Biotech & Life Sciences
Ionis Tryngolza Wins FDA Approval, Expands to 3.6 Million Patients
Ionis Pharmaceuticals submitted a label expansion and the FDA said yes. Replimune has now been rejected twice on the same melanoma drug and just got the FDA to accept a third attempt, this time with an advisory committee meeting attached. One company is celebrating a smooth approval. The other is celebrating an agency that will…
Boundless Bio Stock Up 87% on Failed Drug and Reverse Merger Deal
Boundless Bio’s cancer drug did not work. The company is cutting three-quarters of its staff. Its stock went up 87%. Boundless Bio Hands Control to a Private Gene-Editing Startup After Its Lead Drug Fails On June 22, Boundless Bio (Nasdaq: BOLD) signed a definitive merger agreement with Serapha Bio, a privately held company developing a…
GRI Bio Won Orphan Drug Status the Same Day MAIA Opened a Third Cancer Trial Site
GRI Bio’s stock is down 94% over the past year. On June 18, the FDA handed it seven years of potential market exclusivity. The same day, across the industry, a different small-cap was quietly opening its third US trial site for a lung cancer drug nobody outside biotech circles has heard of. Regulatory wins and…
Pancreatic Cancer Trial Ahead of Schedule, Gastric Cancer Fast Track Win
A drug called givastomig produced a 77% response rate in gastric cancer. The stock trades 71% below its 52-week high. Sometimes the data and the price tell two different stories. AIM ImmunoTech Doses Final Patient in Phase 2 Pancreatic Cancer Trial Ahead of Schedule AIM ImmunoTech (NYSE American: AIM) had a busy stretch in the…
Auvelity FDA Approval Launches the First Non-Antipsychotic Market for Alzheimer Agitation
Roughly 39 million people live with HIV. Most of them are on treatment. A large proportion of those people are aging, developing comorbidities, accumulating drug resistance, and managing the complexity of multi-tablet regimens that have kept the virus suppressed but come with their own set of problems. Gilead Sciences has a drug in FDA review…
Pancreatic Cancer Phase 3 Starts, Ovarian Cancer Phase 1 Wins
51,000 Americans will be diagnosed with pancreatic cancer this year. Roughly 45,000 will die from it. The five-year survival rate has not meaningfully changed since 2000. On June 11, a company called Immuneering dosed its first Phase 3 patient. Immuneering Corporation Doses First Patient in Phase 3 MAPKeeper 301 Pancreatic Cancer Trial Immuneering Corporation (Nasdaq:…
What the FDA’s Mixed Regulatory Signals in 2026 Mean for Smaller Biotechs
The FDA did not produce a landmark approval this week. What it produced was something arguably more useful for investors watching the sector: a clear picture of where the regulatory environment is heading and what that means for the companies positioned inside it. A June 30 PDUFA date for a second major indication from one…
Three Cancer Drug Programs Advanced This Week and Nobody Noticed
MAIA Biotechnology got FDA clearance to open US enrollment for its Phase 2 lung cancer trial on June 3. ADC Therapeutics released Phase 3 data confirming ZYNLONTA extends progression-free survival in lymphoma the same day. Verastem got an FDA Fast Track for its KRAS G12D inhibitor in lung cancer the day after. Three different companies,…
Datroway TNBC Approval and the ADC Platform Sweep That Is Reshaping Oncology
The FDA had a productive week. Two ADC approvals from the same partnership in two weeks. A Phase 3 trial in a rare skeletal disorder with no approved treatment. A Breakthrough Therapy Designation in a market already served by two blockbusters. And the first oral drug approved to prevent COVID-19 after exposure. None of these…
Ivonescimab posted a 34% survival benefit at ASCO — the FDA decides in November
ASCO week closed with one result that changed the conversation about lung cancer. Ivonescimab cut the risk of death by 34% in squamous NSCLC. The data landed in a Plenary Session. It was published simultaneously in The Lancet. It was the first time in the 61-year history of ASCO that a China-originated drug has been…
