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Josh Shimmer

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We have 2 summarized appearances for Josh Shimmer so far. Browse all podcasts to discover more episodes.

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2 episodes
Biotech Hangout

Episode 179 - April 10, 2026

Biotech Hangout
60 minCohost, CellSight biotech colleague

AI Summary

→ WHAT IT COVERS Biotech Hangout Episode 179 covers biotech market performance with XBI up 84% year-over-year, Merck's $6.7B Terns acquisition backstory, Gilead's $3.15B Tubulus ADC platform deal, Neurocrine's $3B Soleno purchase, FDA regulatory developments, and new obesity drug approvals from Novo Nordisk and Eli Lilly. → KEY INSIGHTS - **Biotech Market Outperformance:** The XBI ETF hit a 52-week high near 132, delivering an 84% return over the past year versus 30% for the S&P 500 and 39% for the Nasdaq. Investors who entered biotech at the Liberation Day low of 71 more than doubled their money, making the sector the strongest-performing major equity category over that period. - **M&A Data Room Risk:** The Terns-Merck SEC filing reveals that acquirers accessing confidential data rooms can materially reprice deals downward. Party C dropped its $61 bid entirely after seeing updated Cardinal study data showing degraded MMR rates; Merck lowered its offer from $61 to $50 before settling at $53. Investors should monitor SEC filings post-announcement for deal process disclosures. - **Platform vs. Asset Acquisitions:** Gilead's $3.15B Tubulus deal, following a $20M partnership signed in December 2024, illustrates a strategy of using small licensing deals as due diligence before full platform acquisitions. This approach gave Gilead confidence in Tubulus's differentiated ADC methodology before committing capital, offering a replicable framework for evaluating biotech platform investments. - **Mid-Cap Buyers Expanding M&A Competition:** Neurocrine, Servier, and BioMarin demonstrate that mid-sized pharma companies are now active acquirers alongside large caps, increasing competitive bidding. Neurocrine's Soleno acquisition at roughly $3B adds Vykat XR, annualizing above $400M with blockbuster potential, while reducing dependence on its higher-risk late-stage neurology pipeline and maintaining cash flows within the XBI. - **GLP-1 Genetic Response Variability:** A Nature paper using 23andMe data from approximately 25,600 subjects identified a missense variant in the GLP-1 receptor associated with nearly one additional kilogram of weight loss per gene copy and altered side effect profiles. Comparing efficacy across GLP-1 trials without accounting for patient genetic composition produces misleading conclusions about drug performance. → NOTABLE MOMENT The Terns-Merck SEC filing disclosed that a competing bidder initially offered $61 per share plus a $9 CVR, outbidding Merck, but withdrew entirely after reviewing confidential trial data showing degraded efficacy. Without the acquisition, that data release could have been catastrophic for Terns shareholders. 💼 SPONSORS None detected 🏷️ Biotech M&A, GLP-1 Obesity Drugs, FDA Regulation, XBI Market Performance, ADC Drug Development

AI Summary

→ WHAT IT COVERS Biotech Hangout Episode 176 covers macroeconomic risks from Middle East conflict driving oil toward $100/barrel, Vinay Prasad's FDA departure, Servier's $2.5B Day One acquisition, phase three data from Roche and Xenon, IDEA Biosciences' upcoming uveal melanoma readout, and competitive dynamics in NMIBC, IgAN, and obesity markets. → KEY INSIGHTS - **Biotech macro resilience:** Rising oil prices near $100/barrel and potential inflation-driven rate increases pose sector risk, but panelists argue biotech is increasingly insulated due to cash-flow-positive fundamentals and reduced speculative character. Unlike 2021–2023, the sector now trades on near-term data catalysts and product revenues rather than pure pipeline optionality, making it less vulnerable to rate-driven risk-off sentiment than in prior cycles. - **FDA leadership transition:** Vinay Prasad's April departure from CBER creates regulatory uncertainty. Investors should monitor the April 5 Denali PDUFA for Hunter Syndrome as the first real test of post-Prasad FDA flexibility. The ideal successor sits between Peter Marks (too lenient) and Prasad (too stringent), with industry prioritizing predictability and consistency over directional bias in approval standards. - **IDEA Biosciences uveal melanoma catalyst:** Darovacertib, an oral PKC inhibitor combined with crizotinib, has phase two/three top-line PFS data due end of March 2026. Prior phase one/two data showed seven-month median PFS versus two-to-three months for existing standards. A KOL cited 80% probability of success. Accelerated approval pathway is planned if results clear roughly five-and-a-half months, with potential market launch in 2027. - **NMIBC market structure:** The non-muscle-invasive bladder cancer space is shifting toward combination therapies. Ramada's gemcitabine-docetaxel gel formulation showed an 80% one-year complete response rate in high-risk NMIBC, above competitors further along in development. CG Oncology's oncolytic virus is also moving toward a gemcitabine combination BLA. Monotherapy twelve-month CR rates near 50% mean multiple products can coexist commercially across treatment lines. - **Oral SERD competitive dynamics:** Roche's geridesterant failed its Presevera phase three trial in first-line ER-positive HER2-negative metastatic breast cancer when added to palbociclib. The signal suggests oral SERDs may be incompatible with CDK4/6 inhibitor combinations in first-line settings, while retaining utility in ESR1-mutant refractory patients. Investors should focus oral SERD exposure on adjuvant and CDK4/6-free settings rather than first-line combination strategies. - **Drug pricing expansion in biotech:** Otsuka priced its IgAN anti-APRIL antibody at roughly twice analyst expectations, effectively doubling the estimated total addressable market for the class. Vertex's povetacicept data, despite not exceeding the bull case, drove a 10% single-day move in a $100B-plus market cap company. Companies are increasingly pricing to the upside with limited pushback, a dynamic investors should factor into TAM models for late-stage biologics. → NOTABLE MOMENT Panelists noted that J&J repeatedly attacked CG Oncology's dataset in the NMIBC space, claiming significant competitive advantages — yet every major claim ultimately proved incorrect. The situation was described as a rare and uncomfortable instance of a major pharma company aggressively targeting a small biotech and being demonstrably wrong on the clinical data. 💼 SPONSORS None detected 🏷️ FDA Regulation, Oncology Drug Development, Biotech M&A, IgAN Treatment, NMIBC Competitive Landscape, Biotech Macro Risk

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