Hey, Welcome back to SKim Insights.
Last week we covered Anthropic's pivot into biotech. This week, the FDA itself just moved. Let's get into it.
🔬The Big Story
The FDA Just Launched Real-Time Clinical Trials.
The FDA announced a first ever pilot program that allows clinical trial data to proceed directly to regulators in real time.
Why is this such a big deal?
For over 60 years, clinical trials have ran the same exact way. Data gets collected at trial sites and sent to the pharmaceutical company. Then, it gets analyzed internally and submitted to the FDA. The entire process is incredibly slow and full of lag. A Phase 2 trial that might take a couple of years could have its major safety signal identified in month three, but no one outside the sponsor knows until the final submission comes through.
The FDA announced two prototype trials are already live. AstraZeneca is running a Phase 2 trial called TRAVERSE for mantle cell lymphoma with participation from MD Anderson and the University of Pennsylvania. Amgen is running STREAM-SCLC, a Phase 1b trial for small cell lung carcinoma. Both are transmitting safety and efficacy green light to the FDA in real time as the trials run.
My Take
However, it is way more exciting than some humdrum headline that says, "FDA modernizes data collection."
Real-time trials mean the FDA can flag a safety signal in week five or six instead of year two. This compresses the entire back and forth that currently swamps drug development timelines. AI-native biotechs are already hitting Phase 1 success rates of 80–90% compared to the industry average of 40-65%.
Wait, but what does this do to the drug development business model? If trials get shorter (and faster) and feedback loops are tighter and more controlled, the companies built around managing long trial timelines (like the traditional CROs and legacy data management firms) will face a structural threat. The companies that have been built for speed and agility like Formation Bio (so called “disruptive innovation”) suddenly look even more prescient.
🗓️ Upcoming Deadlines (AI & STEM Fellowships)
Anthropic STEM Fellows Work directly with frontier AI researchers at Anthropic. No ML background required. Based in San Francisco, project-based (a few months)
Paradigm Fellowship 2026 For builders & researchers at the frontier of crypto + decentralized tech. Program dates: Aug 12–15, 2026
O'Shaughnessy Fellowship Global fellowship for unconventional builders & independent thinkers. Fellows across 6 continents (no traditional path required.) Paid, early-career focused.
Astra Fellowship Constellation Institute. Fully funded 5-month in-person AI safety fellowship. Covers housing, travel, meals, and visa.
Pace Research Fellowship 4-week paid summer residency in NYC. For researchers at the intersection of compute, economics & the physical world.
📈 MARKET WATCH
The Biotech IPO Window Is Back Open
After a drought in March, biotech IPOs are surging again this week!
Seaport Therapeutics (SPTX) is targeting up to $212 million in its Nasdaq IPO, pricing expected April 30. Its lead asset is GlyphAllo, an oral treatment for major depressive disorder developed using its proprietary Glyph platform, which is designed to bypass liver metabolism and improve bioavailability of neuropsychiatric drugs.
Hemab Therapeutics (COAG) is also targeting around $180 million. Their goal is to become "the ultimate clotting company." Its lead asset sutacimig is a bispecific antibody for Glanzmann thrombasthenia, a rare bleeding disorder with no existing subcutaneous treatment.
Kailera Therapeutics (KLRA) — the obesity biotech that raised $600 million in Series B just months ago is now seeking upwards of $500 million in its Nasdaq IPO, selling 33.3 million shares at $14–$16 each.
QUICK HITS
Other stories worth knowing about this week:
Formation Bio licenses a Chinese autoimmune drug for up to $500M — Formation Bio brought in FHND5032 from Jiangsu Chia Tai Feng Hai, an oral anti-inflammatory for autoimmune diseases, housing it under a new subsidiary called Kenmare Bio with plans to enter the clinic in 2026.
AI clinical trial success rates are validating the hype — PitchBook predicts AI will nearly double investigational new drug application success rates while reducing timelines and costs. Faster validation cycles mean VC firms can recycle capital into new companies sooner.
GSK pays $50M upfront to license an AI foundation model — Noetik, which builds foundation models trained on human data to predict cancer outcomes, struck a five-year licensing deal with GSK in what its co-founder called "one of the first true foundation model licensing deals in biotech." This is the SaaS-ification of drug discovery.
💼 HOT BIOTECH & HEALTH JOBS THIS WEEK
Seaport Therapeutics — Clinical Program Manager Location: Boston, MA Why it's hot: IPO pricing this week. Getting in pre-IPO at a well-funded neuropsychiatry startup with a Karuna co-founder at the helm is a rare window.
Hemab Therapeutics — Medical Science Liaison Location: US (Remote-friendly) Why it's hot: Also IPO-ing this week. Rare bleeding disorders are a high-value, lower-competition therapeutic area.
Noetik — ML Research Scientist Location: San Francisco, CA Why it's hot: Just closed a landmark $50M foundation model licensing deal with GSK. Ground floor of a company building the "infrastructure layer" of cancer drug discovery.
📖 WORD OF THE WEEK
Real-Time Clinical Trial (RTCT) — A trial in which safety and efficacy data flows directly and continuously to the FDA as it's generated, rather than being collected, analyzed, and submitted in batch after the trial concludes.
This is Issue 02! If this was useful, forward it to one person in biotech, pharma, or finance who would find it interesting.
See you next week.