Free Biopharma Investor Posts

Summary: The CYTK PDUFA for Omecamtiv Mecarbil is coming up on February 28 for heart failure with reduced ejection fraction (HErEF) The Dec 13 AdComm vote was negative: committee voted 8-3 that Omecamtiv benefits do not outweigh risks Other exciting heart failure assets in 2023 include the ESPR presentation in March and two additional PDUFA decisions! CYTK's asset Omecamtiv Mecarbil has a PDUFA target action date of February 28, 2023 for the possible treatment of heart failur

Summary: The TVTX PDUFA for Sparsentan is coming up on February 17 for IgA Nephropathy (IgAN) The market reacted positively when Phase 3 Sparsentan data readout in 2021 Other exciting kidney readouts in 2023 include PROK Ph2/3 data and CARA Ph3 data; and Ph3 KDNY data and Ph3 OMER data in IgAN. TVTX's asset Sparsentan has a PDUFA target action date of February 17, 2023 for the possible treatment of IgA Nephropathy. Sparsentan is a dual endothelin angiotensin receptor antagoni

Summary: ASCO-GU is taking place from Feb 16-19 and abstracts will be released Feb 13 This conference will focus on genitourinary cancers such as prostate cancer and ovarian cancer Several smid-cap biopharmas are presenting data at ASCO-GU, including final results from BTAI We have also determined additional upcoming late stage trials in GU cancers in the next year   ASCO-GU 2023 starts February 16 and focuses on new and innovative findings and studies for the treatment of ge

Summary Yesterday, AGEN presented updated data on its lead candidate, an anti-CTLA-4 at ASCO-GI23 The AGEN ASCO-GI23 presentation included expanded data from the Phase 1a/1b trial expansion cohort in MSS-CRC Key publicly available data from the presentation is provided below. Want more AGEN analysis and trade ideas? Sign up for one of our paid subscriptions HERE  and save with our current promotion Sign up for a BPIQ Pro account and get access to our BPIQ Pro post HERE , with

Summary Recently we posted an article about upcoming gastro readouts including those at ASCO-GI and the upcoming MRK & SGEN PDUFA - HERE   One readout coming at ASCO-GI is from AGEN's lead asset botensilimab  (anti-CTLA-4) in combination with AGEN's anti-PD1 (balstilimab) Botensilimab is currently in a Phase 2 trial, and the ASCO-GI presentation will include expanded data from the Phase 1a/1b trial expansion cohort Here we look at how the Bot/Bal combo data has looked in the

Article currently in progress (1/17/23) Summary: ASCO-GI starts this Thursday, January 19, 2023 This conference focuses on indications including stomach cancer, gastrointestinal cancer, esophageal cancer, and colorectal cancer ( https://conferences.asco.org/gi/program ) In past years, big readouts have happened at this conference including from several Phase 3 trials On Thursday Jan 19 there is also a PDUFA for a GI indication: the SGEN and MRK PDUFA for Tukysa (Tucatinib) to

AUPH PR on settlement of patent disputes with the Indian generic company, Sun is very brief. See entire substantive portion of press release below*. Nothing more filed with SEC. High level of settlement is the following**: Sun gets out of patent infringement litigation and gets covenant not to sue from AUPH for AUPH's '375 and '871 Patents covering Sun's Cequa product for DED Sun agrees to drop USPTO challenge (IPR) against AUPH's '036 Patent '036 Patent relates to using eGFR