Cereno Scientific Reports Favorable Safety and Tolerability after 12 Months of CS1 Treatment in PAH from the Expanded Access Program Cereno Scientific (NASDAQ First North: B) reported initial 12-month Expanded Access Program (EAP) learnings for lead candidate CS1 in pulmonary arterial hypertension (PAH). The EAP enrolled 10 patients; CS1 was well tolerated with no unexpected safety concerns or deaths, and no discontinuations reported as related to CS1.Six of ten patients completed 12 months; two discontinued after atrial fibrillation events assessed as not related, one withdrew consent and one was lost to follow-up. Phase IIa (25 patients, 3 months) met primary safety and tolerability endpoint with no drug-related serious adverse events. Phase IIb enrollment anticipated June 2026; further EAP analyses due Q2 2026.

#B #CRNO Cereno Scientific Reports Favorable Safety and Tolerability after 12 Months of CS1 Treatment in PAH from the Expanded Access Program

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Cereno Scientific Receives Approval to Initiate FDA-aligned Phase I Pharmacokinetic Study of CS014 Supporting Phase II Development in PH-ILD Cereno Scientific (NASDAQ: B) received Swedish Medical Products Agency approval to start a Phase I pharmacokinetic study of CS014, designed using FDA pre-IND feedback. The open-label, randomized, two-period crossover trial in 14 healthy adults compares seven-day repeat dosing of CS014 versus valproic acid to characterize total and unbound plasma concentrations at steady state.The company says a successful PK study could remove the need for additional nonclinical safety work and a Phase IIa trial, supporting a capital-efficient path toward a planned Phase II study in PH-ILD in Q1 2027. Results are expected mid-2026.

#B #CRNO Cereno Scientific Receives Approval to Initiate FDA-aligned Phase I Pharmacokinetic Study of CS014 Supporting Phase II Development in PH-ILD

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Cereno Scientific Receives FDA Clearance to Initiate Global Phase IIb Trial of CS1 in Pulmonary Arterial Hypertension (PAH) Cereno Scientific (B) announced that the U.S. FDA cleared initiation of its global Phase IIb trial of lead candidate CS1 for pulmonary arterial hypertension (PAH).The randomized, double-blind, placebo-controlled, dose-finding study will enroll ~126 patients across ~65 sites in 10–12 countries, run 60 weeks total, and evaluate PVR by right-heart catheterization and 6-minute walk distance at Week 36. CS1 holds Orphan Drug and Fast Track designations. First patient in is planned for Q2 2026, with top-line data anticipated around Q4 2028 subject to enrollment timelines.

#B #CRNO Cereno Scientific Receives FDA Clearance to Initiate Global Phase IIb Trial of CS1 in Pulmonary Arterial Hypertension (PAH)

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Cereno Scientific Submits Phase IIb Trial Protocol for CS1 in Pulmonary Arterial Hypertension (PAH) to the U.S. FDA Cereno Scientific (B) submitted the clinical trial protocol for a planned global Phase IIb study of CS1 in pulmonary arterial hypertension (PAH) to the U.S. FDA on Nov 10, 2025. The submission follows FDA Type C meeting feedback and aims to advance CS1—an oral HDAC inhibitor that targets PAH via epigenetic modulation—after Phase IIa showed favorable safety, tolerability and encouraging efficacy signals (reverse vascular remodeling, improved right heart function, better patient quality of life). The Phase IIb is designed as a global, multicenter, placebo-controlled trial run with an international CRO. Cereno expects the FDA's standard 30-day review and plans to start the trial in H1 2026.

#B #CRNO Cereno Scientific Submits Phase IIb Trial Protocol for CS1 in Pulmonary Arterial Hypertension (PAH) to the U.S. FDA

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Want a NO VOTE?
Here is the list of every phone number for every Senate office. Note that you will have to dial a 202-22 before each of these numbers to reach the correct office (so, for example, you can reach Amy Klobuchar at 202-224-3244, since her phone extension is listed here as 4-3244).
#crno

Both recess (as in Congressional recess) and recession stem from the Latin recessionem (nominative recessio), meaning "a going back"—a noun of (in)action; "to fall back; withdraw."

Mike Johnson’s performative CR & his lackeys' retreat from D.C. are deliberate acts to tank the economy. #CRNo

Shopping time, trying out new outfit for work.
Vreme za kupovinu, isprobavanje nove kombinacije za posao.
#me #selfie #shopping #highheels #skirt #black #white #suit #blackandwhite
#ja #slika #kupovina #visokepete #crno #suknja #belo #crno #crnoibelo

Shopping time, trying out new dress for work.
Vreme za kupovinu, isprobavanje nove haljine za posao.
#me #selfie #shopping #highheels #dress #black
#ja #slika #kupovina #visokepete #crno