Daily Briefing – May 13: biotech FDA catalysts, space-defense earnings and AI execution risk keep the high-beta tape active

The May 13 setup remains concentrated in the same high-beta lanes that have dominated the last several sessions: space-defense, drones, AI software, biotech catalysts and cannabis policy. The space basket is still being judged through recent Q1 results, with Rocket Lab reporting record quarterly revenue of $200.3 million, record backlog of $2.2 billion and Q2 revenue guidance of $225 million-$240 million. Redwire remains active after Q1 revenue rose 57.9% year over year to $97.0 million, while BlackSky keeps the space-AI theme alive after Q1 revenue of $20.8 million and raised 2026 revenue guidance to $130 million-$150 million. Kratos continues to support the defense tape with Q1 revenue of $371.0 million, a 1.6x book-to-bill ratio and increased FY2026 guidance, while Red Cat remains in the drone watchlist after reporting Q1 revenue of $15.5 million, up 849% year over year. In biotech, the calendar is getting more interesting: Capricor’s deramiocel BLA remains under active FDA review with an August 22, 2026 PDUFA date, Coya received FDA Fast Track designation for COYA 302 in ALS, MoonLake reported a positive final pre-BLA meeting with the FDA for sonelokimab in hidradenitis suppurativa, Compass Pathways has May 13 Q1 results and Omeros is scheduled to report Q1 results after the close. Cannabis remains policy-sensitive after the Federal Register notice set the DEA marijuana rescheduling hearing to begin June 29, 2026 and conclude no later than July 15, 2026.

Main single-stock stories
  • CAPR— Capricor remains one of the cleaner FDA-calendar watches after confirming deramiocel is under active FDA review with an August 22, 2026 PDUFA datePDUFA
  • COYA— Coya Therapeutics received FDA Fast Track designation for COYA 302 in ALS, adding a fresh regulatory headline to the neurodegeneration watchlistFDA
  • MLTX— MoonLake reported a positive final pre-BLA meeting with FDA and expects to submit the BLA for sonelokimab in HS at the end of September 2026Biotech
  • CMPS— Compass Pathways is on watch with Q1 results and a May 13 conference call, keeping psychedelic-treatment catalysts in the healthcare rotationEarnings
  • OMER— Omeros is scheduled to report Q1 2026 results after the close, with investors focused on recent developments, cash runway and pipeline executionEarnings
  • RKLB— Rocket Lab remains the space-basket leader after record Q1 revenue of $200.3 million, record backlog of $2.2 billion and Q2 guidance of $225 million-$240 millionSpace
  • RDW— Redwire reported Q1 revenue of $97.0 million, up 57.9% year over year, with gross margin improvement and continued defense-space demandSpace Defense
  • BKSY— BlackSky stays in the space-AI lane after Q1 revenue of $20.8 million and raised 2026 revenue guidance to $130 million-$150 millionSpace AI
  • KTOS— Kratos reported Q1 revenue of $371.0 million, a 1.6x book-to-bill ratio, backlog of $2.01 billion and higher FY2026 guidanceDefense
  • RCAT— Red Cat remains in the drone tape after Q1 revenue of $15.5 million, up 849% year over year, with traders now watching production scale and marginsDrones
Macro & tape pressure
  • FDA calendar is crowded— CAPR, MLTX, COYA, ZYME, LEQEMBI IQLIK and UNCY keep regulatory timing at the center of the biotech tapeFDA
  • Biotech earnings matter again— CMPS, OMER and other Q1 updates are being read less for accounting numbers and more for cash runway, catalyst timing and execution clarityBiotech
  • Space is now an execution trade— RKLB, RDW and BKSY have strong thematic support, but investors are separating real backlog, funded demand and margin progress from pure space hypeSpace
  • Defense backlog is being repriced— KTOS, RCAT, ONDS, AVAV and BBAI remain tied to whether orders convert into revenue, margin expansion and stronger cash-flow visibilityDefense
  • AI remains selective— SOUN and BBAI still have real revenue stories, but the tape is watching organic growth, acquisition integration, backlog quality, dilution and lossesAI
  • IPO window is open, not easy— Odyssey and HawkEye show demand for clear thematic offerings, but the market is still strict on valuation, liquidity and near-term executionIPO
  • Cannabis policy remains live— The DEA marijuana rescheduling hearing is scheduled to begin June 29, 2026, keeping TLRY, CGC, CRON, MSOS and IIPR on watchCannabis
Themes & rotation
  • Biotech catalyst trading is heating up— CAPR, COYA, MLTX, ZYME, UNCY, CMPS and OMER give traders a mix of PDUFA dates, FDA designations, BLA planning, earnings calls and balance-sheet questionsBiotech
  • Space-defense still leads— Rocket Lab, Redwire, BlackSky and HawkEye keep the public-market space theme focused on launch, satellite infrastructure, space intelligence and defense demandSpace
  • Drones are becoming a core defense lane— Red Cat, Kratos, Ondas and AeroVironment keep the rotation focused on unmanned systems, tactical procurement and battlefield technologyDrones
  • Backlog quality matters— The strongest stories now need more than backlog headlines: traders want funded work, revenue conversion, margin improvement and cash disciplineQuality
  • Small-cap AI is under a stricter filter— SOUN, BBAI, CXAI and related software names remain active, but losses, integrations and organic growth are being judged more aggressivelyAI
  • Policy-sensitive trades stay alive— Cannabis remains tied to the June 29 DEA hearing, while defense and space names remain sensitive to federal budget and procurement headlinesPolicy
Tickers to monitor
  • CAPR / COYA / MLTX / CMPS / OMER / ZYME— Biotech names with active FDA, earnings, BLA, PDUFA or clinical-catalyst relevance remain a key part of the May watchlistBiotech
  • UNCY / CING / AYTU / AVTX / STOK / XBI— Small and mid-cap biotech stays active across PDUFA setups, CMC risk, clinical data, financing risk and sector betaBiotech Risk
  • RKLB / RDW / BKSY / HAWK / GSAT / LUNR / PL— The space basket remains active, with focus on launch contracts, satellite intelligence, Gen-3 adoption, defense demand and cash runwaySpace
  • RCAT / KTOS / ONDS / AVAV / DRS / RTX— Defense and drone names stay in focus as traders compare revenue scale, battlefield relevance, funded orders, margins and procurement visibilityDefense Drones
  • SOUN / BBAI / CXAI / AI / PDYN / PATH— Small-cap and software AI should be watched through a stricter lens: real revenue, organic growth, integrations, backlog quality and cash runwayAI
  • NVDA / AMD / ARM / AVGO / MU / AMAT— Semis remain central to the broader tape as traders watch data-center demand, AI capex, China/trade headlines, valuation and earnings reactionsSemis
  • TLRY / CGC / CRON / MSOS / IIPR— Cannabis names remain policy-sensitive ahead of the June 29 DEA hearing tied to the broader marijuana rescheduling processCannabis
Tape watch
  • Capricor PDUFA setup— CAPR now has a visible August 22, 2026 FDA action date for deramiocel, with labeling discussions and manufacturing readiness important to watchPDUFA
  • Coya regulatory momentum— COYA’s Fast Track designation for COYA 302 in ALS helps the story, but the next real test remains clinical execution and financing disciplineFDA
  • MoonLake BLA path— MLTX’s positive pre-BLA outcome gives sonelokimab a clearer HS submission path, with end-September 2026 BLA timing now central to the watch caseBiotech
  • Omeros earnings watch— OMER’s Q1 update is likely to be judged on recent developments, cash runway, regulatory strategy and whether management adds clarity to upcoming milestonesEarnings
  • Rocket Lab leadership test— RKLB still has the strongest space tape, but after the post-earnings move the next question is whether backlog and Neutron expectations support follow-throughSpace
  • Redwire margin check— RDW brings strong growth and better gross margin, but traders should still watch losses, liquidity, backlog quality and Edge Autonomy integrationSpace Defense
  • Kratos funding cycle— KTOS now sits at the intersection of drones, hypersonics, defense electronics and space systems, with guidance and book-to-bill supporting the watch caseDefense
  • PDUFA and policy calendar— CAPR’s August 22 date, ZYME’s August 25 zanidatamab date, UNCY’s June 29 PDUFA and the June 29 DEA hearing all belong on the catalyst calendarCatalysts
Read the full Daily Briefing
Free Course

Run-Up Biotech Masterclass

Learn how to read biotech catalysts, trial results and FDA decisions with a practical framework.

Open
Educational only.
 Tracking Tool

Biotech Catalyst Calendar

Track FDA events, clinical readouts and biotech catalysts with a practical event-driven tool.

Open Archive

Browse the Blog & Archive

Explore articles, biotech deep dives, market notes, reports and archived sector content.

Open Reality Check

Biotech Trading Without the Fairy Tales

A grounded piece on risk, catalysts, dilution, volatility and biotech trading reality.

Open 2026 Watchlist

The New Era – Space, Defense & AI

A thematic watchlist built around military spending, strategic technology and AI-linked trends.

Open Briefing

SPACE AI DEFENCE

A thematic briefing at the intersection of defense, space infrastructure and AI.

Open Top List

Top 10 Defense-Tech Stocks to Watch

A focused list built around defense technology, drones and strategic systems.

Open Top List

Top 5 U.S. Airlines Watchlist

A practical watchlist for pricing power, fuel sensitivity, travel demand and macro tone.

Open Top List

Top 5 Cruise Lines Watchlist

A leisure-focused list centered on major cruise operators and pricing-driven sentiment.

Open
Scanner for active traders

Try ChartsWatcher free, then unlock 10% OFF with SAVE10

ChartsWatcher is a real-time scanner for momentum traders: fast movers, unusual volume and sector rotations — so you can focus on the few tickers that matter right now, instead of watching hundreds of charts.

Start with the free version. When you upgrade, use SAVE10 to get 10% OFF your first paid period.

Start free – then use SAVE10

No credit card required to start. Apply SAVE10 when upgrading.

ChartsWatcher platform screenshot
Recommended platform

One platform. All your brokers.

Medved Trader connects multiple brokers in one workspace, with professional charts, hotkeys and fast execution — without changing your broker accounts.

A single cockpit for positions, Level II and multi-broker order routing, built for active day and swing traders.

Get 1 Month Free ➔

Multi-broker workflow + customizable layouts in one platform.

Medved Trader platform dashboard
Monica.im Monica.im – the AI assistant I use every day
If you find value in the work I publish on Merlintrader and want a practical AI assistant for research and writing, you can sign up using this referral link. Click here to try Monica.im and support the site

Find out how I use AI on Merlintrader: AI, retail and Merlintrader

Disclosure: some of the links in the promotional blocks above are affiliate or referral links. If you choose to subscribe or sign up through them, Merlintrader may receive a small commission or benefit at no extra cost to you.

Merlintrader author

Authors: Merlintrader, Jane and Gemini

Author’s note

In every report I share what I see and how I personally interpret it, based on raw data from official company filings, regulatory documents, conference call transcripts and other primary sources where available. Some parts of the research and structure are supported by AI assistants, which help me organize the data, re-check details and improve charts or visual elements. However, any interpretation, opinion and final judgment remain entirely mine, as a trader and not as a licensed financial advisor or registered analyst. Market sentiment can change quickly, while official documents and numbers remain what they are. It is also possible for me to make mistakes: collecting and cross-checking FDA timelines, clinical data, filings and corporate updates is a complex job, so inaccuracies may occur. If you notice something that seems off, feel free to tell me and I will correct it. Please do not treat this report as professional investment advice, but as one more source of information to compare with your own research and with the opinion of qualified professionals.

AI usage disclosure

This report has been prepared using a human + AI workflow. Drafting, editing and data organization are supported by generative AI tools, such as large language models provided by third parties, based on prompts and instructions defined by the author. All sources used are public, and the final selection of data, checks, opinions and conclusions remains with the author, who takes full responsibility for the content.

If you find these reports useful and want to support the project, you can make a voluntary one-time donation via PayPal or Buy Me a Coffee. It helps cover data, tools and hosting costs, so the content can remain independent and freely accessible.

Buy Me a Coffee

Biotech Catalyst Calendar

For a broader and continuously updated view of upcoming biotech catalysts — PDUFA dates, major clinical readouts, regulatory events and key conferences — you can visit the dedicated calendar on Merlintrader.

Open the Biotech Catalyst Calendar