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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Week of August 10, 2026
For the week, the public indexes were MIXED, with the S&P +0.4% & DOW moving -0.6%. For the year both remain UP +13.5% and +11.1% respectively. The XBI (the biotech index) comes in UP +0.0% for the week and remains +29.7% for the year.
This week in biotech saw significant regulatory developments, major asset sales, and continued momentum in oncology and rare disease therapies. Notable FDA actions included the first approval of a CELMoD drug for multiple myeloma and ongoing review discussions for Duchenne muscular dystrophy cell therapy. Asset sales and licensing deals reshaped the gene therapy landscape, while new clinical data in lung cancer and financing moves in hematology highlighted the sector’s competitive dynamics. Additionally, industry trends pointed to growing interest in psychedelic therapies and regional biotech hub development.
FDA Approval
Bristol Myers Squibb received FDA approval for Zenbexus, the first CELMoD (cereblon E3 ligase modulator) drug for multiple myeloma. The approval marks a regulatory and therapeutic milestone for the company, which acquired the asset through its purchase of Celgene.
This approval introduces a new class of protein-degrading medicines for multiple myeloma, potentially revitalizing Bristol Myers’ oncology franchise and offering new treatment options for patients with this challenging cancer.
Regulatory/Compliance
European regulators revoked the marketing authorization for Amgen’s rare disease drug Tavneos after uncovering serious breaches in the pivotal clinical trial, including unblinded data access and post-hoc data changes that were not disclosed to authorities. The study’s integrity was deemed compromised, leading to the conclusion that the results were unreliable.
The decision raises significant concerns about data integrity and oversight in rare disease drug development. It also puts Tavneos under continued scrutiny in the U.S., where the FDA has requested its withdrawal, and highlights the importance of transparent clinical trial conduct.
Clinical Data
Taiho and Cullinan announced positive Phase 3 results for zipalertinib in non-small cell lung cancer with EGFR exon20 mutations, positioning the drug as a strong competitor to existing therapies.
The data set a new benchmark for EGFR exon20 therapies and may shift the competitive landscape in targeted lung cancer treatments, offering patients additional options.
M&A/Asset Sale
Sangamo Therapeutics, in bankruptcy proceedings, agreed to sell its Fabry disease gene therapy to PTC Therapeutics and its prion disease program and technology platforms to Eli Lilly for a combined $161 million. The sales followed a court-approved bidding process and are pending final court approval.
These transactions reshape the gene therapy and neurodegeneration pipeline landscape, allowing PTC and Lilly to expand their portfolios while Sangamo seeks to address its financial challenges.
FDA Review/Regulatory
Capricor Therapeutics announced that the FDA is open to reviewing new data and may extend the review period for its Duchenne muscular dystrophy cell therapy, deramiocel. The company plans to submit additional analyses and open-label extension data following a mixed advisory committee outcome.
The FDA’s willingness to consider amendments signals regulatory flexibility for high-need rare disease programs. The outcome will be closely watched as it could impact future cell therapy approvals in neuromuscular diseases.
Financing/Deal
Zealand Pharma sold most of its milestone and royalty rights to the investigational polycythemia vera drug rusfertide to Royalty Pharma for up to $100 million, retaining only a small royalty on sales above $1.5 billion.
The deal reflects ongoing investor interest in hematology assets and suggests confidence in rusfertide’s commercial potential, with analysts noting the terms may indicate underappreciated market prospects.
Licensing/Deal
PTC Therapeutics licensed Sangamo’s late-stage Fabry disease gene therapy, isaralgagene civaparvovec, in a deal viewed as a high-risk, high-reward bet by analysts. The therapy is nearing a potential regulatory filing.
This move gives PTC a potentially differentiated asset in the rare disease space and underscores the strategic importance of late-stage gene therapies for companies seeking near-term growth.
Industry Trends
New government funding is fueling competition among U.S. regions, from Pennsylvania to Kansas City, to establish themselves as biotech hubs. However, experts caution that funding alone will not determine future industry growth locations.
The trend could reshape the geographic distribution of biotech investment and innovation, influencing where companies choose to build and expand operations in the coming years.
Regulatory/Clinical
Taiho and Cullinan’s zipalertinib met its primary endpoint in a Phase 3 trial for advanced non-small cell lung cancer with EGFR exon20 mutations. The drug is already under FDA review for previously treated patients, with a decision expected by February, and the new data may support a first-line indication.
The results reinforce zipalertinib’s potential as a first-line therapy and highlight ongoing advances in targeted lung cancer treatments, with implications for patient care and market competition.
Market Access/Trends
Manufacturers of MDMA and psilocybin from countries with more permissive regulations, such as Australia and Canada, are preparing to enter the U.S. market as policy support and commercial interest in psychedelic therapies grow. Companies are investing in manufacturing infrastructure and aligning with FDA standards in anticipation of regulatory changes.
This activity reflects the increasing mainstream acceptance of psychedelic therapies for mental health and the potential for international players to shape the emerging U.S. market, though regulatory and logistical hurdles remain.
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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:
Mondays: Stocks
Tuesdays: Biotech
Wednesdays: Podcast
Thursdays: Markets
Fridays: News
Saturdays: Podcast
Sundays: Strategy
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As a reminder, the purpose of the BowTiedBiotech substack is two-fold. Primarily, we aim to provide our scientist audience the tools to build a biotech company and ultimately translate their ideas into medicines for patients. Secondarily, biotech investors may find this substack useful as we will be providing weekly market updates of the public AND private markets as well as heavily leveraging current financing events as teaching examples.
DISCLAIMER
None of this is to be deemed legal or financial advice of any kind. All updates are sourced from publicly available disclosures. Insights are *opinions* written by an anonymous cartoon/scientist/investor.
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