Sheff

Bio Investor, Entrepreneur, Philanthropy, Dad. Insta: Sheffbiotech. Get it Done! Not InvestAdvice! @VIPSheffTrades-

[Sheff @SheffStation]

Brand new guys!! Listen & watch. Great stuff here & awesome plays to be watching for. 👊🏽 Please like it & RETWEET! Trying to get 250k views on this one. Greatly appreciated!!

[BioPharmCatalyst @BPharmCatalyst]

The "two-trial dogma" is over. 🧬

The FDA's new one-pivotal-trial shift is the new default for 2026, and it’s rewriting trial timelines and cash runways. In biotech, this isn't just a rule change—it's a survival metric.

Full breakdown with John & @SheffStation :
🎧listen here: https://t.co/P9HysM0BR8

#biotech #FDA #stocks #investing

[BioPharmCatalyst @BPharmCatalyst]

How does a small biotech firm turn years of regulatory setbacks into a pivotal FDA appeal victory?

John Gagliano and @SheffStation sit down to analyze $OTLK 's upcoming June resubmission and the massive valuation potential behind it.

We dive deep into:
1️⃣ The strategic impact of the “One Pivotal Study” rule. 2️⃣ How this victory creates a roadmap for other firms. 3️⃣ The explosive growth of FDA de novo approvals for AI medical devices.

Get the full breakdown on navigating the high-stakes world of biotech:
https://t.co/nZW1rL7ErF

#Biotechtrading #FDA #HealthTech #Investing #biotech #biotechstocks #stocks #trading

[Sheff @SheffStation]

$UNCY … “OLC Label Discussions have begun according to Unicycive management” (HCW). PDUFA 6/29/27

[Form4Wire @Form4Wire]

🟢 DIRECTOR BUY — $OTLK

Sukhtian Faisal Ghiath buys $50K
• 122,174 shares @ $0.41
• New/major position
• Stock −88% from 52W high
• Trade: May 27, 2026 | Filed: May 27, 2026

💡 Moderate Signal

#InsiderTrading #OTLK

[Form4Wire @Form4Wire]

🟢 DIRECTOR BUY — $OTLK

Hilzinger Kurt J buys $177K
• 400,000 shares @ $0.44
• New/major position
• Stock −87% from 52W high
• Trade: May 26, 2026 | Filed: May 27, 2026

💡 Strong Signal

#InsiderTrading #OTLK

[Sheff @SheffStation]

$GCTK … $.69… look at the Book Value here of $3.11 per share. Also the shares short. The same thing that Fintel & Nasdaq website show of 59%.
-June 7th IDE Acceptance from the FDA. Also presenting at ADA.

[BioPharmCatalyst @BPharmCatalyst]

$OTLK announced the FDA granted its Formal Dispute Resolution appeal, concluding that substantial evidence of effectiveness supports ONS-5010/LYTENAVA for neovascular AMD, clearing the path for a June 2026 BLA resubmission with a potential 60-day Class 1 review timeline and positioning LYTENAVA as the first FDA-approved ophthalmic bevacizumab formulation if approved.

$OTLK $LLY $SNGX $PHGE $DYN $MDAI $ARTL $QNTM $ADTX $AKTX

See More Pre-market Movers

https://t.co/96SlFc3hx5

[Sheff @SheffStation]

They will resubmit by June for a Class 1 response & a PDUFA decision will be made in 60 days!!! Wowza!

[Sheff @SheffStation]

$OTLK ..$.40 won their appeal!!

[Sheff @SheffStation]

$OTLK ..$.40 won their appeal!!

[Sheff @SheffStation]

I did see $OTLK & that rejection. I traded that well on my private feed. Sold before the PDUFA date. It wasn’t trading right & was feeling it wouldn’t get approved. It has moved off the $.40 low after PDUFA rejection to $.70. There will be some solid PDUFA Plays in 2026 for sure!

[Sheff @SheffStation]

$HCWB $4.00 🤯 🚀

[Sheff @SheffStation]

$HCWB .. $.30 to $1.30 now!! Spoke about this on the podcast a few weeks ago!! Was a great trading opportunity that worked out great even if you were in at $.70 when the news came out yesterday! 👍🏽

[Sheff @SheffStation]

$KTTA … $.79.. MEKi Inhibitors in cancer w/ multiple indications! Open-label Dose Escalation Ph1/1B study is on deck for data. Trading below cash. Recent OPALEYE purchase in April got my attention. Solid tutes in this one!

[Sheff @SheffStation]

$IMMP … $.48.. Key presentations upcoming over the next few weeks!
ASCO on May 30th & a week later at EULAR on June 4th. Big catalysts as well. The one at EULAR is a plenary presentation.

[Sheff @SheffStation]

$HCWB .. $.30 to $1.30 now!! Spoke about this on the podcast a few weeks ago!! Was a great trading opportunity that worked out great even if you were in at $.70 when the news came out yesterday! 👍🏽

[BioPharmCatalyst @BPharmCatalyst]

$HCWB reported a profitable first quarter of 2026, swinging to a net income of $3.47 million on $6.54 million in revenue, driven primarily by a $6.5 million nonrefundable upfront license fee from Trimmune. Supported by reduced operating expenses, the company highlighted key upcoming pipeline milestones, including Phase 1 data for HCW9302 in alopecia areata, expected in the fourth quarter of 2026, and the completion of IND-enabling work for HCW11-018b, targeted for the first half of 2027. Additionally, the company announced preclinical findings from its ongoing IND-enabling studies showing that its pembrolizumab-based fusion immunotherapeutic, HCW11-040, effectively prevented bronchopulmonary dysplasia (BPD) in a highly stringent animal model.

$HCWB $DARE $PPBT $GDTC $KLRS $AARD $LFWD $AERO $WOK $CLDI

See More Pre-market Movers

https://t.co/hWm1SufJPk

[BioPharmCatalyst @BPharmCatalyst]

🚨 Weekly Watchlist: Phase 3 Readouts are coming before 2Q ends.

$ADCT, $PTN, and $DFTX are all approaching clinical data. 📈🧬

🔹 $ADCT: LOTUS-5 data
🔹 $PTN: ED Synergistic data
🔹 $DFTX: MDD Phase 3 data

Watch now: https://t.co/nhUcqRO0nA 📺
Weekly Watchlist:
https://t.co/ajywHrndDZ

Track the countdown at https://t.co/0DViPWRRbe 📈

#Biotech #Stocks #Trading #ADCT #PTN #DFTX #BioPharmCatalyst

[NIU Men's Soccer @NIUMSoccer]

.@rdswan10 presenting the guys with their 💍 to commemorate the accomplishments of the 2025 season.

[Sheff @SheffStation]

$OTLK … $.31…13G Filing from the offering last week & most recent offering. Intracoast Capital took most of this in stocks & warrants. Offering was only 1 day & then they closed it. Extremely fast.

https://t.co/CESWQvevHg…

[Sheff @SheffStation]

Great spring Finale! Ended up w/ 4 goals in this game. 7 goals & 2 assists for the Spring Season (5 games). In soccer 4 goals in a game is called a HAUL! This summer w/ the Portland Bangers will be great then this fall will be fun!

[NIU Men's Soccer @NIUMSoccer]

Final matchday of the spring!

Due to other events happening on campus today, fans are asked to park in lot PS, directly north of the NIU Soccer Complex. Fan should not park in the Convocation Center parking lots.

[Sheff @SheffStation]

$OSTX .. $1.71 bottle rocket 🚀… Finally starting to show what we have been waiting for & to see! @OSTherapies #osteosarcoma

[BioPharmCatalyst @BPharmCatalyst]

Biotech is showing its resilience! 🧬📷 In our latest episode, John Gagliano and Sheff Sheffield dive deep into the mid-2026 outlook. From the White House’s new stance on psychedelics to the regulatory hurdles facing $OTLK, we’re breaking down what you need to know.
Highlights:
🍄 The WH Medical Executive Order on Psychedelics
⚖️ $OTLK’s FDR meeting with the FDA
📈 Sheff’s high-conviction Watchlist for 2026

Catch the full breakdown of #AACR26 & #ASCO26 impacts here:
https://t.co/E2RUm9st0n

#Biotech #StockMarket #FDA #Psychedelics #Investing $IBB

the full breakdown of AACR & ASCO impacts here: N5zgo #biotechstocks #stocks #biotechtrading #biotech #StockMarket #psychedelics #Investing $IBB $XBI

[NIU Athletics @NIUAthletics]

Congratulations to Huskie Newcomer of the Year winners, Emilie Sorensen of @GoHuskiesWBB and Vance Sheffield of @NIUMSoccer

[NIU Men's Soccer @NIUMSoccer]

Congratulations Vance!