Biotech Bulls & Breakthroughs

The FDA is in flux, ESMO is approaching, and a series of clinical and regulatory catalysts could put biotech stocks in focus. John Gagliano and Sheff Sheffield mark their 20th episode together by reviewing developments and the companies on their radar. They discuss:🔹 FDA leadership shakeup 🔹 ESMO in Madrid and the readouts🔹 Catalysts to watch before year-end and early 2027.In this episode, you’ll hear about:Aldeyra Therapeutics (ALDX) and the potential relevance of the Outlook Therapeutics precedent. Inovio (INO) and its accelerated approval review for recurrent respiratory papillomatosis.NRx Pharma (NRXP) and its reported FDA progress with KetafreeUnicycive Therapeutics (UNCY) and its manufacturing-focused turnaround storyVivani Medical (VANI), Fractyl Health (GUTS), and developments in obesity and metabolic programsSavara (SVRA), and other companies facing important regulatory milestonesGossamer Bio (GOSS) and more.🧭 Track upcoming catalysts: https://www.biopharmcatalyst.com/calendars/fda-calendar🎧 Listen to more episodes: https://www.biopharmcatalyst.com/podcast📈 See Sheff’s Watchlist: https://www.biopharmcatalyst.com/sheffs-trades📲 Follow BioPharmCatalyst: https://x.com/BPharmCatalyst📲 Follow Sheff: https://x.com/SheffStationDisclaimer: BioPharmCatalyst is not a registered investment advisory firm and the views on this podcast are not to intended to be financial advice. The stocks discussed in this podcast may be held in personal or other investment accounts. This content is for informational purposes only and should not be considered investment advice. Always do your own research before making any investment decisions.

In this episode, John Gagliano and Sheff Sheffield discuss the biggest biotech catalysts heading into the final months of 2026. They examine continued big-pharma acquisition activity, Novo Nordisk’s pediatric obesity data, GLP-1 expansion, and the importance of pinpointing dates for clinical readouts, regulatory decisions, and conference presentations. You'll discover:🔹 Why big pharma M&A could continue supporting small- and mid-cap biotech stocks🔹  How GLP-1 developments and pediatric obesity data may expand the weight-loss market🔹 How to evaluate catalyst timing, cash runway, institutional ownership, and clinical-trial dataSheff is proud to support the Northwest Association for Blind Athletes. Join us in empowering life-changing opportunities for visually impaired youth and adults through sports and community engagement. You can support this as well at the link below:Support NWABA: https://nwaba.org/support/other-ways-to-help/sheffstation/#join-sheff-station🧭 Track upcoming catalysts: https://www.biopharmcatalyst.com/calendars/fda-calendar🎧 Listen to more episodes: https://www.biopharmcatalyst.com/podcast📈 See Sheff’s Watchlist: https://www.biopharmcatalyst.com/sheffs-trades📲 Follow BioPharmCatalyst: https://x.com/BPharmCatalyst📲 Follow Sheff: https://x.com/SheffStationDisclaimer: BioPharmCatalyst is not a registered investment advisory firm and the views on this podcast are not to intended to be financial advice. The stocks discussed in this podcast may be held in personal or other investment accounts. This content is for informational purposes only and should not be considered investment advice. Always do your own research before making any investment decisions.

In this episode features John Gagliano in conversation with Stephan Jackman, CEO and director of Alzamend, about the company’s mission, “Making Alzheimer’s just a memory,” and its pipeline in Alzheimer’s and related neuropsychiatric disorders. They cover how Alzamend is trying to improve on current treatments by focusing on safer, more targeted approaches, including a next-generation lithium and an autologous immunotherapeutic vaccine.Alzamend Neuro Inc.https://www.biopharmcatalyst.com/company/ALZN#/📲 Follow Stephan Jackman and Alzamend Neuro: - https://www.linkedin.com/in/stephan-jackman-4578328a- https://www.linkedin.com/company/alzamend-neuro?trk=public_profile_topcard-current-company- https://alzamend.com/In this episode:🔹 The real wedge in Alzheimer’s is not efficacy alone - it is safety plus usability🔹 Personalization matters most when one-size-fits-all breaks down🔹 A platform is more valuable than a single indication🧭 Track upcoming catalysts: https://www.biopharmcatalyst.com/calendars/fda-calendar🎧 Listen to more episodes: https://www.biopharmcatalyst.com/podcast📈 See Sheff’s Watchlist: https://www.biopharmcatalyst.com/sheffs-trades📲 Follow BioPharmCatalyst: https://x.com/BPharmCatalyst📲 Follow Sheff: https://x.com/SheffStationDisclaimer: BioPharmCatalyst is not a registered investment advisory firm and the views on this podcast are not to intended to be financial advice. The stocks discussed in this podcast may be held in personal or other investment accounts. This content is for informational purposes only and should not be considered investment advice. Always do your own research before making any investment decisions.

In this episode, John Gagliano and  Sheff Sheffield unlock hidden strategies behind biotech success, from FDA decision dynamics to the most promising upcoming catalysts; they reveal how savvy investors spot opportunities before the crowd catches on. If you're tired of missing the moves that matter and want expert insights into the biotech landscape, this episode is your essential guide. You'll discover:🔹 How to interpret FDA interactions🔹 The impact of early-stage data releases and clinical trial results🔹 The relevance of FDA Advisory Committees🧭 Track upcoming catalysts: https://www.biopharmcatalyst.com/calendars/fda-calendar🎧 Listen to more episodes: https://www.biopharmcatalyst.com/podcast📈 See Sheff’s Watchlist: https://www.biopharmcatalyst.com/sheffs-trades📲 Follow BioPharmCatalyst: https://x.com/BPharmCatalyst📲 Follow Sheff: https://x.com/SheffStationDisclaimer: BioPharmCatalyst is not a registered investment advisory firm and the views on this podcast are not to intended to be financial advice. The stocks discussed in this podcast may be held in personal or other investment accounts. This content is for informational purposes only and should not be considered investment advice. Always do your own research before making any investment decisions.

In this episode, John Gagliano and Sheff Sheffield discuss recent developments in biotech, including FDA policy shifts, key catalysts for upcoming biotech stocks, and market trends amidst frothy conditions. Essential insights for investors looking to navigate the biotech landscape in 2026.🔹 FDA policy shift towards flexible trial requirements🔹 Impact of one pivotal trial on biotech investment strategies🔹 Upcoming biotech catalysts and FDA approval dates🧭 Track upcoming catalysts: https://www.biopharmcatalyst.com/calendars/fda-calendar🎧 Listen to more episodes: https://www.biopharmcatalyst.com/podcast📈 See Sheff’s Watchlist: https://www.biopharmcatalyst.com/sheffs-trades📲 Follow BioPharmCatalyst: https://x.com/BPharmCatalyst📲 Follow Sheff: https://x.com/SheffStationDisclaimer: BioPharmCatalyst is not a registered investment advisory firm and the views on this podcast are not to intended to be financial advice. The stocks discussed in this podcast may be held in personal or other investment accounts. This content is for informational purposes only and should not be considered investment advice. Always do your own research before making any investment decisions.

In this episode, John Gagliano and Sheff Sheffield unpack the game-changing FDA decision that could add millions to Outlook Therapeutics’ valuation overnight. You'll discover how a small biotech overcame years of setbacks, clinched a pivotal FDA appeal, and now eyes a June resubmission with clear skies ahead. Don't miss the detailed analysis, upcoming catalysts, and behind-the-scenes strategies for navigating the biotech wild west.🔹 The real impact of the “One Pivotal Study” rule.🔹 How Outlook’s victory paves the way for other firms.🔹 FDA de novo approvals and the explosive potential of AI-driven medical devices.Outlook Press Release:  https://www.biopharmcatalyst.com/company/OTLK/news/325043🧭 Track upcoming catalysts: https://www.biopharmcatalyst.com/calendars/fda-calendar🎧 Listen to more episodes: https://www.biopharmcatalyst.com/podcast📈 See Sheff’s Watchlist: https://www.biopharmcatalyst.com/sheffs-trades📲 Follow BioPharmCatalyst: https://x.com/BPharmCatalyst📲 Follow Sheff: https://x.com/SheffStationDisclaimer: BioPharmCatalyst is not a registered investment advisory firm and the views on this podcast are not to intended to be financial advice. The stocks discussed in this podcast may be held in personal or other investment accounts. This content is for informational purposes only and should not be considered investment advice. Always do your own research before making any investment decisions.

In this episode, as the biotech earnings season continues, John Gagliano and Sheff Sheffield explore the resilience of the biotech market, the impact of FDA policies, and the significance of conferences like AACR and ASCO. They highlight the potential of smaller companies and the evolving regulatory environment, particularly in the psychedelic space. In this episode:🔹 White House Medical Executive Order on Psychedelics🔹 OTLK on Federal Dispute Resolution (FDR) meeting with the FDA after One Pivotal Trial effects🔹 Sheff's Watchlist for the middle of 2026.Executive Order: https://www.whitehouse.gov/presidential-actions/2026/04/accelerating-medical-treatments-for-serious-mental-illness/Outlook Press Release: https://www.biopharmcatalyst.com/company/OTLK/news/320085🧭 Track upcoming catalysts: https://www.biopharmcatalyst.com/calendars/fda-calendar🎧 Listen to more episodes: https://www.biopharmcatalyst.com/podcast📈 See Sheff’s Watchlist: https://www.biopharmcatalyst.com/sheffs-trades📲 Follow BioPharmCatalyst: https://x.com/BPharmCatalyst📲 Follow Sheff: https://x.com/SheffStationDisclaimer: BioPharmCatalyst is not a registered investment advisory firm and the views on this podcast are not to intended to be financial advice. The stocks discussed in this podcast may be held in personal or other investment accounts. This content is for informational purposes only and should not be considered investment advice. Always do your own research before making any investment decisions.

In this episode of Biotech Bulls & Breakthroughs, John sits down with Michael Heltzen, CEO of exoZymes, to discuss the revolutionary move toward cell-free biomanufacturing. Discover how exoZymes is using AI to bypass the limitations of living cells, engineering "super-enzymes" through brute-force evolution, and bringing high-purity natural compounds like NCT to the mass market.eXoZymes Inc.https://www.biopharmcatalyst.com/company/EXOZ#/📲 Follow Michael Heltzen and eXoZymes: https://www.linkedin.com/in/michaelheltzenhttps://www.linkedin.com/company/exozymeshttps://exozymes.com/In this episode:🔹 Why "cell-free" systems outperform traditional cell fermentation.🔹 How AI is used to "speed run" evolution for enzyme development🔹 Insights into the 2024 exoZymes IPO and their commercial roadmap.🧭 Track upcoming catalysts: https://www.biopharmcatalyst.com/calendars/fda-calendar🎧 Listen to more episodes: https://www.biopharmcatalyst.com/podcast📈 See Sheff’s Watchlist: https://www.biopharmcatalyst.com/sheffs-trades📲 Follow BioPharmCatalyst: https://x.com/BPharmCatalyst📲 Follow Sheff: https://x.com/SheffStationDisclaimer: BioPharmCatalyst is not a registered investment advisory firm and the views on this podcast are not to intended to be financial advice. The stocks discussed in this podcast may be held in personal or other investment accounts. This content is for informational purposes only and should not be considered investment advice. Always do your own research before making any investment decisions.

In this episode, as the biotech earnings season continues, John Gagliano and Sheff Sheffield dive deep into the new FDA one pivotal trial as an alternative to the regulatory pathway, and what it means for trial timelines and company runways in 2026. If you're trading biotech, understanding these structural shifts is no longer optional—it's a matter of survival.https://www.nejm.org/doi/full/10.1056/NEJMsb2517623In this episode:🔹 FDA updates on new pathways are changing the game.🔹 Why a 12-month runway is the new "red line" for investors🔹 Sheff's Watchlist for the following quarter🧭 Track upcoming catalysts: https://www.biopharmcatalyst.com/calendars/fda-calendar🎧 Listen to more episodes: https://www.biopharmcatalyst.com/podcast📈 See Sheff’s Watchlist: https://www.biopharmcatalyst.com/sheffs-trades📲 Follow BioPharmCatalyst: https://x.com/BPharmCatalyst📲 Follow Sheff: https://x.com/SheffStationDisclaimer: BioPharmCatalyst is not a registered investment advisory firm and the views on this podcast are not to intended to be financial advice. The stocks discussed in this podcast may be held in personal or other investment accounts. This content is for informational purposes only and should not be considered investment advice. Always do your own research before making any investment decisions.

In this episode, John Gagliano speaks with Eric Duhaime, Senior VP of Finance and Corporate Development at Diagonal Therapeutics, about the innovative approaches the company is taking in drug development, with a particular focus on clustering agonist antibodies and rare genetic diseases. Eric shares his journey in biotech, the mission of Diagonal Therapeutics, and insights into the current biotech market trends. The conversation also covers the company's pipeline, their strategic use of health data to prove commercial viability, and their novel bispecific antibodies, highlighting the importance of tackling the root causes of diseases like Hereditary Hemorrhagic Telangiectasia (HHT).📲 Follow Eric Duhaime in Diagonal Therapeutics: https://www.linkedin.com/company/diagonal-therapeuticshttps://diagonaltx.com/In this episode:🔹 Novel antibodies for rare diseases.🔹 Restoring normal intracellular signaling pathways.🔹 Navigating the current biotech market.🧭 Track upcoming catalysts: https://www.biopharmcatalyst.com/calendars/fda-calendar🎧 Listen to more episodes: https://www.biopharmcatalyst.com/podcast📈 See Sheff’s Watchlist: https://www.biopharmcatalyst.com/sheffs-trades📲 Follow BioPharmCatalyst: https://x.com/BPharmCatalyst📲 Follow Sheff: https://x.com/SheffStationDisclaimer: BioPharmCatalyst is not a registered investment advisory firm and the views on this podcast are not to intended to be financial advice. The stocks discussed in this podcast may be held in personal or other investment accounts. This content is for informational purposes only and should not be considered investment advice. Always do your own research before making any investment decisions.