Back Bay Life Science Report

As the life sciences industry turns the page to 2026, Back Bay Life Science Advisors’ Dr. Pete Bak and Dr. Mavra Nasir take a detailed look back at FDA drug approvals in 2025, a year marked by regulatory turbulence, shifting policy signals, and several category-defining product launches.Despite a dip in the total number of approvals compared to prior years, 2025 delivered meaningful innovation across oncology, rare disease, pain, infectious disease, and beyond. In this episode, Pete and Mavra break down the key approval trends at both CDER and CBER, highlight standout commercial launches, and discuss what last year’s data may signal for drug development and regulatory strategy going forward.The conversation spans blockbuster forecasts, novel modalities, and evolving FDA expectations—from compressed review timelines to the potential phase-out of animal toxicology studies—offering listeners both a retrospective and a forward-looking view of the regulatory landscape.Podcast topics include:• Key FDA drug approval trends from 2025 and how they compare to prior years• CDER approvals and standout launches, including Insmed’s brensocatib in non-CF bronchiectasis• Vertex’s non-opioid pain drug Journavx and the commercial realities of first-in-class pain therapies• The continued rise of antibody-drug conjugates, with a focus on Daiichi Sankyo’s TROP2 ADC• A wave of innovation in hereditary angioedema, including RNA therapies and oral acute treatments• New approvals in antibiotics, women’s health, and pulmonary fibrosis• CBER approvals, including gene therapies, vaccines, and nonprofit-led commercialization models• What a slowdown in cell and gene therapy approvals may indicate• FDA policy developments to watch in 2026, including priority vouchers, streamlined pivotal trials, and alternative preclinical requirements• A prediction (and friendly wager) on whether 2026 will surpass 2025 in total approvalsThank you for listening. You can find previous episodes of the podcast on our website.We’d love to hear from you—questions and feedback are always welcome.

The topic of bispecific antibodies has been an area of interest in the pharma space for a long time now. The recent news of the notable late-stage data from Akeso and Summit’s PD-1/VEGF bispecific antibody ivonescimab to treat non-small cell lung cancer that has captured the industry writ large encouraged us to revisit the topic. To date, there have been ten bispecific antibody approvals in oncology, seven of which are for hematological malignancies. Recently, there has been more traction in development pipelines for solid tumors. Most bispecific antibody approvals are currently or projected to be above the $1M annual revenue threshold. Podcast topics include: • The biologics of a bispecific antibody • The benefits of a bispecific antibody compared to autologous therapies • The buzz around Akeso and Summit’s PD-1 VEGF bispecific antibody asset • The broad state of bispecifics in approved products and development pipelines • The potential of trispecifics, bispecific conjugates and beyond

After a summer away from podcasting, Back Bay Life Science Advisors’ Dr. Pete Bak and Christian Thienel are back on the mic to discuss current market dynamics in liver disease with a focus on one of the most closely watched space in hepatology, MASH. The big news includes a rebrand from NASH (non-alcohol related steatohepatitis) to MASH (metabolic dysfunction-associated steatohepatitis), the FDA approval of Madrigal Pharmaceutical’s Rezdiffra and real-time court rulings in Europe that may affect the rate of play for Ocaliva, a drug used to treat adults with primary biliary cholangitis here in the US. As Christian mentions in this episode, “The path to success is not always a straight line.”Other topics in this podcast include: Hepatology market dynamics over the past five years, including activity from Gilead, Novo Nordisk, Intercept and CymaBay How treatment for primary biliary cholangitis, an autoimmune condition, went from a one to a three-product market Payer monographs and what’s required for hepatology drugsThe EMA recommendation earlier this month to revoke Ocaliva’s marketing authorization Which companies are active in the rare liver disease space and how they differentiate themselves Thank you for listening. You can find previous episodes of the podcast here. We’d love to hear from you. Ask questions and submit your feedback.

Guests: Pete Bak and Christian Thienel Length: 27 minutes In this episode of The Life Science Report, Dr. Pete Bak and Back Bay Director, Christian Thienel catch up on the area attracting the most industry interest over the past couple of years: the anti-obesity space. From big players looking to capitalize on the renewed interest in the obesity space to the staggering success of Novo Nordisk’s and Eli Lilly’s GLP-1 agonists (Ozempic, Wegovy, Mounjaro, and Zepbound) for glycemic control and weight loss, there’s a lot to cover. Topics in this podcast include:A brief introduction to glucagon-like peptide 1 (GLP-1) agonistsWhy GLP-1s’ popularity is skyrocketing as treatment for type 2 diabetes and obesityHow amylin and petrelintide (a long-acting amylin analogue) are being newly re-imagined for the obesity space, as well as muscle-targeted approaches like myostatin and activinsWhere BD and investor interest lies as these drugs are expected to have north of $150B in sales annually within the next decadeWhat’s happening in early to late-stage drug developmentWhat the future holds for this sector, possibly to include cannabinoid one receptor inverse agonists and mitochondrial targets for metabolic disease As always, thank you for joining us. Did you know we welcome listener questions? If there any areas you’d like us to explore further in metabolic disease and obesity, please let us know. Submit your questions here. Our Nordic-American Healthcare Conference 2025 will feature metabolic track. Learn more: https://nordicamericanhealthcareconference.com/ You can find previous episodes of the podcast here.

Guests: Pete Bak and Christian Thienel Length: 37 minutes With the advent of COVID-19 in 2020 and 2021, we saw a tremendous amount of interest in not only COVID vaccines, but other companies riding the tailwind and developing vaccine therapies that span across viral illness, maternal infections and bacterial infections. In this episode resident immunologist Dr. Pete Bak and Christian Thienel discuss vaccine technology, up-and-coming areas of interest, such as RSV, and the vaccines currently in late-stage clinical development. Topics in this podcast include: Vaccine technology, vaccine types and their varying levels of durabilityThe ongoing interest of vaccine development for RSV, including data from GSK’s Arexvy and Pfizer’s Abrysvo vaccinesHow recommendations from the Advisory Committee on Immunization Practices (ACIP) influence commercial dynamicsThe interesting chess game of scheduling vaccines as they relate to COVID, flu and RSV (seasonality versus strains and antigens) Vaccine development and data as it applies to Cytomegalovirus (CMV) and Epstein-Barr (EBV)News from the bacterial front: MinervaX leading the way with a maternal vaccine against Group B streptococcus infections with a very large series B round for $54M; Pfizer’s recent Prevnar 20 against pneumococcal pneumoniaPricing, reimbursement and the interplay with ACIP guidelines As always, we welcome listener questions and/or topics you’d like to learn more about. You can listen to previous episodes here or submit your inquiries here.

As we move into 2024, Back Bay’s strategic advisors summarize key product approvals from three classes and indications over this past year, including the December CRISPR and Vertex approval of Exa-cel, Biogen and Sage’s August approval of an oral treatment for women with postpartum depression and Genmab and Roche’s May approval in oncology. In this episode: CRISPR and Vertex’s approval of Exa-cel, the first CRISPR-based genetic medicine approved by the FDA in the US The major depressive disorder vs. postpartum depression for Biogen/Sage GenMab and Roche approvals AbbVie acquisition of Cerevel Therapeutics strengthen neuroscience pipeline In 2023, on The Life Science Report, Back Bay covered a wide range of topics featuring stories from the frontline of healthcare development to the rising trends in cardiology to the transactional landscape of antibody drug conjugates. We always welcome listener questions or topics you’d like to learn more about. You can listen to previous episodes or submit your inquiries here. Back Bay provides a snapshot of the healthcare markets every Monday. For IPO, Follow-On and M&A updates, subscribe to our healthcare updates.

With the DNB//Back Bay Partnership for HealthcareIn the current markets, Healthcare continues to rally as the second-largest industry behind technology in the stock market, and in the US markets there’s been roughly $2.5B raised from an IPO standpoint YTD. In Europe, the markets have been more challenging, with IPOs for five companies going public this year, including Schott Pharma, Germany’s largest IPO earlier this year.In the first podcast episode with the DNB//Back Bay Partnership for Healthcare, Jonathan Gertler, Back Bay CEO and Managing Partner is joined by Jim Cirenza, Head of Fixed Income and Equities at DNB, Kristoffer Braaten, Director and Head of Equity Capital Markets at DNB, and Vasilios Kofitsas, Partner and Managing Director of Investment Banking at Back Bay Life Science Advisors, to discuss the current landscape of IPO and capital markets, optimal preparation strategies for companies hoping to go public and why it ultimately matters who you spend your time with.Topics in this episode include:Dynamics leading to the current IPO market and capital markets landscapeThe state of private and partnering markets and the renewed power of partnershipsCrucial roles of private investments, VC and other “mezzanine investors” for public emergence licensingThe importance of optimal prep and aftermarket support, and why spending good time in the preparation phase with both research and individual investor meetings is a key success factor, regardless of where companies are planning to listThe ever-important lesson of starting early

In this episode, Dr. Peter Bak is joined by Trent Gordon and Dr. Mavra Nasir as they discuss their Bioprocess Online article published earlier this year, “The Transactional Landscape of ADCs: A Payday for Payloads.” This conversation explores the dynamics and data within the emerging ADC field, including:Background information on the class of therapeutics known as ADCs, which have been on the market since 2000The number of headlines around ADCs lately, especially the standing ovation the data from Enhertu received at ASCO in 2022, making waves in breast cancer treatmentDeal structures and the BD side of ADCs, and their extended revenue generation potentialWhere the field is headed, in terms of clinical, BD and commercial standpointsRead and connect with our authors: The Transactional Landscape Of ADCs: A Payday for Payloads

For biopharma and medtech companies developing new treatments, capital for advancement and growth is invariably dependent on strategic preparation, differentiation, and persistence. Good preparation can mean funding or famine in a retracted market—and ultimately can impact the trajectory of a company and whether treatment reaches people in the clinical setting. In a down market, there are creative and thoughtful approaches companies can take to stand out as capital becomes more closely guarded and the competition becomes fierce. In this episode of Back Bay’s industry podcast, the Life Science Report, Jonathan Gertler speaks with Goodwin Procter life science partner Kristopher Brown about the current market landscape and how life science companies can recalibrate and prepare for capital raises—no matter the market outlook. This episode focuses on discussion of deal management in the current market, including: The current deal scape—difficult times ahead or par for the course in the life science sector?Approaches to deal preparation in a challenging environmentTentative M&A, licensing, partnering activity and public markets necessitate preparation and strategic focus ahead of capital raise, particularly:Thorough knowledge of asset differentiation - positioning, competitive intensity, pricing, milestone development/definition and valuation, among other activitiesCreative deal financing models – royalty monetization, tranced investments, debt financing, preferred stock, liquidation preferencesStructure and valuation disciplinePortfolio and selection management toward a deal, including the use of AI in population identification Find the video podcast and contribute to the conversation on Back Bay’s website: www.bblsa.com/podcasts

The Nordic Nasdaq system—specifically the Stockholm markets—recently unveiled access to US biopharma and medtech companies to list on the Stockholm Exchange, either primarily or as a dual listing. In this episode Jonathan Gertler and Maria Groschopp Dellwik of Nasdaq talk through how this recent policy shift could change the game for Nordic and US companies and their best practices for companies preparing to go public.

Christian Thieniel and Brendan Wang, two senior members of the Back Bay Life Science Advisors team, offer guidance on issues related to pricing and early market access.

with Peter Bak and Alexander Natz Biopharma companies looking to establish a footprint in Europe face country-specific decision-making processes. The health technology assessments (HTAs) in France and Germany, for example, look very different. Does this regional level of thinking make it easier or potentially more difficult to get medicines to market and into the hands of patients who need them? In this episode of Back Bay’s Life Science podcast, Pete Bak is joined by Alexander Natz, Secretary-General of the European Confederation of Pharmaceutical Entrepreneurs (EUCOPE), Europe’s principal trade body for companies working in the field of pharma, biotech, and medtech. Based in Brussels, EUCOPE provides expertise across a number of strategic issues such as regulatory paths and pricing and market access.