Good day, my nacho-powered news hounds,
This week, it’s all about timing and takeovers, with a touch of taco-fueled inspiration. Merck bags SpringWorks at a discount, Stealth Biotherapeutics is left in limbo after the FDA misses its verdict deadline, Krystal Biotech’s new gene therapy for a rare skin condition gets the green light, the Taco Bell Foundation helps launch the next generation of biotech talent, and yeast hitches a ride into orbit to test in space-based protein production.
That’s a wrap!
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💸 Germany's Merck KGaA in $3.9 billion deal to buy US biotech firm SpringWorks (Reuters): The German pharma giant patiently waited for SpringWorks to secure both US approval and favourable European opinions on their cancer treatment OGSIVEO® (nirogacestat) before swooping in for the deal. With a $3.4 billion enterprise value, after cash deductions, the purchase landed a whopping 20% below analyst expectations – a bargain which CEO Garijo attributes to the dearth of competing bidders, and the rather gloomy state of the US biotech sector.
Our take: After SpringWorks did all the regulatory heavy lifting, Merck has slipped in with their chequebook at precisely the right moment. And considering their spectacular pipeline flops with xevinapant and evobrutinib, these already-approved treasures were exactly what Merck needed. We’re increasingly seeing big pharma sidestepping early R&D gambles in favour of post-approval deals…cheaper, safer, and still potentially lucrative – if you act fast enough!
⌛ FDA misses approval deadline for biotech’s rare disease drug (BioPharma Dive): Stealth BioTherapeutics is still waiting on a verdict for elamipretide, its Barth syndrome treatment, after the FDA missed its April 29 decision deadline. This marks the second time the company has pursued approval. Its 2021 attempt was rebuffed due to concerns over clinical efficacy and was since granted a priority review. The delay follows January’s request for more data, and broader FDA staffing cuts...
Our take: Talk about dreadful timing for Stealth! With regulatory bigwigs Peter Marks and Peter Stein packing their FDA lunchboxes, rare disease companies have lost those internal champions who understood their peculiar challenges. Big pharma giants can simply shrug off these delays, while smaller players watch their funding shrink alarmingly. Investors might need to start factoring ‘FDA delay insurance’ into their valuations…
🦠 Krystal Biotech secures EC approval for Vyjuvek to treat rare genetic disorder (World Pharmaceuticals): Europe has just given the nod to the first corrective treatment tackling dystrophic epidermolysis bullosa, a painful skin-blistering condition. This clever gene therapy hitches a ride on modified herpes viruses to deliver functional COL7A1 genes right where they’re needed, addressing the root cause rather than just managing symptoms. Rather brilliantly, Vyjuvek can be administered either at home or in clinics, which is rather flexible for a gene therapy!
Our take: A gene therapy that ditches the drips and hospital stays? Now that’s progress. Vyjuvek’s topical delivery could pave the way for decentralised gene therapy protocols, especially for chronic, low-prevalence conditions where access barriers loom large. For developers of rare diseases hoping to balance clinical efficacy with real-world usability, this might just be the blueprint to watch.
🔔 Taco Bell Foundation awards $14 million in Live Más Scholarships, including support for future biotech innovator (EdTech Innovation Hub): The foundation has shared an impressive $64M to over 3,000 students nationwide since launching its scholarship program. This year's recipients include aspiring food scientists, emergency physicians, and engineers with $4.5 million going to Taco Bell employees. Among them is Uriel, whose pursuit of biomedical engineering was inspired by his brother losing a leg during a tornado and dreams of designing better prosthetics.
Our take: Well, this is rather refreshing! While biotech traditionally fishes for talent in the same elite academic ponds, the Live Más approach casts a wonderfully wider net. Uriel's journey represents the kind of diverse thinking the sector thrives on. If we want tech to reflect the realities of those it serves, we’ll need more Uriels: minds shaped by hardship, driven by empathy, and quietly building a better future.
And finally…
🚀 Yeast on the final frontier (European Biotechnology Magazine): Imperial College London has launched a tiny orbital laboratory testing yeast-based protein production in space. With astronaut feeding costing £20k daily, hauling supplies from Earth won't work for deep-space missions. The experiment utilises precision fermentation, which is already being used to create dairy-free milk and animal-free meat terrestrially. Post-mission, researchers will study how launch stresses, microgravity, and cosmic radiation affected these microscopic astronauts.
Our take: If successful, this could mark the start of decentralised food biomanufacturing – think more Star Trek replicator, less cold-chain fridge. The UK has rather cleverly positioned itself at this frontier, testing how microbes behave in orbit while laying groundwork for nutrient production systems independent of Earth. For deep space missions and remote terrestrial settings alike, precision fermentation may become a cornerstone of both survival and sustainability. Beam up that protein shake, Scotty!
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🇨🇭5-6.05 | Swiss Biotech Day 2025 | Basel, Switzerland: A large-scale networking event for life science professionals, featuring exhibitors, startups, and discussions.
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👩🏻💻 14.05 | Women in Biotech | Edinburgh, UK: Join this networking event and conversation at the Royal College of Physicians to discuss the findings on the recent report on Women in biotech leadership.
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