Your Weekly Biotech News Fix | Ep. 945
The week of 2.23.2026
Hello Avatar! Another week of biotech news is in the history books. We are proud to bring you the latest edition of our weekly biotech news fix. The content is designed to be consumed as a quick scroll to bring readers up to speed on key events from the week. For those of you interested to read a bit more, we provide links to the source articles.
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BIOTECH NEWS UPDATES FOR THE WEEK 2/23
Lilly Tops Novo in Weight Loss Again, This Time on the Oral Front
Eli Lilly has achieved another significant victory over Novo Nordisk in the competitive weight loss and diabetes drug market. In the ACHIEVE-3 Phase III trial, Lilly’s oral GLP-1 candidate orforglipron outperformed Novo’s oral semaglutide (marketed as Rybelsus for diabetes and Wegovy for weight loss) in both blood sugar control and weight reduction among patients with type 2 diabetes inadequately managed by metformin. Orforglipron also demonstrated superior reductions in cardiovascular risk factors such as cholesterol, blood pressure, and triglycerides. This marks the second major head-to-head win for Lilly over Novo within a single week, following the recent success of Lilly’s Zepbound over Novo’s CagriSema in an obesity trial.
Despite these efficacy gains, orforglipron was associated with a higher rate of treatment discontinuations due to adverse events—8.7% to 9.7% for orforglipron compared to 4.5% to 4.9% for Rybelsus. The main side effects reported were gastrointestinal, including nausea, diarrhea, vomiting, indigestion, and appetite reduction. However, Lilly’s orforglipron may offer a convenience advantage, as it does not require the empty stomach or pre-meal timing restrictions that Rybelsus does. As the battle intensifies between these two industry leaders, Lilly’s continued clinical wins reinforce its position at the forefront of the rapidly evolving obesity and diabetes therapeutics space.
Lilly’s GLP-1 pill tops Novo’s Rybelsus in head-to-head trial
Eli Lilly’s oral GLP-1 drug orforglipron demonstrated superior efficacy compared to Novo Nordisk’s Rybelsus in a head-to-head trial involving people with diabetes whose blood sugar was not adequately controlled by metformin. The study, which randomized nearly 1,700 patients into groups receiving various doses of orforglipron or semaglutide (the active ingredient in Rybelsus), found that both high and low doses of orforglipron led to greater reductions in blood sugar and body weight. Specifically, the high-dose orforglipron group saw an average blood sugar reduction of 1.9 percentage points, compared to 1.5 percentage points in the high-dose Rybelsus group. These findings could bolster Lilly’s efforts to secure FDA approval for orforglipron as early as the second quarter and position the drug as a significant competitor in the expanding obesity and diabetes markets.
However, the improved efficacy came at the cost of increased side effects, with higher discontinuation rates for patients on orforglipron. This safety profile is noteworthy as Lilly vies for market share against Novo Nordisk, which currently offers the only oral GLP-1 agonists for diabetes and obesity. The new data underscore the intensifying rivalry between the two companies as well as the broader competitive pressures impacting Novo, including pricing challenges and encroachment from Lilly and drug compounders. As regulatory decisions loom, orforglipron’s strong clinical performance could reshape the therapeutic landscape for metabolic diseases, though physicians and patients will have to weigh its benefits against the risk of side effects.
Novo Leans Into Oral Route With Weight Loss Partnership Worth up to $2.1B
After the recent clinical setback where Novo Nordisk’s next-generation obesity drug CagriSema underperformed Eli Lilly’s Zepbound in a late-stage trial, Novo is doubling down on innovation in the obesity space. The Danish pharmaceutical giant has announced a partnership with Boston-based Vivtex, focusing on the development of novel oral weight loss pills. While the companies did not disclose the upfront payment details, the total deal value could reach up to $2.1 billion, including research funding and milestone-based payments. As part of the agreement, Vivtex stands to receive tiered royalties on any resulting product sales. The collaboration grants Novo access to Vivtex’s proprietary platform and drug-delivery technologies, which are designed to enable oral administration of biologics that are typically restricted to injectable forms.
Under the terms of the deal, Vivtex will handle early-stage research and drug formulation, after which Novo Nordisk will have the option to select specific programs for further development. Novo will then assume responsibility for later development stages, regulatory approval, manufacturing, and commercialization. This pursuit highlights Novo’s determination to remain a key player in the competitive obesity market, especially following the recent FDA approval of its oral formulation of Wegovy, which quickly reached over 3,000 patients in its first week on the market. The partnership with Vivtex marks another strategic move in Novo’s ongoing rivalry with Eli Lilly, as both companies race to expand their portfolios of innovative, patient-friendly weight loss treatments.
With Vivtex deal, Novo gains a chance at better oral obesity drugs
Novo Nordisk has entered a potentially $2.1 billion collaboration with Boston-based startup Vivtex to access cutting-edge technologies aimed at optimizing the delivery of oral biologic medicines for obesity and other metabolic disorders. While the upfront payment specifics weren’t disclosed, Vivtex could receive milestone payments and royalties should any drugs from the partnership reach commercialization. Traditionally, biologics have been challenging to formulate as pills due to their large molecular size and poor absorption through the digestive tract, often requiring injection instead. Novo has already achieved milestones in this space, bringing the first oral biologic diabetes drug, Rybelsus, to market in 2019 and gaining U.S. approval for an oral version of its best-selling obesity medication, Wegovy, at the end of 2025.
This deal underscores Novo’s strategy of combining internal discoveries with external innovation to expand its cardiometabolic pipeline. Vivtex, which originally developed drug screening diagnostics, has emerged as a key collaborator for pharmaceutical firms aiming to create oral biologics. Since early 2024, Vivtex has formed partnerships with several leading companies, leveraging its proprietary “gut-on-a-chip” platform that accelerates the testing of drug formulations for oral absorption. This latest collaboration represents an opportunity for Novo to further improve oral delivery of complex drugs, potentially enhancing patient convenience and expanding its reach in the competitive obesity treatment market.
FDA’s One Trial Policy Not a Revolution but a Potentially Risky Evolution
The FDA recently formalized its one pivotal trial policy, transitioning from the traditional requirement of two pivotal trials for new drug applications. Industry response has largely characterized the move as an evolution rather than a revolution, particularly because the agency has already been operating this way in areas like oncology and rare diseases. In fact, in 2024, 66% of all new molecular entities approved by the FDA’s Center for Drug Evaluation and Research were supported by evidence from a single clinical trial. Experts such as Harpreet Singh from Precision for Medicine and Kristen Hege, formerly of Bristol Myers Squibb, note this policy codifies existing practice rather than introducing a fundamentally new approach, especially in oncology, a field that has long benefited from the FDA’s accelerated approval pathway, which relies on surrogate endpoints and allows for earlier market access based on one pivotal study.
Despite its formalization, concerns remain about the risks associated with expanding this policy to therapeutic areas beyond oncology and rare diseases, such as neuropsychiatry. The new policy, announced in a New England Journal of Medicine article by senior FDA leadership, prompts questions about what specific evidence will be required to justify single-study approvals across different indications. While acceleration of drug approvals may bring therapies to market sooner, critics caution that relying on fewer trials could increase risks if the single pivotal study does not fully capture a drug’s efficacy and safety. Thus, while the policy is not a sweeping change, it represents a potentially risky evolution in regulatory standards that will require careful monitoring as it is implemented more broadly.
Atara Climbs Amid Report of FDA Inconsistency Leading to Cell Therapy’s Rejection
Atara Biotherapeutics experienced a 20% surge in stock price following reports of possible inconsistency within the FDA that may have contributed to the recent rejection of its cell therapy, Ebvallo. The therapy, targeting children with EBV-positive post-transplant lymphoproliferative disease (PTLD), was denied approval in January, with the FDA citing insufficient evidence of effectiveness. However, according to a former FDA employee interviewed by STAT News, internal reviewers a year earlier had found the data adequate, and the only remaining obstacle had been issues at a manufacturing facility. This reversal in agency stance was termed a “complete reversal” and speculated to be influenced by new FDA leadership at the Center for Biologics Evaluation and Research.
Ebvallo is an allogeneic T cell immunotherapy already approved in Europe since 2022 for the treatment of EBV-positive PTLD. Its mechanism involves targeting and helping to eliminate EBV-infected B lymphocytes. For U.S. regulatory submission, Atara and its partner Pierre Fabre provided data from more than 430 patients, demonstrating a 48.8% overall response rate. The contrasting interpretations between internal FDA reviewers and the agency’s ultimate public position highlight possible regulatory hurdles and shifts, raising questions about consistency and transparency in the approval processes for advanced therapies such as cell and gene treatments.
Gilead, Merck Clear Path to Market for Daily HIV Pills With New Late-Stage Data
At the 2026 Conference on Retroviruses and Opportunistic Infections, Gilead and Merck presented new late-stage Phase 3 data showing that their respective once-daily oral HIV drugs are as effective as current standard therapies in maintaining viral suppression. Gilead shared updated results from its ARTISTRY-1 and ARTISTRY-2 studies, investigating a single-tablet combination of bictegravir (an integrase inhibitor) and lenacapavir (a capsid blocker, also the active in their approved twice-yearly shot Yeztugo). In these studies, patients who were already virologically suppressed either switched to the BIC/LEN combination or stayed on their existing regimens, with the new combo proving non-inferior in keeping HIV levels low after 48 weeks.
The data reinforce Gilead’s strong position in the HIV treatment market and support the company’s plans to pursue regulatory submission for BIC/LEN. According to analysts from Truist Securities, the durability and efficacy shown in these studies suggest Gilead’s leadership in HIV therapy is likely to continue, driving long-term growth. Both Gilead and Merck now appear to have a clear path to market for their daily oral HIV treatments, marking an important advancement in simplifying treatment options and maintaining effective long-term viral suppression for people living with HIV.
Pfizer Advances Beam’s Gene Editor After Pulling Hemophilia Gene Therapy
Pfizer is advancing a liver-directed gene editing program from Beam Therapeutics, taking over all global clinical and regulatory responsibilities for the candidate. This move follows Pfizer’s decision roughly a year ago to withdraw its hemophilia B gene therapy, Beqvez, from the market and discontinue related development efforts, citing limited patient and physician interest in hemophilia gene therapies. Under the new agreement, announced in Beam’s recent fourth-quarter earnings, Pfizer will have exclusive worldwide rights to the gene editor and will lead clinical development, seek regulatory approvals, and establish manufacturing and commercialization infrastructure. Financial terms remain undisclosed, though the companies’ prior arrangement involved a $300 million upfront payment and the potential for up to $1.05 billion in milestone payments to Beam.
Beam Therapeutics retains the right to opt into later-stage development after Phase 1/2 trials, sharing 35% of worldwide development costs and profits should it choose to participate, while Pfizer holds the remaining share. The deal marks a strategic shift for Pfizer as it re-engages in genetic medicine following its withdrawal from hemophilia gene therapy, underscoring the company’s continued interest in the broader field of gene editing for other indications. The specific liver disease target for the Beam editor has not been disclosed. This partnership reflects both companies’ ongoing pursuit of next-generation genetic therapies despite previous commercial setbacks in the sector.
Patient Death Forces Partial Freeze on MacroGenics’ Gynecologic Cancer Study
MacroGenics has temporarily paused enrollment in its Phase 2 trial evaluating the bispecific antibody lorigerlimab for gynecologic cancers after a patient death prompted the FDA to impose a partial clinical hold. The deceased patient developed severe (grade 4) neutropenia and septic shock, while three other patients experienced grade 4 safety events, including myocarditis and thrombocytopenia. Following these safety concerns, MacroGenics’ stock price initially dipped but mostly recovered by market close. The company stated that patient safety remains its top priority, and it will work with the FDA to address the clinical hold and resume enrollment as quickly as possible. Notably, patients already in the study—where 41 have been treated so far—will continue receiving lorigerlimab.
Lorigerlimab is designed as a bispecific antibody targeting both PD-1 and CTLA-4 proteins, aiming to enhance the immune system’s anticancer response and circumvent tumor immune evasion. The Phase 2 LINNET study seeks to enroll about 60 patients with platinum-resistant ovarian cancer or clear cell gynecologic cancer. MacroGenics is also evaluating lorigerlimab in additional mid-stage and early-stage trials across prostate cancer and other advanced solid tumors. The drug’s dual-targeting mechanism places it among a new class of anticancer therapies focused on simultaneously modulating multiple disease pathways, offering a potentially differentiated approach compared to competitors.
15 states sue HHS over changes to childhood vaccine schedule
Fifteen Democrat-led states have filed a lawsuit against the Trump administration over recent changes to the U.S. childhood immunization schedule and the restructuring of the Advisory Committee on Immunization Practices (ACIP). The lawsuit, led by 14 state attorneys general and the governor of Pennsylvania, calls on the Department of Health and Human Services (HHS) to reverse the newly adopted vaccine schedule and to vacate the reformed ACIP, a change overseen last year by Secretary Robert F. Kennedy Jr. Named as defendants are Kennedy, the Centers for Disease Control and Prevention (CDC), and acting CDC director Jay Bhattacharya. Plaintiffs argue that the abrupt move undermines scientific rigor and public trust in vaccines.
California Attorney General Rob Bonta stated that the federal government’s actions could erode vaccine confidence, lower immunization rates, increase instances of infectious diseases, and raise costs for state healthcare programs. The CDC’s revised schedule reduced the number of universally recommended childhood vaccines from 17 to 11, aiming to align more closely with certain other wealthy nations and citing concerns about declining vaccination rates. However, critics claim the policy change circumvented the standard independent scientific review process and was based on comparisons to countries with differing health landscapes, prompting major public health and legal backlash.
CONCLUSION
There you have it, another week of your Weekly Biotech News Fix. We hope you enjoyed it, please drop a comment with any feedback you may have.
We are now publishing 7x per week according to the following cadence:
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