Takeda Reports the P-III (LATITUDE) Studies Data on Zasocitinib in Plaque Psoriasis

Shots: Takeda has reported the 2 P-III (Latitude PsO 3001 & PsO 3002) trial results assessing zasocitinib (QD, PO) in 693 & 1108 adults, respectively, with mod. to sev. PsO, where both studies showed improved NAPSI scores vs PBO at 16wks. Trials also showed that 77% (3001) & 74% (3002) pts reached ssPGA 0/1 response…

ByRidhi Rastogi4 days ago

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The US FDA Approves Celcuity’s Revtorpyk (Gedatolisib) to Treat HR+/HER2- PIK3CA Wild-Type Breast Cancer

Shots: FDA has approved Revtorpyk for HR+, HER2-, PIK3CA wild-type locally advanced or metastatic breast cancer that has progressed after ≥1L of endocrine therapy (ET) in the metastatic setting; launch expected in late Q3’26 Approval was backed by PIK3CA wild-type cohort data from P-III (VIKTORIA-1), where Revtorpyk + fulvestrant + palbociclib improved mPFS (9.3 vs…

ByRidhi RastogiJuly 15, 2026

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BMS Reports US FDA’s NDA Acceptance of Mezigdomide Combination to Treat R/R Multiple Myeloma

Shots: The US FDA has accepted NDA of mezigdomide (PO) + carfilzomib & dexamethasone (MeziKd) for the treatment of pts with r/r multiple myeloma (PDUFA: May 13, 2027) NDA was supported by the P-III (SUCCESSOR-2) trial data assessing MeziKd in 2 stages, where in stage 2, 479 pts with r/r MM were randomized to either MeziKd…

ByRidhi RastogiJuly 13, 2026

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Immunome Reports the US FDA’s NDA Acceptance of Varegacestat to Treat Desmoid Tumors in Adults

Shots: The US FDA has accepted the NDA for Immunome’s varegacestat for the treatment of adults with desmoid tumors, with a PDUFA target action date of Apr 28, 2027 NDA is supported by the global P-III (RINGSIDE) trial assessing varegacestat (1.2mg, QD) vs PBO until disease progression or death in 156 pts with progressing desmoid…

ByRidhi RastogiJuly 8, 2026

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Pharvaris Reports the US FDA’s NDA Acceptance of Deucrictibant IR for On-Demand Treatment of Hereditary Angioedema Attacks

Shots: The US FDA has accepted NDA for deucrictibant immediate-release (IR) capsule (20 mg) for the on-demand treatment of Hereditary Angioedema (HAE) attacks (PDUFA: Apr 23, 2027) NDA was backed by data from >1,300 HAE attacks. In P-III (RAPIDe-3) trial, deucrictibant IR met the 1EP & all eleven 2EPs, with median times to symptom relief,…

ByRidhi RastogiJuly 6, 2026

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Teva Reports the US FDA’s NDA Submission for Ecopipam to Treat Pediatric Tourette Syndrome

Shots: The US FDA has received an NDA for ecopipam, a selective dopamine D1 receptor antagonist, for the treatment of pediatric Tourette syndrome NDA was supported by the P-III trial data showing that ecopipam significantly delayed time to relapse vs PBO in pediatric Tourette syndrome pts who responded to treatment during the open-label treatment period;…

ByRidhi RastogiJune 19, 2026

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Innovent Reports the P-III Trial Results on Arcotatug Tavatecan in G/GEJ Adenocarcinoma

Shots: Innovent has reported the P-III (G-HOPE-001) of arcotatug tavatecan (IBI343/TAK-921) vs investigator-selected therapy in pts with Claudin 18.2 positive, locally advanced unresectable or metastatic G/GEJA who have received ≥2 prior therapies Trial met its 1EP of improved PFS in the interim analysis & showed a favorable safety profile; data to be published in future…

ByRidhi RastogiJune 4, 2026

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Genentech Receives the US FDA Priority Review for Giredestrant as an Adjuvant Treatment of ER+ Early-Stage Breast Cancer

Shots: The US FDA has accepted NDA & granted priority review to Genentech’s giredestrant as an adj. treatment for adults with ER+, HER2-, ESR1-mutated stage I, II, and III breast cancer (PDUFA: Nov 30, 2026) NDA was supported by the P-III (lidERA Breast Cancer) trial (n>4,100), where adj. giredestrant reduced iDFS by 30%, with 92.4%…

ByRidhi RastogiJune 2, 2026

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Cogent Biosciences Receives the US FDA Priority Review for Bezuclastinib Combination to Treat Gastrointestinal Stromal Tumors (GIST)

Shots: The US FDA has accepted NDA & granted priority review to Cogent's bezuclastinib + sunitinib for the treatment of pts with GIST who were treated with imatinib, with no advisory committee meeting planned yet (PDUFA: Nov 30, 2026) NDA was supported by the P-III (PEAK) trial data assessing bezuclastinib + sunitinib vs sunitinib monotx.…

ByRidhi RastogiMay 29, 2026

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Sanofi’s Venglustat Secures the US FDA Priority Review for Type 3 Gaucher Disease

Shots: The US FDA has accepted NDA & granted priority review to Sanofi's venglustat for the treatment of neurological manifestations of type 3 Gaucher disease (GD3), with the PDUFA action date of Nov 25, 2026 NDA was supported by the ongoing P-III (LEAP2MONO) trial assessing venglustat (QD, PO) vs enzyme replacement therapy (IV, Q2W) in 43 pts…

ByRidhi RastogiMay 28, 2026

Takeda Reports the P-III (LATITUDE) Studies Data on Zasocitinib in Plaque Psoriasis

The US FDA Approves Celcuity’s Revtorpyk (Gedatolisib) to Treat HR+/HER2- PIK3CA Wild-Type Breast Cancer

BMS Reports US FDA’s NDA Acceptance of Mezigdomide Combination to Treat R/R Multiple Myeloma

Immunome Reports the US FDA’s NDA Acceptance of Varegacestat to Treat Desmoid Tumors in Adults

Pharvaris Reports the US FDA’s NDA Acceptance of Deucrictibant IR for On-Demand Treatment of Hereditary Angioedema Attacks

Teva Reports the US FDA’s NDA Submission for Ecopipam to Treat Pediatric Tourette Syndrome

Innovent Reports the P-III Trial Results on Arcotatug Tavatecan in G/GEJ Adenocarcinoma

Genentech Receives the US FDA Priority Review for Giredestrant as an Adjuvant Treatment of ER+ Early-Stage Breast Cancer

Cogent Biosciences Receives the US FDA Priority Review for Bezuclastinib Combination to Treat Gastrointestinal Stromal Tumors (GIST)

Sanofi’s Venglustat Secures the US FDA Priority Review for Type 3 Gaucher Disease

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