reports
- Sean Conroy
Cereno Scientific - A productive period with plenty more to come
Cereno Scientific has released its Q324 results, marking a productive and strategically significant period. Following the positive top-line data from the Phase IIa safety study of CS1 in pulmonary arterial hypertension (PAH), Cereno decided to concentrate its development programmes on rare diseases. Key developments included the selection of idiopathic pulmonary fibrosis (IPF) as the target indication for second asset, CS014, and the positioning of its preclinical asset, CS585, towards rare dise...
- Sean Conroy
Cereno Scientific - CMD highlights a ‘rare’ portfolio refocus
Cereno Scientific recently held a capital markets day (CMD), providing greater insight on its development pipeline and strategic objectives. The key takeaway was its decision to focus on the rare disease space across its three programmes, a move we believe was strategically driven to maximise potential clinical and commercial success, and to appeal to future partners. While lead asset CS1 is targeting pulmonary arterial hypertension (PAH), supported by Fluidda and CardioMEMS (pivotal studies exp...
- Sean Conroy
Cereno Scientific - CS1 shines in Phase IIa PAH trial
Cereno Scientific has reported positive top-line results for the Phase IIa CS1-003 trial, which evaluated the HDAC inhibitor CS1 in pulmonary arterial hypertension (PAH). The primary endpoint of safety and tolerability was met and, importantly, CS1 delivered encouraging results on exploratory efficacy measures, creating a strong foundation for the next steps of clinical development, in our view. The recently signed agreement with medical technology company Fluidda to visualise the impact of CS1 ...
- Sean Conroy
Cereno Scientific - CS1 granted OMPD, complementing FDA ODD
Cereno Scientific’s lead asset CS1 has been granted the Orphan Medicinal Product Designation (OMPD) from the European Commission as a potential treatment for pulmonary arterial hypertension (PAH). The OMPD provides 10 years of market exclusivity, assuming CS1 receives EU regulatory approval, in addition to fee waivers during the development process. Further, this regulatory designation complements the FDA Orphan Drug Designation (ODD) granted in 2020, bolstering the value proposition of the cand...
- Sean Conroy
Cereno Scientific - Pressing clinical assets forward to key inflection
Cereno Scientific has announced its Q224 results, reflecting tangible progress with its clinical candidates. Key developments include closing of patient recruitment for the Phase II CS1 trial (as of 1 July) and the rapid clinical entry for CS014. Initial safety data from the CS014 study are anticipated from mid-2025 and will serve as a key catalyst. In the near term, we expect investor interest to be focused on the top-line readouts (within Q324) from the Phase II trial for lead asset CS1 in pul...
- Sean Conroy
Cereno Scientific - CS1 Phase II results inbound; first dose of CS014
Cereno Scientific has released updates on its two most advanced clinical programmes. For CS1, which is being investigated as a potential treatment for pulmonary arterial hypertension, recruitment has been closed for the Phase II trial, meaning that data analysis may commence. Top-line results are on track to be shared in Q324, consistent with prior guidance, and potentially representing the company’s most significant upcoming catalyst. For CS014, Cereno has now confirmed that the first participa...
- Sean Conroy
Cereno Scientific - CS014 (second asset) crosses into the clinic
The European Medicines Agency (EMA) has approved Cereno Scientific’s Clinical Trial Application (CTA) for CS014, a novel HDAC inhibitor with epigenetic effects. CS014 targets thrombosis prevention and is expected to do so without increased risk of bleeding, a key limitation of currently approved antithrombotics. Management has communicated that the drug product has been shipped to the trial sites and work on patient recruitment has begun. The Phase I trial will assess the safety and tolerability...
- Sean Conroy
Cereno Scientific - All eyes on Q3 readout after Q1 update
Cereno Scientific’s Q124 results provided a financial update and recapped the company’s clinical plans and progress. The Phase II trial for lead asset CS1 (pulmonary arterial hypertension, PAH) remains on track for a Q324 readout and we expect the Expanded Access Program approved by the FDA in January 2024 will help Cereno build a more robust data package for the subsequent Phase IIb/III trial. Additionally, the clinical trial application (CTA) submission for CS014 to the EMA in April 2024 bring...
- Sean Conroy
Cereno Scientific - CS014 (thrombosis) progresses towards the clinic
Cereno Scientific has taken a step closer to advancing its second asset, CS014, a novel HDAC inhibitor with epigenetic effects, to the clinic with the submission of the clinical trial application (CTA) to the European Medicines Agency (EMA). The CTA is for the first-in-human Phase I trial for CS014, which Cereno is developing for thrombosis prevention, without increased risk of bleeding. We believe this has the potential to address the main limitation of current standard-of-care antithrombotic m...
Edison issues initiation on Cereno Scientific (CRNO B): Differentiated...
Edison Investment Research Limited Edison issues initiation on Cereno Scientific (CRNO B): Differentiated approach in CVD with potential 22-Feb-2024 / 12:36 GMT/BST The issuer is solely responsible for the content of this announcement. London, UK, 22 Februar 2024 Edison issues initiation on Cereno Scientific (CRNO B): Differentiated approach in CVD with potential Cereno Scientific is a clinical-stage biotech, developing treatments for cardiovascular diseases (CVDs) using novel approaches. Its focus on disease-modifying therapies and a collaboration with Abbott set it apart f...
- Sean Conroy
Cereno Scientific - Differentiated approach in CVD with potential
Cereno Scientific is a clinical-stage biotech, developing treatments for cardiovascular diseases (CVDs) using novel approaches. Its focus on disease-modifying therapies and a collaboration with Abbott set it apart from peers. Lead asset CS1, a delayed immediate release formulation of VPA, is an HDAC inhibitor, aiming to deliver disease-modifying results in pulmonary arterial hypertension (PAH). Preclinical candidates include CS014, for thrombosis prevention without increased risk of bleeding (se...
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