Big Pharma Updates: Trials, Deals and Ratings

AstraZeneca PLC (AZN) reported on April 21 that a prespecified interim analysis of its I CAN Phase III trial showed Ultomiris met the primary endpoint in adults with immunoglobulin A nephropathy at risk of disease progression. The trial demonstrated a statistically significant and clinically meaningful reduction of proteinuria, assessed via 24‑hour urine protein creatinine ratio at week 34.

The company said the safety profile in the study remained consistent with the known profile of Ultomiris, with no new safety concerns identified. A change from baseline in estimated glomerular filtration rate will be measured at week 106 as the trial’s primary endpoint for long‑term kidney function. AstraZeneca (AZN) plans to seek accelerated approval in key markets and to present the results at an upcoming medical meeting.

Sanofi (SANp) announced financial results for the first quarter of 2026 on April 23, highlighting double‑digit sales and business EPS growth. Sales rose 13.6% at constant exchange rates, while business earnings per share reached €1.88. Management pointed to strong contributions from new pharma launches and key products.

Sanofi (SANp) said pharma launch sales increased 49.6% to €1.2 billion, led by Ayvakit, ALTUVIIIO and Sarclisa, while Dupixent sales grew 30.8% to €4.2 billion. Vaccine sales advanced 2.1% to €1.3 billion, benefiting from Heplisav‑B. The company reported R&D expenses of €1.7 billion, up 1.5%, and selling and general expenses of €2.3 billion, up 11.6%, mainly due to recent acquisitions.

Regeneron Pharmaceuticals (REGN) said on April 23 that the U.S. Food and Drug Administration granted accelerated approval for Otarmeni, described as the first gene therapy and second new molecular entity approved under the FDA Commissioner’s National Priority Voucher program. Formerly known as DB‑OTO, Otarmeni is an adeno‑associated virus vector‑based gene therapy.

Regeneron (REGN) stated that Otarmeni is indicated for pediatric and adult patients with severe‑to‑profound and profound sensorineural hearing loss associated with molecularly confirmed biallelic variants in the OTOF gene, preserved outer hair cell function, and no prior cochlear implant in the same ear. The company said Otarmeni is the first and only in vivo gene therapy for OTOF‑related hearing loss and will be made available free of charge in the United States.

AbbVie (ABBV) disclosed on April 23 that it received a Complete Response Letter from the FDA regarding the biologics license application for trenibotulinumtoxinE, a first‑in‑class botulinum neurotoxin serotype E characterized by rapid onset and short duration. The company said the FDA requested additional information on manufacturing processes.

AbbVie (ABBV) reported that the letter did not identify safety or efficacy issues for TrenibotE and did not call for additional clinical studies. The firm plans to respond in the coming months and noted that regulatory reviews in other countries are proceeding as expected. According to AbbVie, safety and efficacy are supported by data from over 2,100 treated patients, including two pivotal Phase 3 studies in glabellar lines and a Phase 3 open‑label safety study.

Gilead Sciences (GILD) announced on April 17 that it had obtained all required regulatory approvals for its previously announced acquisition of Arcellx. At the same time, the company extended the expiration of its tender offer to purchase all outstanding Arcellx common shares, moving the transaction closer to completion.

In a separate analyst note dated April 8, Truist reaffirmed a Buy rating on Gilead (GILD) and increased its price target to $155. The firm cited a broader backdrop of easing sensitivity to regulatory and policy shifts in biotech and pointed to a recent uptick in deal activity, which it believes could sustain momentum through the rest of the year.

Truist said it is watching Gilead’s management commentary on the launch strategy and payer access dynamics for Yeztugo in the U.S. and EU, as well as updates on anito‑cel launch preparations ahead of the December 23, 2026 PDUFA date. Gilead described its portfolio as focused on serious diseases including cancer, HIV, viral hepatitis and COVID‑19.

Biogen received multiple analyst upgrades tied to its development pipeline. On April 22, UBS raised its rating on the stock to Buy from Neutral and lifted its price target to $225. UBS said it has increased conviction in Biogen’s pipeline catalysts over the next 12–15 months and suggested upcoming readouts could support the stock into 2027.

UBS highlighted potential upside from BIIB080 tau data expected in the summer and described Phase III litifilimab data in systemic lupus in fiscal Q4 as a “real upside catalyst.” The bank characterized Biogen as an under‑owned stock with a window of pipeline catalysts that trades at a discount to large‑cap peers. On April 20, Wells Fargo upgraded Biogen to Overweight from Equal Weight and increased its price target to $250.

Regeneron also drew positive attention from TD Cowen, which on April 23 raised its price target to $960 from $880 while reiterating a Buy rating ahead of fiscal first‑quarter results. The firm modestly reduced its Eylea and Libtayo estimates, raised its Dupixent estimate and lifted its non‑GAAP EPS projection for the quarter to $9.30.

AbbVie’s outlook was updated by Piper Sandler on April 23, when the firm cut its price target to $294 from $299 but maintained an Overweight rating. Piper Sandler said the stock has become somewhat controversial, pointing to concerns about Johnson & Johnson’s (JNJ) oral IL‑23 therapy Icotyde in psoriasis and its potential impact on Skyrizi’s trajectory.

The firm said it expects Icotyde to expand the IL‑23 category overall and noted that Skyrizi penetration in inflammatory bowel disease remains low. It added that while consensus expectations for Skyrizi may now better reflect its growth, other parts of AbbVie’s business are not fully captured in estimates.

Amgen (AMGN) was the subject of a new initiation by Canaccord on April 21, with the broker starting coverage at Hold and setting a $366 price target. Canaccord said Amgen has executed well on its key growth drivers and that this performance is already reflected in the share price, citing looming loss of exclusivities and pricing pressure on mature products as constraints on further upside.

For context, Amgen (AMGN) reported that in fiscal fourth quarter 2025, total revenue rose 9% to $9.9 billion, with product sales up 7% on 10% volume growth. Full‑year 2025 revenue was $36.8 billion, up 10%. Analysts cited this double‑digit revenue and EPS growth as evidence of strong recent execution.