Bitopertin

Schizophrenia treatment has evolved from dopamine-focused drugs to exploring non-dopaminergic agents like muscarinic agonists, TAAR1 agonists, GlyT-1 inhibitors, and 5-HT2A antagonists. Despite advancements, current treatments often fail to address negative and cognitive symptoms adequately, highlighting the need for more effective and tolerable pharmacological options.

DelveInsight's report on the Obsessive Compulsive Disorder (OCD) market forecasts a significant CAGR growth from 2020-2034, driven by increasing prevalence and awareness, and the launch of multiple-stage pipeline products. The market was valued at approximately USD 1000 million in 2023, with 12,082,000 prevalent cases of OCD across 7MM in 2022, expected to rise by 2034. Key companies include Biohaven Pharmaceuticals, Inc., AbbVie, AstraZeneca, and others, with therapies such as Troriluzole, Fluvoxamine maleate, and BHV-4157. The report provides insights into epidemiology, market trends, and treatment scenarios in the US, EU4, and Japan.

Trump's deregulatory economic policy and favorable seasonal period for the economy have analysts optimistic about market growth. Raymond James highlights Mural Oncology (MURA) and Disc Medicine (IRON) as stocks with significant upside potential, with MURA potentially gaining nearly 440% and IRON around 70%.

Disc Medicine secures $200m non-dilutive term loan from Hercules Capital to advance clinical trials of its assets, including a confirmatory study of bitopertin for erythropoietic protoporphyria (EPP) and Phase II studies for DISC-0974 and DISC-3405 in anaemia of myelofibrosis (MF) and polycythaemia vera (PV), respectively.

Disc Medicine secures FDA agreement for bitopertin, an investigational drug for erythropoietic protoporphyria (EPP), with potential accelerated approval based on Phase II data. The Phase III APOLLO trial, set to begin mid-2025, will serve as a confirmatory study, focusing on pain-free sunlight exposure. Bitopertin showed good tolerability in Phase II, with no serious adverse events reported.

Raymond James upgraded Disc Medicine's stock to Strong Buy with a $110.00 price target, following a successful FDA meeting for bitopertin, aimed at treating erythropoietic porphyrias. The FDA's willingness to consider accelerated approval based on PPIX reduction allows Disc to proceed with existing data, with an anticipated NDA submission in Q1 2025 and drug launch in 2026. Disc also received positive feedback for its APOLLO study and reported promising Phase 1b results for DISC-0974. Analysts from Jefferies, Wells Fargo, H.C. Wainwright, and BMO Capital Markets have also given positive ratings, and Disc appointed new CTO and CRO. The company announced a $178 million public stock offering to advance research and clinical development.

Disc Medicine announces positive FDA feedback on bitopertin development for EPP, agreeing on study design and potential for accelerated approval. The APOLLO trial, planned for mid-2025, will evaluate a 60 mg dose over 6 months in EPP and XLP patients aged 12+. Disc will host a conference call on November 4 at 8:00 am EST.

Disc Medicine to host conference call on Nov 4 to discuss FDA feedback on bitopertin, an investigational GlyT1 inhibitor for hematologic diseases, including erythropoietic porphyrias. Bitopertin, licensed from Roche, aims to be the first disease-modifying therapy for EPP and XLP, rare, life-threatening conditions affecting heme biosynthesis.