Biotech Breakthroughs — 2026-05-13

Top Breakthroughs This Week

1. Kelun-Biotech Wins IND Approval for SKB118, a PD-1 × VEGF Bispecific Antibody

• Company / Institution: Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd. (6990.HK)
• What happened: Kelun-Biotech received an Investigational New Drug (IND) approval from China's Center for Drug Evaluation (CDE) to initiate clinical trials for SKB118, a PD-1 × VEGF bispecific antibody. The IND clearance marks the program's transition from preclinical to clinical stage, allowing the company to begin Phase I dose-escalation studies.
• Indication / Target: Oncology — solid tumors; dual checkpoint/angiogenesis blockade combining PD-1 immune checkpoint inhibition with VEGF anti-angiogenic targeting
• Why it matters: The PD-1 × VEGF bispecific class has generated extraordinary commercial interest following AstraZeneca's approval of cadonilimab and the global frenzy around similar constructs. SKB118 enters a competitive but high-value space where single-agent bispecifics may replace combination regimens, potentially improving tolerability profiles. Kelun-Biotech's established ADC licensing track record with Merck lends credibility to its pipeline execution and positions SKB118 as a potential future licensing asset.

1 sources

prnewswire.com

prnewswire.com

2. FDA Neurology Action Update: Approvals, Extended Review, and NDA Filing Plans (Week of May 4, 2026)

• Company / Institution: Multiple companies; compiled by NeurologyLive
• What happened: The FDA's neurology action summary for the week of May 4, 2026 confirmed multiple actions including at least one approval, at least one extended review timeline, and disclosure of plans for an NDA (New Drug Application) filing. NeurologyLive's compilation covers the full scope of regulatory activity across neurological disease areas in a single consolidated update published within the coverage window.
• Indication / Target: Neurology — specific approved conditions and filing targets span multiple CNS disease areas
• Why it matters: The FDA's active neurology calendar reflects a resurgent CNS pipeline after years of high-profile failures. Extended review timelines signal complexity in the regulatory path for certain novel mechanisms, while new NDA filings indicate near-term market entry candidates that could reshape treatment algorithms for underserved neurological conditions. This consolidated picture gives investors and clinicians clear visibility into the upcoming approval landscape.

3. Biotech IPO Market Sustains Momentum: Two Companies Raise Combined $556M

• Company / Institution: Seaport Therapeutics and Hemab Therapeutics (BioPharma Dive reporting)
• What happened: Two biotechs — Seaport Therapeutics and Hemab Therapeutics — raised a combined $556 million in IPOs during the week ending May 9, 2026, representing the latest cluster of offerings in what analysts project will total approximately two dozen biotech IPOs in 2026. This follows a broader Q1 2026 trend where the six companies that had priced IPOs banked a median of $287.5 million, surpassing comparable periods in prior years.
• Indication / Target: Seaport (CNS/psychiatry); Hemab (hematology/rare bleeding disorders) — diverse indications demonstrating broad investor appetite
• Why it matters: The combined raise confirms that institutional capital remains available for biotech despite macro headwinds, but the market is increasingly selective, favoring larger and better-capitalized offerings. The trend of "fewer but bigger" IPOs means that only companies with differentiated platforms or validated targets can access public markets, raising the quality bar for the sector overall.

Regulatory Roundup

• Brexucabtagene autoleucel (Tecartus) / Kite Pharma — Received full approval for mantle cell lymphoma (MCL) in April 2026, converting its accelerated approval to a full label. This represents a landmark for CAR-T therapy in MCL, establishing a new standard of care for relapsed/refractory patients who have failed prior lines of therapy.

• Ifinatamab deruxtecan (I-DXd) / Daiichi Sankyo–AstraZeneca — Received Priority Review designation from the FDA in April 2026 for a solid tumor indication. The Priority Review grants a six-month review clock versus the standard ten months, accelerating potential market access for this next-generation ADC.

• Zanidatamab / Jazz Pharmaceuticals–Zymeworks — Granted Priority Review designation in April 2026, with the FDA now actively evaluating submissions for its HER2-targeted bispecific antibody. Zanidatamab targets both HER2 domains simultaneously, potentially offering greater receptor downregulation than single-domain agents; approval would fill a gap in biliary tract cancer.

• FDA Neurology Expanded Access — Daraxonrasib / Revolution Medicines — The FDA issued a "safe to proceed" letter authorizing Revolution Medicines to initiate an expanded access treatment protocol (EAP) for daraxonrasib, its experimental pancreatic cancer drug targeting KRAS. The EAP allows eligible patients access outside of clinical trials, reflecting the urgent unmet need in a disease with a five-year survival rate below 13%.

Therapeutic Modality Watch

Gene & Cell Therapy

• CAR-T Full Approval Milestone: The FDA's conversion of brexucabtagene autoleucel's accelerated approval to a full approval for MCL signals regulatory maturation of the CAR-T class, which began with accelerated approvals that required confirmatory data. This progression validates the original trial endpoints and provides greater commercial certainty for payers and prescribers.

• Bespoke Gene Therapy Pathway: The FDA's "plausible mechanism pathway" for bespoke gene-editing treatments — finalized in February 2026 — continues to generate anticipation, with the agency projecting a flood of rare disease applications from academic centers including Penn-CHOP, University of Wisconsin, and IGI-UCSF. Umbrella trials for severe inborn errors of immunity are expected to initiate in 2026.

• Oricell Therapeutics Pre-IPO Round: The Chinese cell therapy company completed a $110M pre-IPO round (including a prior $70M Series C1 in January), raising over $180M in total ahead of a planned public listing. Lead investors include Vivo Capital, Qiming Venture Partners, and Beijing Medical and Health Care Industry Investment Fund.

Small Molecules & Biologics

• PD-1 × VEGF Bispecific Antibodies: Kelun-Biotech's IND clearance for SKB118 adds another entrant to the hotly contested bispecific antibody space combining immune checkpoint and angiogenesis blockade. The class is attracting major licensing interest globally as companies seek to differentiate from standard checkpoint monotherapy.

• Daraxonrasib / KRAS Targeting: Revolution Medicines' EAP authorization for its KRAS-targeted pancreatic cancer agent reflects growing confidence in direct KRAS inhibition beyond KRAS G12C — a mechanistic expansion that could address a broader patient population than first-generation inhibitors.

• Zanidatamab Bispecific HER2: Priority Review for zanidatamab reinforces the commercial viability of dual-epitope HER2-targeting strategies, particularly in biliary tract cancer and other HER2-overexpressing solid tumors where trastuzumab-based regimens have shown limited efficacy.

Platform & Discovery Tech

• AI-Driven Biotech Goes Public: Generate Biomedicines, an AI-driven protein design startup backed by Flagship Pioneering, raised $400M in its February 2026 IPO, the largest AI-biotech public offering in the current cycle. This week's IPO activity continues to demonstrate that AI-native drug discovery platforms can access institutional capital at substantial scale.

• June 2026 FDA PDUFA Calendar: The FDA's upcoming drug approval decisions in June 2026 span COVID-19, gout, nicotine dependence, severe hypertriglyceridemia, and thyroid eye disease — a diverse therapeutic portfolio that signals active late-stage pipelines across metabolic, autoimmune, and infectious disease areas.

• Real-Time Clinical Trials Pilot: The FDA's pilot program for real-time monitoring of cancer drug trials by AstraZeneca and Amgen — announced in late April 2026 — may fundamentally shorten the interval between Phase II and Phase III initiation by allowing adaptive decisions based on accumulating data rather than fixed interim analyses.

Business & Pipeline Moves

• Seaport + Hemab IPOs: $556M Combined — The two companies pricing in the same week signals a window of investor receptivity in early May 2026. The raises reinforce that CNS and hematology/rare disease remain favored therapeutic areas among public market investors, with differentiated mechanisms commanding premium valuations.

• Oricell Therapeutics: $110M Pre-IPO Round — The Chinese cell therapy company's final pre-IPO funding, bringing total pre-public raises above $180M, demonstrates that Asian cell therapy developers are increasingly well-capitalized to compete for global market share. Vivo Capital's lead position suggests alignment with U.S. institutional investors ahead of a potential dual listing.

• Biotech IPO Market: ~24 Offerings Projected for 2026 — With the sector on pace for approximately two dozen IPOs this year (consistent with 2022–2025), median raise size has surged to $287.5M in Q1 2026 — far above historical comparables — indicating a "quality over quantity" market where only well-differentiated programs reach the public window.

• Revolution Medicines Expanded Access for Daraxonrasib — Gaining FDA "safe to proceed" status for an EAP in pancreatic cancer validates the company's KRAS inhibition platform beyond KRAS G12C and may accelerate partnering or licensing discussions with larger pharma companies seeking next-generation KRAS assets. The EAP also enables real-world data collection ahead of potential accelerated approval pathways.

Analyst Take

• Dominant theme this week: Oncology infrastructure buildout — from bispecific antibodies (PD-1 × VEGF, HER2 bispecifics) to ADCs receiving Priority Reviews, to CAR-T achieving full approval status. Every major modality segment in oncology advanced at least one step on the regulatory or clinical ladder this week.

• Momentum shift: Bispecific antibodies gained the most ground this week, with Kelun-Biotech's IND adding to the already-surging interest in PD-1 × VEGF constructs and zanidatamab's Priority Review cementing HER2-bispecific as a validated approach. Conversely, traditional monoclonal antibody monotherapies continue to lose strategic priority as combination modalities and bispecifics demonstrate superior efficacy profiles.

• Risk signals: The FDA's real-time trials pilot with AstraZeneca and Amgen (announced late April), while promising, introduces regulatory uncertainty for the broader industry: companies not selected for the pilot may face competitive disadvantages if adaptive trial designs shorten the clock to approval for pilot participants. Additionally, the concentration of large biotech IPOs in narrow market windows suggests fragility — a macro shock could rapidly close the IPO window and strand companies mid-fundraise.

What to Watch Next Week

• June 2026 PDUFA Calendar Preview: The FDA is expected to make decisions on treatments for COVID-19, gout, nicotine dependence, severe hypertriglyceridemia, and thyroid eye disease in June 2026. Watch for PDUFA dates dropping into the final two weeks of May as the calendar fills — each represents a potential catalyst or disappointment for the respective sponsor.

• Kelun-Biotech SKB118 Phase I Protocol Disclosure: Following this week's IND clearance, the company is expected to release Phase I trial design details for SKB118. Dose escalation strategy, patient selection criteria, and planned combination cohorts will clarify how the asset will be differentiated in an increasingly crowded bispecific field.

• FDA Neurology Pipeline — Next Batch of Actions: With the May 4 update confirming activity across approvals, extended reviews, and NDA filings, the May 11–18 window is likely to bring additional neurology-sector regulatory decisions. Track any PDUFA actions for CNS assets as potential catalysts for mid-cap biotech names.

Reader Action Items

• For investors: Monitor Revolution Medicines (RVMD) — the FDA's expanded access authorization for daraxonrasib in pancreatic cancer removes a key de-risking step and positions the company for potential partnership discussions. Any announcement of a collaboration with a major oncology pharma company could serve as a significant near-term catalyst.

• For operators & scientists: Read the full FDA press announcement on expanded access for daraxonrasib, which outlines the criteria for the EAP and the mechanism of action — directly relevant to researchers working on RAS pathway inhibition and pancreatic cancer: []

• For patient advocates: The FDA's full approval of brexucabtagene autoleucel (Tecartus) for mantle cell lymphoma — converting from accelerated to standard approval — is the most directly impactful access development this cycle for MCL patients. Full approval typically triggers broader payer coverage decisions and removes uncertainty that can delay treatment access under accelerated approval labels.

5 sources

fda.gov

Novel Drug Approvals for 2026 | FDA

fda.gov

Novel Drug Approvals for 2025 | FDA

fda.gov

2026 Biological Approvals | FDA

fda.gov

Novel Drug Approvals for 2024 | FDA

fda.gov

FDA Permits Expanded Access for Investigational Pancreatic Cancer Drug | FDA