r/biotech_stocks

$SPRO - A sleep easy biotech?

$SPRO - A sleep easy biotech?

Spero Therapeutics have a PDUFA date coming on June 18th. This is the second attempt at approval for the same drug, this time with a clear SPA from the FDA and the backing of GSK.

The drug, Tebipenem HBr will be the only non-IV carbapenem on the market. This is the last resort treatment for antibiotic resistant infections.

The Phase 3 was extensive and GSK know what they are doing, rejection probability is very low here.

The commercialisation will be funded and ran by GSK also, no dilution and strong sales team. Milestone payments of $100m on the first commercial sale, with payments up to $225m plus low double digit royalties.

The royalty agreement is quite punitive however, with royalties also owed out on the royalties they earn.

This isn’t a 10x. It’s a simple ride to the first milestone payments, with short time horizon and no dilution. Money could be made if GSK buy them out, which is a possibility.

Check out the full write up here:

https://open.substack.com/pub/needlefinder/p/spero-therapeutics-a-sleep-easy-biotech?r=378x0l&utm\_medium=ios

u/Low-Replacement-1702 — 6 hours ago
▲ 6 r/sideprojects+5 crossposts

I corrected my own model before it cost someone money. Here's what changed.

TVTX update:

Yesterday I posted a TVTX breakdown showing 77.5% PoA and MODERATE sell-the-news risk. Someone in the comments called me out on the surrogate endpoint issue. They were right. And if I hadn't fixed it, someone could have held through approval expecting a 20% pop and watched their position do the opposite and bleed out instead.

That's why I built this thing. Not so people can feel smart about biotech. So they stop losing money on events they didn't fully understand.

RCKT got approved two weeks ago. Stock dropped 20%. BIIB got approved last week. Dropped 5%. Both were "good news." Both destroyed retail positions!

The people who lost money on those trades didn't lose because they were wrong about the drug. They lost because they didn't see the sell-the-news setup, the dilution signals, or the surrogate endpoint risk hiding in the data.

Here's what the corrected model shows on TVTX now.

The old score ran on generic FDA text. It saw "sNDA" and "rare disease" and output 77.5% PoA. It didn't know that Filspari's confirmatory trial hit on proteinuria (surrogate endpoint) but missed on eGFR (hard endpoint: actual kidney function). That's the difference between "the biomarker improved" and "the patient actually got better." The FDA sometimes approves on the surrogate anyway. The market doesn't always reward it.

Updated numbers:

PoA: 65.7% (down from 77.5%)

STN Risk: HIGH (up from MODERATE)

Net Edge: 53.0 (down from 65.4)

Grade: WATCH (down from STRONG)

Dilution: MINIMAL, EDGAR filings are clean, no ATM, no shelf

The model now classifies this as a Sell-The-News setup. Not because the drug won't get approved. Because even if it does, the eGFR miss is public, and a surrogate-only label expansion doesn't generate the surprise that moves a stock up. This is the same pattern that burned people on RCKT.

Five hours of research per ticker compressed into one screen. Eight risk layers. Dilution detection that would have caught RCKT's $100M ATM filing 18 days before their PDUFA. Sell-The-News scoring that would have flagged every one of our backtest losses before they happened. Surrogate endpoint detection that just saved the TVTX score from being dangerously optimistic.

Also built a buyout scanner this today. 46 recently approved drugs where the company hasn't been acquired yet, scored across 12 factors with live market data. Small company gets FDA approval, big pharma buys them at a 40-100% premium. The scanner finds the ones still sitting there waiting. That's a different kind of trade. Longer hold, less binary, real upside.

I'd rather you check the free pages and learn something tonight than subscribe and not understand what you're looking at.

Model outputs are quantitative data classifications, not financial advice.

submarinecatalyst.com
u/Clean_Reference_9927 — 15 hours ago

$APLT investors — there's a $15M settlement and the deadline is this Wednesday, April 8

Hey guys, so quick heads up here! If you held Applied Therapeutics stock between January 2024 and December 2024, you may be eligible to file a claim in the $15M settlement. The deadline is this Wednesday, April 8.

Here's what happened: the company spent most of 2024 making optimistic statements about Govorestat, its drug candidate for galactosemia, citing positive Phase III trial results and progress toward FDA approval.

However, in November 2024, the FDA issued a CRL rejecting the application, citing incomplete data and protocol inconsistencies.

Days later, the company received a warning letter for failing to address past trial issues, and the stock dropped over 80% following the news.

Investors filed suit alleging the company hid dosing errors and missing trial data while publicly projecting confidence in the approval process.

The claim deadline is April 8, 2026. 2 days away.

reddit.com
u/EducationalMango1320 — 22 hours ago

Inovio Pharmaceuticals is now a good time to buy?

Inovio Pharmaceuticals INO Public Offering Summary 06Apr2026

https://youtu.be/oxCrOqpy9TM

Ok peeps, its is a simple story, they had the offering share price went down but why do I think its going to go back up?

They now have cash to get the PDUFA. With around 80-85M shares the company is still worth less then 100M, and they are going into a market with a single competitor with a market size of 10k+ people. So there is def room for 2 companies there, and since its a orphan drug they can charge anywhere between 200k-600k. Even if they only get 500 a year people (out of 10k+) that's 200M a year. The companies cost are a little less then 100M a year. So the math is simple. We will see a price increase and run up heading into the PDUFA

u/RunningRobert1980 — 24 hours ago
Week