Crescent Biopharma Inc Stock Price, News & Analysis

Catalyst Biosciences (NASDAQ: CBIO) announced four poster presentations at the International Society on Thrombosis and Haemostasis Virtual Congress from July 17-21, 2021. The presentations will focus on marzaptacog alfa (MarzAA) and dalcinanonog alfa (DalcA), highlighting various dose selection strategies and efficacy in treating bleeding disorders. These insights aim to advance the understanding of their engineered proteases, which target rare coagulation disorders. Access to presentation materials will be available on the Catalyst website once the congress begins.

Catalyst Biosciences (NASDAQ: CBIO) will host an R&D day on July 19, 2021, focusing on its protease medicines platform, particularly CB 4332, which addresses complement disorders. Key speaker, Dr. Filomeen Haerynck, will discuss CFI deficiency and unmet medical needs. Catalyst plans to initiate screening studies for CFI deficiency in mid-2021, leading to a Phase 1/2 study for CB 4332 in 2022. The company’s complement pipeline also includes CB 2782-PEG, in development for dry AMD. Registration for the event is available online.

Catalyst Biosciences announced that the FDA has granted a second Fast Track Designation for Marzeptacog alfa (MarzAA), an engineered coagulation Factor VIIa for treating episodic bleeding in patients with Factor VII deficiency.

This designation allows for expedited development and review, facilitating greater access and priority review by the FDA. Catalyst is currently enrolling patients in a Phase 1/2 open-label study for MarzAA and conducting a Phase 3 registration trial for Hemophilia A or B with inhibitors.

Catalyst Biosciences, Inc. (NASDAQ: CBIO) announced participation in two investor conferences in June 2021, aiming to engage with investors and discuss its pipeline. The JMP Securities Life Sciences Conference is on June 16, 2021, at 1:30 PM ET. A webcast is available here. The Raymond James Human Health Innovation Conference will be on June 23, 2021, at 11:20 AM ET, with a webcast available here. Archived presentations will be available for 90 days.

Catalyst Biosciences (NASDAQ: CBIO) has initiated dosing in its Phase 1/2 trial (MAA-202) for MarzAA, a novel subcutaneous treatment for bleeding disorders including FVII deficiency and Hemophilia A. This open-label study will assess the pharmacokinetics, safety, and efficacy of MarzAA. CEO Nassim Usman emphasized the significance of MarzAA as a unique bypassing agent for rapid bleeding treatment. The ongoing Phase 3 study (MAA-304) complements this effort, targeting hemophilia patients on Hemlibra prophylaxis. Updates on the clinical program are expected later this year.

Catalyst Biosciences (NASDAQ: CBIO) will participate in a fireside chat at the Truist Securities Life Sciences Summit on May 17, 2021, at 1:00 PM ET.

Investors can access a live webcast of the presentation through the company’s website, with an archived version available for 90 days post-event. Catalyst focuses on rare disorders, utilizing its engineered protease platform to develop therapies like MarzAA for bleeding disorders and a preclinical C3-degrader program licensed to Biogen for age-related macular degeneration.

Catalyst Biosciences (NASDAQ: CBIO) reported its financial and operational results for Q1 2021, highlighting advances in their Protease Medicines platform. The company plans to initiate a trial for its CFI deficiency candidate, CB 4332, by mid-2021 and has started dosing patients in the Phase 3 trial of MarzAA for hemophilia. Financially, Catalyst had $107 million in cash but reported a net loss of $22.4 million, significantly higher than the prior year's loss of $4.1 million. Research and development expenses rose 28% to $17 million, largely due to increased preclinical costs.

Catalyst Biosciences, Inc. (NASDAQ: CBIO) has commenced dosing in the Crimson 1 Study, a Phase 3 trial for Marzeptacog alfa (activated) – MarzAA, a subcutaneous treatment for bleeding events in congenital Hemophilia A or B patients with inhibitors. This trial is a pivotal step, especially amid the challenges posed by the COVID-19 pandemic. MarzAA is the only subcutaneously administered therapy in development for this purpose. The study's primary goal is to evaluate the efficacy and safety of MarzAA in episodic bleeding treatment, anticipating updates later this year.

Catalyst Biosciences disclosed promising preclinical data for its gene therapy candidate CB 2679d-GT in hemophilia B, published in Blood. The study showed that CB 2679d-GT outperformed the R338L-Padua variant, demonstrating enhanced efficacy with significantly reduced bleeding times. Conducted by Vrije Universiteit Brussel, the findings suggest CB 2679d-GT may allow for lower vector doses in future human trials. This advancement supports further clinical development of CB 2679d-GT as a leading option for hemophilia B treatment.