Ph 3 initiation around the corner

Cinclus Pharma: Q2 driven by BD progress, Phase 3 trial nearing initia...

Cinclus’ Q2 update focused on balance sheet items and a recap of corporate achievements. The company reported a cash position of SEK589m and operating expenses of SEK80.9m, up from the prior quarter - consistent with expectations given the Phase 3 trial ramp-up. With support from the Zentiva partne

Cinclus read-x: Voquezna CP win secures 2032 exclusivity

On Friday, Phathom's Voquezna (vonoprazan) has been granted its Citizen Petition (CP), securing 10-year exclusivity through 2032. This follows months of uncertainty after the FDA initially failed to reflect the full exclusivity (5 years NCE + 5 years GAIN) in the Orange Book, similar to the Voquezn

Cinclus Pharma: model update

Following last week’s licensing agreement with Zentiva for the EU rights to linaprazan glurate -valued at up to EUR220m - we have updated our model to reflect, i) the deal structure, including the total potential value and tiered double-digit royalties, and ii) a higher EU market penetration foreca

Strikes license deal with Zentiva

Cinclus Pharma: partners with Zentiva in a deal worth EUR220m for its ...

Cinclus Pharma entered into a agreement with Zentiva for the EU rights of linaprazan glurate in a total deal value of EUR220m, including an upfront payment of EUR13m and a near-term milestone of EUR5m in 2026, and is entitled to receive tiered double-digit royalties on net sales in Europe, starting

Cinclus Pharma: start of phase 3 reiterated for Q3'25

Cinclus Pharma reported its Q1 results which focused on balance sheet items and a recap of corporate achievements for the quarter, with a cash position at SEK523.9m and an EBIT at SEK(47.519m). With the current cash position and operational cash burn, we forecast a runway into H1 2027. On the opera

Q1'25: as planned

Cinclus Pharma: PCABs off to a strong start since launch in the US

In its first year on the market, PCABs have shown strong uptake as highlighted by Phathom's FY'24 results on vonoprazan (1st-gen PCAB), which exceeded market expectations coming in at USD29.7m (+81% QoQ, +19% vs. CSS) — despite the positives the stock remained under pressure after open likely due t

Phathom Q4 shows US PCAB market potential

Cinclus Pharma: US phase 3 trial to start in Q3'25

Cinclus Pharma reported its Q4 results with a cash position at SEK566.7mm and an EBIT at SEK(56.89m). With the current cash position and operational cash burn, we forecast a runway into H1 2027 — i.e. beyond the next value inflection point of the phase 3 readout in Q3 2026. On the operational side,

Q4'24: Ph 3 study delayed

Cinclus Pharma: Linaprazan glurate approved in China

Yesterday, Cinclus' Asian partner Sinorda received marketing approval in China for Linaprazan glurate, where pricing and reimbursement discussions will now be initiated, with an expected launch in 2025 where Cinclus' is eligible for low single-digit royalties on net sales. The commercialisation wil

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

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

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

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

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

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

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