Category: Company Updates

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Celldex (CLDX) — The Barzo Failure in PN Does Little To Change Our Bullish Stance

BIOINVEST BREAKING NEWS – Celldex (CLDX) — After the close, CLDX announced that treatment with barvolvolimab (“barzo”) did not work in the Phase IIb trial in prurigo nodularis (PN). While barzo significantly and safely depleted mast cells, PN is complex immune-mediated neurological condition that is not obviously driven by primarily mast cells – which urticaria is. (…more)

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Skye (SKYE) — NIMACIMAB Misses But Likely Underdosed

BIOINVEST BREAKING NEWS – Skye (SKYE) – On a negative note, Nimacimab’s Phase II study missed its primary endpoint, with a much lower/negligible effect on weight loss at Week 26 (-1.26%, n.s.) than expected. The monotherapy trial failure was attributed to (…more)

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Celldex (CLDX) — EoE Misses But MC Efficacy Still The Best & Safety Profile Intact — BUY

BIOINVEST BREAKING NEWS – Celldex (CLDX) — The Phase II study with barzolvolimab for eosinophilic esophagitis (EoE) met the primary endpoint of a statistically significant drop in mucosal mast cells (MC). However, the strong MC efficacy did not translate into a clinical benefit. (…more)

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Ionis (IONS) – IONS’ Wainua Fails in ATTR, Focus on Tryngolza Launch in SHTG

BIOINVEST BREAKING NEWS – Ionis (IONS) IONS and their partner AZN are both down on negative trial results from CARDIO-TTRansform. The trial failed to meet its primary endpoint of the composite outcome of cardiovascular (CV) mortality and recurrent CV clinical events in ATTR-CM patients through Week-140. (…more)

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Viking Therapeutics (VKTX) – Phase II VENTURE Oral VK2735 Delivers Great Efficacy

BIOINVEST BREAKING NEWS – Viking (VKTX) – On a positive note, MTSR’s preliminary merger proxy statement released today and stated there were up to seven interested parties and three companies with bids offered, including PFE. (…more)

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Viking Therapeutics (VKTX) – Phase II VENTURE Oral VK2735 Delivers Great Efficacy

BIOINVEST BREAKING NEWS – Viking (VKTX) – VKTX reported topline data from Phase II VENTURE-Oral VK2735 this morning with strong dose-dependent efficacy but a slightly higher GI side effect profile (albeit a higher placebo GI rate, too). We believe the compound’s competitiveness (…more)

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Wave (WVE) — WVE-007 240 mg Looks Good, 400 mg Underwhelms

BIOINVEST BREAKING NEWS – WVE has announced new data from the Phase 1 portion of its first-in-human INLIGHT trial evaluating WVE-007 in otherwise healthy individuals living with overweight or obesity. After six months of follow-up, a single 240 mg dose led to further improvements in body composition, (…more)

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BioInvest News – Ionis (IONS) – IONS Hits Homerun with Phase III Olezarsen CORE Data for High TGs & Acute Pancreatitis

BIOINVEST BREAKING NEWS – Ionis (IONS) had great news today when they reported positive topline data from the Phase III CORE (n=617) and CORE2 (n=446) trials of Olezarsen in severe hypertriglyceridemia (sHTG), where there was a statistically significant placebo-adjusted mean reduction (…more)

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Precigen

Precigen (PGEN) — FDA Fully Approves PGEN’s PAPZIMEOS for RRR

BIOINVEST BREAKING NEWS – Precigen has received FDA approval for PAPZIMEOS for the treatment of adults with recurrent respiratory papillomatosis (RRP). PAPZIMEOS is the first and only FDA-approved therapy for the treatment of adults with RRP. In a major positive for the Company, the approval came early as the FDA PDUFA date was Aug. 27. (…more)

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