🐻 ABVX $2.3M Bearish Block — A Desk Hedges the Regulatory Overhang Left Behind by the Phase 3 Cancer Signal

Last updated: 2026-06-09

✅ RESOLVED — Next-Day OI Update (2026-06-09): ✅ The $100 put OI rose 142 → 2,500 (+2,358 — heavy put accumulation beyond the 1,500 block). The bearish/hedge read on the regulatory overhang is confirmed.

📅 June 8, 2026 | 🔥 Unusual Activity Detected

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🎯 The Quick Take

Someone just paid ≈$2.3 MILLION for 1,500 near-dated put contracts on Abivax (ABVX) — a small clinical-stage biotech whose Phase 3 data dropped just seven days ago and rocked the stock ≈40% lower before a violent ≈45% rebound. This is not a bet on a fresh binary event — there's no confirmed readout before July 2. Instead, a desk is paying to protect against a re-test of the crash lows while an unresolved FDA regulatory overhang (potential black-box warning, possible Advisory Committee review) hangs over the stock. One important note before anything else: this was printed as a negotiated block cross — there was a known counterparty on the other side. This is hedge / positioning flow, not a Wall Street insider alarm bell. Read on for the full picture.

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📊 Company Overview

Abivax S.A. (NASDAQ: ABVX) is a Paris-based clinical-stage biotech whose entire valuation rests on a single asset: obefazimod (ABX464), a first-in-class oral small-molecule miR-124 enhancer being developed for moderately to severely active ulcerative colitis (UC) — a chronic inflammatory bowel disease affecting millions of patients who cycle through and fail existing therapies.

• Market Cap: ≈$7–8B on ≈78.5M shares outstanding (highly volatile given the post-readout whipsaw — Yahoo Finance; companiesmarketcap.com)
• Industry: Clinical-stage pharmaceutical / biopharmaceuticals
• Cash position: €491.6M as of March 31, 2026, with runway into Q4 2027 per the Q1 2026 6-K (SEC)
• Stage: Pre-revenue. Value is 100% probability-weighted NPV of obefazimod approval in UC — and optionality in Crohn's disease (Phase 2b ongoing)
• The pitch: Oral (no injection), novel mechanism, blowout Phase 3 efficacy. The problem (explained below): a dose-dependent cancer signal at the 50 mg dose that upended the safety story

Real talk: ABVX is a single-asset, all-or-nothing biotech where the FDA approval process — and specifically how regulators treat that cancer signal — is now the most important variable in the company's story.

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💰 The Option Flow Breakdown

📊 The Tape (June 8, 2026 @ 10:00:45)

Flow type: 🤝 BLOCK CROSS (OPRA condition code 127 — Single-Leg Cross Non-ISO)

What does "block cross" actually mean, and why does it matter?

A block cross is the opposite of an aggressive sweep. When you see a sweep, a buyer blasts through multiple price levels on the public order book consuming real liquidity — that's urgency. A cross is different: a broker matched a willing buyer and a willing seller at a pre-negotiated price, off the open lit order book. There is a known counterparty. No public depth was taken. No urgency was required.

In plain English: two parties agreed on a price and a desk facilitated the trade. One of those parties wanted to buy 1,500 puts. The other party was happy to sell them. This is negotiated flow — which means the headline "≈$2.3M bearish block" tells you a position was established, not that a single conviction-driven actor was aggressively pounding the bid. It could just as easily be a long-stock holder buying portfolio insurance. Do not read this as "smart money is loading up on a bearish bet." Weigh the structure, the catalyst context, and the strike geometry over the raw dollar number.

Order type: BTO (Long Put) — MEDIUM confidence. Volume 1,500 contracts vs. prior OI of just 142 — the vol/OI ratio is 10.56×. When today's volume exceeds prior OI by this wide a margin, the math is nearly unambiguous: ≈1,358 of these contracts had to be freshly opened (prior OI can absorb at most 142 contracts of closing trades). This is as close to a confirmed fresh open as you can get without the next-day OI snapshot. The MEDIUM (not HIGH) confidence reflects the block-cross mechanic — we know new puts were bought, but we cannot rule out the buyer already held a long stock position and was purchasing downside protection.

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⏳ OI Check — Come Back Pre-Market Tomorrow (≈06:30 ET)

The next-morning OPRA open interest snapshot (≈06:30 ET on June 9) will show whether OI on ABVX20260702P100 rises from today's baseline of 142 toward ≈1,642 (up ≈+1,500).

Expected OI move: Given vol/OI = 10.56× (volume vastly exceeds prior OI), we expect OI to rise sharply — OI up ≈+1,500 = fresh open confirmed. If OI somehow falls or stays flat, the read inverts — but this scenario is statistically implausible given the size differential.

Because size (1,500) vastly exceeds prior OI (142), today's tape alone is sufficient to state: ≥1,358 contracts were new opens. The June 9 morning OI snapshot provides the definitive confirmation. Check back pre-market before acting on this flow.

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🤓 What This Actually Means — Plain English

Let's break this down completely — the trade structure, the cross mechanic, and what the bet is actually targeting.

The basic structure — a Long Put:

Buying a put option gives you the right to sell shares (or profit on a decline) at the strike price. This buyer paid $15.53 per contract for the right to sell ABVX at $100 per share any time before July 2, 2026. With ABVX spot at $96.84 when the trade printed, the $100 put is already slightly in-the-money (the strike is above the stock price). You're paying for immediate downside coverage.

The math that matters:

• 1,500 contracts × 100 shares × $15.53 = ≈$2.33M in premium paid
• Strike ($100) is ≈$3.16 above spot ($96.84) — this put is slightly in-the-money (ITM)
• Break-even at expiration: $100 − $15.53 = $84.47 (ABVX needs to be below $84.47 on July 2 for this trade to be profitable)
• Maximum profit: if ABVX goes to zero, the put is worth $100 per contract; unlikely but it illustrates the structure
• Maximum loss: $15.53/contract × 1,500 × 100 = ≈$2.33M (the full premium, if ABVX is above $100 on July 2)

What is this bet actually targeting?

This is the critical insight. The big binary catalyst — the Phase 3 ABTECT maintenance readout — already printed on June 1. There is no confirmed new data readout between today (June 8) and this put's July 2 expiration. So whoever bought these puts is NOT playing a dated lottery on a fresh readout. They are positioning against:

1. The unresolved regulatory overhang: The Phase 3 data showed blowout efficacy (≈50% clinical remission vs 10.4% placebo, p<0.0001) BUT a dose-dependent malignancy signal at the 50 mg dose — approximately seven cancer cases on 50 mg versus one each on 25 mg and placebo. Wedbush flagged that these signals "increase the risk of a black box warning and potential FDA advisory committee review". A black-box warning on a drug whose competitive pitch was a clean oral safety story vs. JAK inhibitors (which already carry black boxes) would materially change the commercial outlook.

2. Post-crash volatility / re-test risk: The stock crashed ≈40% on June 2 before rebounding ≈45% off the low. The $100 put at roughly at-the-money-to-slightly-ITM is positioned to profit from a re-test of the ≈$77 crash low — a live scenario given the unsettled analyst community (PT range: $90 to $187).

3. ADS dilution overhang: Traders are also digesting a fresh American Depositary Shares deal, a separate mechanical pressure on the share price independent of the clinical data.

And one more time on the cross — because it changes everything about how you should read this:

An aggressive sweep on 1,500 put contracts would say "someone urgently needed to own this downside protection and paid up to get filled fast." A block cross says "two parties agreed on terms and a broker matched them." The buyer of these puts may very well be a long-stock holder who rode the rebound from $72 to $97 and wants to protect unrealized gains through July 2 while the FDA regulatory picture remains unclear. That is a completely rational, low-drama reason to buy puts — and it's the interpretation you should keep in mind before concluding this is a "directional bet."

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📈 Technical Setup / Chart Check-Up

YTD Performance

ABVX has had one of the most violent YTD journeys of any NASDAQ biotech in 2026. The stock was trading near $132–133 heading into the June 1 Phase 3 readout — a level built on the 2025 Phase 3 induction wins and strong clinical momentum. Then the maintenance results hit after hours: efficacy was extraordinary, but seven malignancy cases at the 50 mg dose overshadowed the data. The stock opened June 2 into a waterfall, touching ≈$72 intraday before closing around $77 — a loss of roughly ≈40% in a single session. By June 4, the stock had rebounded to $104.93 — a ≈45% surge off the lows — as buyers stepped in on the efficacy story. As of June 8 the stock sits at ≈$96.84, roughly at the $100 strike of the put block, now stuck in a no-man's land between two very different analyst narratives.

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Gamma-Based Support & Resistance

Current Price: ≈$96.84–$102.07 (per GEX snapshot at time of analysis)

Important context: ABVX is a small-cap biotech with a thin options market. The gamma exposure numbers here are measured in fractions of a $1M GEX unit — far smaller than what you'd see on a large-cap like AMD or SPY. This means market-maker gamma hedging is a much weaker force on ABVX's price than on liquid names. Use these levels as reference zones, not hard floors/ceilings.

🟠 Call Gamma Resistance (Orange Bars — Overhead Sellers):

• $100 — The most gamma-dense strike on the entire board, total GEX 1.61 (net call-dominant +0.497). This is the gravitational center of the chain. With spot right at $96.84, the $100 strike acts as both the traded put strike AND a near-term call-resistance ceiling. Expect choppy price action in the $95–$105 range.
• $110 — Moderate resistance, total GEX 0.793, net call +0.069. A secondary cap ≈$13 above spot.
• $120 — Moderate resistance, total GEX 0.566, net call +0.194. Further wall.
• $125–$130 — Call-dominant GEX walls (0.506 / 0.585) marking the pre-crash trading range the stock fell from.

🔵 Put Gamma Support (Blue Bars — Downside Floors):

• $90 — Balanced GEX zone (0.762 total, net call +0.056). This is the first significant level below spot — a break below $90 would remove meaningful put-gamma support.
• $85 — Mixed zone (0.323 total, net put -0.042). Modest put-gamma floor.
• $75–$70 — Deeper put-heavy zones (0.158 / 0.244 total GEX, both net put-dominant). These correspond to the crash-low territory the stock visited on June 2 — and where the put buyer would capture maximum near-term value.
• $65 — Light put-gamma support at the lower extreme of the visible chain.

What this means for you:

The $100 strike is the gravitational anchor for ABVX right now — it's where the most options market activity is concentrated, it's the traded put strike, and it's just above today's spot ($96.84). The stock is essentially pinned at the $100 gamma wall. A break below $90 (first meaningful put-support level) would open a path toward the $77 crash low — which is precisely what the $100-strike put is designed to profit from. On the upside, $110 and $120 are the first call-resistance layers — but given the overhanging regulatory uncertainty, the short-term path of least resistance is sideways-to-lower.

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Implied Move Analysis

This is where things get important for biotech context. ABVX's options market is pricing in extraordinary volatility — and that's not surprising given what just happened.

Key implied move ranges (from ≈$102 reference):

What this tells us about the Jul-2 put specifically:

The put's $100 strike and $84.47 breakeven sit well within the implied move cone for the monthly OPEX window (lower bound $62.38 on July 17). The market is pricing a ≈39% move — in either direction — by mid-July. For a 24-day put expiring July 2, the options market is saying a return to the $77 crash lows (roughly $84-87 area) is a plausible ±1 standard deviation outcome.

Translation for retail: the $15.53 premium sounds expensive, but it's priced for a biotech trading with 60%+ annualized implied volatility right after a safety-driven crash-and-recovery. These options are expensive because the market expects large moves. The put buyer is paying for insurance against a move that the market itself assigns reasonable probability to.

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🎪 Catalysts

✅ Already Happened — In the Books

• Phase 3 ABTECT Maintenance Readout (June 1, 2026) — THE pivotal event. Abivax reported blowout efficacy: ≈50–51% Week-44 clinical remission at both 25 mg and 50 mg doses vs. 10.4% placebo, all secondary endpoints met, p<0.0001. But the malignancy imbalance at 50 mg crashed the stock ≈40%: seven cancer cases (non-skin malignancies + non-melanoma skin cancers) on 50 mg vs. one each on 25 mg and placebo in a 44-week trial. Per GlobeNewswire's full data extract.

• Post-crash volatility (June 2–4, 2026). Stock opened June 2 around $133 pre-market, closed June 2 ≈$77 (≈-40%), recovered to $90.15 on June 3, then spiked to $104.93 on June 4 (+45% off lows). All in 72 hours.

• Analyst downgrades and PT cuts (early June 2026). Jefferies downgraded Buy → Hold and slashed PT to $90 (from $160). Wedbush upgraded Underperform → Neutral but cut PT to $90 (from $110), specifically warning about black-box warning and FDA Advisory Committee review risk. Meanwhile Truist maintained Buy with a trimmed $135 PT (from $140) and Citizens raised their PT to $187 (from $131). The $90-to-$187 PT dispersion tells the whole story.

• Unusual options activity flagged (June 3, 2026). ABVX was specifically flagged for unusually high options trading in the immediate aftermath of the Phase 3 readout — today's block cross is part of a broader wave of institutional repositioning.

• Digestive Disease Week (DDW), May 2–5, 2026. Nine abstracts on obefazimod were presented, covering efficacy, safety, patient-reported outcomes, and anti-fibrotic preclinical work. Now in the books; reinforced the efficacy story before the safety issue emerged.

• Study 108 open-label extension durability data. An interim ITT analysis showed 68% clinical remission at Week 144 after dose de-escalation — supportive of long-term durability, but does not address the malignancy concern.

🚀 Upcoming — What's on the Calendar

Inside the Jul-2 put window (today → July 2): No confirmed binary data readout is scheduled. The put is a headline-risk / regulatory-overhang play, not a dated catalyst lottery. Any of the following could move the stock materially:

• FDA commentary or label-discussion signaling: If the FDA communicates informally or publicly about a black-box warning or AdCom review for the NDA process, the stock could gap down sharply and the $100 put would pay off quickly. Timing is unknowable — this is the primary "unscheduled" risk the put is hedging.
• ADS dilution overhang (ongoing): A fresh American Depositary Shares registration is in play per QuiverQuant reporting. Selling pressure from a new ADS issuance could weigh on the stock independent of the clinical picture.
• Full maintenance safety dataset or OLE presentations: Abivax may present additional data at future medical congresses (timing unspecified). Any new safety data point that worsens the malignancy narrative — or resolves it — would be a major catalyst.

Beyond the put window:

• ≈September 21, 2026: H1 2026 financial results / corporate update — next confirmed reporting date per StockTitan. After the Jul-2 put expiry.
• Late Q4 2026: Planned U.S. NDA submission to the FDA for obefazimod in UC — the company's stated filing timeline per the ABTECT press release. This is where the black-box/AdCom debate gets formally adjudicated. The biggest catalyst of 2026/2027 for ABVX.
• Mid-2027: Phase 2b Crohn's disease induction topline — per the Q1 2026 6-K.

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🎲 Price Targets & Scenarios (Through July 2, 2026)

Using gamma levels, implied move ranges, and the catalyst context:

📉 Bear Case — Put Profits (30% probability by July 2)

Target: $84 or below (put in-the-money at expiry)

How ABVX gets there: Any one of — (a) FDA signals concern about the malignancy data and flags AdCom review, spooking analysts who just upgraded; (b) new adverse event data emerges at a medical congress; (c) the ADS deal pressures the stock mechanically; (d) the post-crash bounce exhausts itself and the stock gives back the June 3–4 gains. The $84.47 breakeven is ≈13% below today's spot. The implied-move cone says the market assigns reasonable probability to this range.

Put P&L in bear case:

• ABVX at $84.47: Put at breakeven, trade returns zero profit
• ABVX at $77 (the June 2 crash low): Put intrinsic value = $100 − $77 = $23; net profit ≈$23 − $15.53 = $7.47/contract × 1,500 × 100 = ≈$1.12M gain on ≈$2.33M invested
• ABVX at $65 (extreme bear): Put intrinsic = $35; net profit ≈$19.47/contract = ≈$2.9M

🎯 Base Case — Stock Range-Bound (50% probability)

Target: $85–$110 range through July 2

The Street is deeply divided ($90 to $187 PT range), the company has strong cash ($491.6M), and the efficacy data is genuinely impressive. In a base case, the stock chops sideways as investors wait for the NDA filing timeline and any FDA color. The $100 put likely expires at or near worthless (if ABVX stays above $100) or with a modest gain (if ABVX drifts to the $90–$97 range).

Put P&L in base case: Expires worthless or with $0–$5 of intrinsic value → partial to full loss of ≈$2.33M premium.

📈 Bull Case — Put Worthless (20% probability)

Target: $120–$130+ (pre-crash levels)

If an analyst upgrade wave follows — or if Abivax provides reassuring regulatory guidance or safety context at a conference — the stock could re-rate toward the $120–$130 range where it traded pre-readout. Citizens' $187 PT reflects the bull scenario where the 25 mg dose (clean safety profile) gets approved without a black box.

Put P&L in bull case: Expires worthless → full $2.33M loss for the put buyer. This is why the cross/hedge interpretation matters: a long-stock holder losing the $2.33M on put premium while gaining $25–35/share on 150,000 shares of stock exposure would still come out well ahead.

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💡 Trading Ideas for Different Investors

🛡️ Conservative — "Wait for Regulatory Clarity"

For investors with $5K–$25K, entry-level biotech exposure

If you own ABVX stock from a pre-crash entry (say, $80–$90 range), the conservative move is to wait for the June 9 OI confirmation and then track the FDA/AdCom signaling news. The stock's ≈$491.6M cash position (runway into Q4 2027) provides a real floor — this isn't a cash-burn-to-zero story before the NDA filing. If you're flat and considering a new position, do not buy based on this put block alone — the cross mechanic means you don't know if the buyer was hedging a long position (bullish at heart) or making a directional bearish bet.

The conservative action: Watch the $90 gamma-support level. A clean hold of $90 with stabilizing analyst sentiment = a reasonable risk-managed long entry targeting $110–$120 on a clean NDA narrative.

⚖️ Balanced — "Covered Downside Play"

For swing traders with $10K–$50K, 1–3 month horizon

If you believe the stock is range-bound ($85–$110) through July — but want to express that view without unlimited downside — consider a bull put spread: sell the $90 put, buy the $80 put (same July 2 or July 17 expiry). You collect premium for the $90 put sale while the $80 put limits your risk if the stock crashes again. This structure profits if ABVX stays above $90 through expiry.

Why this works in context: The $90 gamma-support level is meaningful, the stock rebounded hard off $77, and the company has cash. But the structure caps your risk if the FDA drops a black-box bomb before July 17.

Key watch levels: $100 (gamma anchor/resistance), $90 (put-spread short strike / gamma support), $84.47 (put block breakeven), $77 (June 2 crash low).

🚀 Aggressive — "Directional Bearish / Regulatory-Risk Play"

For experienced biotech options traders, $5K–$15K, defined-risk plays only

The thesis: the FDA black-box / AdCom risk is underpriced by the market's ≈45% rebound, the $90 Wedbush/Jefferies target reflects the real regulatory bear case, and the stock is ripe for a re-test of the crash low on any negative catalyst.

Illustrative structure (verify live prices before trading):

• Buy the ABVX Jul-17 $95 Put
• Sell the ABVX Jul-17 $80 Put (reduce premium outlay, defined risk)
• Net debit: ≈$8–10 estimated (verify live)
• Max profit ≈$5–7/spread if ABVX is at or below $80 at Jul-17 expiry
• Max loss: the debit paid

YOLO version: buy the Jul-2 $100 put outright — but understand you're paying elevated biotech implied volatility and need a ≈$15 move in your favor just to break even. At these IV levels, the put is expensive.

Critical warning: Biotech options go to zero on both sides. If the FDA provides positive guidance or a partnership/buyout materializes, the $95 put or $100 put is worthless. Define your risk, size appropriately, and never allocate more than 1–2% of portfolio.

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⚠️ Risks & Honest Limits

What the tape and this analysis CANNOT tell us:

• Who the counterparty is: A block cross means a broker matched a buyer and seller. We do not know if the buyer of these puts is a directional bearish speculator or a long-ABVX shareholder buying portfolio insurance. The motive changes the interpretation completely — insurance against a known long position is very different from a standalone bearish bet.
• The FDA's timeline or informal communications: No one outside the FDA knows when (or if) an AdCom review or black-box comment will come. The put is positioned for this risk, but the timing is unknowable.
• Whether the malignancy signal is clinically meaningful: The sample size (N=580, 44 weeks) is limited. Analysts are split $90-to-$187 precisely because reasonable scientists disagree on how to interpret dose-dependent cancer signals in UC patients (who have elevated colorectal cancer risk at baseline). The FDA may view the 50 mg signal as noise; it may view it as disqualifying. We don't know yet.
• Broker identity, customer identity, or order source: OPRA shows the print. It does not show the desk, the fund, or the PM behind the trade.

Binary biotech risk — both directions:

ABVX is a clinical-stage, single-asset, pre-revenue company. The valuation is essentially a bet on obefazimod approval. A positive FDA outcome (clean label, no AdCom, 25 mg approved on the strong efficacy without black box) sends this stock sharply higher and the $100 puts expire worthless. A negative FDA outcome (black box, AdCom, or outright rejection) could revisit or break through the June 2 crash lows. The ≈$7–8B market cap is only appropriate if the UC approval probability remains high — and the malignancy signal has meaningfully reduced that probability in the market's eyes, hence the June 2 crash.

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🎯 The Bottom Line

Here's the deal: A desk just paid ≈$2.3M for 1,500 slightly-in-the-money put contracts on Abivax, expiring July 2 — 24 days from today. The stock is sitting right at the $100 gamma anchor, ≈$27 below where it traded a week ago, after one of the most violent Phase 3 readout reactions in 2026 biotech.

The trade is a hedge/bearish bet on the unresolved regulatory overhang — specifically the FDA's eventual response to a dose-dependent cancer signal that crashed the stock 40% last week. There is no scheduled binary data before July 2. This is not a lottery ticket on a fresh catalyst; it's a 24-day instrument designed to profit from continued de-rating or a re-test of the crash lows if the FDA / analyst community turns further negative on the malignancy data.

The block-cross framing is everything. This was NOT an aggressive sweep — a broker matched a buyer and a seller at a pre-agreed price. The buyer could very plausibly be a long-stock holder protecting unrealized gains from the June 3–4 rebound. Do not treat this as a conviction directional signal from a single informed actor.

What to watch:

• 📅 June 9, 2026 pre-market (≈06:30 ET): Check ABVX20260702P100 OI — expect ≈1,642 if the BTO is confirmed as a fresh open
• 📅 July 2, 2026: Put expiry — the 24-day window closes
• 🎯 $90 level: The first meaningful put-gamma support below today's spot; a break below $90 with no bounce signals a re-test of June 2 crash lows
• 🎯 $100 level: The gamma anchor and put strike — choppy price action expected in the $95–$105 range
• 📅 ≈September 21, 2026: H1 2026 financial results / corporate update (next confirmed catalyst event)
• 📅 Late Q4 2026: U.S. NDA submission — the defining event for Abivax's 2026–2027 story

Analyst PT reality check:

The $90 to $187 range across major analyst PTs — a 2× spread — is the market's honest admission that it doesn't know how the FDA will handle the malignancy signal. The $100 put block is one desk's answer: hedge first, ask questions later.

Final thought: If you're long ABVX and riding the rebound, the put block is a reminder that the bear case ($90) is real and well-supported by credible analysts. The bull case ($187) is also real. What's rare is a stock with equal-weight $90 and $187 analyst targets sitting at $97 — that's the options market's nightmare scenario for near-dated theta sellers, and exactly why implied volatility (and $15.53 premiums on a 24-day put) are this elevated. Respect both sides.

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Disclaimer: Options trading involves substantial risk of loss and is not suitable for all investors. Buying put options can result in total loss of the premium paid — in this case $15.53/contract or the full ≈$2.33M for the block buyer — if ABVX closes above $100 on July 2, 2026. This analysis is for educational purposes only and does not constitute financial advice. The BTO classification carries MEDIUM confidence; the next-day OPRA OI snapshot (≈06:30 ET June 9) is the definitive test. The block-cross mechanic (OPRA cond 127) means the counterparty and motivation of the buyer are unknown — this could be a hedge on an existing long position rather than a standalone directional bet. Biotech stocks can move dramatically in either direction on regulatory news, analyst commentary, or secondary offerings. Past unusual options activity does not guarantee profitable trading outcomes. Always do your own research and consult a licensed financial advisor before trading.

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Last updated: 2026-06-08

About Abivax S.A.: Clinical-stage biopharmaceutical company (NASDAQ/Euronext Paris: ABVX) developing obefazimod (ABX464), a first-in-class oral miR-124 enhancer for moderately to severely active ulcerative colitis, with a Phase 2b program in Crohn's disease. Market cap ≈$7–8B. Based in Paris, France. Cash runway into Q4 2027 (€491.6M as of March 31, 2026). Pre-revenue; entire valuation driven by obefazimod NDA pathway and FDA approval probability.