FDA briefing documents show regulators are increasingly open to approving Moderna's (MRNA) experimental mRNA flu vaccine, indicating the shot met key study goals and may be effective in adults 65 and older, according to Investing.com and Endpoints News. If approved, it would be the first mRNA-based seasonal flu vaccine in the U.S. Moderna shares continued to rise on the news.

Fierce Biotech profiled Daiichi Sankyo's new head of R&D, framing the challenge as "outrunning the very ADC gold rush the company helped ignite." With $14.6B in oncology revenue targeted by 2030, the company must maintain its ADC leadership as Gilead, Merck, Lilly, and dozens of others crowd into the space.

Curium prevailed in a patent dispute brought by Novartis subsidiary Advanced Accelerator Applications over Lutetium Lu 177 dotatate, according to The Pharma Letter. The ruling strengthens Curium's radiopharmaceutical position as it pursues the $7B Lantheus take-private.

Four biotechs have raised at least $400M in 2026 IPO proceeds, the most in a single year since 2021, according to BioPharma Dive. Kardigan Therapeutics' cardiac drug IPO was the latest.

Merck (MRK) won FDA approval to expand Capvaxive (pneumococcal 21-valent conjugate vaccine) to children and adolescents aged 2 to 17 at increased risk of pneumococcal disease.

BIO International Convention (Opens Monday, June 22 to 25): San Diego. The industry's largest partnering event. We will cover significant deal announcements and strategic presentations.

Moderna FDA Advisory Committee: An advisory meeting on the mRNA flu vaccine could come in the coming weeks. A positive recommendation would be the final step before approval.

Revolution Medicines CNPV Filing: Approaching three weeks post-ASCO plenary. The most anticipated filing of the summer.

Medicare GLP-1 Bridge (July 1): 12 days out.

Section 232 Tariffs (July 31): 42 days out for large companies.

FDA briefing documents released ahead of an advisory committee meeting show that regulators are increasingly open to approving Moderna's experimental mRNA flu vaccine, according to Investing.com and Endpoints News. The documents indicate the shot met key study goals and may be effective in adults aged 65 and older, a population that accounts for the majority of flu-related hospitalizations and deaths. Endpoints reported the FDA "provided tepid support" but "didn't appear to raise any major concerns that could hinder its prospects." If approved, this would be the first mRNA-based seasonal flu vaccine in the U.S. and would validate the mRNA platform beyond pandemic applications. Moderna shares have risen on the news.

Fierce Biotech profiled Daiichi Sankyo's new head of R&D on June 17, framing the challenge as "outrunning the very ADC gold rush the company helped ignite." Daiichi Sankyo co-developed Enhertu with AstraZeneca, creating the template for the modern ADC wave. But the competitive landscape has exploded: Gilead spent $15B on ADC-related acquisitions (Arcellx, Tubulis), Merck's sac-TMT produced two Phase 3 wins with Kelun-Biotech, Lilly acquired CrossBridge for dual-payload ADC technology, and dozens of clinical-stage ADC programs are advancing. Daiichi Sankyo's $14.6B oncology revenue target by 2030 depends on maintaining ADC leadership through next-generation programs, label expansions (Enhertu in early breast cancer, Datroway in first-line TNBC), and new targets beyond HER2 and Trop-2. The new R&D head must execute against this backdrop while managing the $606M manufacturing charge the company disclosed in May.

Curium prevailed in a patent dispute brought by Novartis subsidiary Advanced Accelerator Applications (AAA) concerning Curium's Lutetium Lu 177 dotatate product, according to The Pharma Letter. The ruling clears a legal overhang for Curium's radiopharmaceutical portfolio and strengthens its competitive position as it pursues the potential $7B take-private of Lantheus Holdings (first reported May 23). Novartis's Pluvicto (lutetium Lu 177 vipivotide) grew 70% in Q1 2026 and is the leading radioligand therapy for prostate cancer. A Curium generic Lu-177 product could eventually compete at the manufacturing and supply level while Curium builds its diagnostic franchise through a Lantheus combination.

BioPharma Dive reported that four biotechs have raised at least $400M in IPO proceeds in 2026, the most in a single year since 2021. This year's IPO class has accounted for five of the six largest new biotech stock offerings since the start of 2022. Key names: Kailera ($625M), Parabilis ($475M), Kardigan ($400M+), and one additional company. Total 2026 IPO proceeds now exceed $3.6B across 13 companies.

Merck won FDA approval to expand Capvaxive (pneumococcal 21-valent conjugate vaccine) to children and adolescents aged 2 to 17 at increased risk of pneumococcal disease, according to The Pharma Letter. The expansion broadens Capvaxive's addressable population from adults to pediatric high-risk patients, positioning it against Pfizer's Prevnar franchise.

June 15 (Monday): Ajax JAK2 early data "working right out of the gate" (validates Lilly $2.3B). AstraZeneca Truqap approved for PTEN prostate cancer. Kardigan IPO $373M+ terms.

June 16 (Tuesday): Novartis/Orionis $1.4B molecular glue (total $7.1B+ commitment). EFPIA Biotech Act patent push. SonoThera $125M non-viral gene therapy. Survodutide: underwhelming weight loss, impressive fat composition.

June 17 (Wednesday): India cisplatin/carboplatin shortage. Amgen Tavneos FDA death flagging. Biogen "new Biogen" pivot. enGene/Neumora/Genentech layoffs.

June 17 (Wednesday): PwC midyear: biopharma "back to full health" ($65B Q1). Lilly/4E Therapeutics (13th deal, non-opioid pain). UniQure Huntington's gene therapy FDA reversal. Jazz/AbCellera TCE deal. FDA approves Utebzi oral carbapenem.

June 18 (Thursday): Moderna mRNA flu vaccine positive FDA briefing. Daiichi Sankyo ADC strategy. Curium wins Novartis Lu-177 patent. 4 IPOs at $400M+. Merck Capvaxive pediatric expansion.

Monday (June 22 to 25): BIO International Convention (San Diego)

Imminent: Revolution Medicines CNPV NDA filing

Imminent: Lilly Foundayo T2D filing under CNPV

July 1: Medicare GLP-1 Bridge program launches

July 31: Section 232 pharma tariffs effective (large companies)

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