News
The day at a glance · 3 min read
Mood · Cautious
-15
Sentiment, −100 to +100
WELIREG dosage
120 mg
FDA & Regulation
LENVIMA dosage
20 mg
FDA & Regulation
Pfizer cost cut target
$2.7B
Big Pharma & Biotech
Key driverFDA approvals and patent cliff concerns weigh on major pharma names amid pipeline development activity
Daily briefHealthcare· Money365.Market AI ·

Merck FDA Win, J&J Patent Cliff, Moderna Rejoins Nasdaq-100

FDA approves Merck's WELIREG/LENVIMA combo for kidney cancer; J&J faces patent expirations on Imbruvica and Darzalex; Moderna returns to Nasdaq-100

FDA & Regulation

Bullish
MRKBMY
Merck ($MRK) reported FDA approval of WELIREG plus LENVIMA for adults with advanced renal cell carcinoma after prior PD-1/PD-L1 therapy. The approved combination involves WELIREG at 120 mg taken once daily together with once daily LENVIMA at 20 mg. Merck also began a first-in-human Phase I trial using Cyprumed's oral peptide delivery platform for an undisclosed peptide candidate.
Bristol Myers Squibb ($BMY) saw its Zenbexus meet a progression-free survival endpoint in a pivotal multiple myeloma trial. The FDA had previously granted approval to Zenbexus based on a different primary endpoint being achieved in the same trial.

Big Pharma & Biotech

Neutral

Pfizer 3-month return

17.5%+13.8 pp vs S&P

Moderna 12-month return

571.42%

Moderna price

$196+4.81%

Regeneron P/E

17.6x
JNJPFEREGNMRNA
Johnson & Johnson ($JNJ) faces upcoming patent expirations on key cancer drugs Imbruvica and Darzalex over the next several years. These expiries are part of a broader pharmaceutical industry patent cliff affecting multiple large drugmakers through the early 2030s. Management has been investing in research pipelines and dealmaking as it prepares for revenue pressure once exclusivity on these therapies ends.
Pfizer ($PFE) outlook improves beyond COVID as cost cuts target $2.7B by 2029, though patents and pricing pose risks. Pfizer stock has returned 17.5% over the past three months, easily outpacing the 3.7% return for the S&P 500. The board declared its 352nd quarterly dividend in a row, though management was asked on the latest earnings call what it would take to cut that dividend.
Regeneron Pharmaceuticals ($REGN) stock currently trades at 17.6 times earnings, representing a notable discount to the 21.5 multiple of the median S&P 500 company. The shares have lost 4.1% over the past six months, trailing the 15.7% return of the broader index. Over twelve months, however, the stock returned 27% against the index's 17.1%.
Moderna ($MRNA) traded at around $196, up 4.81% on the day and 571.42% higher over twelve months. Nasdaq said the company will rejoin the Nasdaq-100 before the open on October 9, replacing Warner Bros. Discovery. Moderna left that index in December 2024.

Healthcare M&A & Deals

Bullish

Pacira acquisition value

$1.7 billion
Viatris has agreed to acquire Pacira BioSciences for $1.7 billion, acquiring its portfolio of non-opioid pain medications. Pacira BioSciences stock is having its best day ever following the announcement of the acquisition.

MedTech & Devices

Neutral
TMO
Thermo Fisher Scientific ($TMO) has helped launch the Digital CMC Consortium to advance digital Chemistry, Manufacturing, and Controls for biopharma. The initiative brings together biopharma companies, technology providers, and regulators to work on shared digital standards for CMC data. The Consortium aims to support faster therapy development, more efficient regulatory reviews, and digital lifecycle management across drug programs.

Health Insurance & Managed Care

Bearish

UNH closing price

$370.63-1.42%
UNH
UnitedHealth Group ($UNH) stood at $370.63 in the closing of the recent trading day, denoting a -1.42% move from the preceding trading day.
CVS Health trades below industry peers as Aetna margins recover, pharmacy trends improve and Health Services gains momentum, but 340B headwinds persist.

Patent & IP Developments

Bearish
MRK
Halozyme wins a Dutch court order blocking Merck ($MRK)'s Keytruda SC in eight European markets, strengthening its position in the patent dispute. The court order represents a significant development in the ongoing intellectual property conflict between the two companies over subcutaneous delivery technology.

Emerging Biotech & Pipeline

Neutral
Everest Medicines announced the appointments of Lakshmi Srinivasan, PhD, as Senior Vice President, Head of Translational Medicine, and Brandon Coder, PhD, as Vice President, Translational Sciences & Discovery. The appointments further strengthen the Company's global R&D capabilities in mRNA therapeutics.

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