Moderna Surges on FDA Flu Vaccine Review; Gilead HIV Filing

MRNA jumps 94% YTD ahead of advisory panel; Gilead wins FDA acceptance for weekly oral HIV prevention; AbbVie beats on Q1 revenue.

Money365.Market AI
3 min read
Market MoodRisk-On
Sentiment+65Bullish

Key DriverPositive FDA briefing documents for Moderna's mRNA flu vaccine ahead of June 18 advisory committee meeting drove biotech momentum

Today in 30 Seconds

  • Moderna up 94% YTD as FDA releases positive briefing ahead of June 18 panel
  • Gilead wins FDA acceptance for weekly oral Yeztugo HIV prevention filing
  • AbbVie Q1 revenue beat by $284M; raises FY guidance to $14.08-$14.28 EPS

Top Movers

$MRNA +9.1%

Moderna

FDA briefing docs ahead of flu vaccine advisory panel

All Briefs

FDA & Regulation

Bullish

MRNA Stock Price

$57+9.1%

MRNA YTD Gain

94%+94%
$MRNA$GILD

Moderna ($MRNA) extended gains, rising 9.1% as the FDA released positive briefing documents ahead of a June 18 advisory committee meeting to assess the benefit-risk profile of mFluvia, the company's mRNA seasonal flu vaccine. The stock climbed to $57 in afternoon trading and has surged 94% year-to-date, marking the strongest performance among major vaccine manufacturers. $MRNA announced it expects to launch three new vaccines over the next two years, broadening its commercial pipeline beyond COVID-19 products.

Gilead Sciences ($GILD) won FDA acceptance for a filing seeking approval of once-weekly oral Yeztugo for HIV prevention, aiming to expand access with a new long-acting PrEP option. The filing could broaden Yeztugo into a once-weekly oral HIV prevention option, expanding $GILD's HIV portfolio beyond existing therapies.

Big Pharma & Biotech

Bullish

AbbVie Q1 Revenue

$15.002B+$284M

AbbVie FY EPS Guidance

$14.08-$14.28+raised

AbbVie Dividend Yield

~3%
$ABBV$JNJ$BMY$PFE

AbbVie ($ABBV) posted Q1 2026 revenue of $15.002 billion, beating consensus estimates by $284 million, prompting management to raise full-year adjusted EPS guidance to a range of $14.08 to $14.28. The stock yields nearly 3%, and the operational beat has shifted investor sentiment on the company's post-Humira transition strategy.

Johnson & Johnson ($JNJ) reported late-stage trial results for its blood-cancer drug TALVEY on June 13, as the company seeks to demonstrate sustained growth following the loss of a multibillion-dollar product. Bristol Myers Squibb ($BMY) is pursuing FDA approval to expand Camzyos into adolescents with obstructive HCM, aiming to strengthen its cardiovascular portfolio and broaden the drug's market reach.

Pfizer ($PFE) entered a new partnership with SINOPHARM to promote antifungal drug Diflucan in China, with the collaboration also covering future product launches, supply chain optimization, and commercial execution across the Chinese market. The agreement deepens $PFE's presence in one of the world's most important pharmaceutical markets.

GLP-1 & Weight Loss Market

Bullish

GLP-1 Market 2025

$28.7B

GLP-1 Market 2026E

$34.2B

GLP-1 Market 2035E

$95.3B+12.1% CAGR

LLY 1-Month Gain

>18%+18%

LLY 1-Year Gain

~50%+50%
$NVO$LLY

The global GLP-1 receptor agonist market was valued at approximately $28.7 billion in 2025 and is expected to reach $34.2 billion in 2026, advancing toward a projected $95.3 billion by 2035 at a compound annual growth rate of 12.1%, according to a market research study. Key players include Novo Nordisk ($NVO) and Eli Lilly ($LLY).

$NVO has lost GLP-1 leadership against $LLY, according to analyst commentary, with the stock now trading at fair value rather than a bargain. $NVO CEO Doustdar expects to submit oral Wegovy for Chinese regulatory approval within a few months, seeking to expand the drug's geographic footprint.

$LLY shares have gained more than 18% in the past month and soared nearly 50% over the past year, driven by strong performance of its obesity and diabetes medications including Mounjaro and Zepbound. The company presented results from late-stage trials of weight-loss drug candidate retatrutide on June 6. $LLY became the first pharmaceutical company to cross a $1 trillion market valuation in November last year, though demand for its hottest drugs now faces operational friction.

M&A & Licensing Deals

Neutral
$RIGL

Rigel Pharmaceuticals ($RIGL) announced the closing of its exclusive global license agreement for VEPPANU (vepdegestrant) with Arvinas, following early termination of the Hart-Scott Rodino waiting period and satisfaction of other customary closing conditions. The deal advances $RIGL's commercial-stage pipeline focused on hematologic disorders and cancer.

Looking Ahead

Neutral
$MRNA$NVO$BMY$GILD

The FDA's Vaccines and Related Biological Products Advisory Committee will convene on June 18 to assess the benefit-risk profile of Moderna's ($MRNA) mFluvia, a pivotal review for the company's mRNA seasonal flu vaccine program. Novo Nordisk ($NVO) expects to file oral Wegovy for Chinese regulatory approval within a few months, potentially opening a major new geographic market. Bristol Myers Squibb ($BMY) awaits FDA review of its application to expand Camzyos into adolescents with obstructive HCM, while Gilead Sciences ($GILD) progresses through regulatory review for once-weekly oral Yeztugo as an HIV prevention therapy.

What to Watch

Wed, Jun 18

FDA VRBPAC meeting on Moderna mFluvia mRNA flu vaccine

$MRNA
High

Risk Flags

NoteNovo Nordisk has ceded GLP-1 leadership to Eli Lilly per analyst views
NoteEli Lilly faces operational friction from high demand for obesity/diabetes drugs

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