Wednesday: FDA greenlights long-acting asthma

BioBucks Newsletter

Wednesday, 17 December, 2025

Upfront Briefing

Regulatory and financing did the heavy lifting overnight: GSK notched an FDA approval in asthma, while Sanofi picked up EU orphan designation in alpha-1 antitrypsin deficiency-related emphysema.

On the funding front, Alvotech placed an oversubscribed $108M convertible bond deal to keep R&D, manufacturing, and launches moving (because nothing says “confidence” like investors fighting for your convert).

Tape Action

Instrument	Last close	1D %	YTD %
S&P 500	6,798.5	(0.2%)	15.6%
Nasdaq 100	25,126.6	0.2%	19.6%
Russell 2000	2,519.2	(0.5%)	13.0%
XBI	122.0	(0.7%)	35.5%
NBI	5,676.2	(0.6%)	31.7%
Clinical Trials ETF (BBC)	39.7	(0.3%)	65.8%

A definsive tape with Biotech feeling the heat more than S&P500 and NDX.

The Big 3

1	GSK's Long-Acting Asthma Drug Receives FDA Approval

GSK's new asthma drug, depemokimab, has received FDA approval. This approval could lead to significant peak sales and strengthen GSK's respiratory portfolio.
Why it matters: A twice-yearly asthma biologic gives GSK a durable, high-margin growth pillar just as older respiratory assets age, and raises the bar on dosing convenience in a crowded severe asthma market.
Source: Endpoints

2	Alvotech Raises $108M in Oversubscribed Convertible Bond Offering

Alvotech successfully raised $108 million through an oversubscribed convertible bond offering. This financing will support R&D, manufacturing, and global product launches, reaffirming its 2025 outlook.
Why it matters: An oversubscribed convert signals that investors are still willing to fund biosimilar-heavy stories, giving Alvotech fresh firepower to execute on launches while everyone else worries about balance sheets.
Source: PR
More: PR; PR

3	Sanofi's Efdoralprin Alfa Gets EU Orphan Drug Designation

Sanofi's efdoralprin alfa has received orphan drug designation in the EU for emphysema related to alpha-1 antitrypsin deficiency. This could accelerate its development for the rare lung disease.
Why it matters: Orphan status in A1AT-deficiency emphysema locks in regulatory support and future exclusivity, giving Sanofi a potentially de-risked rare-lung asset to balance its more turbulent MS franchise.
Source: PR
More: PR

Everything Else that broke

DBV Technologies reports positive Phase 3 results for its peanut allergy patch, charting a renewed regulatory path after previous setbacks. — Endpoints
Bristol Myers Squibb makes a $90M upfront payment to Harbour for new antibodies. — Endpoints
Nektar's lead immunology drug misses its Phase 2b goal; execs cite enrollment errors but still plan a Phase 3. — Endpoints
Pfizer is betting big on obesity research to offset an impending patent cliff. — Endpoints
Verge Genomics' ALS drug fails in clinical trials; the company pivots to a partnership model for its AI platform. — Endpoints
Mythic Therapeutics shuts down and terminates its ADC trial due to funding issues. — Endpoints
Orchard Therapeutics celebrates the addition of metachromatic leukodystrophy (MLD) to the U.S. newborn screening panel. — PR
Trethera receives a $2.7M NIH grant supporting TRE-515 in lung cancer aimed at overcoming KRAS inhibitor resistance. — PR
Sanofi's BTK inhibitor story in MS stays mixed, with an FDA decision pending in secondary progressive disease and a miss in primary progressive MS. — BioCentury
RTW leans into a NewCo model with a GenSci deal for an ocular autoimmune therapy. — BioCentury
More than $12B has been raised in new life sciences funds this year. — BioCentury
FDA Commissioner Makary walks back prior talk around Covid-19 vaccine risk amid internal debate. — Endpoints
Pfizer scientists advance research into cancer cachexia. — BioPharma Dive
Biopharma M&A expectations rise as companies look to offset patent cliffs and buy late-stage assets. — BioSpace

Deal Flow

M&A / BD&L

Harbour and Bristol Myers Squibb ink a $90M upfront antibody deal. — Endpoints
RTW partners with GenSci for an ocular autoimmune therapy under a NewCo model. — BioCentury

VC / Private Financings

MAIA Biotechnology announces a $1.51M private placement to support its clinical-stage immunotherapy development. — PR

IPOs / Follow-Ons

Alvotech raises $108M in an oversubscribed senior unsecured convertible bond offering to support R&D, manufacturing, and global launches. — PR

Academic Corner

Targeting glycans for cancer immunotherapy. — Nature Biotech
Antibody-lectin chimeras for glyco-immune checkpoint blockade. — Nature Biotech
Eleven clinical trials that will shape medicine in 2026. — Nature Medicine

Thanks for reading BioBucks — where asthma biologics, convertibles, and obscure orphan designations all get the same airtime as mega-cap GLP-1s.