Your Weekly Biotech News Fix | Ep. 736
The week of 7/14/25
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 7/14
5 Women Biotech Leaders Bagging Billions in M&A Dollars
In recent years, some of the biotech industry’s largest and most strategic M&A deals have been driven by women CEOs, whose leadership and vision helped transform their companies into attractive acquisition targets. Sharon Mates of Intra-Cellular Therapies led her company to a $14.6 billion buyout by Johnson & Johnson, fueled by the success of Caplyta. Kate Haviland guided Blueprint Medicines through label expansions and commercial growth of Ayvakit, culminating in a $9.5 billion acquisition by Sanofi. Similarly, Heather Turner played a pivotal role at Carmot Therapeutics, securing a $2.7 billion deal with Roche on the strength of early obesity drug data. Each of these leaders not only advanced pipelines but also rebuilt partnerships and executed turnarounds that increased shareholder value.
Other notable examples include Laura Shawver of Capstan Therapeutics, who led the startup from inception to a $2.1 billion acquisition by AbbVie through smart fundraising and preclinical CAR-T progress, and Ivana Magovcevic-Liebisch of Vigil Neuroscience, who defied skepticism around TREM2 targets to land a $470 million deal with Sanofi. These women-led exits underscore how effective leadership can navigate scientific risk, investor sentiment, and strategic dealmaking. In an industry where women remain underrepresented in the C-suite, these accomplishments are particularly impactful, showcasing the value of inclusive leadership in generating billion-dollar outcomes.
Obesity in Focus: ADA Reveals R&D Priorities for Blockbusters-in-Waiting
At the 2025 ADA Scientific Sessions, obesity emerged as the central theme, with analysts projecting the weight loss drug market could reach $150 billion annually by the early 2030s. The focus has shifted toward next-generation therapies that go beyond mere fat reduction, emphasizing muscle preservation, improved side effect profiles, and more convenient dosing. Lilly’s orforglipron and bimagrumab drew significant attention, with the latter showing strong fat-selective weight loss in combination with semaglutide. Novo Nordisk responded with updated data on its next-gen amylin asset, amycretin, which showed up to 24% weight loss but raised tolerability concerns. Meanwhile, Zealand Pharma’s dual GLP-1/GLP-2 agonist dapiglutide introduced an inflammation-targeting mechanism, while Scholar Rock’s myostatin-targeting apitegromab demonstrated significant muscle-sparing potential when paired with tirzepatide.
Beyond the marquee names, innovation continues in more targeted or experimental mechanisms. Terns Pharmaceuticals’ TERN-501, a THR-β agonist, showed promising fat loss effects in preclinical models when combined with semaglutide, offering a more liver-selective and potentially safer approach to metabolic modulation. Across these presentations, a new paradigm is taking shape—one where the success of weight loss drugs is increasingly measured not just by pounds shed, but by how well they maintain muscle, minimize side effects, and integrate with other therapies. As this therapeutic arms race intensifies, the obesity drug landscape is poised to expand well beyond GLP-1s, unlocking new market segments and pushing developers to differentiate on mechanism, safety, and long-term health outcomes.
Hengrui’s Dual GLP-1/GIP Elicits 17.7% Weight Loss in Phase III
Hengrui Pharma, in collaboration with Massachusetts-based Kailera Therapeutics, reported positive Phase III results for its dual GLP-1/GIP receptor agonist HRS9531, demonstrating an average weight loss of 17.7% in Chinese patients with obesity. The 567-patient trial met its primary endpoint across all tested doses, with 88% of participants achieving at least 5% weight loss and nearly half reaching 20% weight loss. The treatment was well tolerated, with side effects consistent with other GLP-1 therapies. Based on these results, Hengrui plans to file for regulatory approval in China, while Kailera will initiate global clinical trials exploring higher doses and longer treatment durations.
This milestone marks a key validation for Kailera’s China-first development strategy, launched with $400 million and a pipeline of four obesity-focused programs licensed from Hengrui. Alongside KAI-9531 (the global name for HRS9531), Kailera is advancing a triple-agonist (GLP-1/GIP/glucagon), an oral GLP-1 small molecule, and an oral version of KAI-9531. The company aims to use China as a fast-track engine for clinical proof-of-concept before expanding globally, with these early results now providing compelling evidence to support that model. Full Phase III results will be presented at an upcoming scientific meeting.
The Gaps Between the Administration’s Pro-Innovation Words and Policy
At BIO 2025, government leaders publicly emphasized collaboration and support for U.S. drug developers, but behind the scenes, actions told a different story. Despite FDA Commissioner Marty Makary’s pledge to foster public-private partnerships and streamline regulatory pathways, the abrupt administrative leave of two top FDA officials in gene therapy raised alarm across the life sciences community. These departures, along with prior high-profile exits and deep federal cuts to science funding, have created a disconnect between the administration’s pro-innovation rhetoric and its actual policy decisions. Industry stakeholders have grown increasingly wary as federal support erodes just as companies face prolonged funding scarcity, declining NIH grants, and heightened regulatory uncertainty.
The investment environment has become especially challenging, with critical gaps in leadership, capital, and operational capability threatening the viability of many biotech firms. Nearly five years into a funding drought, companies are downsizing management, scaling back R&D, and struggling to advance programs through late-stage development. State leaders like Massachusetts Governor Maura Healey have called for stronger regional collaboration, but private sector leaders stress that neither VCs nor states can fill the void left by shrinking federal support. Policy threats like Most Favored Nation drug pricing and the passage of the “One Big Beautiful Bill” have compounded pressures, prompting urgent calls for unified advocacy. Without a course correction, biotech’s innovation engine risks long-term damage from both internal attrition and rising global competition.
BMS, Pfizer Join DTC Trend, Offering Eliquis to Patients for 40% Below List Price
Biopharmaceutical corporations Bristol-Myers Squibb (BMS) and Pfizer are planning to sell their blood thinner, Eliquis, at 40% below its list price directly to patients through their patient support program, Eliquis 360 Support. This initiative is designed to reduce out-of-pocket expenses for uninsured, underinsured, and self-pay patients, and is aligned with the industry's growing Direct-to-Consumer (DTC) trend. The two companies currently utilize the Eliquis 360 Support program to offer healthcare education and insurance support to patients, but will expand it to include DTC sales starting on September 8th.
Eliquis was a top-selling drug in 2024 and is one of the initial medications targeted by the Centers for Medicare and Medicaid Services for pricing negotiations under the Inflation Reduction Act. The aim of the DTC sales model is to enhance sales towards the end of a medication's lifecycle; this decision by BMS and Pfizer is reportedly a response to the recent executive order issued by the US President to align US drug costs with those in other developed countries. This DTC move for Eliquis is described by Leerink Partners analysts as "the first non-obesity DTC branded offering of its kind" in the pharmaceutical industry.
AI-Focused Biotech Unicorns Face Chilly Market Where IPOs Aren’t Guaranteed
A growing class of biotech unicorns leveraging AI for drug discovery faces a challenging investment climate where traditional exit strategies like IPOs are no longer assured. While companies like Xaira Therapeutics, Generate:Biomedicines, and Eikon Therapeutics have attracted billions in funding and marquee partnerships, their long-term viability hinges on proving clinical differentiation and maintaining investor confidence. Valuations remain highly speculative, tied to binary clinical outcomes that take years to materialize. With IPO markets effectively frozen, startups must consider alternative exit paths such as private M&A, reverse mergers, or continued private fundraising. In today’s environment, a billion-dollar valuation is more a fragile milestone than a guarantee of enduring success.
Despite the tough backdrop, several AI-driven biotech companies are showing momentum. Xaira, with $1B in launch capital and a $2.7B valuation, is applying generative AI to molecular design but lacks disclosed assets. Generate has forged major partnerships with Amgen and Novartis and is advancing its own clinical programs. Eikon’s single-molecule tracking platform has progressed to a Phase III melanoma asset, while ArsenalBio is building next-gen CAR-Ts supported by Nvidia and Genentech. Other standouts include Alphabet-backed Isomorphic Labs, in-licensing powerhouse Formation Bio, and gene writer Tessera Therapeutics. Yet across the board, these unicorns must now demonstrate that AI can deliver differentiated molecules (not just elegant models) to justify their lofty valuations and secure sustainable exits.
Sarepta Up 18% After Business Overhaul as Analysts Cautiously Optimistic
Sarepta Therapeutics is experiencing a rise in stock rates following a significant business overhaul. This process includes a shift in the pipeline to its siRNA platform assets, a downsizing of around 500 employees, and the addition of a black box warning to its Duchenne muscular dystrophy gene therapy Elevidys due to previous patient deaths. While analysts initially respond with cautious optimism, there is evidence of increased investor confidence in the company's ability to pay off its long-term debts are evident in a 30% increase in stock rates, which are currently trading at $21.65 with an 18% increase. The future of Elevidys seems quite positive according to BMO Capital Markets, pointing out the gene therapy's "ambulatory approval [is] out of the woods.”
This optimistic outlook is slightly tempered by BMO’s warning that the death of a third Elevidys patient could pose a future risk. Nevertheless, they also identify potential growth opportunities, highlighting upcoming results from trials in myotonic dystrophy type 1 (DM1) and facioscapulohumeral muscular dystrophy type 1 (FSHD)—both for siRNA assets—as factors that could attract new or more investors. In the midst of its restructuring, Sarepta has announced sales of $513 million for its entire DMD portfolio in the second quarter. Providing potential reassurance, Jefferies suggests that if Sarepta "can prove the rate of fatal liver [toxicity] can stop creeping higher (and remains confined in non-ambulatory DMD), the Street could have confidence in Elevidys becoming a sustainable $500M+ product - at least in ambulatory DMD.”
Novartis ‘Moving as Fast as Possible’ to Fully Manufacture Key Drugs in US as Tariffs Near
In response to potential tariffs, pharmaceutical company Novartis is hastening its efforts to shift all key drug manufacturing operations for the US market to America, according to CEO Vas Narasimhan. Narasimhan disclosed this during Novartis's Q2 earnings call, which saw the company reporting an 11% year-on-year growth, amounting to just over $14 billion for the quarter. Novartis is investing $23 billion into new US-based ventures and has recently signed a lease for a large-scale research facility in San Diego. The relocation of most drug productions typically takes three to four years.
President Donald Trump earlier warned that pharma tariffs could reach up to 200%, which could be implemented as early as August 1. The tariffs' impact will be significant for Novartis' business, but the exact effects will be determined on a case-by-case basis per product, Narasimhan said. Trump also mentioned a grace period of about a year to a year and a half for pharma companies to adjust their supply chains. Narasimhan voiced hope for consideration from the administration for companies like Novartis making significant investments to shift productions to the US.
CDER Employees Leave FDA in Droves Amid HHS Overhaul
In the first half of 2025, the US Center for Drug Evaluation and Research (CDER) under FDA experienced a significant staff turnover with 385 employees leaving their positions, as compared to under 130 staff leaving in the same period the previous year. The employee exodus comes amidst an underway restructuring process under Health and Human Services (HHS) Secretary Robert F. Kennedy Jr. The overhaul includes eliminating around 10,000 positions across the department and massive consolidation of its branches, with FDA slated to lose about 3,500 posts.
An important event happened last week when the Supreme Court ruled in favor of the government, countering an injunction from a California judge, and greenlit the ongoing reorganisation of HHS. Following this, HHS started the process of laying off workers, some of whom had already received email notifications about their termination. It is estimated that the total HHS workforce will reduce by about 20,000 employees, including the probationary staff dismissed in February and individuals who chose to resign following buyout offers. However, more recently, the department has been backtracking on several hundreds of these layoffs, with Kennedy admitting that over 2,000 workers were wrongly dismissed.
Patients Fight for Access to BrainStorm’s ALS Drug After Expanded Access Data ‘Defy Logic’
Patients trialling BrainStorm's Cell Therapeutics’ NurOwn have filed a Citizens’ Petition with the FDA demanding a new review of the stem cell therapy after it was rejected in 2022, based on real-world data showing 90% survival in an expanded access program. In an email to BioSpace, lead petitioner Nick Warack, an ALS sufferer, claimed the recently published expanded access program (EAP) data for NurOwn demonstrates a dose-dependent response that enhances the impressive results observed from three doses in the phase 3 trial. Warack highlighted that in the EAP, nine out of ten phase III participants survived for more than five years. BrainStorm announced these findings in a June 2026 press release.
Despite its Biologics License Application being rejected by the FDA in 2022, BrainStorm secured a follow-up meeting the next year, during which the therapy was once again dismissed, this time by advisors who voted 17-1 against its approval. As a result, the company withdrew its BLA ahead of its December 2023 PDUFA date. These events have potentially delayed the therapy by several years. BrainStorm is now attempting to garner funding for a Phase IV trial, marking a significant setback after showing such promising results.
Sarepta Tags DMD Gene Therapy Elevidys With Black Box Warning, Axes 500 Staff
Following the death of two teenage patients due to acute liver injury after undergoing treatment with Duchenne muscular dystrophy gene therapy, Elevidys, Sarepta Therapeutics has added a black box warning to the gene therapy and also parted ways with more than a third of its employees. Despite facing two fatalities linked to Elevidys, Sarepta will be focusing more on its "high-impact programs" and prioritising "potentially best-in-class siRNA platform assets". Among these are programs for facioscapulohumeral muscular dystrophy, idiopathic pulmonary fibrosis and Huntington's disease, with plans to pause several other programs, including most gene therapies in development for limb-girdle muscular dystrophy (LGMD).
Sarepta's issues with Elevidys started in March when a patient undergoing the treatment died due to acute liver failure, a known adverse effect of adeno-associated virus (AAV) vector–based gene therapies. Even after this incident, the company persisted that Elevidys' benefit-risk ratio remained positive. However, when a second teenage patient died in June, also from acute liver failure, Sarepta acknowledged the need for strategic changes. As part of these changes, it announced a significant layoff of around 500 employees, as part of a move expected to generate about $120 million in annual cash cost savings in 2026 and approximately $300 million in annual non-personnel cost savings from next year due to pipeline reprioritisation.
J&J Targets $50B Oncology Sales By 2030: Updated
Johnson & Johnson (J&J) has exceeded analyst expectations by reporting second-quarter earnings of $23.7 billion. This substantial profit was primarily generated by the company's cancer and neuroscience drugs. J&J's CEO Joaquin Duato has set an ambitious goal to reach $50 billion in oncology sales by 2030. The company's oncology and neuroscience divisions were the primary forces driving medicine sales up by 4.9%, effectively offsetting pressures on other areas of the business.
The New Jersey-based pharmaceutical company declared global sales of $23.7 billion and diluted earnings per share of $2.29. J&J's medicine unit accounted for $15.2 billion of these sales, while medtech products contributed the remaining $8.5 billion. Both units surpassed analysts' consensus estimates. The company's medicine sales were reported to be 4% above expectations. J&J attributes this success to a broad set of products that drove the growth of their pharmaceutical unit. Standout performers were the Oncology and neuroscience divisions, which benefited from market share gains for multiple high performing drugs. J&J plans to grow oncology sales to $50 billion by 2030.
Vinay Prasad Overruled Reviewers on Moderna’s COVID-19 Shot for Kids
Vinay Prasad, director of the FDA’s Center for Biologics Evaluation and Research, publicly diverged from the FDA reviewer consensus about the Moderna’s COVID-19 vaccine, Spikevax, for children. While applications had been presented for the vaccine to be approved for all children between six months to 11 years, Prasad approved it exclusively for children within that age range who have at least one pre-existing condition that could heighten their risk of severe COVID-19 outcomes. He justified this narrow approval on the grounds that Moderna has not demonstrated a reduction in severe COVID-19 consequences such as hospitalization, ICU stays, or death in randomized studies involving children.
Prasad noted that severe COVID-19 outcomes among children are "extremely low" and have actually decreased. Moderna has also yet to provide high-quality evidence that COVID-19 immunization reduces long-term consequences of the disease or transmission in any setting, at any age, or that vaccinated children miss fewer school days. Prasad emphasized that the FDA only approves products when benefits confidently outweigh risks, and he argued that there isn't substantial certainty of the benefits outweighing risks for healthy children using Moderna's vaccine. This marks the third occasion Prasad unilaterally decided on drug approvals, earlier overriding FDA reviewer recommendations on Novavax’s Nuvaxovid and Moderna’s next-gen shot MNEXSPIKE—both COVID-19 vaccines.
Moderna’s latest approval again reveals FDA rift over COVID vaccines
Vinay Prasad, the head of the FDA's office that controls vaccines, has overruled other agency reviewers for a third time, restricting the use of Moderna’s COVID-19 vaccine, SpikeVax, in young children. According to a recently released FDA memo, the approval for Spikevax has been limited to children aged 6 months to 11 years who are at an increased risk of COVID-19. Prasad disagreed with other reviewers' assessments and expressed doubt about the vaccine's benefits in healthy children.
Before his appointment as head of the FDA’s Center for Biologics Evaluation and Research, Prasad had voiced concerns about using COVID vaccines in children and had disagreed with many decisions made by his predecessor, Peter Marks. Since taking up his new role, Prasad, alongside Commissioner Martin Makary, has implemented stricter guidelines for approving COVID vaccines and has overruled other staff members three times in decisions dealing with COVID vaccines developed by Moderna and Novavax. Prasad's critics include companies who argue that he has recommended narrower use of their vaccines than they had requested.
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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Tuesdays: Biotech
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