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Even as FDA approvals for biologic therapies fell in the first half of 2026, regulatory experts are optimistic about a turnaround in the rare disease space after the departure of key leaders at the agency. Still, there will continue to be tension between science and politics.
FEATURED STORIES
A mostly black box since emerging with more than a billion dollars in hand, Xaira Therapeutics is slowly pulling back the curtain, revealing plans to find partners and validate its pipeline.
IPO
After debuting on the public markets with $256.3 million and raking in an additional $472 million, Veradermics has emerged as one of biotech’s biggest post-IPO standouts. CEO Reid Waldman credits the weight loss craze for establishing consumer-driven channels.
Molecular glue degraders are gaining traction in the clinic as well as funding from Big Pharma, with their potential to treat previously “undruggable” cancers and immunological diseases. Here are five clinical programs worth keeping an eye on.
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Congressional letters sent to the CEOs of Eli Lilly, Pfizer, Merck, BMS and AbbVie this week voicing concerns about the pharmas’ clinical trials in China highlight an ongoing discrepancy in how government and industry think about the rise of the Asian country’s biotech industry.
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After the successful development of mavacamten and the sale of MyoKardia to BMS in 2020, former executives of the biotech are back together with a mission to make cardiovascular disease curable and preventable.
The Biotech Ecosystem Venture Fund will combine the sourcing capabilities of venture capital firm Andreessen Horowitz (a16z) with Eli Lilly’s expertise in R&D—plus half a billion in capital from the Big Pharma.
Research has shown remnant cholesterol is a significant factor in cardiovascular disease risk.
If approved, Pfizer’s sasanlimab will distinguish itself from Merck’s blockbuster Keytruda as the first PD-1 inhibitor indicated in combination with BCG for high-risk non-muscle invasive bladder cancer patients who had not previously undergone BCG treatment.
Concurrently, a preprint from the industry-backed Vital Transformation found a 50% drop in company investments into small-molecule drug development.
Eli Lilly’s idiopathic pulmonary fibrosis deal with Mediar is centered around MTX-463, an anti-WISP1 antibody that early studies have found to be safe and capable of engaging its target.
On Thursday, Boehringer Ingelheim announced a partnership with Synaffix to advance antibody-drug conjugates and exercised its fourth license option under a 2013 collaboration with Oxford BioTherapeutics.
Ouro is planning to leverage T cell engagers to deplete B cells and “reset” the immune system to treat immune-mediated diseases.
ALS
Misses from amyotrophic lateral sclerosis hopefuls Denali Therapeutics and partners AbbVie and Calico Life Sciences mark the latest setbacks for the controversial platform trial, the results from which have largely mirrored the dismal success rate in ALS overall.
Initial rounds of VC financing totaled $7.7 billion over 137 deals for biopharma in 2024, compared to $3.8 billion over 156 deals in 2023.