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In this episode of Denatured, Jennifer C. Smith-Parker speaks to Erik Digman Wiklud, CEO of Circio and Jacob Becraft, CO-founder and CEO of Strand Therapeutics. Since the mRNA vaccine breakthroughs of the COVID-19 era, attention has turned to what's next for programmable medicines. While first- generation mRNA prove the power of transient genetic instruction, its instability, immune reactivity, and short-lived expression have limited its use mainly to vaccines. Emerging platforms like circular and logic circuit RNA are expanding the field's therapeutic horizons. Host Jennifer Smith-Parker, Director of Insights, BioSpace Guests Erik Digman Wiklund⁠, CEO, Circio Jacob Becraft, Co-founder and CEO, Strand Therapeutics Disclaimer: The views expressed in this discussion by guests are their own and do not represent those of their organizations.

Pfizer reported the first data from its new obesity pipeline, picked up in the nearly $10 billion acquisition of Metsera last fall. While BMO Capital Markets said in a Tuesday note that the data “look competitive,” analysts clamored for more details on Pfizer’s earnings call the same morning—and were left wanting more. Meawhile, Merck batted away accusations of “modest growth” from analysts on its own earnings call, as CEO Robert Davis touted “probably the broadest and widest pipelinewe’ve had in years.”   These calls followed Roche last week and Johnson & Johnson before that, but earnings season is just getting started. On the docket today is Eli Lilly, which has been acquisitive of late, plus Novo Nordisk, Novartis, AbbVie and more.   On the regulatory front, the FDA is expected to decideon eight products this month, including REGENXBIO’s Hunter syndrome gene therapy RGX-121. The biotech ran into a regulatory snag last week, however, as the FDA placed a clinical hold on two of its programs, including RGX-121. The agency also launched its much-anticipated PreCheck pilot program, which aims to make it easier for companies to build manufacturing plants in the U.S. And President Donald Trump’s TrumpRx platform is delayed, potentially amid anti-kickback concerns.   In ClinicaSpace this week, we took a deep dive intothe resurgent psychedelics space, which could see two companies—Compass Pathways and Definium—submit FDAapplications this year. H.C. Wainwright analyst Patrick Trucchio told BioSpace 2026 is set to be “the biggest year from a clinical data standpoint,” since the firm began covering Compass in 2018.   And check your inboxes Wednesday for BioPharmExecutive, where we take a look back at the banner IPO year that was 2021: Where are these companies now?

In this episode of Denatured, Jennifer C. Smith-Parker speaks with RTW’s Rod Wong and Stephanie Sirota how shifting JPM deal timing masks record M&A potential; why oncology, obesity, psychedelics, and neuroscience are attracting fresh capital; and how “alpha stacking” shapes their investment edge in an age of chronic uncertainty. They cover topics discussed in RTW's new book, "Innovation is the Best Medicine." Hosts⁠⁠⁠ ⁠Jennifer Smith-Parker⁠⁠, Director of Insights, BioSpace Guests Roderick Wong, Managing Partner, Chief Investment Officer, RTW Investments Stephanie Sirota, Partner, Chief Business Officer, RTW Investments Disclaimer: The views expressed in this discussion by guests are their own and do not represent those of their organizations.

Roche made the biggest splash this week so far, announcing on Tuesday that GLP-1/GIP injectable CT-388 led to 22.5%weight loss in a Phase II trial. These numbers appear to put CT-388, which Roche acquired in its $2.7 billion Carmot buy, in line with Eli Lilly’s Zepbound, according to William Blair analysts. Roche plans to start a Phase III study of CT-388 in the first half of this year and is also pairing the drug with a therapy from Zealand Pharma, with the aim of offering a weight lossoption with fewer gastrointestinal side effects.   Meanwhile, Baseline Therapeutics debuted to challenge Lilly with a Phase III–ready GLP-1 for alcohol use disorder.   In the vaccines sector, Moderna took perhaps the biggest action to date amid Health Secretary Robert F. Kennedy’s anti-vaccine policies and rhetoric, last week announcing that the company will no longer run late-stage vaccine trials for infectious diseases. “You cannot make a return on investment if you don’t have access to the U.S. market,” CEO Stéphane Bancel saidthe World Economic Forum at Davos, Switzerland. Pfizer CEO Albert Bourla, also speaking at Davos, called RFK Jr.’s rhetoric and policies on vaccines “anti-science.”   Finally, Sarepta released new data on Monday for Elevidys, the company’s embattled gene therapy for neuromuscular disease Duchenne muscular dystrophy. Plus, check out up-and-coming treatments for Alzheimer’s and Parkinson’s.

In this episode of Denatured, BioSpace editorial team members, Senior Editor, Annalee Armstrong, and News Editor, Dan Samorodnitsky, discuss their post-JPM takeaways and 2026 forecasts after speaking to a range of pharma and biotech executives and investors last week. Hosts⁠ Jennifer Smith-Parker⁠, Director of Insights, BioSpace⁠ Guests ⁠Annalee Armstrong, Senior Editor, BioSpace ⁠Dan Samorodnitsky, News Editor, BioSpace Disclaimer: The views expressed in this discussion by guests are their own and do not represent those of their organizations.

The 2026 J.P. Morgan Healthcare Conference concludedlast week without a big M&A deal. But the meeting was anything but boring, with President Donald Trump’sMost Favored Nation drug pricing scheme and the perpetual battle for supremacyin the obesity space between Eli Lilly and Novo Nordisk prime topics of conversation. Meanwhile, other companies like Biohaven refuse tocede the entire weight loss market, stating their intention to carve out apiece of the massive pie.   On the competitive front, Novo took a step forwardMonday with the news that its Wegovy pill reached nearly 3,100 patients since its launch on Jan. 5. Meanwhile, an FDAdecision for Lilly’s own oral offering, orforglipron, has been delayed from March28 to April 10. Orforglipron is being reviewed under the FDA’s new Commissioner’sNational Priority Voucher (CNPV) program, which aims to shorten the reviewperiod from 10–12 months to 1–2 months. Other voucher recipients—includingSanofi and Disc Medicine—have also had their decisions delayed.   While the FDA wasn’t a primary focus at JPM, severalbiotechs sought to make clear during their investor presentations that they hadsecured alignment with the regulator on trial design or pathways to approval. This comesafter a year that has seen many of their peers experience regulatory whiplashas previous FDA guidance was seemingly reversed.   And on the business front, IPOs are back! This week, SpyGlass Pharma and AgomAb Therapeutics joined Veradermicsand Eikon Therapeutics on the rapidly accelerating IPO train. Aktis Oncology,which announced its bid in late 2025, debuted on the Nasdaq earlier this month.   And in BioPharm Executive this week, Annalee Armstrongand Dan Samorodnitsky catch up with execs from Novo Nordisk, Korro Bio, Biohaven and Galapagos.

In this episode, BioSpace’s Vice President of Marketing Chantal Dresner and Careers Editor Angela Gabriel discuss Q4 2025 job market performance, sharing the latest BioSpace data. They touch on positive signs they saw last quarter and what this year might have in store for those seeking employment.  Want to receive our latest quarterly job market reports as soon as they’re published? ⁠⁠⁠Subscribe⁠⁠⁠ to Career Insider for our job market updates, job trends, career advice and more.

AbbVie bet nearly $5 billion for the ex-China rights to RemeGen’s PD-1/VEGF bispecific and Novartis struck a $1.5 billion Alzheimer’s-focused deal with China-based SciNeuro Pharmaceuticals as the 2026 J.P. Morgan Healthcare Conference got underway on Monday. These and other recent tie-ups speak to the therapeutic trends predicted to be hot this year by experts who spoke with BioSpace, who particularly noted that cancer and neuroscience would remain top of the list.   Meanwhile, attendees are still waiting for that “one big M&A deal.” Could it come from Merck? CEO Rob Davis expressed high confidence during the company’s JPM presentation on Monday, revealing that Merck is open to deals in the range of “multi tens of billions of dollars.”   On the weight loss front, Eli Lilly and Novo Nordisk both updated attendees on the state of play, with Lilly expressingconfidence in its supply chain to support the launch of obesity pill orforglipron and Novo continuing to lament the business it is still losing to compounders.   Just in time for JPM, the IPO window cracked open, with Aktis Oncology debuting on the public markets last week and Veradermics and Eikon Therapeutics announcing their bids to follow suit. A similar thaw occurred last year before the window slammed shut again as myriad policy changes frightened investors. How will this year play out?   2025 had its challenges, especially on the policy front. In his annual letter, Flagship CEO Noubar Afeyan cited “growing contempt” in the U.S. for the scientific method and arapidly emerging Chinese biopharma ecosystem among the greatest challenges facing the industry. And while the funding may now be flowing, it still favors later-stage companies. A .J.P. Morgan report released prior to the conference showed VC funding was down across the board last year, but especially for biotechs recruiting early rounds.   Finally, while JPM is the primary focus, the FDA hasn’t taken the week off. Just prior to recording, the regulator requestedthat Lilly and Novo remove the suicide warning from the labels of certain GLP-1 medications after a comprehensive review found no increased risk of suicidal ideation and behavior with these drugs. On the policy front, the FDA continued its quest to accelerate the development of cell and gene therapies with new manufacturing exemptions.   The regulator also took action on two applications this week, approving a rare disease drug developed by Sentynl Therapeutics and Fortress Biotech and denying a cell therapy submitted by Atara Biotherapeutics. To learn about key upcoming FDA action, check out 6 FDA Decisions To Watch in Q1 2026 in ClinicaSpace this week.

In this episode of Denatured, Jennifer C. Smith-Parker speaks to Maha Katabi, general partner at Sofinnova Investments and Andrew Lam, managing director, head of Biotech Private Equity at Ally Bridge Group, about how M &A dynamics, dealmaking and global partnerships are reshaping portfolio valuations and paths to growth in 2026. Host Jennifer Smith-Parker, Director of Insights, BioSpace Guests Maha Katabi, General Partner, Sofinnova Investments Andrew Lam, Managing Director, Head of Biotech Private Equity, Ally Bridge Group (ABG) Disclaimer: The views expressed in this discussion by guests are their own and do not represent those of their organizations.

Obesity titans Novo Nordisk and Eli Lilly characteristically kicked off 2026 in the headlines. After capping 2025 with the first-ever FDA approval of an oral GLP-1 for obesity, Novo launched its Wegovy pill on Monday, starting at $149 per month out of pocket for the lower doses. Meanwhile, all eyes are on Lilly, which expects a greenlight for orforglipron as early as March. The oral weight loss play is set to be a key aspect of a pivotal year for Lilly, which hopes to more than double its annual revenue in just a few years.     Also pulling a rabbit out of a hat just before Christmas were nine drugmakers—including Amgen, Bristol Myers Squibb, Boehringer Ingelheim—which signed Most Favored Nation drug pricing agreements with the Trump administration, likely securing their businesses against the threat of tariffs. However, drug pricing will continue to be top of mind in 2026, experts told BioSpace, as only about half of Big Pharmas have signed a deal, and small and mid-sized companies haven’t yet begun.     Another area biopharma leaders are watching with bated breath is the FDA. The overwhelming consensus from experts who spoke with BioSpace is that last year was a disaster—particularly from a workforce standpoint. Still, the agency approved 56 novel drugs, down just a tick from 2024’s 59. Advisory committees fell off considerably, in both number and concordance, however, according to a report by Jefferies, as these meetings came under scrutiny by FDA leadership.  In 2026, will the unprecedented leadership turnover—especially at CDER—settle down? Will the new rare disease and cell and gene therapy policies bear first fruits? Also on the regulatory front, the CDC has already been busy this year, axing several childhood vaccines from its recommended schedule with potential implications for biopharma companies including Pfizer and Merck.     And if there’s one area biopharma watchers anticipate even more than regulatory action, it’s M&A action. Last month, analysts shared their top targets with BioSpace, listing names like Summit Therapeutics, Apogee Therapeutics and Axsome Therapeutics. Here at BioSpace, we’ll stick with Viking.     Finally, don’t forget to check out our NextGen Class of 2026—featuring 15 biotech startups whose mission and platforms cut through a challenging environment. And make sure to join us next week when senior editor Annalee Armstrong and news editor Dan Samorodnitsky will provide dispatches from the J.P. Morgan Healthcare Conference.  

In this episode of Denatured, Jennifer Smith-Parker speaks to Kenneth Galbraith, CEO at Zymeworks and Josh Smiley, president and COO at Zai Lab, about how renewed confidence is driving biotech entering 2026. As we look towards conversations that will shape this year's J.P. Morgan Healthcare Conference, the biotech industry is fueled by improving market sentiments, visible at recent meetings like Jeffries in London, and reinforced by a wave of partnerships, strategic acquisitions and Chinese collaboration that is recalibrating investor expectations. Host Jennifer Smith-Parker, Director of Insights, BioSpace Guests Kenneth Galbraith, CEO, Zymeworks Josh Smiley, President and Chief Operating Officer, Zai Lab Disclaimer: The views expressed in this discussion by guests are their own and do not represent those of their organizations.

Eli Lilly is wrapping up 2025 with record-breaking weight loss in a late-stage trial for its triple hormone receptor agonist retatrutide. Results from the Phase III TRIUMPH-4 trial exceeded analyst expectations, leading BMO Capital markets to cleverly dub it “a true TRIUMPH.” Also in the weight loss arena, Zealand Pharma inked a deal with China’s OTR Therapeutics worth up to $2.5 billion to collaborate on next-gen drugs for obesity and other metabolic diseases, and Rhythm Pharmaceuticals awaits a Dec. 20 FDA verdict for Imcivree in hypothalamic obesity.     Turning to the FDA, reports broke late last week that the agency was considering slapping a black box label—its strictest warning—on COVID-19 vaccines. Commissioner Marty Makary denied those reports on Monday, stating on Bloomberg TV that the FDA has “no plans” to make such a move. This follows an internal memo from Vinay Prasad leaked over Thanksgiving in which the CBER director claimed that “at least” 10 children have died “because of” COVID-19 vaccines. An internal safety review published last week refuted this conclusion, instead concluding that between zero and seven deaths could be linked to the shots.     Pfizer CEO Albert Bourla, for one, is tired of the recent rhetoric from HHS on vaccines and hopes they are “an anomaly” that will be corrected soon. With strong words about the administration’s sentiment on vaccines, Bourla prominsed Pfizer’s continued investment in vaccines despite declining revenue. Pfizer this week lowered its 2026 guidance to $62.5 billion in revenue, missing analyst consensus.    The FDA has also granted several approvals in the past week, to Amgen, Milestone Pharmaceuticals and AstraZeneca and Daiichi Sankyo. USAntibiotics also snagged a greenlight, for Augmentin XR, the first approval to be given under the agency’s new Commissioner’s National Priority Voucher (CNPV) program. Also this week, Johnson & Johnson scored a CNPV ticket—without even having to apply—for its investigational combo of Tecvayli plus Darzalex for relapsed or refractory multiple myeloma after the FDA was impressed by Phase III data.     In ClinicaSpace this week, we highlighted 5 of 2025’s Defining Clinical Wins and The 5 Most Painful Clinical Trial Failures of 2025. This past week provided a few more on each front. In the winner’s circle, Immunome’s desmoid tumor drug and and Kyverna’s CAR T for stiff person syndrome both aced pivotal trials, while Sanofi’s MS drug tolebrutinib and Gilead and Arcus’ TIGIT therapy domvanalimab each failed Phase III tests.     And in BioPharm Executive, we highlight 6 Biotechs That Could Be Big Pharma’s Next M&A Target, and more M&A predictions for 2026.  

In this episode presented by AnaptysBio, Jennifer Smith-Parker speaks to Dr. Joe Murray, professor of medicine, Division of Gastroenterology and Hepatology, Department of Internal Medicine, and Department of Immunology, The Mayo Clinic; Marilyn Gellar, CEO, The Celiac Disease Foundation; and Dr. Paul Lizzul, chief medical officer, AnaptysBio, about the unmet need for effective treatments for celiac disease, the limitations of the gluten-free diet and the development of ANB033, a first-in-class CD122 antagonist designed to modulate IL-2/IL-15 signaling. Host Jennifer Smith-Parker, Director of Insights, BioSpace Guests Dr. Joe Murray, Professor of Medicine, Division of Gastroenterology and Hepatology, Department of Internal Medicine and Department of Immunology, The Mayo Clinic Marilyn Geller, CEO, Celiac Disease Foundation Dr. Paul Lizzul, Chief Medical Officer, AnaptysBio   Disclaimer: The views expressed in this discussion by guests are their own and do not represent those of their organizations.

Pfizer followed up its winning $10 billion bid forobesity startup Metsera by adding another molecule to its obesity cabinet, thisone from Chinese firm YaoPharma in a deal worth up to $1.9 billion licensing deal announced Tuesday. Meanwhile, Wave Life Sciences and Structure Therapeutics may have changed the weight loss landscape with early and mid-stagedata from their candidates that analysts called “very disruptive” and “highlycompetitive,” respectively.   At the FDA, the confusion and instability continuewith the retirement of agency veteran Richard Pazdur just three weeks into hisrole as CDER director. Pazdur’s exit leaves the FDA with just three veteran leaders from one year ago. The CDC similarly made headlines last week as therevamped vaccines advisory committee voted to recommend postponing the hepatitis B vaccination from birth to two months of age for some infants.   Meanwhile, the Clinical Trials on Alzheimer’s Disease (CTAD)conference generated excitement in the space as Roche, Eisai and others presentednew data from their respective candidates. The star of the show was Roche’snext-gen antibody trontinemab, which lowered amyloid levels below the threshold of positivity in 92%of treated patients in a mid-stage study. Meanwhile, Eisai isdetermined to buck the losing the trend in the anti-tau space. The company’s etalanetugreduced all measurable forms of MTBR-tau243—a specific biomarker of tau tanglepathology in Alzheimer’s—in a Phase Ib/II trial, according to an oralpresentation at CTAD.   Finally, check outthis week’s deep dives in BioPharm Executive on what pharmas are learning fromthe Chinese biotech sector and how Japan’s pharma industry is setting itssights on the global market.

Momentum is building behind New Approach Methodologies (NAMs) that offer stronger human relevance than traditional animal testing. The FDA issued on December 2 a draft guidance outlining specific product types for which the agency believes six-month non-human primate toxicity testing can be eliminated or reduced.  The guidance followed a proposed agency template for NAMs in April. There is also an initiative called the Validation and Qualification Network, with dozens of partners from regulators, like the FDA and European Commission, to Big Pharmas and CROs, such as Sanofi, Novo Nordisk, GSK and Charles River Laboratories, that had a July meeting. In addition, Reuters reported in September that AI-driven drug discovery picks up as FDA pushes to reduce animal testing. In this episode of Denatured, Jennifer C. Smith-Parker speaks to Stacey Adam, PhD, Vice President of Science Partnerships at the Foundation for the National Institutes of Health and Patrick Smith, Senior Vice President, Translational Science at Certara, to discuss the latest regulatory news and the future for NAMs development. Host Jennifer Smith-Parker, Director of Insights, BioSpace Guests Patrick Smith, Senior Vice President, Translational Science, Certara Stacey Adam, PhD, Vice President of Science Partnerships, Foundation for the National Institutes of Health Disclaimer: The views expressed in this discussion by guests are their own and do not represent those of their organizations.