Goldman reviews key 2H26 biotech catalysts, with greatest optimism on AMLX, AVBP, and ROIV readouts

Overview

In this report, Goldman reviews the key clinical and commercial catalysts for 2H26 across its healthcare biotechnology coverage. The report primarily covers clinical readouts for companies including AMLX, AVBP, CGON, ROIV, SNDX, ORIC, TYRA, and MBX, while also discussing commercialization debates for NBIX, RYTM, and SNDX around 2Q26 results.

Core views

The core view is that 2H26 will be an important catalyst window for the biotechnology sector. Goldman has the highest conviction in AMLX's Ph3 LUCIDITY, AVBP's Ph3 FURVENT, and ROIV's NIU/DM-related progress, believing positive results could materially reduce both clinical and commercialization risk. At the same time, projects at CGON, TYRA, SNDX, ORIC, and MBX still carry substantial indication, efficacy, safety, or translation risk, and readout outcomes will affect the market's reassessment of peak sales, PoS, and valuation.

Analysis framework

The report uses a project-by-project catalyst framework: it first explains the clinical background and key endpoints, then summarizes investor debates, and finally provides Goldman's view, probability of success, peak sales assumptions, and potential market reactions under upside and downside scenarios. The commercialization section focuses on key sales trajectories, guidance, and patient start data ahead of upcoming results releases.

Methodology notes

• Clinical catalyst analysisPoS and scenario analysis

  Assessing the risk-reward of clinical programs through probability of success, endpoint thresholds, and positive/negative readout scenarios.

  The report provides PoS or implied confidence for multiple projects, and separately discusses statistical significance, clinical relevance, commercial thresholds, and share-price reactions.

• Valuation analysisDCF and peak sales

  Using peak sales, risk-adjusted revenue, and DCF sensitivity to evaluate a project's contribution to company value.

  The report repeatedly references peak sales opportunities, such as about $2.2 billion for AMLX, about $4.1 billion for ROIV NIU, and about $1.3 billion of SNDX IPF economics, and discusses DCF impact under ROIV failure scenarios.

• Commercialization analysisPre-earnings debate framework

  Monitoring commercialization execution through key product trajectories, guidance, and patient starts ahead of quarterly results.

  The report identifies NBIX, RYTM, and SNDX as the most debated names ahead of 2Q26 EPS, focusing respectively on Ingrezza guidance, acquired HO new patient starts, and r/r AML treatment dynamics.

Asset mapping & comparison

Structured mapping from thesis to named assets (strengths, weaknesses, peers, risks).

• AMLX

  avexitide Ph3 LUCIDITY for post-bariatric surgery hypoglycemia

  Strengths

  Prior Ph1/2 studies showed consistent clinical effects, the Ph3 design is relatively conservative, and the peak sales opportunity is about $2.2 billion.

  Weaknesses

  Investors are focused on trial execution, dietary control, adherence, and handling of discontinuations.

  Comparison

  If successful, the market will revisit PBH market size and penetration; if unsuccessful, the stock may trade toward cash value.

  Risks

  Clinical failure, execution bias, insufficient patient adherence, and disputes over statistical handling.

• AVBP

  firmonertinib Ph3 FURVENT for 1L EGFR exon20 NSCLC

  Strengths

  Delayed event accumulation may indicate stronger-than-expected efficacy, and Goldman believes it could achieve statistical significance and exceed the efficacy threshold of Rybrevant.

  Weaknesses

  The data readout has been delayed multiple times, and investors have raised their requirements for the magnitude of clinical benefit and relative competitiveness.

  Comparison

  Primarily benchmarked against JNJ Rybrevant and Dizal sunvozertinib on mPFS performance.

  Risks

  Failure to be best-in-class, failure to achieve statistical significance, poor safety read-through, or reduced confidence in the early ADC pipeline.

• ROIV

  brepocitinib NIU Ph3 CLARITY and mosliciguat PH-ILD Ph2 PHocus

  Strengths

  NIU has a reference path from the Humira VISUAL study and strong Ph2 NEPTUNE data, while the PH-ILD program has differentiation in local delivery and tolerability.

  Weaknesses

  NIU patients are highly heterogeneous, and PH-ILD has historically been difficult in terms of translation and trial execution.

  Comparison

  NIU is benchmarked against historical Humira efficacy, while PH-ILD focuses on competition with approved or in-development pulmonary hypertension drugs.

  Risks

  CLARITY failure would remove NIU revenue and reduce DCF, while PHocus failure would have limited downside but create negative headline risk.

• SNDX

  axatilimab Ph2 MAXspire for IPF, alongside AML commercialization dynamics

  Strengths

  The CSF-1R mechanism and BOS data support antifibrotic rationale, and the Ph2 design is viewed as relatively solid.

  Weaknesses

  IPF clinical development has historically been difficult, and there is a lack of directly de-risking clinical data in this indication.

  Comparison

  If Ph2 is positive, the debate will shift to Ph2-to-Ph3 translation, whether INCY will opt in, and the timeline.

  Risks

  Insufficient FVC improvement, difficulty translating Ph2 results into Ph3 success, and commercialization growth below expectations.

• ORIC

  rinzimetostat is affected by read-through from PFE MEVPRO-1 PRC2 mechanism Ph3 results

  Strengths

  If PFE's same-mechanism program succeeds, it would de-risk class efficacy for PRC2 in mCRPC; ORIC may differentiate on dosing convenience and tolerability.

  Weaknesses

  ORIC's own Ph3 data are not yet mature, and MEVPRO-1 cannot fully resolve questions around rinzimetostat competitiveness.

  Comparison

  Cross-trial benchmarking against PFE mevrometostat, including mPFS, safety, and dosing regimen.

  Risks

  MEVPRO-1 efficacy failure would create negative read-through for ORIC, and safety issues could also affect class perception.

• TYRA

  dabogratinib Ph2 SURF302 for intermediate-risk NMIBC

  Strengths

  If the 3-month complete response rate exceeds 70% with good safety, it could support advancement into Ph3 and de-risk a $2.4 billion opportunity.

  Weaknesses

  Some investors believe the commercial threshold should be above an 80% complete response rate, and safety tolerance is lower in this population.

  Comparison

  Compared with JNJ erdafitinib data and standard practice in FGFR3-mutant patients.

  Risks

  Efficacy below threshold, overly high discontinuation rate or Grade 3 AEs, and high competitive thresholds in subsequent indications such as achondroplasia.

• CGON

  cretostimogene Ph3 PIVOT-006 for intermediate-risk NMIBC

  Strengths

  The drug already has evidence of efficacy and tolerability in other NMIBC settings, and positive data could de-risk a $2.3 billion peak sales opportunity.

  Weaknesses

  There is little precedent in this broad IR-NMIBC population, and uncertainty remains around control-arm recurrence speed and study power.

  Comparison

  Investors are divided between HR 0.7 as a statistical/clinical threshold and HR 0.6 as a commercial threshold.

  Risks

  Failure to achieve HR<0.7, results that are positive but commercially insufficient, and near-term share pressure due to expectation reset.

• MBX

  MBX-4291 Ph1 12-week obesity data

  Strengths

  Early efficacy, pharmacokinetic, and tolerability signals remain attractive, with a peak sales opportunity of about $2.0 billion.

  Weaknesses

  Steady-state tolerability and differentiation remain unresolved, and the stock may already reflect a positive readout.

  Comparison

  Needs to be compared with existing and in-development obesity therapies in efficacy, dosing convenience, and tolerability.

  Risks

  Twelve-week data may be insufficient to prove differentiation, tolerability issues, and limited BD support.

Key data

• AMLX avexitide PBH peak sales$2.2BGoldman believes LUCIDITY has a high probability of success, with the Ph3 study having about 90% power to test a 35% placebo-adjusted difference.
• AVBP firmonertinib EGFRex20 NSCLC peak sales$500MIn Goldman's base case, FURVENT may achieve statistical significance and best-in-class efficacy, while the upside case could raise peak sales by about 80%.
• ROIV brepocitinib NIU peak sales$4.1BGoldman assigns 85% PoS and believes market consensus may be underestimating the NIU opportunity.
• ROIV mosliciguat PH-ILD peak sales$2.6BThe report believes the inhaled local sGC activator has differentiated potential in efficacy, tolerability, and convenience.
• SNDX axatilimab IPF-related economics peak sales$1.3BThe global peak sales assumption is $4.0 billion, of which SNDX would realize about $1.3 billion under the INCY agreement, with PoS of 25%.
• TYRA dabogratinib IR-NMIBC market opportunity$2.4BGoldman believes a 3-month complete response rate above 70% and discontinuation rate below 10% would materially de-risk the opportunity.
• CGON cretostimogene IR-NMIBC peak sales$2.3BPIVOT-006 has a 50% probability of success, with the key debate being whether HR below 0.7 is sufficient and whether it meets a higher commercial threshold.
• ORIC rinzimetostat prostate cancer peak sales$2.6BPFE MEVPRO-1 results will have important read-through implications for the PRC2 mechanism and the ORIC program.

Impact & implications

If key readouts are positive, the market may shift from debating whether the programs succeed to discussing market size, registration design, competitive positioning, and commercialization penetration; if they fail, some companies may face removal of program revenues, valuation cuts, or declining confidence in the pipeline. The report emphasizes that the impact of a given catalyst depends not only on statistical significance, but also on magnitude of efficacy, safety, commercializability thresholds, and read-through to subsequent indications.

Risks

• Key clinical trials may fail to achieve statistical significance or the efficacy thresholds required for commercialization.
• Even if results are positive, safety, tolerability, or discontinuation rates may limit the market opportunity.
• Ph2-to-Ph3 translation risk, especially more pronounced in indications with historically difficult development such as IPF and PH-ILD.
• Timing of data readouts remains uncertain, and event-driven endpoints may be delayed further.
• Commercialization debates may lead to post-earnings guidance, patient starts, or revenue trajectories falling below market expectations.
• Changes in competing products or standard of care may compress peak sales and market share.

What to watch

• Whether AMLX LUCIDITY achieves the primary endpoint of reducing Level 2/3 hypoglycemic events.
• Whether AVBP FURVENT demonstrates differentiated mPFS at the 240mg dose versus Rybrevant and sunvozertinib.
• ROIV CLARITY's time to treatment failure in NIU, back-end ocular signals, and 1L/2L penetration potential.
• Whether PVR and 6MWD results in ROIV PHocus are sufficient to support subsequent Ph3 development in PH-ILD.
• Whether the magnitude of FVC decline reduction in SNDX MAXspire reaches the roughly 40-50% improvement threshold.
• TYRA SURF302's 3-month complete response rate, safety, and discontinuation rate.
• Whether CGON PIVOT-006 achieves an HR below 0.7 and whether it approaches the 0.6 threshold investors view as more commercially meaningful.
• Commercialization metrics and management guidance from NBIX, RYTM, and SNDX in 2Q26 results.