No investment advice. Do your own DD Market is all about taking the shares from the weak holders& providing opportunities to those that have the stamina to hold
Joined April 2014
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Emmanuele retweeted
$TGTX @biomaven expert on COGS but important nugget many investors don’t realize is how profitable SUBq will become - same sales force etc - Peter I can’t find your tweet on this from the past
The two key charts from the $TGTX subq dosing trial. The AUC for the every 3 month dose is numerically modestly higher than the current IV every 6 months, and injection site reactions were extremely low and completely absent after the second dose. This is undoubtedly going to be a several billion dollar product. They have a clear advantage here over monthly Kesimpta, and pricing is very favorable for both the company and payors (avoids the high infusion charges).
Emmanuele retweeted
$TGTX 6 billion with quarterly in home SUBq along with IV doable - why models been going up recently
$TGTX Jeffries Upside Scenario, 6.8 Billion
$98, +84%
• IV Briumvi: US peak penetration of 35% in RMS
and peak sales of ~$2.6B
• SC Briumvi: 100% POS for US peak penetration
of 35% and peak sales of ~$4.2B
Emmanuele retweeted
I think the best way to think about $TGTX SubQ is to compare the IV market and the SubQ market.
In the IV market, Briumvi was up against an entrenched competitor with a massive sales force in Ocrevus. Both drugs are excellent - Briumvi (in my estimation) is only modestly better. The key dynamic here is that the IV market is very sticky - people only see their doc twice a year and so most just stay on their drug given it works well for most. So $TGTX priced lower and focused on gaining dynamic share, which is now around 50%, split 3 ways between naive, switches from other non-CD20's and switches from Ocrevus. But the overwhelming bulk of the IV market is still Ocrevus (pts stay on it an average of 5 years).
SubQ is different. First, it's inherently much less sticky, with refills every 3 months. Next, the comparative advantage TGTX has here with injections every 3 months vs every month with Kesimpta is significant. Based on the recent trial, Briumvi injection site reactions are a bit better than Kesimpta (needs to be confirmed in current trial). Offering the same drug as IV and SubQ is also an advantage - lets docs switch easily. Next, they can price at roughly same level as Kesimpta, which is currently priced significantly higher than Ocrevus (OK with insurers as save the outrageous costs of the IV). Kesimpta run rate is around $6 billion.
(Note TGTX margins currently artificially depressed because they are expensing inventory build for SubQ).
Emmanuele retweeted
$PGEN $INO Inovio has to run a placebo-controlled confirmatory trial it has not designed or started, fund it on a balance sheet that until tonight had about a quarter of cash, and recruit patients to a placebo arm now that the drug is available on prescription.
And the FDA’s published efficacy figure is 27% with no surgery in year one, in the enriched subgroup, from an open-label 32-patient study. Precigen’s (PGEN) is about 51% complete response as the powered primary of a registrational trial, which the agency accepted as proof of benefit rather than a predictor of it.
Precigen $pgen overreaction to the $ino news. Their drug was not approved like Precigen’s is. Inovio still has work to do 👇
“The agency based this accelerated approval on clinical trial data showing Voceryq helps reduce the frequency of surgical procedures required to remove growths in adult patients with RRP — an intermediate clinical endpoint reasonably likely to predict clinical benefit. The accelerated approval pathway allows the FDA to approve drugs or biologics for serious or life-threatening conditions based on an effect on a surrogate or intermediate clinical endpoint reasonably likely to predict clinical benefit. The manufacturer must conduct post-approval clinical trials to verify and describe Voceryq’s clinical benefit.”
Emmanuele retweeted
$TGTX 1,000 of November $85 calls were bought for 35c.
The only way it gets there is a BO in the next three weeks.
I'll not be surprised if they PR earnings date today AH for Monday or Tuesday PM, minimum warning for the shorts.
TGTX is surging, Heavy volume, a new 52 week high on a terrible tape.
If they don't announce today, there may be a BO on Monday.
30M shares short, almost $2B.
Emmanuele retweeted
$INO : The FDA decides today. My timeline is mostly debating whether INO-3107 works. The more useful question is which approval path the FDA takes, and there's a precedent in this exact disease that almost nobody is talking about.
THE PRECEDENT
In Aug 2025, $PGEN filed Papzimeos for accelerated approval. The FDA gave it full approval instead, no confirmatory trial required, on a single-arm study of 35 patients.
So the FDA has already accepted single-arm data as enough in RRP. That's the bull case people miss: a traditional approval doesn't require beating an existing drug, just substantial evidence that yours works.
THE CATCH
INO-3107 is filed under accelerated approval. That pathway is meant for unmet need, and when an approved therapy exists, a new drug generally has to show a meaningful advantage over it. Papzimeos is now that therapy.
That's why the FDA's filing letter flagged a preliminary concern about eligibility. In the Q2 update, Inovio said the FDA hadn't discussed it since, but told them feedback on the confirmatory trial design "would be forthcoming." Read that as the FDA working on an accelerated path with strings, not shutting the door.
THE STRINGS
Since FDORA (2022), the FDA can require the confirmatory trial to be underway before approval, or within a set time after. Its Jan 2025 draft guidance says "underway" means at least enrollment started and a credible completion timeline.
For a company with $36.7M at June 30, ~$18.3M raised in July and ~$18M of quarterly burn, a randomized trial is a funding question, not a formality.
THE DATA SIDE BY SIDE
INO-3107, n=32: 28.1% needed no surgery (9/32), 81% had at least one fewer, ORR 72%. No treatment-related side effects above grade 2. About half surgery-free in year two.
Papzimeos, n=35: 51% surgery-free in the 12 months after treatment (18/35), and 15 of 18 still in CR at 24 months.
Not apples to apples: Precigen counted from after its 12-week dosing window, Inovio counts from day one. But the FDA will see the gap.
THE STOCK
~103M shares plus up to ~98M from warrants, the July ones struck at $1.10. Above that, exercises add supply.
Short interest ~20% of shares (Sept 30). Implied volatility around 250%.
For scale: Precigen puts US adult RRP at ~27,000 patients, and Papzimeos did $53.1M in Q2.
WHAT TO READ IN THE PRESS RELEASE
1. "Accelerated" or "approval" alone. Traditional approval is the best case.
2. "Confirmatory," and whether it has to be underway now.
3. The indication. Narrower than "adults with RRP" means a smaller market.
A CRL citing eligibility means the FDA wants randomized data, and that's hard to fund from here.
No position.
#FDA #Biotech
Emmanuele retweeted
$PGEN PAPZIMEOS delivers explosive commercial growth. FDA validates Precigen’s AdenoVerse platform. US market exclusivity, European expansion. Full breakdown oliviersevers.substack.com/p…
Emmanuele retweeted
$TGTX - market & many investors long/SHORT still not digested the implications of $TGTX having Q3m SUBq that can be given at home
The two key charts from the $TGTX subq dosing trial. The AUC for the every 3 month dose is numerically modestly higher than the current IV every 6 months, and injection site reactions were extremely low and completely absent after the second dose. This is undoubtedly going to be a several billion dollar product. They have a clear advantage here over monthly Kesimpta, and pricing is very favorable for both the company and payors (avoids the high infusion charges).
Emmanuele retweeted
$TGTX Jefferies PT $83 like the updates from TGTX at MSToronto. Azer-cel first-in-human allo CD19 CART in
PMS data showed good tolerability/ safety &encouraging benefit. Still early days (no credit in current
stock), this could evolve into a bigger story if efficacy/ durability continues. Subq Ph1 data continued to
point to a potential Ph3 win ~'26/ '27.
$TGTX unreal to think we’re talking -REGISTRATION trials for something not ONE analyst had anything in their models for - but that’s what GREAT data in UNMET needs does - Q3 call in weeks. Azer & SUBq should dominate the call - I fully believe Weiss & $DTIL moves quickly as they can- Enthusiasm by DOCS & patients quickly growing
Emmanuele retweeted
$TGTX BRILEY PT $86 AZER CEL TGTX (Buy, $86 PT): Azer-cel’s first data show a clean safety profile, with efficacy now a function of dose &time. All 26 participants
had progression independent of relapse activity (PIRA) in the prior 12 months despite anti-CD20 therapy. They had a median of 3 prior
therapies, a median age of 51.5, a median of 8.6 years since diagnosis, and a median EDSS of 6.0, split across PPMS (9), naSPMS (10), and
active SPMS (7). CRS (2/26, Grade 1-2) and ICANS (2/26, Grade 1) showed no dose trend from DL1 (30M cells) to DL6 (500M cells). There was
no immune effector cell-associated hemophagocytic lymphohistiocytosis-like syndrome (IEC-HS), no graft-versus-host disease, no Grade 3
or higher infection, and 42.3% (11/26) of patients experienced Grade 3 or higher treatment-emergent AEs and 15.4% (4/26) experienced
serious AEs (4/26).
$TGTX AZER CEL data even more impressive when you look at baseline of these hard to treat patients - All 26 participants had PIRA in the prior 12 months; all had prior anti-CD20 therapy
Emmanuele retweeted
$TGTX most thought before 2025 at best $TGTX SUBq would be Q2M - as you point out Peter Q3m looking likely - Cowen probably needs to redo their 2025 Q2m survey on SUBq - agree if K can do 5 BILLION on SUBq alone no reason why $TGTX cant either - longterm models on SUBq steadily been going up
The two key charts from the $TGTX subq dosing trial. The AUC for the every 3 month dose is numerically modestly higher than the current IV every 6 months, and injection site reactions were extremely low and completely absent after the second dose. This is undoubtedly going to be a several billion dollar product. They have a clear advantage here over monthly Kesimpta, and pricing is very favorable for both the company and payors (avoids the high infusion charges).
Emmanuele retweeted
The two key charts from the $TGTX subq dosing trial. The AUC for the every 3 month dose is numerically modestly higher than the current IV every 6 months, and injection site reactions were extremely low and completely absent after the second dose. This is undoubtedly going to be a several billion dollar product. They have a clear advantage here over monthly Kesimpta, and pricing is very favorable for both the company and payors (avoids the high infusion charges).
Emmanuele retweeted
$TGTX real world data confirms why so many switches to Briumvi most frequent reason for switching to ublituximab
from a previous DMT was lack of efficacy (40.9%,
45/110;
$TGTX Salmen A, et al. Real-World Data of Ublituximab in Relapsing Forms of Multiple Sclerosis: 48-Week Interim Results from the Non-Interventional BRILL Study
Emmanuele retweeted
$TGTX SUBq PK data Pharmacokinetic/Pharmacodynamic Evaluation of Ublituximab in Patients With Autoimmune Diseases (ACTRIMS-ECTRIMS
$TGTX staying focused here 3 different models today on DCF or some types of valuation of $78 - $80-$85/share - one thing that standouts in all 3 models -severely underestimated peak Revenue once SUBq comes on board & profitability = plenty of room to upside in outward years
Emmanuele retweeted
$TGTX AZER CEL data even more impressive when you look at baseline of these hard to treat patients - All 26 participants had PIRA in the prior 12 months; all had prior anti-CD20 therapy
$TGTX AZER CEL does not disappoint- 89% of evaluable participants (16/19) had stable or improved disability scores at Day 90, despite documented progression prior to enrollment on high-efficacy therapies
Emmanuele retweeted
$TGTX Briumvi in its two 2-year pivotal trials vs teriflunomide reduced relapse rate by 59% and 49% (and relapse rate kept dropping further each year in the multi-year extension study).
Novartis BTK drug reduced annualized relapse rates by only 35.2% and 31.2% compared with teriflunomide, so not competitive on efficacy (with usual warnings on cross-trial comparisons).
Roche BTK did better on efficacy, but liver tox worries.
Neither in my view pose a significant threat to Briumvi.
$TGTX as much as I like the AZER data & also how nothing was priced in - the MOVE in $TGTX today I am confident in has all to do with $NVS underwhelming data - as that was one of last bear thesis even BofA had kelo.com/2026/10/23/novartis…
Emmanuele retweeted
Why is preserving shingles (VZV) antibodies (21/21 seropositive) such a big deal in $TGTX's azer-cel (allogeneic CD19 CAR-T) progressive MS data?
4 critical reasons:
1. The CD19 vs. CD20 Plasma Cell Question
Unlike anti-CD20 mAbs (like Briumvi), CD19 is expressed across a broader B-cell spectrum, including plasmablasts and some plasma cells. A major concern with CD19 CAR-T in autoimmune disease is whether it wipes out bone marrow plasma cells and erases lifelong immunity. Flat Anti-VZV IgG titers (21/21) prove CD19-negative long-lived plasma cells survive azer-cel intact.
2. Proof of a True "Selective Immune Reset"
Look at the B-cell reconstitution panels together:
- Pathogenic switched memory B-cells plummeted (34.7% at screening down to 9.6% at M3)
- Reconstitution is heavily enriched for fresh, antigen-inexperienced Transitional (4.1% to 29.4%) and Naive B-cells (19.7% to 42.6%)
- Yet VZV IgG stays intact
Azer-cel resets the autoreactive B-cell compartment to a naive state without causing "immunological amnesia."
3. De-Risking Post-CAR-T Infection
CAR-T requires pre-conditioning lymphodepletion followed by deep B-cell aplasia (25/26 achieved <10 CD19+ cells/uL). Shingles reactivation is a classic infectious risk post-CAR-T. Preserving baseline protective antibodies in older, higher-disability progressive MS patients (median EDSS 6.0) reduces the risk of opportunistic infections and chronic IVIG dependence.
4. Neurologist Adoption & FDA Positioning
Neurologists are far more conservative about long-term infection risk than oncologists. Showing VZV IgG preservation gives clinicians and regulators the gold-standard proof that deep peripheral and CSF B-cell depletion doesn't strip patients of their pre-existing vaccine and viral immunity.
Emmanuele retweeted
📊 $SGMOQ | $SGMO @SangamoTx Chapter 11 update:
Docket 536 reveals $138.45M in cash, DIP financing fully repaid in October and $141.23M in positive accounting equity.
Encouraging for potential shareholder recovery, with the ST-503 auction still ahead.
Source: Docket 536 👇
