reports
- Oscar Haffen Lamm
Cinclus: agreement with the FDA on the iPSP
Similar to the agreement for the PIP concluded with the EU's EMA a couple of weeks ago, Cinclus has reached an agreement with the FDA on the company’s initial Paediatric Study Plan (iPSP) for linaprazan glurate, which is a prerequisite for market approval for adult use in the US. The study plan wil
- Oscar Haffen Lamm
Cinclus: preparations on track to start phase 3 trial
Cinclus Pharma reported its Q3'24 results with a cash position at SEK644.2m and an EBIT at SEK(39.15m). On the operational side, i) all is on track to recruit the first patient for its phase 3 trial in 2025, with topline data on the healing part expected in Q2/Q3 2026, and ii) market approval of li
- Oscar Haffen Lamm
Cinclus: Positive read-x, PCABs are growing in the US
We are encouraged to see that since its launch on the US market, PCABs have seen steady market penetration, as highlighted by Phathom Pharma's Q3'24 on vonoprazan (1st gen. PCAB) (+30% beat vs css on sales), which highlighted i) a strong growth in filled prescriptions, which amounted 69,000 (+97% Q
- Oscar Haffen Lamm
Cinclus: reaches agreement with the EMA on the PIP
Cinclus Pharma has secured an agreement with the EMA Paediatric Committee (PDCO) on their Paediatric Investigation Plan (PIP) for linaprazan glurate, a necessary step toward obtaining marketing approval for adult use in the EU. A PIP outlines the approach for studying new medications in paediatric
- Oscar Haffen Lamm
Cinclus: Q2 reiterated phase 3 trial timeline
Cinclus Pharma reported its Q2'24 results with a cash position at SEK 684.72m and an EBIT at SEK (37.329m). On the operations side, it has been reiterated that i) the company is looking to enroll the first patient in the 1st phase 3 study in 2025, with a readout expected in 2026, and ii) its Chines
- Oscar Haffen Lamm
Cinclus: Positive read-x, US market showing growing interest in PCABs
Phathom Pharma reported its Q2 report yesterday, which highlighted a positive launch of its 1st generation PCAB Voquezna (vonoprazan), where filled prescriptions amounted 35,000 (+265% QoQ) for the quarter, with 77% of total US commercial lives covered. We are encouraged by such a positive launch t
- Oscar Haffen Lamm
Better, faster, stronger! Taking on the eGERD market
Cinclus Pharma is a Swedish late-stage biopharmaceutical company developing a proprietary drug candidate, linaprazan glurate (LG), a next generation and potential best-in-class Potassium Competitive Acid Blocker (PCAB), which is a fast-acting regulator of intragastric pH by a different MoA than PPI
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