Selena Koch — Podcast Appearances & Summaries

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BioCentury This Week

6 episodes

All Appearances

6 episodes

Ep. 355 - Capital market mood, Xenon data, Friedreich ataxia pipeline

BioCentury This Week

Mar 17, 202625 minExecutive Editor

AI Summary

→ WHAT IT COVERS BioCentury This Week examines biotech capital markets momentum amid geopolitical uncertainty, Xenon Pharmaceuticals' phase three epilepsy data validating the KV7 potassium channel target, and the shifting Friedreich's ataxia pipeline from mitochondrial stabilizers toward frataxin-restoring gene therapies, with at least five programs now in development. → KEY INSIGHTS - **Biotech follow-on strength vs. venture lag:** Over $7B was raised in follow-on financings in Q1 2026—nearly matching all of 2025—with deals like Xenon upsizing from $500M to $750M on strong data. However, venture financing sits at roughly $5.4B for the quarter, potentially the lowest since 2017, suggesting a lag between public and private market recovery cycles. - **KV7 channel revival strategy:** Xenon's azetukalner achieved a 42% reduction in median monthly seizure frequency versus placebo with an extraordinarily low p-value in phase three focal epilepsy. The molecule avoids predecessor GSK drug safety issues—skin discoloration and retinal abnormalities—by preventing dimerization via a novel chemical structure, with NDA submission planned for Q3 2025. - **Dosing timing as a side effect mitigation tool:** KV7 openers cause dizziness and somnolence by allowing potassium ions to flow out of neurons, stabilizing membrane potential. Xenon addresses this by extending the molecule's half-life for once-daily dosing administered in the evening, so peak side effects occur during sleep rather than waking hours—a replicable strategy for CNS drugs with sedating mechanisms. - **Friedreich's ataxia gene therapy differentiation:** Among five FA gene therapy programs, four use AAV vectors while Replay Holdings' spinout Calib uses herpes simplex virus vectors, which offer higher payload capacity. This allows delivery of the full frataxin gene with its native regulatory elements—exceeding AAV's five-kilobase limit—potentially producing more physiologically accurate protein expression across affected tissues. - **FA accelerated approval pathway established:** Alexio Therapeutics' LX2006 secured FDA agreement on an accelerated approval pathway targeting FA-associated cardiomyopathy, the leading cause of death in FA patients. The agreed endpoints are left ventricular mass index and frataxin expression levels—providing a regulatory template other FA gene therapy developers can reference when designing their own pivotal trial endpoints. → NOTABLE MOMENT Biotech venture financing in Q1 2026 may reach its lowest quarterly total in roughly nine years, despite public market follow-ons performing strongly. The divergence suggests rising valuations are making venture investors more selective, even as generalist capital returns to larger public biotech deals. 💼 SPONSORS [{"name": "Bioequity Europe", "url": "https://bioequityeurope.com"}] 🏷️ Biotech Capital Markets, KV7 Epilepsy, Friedreich's Ataxia, Gene Therapy, Follow-On Financings

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Ep. 352 - A Multipolar Biopharma World; Rare Disease Spotlight

BioCentury This Week

Mar 3, 202635 minExecutive Editor

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→ WHAT IT COVERS Frank LeDoux, McKinsey Asia veteran and new Aulus Capital venture partner, argues biopharma should embrace a multipolar world where US, China, Europe, and emerging regions collaborate rather than compete. The episode also covers Stargardt disease treatment advances, FDA Commissioner McCary's controversial public statements, and the plausible mechanism framework for rare diseases. → KEY INSIGHTS - **Multipolar Biopharma Strategy:** Rather than treating China's biopharma rise as a zero-sum threat, Western companies should selectively integrate regional strengths. LeDoux notes multinationals publicly decry China's growth while simultaneously investing billions there — a contradiction that reveals the real market logic: more therapies developed anywhere benefits patients everywhere, including US markets. - **Europe as Cautionary Tale:** Europe holds comparable population to the US and strong science infrastructure but lacks growth capital and competitive drug pricing. LeDoux argues that European pricing reform could directly unlock investment capital, and that the US risks replicating Europe's stagnation if current policy trends — described by former FDA Commissioner Gottlieb as "stepping on the brakes" — continue. - **Stargardt Disease Pipeline Milestone:** Beelite Bio's oral small molecule targeting visual cycle substrate reduction reached phase three endpoints in late 2024, positioning it for the first-ever Stargardt approval within the year. The drug slows toxic byproduct accumulation caused by dysfunctional ABCA4 protein, making it most effective for early-stage patients who retain more photoreceptor function. - **Split AAV Technology Unlocks Large Gene Delivery:** ABCA4, at 6.8 kilobases, exceeds the standard 5kb single-AAV capacity. Companies now use split intein AAV strategies — dividing the gene across two vectors that reconstitute into full-length protein inside the cell — enabling gene therapy for Stargardt. The RORA gene therapy in phase two showed a 54% reduction in atrophic lesion growth at 12 months. - **FDA Plausible Mechanism Framework:** FDA released draft guidance establishing a plausible mechanism framework — not pathway — primarily targeting bespoke therapies for ultra-rare conditions. The docket is open for comment from companies, academics, and patient advocates. Stakeholders including Tracy Beth Hoag expect the framework to expand beyond strict N-of-one applications while maintaining evidence guardrails for broader rare disease development. → NOTABLE MOMENT FDA Commissioner McCary publicly discussed a pending UniCure Huntington's disease regulatory application on CNBC, causing the company's shares to drop 30%. Former FDA officials consider publicly commenting on live applications a serious breach of longstanding institutional norms designed to protect patients, developers, and regulatory integrity. 💼 SPONSORS [{"name": "BioCentury East West Biopharma Summit", "url": "https://biocenturyeastwest.com"}] 🏷️ Biopharma Geopolitics, Rare Disease, Gene Therapy, FDA Regulation, China Biotech

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Ep. 353 - Prasad Departure and Future of Fibrosis Therapies

BioCentury This Week

Mar 9, 202637 minExecutive Editor

AI Summary

→ WHAT IT COVERS BioCentury This Week examines Vinay Prasad's second FDA departure and its structural implications for CBER leadership, the expanding phase two fibrosis pipeline targeting IPF with over 20 programs across novel mechanisms, plus clinical setbacks for psychedelic GAD therapy and Novo Nordisk's Cagrisema head-to-head obesity trial against Lilly's tirzepatide. → KEY INSIGHTS - **FDA Leadership Risk:** When one or two individuals centralize drug approval decisions outside established review team structures, the entire regulatory system becomes vulnerable to political interference. Biotech investors and companies should monitor not just who replaces Prasad at CBER, but whether the successor restores multi-reviewer consensus processes or continues single-decision-maker precedent set under McCarrie. - **IPF Pipeline Timing:** With over 20 programs in phase two targeting IPF across mostly first-in-class mechanisms, a wave of proof-of-concept data is approaching. Companies are shifting strategy downstream in the fibrotic cascade to improve therapeutic index, avoiding broad pathway suppression that disrupts normal wound healing — a key lesson from prior phase three failures in this indication. - **Fibrosis Reversal Signal:** Evidence from MASH liver fibrosis trials showing partial reversal has re-energized the broader antifibrotic field. Boehringer's December approval of nerandomilast marks the first new IPF drug in a decade. Investors should track whether downstream pathway targeting or novel modalities beyond small molecules can replicate liver fibrosis reversal results in pulmonary settings. - **Psychedelic Trial Design Flaw:** Siebert Hellas reported 67% remission at six months for DMT compound in treatment-resistant generalized anxiety disorder, yet shares fell 34%. The collapse stemmed from pooling two dose groups that performed identically, eliminating dose-response evidence and raising expectation-bias concerns. Future psychedelic trials require placebo arms or validated active comparators to produce credible efficacy signals. - **Amylin Tolerability Differentiation:** Zealand Pharma's petrelintide showed placebo-adjusted 9% weight loss at 42 weeks — roughly half of Lilly's oleoylethanolamide benchmark — but reported near-zero vomiting, diarrhea, and constipation, with treatment discontinuation rates lower than placebo. Given that roughly 80% of GLP-1 patients discontinue within one year due to GI side effects, tolerability-optimized amylins may capture a durable second-line market position. → NOTABLE MOMENT The Moderna flu vaccine decision this summer creates an unresolvable political trap for FDA: approving it will energize the MAHA base against the administration, while rejecting it causes industry and public health backlash — and delaying past summer makes timely manufacturing for flu season impossible. 💼 SPONSORS None detected 🏷️ FDA Leadership, IPF Fibrosis Pipeline, Psychedelic Clinical Trials, Obesity Drug Competition, Amylin Therapeutics

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Ep. 348 - Biotech's 2026 Catalysts. Plus: China's New Orphan Rules

BioCentury This Week

Feb 3, 202631 minExecutive Editor

AI Summary

→ WHAT IT COVERS BioCentury This Week episode 348 covers the second installment of 2026 biotech catalysts, focusing on RNAi and antisense therapies across cardiovascular, neuromuscular, and renal indications, plus analysis of China's first orphan drug exclusivity law granting seven years of market protection, effective May 15, 2026. → KEY INSIGHTS - **Lp(a) Phase 3 Benchmark:** Ionis and Novartis's HORIZON trial of pelacarsen will deliver the first cardiovascular outcomes data testing whether Lp(a) reduction translates to clinical benefit. Affecting up to 30% of cardiovascular disease patients, this readout will influence development decisions across three competing phase 3 programs in different modalities targeting the same genetic risk factor. - **RNAi Pipeline Breadth:** Ten phase 3 trials across RNAi and antisense therapies are expected to read out in 2026, spanning IgA nephropathy, Angelman syndrome, DMD exon skipping, myotonic dystrophy type 1, and FSHD. Investors tracking this space should monitor Novartis, Ionis, Arrowhead, Wave, Alnylam, Biogen, and Avidity as the primary companies with late-stage catalysts. - **IgA Nephropathy Regulatory Template:** Five drugs received approval for IgA nephropathy in five years after the 2021 precedent of using proteinuria reduction as a surrogate endpoint. This pathway is now enabling regulatory submissions for at least three additional renal diseases without approved therapies, including APOL1-mediated kidney disease, FSGS, and membranous nephropathy, all with 2026 catalysts. - **China Orphan Drug Exclusivity:** China's new regulation, effective May 15, 2026, grants seven years of market exclusivity for orphan drugs plus a potential two additional years for pediatric indications. Key uncertainties remain: China lacks a formal rare disease definition beyond its 207-disease catalog, and whether pediatric exclusivity stacks onto or is included within the seven-year term is unresolved. - **UK as Clinical Trial Destination:** MHRA reduced clinical startup time from 250 days back toward 150 days under CEO Lawrence Tallon, and is building incentives specifically for ultra-orphan drug development. The UK's genomic data infrastructure and integrated HTA-reimbursement pathway position it as an emerging early-phase trial hub, particularly for genetic medicines where FDA safety margin requirements create friction. → NOTABLE MOMENT A Cambridge Bioscience CEO noted that China has historically been an afterthought for rare disease drug development and sales. The new exclusivity law targets changing that, particularly for diseases with patient populations above 10,000, which he described as the medium-rare range of orphan indications. 💼 SPONSORS [{"name": "East West Biopharma Summit", "url": "https://biocenturyeastwest.com"}] 🏷️ RNAi Therapeutics, Orphan Drug Policy, Cardiovascular Drug Development, China Biopharma Regulation, Renal Disease Pipeline

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Ep. 347 - Speeding China's Innovation. Plus: Neuro Catalysts and Newcos

BioCentury This Week

Jan 27, 202630 minExecutive Editor

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→ WHAT IT COVERS China's new May 2026 gene and cell therapy rules allow 1,700 hospitals to charge for investigational treatments post-IIT completion, with national authorities responding within 20 working days. The episode also covers 2026 neuro biotech catalysts and two CNS-focused startups: Elkadonia targeting ELK1 for depression and Bexorg using post-mortem human brains for drug testing. → KEY INSIGHTS - **China IIT Commercialization Pathway:** Starting May 2026, Chinese class-A tertiary hospitals — approximately 1,700 facilities — can apply to charge patients for cell and gene therapies proven in investigator-initiated trials. National authorities must respond within 20 working days. Western companies should monitor this as a fast-track derisking route for acquiring Chinese biotech assets with human proof-of-concept data. - **Psychedelic Therapeutics Pipeline:** Four phase 3 trials — three in depression, one in anxiety — from companies including Compass and Saiven report data in 2026. Effect sizes from phase 2 have been large. The key variables to track are blinding integrity and durability of treatment response. Regulatory tailwinds from new FDA and HHS leadership reduce historical approval barriers for this drug class. - **Precision Psychiatry Biomarkers:** Alto Neuroscience delivers three phase 2 proof-of-concept readouts in 2026 — two in depression, one in schizophrenia — using EEG and cognitive testing to stratify responsive patients. MNC, partnered with Spruce, also reports phase 2 data using a companion genetic diagnostic targeting a thyroid pathway mechanism, establishing early validation for biomarker-driven psychiatric drug development. - **ELK1 as Intracellular Depression Target:** French startup Elkadonia is developing a small molecule that blocks the ERK-ELK1 protein-protein interaction in hippocampal and nucleus accumbens neurons, modulating neuroplasticity gene expression including inflammation-related genes. Unlike SSRIs acting at the synapse, this intracellular mechanism could produce more durable antidepressant effects without the hallucinogenic monitoring requirements associated with ketamine or psychedelics. - **Post-Mortem Brain Drug Testing Platform:** Yale spin-out Bexorg maintains donated human brains in a molecularly active — but not functionally firing — state using hemoglobin-based cytoprotective perfusion at normal body temperature. Pharma partners can measure drug PK, blood-brain barrier penetration, and biodistribution across tissue, plasma, and CSF. Bexorg has raised $42.5M and holds a partnership with Biohaven for preclinical program advancement. → NOTABLE MOMENT Bexorg's platform traces back to a Yale postdoc experiment that revived cellular activity in pig brains hours after death. That same hemoglobin-based perfusion science now underlies a commercial CNS drug-testing service using donated human brains — a direct line from a headline-grabbing lab result to a funded biotech startup. 💼 SPONSORS [{"name": "BioCentury East West Biopharma Summit", "url": "https://biocenturyeastwest.com"}] 🏷️ Gene Cell Therapy China Regulation, Psychedelic Therapeutics, Precision Psychiatry, CNS Drug Discovery, Biotech Catalysts 2026

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Ep. 346 - 2026 Public Markets Preview

BioCentury This Week

Jan 23, 202631 minExecutive Editor

AI Summary

→ WHAT IT COVERS BioCentury's 2026 public markets preview examines why biotech's recovery—marked by XBI returning 36% in 2024 and outperforming the Magnificent Seven—may finally be durable, analyzing 23 commercial-stage companies, generalist capital rotation, sustained M&A activity, and FDA regulatory uncertainty as the primary remaining headwind. → KEY INSIGHTS - **Recovery Benchmark:** The XBI rose 36% in 2024 and 83% from its April trough, outperforming the S&P 500, tech sector, and Magnificent Seven. Investors tracking sector re-entry should use this baseline to assess whether current valuations still represent undervalued entry points relative to four years of underperformance. - **2012–2013 Analog:** Investors who lived through the post-2008 recovery draw a direct parallel to today: then, six mid-cap biotechs (Gilead HCV, Vertex Kalydeco, Regeneron Eylea, Biogen Tecfidera, Amgen Denosumab, Celgene Revlimid) drove a sector-wide IPO wave. Today, at least 23 companies enter 2026 with high-growth commercial launches, distributing risk more broadly. - **Generalist Capital Signal:** On December 9, 2024 alone, $3.3 billion in follow-on offerings closed, all substantially upsized. Mutual funds that previously requested minimum allocations began offering to fund entire deals solo. Investors monitoring sector momentum should track follow-on upsizing rates as a leading indicator of generalist re-entry before IPO windows open. - **IPO Quality Discipline:** Bankers and investors identify a slew of underperforming post-IPO stocks as the single most likely momentum killer for 2026. The strategy: only the highest-quality, late-stage private companies—seasoned through an extended bear market—should price first, with a broader window expected around May–June if early names like Aptis Oncology hold their pricing. - **FDA Risk Framework:** FDA remains the sole major overhang, splitting investors into two camps. One camp notes that most portfolio companies still report normal FDA interactions despite staffing reductions. The other warns that accumulated disruption will compound over time, potentially delaying PDUFA-dated launches and shifting valuation models by one to two years for pipeline-stage assets. → NOTABLE MOMENT A banker described how mutual fund behavior reversed completely within twelve months: funds that once requested only minimum follow-on allocations began offering to purchase entire $150 million deals outright, forcing banks to upsize offerings just to accommodate other investors seeking access to the same positions. 💼 SPONSORS [{"name": "BioCentury East West Biopharma Summit", "url": "https://biocenturyeastwest.com"}] 🏷️ Biotech Public Markets, XBI Recovery, Biotech IPO Pipeline, FDA Regulatory Risk, Generalist Capital Rotation

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