Back Bay Life Science Report

Examining the dynamic progress in targeted oncology, the episode delves into the shift from single-mutation therapies to broad pathway targeting, highlighting advances in EGFR, KRAS, and the MAPK axis. Recorded prior to the recent release of Revolution Medicine’s impressive Phase 3 data for daraxonrasib in pancreatic cancer, Mavra Nasir interviews Peter Bak for an in-depth exploration of the commercial, clinical, and investment trends influencing major pharma, biotech, and investors, showcasing why validated biology and platform innovations continue to drive both deal-making and patient impact.

Key clinical challenges such as resistance, CNS coverage, and durable efficacy are unpacked, alongside the ongoing appetite for early-stage platforms and the evolution of M&A strategy in the sector.

You can find our paper on the targeted oncology here: https://www.bblsa.com/analyst-reports/a-map-to-the-future-of-targeted-oncology

As ovarian cancer research enters a pivotal new era, Back Bay Life Science Advisors' Dr. Pete Bak is joined by Director Mavra Nasir and Consultant Trent Gordon for a deep dive into one of oncology's most active and rapidly evolving therapeutic landscapes.

Despite ranking as one of the top causes of cancer death among women worldwide—with a five-year survival rate still hovering around 50%—ovarian cancer has historically suffered from a sparse treatment pipeline. That is changing fast. This episode traces the field's major inflection points, from the landmark approvals of bevacizumab and PARP inhibitors in 2014, to the game-changing 2022 ADC approval of Elahere, to the recent Keytruda approval in high PD-L1 expressors—and looks ahead to a wave of innovation that could fundamentally reshape how patients are treated.

Pete, Mavra, and Trent break down the competitive ADC landscape, discuss next-generation entrants targeting folate receptor alpha and beyond, and examine what a crowded pipeline means for clinical development strategy in a space where the standard of care is moving fast.

Podcast topics include:

• The ovarian cancer patient landscape: why late-stage diagnosis remains the norm and what that means for treatment
• Key historical milestones in ovarian cancer drug development and why the pace of innovation is now accelerating
• Elahere's approval, efficacy profile, and the real-world challenges of ocular toxicity and patient eligibility
• Next-generation folate receptor alpha ADCs from Genmab, Lilly, and AstraZeneca—and how they may differentiate on payload, ORR, and sequencing
• Emerging targets beyond folate receptor alpha: B7H3, B7H4, NAPI2B, and CDH6
• The role of ADC stacking and sequencing as the platinum-resistant setting becomes increasingly crowded
• Bispecific antibodies and the potential to convert immunologically "cold" ovarian tumors into candidates for immunotherapy
• AbbVie's strategy to expand Elahere into earlier lines of therapy
• How clinical trial sponsors can future-proof development programs against an evolving standard of care—adaptive protocols, investigator's choice comparator arms, pre-specified amendment triggers, and FDA alignment strategies
• The importance of competitive intelligence, NCCN/ESMO guideline tracking, and reimbursement analysis for drugs in development

Thank 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.

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 approvals

Thank 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.

In this DNB//Back Bay Healthcare Capital Markets podcast episode, 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, review the performance of the healthcare markets in 2024, offering insights into what 2025 could bring. With a detailed analysis of market trends, IPO activities, and investor behaviors, they evaluate the past year's challenges and the cautious optimism prevailing in the sector as the new year unfolds. As well, there's an emphasis on the importance of European investor engagement for companies looking to list in the U.S. market.

Learn more about the DNB//Back Bay Partnership and read our disclosures here.

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

In this DNB//Back Bay Healthcare Capital Markets Episode, Vasilios Kofitsas, Partner and Managing Director at Back Bay Life Science Advisors speaks with Jim Cirenza and Kristoffer Braaten of DNB Bank in New York. They focus on key drivers affecting markets this year and discuss the recent news of the Fed’s decision to cut interest rates by 50-basis points. 

Topics in the podcast include: 

• After two difficult years, the appearance of a healthy market rotation since July 
• The Fed’s decision mid-September to cut rates by 50 basis points 
• Healthcare IPOs: historical and recent activity – is the window opening?
• An outlook including headwinds and tailwinds that may impact the healthcare sector

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.

Learn more about the DNB//Back Bay Partnership and read our disclaimers at https://www.bblsa.com/dnb-back-bay-partnership.

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 drugs
• The 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. 

In this DNB//Back Bay Healthcare Capital Markets podcast episode, learn about the key considerations, mechanics and timelines of going public on a US exchange.

 Topics in this podcast include: 

• An overview of the decision-making process through execution for US-based and ex-US healthcare companies thinking about listing in the US
• Core considerations after deciding to pursue a US listing and how to prepare most effectively
• Building the “IPO advisory team”: types of advisors (legal, accounting, banking, IR firms, IP, etc.) and when to bring them in
• Key documents and associated timelines related to the SEC documentation as well as investor outreach
• What are the “don’ts” or mistakes companies make and how to avoid them

You can listen to previous episodes here or submit your inquiries here.

About our guests:

DNB//Back Bay is a committed partner throughout the healthcare development journey, addressing positioning, partnering, financing, M&A strategies, and listing support and execution on US and Nordic exchanges. Our team of more than 100 healthcare strategy and financial specialists spans the globe. Learn more about the DNB//Back Bay Partnership and read our disclaimers at https://www.bblsa.com/dnb-back-bay-partnership.

Cooley is among the top law firms for healthcare, tech and life science IPOs on both the issuer-side and underwriter-side. Their team of 1,300 lawyers is spread across 19 offices worldwide.

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) agonists
• Why GLP-1s’ popularity is skyrocketing as treatment for type 2 diabetes and obesity
• How 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 activins
• Where BD and investor interest lies as these drugs are expected to have north of $150B in sales annually within the next decade
• What’s happening in early to late-stage drug development
• What 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.

Welcome to another episode with the DNB//Back Bay Partnership for Healthcare.

In this episode Jonathan Gertler, Back Bay CEO and Managing Partner, is once again joined by James Cirenza, Head of Fixed Income and Equities at DNB, Kristoffer Braaten, Director of US Equity Capital Markets at DNB, and Vasilios Kofitsas, Managing Director of Investment Banking at Back Bay Life Science Advisors, to talk about current market dynamics and the 2024 IPO outlook in the US and in Europe.

Topics in this podcast include:

• Trends, cycles and the current state of capital markets in Europe and the US
• IPO performance for Q1 2024 vs. previous years
• Top characteristics of companies well-suited to go public and be successful
• IPO market dynamics in Europe vs. the US
• Expectations and advice for companies contemplating going public

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 to [email protected].

Learn more about the DNB//Back Bay Partnership and read our disclaimers at https://www.bblsa.com/dnb-back-bay-partnership.