Amolyt Pharma SAS

Ipsen and ImCheck Therapeutics have entered into a definitive share purchase agreement. ImCheck's shareholders will be eligible to receive a payment of EUR 350 million and downstream payments, for a total potential consideration of up to EUR 1 billion. ImCheck Therapeutics is a private French biotechnology company pioneering next-generation immuno-oncology therapies. EQT Life Sciences has backed ImCheck since 2017 and has provided comprehensive support beyond capital, at the board level. STOCKHOLM, Oct. 22, 2025 /PRNewswire/ -- EQT Life Sciences is pleased to announce that Ipsen (Euronext: IPN; ADR: IPSEY) has entered into a definitive agreement to acquire its portfolio company ImCheck Therapeutics for EUR 350 million at closing, with a total transaction value of up to USD 1 billion. ImCheck Therapeutics, based in Marseille, France, is pioneering immuno-oncology therapies by targeting butyrophilins, a novel group of immune-regulating proteins. Its lead drug, ICT01, is being tested in acute myeloid leukemia (AML) patients who are not fit for standard treatment, with early Phase I/II trial results showing promising responses. ICT01 is a first-in-class monoclonal antibody targeting BTN3A, a key immune-regulatory molecule broadly expressed across cancer. EQT Life Sciences invested in the business in 2017, as part of a syndicate of investors, and has since provided comprehensive support, including at the board level. Vincent Brichard, Venture Partner at EQT Life Sciences and board member at ImCheck Therapeutics, said: "We are immensely proud to have supported ImCheck's journey to this significant acquisition by Ipsen. The transaction highlights the strength of ImCheck's platform and exceptional leadership and team. It is also a testament to our ability to identify hidden gems and support transformative biotech companies." Pierre d'Epenoux, CEO of ImCheck Therapeutics, said: "This transaction is an extraordinary milestone for ImCheck and puts the spotlight on groundbreaking science originating from French academia. EQT Life Sciences' support has extended far beyond financing – their strategic guidance and confidence in my leadership has been instrumental in our success. Together, we have advanced pioneering science from concept to late-stage clinical development, demonstrating what visionary investors and dedicated teams can accomplish together." Together with the Amolyt Pharma exit to AstraZeneca in 2024, EQT Life Sciences has achieved successful exits from its two portfolio companies under the France 2030 investment program – a government initiative supporting the most promising French biotech innovations. This highlights EQT Life Sciences' expertise in identifying leading European biotech companies and turning them into global success stories. The transaction is expected to close by the end of Q1 2026, subject to customary closing conditions, including regulatory approvals under French and U.S. regulations. Contact EQT Press Office, [email protected] This information was brought to you by Cision The following files are available for download: WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

MBX Biosciences said Monday that its experimental drug canvuparatide cleared the bar in a Phase 2 trial in a rare endocrine disorder called hypoparathyroidism. The once-weekly drug helped 63% of patients (30 out of 48 participants) maintain a normal range of albumin-adjusted serum calcium levels while also staying off conventional therapy of active vitamin D and daily calcium supplements at week 12, the Indiana-based drug developer said. At the same time point, 31% of patients on placebo (5 out of 16 people) achieved the composite primary endpoint. The study results were statistically significant at a p-value of 0.042. Investors were anticipating strong results from MBX’s Phase 2 study, codenamed Avail. The company’s share price $MBX rose 36% in post-market trading on Friday night after MBX said it would present the topline data before Monday’s opening bell. If Monday’s data are replicated in a larger Phase 3 trial, anticipated to begin next year, the biotech’s contender could potentially offer an alternative to an approved daily medicine marketed as Yorvipath by Ascendis Pharma. Other biopharmas also aim to treat the rare endocrine disorder, like Septerna and AstraZeneca, whose Amolyt-developed drug succeeded in a Phase 3 in March. Hypoparathyroidism impacts about 250,000 people in the US and Europe and can sometimes lead to chronic kidney disease. Takeda previously marketed a treatment for the rare endocrine condition, which is marked by reduced calcium levels and impairments to daily quality of life, but the Japanese pharma took it off the market due to manufacturing hurdles. “Hypoparathyroidism poses a substantial burden to patients, who often face complex treatment regimens and unpredictable swings in calcium levels that can lead to serious complications,” Mishaela Rubin, study investigator and Columbia University professor, said in a press release. “The 12-week and 6-month data provide promising early evidence that this investigational therapy may offer a potential option for long-term management, pending further study.” The study’s placebo-adjusted response rate of 32% came in below management expectations. In a note to clients last month, Mizuho analyst Uy Ear said MBX management anticipated a placebo-adjusted rate of 48%. While the response rate ended up being higher in the treatment arm, at 63% versus a projection of 55%, the placebo performed much better than expected. MBX had anticipated a 7% placebo response rate. The end result was 31%. In an interview with Endpoints News , CEO Kent Hawryluk said the placebo group was a “small sample size.” “While the placebo response was higher than originally planned, it’s not unusual. If we looked at the once-daily injectable,” Hawryluk said, referring to Ascendis’ Yorvipath, “in their Phase 2, they had a 27% placebo response for their primary endpoint. Importantly, that reduced in their longer Phase 3 study. “There’s a logical reason for that,” the MBX CEO continued. Hypoparathyroidism patients “can’t stay in the normal range of serum calcium for long without their conventional therapy,” he said. MBX said canvuparatide, previously known as MBX 2109, was “generally well-tolerated.” No treatment-related discontinuations were reported in the Phase 2 trial. The biotech also said 94% of patients elected to enroll in the open-label extension, with a 79% responder rate at six months. “We hope [to] provide a best-in-class treatment option for patients, which gives them freedom from having to take a daily injection, which is a daily reminder of their disease,” Hawryluk said. “We believe that we’ve shown with these results that we offer continuous infusion-like PTH exposure, which brings back their natural physiology, which they’re lacking with their disease.” Three doses were tested in the Phase 2. Chief medical officer Sam Azoulay told Endpoints that the biotech is still sifting through the full data package to determine the dose for the upcoming Phase 3. The topline data marked the second clinical readout for MBX since the biotech went public . The only other key clinical results since last year’s $163 million IPO were Phase 1 data for a different drug in treating post-bariatric hypoglycemia. That investigational medicine, called MBX 1416 or imapextide, is now in Phase 2 . Another drug, nicknamed MBX 4291, entered Phase 1 for obesity earlier this month. The biotech hopes MBX 4291 could compete in the obesity drug market as a once-monthly GLP-1 and GIP co-agonist. All of the drug candidates derive from the same platform at MBX, which aims to extend the half-life of peptide therapies. Hawryluk said Monday’s results could have “readthrough” to those other pipeline drug candidates. With canvuparatide, he noted, MBX was able to take a hormone peptide with a natural half-life of about one hour and turn it into a once-weekly treatment candidate.

MBX Biosciences posted positive Phase II results for its experimental hypoparathyroidism treatment — prompting its share price to double on Monday — as the company looks to challenge Ascendis Pharma's Yorvipath (palopegteriparatide), the first US-approved treatment for the rare parathyroid hormone (PTH)-deficiency disorder.Canvuparatide is a long-acting PTH prodrug designed for once-weekly subcutaneous injection. Leveraging MBX's Precision Endocrine Peptide platform, the therapy is meant to help reduce daily swings in calcium levels that can lead to serious complications."We believe the totality of the data support a once-weekly product profile with continuous infusion-like PTH exposure," said CEO Kent Hawryluk. He added that preparations are underway to initiate a Phase III trial of canvuparatide in 2026. The Avail trial enrolled 64 adults with chronic hypoparathyroidism, a rare endocrine disease marked by low blood calcium and associated symptoms such as muscle cramping or spasm, and neurological symptoms such as depression, confusion and cognitive impairment. 63% responder rate In the 12-week randomised phase, 63% of patients on canvuparatide (30/48) achieved the primary composite endpoint — defined as normal serum calcium without dependence on active vitamin D and high-dose calcium supplements — compared with 31% for placebo (5/16). In the open-label extension portion, 79% of patients who received canvuparatide (44/56 evaluable) maintained responder status at six months, including those initially randomised to placebo.MBX said secondary endpoints showed positive results for bone turnover and formation markers, including BSAP, CTx, and P1NP, consistent with enhanced bone remodeling. Kidney activity also improved; in patients with elevated baseline urine calcium, mean levels fell 48% on canvuparatide at 12 weeks, versus a 33% reduction in placebo. MBX said there were no treatment-related serious adverse events or discontinuations reported. Mild injection site reactions occurred in 19% of treated patients in the pooled treatment groups, versus 13% on placebo.Another contender in the field is AstraZeneca, which is advancing eneboparatide following its acquisition of Amolyt Pharma for about $1.1 billion in 2024. The PTH receptor 1 agonist succeeded at normalising serum calcium in adults in the 202-patient CALYPSO study compared to placebo, according to topline data unveiled earlier this year.