20260722156396&amp;lan=en-US&amp;anchor=Pfizer+Inc.&amp;index=1&amp;md5=4c9ea455a32c52bc7f26de89190150de" shape="rect">Pfizer Inc. </a>(NYSE: PFE) today announced that the U.S. Food and Drug Administration (FDA) accepted for Priority Review a supplemental New Drug Application (sNDA) for TALZENNA<b>®</b> (talazoparib), an oral poly ADP-ribose polymerase (PARP) inhibitor, in combination with XTANDI<b>®</b> (enzalutamide), an androgen receptor pathway inhibitor (ARPI), in men with homologous recombination http://www.streetinsider.com/Press+Releases/FDA+Grants+Priority+Review+for+Pfizer%E2%80%99s+TALZENNA+Plus+XTANDI+for+the+Treatment+of+Metastatic+Prostate+Cancer/26802114.html Wed, 22 Jul 2026 16:30:00 -0400 4503 A.06822034 A.31066700 A.60012004 O.00000313 O.01115933 O.01304637 O.20026344 O.22422661 PFE http://www.streetinsider.com/Press+Releases/FDA+Grants+Priority+Review+for+Pfizer%E2%80%99s+TALZENNA+Plus+XTANDI+for+the+Treatment+of+Metastatic+Prostate+Cancer/26802114.html <ul class="bwlistdisc"> <li> <i>Supplemental application aims to expand use to men with HRR gene-mutated metastatic castration-sensitive prostate cancer</i> </li> <li> <i>Filing supported by Phase 3 TALAPRO-3 data demonstrating greater than 50% improvement in radiographic progression-free survival, with consistent benefit across BRCA and non-BRCA HRR gene alterations</i> </li> </ul> <p> NEW YORK--(BUSINESS WIRE)-- <a target="_blank" rel="nofollow" href="https://cts.businesswire.com/ct/CT?id=smartlink&amp;url=http%3A%2F%2Fwww.pfizer.com%2F&amp;esheet=54575233&amp;newsitemid=20260722156396&amp;lan=en-US&amp;anchor=Pfizer+Inc.&amp;index=1&amp;md5=4c9ea455a32c52bc7f26de89190150de" shape="rect">Pfizer Inc. </a>(NYSE: PFE) today announced that the U.S. Food and Drug Administration (FDA) accepted for Priority Review a supplemental New Drug Application (sNDA) for TALZENNA<b>®</b> (talazoparib), an oral poly ADP-ribose polymerase (PARP) inhibitor, in combination with XTANDI<b>®</b> (enzalutamide), an androgen receptor pathway inhibitor (ARPI), in men with homologous recombination http://www.streetinsider.com/Press+Releases/FDA+Grants+Priority+Review+for+Pfizer%E2%80%99s+TALZENNA+Plus+XTANDI+for+the+Treatment+of+Metastatic+Prostate+Cancer/26802114.html Wed, 22 Jul 2026 16:30:00 -0400 4503 A.06822034 A.31066700 A.60012004 O.00000313 O.01115933 O.01304637 O.20026344 O.22422661 PFE http://www.streetinsider.com/Press+Releases/FDA+Grants+Priority+Review+for+Pfizer%E2%80%99s+TALZENNA+Plus+XTANDI+for+the+Treatment+of+Metastatic+Prostate+Cancer/26802114.html <ul class="bwlistdisc"> <li> <i>Supplemental application aims to expand use to men with HRR gene-mutated metastatic castration-sensitive prostate cancer</i> </li> <li> <i>Filing supported by Phase 3 TALAPRO-3 data demonstrating greater than 50% improvement in radiographic progression-free survival, with consistent benefit across BRCA and non-BRCA HRR gene alterations</i> </li> </ul> <p> NEW YORK--(BUSINESS WIRE)-- <a target="_blank" rel="nofollow" href="https://cts.businesswire.com/ct/CT?id=smartlink&amp;url=http%3A%2F%2Fwww.pfizer.com%2F&amp;esheet=54575233&amp;newsitemid=20260722156396&amp;lan=en-US&amp;anchor=Pfizer+Inc.&amp;index=1&amp;md5=4c9ea455a32c52bc7f26de89190150de" shape="rect">Pfizer Inc. </a>(NYSE: PFE) today announced that the U.S. Food and Drug Administration (FDA) accepted for Priority Review a supplemental New Drug Application (sNDA) for TALZENNA<b>®</b> (talazoparib), an oral poly ADP-ribose polymerase (PARP) inhibitor, in combination with XTANDI<b>®</b> (enzalutamide), an androgen receptor pathway inhibitor (ARPI), in men with homologous recombination http://www.streetinsider.com/Press+Releases/FDA+Grants+Priority+Review+for+Pfizer%E2%80%99s+TALZENNA+Plus+XTANDI+for+the+Treatment+of+Metastatic+Prostate+Cancer/26802114.html Wed, 22 Jul 2026 16:30:00 -0400 4503 A.06822034 A.31066700 A.60012004 O.00000313 O.01115933 O.01304637 O.20026344 O.22422661 PFE http://www.streetinsider.com/Press+Releases/FDA+Grants+Priority+Review+for+Pfizer%E2%80%99s+TALZENNA+Plus+XTANDI+for+the+Treatment+of+Metastatic+Prostate+Cancer/26802114.html <ul class="bwlistdisc"> <li> <i>Supplemental application aims to expand use to men with HRR gene-mutated metastatic castration-sensitive prostate cancer</i> </li> <li> <i>Filing supported by Phase 3 TALAPRO-3 data demonstrating greater than 50% improvement in radiographic progression-free survival, with consistent benefit across BRCA and non-BRCA HRR gene alterations</i> </li> </ul> <p> NEW YORK--(BUSINESS WIRE)-- <a target="_blank" rel="nofollow" href="https://cts.businesswire.com/ct/CT?id=smartlink&amp;url=http%3A%2F%2Fwww.pfizer.com%2F&amp;esheet=54575233&amp;newsitemid=20260722156396&amp;lan=en-US&amp;anchor=Pfizer+Inc.&amp;index=1&amp;md5=4c9ea455a32c52bc7f26de89190150de" shape="rect">Pfizer Inc. </a>(NYSE: PFE) today announced that the U.S. Food and Drug Administration (FDA) accepted for Priority Review a supplemental New Drug Application (sNDA) for TALZENNA<b>®</b> (talazoparib), an oral poly ADP-ribose polymerase (PARP) inhibitor, in combination with XTANDI<b>®</b> (enzalutamide), an androgen receptor pathway inhibitor (ARPI), in men with homologous recombination http://www.streetinsider.com/Press+Releases/FDA+Grants+Priority+Review+for+Pfizer%E2%80%99s+TALZENNA+Plus+XTANDI+for+the+Treatment+of+Metastatic+Prostate+Cancer/26802114.html Wed, 22 Jul 2026 16:30:00 -0400 4503 A.06822034 A.31066700 A.60012004 O.00000313 O.01115933 O.01304637 O.20026344 O.22422661 PFE http://www.streetinsider.com/Press+Releases/FDA+Grants+Priority+Review+for+Pfizer%E2%80%99s+TALZENNA+Plus+XTANDI+for+the+Treatment+of+Metastatic+Prostate+Cancer/26802114.html <ul class="bwlistdisc"> <li> <i>Supplemental application aims to expand use to men with HRR gene-mutated metastatic castration-sensitive prostate cancer</i> </li> <li> <i>Filing supported by Phase 3 TALAPRO-3 data demonstrating greater than 50% improvement in radiographic progression-free survival, with consistent benefit across BRCA and non-BRCA HRR gene alterations</i> </li> </ul> <p> NEW YORK--(BUSINESS WIRE)-- <a target="_blank" rel="nofollow" href="https://cts.businesswire.com/ct/CT?id=smartlink&amp;url=http%3A%2F%2Fwww.pfizer.com%2F&amp;esheet=54575233&amp;newsitemid=20260722156396&amp;lan=en-US&amp;anchor=Pfizer+Inc.&amp;index=1&amp;md5=4c9ea455a32c52bc7f26de89190150de" shape="rect">Pfizer Inc. </a>(NYSE: PFE) today announced that the U.S. Food and Drug Administration (FDA) accepted for Priority Review a supplemental New Drug Application (sNDA) for TALZENNA<b>®</b> (talazoparib), an oral poly ADP-ribose polymerase (PARP) inhibitor, in combination with XTANDI<b>®</b> (enzalutamide), an androgen receptor pathway inhibitor (ARPI), in men with homologous recombination http://www.streetinsider.com/Press+Releases/FDA+Grants+Priority+Review+for+Pfizer%E2%80%99s+TALZENNA+Plus+XTANDI+for+the+Treatment+of+Metastatic+Prostate+Cancer/26802114.html Wed, 22 Jul 2026 16:30:00 -0400 4503 A.06822034 A.31066700 A.60012004 O.00000313 O.01115933 O.01304637 O.20026344 O.22422661 PFE http://www.streetinsider.com/Press+Releases/FDA+Grants+Priority+Review+for+Pfizer%E2%80%99s+TALZENNA+Plus+XTANDI+for+the+Treatment+of+Metastatic+Prostate+Cancer/26802114.html <ul class="bwlistdisc"> <li> <i>Supplemental application aims to expand use to men with HRR gene-mutated metastatic castration-sensitive prostate cancer</i> </li> <li> <i>Filing supported by Phase 3 TALAPRO-3 data demonstrating greater than 50% improvement in radiographic progression-free survival, with consistent benefit across BRCA and non-BRCA HRR gene alterations</i> </li> </ul> <p> NEW YORK--(BUSINESS WIRE)-- <a target="_blank" rel="nofollow" href="https://cts.businesswire.com/ct/CT?id=smartlink&amp;url=http%3A%2F%2Fwww.pfizer.com%2F&amp;esheet=54575233&amp;newsitemid=20260722156396&amp;lan=en-US&amp;anchor=Pfizer+Inc.&amp;index=1&amp;md5=4c9ea455a32c52bc7f26de89190150de" shape="rect">Pfizer Inc. </a>(NYSE: PFE) today announced that the U.S. Food and Drug Administration (FDA) accepted for Priority Review a supplemental New Drug Application (sNDA) for TALZENNA<b>®</b> (talazoparib), an oral poly ADP-ribose polymerase (PARP) inhibitor, in combination with XTANDI<b>®</b> (enzalutamide), an androgen receptor pathway inhibitor (ARPI), in men with homologous recombination http://www.streetinsider.com/Press+Releases/FDA+Grants+Priority+Review+for+Pfizer%E2%80%99s+TALZENNA+Plus+XTANDI+for+the+Treatment+of+Metastatic+Prostate+Cancer/26802114.html Wed, 22 Jul 2026 16:30:00 -0400 4503 A.06822034 A.31066700 A.60012004 O.00000313 O.01115933 O.01304637 O.20026344 O.22422661 PFE http://www.streetinsider.com/Business+Wire/FDA+Grants+Priority+Review+for+Pfizer%E2%80%99s+TALZENNA+Plus+XTANDI+for+the+Treatment+of+Metastatic+Prostate+Cancer/26802114.html <ul class="bwlistdisc"> <li> <i>Supplemental application aims to expand use to men with HRR gene-mutated metastatic castration-sensitive prostate cancer</i> </li> <li> <i>Filing supported by Phase 3 TALAPRO-3 data demonstrating greater than 50% improvement in radiographic progression-free survival, with consistent benefit across BRCA and non-BRCA HRR gene alterations</i> </li> </ul> <p> NEW YORK--(BUSINESS WIRE)-- <a target="_blank" rel="nofollow" href="https://cts.businesswire.com/ct/CT?id=smartlink&amp;url=http%3A%2F%2Fwww.pfizer.com%2F&amp;esheet=54575233&amp;newsitemid=20260722156396&amp;lan=en-US&amp;anchor=Pfizer+Inc.&amp;index=1&amp;md5=4c9ea455a32c52bc7f26de89190150de" shape="rect">Pfizer Inc. </a>(NYSE: PFE) today announced that the U.S. Food and Drug Administration (FDA) accepted for Priority Review a supplemental New Drug Application (sNDA) for TALZENNA<b>®</b> (talazoparib), an oral poly ADP-ribose polymerase (PARP) inhibitor, in combination with XTANDI<b>®</b> (enzalutamide), an androgen receptor pathway inhibitor (ARPI), in men with homologous recombination http://www.streetinsider.com/Business+Wire/FDA+Grants+Priority+Review+for+Pfizer%E2%80%99s+TALZENNA+Plus+XTANDI+for+the+Treatment+of+Metastatic+Prostate+Cancer/26802114.html Wed, 22 Jul 2026 16:30:00 -0400 4503 A.06822034 A.31066700 A.60012004 O.00000313 O.01115933 O.01304637 O.20026344 O.22422661 PFE http://www.streetinsider.com/Business+Wire/FDA+Grants+Priority+Review+for+Pfizer%E2%80%99s+TALZENNA+Plus+XTANDI+for+the+Treatment+of+Metastatic+Prostate+Cancer/26802114.html <ul class="bwlistdisc"> <li> <i>Supplemental application aims to expand use to men with HRR gene-mutated metastatic castration-sensitive prostate cancer</i> </li> <li> <i>Filing supported by Phase 3 TALAPRO-3 data demonstrating greater than 50% improvement in radiographic progression-free survival, with consistent benefit across BRCA and non-BRCA HRR gene alterations</i> </li> </ul> <p> NEW YORK--(BUSINESS WIRE)-- <a target="_blank" rel="nofollow" href="https://cts.businesswire.com/ct/CT?id=smartlink&amp;url=http%3A%2F%2Fwww.pfizer.com%2F&amp;esheet=54575233&amp;newsitemid=20260722156396&amp;lan=en-US&amp;anchor=Pfizer+Inc.&amp;index=1&amp;md5=4c9ea455a32c52bc7f26de89190150de" shape="rect">Pfizer Inc. </a>(NYSE: PFE) today announced that the U.S. Food and Drug Administration (FDA) accepted for Priority Review a supplemental New Drug Application (sNDA) for TALZENNA<b>®</b> (talazoparib), an oral poly ADP-ribose polymerase (PARP) inhibitor, in combination with XTANDI<b>®</b> (enzalutamide), an androgen receptor pathway inhibitor (ARPI), in men with homologous recombination http://www.streetinsider.com/Business+Wire/FDA+Grants+Priority+Review+for+Pfizer%E2%80%99s+TALZENNA+Plus+XTANDI+for+the+Treatment+of+Metastatic+Prostate+Cancer/26802114.html Wed, 22 Jul 2026 16:30:00 -0400 4503 A.06822034 A.31066700 A.60012004 O.00000313 O.01115933 O.01304637 O.20026344 O.22422661 PFE http://www.streetinsider.com/Business+Wire/FDA+Grants+Priority+Review+for+Pfizer%E2%80%99s+TALZENNA+Plus+XTANDI+for+the+Treatment+of+Metastatic+Prostate+Cancer/26802114.html <ul class="bwlistdisc"> <li> <i>Supplemental application aims to expand use to men with HRR gene-mutated metastatic castration-sensitive prostate cancer</i> </li> <li> <i>Filing supported by Phase 3 TALAPRO-3 data demonstrating greater than 50% improvement in radiographic progression-free survival, with consistent benefit across BRCA and non-BRCA HRR gene alterations</i> </li> </ul> <p> NEW YORK--(BUSINESS WIRE)-- <a target="_blank" rel="nofollow" href="https://cts.businesswire.com/ct/CT?id=smartlink&amp;url=http%3A%2F%2Fwww.pfizer.com%2F&amp;esheet=54575233&amp;newsitemid=20260722156396&amp;lan=en-US&amp;anchor=Pfizer+Inc.&amp;index=1&amp;md5=4c9ea455a32c52bc7f26de89190150de" shape="rect">Pfizer Inc. </a>(NYSE: PFE) today announced that the U.S. Food and Drug Administration (FDA) accepted for Priority Review a supplemental New Drug Application (sNDA) for TALZENNA<b>®</b> (talazoparib), an oral poly ADP-ribose polymerase (PARP) inhibitor, in combination with XTANDI<b>®</b> (enzalutamide), an androgen receptor pathway inhibitor (ARPI), in men with homologous recombination http://www.streetinsider.com/Business+Wire/FDA+Grants+Priority+Review+for+Pfizer%E2%80%99s+TALZENNA+Plus+XTANDI+for+the+Treatment+of+Metastatic+Prostate+Cancer/26802114.html Wed, 22 Jul 2026 16:30:00 -0400 4503 A.06822034 A.31066700 A.60012004 O.00000313 O.01115933 O.01304637 O.20026344 O.22422661 PFE http://www.streetinsider.com/Business+Wire/FDA+Grants+Priority+Review+for+Pfizer%E2%80%99s+TALZENNA+Plus+XTANDI+for+the+Treatment+of+Metastatic+Prostate+Cancer/26802114.html <ul class="bwlistdisc"> <li> <i>Supplemental application aims to expand use to men with HRR gene-mutated metastatic castration-sensitive prostate cancer</i> </li> <li> <i>Filing supported by Phase 3 TALAPRO-3 data demonstrating greater than 50% improvement in radiographic progression-free survival, with consistent benefit across BRCA and non-BRCA HRR gene alterations</i> </li> </ul> <p> NEW YORK--(BUSINESS WIRE)-- <a target="_blank" rel="nofollow" href="https://cts.businesswire.com/ct/CT?id=smartlink&amp;url=http%3A%2F%2Fwww.pfizer.com%2F&amp;esheet=54575233&amp;newsitemid=20260722156396&amp;lan=en-US&amp;anchor=Pfizer+Inc.&amp;index=1&amp;md5=4c9ea455a32c52bc7f26de89190150de" shape="rect">Pfizer Inc. </a>(NYSE: PFE) today announced that the U.S. Food and Drug Administration (FDA) accepted for Priority Review a supplemental New Drug Application (sNDA) for TALZENNA<b>®</b> (talazoparib), an oral poly ADP-ribose polymerase (PARP) inhibitor, in combination with XTANDI<b>®</b> (enzalutamide), an androgen receptor pathway inhibitor (ARPI), in men with homologous recombination http://www.streetinsider.com/Business+Wire/FDA+Grants+Priority+Review+for+Pfizer%E2%80%99s+TALZENNA+Plus+XTANDI+for+the+Treatment+of+Metastatic+Prostate+Cancer/26802114.html Wed, 22 Jul 2026 16:30:00 -0400 4503 A.06822034 A.31066700 A.60012004 O.00000313 O.01115933 O.01304637 O.20026344 O.22422661 PFE http://www.streetinsider.com/Business+Wire/FDA+Grants+Priority+Review+for+Pfizer%E2%80%99s+TALZENNA+Plus+XTANDI+for+the+Treatment+of+Metastatic+Prostate+Cancer/26802114.html <ul class="bwlistdisc"> <li> <i>Supplemental application aims to expand use to men with HRR gene-mutated metastatic castration-sensitive prostate cancer</i> </li> <li> <i>Filing supported by Phase 3 TALAPRO-3 data demonstrating greater than 50% improvement in radiographic progression-free survival, with consistent benefit across BRCA and non-BRCA HRR gene alterations</i> </li> </ul> <p> NEW YORK--(BUSINESS WIRE)-- <a target="_blank" rel="nofollow" href="https://cts.businesswire.com/ct/CT?id=smartlink&amp;url=http%3A%2F%2Fwww.pfizer.com%2F&amp;esheet=54575233&amp;newsitemid=20260722156396&amp;lan=en-US&amp;anchor=Pfizer+Inc.&amp;index=1&amp;md5=4c9ea455a32c52bc7f26de89190150de" shape="rect">Pfizer Inc. </a>(NYSE: PFE) today announced that the U.S. Food and Drug Administration (FDA) accepted for Priority Review a supplemental New Drug Application (sNDA) for TALZENNA<b>®</b> (talazoparib), an oral poly ADP-ribose polymerase (PARP) inhibitor, in combination with XTANDI<b>®</b> (enzalutamide), an androgen receptor pathway inhibitor (ARPI), in men with homologous recombination http://www.streetinsider.com/Business+Wire/FDA+Grants+Priority+Review+for+Pfizer%E2%80%99s+TALZENNA+Plus+XTANDI+for+the+Treatment+of+Metastatic+Prostate+Cancer/26802114.html Wed, 22 Jul 2026 16:30:00 -0400 4503 A.06822034 A.31066700 A.60012004 O.00000313 O.01115933 O.01304637 O.20026344 O.22422661 PFE