Biotech Caught Between AI Momentum and Political Turbulence — This Week in Biotech #56
Novo bets on AI drug discovery, RFK Jr. reshapes the CDC, and Congress targets $5B in pharma ad spending. Catch up on the latest biotech breakthroughs and upcoming trends (June 6-12, 2025).
Hi and welcome to This Week in Biotech by Biotech Blueprint, edition 56.
🎙️ Biotech Blueprint is now a podcast. You can find us on YouTube, Spotify, and Apple Podcasts.
Our latest podcast episode (published June 11) features Steve Swan, a biotech recruiter with over 25 years of experience. We talked about how hiring has changed post-COVID, the rise of AI in recruitment, what candidates get wrong about job searches, and what companies are really looking for. Whether you’re hiring, job hunting, or just biotech-curious, this one’s worth a listen.
THIS WEEK IN BIOTECH VIDEO SUMMARY
THIS WEEK’S KEY TAKEAWAYS 🔑
Bladder cancer gets its first non-surgical drug. UroGen’s Zusduri won FDA approval, giving patients an alternative to repeated surgeries, and giving the company a first-mover edge in a market with few outpatient options.
Gilead’s HIV program hits a speed bump. The FDA put a clinical hold on its once-weekly oral regimen after CD4+ T cell drops raised safety flags, but GILD shares quickly rebounded. With lenacapavir’s long-acting PrEP decision expected later this month, Gilead’s broader HIV pipeline remains robust.
Congress takes another shot at banning drug ads. Sanders and King reintroduced legislation to ban pharma’s $5B+ direct-to-consumer ad machine. It won’t pass easily, but pressure on drug pricing narratives is growing.
AI drug discovery wins big pharma backing. Novo Nordisk added a sixth partnership this year, committing up to $812M to Deep Apple’s AI-fueled search for non-incretin cardiometabolic targets, a quiet pivot beyond GLP-1s.
Vaxart surged 28% after early data showed its second-gen oral norovirus vaccine triggered a stronger immune response than its predecessor.
RFK Jr. overhauls the CDC’s vaccine panel (ACIP). All 17 members were removed and replaced with new appointees, several of whom have previously questioned mRNA vaccines. The move has drawn criticism from public health experts who warn it politicizes vaccine guidance.
CRISPR Therapeutics keeps riding RFK Jr.’s tailwinds. Regulatory momentum and a gene-editing-friendly FDA tone helped extend CRSP’s rally, but analysts warn that platform hype must soon meet commercial reality.
MARKET UPDATES 📈
🔹 Biotech markets got a modest boost this week as both major ETFs edged higher amidst cautious investor sentiment. The SPDR Biotech ETF (XBI) climbed about 3.5% over the past five days, now at ~$84.36. Meanwhile, the iShares Nasdaq Biotech ETF (IBB) sits near $129.00. Look out for incoming earnings reports and late June M&A headlines, which could further influence momentum going into summer.
🔹 Crispr Therapeutics extended its winning streak to seven trading days, though it dipped 3.3% on June 11 to close at $41.52. The stock had gained over 15% in the six sessions prior, lifted by optimism after HHS Secretary RFK Jr. said the FDA would explore accelerated approval pathways for rare disease drugs. Shares notably jumped 8.5% on June 6 and remain up ~12% over the past month. While CRISPR’s platform, bolstered by the approval of Casgevy, is seen as a gene-editing frontrunner, analysts caution that high development costs and competition remain hurdles.
BIOTECH/PHARMA NEWS 🧬
🔹 The FDA approved UroGen Pharma’s Zusduri (UGN-102), the first and only approved drug for treating recurrent low-grade intermediate-risk non-muscle invasive bladder cancer. Zusduri is a non-surgical alternative to repeated tumor resections. In the phase 3 trial, 78% of patients achieved a complete response at 3 months, and 79% of those remained disease-free at 12 months. The drug showed a manageable safety profile, with mostly mild/moderate urinary symptoms. ZUSDURI is expected to launch in the U.S. around July 1, 2025, offering an outpatient treatment option for the estimated 59k Americans.
🔹 Senators Bernie Sanders and Angus King have introduced the End Prescription Drug Ads Now Act, which would ban all direct-to-consumer advertising for prescription drugs across TV, radio, print, digital, and social media platforms. The bill echoes long-standing calls from HHS Secretary RFK Jr., who has argued that such ads are misleading and contribute to overmedication. The legislation arrives amid record ad spending by drugmakers: $5B in 2024 alone, with over $750M spent in Q1 2025 on just ten drugs. Sanders and King specifically cited Novo Nordisk’s $471M in U.S. ads for Ozempic and Wegovy in 2023, contrasting that with lower prices abroad. The bill is co-sponsored by several Democratic senators, but is expected to face First Amendment challenges.
🔹 BioNTech announced it will acquire CurVac for ~$1.25B, expanding its capabilities in mRNA-based cancer immunotherapy. The deal will integrate CurVac’s research and manufacturing operations and consolidate mRNA platform assets under BioNTech’s oncology strategy.
🔹 Novo Nordisk has signed a deal worth up to $812M with Deep Apple Therapeutics to develop small molecules targeting non-incretin GPCRs for cardiometabolic diseases. Deep Apple combines structural biology and AI-generated virtual libraries to identify small molecule drug candidates. While the exact target remains undisclosed, the collaboration focuses on advancing non-incretin GPCR therapies beyond current agonists that target GLP-1 and GIP. The deal continues Novo’s push into oral cardiometabolic medicines, marking its sixth such partnership this year.
🔹 The FDA has placed a clinical hold on Gilead’s phase 2/3 HIV trials (WONDERS-1 and WONDERS-2) investigating a weekly oral regimen combining GS-1720 and GS-4182, due to safety concerns over drops in CD4+ T cell counts. Both agents, an integrase inhibitor and a capsid inhibitor, are experimental. Three phase 1 studies have also been paused. Gilead emphasized the issue does not affect its other HIV programs and is working with regulators to investigate the signal. GILD shares fell ~2.6% on the news.
CLINICAL TRIAL UPDATES 📊
🔹 Vaxart reported positive data from its phase 1 trial of its second-generation oral norovirus vaccine candidates, tested head-to-head against its first-generation constructs. The GI.1 and GII.4 candidates generated significantly higher levels of norovirus blocking antibodies (141% and 94% respectively) compared to the first-gen candidates. All candidates were safe and well-tolerated. These data will be used to inform upcoming phase 2b trials. Shares of VXRT surged over 28% on the news.
🔹 NewAmsterdam released biomarker data from a phase 3 sub-study suggesting its CETP inhibitor obicetrapib may reduce Alzheimer’s disease risk. Among 1,727 participants with risk factors, treatment lowered p-tau217 levels over 12 months. Cognitive outcomes have not yet been reported.
🔹 Metsera reported promising phase 1 data for its once-monthly amylin analog MET-233i, showing up to 8.4% placebo-adjusted weight loss at day 36 in people with overweight or obesity. The drug was well tolerated with no serious adverse events, and its long 19-day half life supports monthly dosing. Metsera plans to advance MET-233i as a monotherapy and in combination with its GLP-1 candidate MET-097i, with more data expected later this year. Shares rose ~16% on continued investor optimism, and Guggenheim raised its price target to $62, calling the results a validation of Metsera’s obesity platform.
🔹 Insmed announced positive phase 2b results for its once-daily inhaled therapy TPIP (treprostinil palmitil inhalation powder) in pulmonary arterial hypertension (PAH). TPIP met its primary endpoint, achieving a 35% reduction in pulmonary vascular resistance, and also hit all secondary endpoints. The drug was well tolerated, with most patients reaching the maximum dose. Based on these results, Insmed plans to initiate phase 3 trials in PH-ILD by late 2025 and in PAH in early 2026. Shares of Insmed rose ~19%, while PAH competitors Liquidia and United Therapeutics declined.
🔹 Merck announced positive topline results from the first two phase 3 CORALreef trials evaluating enlicitide decanoate, a first-in-class oral PCSK9 inhibitor for high cholesterol. In both studies, the drug significantly reduced LDL cholesterol levels compared to placebo and leading oral non-statin therapies, with no notable safety concerns. If approved, it would be the first oral PCSK9 inhibitor on the market, offering a more convenient alternative to current injectable options.
PUBLIC HEALTH SPOTLIGHT 🦠
🔹 On June 9, RFK Jr. removed all 17 members of the CDC’s vaccine advisory panel (ACIP), citing conflicts of interest, and on June 12 named eight replacements—several of whom have criticized mRNA vaccines. The overhaul drew sharp criticism from health experts who warned it undermines trust in evidence-based policy, especially amid declining childhood vaccination rates. The new committee meets June 25 to advise on COVID vaccine use for the fall. Despite the controversy, shares of Pfizer, Moderna, BioNTech, and Sanofi held steady.
AI SUMMARY 🎙️
Listen to an AI-generated summary of this episode below.
ON THE HORIZON 🔭
🔹 June 2025 FDA PDUFAs:
June 10: Merck’s BLA for clesrovimab. ✅ APPROVED
June 12: UroGen’s UGN-102. ✅ APPROVED
June 17: KalVista’s sebetralstat.
June 19: Gilead’s lenacapavir.
June 23: Nuvation Bio’s taletrectinib.
June 28: Unicycive’s oxylanthanum carbonate.
June 30: Verastem’s avutometinib + defactinib combo.
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