Biotech News — analysis

All breakingfdaanalysisguide
analysis

Camurus Oclaiz Dec 18 PDUFA: 85% Approval Odds

Oclaiz's two CMC-only CRLs make the Dec 18 PDUFA a near-certain approval, but Vertex's $10B Palsonify bet means Camurus wins an injection war in a pill market.

September 28, 2026
analysis

JPM 2027: 6 Names That Move on Deals, Not Data

ASCO moves oncology, ASH moves hematology, JPM moves deals. Six names with a 2027 catalyst and a cash runway or buyout question, ranked by deal-flow potential.

September 27, 2026
analysis

2027 FDA Calendar: 5 PDUFAs Ranked

2027's first half has 9 confirmed PDUFA dates. Five are investable binary events. Two are ghosts: one approved, one with no US ticker. Here is the playbook.

September 26, 2026
analysis

Q3 2026 Biotech Earnings: 8 Names to Watch

Ignore GAAP EPS. Q3 earnings matter only when they carry a pipeline, guidance, or runway signal. Here are the 8 names and the one number to watch on each.

September 26, 2026
analysis

VKTX VK2735: 90% Maintenance, $4.9B Market Cap

VK2735 kept 90% of weight loss on monthly dosing and hit 22% placebo-adjusted loss. Viking priced a $500M raise into the rally. Buy the pullback, size it small.

September 24, 2026
analysis

VRTX Inaxaplin Cuts Proteinuria 42.7% in AMKD

Inaxaplin cut proteinuria 42.7% in AMKD, but the type 2 diabetes cohort missed significance. The 466-patient AMPLITUDE interim in early 2027 is the real test.

September 24, 2026
analysis

ACET Prula-cel: $88M CD20 CAR-T Lupus Primer

Adicet's allogeneic CD20 CAR-T reads out in 22 lupus patients this month. At $88M, a clean 12-month print re-rates the stock; a safety stumble halves it.

September 4, 2026
analysis BMRN

BioMarin's 20% Yuviwel Royalty Is a Bridge, Not a Win

BioMarin collects 20% on Ascendis weekly achondroplasia drug through 2030. That is roughly $720M by 2030, but it recovers only 20 cents per lost Voxzogo dollar.

September 2, 2026 · Rare Disease · $BMRN
analysis

REGN Cemdisiran: gMG PDUFA vs Vyvgart's $4.2B

Cemdisiran, the first RNAi therapy for gMG, hits a November PDUFA with best-in-class data. The real beneficiary is Alnylam's platform, not Regeneron's stock.

August 26, 2026
analysis

Roche Enspryng: Oct 15 TED PDUFA vs Tepezza

Enspryng's Oct 15 TED PDUFA is the first at-home challenger to Amgen's $1.9B Tepezza monopoly. Split Phase 3 data make this Amgen's loss, not Roche's win.

August 26, 2026
analysis

IRA Drug Pricing: Reshaping Biotech Valuations

The IRA is the biggest structural change to biotech economics since Hatch-Waxman. Here is which companies face the most risk and how to screen for IRA exposure.

August 10, 2026
analysis

Q1 2027 Biotech Catalysts: 4 PDUFAs Ranked

Q1 2027 opens with four PDUFA dates: an sNDA label update, two first approvals, and one accelerated-to-full conversion. We rank each by tradeable risk-reward.

August 9, 2026
analysis

GSK Neladalkib: Nov 27 ALK NSCLC PDUFA Primer

GSK paid $10.6B for Nuvalent. Zidesamtinib delivered. Neladalkib heads to a Nov 27 PDUFA for TKI-pretreated ALK NSCLC. Data is real but GSK stock will not move.

August 7, 2026
analysis NVO

GLP-1 for Alzheimer's: A Good Bet That Did Not Pay Out

Semaglutide failed Alzheimer's Phase 3 EVOKE trials. Tirzepatide and retatrutide are next. The GLP-1 Alzheimer's hypothesis is dead as monotherapy. Here is what survives.

August 5, 2026 · Neuroscience · $NVO
analysis

BBOT BBO-11818: $648M pan-KRAS vs RVMD $40B

BridgeBio Oncology's pan-KRAS inhibitor enters Phase 1 with a confirmed PR in pancreatic cancer. At $648M vs RVMD's $40B, a cheap option on the KRAS race.

August 1, 2026
analysis

IMMX NXC-201 AL Amyloidosis: 95% CR at $592M

IMMX autologous BCMA CAR-T shows a 95% complete response rate in AL amyloidosis. At $592M market cap, the stock is a binary bet on the September data update.

August 1, 2026
analysis

BMY Q2 Earnings: 58% Growth, Priced In

BMY's Growth Portfolio hit 58% of revenue at +15% growth — but the $129B market cap already prices in the CELMoD pipeline and then some.

July 30, 2026
analysis

Why 99% of Alzheimer's Drug Trials Fail

Alzheimer's trials fail 99% of the time. Five structural reasons, why Leqembi changed the bar but not the odds, and a framework for evaluating any catalyst.

July 30, 2026