Alvotech: US manufacturing deal with LOTTE Biologics
Alvotech signed a long-term deal for LOTTE Biologics to make drug substance for several of its antibody biosimilars at LOTTE’s plant in Syracuse, New York, which has 40,000 litres of bioreactor capacity. Terms were not disclosed, and supply starts only after technology transfer, qualification and regulatory approval. Alvotech says it now has enough capacity for its pipeline for the next ten years.
Context The point is supply security. Alvotech’s products come from its Reykjavik plant, where findings from a July 2025 FDA inspection led to three complete response letters for pipeline biosimilars, and an improvement programme slowed output this year: product revenue fell 48% to $106 million in the first half of 2026. On 5 October the FDA approved a second Reykjavik production suite for Simlandi, its Humira biosimilar and the second-largest adalimumab biosimilar in the US. Alvotech does not report sales by product, but Simlandi and its Stelara biosimilar Selarsdi produced its 2025 product revenue of $276 million. For scale, 40,000 litres is a mid-sized commercial site: about 5% of Samsung Biologics’ 845,000 litres and under 1% of global mammalian cell-culture capacity, estimated at about 6.5 million litres in 2023.
Source: Alvotech release · Alvotech H1 2026 results · Samsung Biologics · BioProcess International
Rest of Europe
BridgeBio: FDA priority review for oral infigratinib in achondroplasia
The FDA accepted BridgeBio’s application for infigratinib, an oral FGFR inhibitor, in children with achondroplasia, with a decision due by 4 February 2027. In the Phase 3 PROPEL 3 trial it raised annualised height velocity by 2.10 cm a year over placebo (p<0.0001), which BridgeBio calls the largest effect of any Phase 3 in the condition. An EU filing is planned for the fourth quarter of 2026.
Context The US market is already contested by two injectable drugs. BioMarin’s daily Voxzogo had sales of $253 million in the second quarter of 2026, and Ascendis’ once-weekly Yuviwel, launched after accelerated approval in February 2026, had €8 million. Infigratinib would be the first oral option. Cross-trial comparisons of height gains are only indicative.
Read-across Adds competition for Ascendis Pharma’s (ASND) Yuviwel, early in its launch and awaiting an EU decision in the fourth quarter of 2026, and for BioMarin’s (BMRN) Voxzogo. Yuviwel is still a small part of Ascendis’ revenue, which is led by Yorvipath (€252 million in the second quarter).
Source: BridgeBio release · Ascendis Q2 2026 · BioMarin Q2 2026
Lundbeck: Parkinson’s data for Lu AF28996, Phase II starts
In an open-label Phase Ib trial in 34 patients with advanced Parkinson’s disease and motor fluctuations, Lu AF28996, an oral prodrug of a D1/D2 dopamine agonist taken twice daily, added 3.6 hours a day of “good ON-time” at week 6 and 3.4 hours at week 18, from a baseline of 9.5 hours. OFF-time fell by 2.3 hours, troublesome dyskinesia decreased, and side effects were mostly mild (nausea, dizziness, falls). The placebo-controlled Phase II DARE2 trial, with about 150 patients, has started; its primary endpoint is the change in good ON-time at week 19.
Context The trial had no placebo arm, so the gain is not comparable with controlled studies. For reference, AbbVie’s tavapadon (Juvmo), a D1/D5 agonist approved by the FDA on 28 September, added 1.7 hours of good ON-time against 0.6 hours on placebo in its Phase 3 TEMPO-3 trial. For Lundbeck, whose first-quarter revenue of DKK 7.1 billion was led by Rexulti and Vyepti, this is an early-stage programme; it describes Lu AF28996 as a first-in-class oral D1/D2 agonist.
Read-across Lu AF28996 would follow AbbVie’s (ABBV) newly approved Juvmo as a new dopamine-agonist option for motor fluctuations, using the same good ON-time endpoint.
Source: Lundbeck release · Pharmacy Times (Juvmo) · Lundbeck Q1 2026
Forbion: €2.3bn raised across two new funds
The Dutch life-sciences investor closed Ventures Fund VIII, for start-ups and young therapeutics companies, and Growth Opportunities Fund IV, for later-stage biopharma in Europe and North America, for a combined €2.3 billion ($2.6 billion). Investors include Dutch pension managers MN and PGGM, KfW Capital, the Kauffman Foundation and Eli Lilly.
Context It is Forbion’s largest raise, up from $2.2 billion in 2024, and lifts its assets under management to about €7.5 billion. The funds can back about 30 companies; Forbion has backed 142 since it started, 21 of whose products reached the market. The raise comes as European biotech, BioPharma Dive notes, has fallen behind the US and China on investment and clinical trial activity.
Alzinova: rights issue 80% subscribed
Alzinova’s rights issue of units was about 80.4% subscribed, according to the preliminary count, raising about SEK 41 million before costs; the final outcome is due today. The money goes about 60% to the Phase II trial of ALZ-101, its vaccine against toxic amyloid-beta oligomers in early Alzheimer’s disease, 20% to manufacturing and 20% to working capital.
Context The issue was 79.3% covered in advance by underwriting and insider commitments, so take-up was close to the guaranteed level. The sum is about three times the SEK 13 million cash Alzinova held at the end of June. The Phase II trial will enrol about 120 patients, with cognition (ADCOMS) measured after 52 weeks; Alzinova has not said how long the money lasts. Warrants attached to the units, exercisable in January and October 2027, could bring in more.
Source: Alzinova release · Rights issue terms · Alzinova H1 2026 · Biostock
Abionyx: OLON to manufacture CER-001
Abionyx signed a manufacturing agreement with OLON, an Italian contract manufacturer, for CER-001, its recombinant apoA-I protein assembled into HDL-like particles. OLON will handle protein production, particle assembly and fill-and-finish at its French sites, starting with the validation batches needed for a filing in LCAT deficiency, and will build capacity for the larger sepsis indication. Financial terms were not disclosed.
Context Manufacturing is the gating step for Abionyx’s first filing: it plans two GMP validation batches in 2027 and an application to the EMA in LCAT deficiency, an ultra-rare inherited lipid disorder, in early 2028. In sepsis, a pivotal Phase 2b trial is due to start by the end of 2026, with first data in the first half of 2028. The deal follows a viral-safety partnership with Texcell in September. Abionyx had €26.9 million in cash at the end of June, after a financing of up to €33 million, and says this lasts into the fourth quarter of 2028.
Source: Abionyx release · CER-001 timelines · Cash and runway · Texcell partnership