ALETH / LIFESCI-BRIEF / 2026-05-08 / ANGELINI BUYS CATALYST FOR $4.1BNThe Aleth Briefs link to the sources behind the stories and show how the week unfolded.
The week in five lines:
Angelini Pharma will buy Catalyst for $4.1bn, its first move into the US market.
Cytokinetics’ Myqorzo met both goals of a phase 3 in non-obstructive HCM.
BioNTech said it would exit plants affecting up to 1,860 jobs.
UCB agreed to buy Candid for $2bn upfront for its autoimmune T-cell engagers.
Roche agreed to buy digital pathology company PathAI for up to $1.05bn.
Browse by day:
Weekend catch-up: Celcuity · Veppanu · Jakafi XR · Esperion · UCB-Candid
Monday: US mifepristone · NHS Keytruda · Takeda · Windward
Tuesday: Cytokinetics · BioNTech · Madrigal · Avalo · MFN · GRAIL
Thursday: Angelini-Catalyst · Roche-PathAI · Entrada · Odyssey
Friday: Bizengri · 10x v Element
Weekend catch-up
Celcuity’s gedatolisib beat Piqray (alpelisib) in the PIK3CA-mutant cohort of the phase 3 VIKTORIA-1 breast cancer trial.
On Friday, Celcuity said gedatolisib with Faslodex (fulvestrant) and Ibrance (palbociclib) significantly improved progression-free survival against Piqray plus Faslodex. The FDA is due to rule on gedatolisib in PIK3CA wild-type disease by 17 July.
Celcuity’s VIKTORIA-1 achieves primary endpoint in PIK3CA mutant cohort · SEC
The FDA approved Arvinas’s Veppanu (vepdegestrant) for ESR1-mutated advanced breast cancer that has progressed after endocrine therapy.
The approval covers ER-positive, HER2-negative disease, with Guardant Health’s Guardant360 CDx as the companion diagnostic. In the VERITAC-2 trial’s ESR1-mutated patients, median progression-free survival was 5 months on Veppanu against 2.1 months on Faslodex (fulvestrant).
FDA approves vepdegestrant for ESR1-mutated advanced breast cancer · FDA
The FDA approved Incyte’s Jakafi XR, a once-daily version of Jakafi (ruxolitinib), for myelofibrosis, polycythaemia vera and graft-versus-host disease.
Approval rested on a study showing one 55 mg Jakafi XR tablet is bioequivalent to 25 mg of Jakafi twice a day. Pharmacy orders open by 8 May.
Incyte announces FDA approval of Jakafi XR · Incyte
ArchiMed agreed to buy Esperion Therapeutics for $3.16 a share in cash plus up to $100m in sales-linked payments, a total equity value of up to $1.1bn.
The cash price is a 58% premium to Esperion’s closing share price on 30 April.
Esperion to be acquired by ArchiMed, Exhibit 99.1 · SEC
UCB agreed to buy Candid Therapeutics for $2bn upfront.
UCB announced the deal on Sunday evening and will pay up to $200m more in milestones. Candid’s lead drug, cizutamig, is a T-cell engager that targets BCMA on plasma cells. It is in phase 1 trials across autoimmune diseases. The deal should close by early Q3 2026.
UCB to acquire Candid Therapeutics · UCB
Monday 4 May
Justice Alito temporarily restored mail access to the abortion pill mifepristone by staying a US appeals court order.
The administrative stay, granted on Danco Laboratories’ application, puts the Fifth Circuit’s 1 May order on hold until 11 May. Louisiana was told to respond by 7 May.
Docket for 25A1207 · US Supreme Court
Court issues temporary order allowing access to abortion pill by mail · SCOTUSblog
The NHS began rolling out an injectable Keytruda (pembrolizumab) that takes one or two minutes to give, against up to two hours for the drip.
MSD’s jab covers 14 cancer types, including lung, breast and cervical cancer. It is given every three weeks as a one-minute jab or every six weeks as a two-minute jab. Around 14,000 patients a year start Keytruda in England.
‘1-minute’ immunotherapy jab on NHS for patients with cancer · NHS England
Takeda’s TAK-881 matched HyQvia on antibody exposure in a pivotal phase 2/3 trial in primary immunodeficiency, with smaller and shorter infusions.
The trial met its primary endpoint of equivalent IgG levels. Takeda plans US, EU and Japanese filings in fiscal 2026.
TAK-881 shows PK comparability to HyQvia in PID · Takeda
Windward Bio raised a $165m crossover round led by OrbiMed to take its twice-yearly anti-TSLP antibody WIN378 into phase 3 in asthma.
Windward licensed WIN378 from China’s Kelun-Biotech and Harbour BioMed. The first phase 3 trial should start in Q4 2026.
Windward Bio announces $165m crossover financing · Windward Bio
Tuesday 5 May
Cytokinetics’ Myqorzo met both primary endpoints in non-obstructive HCM.
In the phase 3 ACACIA-HCM trial, Myqorzo (aficamten) improved symptom scores by 3.0 points and peak VO2 by 0.67 mL/kg/min against placebo at week 36. The cardiac myosin inhibitor is already approved in the US, EU and China for obstructive hypertrophic cardiomyopathy (HCM). Left ventricular ejection fraction (LVEF) fell below 50% in 10% of patients on Myqorzo and 1% on placebo. Two patients on Myqorzo had serious heart failure associated with LVEF below 50%. About half of HCM patients have the non-obstructive form. Cytokinetics will discuss the data with the FDA.
Cytokinetics announces positive topline results from ACACIA-HCM · Cytokinetics
BioNTech plans to exit sites affecting up to 1,860 jobs.
BioNTech plans to leave its manufacturing sites in Idar-Oberstein, Marburg and Singapore, and those of CureVac, which it bought in 2025. It plans the German exits by end-2027 and the Singapore exit in Q1 2027. BioNTech is exploring sales of each site and expects no impact on supply.
BioNTech announces first quarter 2026 financial results, Exhibit 99.1 · SEC
Madrigal Pharmaceuticals licensed Arrowhead’s ARO-PNPLA3 for $25m upfront and up to $975m in milestones.
The RNAi drug targets metabolic dysfunction-associated steatohepatitis (MASH) in patients with a PNPLA3 gene variant. In phase 1, a single top dose cut liver fat by up to 46% at 12 weeks in patients with two copies of the variant.
Arrowhead licenses MASH program targeting PNPLA3 to Madrigal · Arrowhead
Avalo Therapeutics’ abdakibart met its primary endpoint in the 253-patient phase 2 LOTUS trial in hidradenitis suppurativa.
42% and 43% of patients on the two doses reached HiSCR75 at week 16. Pooled across both doses, 42.5% responded against 25.6% on placebo, a gap of 16.9 percentage points. This fell short of the bar set by Avalo, analysts and AbbVie’s rival drug, which was tested in a separate trial. Avalo is raising $375m and plans a phase 3.
Avalo achieves positive topline results in phase 2 LOTUS trial, Exhibit 99.1 · SEC
Avalo’s phase 2 win fuels AbbVie chase despite placebo headwind · Fierce Biotech
The White House said its most-favoured-nation (MFN) drug pricing deals would save $529bn over 10 years.
The administration has voluntary MFN agreements with 17 of the largest drugmakers and expects most makers of sole-source branded drugs to follow. The $529bn comes from pricing new launches in line with other rich countries. Medicaid pricing of existing drugs adds $64bn.
Savings from Most-Favored-Nation Drug Pricing Policy · The White House
GRAIL’s Q1 revenue rose 28% YoY to $40.8m, and Galleri test volume grew 50% to >56,000.
Detailed results of the NHS-Galleri trial in England go to ASCO as a late-breaking oral presentation on 30 May.
GRAIL reports first quarter 2026 financial results · GRAIL
Zentalis dosed the first patient in ASPENOVA, a phase 3 trial of azenosertib in Cyclin E1-positive, platinum-resistant ovarian cancer.
The trial compares azenosertib with chemotherapy. It is designed as the confirmatory study for an accelerated approval based on the phase 2 DENALI trial, pending FDA feedback.
Zentalis announces first patient dosed in ASPENOVA phase 3 trial · Zentalis
Thursday 7 May
Angelini Pharma agreed to buy Catalyst Pharmaceuticals for $4.1bn.
Catalyst shareholders get $31.50 a share in cash, and the deal should close in Q3 2026. The purchase takes the Italian company into the US market. Catalyst’s Firdapse (amifampridine) for Lambert-Eaton myasthenic syndrome had 2025 sales of $358m.
Angelini to acquire Catalyst Pharmaceuticals for 4.1 billion USD · Angelini Pharma
Catalyst Pharmaceuticals Form 8-K on the Angelini merger agreement · SEC
Italian pharma Angelini scoops up Catalyst in $4.1B deal · Fierce Pharma
Roche agreed to buy digital pathology company PathAI for $750m upfront and up to $300m in milestones.
Roche will add PathAI’s AISight image management software to its digital pathology business.
Roche enters into a definitive merger agreement to acquire PathAI · Roche
Entrada reported “an increase of 2.36% in dystrophin over a baseline of 4.00%” in the first phase 1/2 cohort of its Duchenne drug ENTR-601-44.
Entrada blamed lower drug exposure in children than in adults and has started a 12 mg/kg cohort. Its shares fell 59% at Thursday’s open.
Entrada announces topline results from Cohort 1 of ELEVATE-44-201 · SEC
Entrada’s stock craters as DMD data underperform expectations · Fierce Biotech
Odyssey Therapeutics priced an upsized initial public offering of 15.5m shares at $18 each.
With a private placement to a TPG affiliate, gross proceeds are ~$304m. Trading on Nasdaq was due to start on Friday.
Odyssey Therapeutics announces pricing of upsized initial public offering · Odyssey
Friday 8 May
The FDA approved Partner Therapeutics’ Bizengri (zenocutuzumab) for advanced NRG1 fusion-positive cholangiocarcinoma after systemic therapy.
The approval covers adults whose unresectable or metastatic disease progressed on or after prior systemic therapy. In 19 patients, the confirmed response rate was 36.8%.
FDA approves zenocutuzumab for NRG1-positive cholangiocarcinoma · FDA
Element Biosciences said a 10x Genomics patent suit against its AVITI24 sequencing platform is “without merit”.
The complaint cites four US patents. Element said it will defend its technology.
Element responds to 10x Genomics patent complaint · Element Biosciences
Aleth · Open Access Research