Longeveron Inc (LGVN)

[shurtha2000]

Above average volume the past few trading days

[shurtha2000]

This mother was $50 not too long ago

[81vette]

institutions loading up,nhod,ka-freaking-BOOM!!!

[81vette]

ZERO BORROW,just now out of shares,1st time in year history,buckle up!!!

[81vette]

5m float,short 166k shares,197Xs ave volume should push this way up!!

[heyitsmeagain]

$LGVN 5000 shares holding for 2x at least

[heyitsmeagain]

Looking for $5

[heyitsmeagain]

Load up! Gonna fly

[help me]

Insiders are selling great sign of a good company. (NOT)

Hartold

[vhgier]

After hours just took off last 5 minutes of trading......

[subslover]

U.S. Food and Drug Administration (FDA) Grants Fast Track Designation for Longeveron’s Lomecel-B™ Product for Treatment of Hypoplastic Left Heart Syndrome (HLHS) in Infants
August 31 2022 - 08:30AM
GlobeNewswire Inc.
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Longeveron Inc. (NASDAQ: LGVN) ("Longeveron" or "Company"), a clinical stage biotechnology company developing cellular therapies for chronic aging-related and life-threatening conditions, today announced the U.S. Food and Drug Administration (FDA) has granted Fast Track Designation to Lomecel-B™ for the treatment of Hypoplastic Left Heart Syndrome (HLHS), a rare and life-threatening congenital heart defect affecting approximately 1,000 infants per year. Lomecel-B™, an investigational allogeneic, bone marrow-derived medicinal signaling cell (MSC) product, is currently in a Phase 2a trial for HLHS.
Fast Track Designation is intended to facilitate development and expedite the review of drugs that treat serious conditions and fill an unmet medical need so a product can potentially be approved and reach patients more quickly. Fast Track Designation enables the company to have more frequent interactions with the FDA throughout the drug development process and allows for eligibility for priority review and accelerated approval if certain criteria are met, as well as a rolling review. The Fast Track Designation must continue to be met or FDA can withdraw the designation. The FDA previously granted Longeveron’s Lomecel-B™ Orphan Drug and Rare Pediatric Disease designations in November of 2021 for HLHS.

“Fast Track Designation represents a significant milestone in our efforts to develop Lomecel-B™ as a treatment for infants with HLHS,” said Chris Min, M.D., Ph.D., Longeveron’s Interim Chief Executive Officer and Chief Medical Officer. “Fast Track Designation underscores the urgent need in HLHS, and we look forward to continuing to work closely with the FDA to bring this potential new therapy to infants as expeditiously as possible.”

HLHS is a rare congenital heart defect that affects approximately 1,000 babies per year in the U.S. Infants born with HLHS have an underdeveloped or absent left ventricle, which impairs the heart’s ability to pump adequate amounts of blood throughout the body. Patients require three reconstructive heart surgeries within the first five years of life, and many require a heart transplant. Without treatment, the condition is always fatal. Even with reconstructive surgical interventions, HLHS is still associated with high mortality. Overall survival from birth to adolescence is estimated to be 50% to 60%.

Longeveron is currently evaluating Lomecel-B™ in ELPIS II, an ongoing 38-patient, randomized (1:1), blinded, controlled Phase 2a clinical trial intended to evaluate the safety and efficacy of intramyocardial (directly into the heart) injection of the Lomecel-B™ product in infants with HLHS who are undergoing Stage II reconstructive cardiac surgery. In ELPIS, a Phase 1 open-label trial in ten HLHS patients, Lomecel-B™ was found to be well tolerated with no major adverse cardiac events one-year post-surgery, and/or treatment-related infections.

One hundred percent of the infants enrolled in the ELPIS Phase 1 trial (n=10) were alive and had not required a transplant between 2-3.5 years post-surgery. Normally, approximately 20% of patients require heart transplants to survive within one year of Stage II reconstructive surgery. Longeveron recently announced the release of a manuscript entitled “Intramyocardial cell-based therapy during bidirectional cavopulmonary anastomosis for hypoplastic left heart syndrome: The ELPIS phase I trial” on MedRxiv, a preprint server that posts papers before they are peer reviewed. The paper will now undergo peer review prior to publication of the final study report.

About Longeveron Inc.

Longeveron is a clinical stage biotechnology company developing cellular therapies for specific aging-related and life-threatening conditions. The Company’s lead investigational product is the Lomecel-B™ cell-based therapy product, which is derived from culture-expanded medicinal signaling cells (MSCs) that are sourced from bone marrow of young, healthy adult donors. Longeveron believes that by using the same cells that promote tissue repair, organ maintenance, and immune system function, it can develop safe and effective therapies for some of the most difficult disorders associated with the aging process and other medical disorders. Longeveron is currently sponsoring Phase 1 and 2 clinical trials in the following indications: Alzheimer’s disease, hypoplastic left heart syndrome (HLHS), Aging Frailty, and Acute Respiratory Distress Syndrome (ARDS). Additional information about the Company is available at www.longeveron.com.

[Anite]

https://finance.yahoo.com/news/longeveron-receives-intent-grant-notice-120000981.html

Issued claims will protect use of a biomarker to assess response to Lomecel-B™ in patients with blood vessel dysfunctionMIAMI, Aug. 25, 2022 (GLOBE NEWSWIRE) -...

[Roadtojourney]

Makes no sense, whats wrong with you pos management?? Market goes up this pos goes down.

[pinkslipjunkie]

It looks like this little piggy stayed home.

This little piggy went to market.
This little piggy stayed home.
This little piggy had roast beef.
This little piggy had none.
This little piggy went
Wee wee wee
All the way home.

[Roadtojourney]

Common man atleast go with the market pos??

[Roadtojourney]

Common most of pos stocks doubled 1 more will not hurt?? Imo

[pinkslipjunkie]

Been watching this move all around on tiny volume...if big volume hits I can see this busting into the 20s again

[timetomakemoney]

Looking for a pullback. around 6

[dennisv]

Keep It Low And Wait For The Breakout!

[timetomakemoney]

Agree, CLOV did the same thing destroyed the upwarded movement and PPS dropped 75 percent. I believe the same thing with PPS can happen with LGVN.

[TheFinalCD]

so many holes to leak from



NO DOUBT THIS WAS A NEFARIOUS move

A $50M OFFERING doesnt happen overnight

there are plenty of people that knew

and plenty of ways to get leaked

[dinogreeves]

There it goes, another one bites the dust. Stop loss took me out at 14.

[Roadtojourney]

Or the news was leaked?? Todays action should be investigated?? Imo

[TheFinalCD]

makes me think the people involved with the offering helped run it up, to short it back

[TheFinalCD]

$50M Offering https://ih.advfn.com/stock-market/NASDAQ/longeveron-LGVN/stock-news/87764259/securities-registration-statement-simplified-form

[TheFinalCD]

check the S-3 Filing


Message in reply to:

And back to where it was, seems like theres more shares in mkt than before?? Imo

[Roadtojourney]

And back to where it was, seems like theres more shares in mkt than before?? Imo

[TheFinalCD]

CONGRAT$

[dennisv]

Is Attached!

[dennisv]

We Are Back In Town!

[dennisv]

Breakthrough!

[dennisv]

A Lot Of Interest!

[dennisv]

Just Carry On!

[Pedro2004]

I made $1,100 of the play

[dennisv]

Recovery Day!!!

[THEMASTERS_SON]

,,,,,,,They wanna take this pos to $11

[dinogreeves]

Both

[conix]

Was wondering when profit taking would begin. But the biotechs are beginning to move up across the board

[Roadtojourney]

Pos, they keep shorting or dumping imo

[dinogreeves]

Could see 20 premarket and make a run to 22, will hold for the next two weeks, possible 40-50 with decent volume in the couple of weeks. The setup is similar to SAV*A.....

[Marvy]

Phase 2 already commenced December 2021

[bobbyinredwood]

There’s a very small float and that will lend itself to bigger swings, in both directions.

[dennisv]

Partnership And/Or Takeover Is A Logical Consequence!

[dennisv]

Partnership And/or Takeover Is A Logical Consequence!

[goingUPagain]

Float is so low.. 50 possible..imo

[Nealmi1971]

Yes we going to run it up.

[Marvy]

This is about to burst upwards IMO

[Roadtojourney]

Where are all these shares coming from??

[Sibware]

LGVN: Psar flipped on the 30' now

[TheFinalCD]

wow LGVN 16z aGAIN


wish some other plays bounced like this


SMH