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Biotech catalyst, news and analysis PDUFA tracker

Biotech catalyst, news and analysis PDUFA tracker
Tickers reports and analysis

$CAPR Total Catalyst Map: Capricor Therapeutics FDA date, HOPE-3, WMS, cash, partnerships and 2026–2027 milestones, verified against primary sources.

Five biotech stocks face a packed calendar of clinical data and FDA decisions. This map separates major evidence from presentations and study starts without inflating correlated events.

Alpha Tau Medical ($DRTS): 18 catalysts, 2026–2027 timelines, clinical readouts, FDA milestones, Tolmar, Japan and potential stock impact.

Biotech Radar: CNTB asthma data, BIVI Long COVID findings, CRBP obesity results and ARMP FDA designation, plus financing, diagnostics and medtech updates.

Biotech Radar: $ROIV, $BEAM, $UPB and $BMY report clinical progress. Mosliciguat, BEAM-302, verekitug and arlo-cel: evidence and next steps.

Merlintrader Biotech Radar · September 4, 2026 Biotech Radar — September 4, 2026: $IONS, $STOK, $CLYM & $APVO Lead an FDA, Dravet, IgAN and AML Tape Four companies sit at four different points on the biotech evidence ladder: Ionis has…

Travere Therapeutics and Vera Therapeutics look like an easy pair to compare: both operate in rare kidney disease, both have major exposure to IgA nephropathy, and their flagship products will increasingly compete for attention from the same nephrologists. Yet investors are actually choosing between two almost opposite profiles.

Biotech Radar for Aug. 15, 2026: CAPR, ABCL and DFTX lead, plus TENX, SION, PDSB, FDA approvals, clinical data, earnings and biotech deals.

Biotech Radar for August 5, 2026: $OBX, $ACRV and $URGN lead, with clinical, commercial and financing news across nine additional biotech names.

PolyPid receives FDA Priority Review for D-PLEX100, Processa rebuilds around VT-7208 with a $200 million financing, and TScan begins pivotal Phase 3 execution.

Today’s Radar separates a genuine commercial-plus-clinical rerating at Kiniksa from a material commercialization-timeline reset at Nautilus Biotechnology and a strong but more complex post-acquisition quarter at Alkermes. NeoGenomics and Mirion remain on the closing-bell watchlist, with results scheduled after the market closes.

Four biotech stories moved onto the radar for four very different reasons: a company-changing financing at $ENTX, a first commercial FDA approval at $FRNM, a planned leadership handoff at $SRPT and a sudden CEO departure at $LEGN.

Six verified biotech developments published today: an accepted rare-disease NDA, updated PCNSL response data, the opening of a rolling Wilson-disease application, a positive brain-metastases imaging study, a Canadian ALS regulatory path and a $1.5 billion cell-therapy tools acquisition.

Kalshi launched a pilot program on July 16, 2026, enabling trading on clinical trial outcomes and FDA decisions linked to biotech firms. This new prediction market offers a public price reflecting the probability of drug approval, but raises ethical concerns and potential manipulation risks due to limited participant knowledge and liquidity challenges.

A full three-company edition covering an early wet-AMD durability signal, a $100 million gene-therapy financing that materially resets per-share ownership, and a traditional FDA approval that raises the evidence standard across the increasingly competitive IgA-nephropathy market.

Three biotech updates, three very different evidence problems: an early Parkinson’s disease signal moving toward Phase 2, a post hoc attempt to rescue a pulmonary sarcoidosis program after a missed Phase 3 endpoint, and an FDA-guided protocol optimization that may make a urology study faster and less expensive without yet proving efficacy.

Phase 2 CELIA produced one of the most intriguing tau signals yet seen in Alzheimer’s disease, but it did not settle the key issue: why did the lowest dose show the most persuasive cognitive benefit while higher doses failed to produce a stronger response?
$BIIB · $IONS
Alzheimer’s · Tau · Antisense

Merlintrader Biotech Radar Biotech Radar July 14, 2026: Biogen, AstraZeneca, GSK and Evotec — $BIIB, $AZN, $GSK, $EVO A deeper four-company edition covering an FDA delivery breakthrough in Alzheimer’s disease, a $1.5 billion lung-cancer licensing deal, a potentially treatment-changing organ-preservation…

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…

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.