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)
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)
BIOINVEST BREAKING NEWS – Viking (VKTX) – Merck will pay the Chinese company Hansoh $112 million up front to develop, manufacture and commercialize HS-10535, a pre-clinical pill that targets GLP-1. Hansoh is also eligible to receive up to $1.9 billion in milestone payments as well as royalties on sales.. (…more)
BIOINVEST BREAKING NEWS – MDGL’s Rezdiffra had a very strong 3Q, significantly exceeding very high investor expectations with Rezdiffra revenues of $62 million with a huge beat over the FactSet consensus estimate of $35 million. (…more)
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)
BIOINVEST BREAKING NEWS – Celldex (CLDX) — Celldex delivered another unprecedented clinical update for barzolvolimab (“barzo”) in CSU, further cementing the antibody’s position as the leading compound to change clinical practice in this disease of suffering. (…more)
Bicycle (BCYC) — BCYC has been under pressure recently after the company provided updates on its zelenectide (BT8009) program. The company provided topline Phase I/II Duravelo-1 data of zelenectide+pembro combo in 1L mUC, timing expectations for subsequent Phase II/III Duravelo-2 readouts (…more)
BIOINVEST BREAKING NEWS – Celldex (CLDX) — Celldex reported the eagerly-awaited 52-week data for barzolvolimab (c-KIT antibody) in chronic spontaneous urticaria (CSU) as a late-breaker at EADV occurring in Amsterdam. We believe the data is overwhelming positive, continue to paint the best-in-class compound in urticaria and below address reasons for the stock weakness. (…more)
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)
BIOINVEST BREAKING NEWS – Viking (VKTX) – Yesterday VKTX has checked off another important box in its obesity drug competitiveness by securing production capacity for their second generation GLP drug, VK2735. The Company will prepay leading global contract manufacturer CordenPharma (…more)
BIOINVEST BREAKING NEWS – Viking (VKTX) presented excellent updates for both high dose oral and subQ VK2735 at Obesity Week. The data continues to demonstrate best in class potential for the leading 2nd generation oral/subQ GLP-1/GIP program. (…more)
BIOINVEST BREAKING NEWS – Skye (SKYE) This morning Novo Nordisk announced mixed data for their CB1 receptor inverse agonist, monlunabant with solid weight loss but questionable neuropsychiatric side effects. The data showed that after 16 weeks of treatment, patients with a baseline bodyweight of 110.1 kg lost a mean of 7.1 kg after treatment with 10 mg doses of monlunabant. (…more)
