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Less than a month after its stock roller-coastered on safety signals associated with its late-stage ulcerative colitis (UC) drug candidate obefazimod, shares of Abivax (Euronext Paris and Nasdaq: ABVX) enjoyed smoother sailing this past week—namely a 63% surge in Europe and a 50% leap in the United States over four trading days, following more positive data that appeared to reassure investors.
Abivax declared that obefazimod “delivered meaningful clinical benefit” to adults with moderately to severely active UC in the ABTECT Maintenance Part 2 supplemental portion of its Phase III UC maintenance program, with 37.2% of induction nonresponders achieving clinical remission and 34.5% achieving endoscopic remission at Week 44 following continued 50 mg treatment. Of those patients, 61.5% also showed clinical response, 48.0% endoscopic improvement, and 44.6% Histologic-Endoscopic Mucosal Improvement (HEMI).
In patients whose doses were escalated to 50 mg, clinical remission was recaptured in 45.5% of patients who relapsed during ABTECT Maintenance Part 1—a result Abivax said supported a practical dose-escalation strategy for regaining and sustaining disease control over time.
Of special interest to investors, no new safety signals were seen since earlier this month, when Abivax disclosed various malignancies in nine patients among the 580 enrolled in the study. The earlier disclosure triggered price plunges of 44% for both Abivax’s ordinary shares traded on Euronext Paris and the company’s American depositary shares (ADSs) traded on the Nasdaq Global Market.
The latest data from ABTECT Maintenance Part 2 showed four total cases of non-melanoma skin cancer (NMSC)—two in the study’s 25 mg arm, two in the 50 mg arm: “All occurred in patients with established NMSC risk factors including advanced age, thiopurine use, prior skin cancer history, and failure of multiple prior advanced therapies,” Abivax stated.
Significantly, incidence rates of malignancies (including NMSCs) when adjusted for patient-year exposure were well within the pre-defined background reference ranges based on previous UC studies.
Exposure-adjusted incidence rates (EAIRs) for malignancies excluding NMSC were 0.48 and 0.69 events per 100 person-years (PYs) in the all-active combined (50 mg + 25 mg) and 50 mg cohorts, respectively, and for NMSC were 0.95 and 0.69 events per 100 PYs, in the all-active combined (50 mg + 25 mg) and 50 mg cohorts respectively, all consistent with expected UC background rates
EAIRs for malignancies excluding non-melanoma skin cancer (NMSC) were 0.48 per 100 PYs in the all-active combined (50 mg + 25 mg) cohort, and 0.69 events per 100 PYs in the 50 mg cohort. For NMSC, EAIRs were 0.95 in the all-active combined cohort and 0.69 in the 50 mg cohort. All those results were consistent, Abivax said, with expected UC background rates ranging from 0.30–0.70 for malignancies excluding NMSC, and 0.70–1.40 for NMSC.
“The expanded cumulative safety data further strengthens our confidence in the long-term safety profile of obefazimod and reinforces the favorable benefit-risk profile for our program as we prepare for our planned NDA [New Drug Application] submission later this year,” Abivax CEO Marc de Garidel stated. “We believe this growing body of evidence positions obefazimod, if approved, to become a paradigm-defining treatment option for patients living with ulcerative colitis.”
Investors appeared to share de Garidel’s optimism. The data sparked a buying surge among investors, who sent Abivax shares traded on Euronext Paris soaring 39% the day after the announcement, from €83.30 ($94.71) to €115.50 ($131.31) on Tuesday. The shares rose another 1.7% Wednesday, closing at €117.50 ($133.59), then climbed another 9% Thursday to €127.80 ($145.28) before finishing the week with a 6% increase, to €135.80 ($154.38) and a 63% one-week gain.
On Nasdaq, Abivax ADSs surged 50% for the week, consisting of a roughly 39% leap Tuesday from $96.15 to $133.26. From there, shares dipped 0.5% the following day to $132.56, before rebounding 9% Thursday, finishing the Independence Day holiday-shortened week at $144.65.
Wednesday was a shorter trading day than usual since the company requested a temporary, single-day halt. Abivax requested the halt to price an upsized offering of its U.S. American depositary shares (ADSs), which increased from the originally announced $600 million to $800 million—6.4 million ADSs at $125 per ADS, which the company expected would extend its cash runway into the second quarter of 2029.
The offering closed Thursday at $920 million, of which approximately $874.1 million consisted of net proceeds, after underwriters exercised in full their option to purchase 960,000 additional ADSs representing 15% of the total number initially sold in the offering.
The size of the offering appeared, based on investor chatter cited by Stocktwits, an effort to dampen speculation about Abivax being a prime candidate for a buyout; the company appears in GEN’s most recent A-List of Top 10 Takeover Targets of 2026. But the upsizing of the offering rekindled buyout speculation by individual or “retail” investors, the same outlet reported Thursday.
Abivax said it intends to use the net proceeds toward expenses relating to potential commercialization of obefazimod in the United States; clinical R&D expenses, primarily related to UC and Crohn’s disease; and the remainder, if any, for general corporate purposes.
Leerink Partners, Morgan Stanley, Piper Sandler, and Guggenheim Securities were joint bookrunning managers for the offering, while LifeSci Capital acted as a passive bookrunning manager and Van Lanschot Kempen as the lead manager.
“Response rates (clinical & endoscopic remission) in this portion also appear compelling, especially given the refractory nature of patients in this subset, reaffirming obe’s best-in-disease efficacy,” Thomas J. Smith, senior managing director, immunology and metabolism, and a senior research analyst with Leerink Partners, commented in a research note.
“We believe this update further de-risks obe’s profile in UC and Crohn’s and should allay investor concerns following Part 1 maintenance data released earlier this month,” Smith added.
Smith raised his firm’s 12-month price target on Abivax shares 6%, from $140 to $148.
Two other firms also raised their price targets on Abivax stock:
Even more positive feedback on the latest data came from Faisal Khurshid, a managing director and equity research analyst with Jefferies. Khurshid upgraded his firm’s rating on Abivax’s stock from “Hold” to “Buy,” and boosted Jefferies’ price target 46%, from $108 to $158.
On June 1, Khurshid downgraded Jefferies’ rating on Abivax from “Buy” to “Hold,” citing the safety concerns he said have since been addressed.
“Mgmt. did a nice job addressing investor concerns w/ how they presented the safety data [June 29] vs. the Part 1 update. On top of that, the efficacy profile strengthens w/ each add’l piece of data,” Khurshid observed.
He also cautioned: “There is still risk on cash runway, catalyst path, and commercial needs for a pot’l standalone launch. But ultimately, good data should generate value.”
The biggest outstanding risk for Abivax, Khurshid wrote, is the need for significant resources associated with a commercial launch for an indication in inflammatory bowel disease (IBD): “We still think pot’l of asset better realized w/ a strategic partner.”
Obefazimod is a small molecule upregulator of miR-124, an anti-inflammatory microRNA. It enhances the selective splicing of a single long noncoding RNA to generate miR-124, which downregulates cytokines and chemokines shown to promote inflammation, including tumor necrosis factor (TNF) alpha, IL-6, monocyte chemoattractant protein-1 (MCP-1), and IL-17, as well as Th17+ cells.
Under its former name ABX464, obefazimod was initially developed against HIV but was repurposed to fight inflammatory conditions based on its anti-inflammatory effect.
The post StockWatch: New UC Data Sparks Smoother Sailing for Abivax appeared first on GEN – Genetic Engineering and Biotechnology News.
A European survey launched at the 42nd Annual Meeting of the European Society of Human Reproduction and Embryology (ESHRE) suggests broad public support for fertility treatment and research, including genome editing in human embryos for specific reasons.
The report, “Fertility, Embryo Research and Genome Editing: Public Attitudes in Europe,” was commissioned by the charity Progress Educational Trust (PET), which aims to improve choices for people affected by infertility and/or genetic conditions, and was supported by ESHRE. It explored public attitudes towards fertility treatment, embryo research, genome editing, surrogacy, and related topics.
The authors say the findings will “inform ESHRE’s ongoing work in Europe, linked to implementation of the European Union’s SoHO (Substances of Human Origin) Regulation and to the ethical considerations that arise in our field.”
The survey included 8688 participants aged 16–75 years across the U.K., Netherlands, Spain and Italy, with more than 2000 respondents in each country.
Across all four countries, a large proportion of respondents supported state-funded fertility treatment for people experiencing infertility and wishing to conceive, ranging from 54% in the Netherlands to 57% in the U.K., 62% in Spain, and 64% in Italy. Support was highest for heterosexual couples (47–59%) and lowest for transgender people (12–18%).
Conversely, most respondents said they did not support people being able to choose the biological sex of their child, based on personal preference. Opposition was strongest in the Netherlands (72%) followed by the U.K. (59%), Italy (55%) and Spain (47%). Nonetheless, there was still a significant minority that expressed support for sex selection. This support was strongest in Spain (32%) followed by the U.K. (26%), Italy (22%) and the Netherlands (18%), and was more common among younger participants than their older counterparts.
The age differential across responses could mean that with time, there will be a shift in views and potential changes in policy, the authors note.
The survey also found public backing for the use of human embryos in research to better understand and develop treatments for congenital diseases. Support ranged from 41% in Italy to 48% in the Netherlands and Spain, substantially exceeding opposition in all four countries (15–24%), including Italy, where research uses of human embryos are currently prohibited.
Respondents were then asked whether they supported or opposed the use of genome editing in human embryos, in three different scenarios:
In all four of the countries, more respondents supported than opposed all three of the uses of genome editing, with the highest level of support given if the technique helps eliminate a severe or life-threatening condition.
It is important to note that this use of genome editing—which was supported by 55% in the Netherlands, by 53% in Spain, by 52% in the U.K. and by 46% in Italy—is not permitted by law in any of these four countries at present.
PET commented: “It is heartening to see such substantial support for uses of genome editing in human embryos, across all four of the countries surveyed. That said, these findings present an interesting conundrum. Respondents seem to be more ready to countenance the use of genome-edited embryos in treatment—at least, if helps to eliminate a severe or life-threatening condition—than they are to countenance the use of genome-edited embryos in research. Realistically, research must occur first. There is therefore a need for wide-ranging public conversations, where the vital role played by research—in enabling treatment, and ensuring that treatment is safe and effective—can be conveyed.”
Professor Karen Sermon, immediate past chair of ESHRE, said, “Reproductive medicine and embryo research are advancing rapidly, and these findings show the importance of understanding how the public views those developments. It is particularly striking that support for some applications extends beyond what is currently permitted in certain countries. As science advances, it is essential that public awareness keeps pace, so that decisions about future treatments are informed by both evidence and societal values.”
The post Strong Public Support for Embryonic Genome Editing to Eliminate Severe Conditions, European Survey Shows appeared first on Inside Precision Medicine.