Biotech & Life Sciences
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…
Biotech Weekly: Lung Cancer Data, Emerging Stock Drug Launch, Stroke Trial
Three biotech stories this week that most people missed. A clinical-stage oncology company posted Phase 2 lung cancer data that sent its stock up 16% and earned an ASCO podium. A under-the-radar stock with a real FDA-approved product secured national pharmacy coverage and launched a real-world evidence study. And a micro-cap developing a stroke drug…
Enhertu Double Approval, Regeneron Miss: What It Means for Smaller Biotechs
Two FDA decisions landed on the same Monday and pulled the sector in opposite directions. AstraZeneca and Daiichi Sankyo’s Enhertu picked up two new approvals in early breast cancer. Regeneron dropped 12% after its melanoma trial missed statistical significance against Keytruda. One validated a platform that smaller biotechs are actively building on. The other confirmed…
Biotech & Health Weekly: FDA Loses Its Commissioner
Marty Makary resigned on May 12. Three of the FDA’s top drug review positions are now held by acting officials. All three have a 210-day time limit under federal law before the White House has to make a decision on who fills them permanently. That did not slow the calendar. ENHERTU got a landmark approval…
How LOTTE Biologics Plans to Become a Top-Ten Global Biomanufacturing CDMO
LOTTE Biologics did not exist four years ago. Today it is operating a 40,000-litre biomanufacturing campus in New York, running a dedicated antibody-drug conjugate facility, breaking ground on a $3.3 billion manufacturing campus in South Korea, and expanding its second antibody manufacturing agreement with a clinical-stage biotech targeting dual-paratopic cancer immunotherapy. The pace is intentional.…
