BioBucks Newsletter
Oral GLP-1 gets an FDA greenlight, CMS floats new pricing demos, and Shionogi drops $2.5B on ALS.
|
|
Upfront Briefing
Big day for obesity: the FDA approved Novo Nordisk’s oral Wegovy as the first oral GLP-1 for weight management (yes, a pill).
Policy also stayed loud: CMS floated new Medicare drug pricing models that look built to attract industry pushback.
And in deal-land, Shionogi is paying $2.5B for one of the few approved ALS drugs — a reminder that rare disease appetite hasn’t gone anywhere.
Tape Action
| Instrument |
Last close |
1D % |
YTD % |
| S&P 500 |
6,878.5 |
0.6% |
16.9% |
| Nasdaq 100 |
25,461.7 |
0.5% |
21.2% |
| Russell 2000 |
2,558.8 |
1.2% |
14.7% |
| XBI (Biotech ETF) |
125.9 |
2.0% |
39.8% |
| Nasdaq Biotech |
5,824.2 |
1.5% |
35.1% |
| Clinical Trials ETF (BBC) |
40.2 |
1.8% |
67.8% |
|
-
Biotech outpaced the big indices: XBI (+2.0%) beat the S&P 500 (+0.6%) into the close.
- Broad biotech kept the bid — BBC (+1.8%) was among the day’s standouts.
-
Market data: US close Mon 22 Dec 2025.
The Big 3
|
1
|
FDA approves oral Wegovy for weight management
|
-
The FDA has approved Novo Nordisk's oral version of Wegovy, marking the first oral GLP-1 treatment for weight management. This approval could significantly broaden access to obesity treatments.
-
Why it matters:
FDA just made GLP-1 weight loss a pharmacy-counter habit: a daily pill can broaden adoption (needle-averse patients), shift adherence dynamics, and intensify the “capacity + access” chess match as Novo tries to meet demand.
-
Source:
STAT
-
More:
Endpoints; PR
|
|
2
|
Trump administration proposes Medicare drug pricing models
|
-
The Trump administration has proposed new Medicare drug pricing models, which are expected to face pushback from the pharmaceutical industry. These models could significantly impact company revenues and drug access.
-
Why it matters:
This is a live policy stress-test for pricing power: even “demo” models can reset contracting expectations, pull PBMs/payers into new lanes, and create real downside risk for exposed products long before anything becomes permanent.
-
Source:
Endpoints
-
More:
STAT; BioPharma Dive
|
|
3
|
Shionogi to acquire ALS drug for $2.5 billion
|
-
Shionogi is set to acquire one of the few approved ALS drugs for $2.5 billion. This significant acquisition will impact the ALS treatment landscape and Shionogi's market position.
-
Why it matters:
A significant acquisition in the rare disease space, impacting the ALS treatment landscape and Shionogi's market position.
-
Source:
Endpoints
|
Everything Else that broke
-
Dupixent approved in Japan for pediatric asthma. — PR
- Biogen's QALSODY Phase 3 results published in JAMA Neurology. — PR
- Bristol Myers Squibb challenges IRA drug pricing in Supreme Court. — Endpoints
- China's new insurance model to broaden Alzheimer's drug access. — Endpoints
- US charges six with insider trading, including Olema Oncology. — Endpoints
- BioSpace reviews 2025 features and manufacturing trends. — BioSpace
Deal Flow
M&A / BD&L
-
Shionogi to acquire ALS drug for $2.5 billion. — Endpoints
- Windward Bio acquires bispecific from Qyuns in China deal. — Endpoints
-
Samsung Biologics to buy GSK’s U.S. biologics manufacturing site in Rockville, Maryland for $280M, adding stateside capacity as it expands beyond Korea. — Fierce Pharma
VC / Private Financings
-
Celularity announces closing of financing transactions. — PR
IPOs / Follow-Ons
-
No notable IPOs / follow-ons in the last 24 hours.
Academic Corner
- Vagus nerve-mediated neuroimmune modulation for rheumatoid arthritis: a pivotal randomized controlled trial. — Nature Medicine
|
|
Thanks for reading - Biobucks Team
|
|
|
