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Biotech catalyst, news and analysis PDUFA tracker
Biotech catalyst, news and analysis PDUFA tracker
Merlintrader Regulatory Deep Dive · July 13, 2026 FDA U-Turns: Moderna $MRNA, Sarepta $SRPT and uniQure $QURE Lead a Year of Regulatory Reversals Six major cases — including Regenxbio, Replimune and Valneva — show how quickly a drug review, safety…
Off-label economics explained with Outlook Therapeutics ($OTLK): why the most-used wet AMD treatment costs $50 and is not approved, while approved alternatives cost twenty times more. FDA PDUFA July 29, 2026.
An accessible three-act explainer using ImmunityBio ($IBRX) and its bladder-cancer drug Anktiva to show why FDA approval is only the starting line: the human stakes, the commercial launch curve, and who controls the company.
Macro & Markets Editorial Oil Shock Returns: Trump, Iran and the Fed Put Wall Street’s Summer Rally Under Pressure The renewed battle over the Strait of Hormuz is no longer only a geopolitical story. It is an inflation story, a…
Beyond ReWalk: Public Exoskeleton and Neurorehabilitation Companies | $LFWD $MYO $CHRN $APLD Merlintrader Sector Deep Dive · Medical Robotics · Wearable Technology · Neurorehabilitation Beyond ReWalk: The Public Companies Competing for the Future of Exoskeletons and Neurorehabilitation — $LFWD $MYO…
Biotech Radar July 13, 2026 $SNY $GH $PHVS Three-name biotech watch Biotech Radar July 13, 2026: Sanofi ($SNY), Guardant Health ($GH) and Pharvaris ($PHVS) Three distinct healthcare setups define today’s watch: a first-of-its-kind oncology delivery approval, a competitive read-through in…
Week two of the DEA marijuana rescheduling hearing: Dr. Kenneth Finn's testimony, the Tennessee Bureau of Investigation, the July 13-15 final stretch, and the non-binding path to a Schedule III Final Rule - and what it means for $MSOS, $TLRY, $CGC and $ACB.
A plain-English guide to the economics of reusable rockets: why refurbishing beats rebuilding, how cost-per-kg collapsed, where SpaceX ($SPCX), Blue Origin, China's Long March 10B and Rocket Lab ($RKLB) sit on the reuse ladder, a reusable triage for launch news, and what China's first booster catch does and doesn't change. Educational, not investment advice.
An educational guide to the AI optical interconnect stack - switch silicon, lasers, modulators, optical engines and modules - using POET Technologies (POET) as the highlighted optical-engine example.
Why space stocks pulled back in July 2026: profit-taking after a huge run, capital rotating to the newly public SpaceX, insider selling at Rocket Lab, the Rocket Lab-Iridium deal and the company-specific Planet Labs case. Educational, no recommendations.
Insider trading this week (July 6-10, 2026): the 20 biggest open-market buys and 20 biggest sells by dollar value, with names, tickers, amounts and next catalysts. Educational, no recommendations.
Today’s radar compares three very different catalyst structures: Chemomab’s proposed merger with Scipher Medicine and shift toward AI-guided rheumatoid arthritis development, CervoMed’s completed Phase 2a enrollment in nonfluent variant primary progressive aphasia, and AtaiBeckley’s completion of dosing in the VLS-01 Phase 2b Elumina trial ahead of a Q4 2026 topline readout.
Obesity drugs radar: Viking ($VKTX), Structure ($GPCR) and Skye ($SKYE) — three clinical-stage weight-loss stocks, their trials, cash positions and 2026 catalysts, with the Novo/Lilly landscape as context.
Mesoblast ($MESO) Deep Dive: Ryoncil Hits $36M in Q4 and $115M in FY2026 Merlintrader Deep Dive Published / updated: July 10, 2026 Biotech / Cell Therapy / Commercial Launch Analysis Mesoblast ($MESO) Deep Dive: Ryoncil Hits $36M in Q4 and…
Ionis and AstraZeneca’s CARDIO-TTRansform trial did not meet its primary endpoint in transthyretin-mediated amyloid cardiomyopathy. The result does not erase Wainua’s existing polyneuropathy franchise, but it changes the near-term ATTR-CM competitive map and puts Alnylam and BridgeBio back at the center of investor attention.
Immunome (Nasdaq: IMNM) deep dive: the FDA accepted the varegacestat NDA for desmoid tumors with an April 28, 2027 PDUFA date, backed by strong Phase 3 RINGSIDE data, 82.7M cash and a broader ADC pipeline.
Penguin Solutions has moved from the old SMART Global Holdings identity into a more focused AI infrastructure story. The market is no longer looking at PENG as a simple memory-cycle name. It is looking at a company trying to sit at the intersection of accelerated compute, advanced memory, AI cluster software, deployment services and enterprise-scale AI factory buildouts.
Biotech radar: Vertex to acquire Crinetics ($CRNX) for ~$10B, Seres ($MCRB) posts an early 80% Day 15 SER-155 signal in checkpoint-inhibitor enterocolitis, and OKYO ($OKYO) moves urcosimod to Phase 3 NEPTUNE after FDA Type D feedback.
Oil surged over 6% and energy stocks jumped after the U.S.-Iran framework broke down and Iranian oil sanctions returned. The Strait of Hormuz premium puts Chevron ($CVX), Exxon Mobil ($XOM) and Occidental ($OXY) back in focus.
The July cannabis trade is no longer about a simple “rescheduling soon” headline. It is about the administrative record being built inside the DEA hearing room: medical use, abuse potential, dependence profile, public-safety arguments, product-standardization attacks, impaired-driving concerns and the litigation path that may follow any final Schedule III decision.