ALETH / LIFESCI-BRIEF / 2026-03-20 / A NEW KIND OF PSORIASIS PILL WINS FDA APPROVALThe Aleth Briefs link to the sources behind the stories and show how the week unfolded.
The week in five lines:
J&J’s Icotyde, a daily pill blocking the IL-23 receptor, was approved for psoriasis.
A judge froze RFK Jr.’s overhaul of vaccine advisers and the childhood schedule.
Novartis will pay $2bn upfront, up to $3bn, for Synnovation’s breast cancer drug.
Lilly’s retatrutide cut weight by up to 16.8% in its first phase 3 diabetes trial.
Novo’s 7.2 mg Wegovy HD was cleared 54 days from filing, on a priority voucher.
Browse by day:
Weekend catch-up: GSK Arexvy
Monday: Amplifon-GN · Bayer · Structure · BioMarin · US vaccines
Tuesday: Pfizer · UK MHRA-NICE · Bicycle · Aldeyra · US NIH funding
Wednesday: Icotyde · JenaValve · US animal testing · Basecamp
Thursday: Lilly · Talzenna · Lynavoy · AZ · Collegium · Rhythm · Wegovy HD · Verily
Friday: Novartis-Synnovation
Weekend catch-up
The FDA expanded GSK’s RSV vaccine Arexvy to adults aged 18 to 49 at increased risk of severe disease.
The approval rests on a phase 3b trial in which the immune response in this group was no worse than in adults aged 60 and over. GSK estimates that 21 million US adults under 50 have at least one risk factor for severe RSV.
Arexvy approved in US for expanded age indication in adults aged 18-49 · GSK
Monday 16 March
Amplifon agreed to buy GN’s hearing business for DKK 17.0bn ($2.6bn).
GN Store Nord takes DKK 12.6bn in cash and 56 million Amplifon shares, giving it about 16% of Amplifon assuming the planned equity raise. The business includes the ReSound and Beltone brands and made DKK 7.2bn of revenue in 2025. Amplifon puts the combined group’s revenue at €3.3bn. GN will become “a pure technology company” in audio and video. Completion is expected by the end of 2026.
GN Store Nord to sell Hearing business to Amplifon for DKK 17.0bn · GN Store Nord
Bayer’s Kerendia (finerenone) slowed kidney function decline in non-diabetic chronic kidney disease in the phase 3 FIND-CKD trial.
The trial enrolled more than 1,500 patients and met its primary endpoint, measuring the annual change in eGFR through month 32. Kerendia is approved for chronic kidney disease linked to type 2 diabetes in >100 countries, and Bayer will submit the new data to regulators.
Finerenone meets primary endpoint in pivotal phase 3 FIND-CKD study · Bayer
Structure Therapeutics’ oral GLP-1 drug aleniglipron produced 16.3% placebo-adjusted weight loss at 44 weeks in the phase 2 ACCESS II trial.
The 180 mg dose produced 16.3% weight loss, compared with 16.0% at 240 mg. Both figures are based on analyses assuming patients remained on treatment. Structure says this is the highest weight loss yet reported for an oral GLP-1 drug. It plans to meet the FDA in Q2 and start phase 3 in H2 2026.
Structure reports positive data from phase 2 ACCESS II trial · Structure Therapeutics
BioMarin paused Voxzogo dosing in three growth conditions.
BioMarin has stopped enrolment and dosing in its phase 2 CANOPY trials of Voxzogo (vosoritide) in children with Turner syndrome, SHOX deficiency and ACAN deficiency.
The decision follows several cases of slipped capital femoral epiphysis, a hip complication, in two investigator-sponsored trials. Studies in children with Noonan syndrome and most forms of idiopathic short stature will continue, with additional imaging to monitor for the complication. BioMarin says it has seen no cases in its own trials or among more than 5,000 children treated with Voxzogo for achondroplasia.
BioMarin clinical trial update on Voxzogo · BioMarin
A federal judge blocked cuts to the US childhood vaccine schedule and froze Robert F. Kennedy Jr.’s new vaccine advisers.
Judge Brian Murphy in Boston said Kennedy likely broke federal law in reconstituting the Advisory Committee on Immunization Practices (ACIP), and put its appointments and decisions on hold. The order remains in place pending trial or summary judgment. HHS plans to appeal. An ACIP meeting set for the week was postponed. The American Academy of Pediatrics (AAP), which is suing the government, called it “a historic and welcome outcome”.
Judge blocks US government from slimming vaccine recommendations · WBUR
AAP statement on historic ruling in vaccine lawsuit · AAP
Tuesday 17 March
Pfizer’s CDK4 inhibitor atirmociclib met its primary endpoint in the phase 2 FOURLIGHT-1 trial in breast cancer that had progressed on CDK4/6 inhibitors.
Given with Faslodex (fulvestrant), it cut the risk of progression or death by 40% (HR 0.60) against Faslodex alone or Afinitor (everolimus) plus Aromasin (exemestane) in HR-positive, HER2-negative advanced disease. Overall survival data are immature. A first-line phase 3 trial is under way.
Pfizer announces positive topline phase 2 results for atirmociclib · Pfizer
The MHRA and NICE will launch a joint pathway on 1 April that makes licensing and NHS value decisions in England at the same time.
The government says some patients will get new medicines three to six months sooner. Twenty-seven companies signed up as early adopters, and the first guidance through the pathway is due in June 2026.
Medicines up to six months sooner under new MHRA-NICE process · GOV.UK
Bicycle Therapeutics proposed cutting about 30% of its staff and deprioritised zelenectide after regulators said its trial design no longer supports approval.
The Cambridge, UK company will convert the Duravelo-2 trial of zelenectide plus Keytruda (pembrolizumab) in metastatic urothelial cancer into a randomised phase 2 study. The restructuring is expected to halve annual operating expenses and stretch $628m of cash into 2030.
Bicycle Therapeutics reports Q4 and full-year 2025 results · Bicycle Therapeutics
The FDA rejected Aldeyra Therapeutics’ dry eye drug reproxalap again, saying the trials failed to show it works.
The complete response letter said the “inconsistency of study results raises serious concerns about the reliability and meaningfulness of the positive findings”. It raised no safety or manufacturing concerns and did not ask for more trials. Aldeyra, previously rejected in April 2025, will request a Type A meeting and says its cash lasts into 2028.
Aldeyra receives FDA complete response letter for reproxalap · Aldeyra Therapeutics
The Office of Management and Budget (OMB) released NIH’s FY2026 funding, which it had previously restricted to salaries and other essential costs.
Representative Rosa DeLauro disclosed the release at a House appropriations hearing, and NIH director Jay Bhattacharya confirmed it, saying new grants would soon roll out. Congress had approved a $415m rise for the $47.2bn agency.
White House lifts hold on NIH research spending · Science
Wednesday 18 March
The FDA approved Icotyde, a once-daily pill for plaque psoriasis.
J&J’s Icotyde (icotrokinra) is the first targeted oral peptide to block the IL-23 receptor. It is approved for moderate-to-severe plaque psoriasis in adults and children aged 12 and over who weigh at least 40 kg. Approval was based on four phase 3 studies in 2,500 patients. Protagonist receives a $50m milestone and is eligible for up to $580m more, plus royalties of 6% to 10%.
Protagonist announces US FDA approval of Icotyde · Protagonist Therapeutics
Novel drug approvals for 2026 · FDA
The FDA approved JenaValve Technology’s Trilogy, the first transcatheter valve in the US for symptomatic, severe aortic regurgitation.
The approval covers patients at high or greater risk from surgical valve replacement and rests on the single-arm ALIGN-AR pivotal trial. Trilogy has carried a CE mark since 2021 and has been used in >1,200 commercial procedures in Europe.
JenaValve announces FDA approval of Trilogy transcatheter heart valve · JenaValve
The FDA proposed how drug developers should validate non-animal testing methods, and the NIH committed >$150m to develop them.
The draft guidance sets four validation principles for new approach methodologies replacing animal studies. The NIH money is the first awards under its Complement-ARIE programme, which builds lab and computer models of human biology.
FDA draft guidance on alternatives to animal testing in drug development · FDA
NIH invests $150m in human-based research to reduce use of animal models · NIH
Basecamp Research launched a Trillion Gene Atlas with Anthropic, Ultima Genomics and PacBio to build genomic data for AI-designed therapeutics.
The project aims to expand known evolutionary genetic diversity 100-fold with data from >100 million species collected across thousands of sites. Ultima and PacBio supply the sequencing, and Nvidia the computing.
Basecamp launches Trillion Gene Atlas to scale AI-designed therapeutics · Basecamp
Thursday 19 March
Lilly’s retatrutide cut weight by up to 16.8% in its first phase 3 diabetes trial.
In TRANSCEND-T2D-1, the triple GIP, GLP-1 and glucagon agonist lowered HbA1c by up to 2.0 percentage points (at 9 mg) over 40 weeks in adults with type 2 diabetes, beating placebo on the primary and all key secondary endpoints. The 16.8% weight loss was at 12 mg, in an analysis assuming participants stayed on treatment. Weight was still falling at the end of treatment. Full results go to the ADA meeting in June.
Retatrutide significantly reduced A1C and weight in first phase 3 diabetes trial · Lilly
Pfizer’s Talzenna plus Xtandi improved radiographic progression-free survival in HRR-mutated metastatic hormone-sensitive prostate cancer (TALAPRO-3).
The combination reduced the risk of radiographic progression or death beyond the trial’s target, with benefit in patients with both BRCA and non-BRCA mutations.
Talzenna plus Xtandi improves progression-free survival in prostate cancer · Pfizer
The FDA approved GSK’s Lynavoy (linerixibat) for cholestatic pruritus, the itch of primary biliary cholangitis, days after GSK agreed to license it to Alfasigma.
GSK announced the approval on 19 March, ahead of the FDA’s 24 March target date. GSK is due $100m on approval under the Alfasigma deal, which has not yet closed. The approval rests on the phase 3 GLISTEN trial.
Lynavoy (linerixibat) approved by US FDA for cholestatic pruritus in PBC · GSK
Novel drug approvals for 2026 · FDA
GSK and Alfasigma announce agreement on worldwide rights for linerixibat · GSK
AstraZeneca will build a commercial manufacturing plant and an R&D centre for cell therapies in Shanghai.
The plant in Shanghai’s Lin-gang area will make CAR-T therapies from patients’ own cells for China and other Asian markets, including AZD0120, a BCMA/CD19 CAR-T in trials for multiple myeloma and autoimmune disease. The R&D centre will sit in the Zhangjiang High-Tech Park. AstraZeneca plans to invest $15bn in China through 2030.
Shanghai cell therapy base and innovation centre (Chinese) · AstraZeneca China
AstraZeneca plans to invest $15 billion in China through 2030 · AstraZeneca
Collegium agreed to buy the ADHD drug Azstarys (serdexmethylphenidate and dexmethylphenidate) from Corium Therapeutics for $650m in cash.
A further $135m is contingent on commercial and regulatory milestones. Collegium expects the acquisition to add to adjusted EBITDA immediately and extend its revenue visibility through 2037.
Collegium to acquire Azstarys from Corium · Collegium Pharmaceutical
The FDA approved Rhythm’s Imcivree for acquired hypothalamic obesity, three days after it missed every primary endpoint in the phase 3 EMANATE trial.
The label covers adults and children aged 4 and over. In the phase 3 TRANSCEND trial of 142 patients, Imcivree cut BMI by 18.4% against placebo at 52 weeks. On 16 March Imcivree missed the primary endpoint in all four substudies of the phase 3 EMANATE trial in rare genetic obesities, with placebo-adjusted BMI reductions of 1.7% to 4.3% at 52 weeks. A post hoc analysis that handled missing data differently showed significant reductions in two of the four groups.
Rhythm wins FDA approval of Imcivree for acquired hypothalamic obesity · Rhythm
Rhythm announces results from phase 3 EMANATE trial · Rhythm Pharmaceuticals
The FDA approved Wegovy HD 54 days after filing, using a national priority voucher.
Wegovy HD is a higher, 7.2 mg once-weekly dose of semaglutide. In the STEP UP trial, patients lost an average of 20.7% of their body weight. It is the fourth drug approved through the FDA Commissioner’s National Priority Voucher pilot. The FDA highlighted altered skin sensation, which was more common at the higher dose and remains under investigation. Novo plans to launch in the US in a single-dose pen in April.
Novo Nordisk announces FDA approval of Wegovy HD · Novo Nordisk
FDA approves fourth priority voucher product, higher dose semaglutide · FDA
Verily raised $300m in a round led by Series X Capital, and Alphabet gave up control of the company.
Alphabet invested in the round and will be a significant minority investor. UCHealth and the University of Colorado Anschutz also invested, and the company is now a corporation named Verily Health Inc.
Verily secures $300m investment to advance its precision health AI strategy · Verily
Friday 20 March
Novartis agreed to pay $2bn upfront for Synnovation’s breast cancer drug SNV4818.
Up to $1bn more is due in milestones. Novartis buys Synnovation’s subsidiary Pikavation Therapeutics, which holds SNV4818, and expects to close in H1 2026. SNV4818 is an oral PI3Kα inhibitor in a phase 1/2 trial. It is designed to hit the mutated enzyme in cancer cells and spare the normal form, which existing PI3Kα inhibitors also block. About 40% of HR-positive, HER2-negative breast cancer patients carry PIK3CA mutations.
Novartis agrees to acquire a pan-mutant-selective PI3Kα inhibitor · Novartis
Aleth · Open Access Research