BMS reports liver injury events in lung disease program, with key readout near. October 1, 2026 | Bristol Myers Squibb will soon release Phase 3 data for admilparant that could make or break Contineum Therapeutics' rival product. But reports of a death due to liver injury in the pharma's program have caused some unease about the drug class. Bristol Myers Squibb has amended the protocol for a Phase 3 clinical program testing pulmonary fibrosis candidate admilparant, reporting multiple cases of liver injuries, including one death. But the study has yet to be fully unblinded, leaving the cause of the events unclear at this time, the company said. The disclosure unsettled investors in Contineum Therapeutics, which is developing a similar product, due to fears about a potential class-wide effect. The issue came to light this week, despite the protocol change being made in May. BMO Capital Markets analysts flagged the issue in a Wednesday note, suggesting that too many questions remain unanswered to determine if admilparant caused the liver issues. "A limited number" of liver events have been observed in the Phase 3 ALOFT program, BMS confirmed to BioSpace in an emailed statement. Most were mild, transient and linked to other medical conditions or in patients taking other medications that have known liver risk factors. There was one death, reportedly due to multi-organ failure after acute liver injury, but it's unclear whether the patient was taking admilparant because BMS is still blinded to the data. "Without identifying whether the patient was on treatment, investors cannot clearly assume this acute hepatic injury-driven death was tied to admilparant or even associated with treatment," BMO wrote. The protocol amendment flagged interstitial lung disease and multiple other comorbidities as complicating factors related to the death. BMS is barreling toward a clinical trial readout that an H.C. Wainwright analyst believes could contribute to the return of mergers between mega-cap drugmakers. September 2, 2026 The independent data monitoring committee, however, has been reviewing incoming unblinded data regularly and has recommended that the trial continue, BMS said. Another committee has been created to specifically look at potential liver injury, BMO noted. The ALOFT program features multiple pulmonary fibrosis indications, with a near term readout for the Phase 3 ALOFT-IPF study in idiopathic pulmonary fibrosis "likely to be significant" for BMS, BMO said. The firm remains cautious about that readout, which is expected in the fourth quarter. "Limited information on potential drug-related liver injury raises overall risk of ALOFT program, but data remains on track for a 4Q26 disclosure," BMO said. While analysts note that admilparant is one of BMS' most important near-term catalysts, BMO said fourth quarter data for the secondary stroke prevention candidate milvexian is a higher priority. A class action? BMS investors are not alone in awaiting the ALOFT-IPF readout, with the protocol amendment raising some questions about the lysophosphatidic acid receptor 1 (LPA1-R) class. Contineum Therapeutics is developing a rival therapy called PIPE-791, currently in a Phase 2 trial called PROPEL-IPF. BMS' protocol amendment sent Contineum's shares down sharply on Wednesday, Stifel said in an investor note. The stock has since recovered to $13.42 as of Thursday morning, slightly above its closing price Tuesday. The ALOFT-IPF outcome "is core to the CTNM thesis for PIPE-791," Stifel said. But the firm does not believe the evidence so far suggests that the LPA1-R mechanism is the culprit. While expressing disappointment, William Blair analysts were unsurprised by the Phase II failure, having assigned the VISTA study a high level of risk given the "mixed" performance of a similar drug in a prior multiple sclerosis study. November 21, 2025 Contineum's therapy also has a different molecular makeup and much lower dose, so Stifel downplayed any readthrough. William Blair caught up with Contineum CEO Carmine Stengone, who similarly brushed off concerns. "We continue to believe there is minimal on-mechanism risk here and that this potential signal is molecule and dose specific, if anything, which bodes well for PIPE-791 differentiation," the firm wrote in a Thursday morning note. If BMS' forthcoming readout is positive, William Blair believes it will help derisk the LPA1-R mechanism in IPF. The indication is currently served by Boehringer Ingelheim's Ofev and Jascayd and Legacy Pharma's Esbriet. Stengone estimated a total addressable market of $10-14 billion, if PIPE-791 clears clinical trials and becomes standard-of-care. Annalee Armstrong is an award-winning biopharma journalist covering the business of drug development. She has been a journalist for more than 18 years, covering the pharmaceutical and biotech industry for the last eight. She is senior editor at BioSpace and curates the Biopharm Executive newsletter every Wednesday. You can reach her at [email protected]. Follow her on LinkedIn.

Continuum Therapeutics reported its second-quarter 2026 financial results, announcing it has streamlined its discovery programmes to focus on inflammatory and fibrotic diseases. This resulted in a workforce reduction, including the departure of Chief Scientific Officer Daniel Lorrain. The company's global Phase 2 PROPEL-IPF trial evaluating PIPE-791 for idiopathic pulmonary fibrosis now has over 55 sites online across eight countries. Johnson & Johnson completed enrollment of 107 participants in June 2026 for its Phase 2 trial of JNJ-5120/PIPE-307 in major depressive disorder. Cash and marketable securities totalled $236.6 million as of 30 June 2026, which the company projects will fund operations through mid-2029. Research and development expenses decreased 10% to $12.7 million year-on-year, whilst general and administrative expenses rose 23% to $4.7 million. Net loss was $15.2 million for the quarter.