Oct 16, 2026 · 46 min
FDA turnover and ESMO put biotech catalysts under scrutiny
Biotech Stocks to Watch: FDA Shakeups, ESMO Data & Late 2026 Biotech Catalysts Sheff Is Watching
The episode connects regulatory uncertainty with a dense pipeline of oncology, ophthalmology, and clinical-development catalysts that could move biotech stocks.
- 1FDA leadership turnover, workforce reductions, and more PDUFA extensions are reshaping the regulatory backdrop for biotech investors.
- 2ESMO’s upcoming data may offer an early read on oncology themes that later surface at ASCO.
- 3The watchlist spans Aldeyra, NRx, Unicycive, Vivani, and Fractyl as clinical and regulatory milestones approach.
Don't miss
Sheff’s discussion of Aldeyra’s positive Phase 3 data shows how a single ophthalmology result can become a broader clinical and regulatory trading catalyst.
The brief
John Gagliano and Sheff Sheffield frame the discussion around a biotech market facing both regulatory uncertainty and a crowded calendar of clinical catalysts.
Sheff points to FDA workforce reductions, senior leadership turnover, novel-drug approvals, and more PDUFA extensions as signs of a changing regulatory environment.
The hosts treat ESMO as an important oncology checkpoint, with presentations from large pharmaceutical companies and smaller partners potentially previewing themes for ASCO.
The catalyst watchlist moves from Aldeyra’s positive Phase 3 ophthalmology data to upcoming developments at NRx, Unicycive, Vivani, and Fractyl.
The episode’s central tension is whether company-specific milestones can outweigh the uncertainty created by evolving FDA leadership and review dynamics.
What was said on this episode
16 statements · 11 positive · 1 negative · 1 mixed · 3 neutral
FDA leadership changes could occur in 2027
“2027 could be the year that we see this change with the FDA”
Listen at 6:44
Aldeyra should submit its FDA dispute resolution soon
“we should hear. you know, in the next week or so that they've actually submitted this”
Listen at 14:14
Aldeyra could receive approval in early January
“we're probably looking at early January for them to get approved”
Listen at 16:25
Chef views Aldeyra’s current position favorably
“I really like where the company is at right now”
Listen at 16:48
Inovio appears well positioned ahead of its FDA decision
“they look like they're in good standing”
Listen at 19:08
Inovio could rise around its October FDA decision
“we might start to see that one really pop up”
Listen at 20:37
Chef sees Unicycive’s potential inspection outcome as an opportunity
“I think it'll be a great opportunity”
Listen at 25:50
Additional weight loss with Vivani’s implant could materially benefit the company
“If weight loss is shown in addition to using Wagovi or semaglutide, it's going to be big for the company”
Listen at 28:35
Fractyl Health’s pivotal cohort data should arrive soon
“data should be in the next week or two”
Listen at 32:24
OsteoVax could receive accelerated approval in December
“if they get accelerated approval in December”
Listen at 33:24
OsteoVax could sell its priority review voucher for $200–250 million
“which they can sell for 200 to 250 million”
Listen at 33:34
Pasithea Therapeutics’ stock has recently declined
“that stock has been getting hit”
Listen at 35:08
Kineta’s fourth-quarter data could materially affect the company
“they've got data in the fourth quarter that could be significant for the company”
Listen at 38:02
Ovid’s OV329 data will be reported at year end
“that data is going to be year end readout”
Listen at 38:52
Gossamer’s NDA acceptance could occur around November 27
“it should be around November 27th because it's usually 60 days from when they send it out”
Listen at 41:26
Gossamer’s financing suggests investors expect no refuse-to-file decision
“I think obviously with this, you know. The structured financing investors and institutions are pretty confident that that's not going to happen”
Listen at 42:55
Statements are attributed to the speaker as said on the episode and reflect their view at the time, not PodLume's. They are not advice.