Ruxolitinib Phosphate

In a first for the neurotoxin market, Ipsen announced Thursday that its Dysport has hit the goals in two phase 3 trials for the prevention of both episodic and chronic migraines. While AbbVie’s market-leading Botox has been approved by the FDA to prevent headaches in patients with chronic migraine since 2010, Dysport is now the first botulinum toxin to also report positive phase 3 results in episodic migraine, according to Ipsen. The readouts come from studies in Ipsen’s Beond program, comprising 1,510 patients, split between C-Beond (chronic) and E-Beond (episodic). Both trials have met their primary endpoints, showing a statistically significant reduction in monthly migraine days versus placebo. “Together, these findings position Dysport as a potential first-in-class treatment for a broad migraine population,” Ipsen’s global head of R&D, Christelle Huguet, Ph.D., said in a July 9 statement. Ipsen will review the full data and prepare for regulatory filings, including with the FDA, a company spokesperson told Fierce Pharma. Episodic migraine represents a “substantially larger patient population” than chronic patients, Ipsen pointed out. The E-Beond trial defines episodic migraine as patients experiencing no more than 14 headache days per month, including at least six migraine days. Specific definitions of episodic versus chronic migraine may vary, but the 14-headache-day per-month cutoff is a widely accepted standard. The clinical victory gives Ipsen another venue to chip away at Botox’s dominance. The AbbVie blockbuster pulled in nearly $6.4 billion in sales last year across therapeutic and cosmetic indications. By comparison, Ipsen recorded 298 million euros ($341 million) and 436 million euros (about $500 million) in Dysport’s 2025 revenues between the two fields, respectively. First approved by the FDA in 2009 for cervical dystonia and glabellar lines, Dysport is also indicated for certain patients with spasticity. Migraine, including both episodic and chronic forms, affects around 14% to 15% of the global population. Coming at both forms of the disease from another angle, Ipsen is advancing a recombinant neurotoxin called corabotase (IPN10200) in phase 2, while having already moved the asset into phase 3 in aesthetics. In the phase 2 Lantic study in aesthetics, corabotase offered a significantly longer duration of effect versus Dysport in terms of achieving a score of “none” or “mild” line severity at week 24, Ipsen reported in September 2025. RELATED: Ipsen pens $1.7B deal to acquire Kartos for potential Jakafi add-on therapy for myelofibrosis The newer molecule was also embroiled in a dispute between Ipsen and its long-time commercialization partner Galderma. The two companies had previously clashed over the control of next-generation neuromodulator projects, as Ipsen moved to terminate their R&D partnership signed in 2014. In a final decision issued in January 2026, the arbitral tribunal of the International Chamber of Commerce sided with Ipsen, allowing the French pharma to terminate the R&D agreement and take full control of its clinical-stage toxin programs in the aesthetic field. The R&D legal brouhaha didn’t affect the two companies’ commercialization collaboration around Dysport.

Shares in Forte Biosciences were up more than 55% on Thursday after reporting positive Phase Ib data showing that its anti-CD122 monoclonal antibody FB102 let to significant improvement in vitiligo, while maintaining a favourable safety profile."[Our] optimised FB102 blockade of CD122 was designed to modulate both IL-2– and IL-15–dependent pathogenic T-cell biology while preserving regulatory T cells, and clinical data to date support this profile," said CEO Paul Wagner. "This may enable broader immune pathway modulation than IL-15 blockade alone and may avoid the regulatory T-cell modulation that can occur with overly potent CD122 inhibition."Benefit after treatmentIn the intent-to-treat (ITT) population, FB102 was associated with a 29.6% mean improvement in Facial Vitiligo Area Scoring Index (FVASI) from baseline to week 24, while the placebo group experienced a mean 16.2% worsening, for a placebo-adjusted benefit of 45.8% in favour of FB102 (p=0.005).Gains were more pronounced in patients with more extensive disease. Among those with baseline FVASI scores of at least 0.75, FB102 produced a 43.2% mean improvement from baseline at week 24, versus 0.5% for placebo (p=0.006). Nearly 59% of these patients achieved at least a 50% improvement in facial vitiligo (FVASI50), while 23.5% reached the FVASI75 threshold.Overall, 84% of FB102-treated patients improved by week 24 and none experienced worsening disease, versus 27% of placebo recipients whose vitiligo progressed.Forte noted that one placebo participant, out of the 11 in the ITT population, was excluded from the protocol-defined efficacy-evaluable analysis due to facial hair interfering with assessment, and that their vitiligo had worsened during the study. Excluding that person from the analysis removed a case that would have favoured FB102, making the results a more conservative estimate of the drug's true effect, the company added.Early onset of activityForte said its treatment also demonstrated an early onset of activity. Statistically significant benefit emerged by day 64 and continued through week 24 despite dosing ending after 12 weeks; an additional 8 percentage points in FVASI improvement was observed between weeks 12 and 24.FB102 was generally well tolerated, with only mild-to-moderate adverse events and a safety profile "comparing favourably to placebo," the company said.Incyte's JAK inhibitor Opzelura (ruxolitinib) cream is currently the only FDA-approved therapy specifically indicated for repigmentation in non-segmental vitiligo.Meanwhile, Incyte recently reported positive Phase III results for its oral JAK1 inhibitor povorcitinib, which met the primary endpoint in two late-stage vitiligo studies and is expected to be submitted for regulatory approval in the first half of 2027.Forte, which targeted a $150-million in a public offering earlier this year, is also developing in FB102 coeliac disease, where it reported Phase Ib results a year ago. "We look forward to the imminent readout from our ongoing Phase II coeliac disease trial as the next important clinical catalyst for FB102," Wagner said.