Michele

[S A I ™️ @WallStSai]

$ABVX ABIVAX’S $920 MILLION CASH RAISE LETS IT PREPARE FOR SOLO U.S. LAUNCH INSTEAD OF RELYING ON A BUYER, CEO MARC TELLS CNBC

https://t.co/aYdqESjwSC

[MASi @TOWiU2]

Best defense is the offense, says Abivax CEO after takeover speculation https://t.co/1bNnaDQXRp $ABVX

[Michele @mic_h_el]

@Azzurri si, continuiamo a vivere di ricordi; semplicemente ridicoli e senza vergogna

[Monaco @monaco_biotech]

$XENE has shown remarkable performance in recent days. Will this name (one of my top 5 positions) soon see the buyout it deserves ? The price trend is too noticeable. But don't listen to me - I'm just biased 😅

[Seedy19 @seedy19tron]

***Blockbuster binary, long idea***
It’s almost $TENX time, which to me is the cleanest shot at the 1st win in PH HFpEF.

Oral levosimendan (Levo) in PH-HFpEF. Topline Aug (should be before the ESC abstracts drop imho)
Pure binary +300% / -80%
FDOS ~$750m.

My base case: LEVEL hits primary >60%. Consensus sits ~40%.

PH-HFpEF is the most common form of pulmonary hypertension. Multibillion market, ~2M+ US pts, zero approved therapies, high mortality.

$INSM $ABVX $MDGL and a host of other binaries in the recent past where consensus said the drug wouldn’t work for various reasons. $TENX going into this feels like a similar setup, but with huge upside.

So getting into it. First it’s important to note that the defining lesion is NOT the pulmonary artery. It’s the exercise induced spike in wedge pressure. On exertion splanchnic vasoconstriction auto transfuses blood from the abdomen into the chest. Lungs flood. Wedge, PA and RA pressure surge. As a result the pt can’t walk.
^the disease in short
(Borlaug Circ HF 2010; Yaku/Fudim/Shah J Cardiol 2024)

One fact to hold onto, it decides everything below. HFpEF pts still recruit cardiac output on exercise. They are NOT flow limited. Their limiter is the congestion, so the job is to decongest, not to pump harder.

Every drug that failed here fixed the wrong node. Riociguat, macitentan, sildenafil: lowered PVR/PA pressure, never touched the wedge, no 6mwd benefit. Some risked pulmonary edema pushing more flow into a stiff LV.
Relaxin: dropped MAP. Wrong prong.
Milrinone, dobutamine: raised output via cAMP with an O2/arrhythmia/mortality tax. Wrong lever in a preserved EF heart.

So what does a real 6mwd win actually need in preserved EF disease?
•↓ wedge/RAP (decongest)
•preserved CO reserve (not augmented)
•stable MAP
•no O2/arrhythmia tax

Every failure violated a prong. Levo is the only agent that checks all four, and here’s the part almost nobody gets right…

Levo isn’t one mechanism, it’s 2, and only one of them matters here.
Vascular effect: K-ATP venodilation → less blood volume in the chest → lower wedge. This is a property of the vessels not the ventricle, so it’s EF independent. It ports from HFrEF to HFpEF unchanged. It is the effect the disease needs.
Inotropic effect: Ca sensitization → more output. Shows up in low output HFrEF because those hearts are flow starved. In HFpEF it didn’t show. CO was flat in HELP at rest and exercise, and that is fine because HFpEF doesn’t need it as I mentioned above.

So when you read “levo is a dangerous inodilator flogging a stiff heart” know it’s dead on arrival. There was zero inotropy in HELP. No extra squeeze. No O2 demand spike. The benefit came from decongestion (Burkhoff ESC HF 2021: mechanism is stressed blood volume reduction, no inotropy).

The vascular effect also has a second arm. K-ATP opening drives pulmonary vasodilation AND antiproliferation. Glibenclamide blocked in the monocrotaline model (Intensive Care Med 2011). It replaces the K-ATP downregulation seen in PH remodeling. And Ca sensitization does earn its keep in one spot: RV support, no calcium overload no O2 cost.

The target also has drug independent human proof of concept. SVC balloon occlusion and acute splanchnic nerve block both drop filling pressures with preserved output (Fudim/Burkhoff JACC HF 2020/2021). HELP’s levo curves are near superimposable on the nerve block curves. Same signature, different tool.

Now HELP honestly, because the bears live here. The hemodynamic primary (exercise wedge at 6 weeks) missed. p=0.65… they stop there. They shouldn’t. READ the paper. The 6 week cath was done a full week after the last weekly infusion, at OR-1896 (the active metabolite) trough. Drug basically gone. The authors say so directly and say greater effects would show with drug on board.
(Burkhoff JACC HF 2021; restated in the LEVEL design paper J Card Fail 2025)

[Bloomberg @business]

Biotech dealmaking has hit a “torrid pace” in 2026, with more transactions exceeding $1 billion already completed this year than in all of 2025 combined, says Krishna Veeraraghavan, co-head of global M&A at Paul Weiss https://t.co/E8D4RkJaXC

[Michele @mic_h_el]

@RafaelFontana intanto v'ha purgato!

[Michel Doepke @doepke_michel]

$KYTX should soon be trading well above $10. The company has an exciting platform (CAR-T for autoimmune diseases), with its first approval on the horizon. For me, it's a top long-term investment (like $CRNX was...).

[Bio Stocks™ @BioStocks]

$RLAY initiated with an Overweight at JPMorgan. PT $28

[Michele @mic_h_el]

$OVID taps Kevin Norrett as CBO — led Soleno’s sale to Neurocrine. Clear signal: Ovid gearing up for BD/deal activity

[quantumup @Quantumup1]

Oppenheimer reiterated $CMPS Outperform-$20 and said—We view the Ph3 COMP006 26-week data as reinforcing the durable efficacy profile of COMP360 (psilocybin), representing a transformative approach for the ~4M addressable TRD patients.
$JNJ $DFTX HELP
Oppenheimer added—CMPS previously observed 26-week durability in the Ph3 COMP005 study, and now shows consistent results for this second pivotal study with ~30% of responders achieving remission following re-treatment in the Part-B portion.

We believe these data strengthen the overall dataset that could support the first-ever FDA approval for a classical psychedelic while informing real-world expectations.

CMPS remains on track to complete its rolling NDA submission in 4Q26 with potential launch likely in 1H27 following DEA rescheduling.

We believe the commercial opportunity remains undervalued.

Our psychedelics expert panel provided insights on regulatory and commercial dynamics, affirming our bullish outlook.

COMP360 (psilocybin) provides a transformational approach for TRD patients.
Ph3 COMP006 trial Part-A previously showed rapid onset of efficacy with COMP360 25mg driving -3.8pts MADRS score reduction vs. 1mg low-dose active-control (p<0.001) at the week-6 primary endpoint, and patients continued to week-26 with potential for re-treatment. Ph3 COMP005 Part-B data previously supported expectations for 26-week durability with maintained or improved response upon one additional dose.
Ph3 COMP006 26-week data now reinforce the durable efficacy profile.
CMPS observed maintained separation for COMP360 25mg vs. 1mg active-control through the blinded COMP006 study Part-B portion with 39% of patients sustaining a clinically meaningful MADRS score reduction of ≥25% by week-26, while 28% of responders notably entered remission following re-treatment.

We believe these findings support ~3-4x annual dosing with flexibility for real-world practice.

Safety data appear consistent and differentiated.
COMP360 demonstrated a favorable safety profile with no new findings through 26 weeks in this second registrational Ph3 study. CMPS notes most TEAEs were transient while consisting of expected events including nausea, headache, anxiety, and visual hallucinations. SAE rates remained low and balanced between treatment arms.

We expect the safety database with >1K patients to facilitate FDA review.

We believe the Ph3 program supports the regulatory outlook.

CMPS expects to complete its rolling NDA submission in 4Q26 followed by potential launch in 1H27, although plans for launch readiness by YE26 considering potential accelerated timelines with the CNPV that could enable a shortened review while DEA rescheduling occurs within 90 days following potential FDA approval.
We believe CMPS applied lessons from the Lykos CRL.

We see underappreciated commercial advantages for COMP360.
Management identifies ~7.5K existing clinics for Spravato and outlined priorities for the launch including physician education and payor discussions.
CMPS expects Category-III CPT codes to facilitate reimbursement for the entire ~6-hour treatment session, and sees advantages of fewer patients occupying treatment rooms which circumvents friction arising from turnover.

We anticipate CMPS to unlock value upon commercial execution.

[Michele @mic_h_el]

@seedy19tron @statnews Hi friend, have a look at $JBIO

[Bio Stocks™ @BioStocks]

$PRAX and Remagine Labs Announce Strategic Collaboration to Develop Transdermal Ulixacaltamide for Essential Tremor.
Praxis to make equity investment in Remagine Labs

https://t.co/FOYA8nSaH3

[zohm @zohmbastic]

$ABCL
Benchmark upgraded AbCellera (ABCL) to Buy from Hold with an $11 price target. The company's recent development agreement with Jazz Pharmaceuticals (JAZZ), which includes $56M in upfront payments for the first two discovery and early-stage programs and an additional $28 million due when a third discovery program is started, is the first new agreement in a number of years and a deal which is expected to increase revenues in the near- and medium terms, the analyst tells investors.

[Michele @mic_h_el]

$CMPS COMP360 COMP006 26-wk data confirm durable TRD benefit, clean safety. NDA on track Q4’26, launch H1’27

[HODOR @Maximus_Holla]

$CMPS

[Michel Doepke @doepke_michel]

Myricx Bio to be Acquired by $NVS to Advance Next-Generation ADC Payloads for Oncology with Novel NMTi Platform for up to $1.5 billion including $1.1 billion cash upfront plus potential milestone payments. https://t.co/QusSz2yQup

[Bio Stocks™ @BioStocks]

Drugmaker Ipsen Sees More Deals Coming to Continue Buying Spree. $XBI

'We are going to continue to see what we can add to rare liver, but we are looking at adjacent areas. We have a lot of firepower left' - CFO

https://t.co/6l5vVBN6fn

[HODOR @Maximus_Holla]

$TENX we have a date now!
this will make it more interesting for run up!
Abstract recently submitted in anticipation of initial data analysis ahead of ESC

Company expects to report topline LEVEL results in August

CHAPEL HILL, N.C., July 02, 2026 (GLOBE NEWSWIRE) -- Tenax Therapeutics, Inc. (Nasdaq: TENX) (“Tenax” or “Tenax Therapeutics” or the “Company”) announced today that results from the Phase 3 LEVEL clinical trial will be presented in a Late-Breaking Clinical Science session at the European Society of Cardiology (ESC) Congress 2026, being held August 28-31 in Munich, Germany.

In anticipation of potentially receiving topline results from the LEVEL clinical trial in time for presentation at ESC, an abstract was recently submitted. The Company now expects to report data in August 2026, and in the weeks ahead will proceed towards the planned database lock and statistical analysis.

Presentation Details

Title: “Levosimendan in patients with pulmonary hypertension due to heart failure with preserved ejection fraction: results of the LEVEL trial”
Presenter: Professor Sanjiv Shah, MD, Northwestern University
Presentation Date/Time: Saturday, 29 August 2026, 11:15-11:30 CEST
Location: Messe München GmbH, Munich, Germany

[Michele @mic_h_el]

$ABVX nears $11 billion valuation after fundraising eases M&amp;A pressure https://t.co/ibr2kZNAXO