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      6. Humacyte Inc (HUMA)

      7. Humacyte Inc (HUMA) News

      Humacyte Inc

      Humacyte Inc (HUMA)

      NASDAQ
      4.39
      -0.22
      (-4.77%)
      Closed January 13 4:00PM
      Delayed by 15 minutes
      4.44
      0.05
      (1.14%)
      After Hours: 7:38PM
      Delayed by 15 minutes

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      HUMA News

      Official News Only

      Form 4 - Statement of changes in beneficial ownership of securities
      Edgar (US Regulatory)
      September 03 2024
      HUMA (-4.77%)

      HUMA Discussion

      View Posts
      roadkilll roadkilll 1 week ago
      Acellular Tissue Engineered Vessels - ATEV
      FDA approved as safe and effective in human use

      Vascular Trauma - big step in validation of ATEV and future indications

      * Dialysis (AV access) - phase III study completed and proved safe and effective
      * Peripheral Artery Disease - just a matter of time for approval as same technology for vascular Trauma
      * Coronary Artery Bypass Grafting (CABG) - same technology works here as in vascular Trauma. Around 400,000 patients yearly.
      .
      This would all be low hanging fruit now that ATEV is FDA approved and are just a matter of patience. The technology has potential well beyond ATEV.
      👍️0
      Tiger Money Tiger Money 2 weeks ago
      Very nice DD
      👍️0
      Rubraquercus Rubraquercus 2 weeks ago
      1. Assigned Priority Review Designation by Secretary of Defense under Law 115-92 which is used for military purposes. mrdc.health.mil/index.cfm/a...

      2. In the latest Humacyte slide deck it says "Humacyte expects DOD to stockpile for deployment to sites of conflicts.

      3. The Phase 2/3 clinical data included wartime injuries in both Ukraine, and Israel the two largest warzones right now.

      4. In this article from 10/16/24 CEO Laura says the Department of Defense "Sponsored some of their trials". ncchamber.com/2024/10/16/du...

      5. Received RMAT designation only given to products with an "unmet need" in the field fda.gov/vaccines-blood-biol....

      6. The DOD gave them $1,000,000 Grant in 2017 Through the Medical Technology Enterprise Consortium (MTEC).

      7. The DOD gave them $3,400,000 Contract Award through the BAA to support the Phase 2 studies. biospace.com/humacyte-award...
      👍️ 2
      Rubraquercus Rubraquercus 2 weeks ago
      In 2010, the HUMA co-founder and CEO, Dr. Laura Niklason and her colleagues were able to successfully produce an engineered rat lung that could inhale and exhale carbon dioxide.

      Her work on lab-grown lungs was recognized as one of the top 50 most important inventions of 2010 by Time magazine.[3][4] Niklason was included on Fortune’s “Digital Health Care Leaders” list in 2017 for her work in regenerative medicine.

      en.wikipedia.org/wiki/Laura...
      👍️ 1
      threebabiesbusy threebabiesbusy 3 weeks ago
      Humacyte price target raised to $17 from $15 at Benchmark. Looking forward to 2025. Insider buying and pt upgrades bode well for positive moves going forward.
      GLTA
      3
      👍 1
      sblzng sblzng 3 weeks ago
      It's gonna go .Interest is picking up and more buys than sells
      👍️0
      Monksdream Monksdream 3 weeks ago
      HUMA under $5

      [color=red][/color]
      👍️0
      threebabiesbusy threebabiesbusy 3 weeks ago
      Wainwright analyst Vernon Bernardino raised the firm's price target on Humacyte (HUMA) to $15 from $12 and keeps a Buy rating on the shares after the FDA granted full approval for Symvess for use in adults as a vascular conduit for extremity arterial injury when urgent revascularization is needed to avoid imminent limb ...
      👍️0
      threebabiesbusy threebabiesbusy 3 weeks ago
      Let's push through the $4.80 wall!
      👍️0
      threebabiesbusy threebabiesbusy 3 weeks ago
      awww so you're out. Looks difficult for afternoon move up
      👍️0
      threebabiesbusy threebabiesbusy 3 weeks ago
      We're trading substantially below days VWAP....
      👍️0
      threebabiesbusy threebabiesbusy 3 weeks ago
      Lunch time pull back. Do you anticipate afternoon trend back up? Or do we call it one and done!
      👍️0
      TrendTrade2016 TrendTrade2016 3 weeks ago
      EXITED ON THAT PUSH BOTTOM BOUNCE
      👍️0
      Tiger Money Tiger Money 3 weeks ago
      Love having you back.  You are one of the smartest traders out there.  Unfortunately you like to be mean to less intelligent people 😝.  Anyways, how far do you think this could run?  Thanks
      👍️0
      FooBarAndGrill FooBarAndGrill 3 weeks ago
      Now, reality bites.
      Cash and time to ramp up.
      Will vascular surgeons switch from the old and familiar?
      TBD.
      👍️0
      TrendTrade2016 TrendTrade2016 3 weeks ago
      HUMA READY TO RUN AGAIN
      👍️0
      Tiger Money Tiger Money 3 weeks ago
      Finally!
      👍️ 1
      FooBarAndGrill FooBarAndGrill 4 weeks ago
      Approved
      https://investors.humacyte.com/news-releases/news-release-details/humacyte-announces-fda-approval-symvesstm-acellular-tissue
      👍️ 1
      FooBarAndGrill FooBarAndGrill 1 month ago
      Today is Dec 9th. Dec 9th marks 10 months since HUMA's PDUFA application.
      FDA has performance goals. For regular PDUFA applications the goal is 90% within 10 months.
      FDA performance goals: https://www.fda.gov/media/151712/download
      👍️0
      FooBarAndGrill FooBarAndGrill 1 month ago
      I don't know of any. But you can roll your own using eg. Amazon Transcribe.
      👍️0
      tm100 tm100 1 month ago
      Is there a transcript available anywhere? Have not had any success finding a transcript
      👍️0
      Tiger Money Tiger Money 1 month ago
      Good news that they don't pull the plug.  This will be accepted by RFK less than a month in office 
      👍️0
      FooBarAndGrill FooBarAndGrill 1 month ago
      The FDA is the wall. She can't say anything.
      Adding that FDA has performance goals which, in this case, are not being met.
      👍️0
      Tiger Money Tiger Money 1 month ago
      You say ok.  So everything is moving forward with the fda still?  Thanks 
      👍️0
      FooBarAndGrill FooBarAndGrill 1 month ago
      Webcast OK. Direct questions and direct answers.
      👍️0
      FooBarAndGrill FooBarAndGrill 1 month ago
      Supplemental BLA. Discussed during webcast.
      Replay is up. https://investors.humacyte.com/news-events/events-and-presentations
      👍️0
      Tiger Money Tiger Money 1 month ago
      If they are selling for any other reason than to keep it below 5%, there will be a ton of lawsuits....
      👍️0
      FooBarAndGrill FooBarAndGrill 1 month ago
      Stonewalled.
      The family sold with the excuse to reduce below 5% holding. That's no excuse at all. They're still insiders and know exactly what's up.
      👍️0
      Tiger Money Tiger Money 1 month ago
      Crazy
      👍️0
      FooBarAndGrill FooBarAndGrill 2 months ago
      $HUMA It's all in the family:
      Mr. Dougan is married to Dr. Niklason and Mr. Dougan has sole voting and dispositive power over the shares held by Ayabudge LLC. By virtue of these relationships, Mr. Dougan may be deemed to share beneficial ownership of the securities held of record by Dr. Niklason, The Niklason Living Trust and Ayabudge LLC.
      👍️0
      Tiger Money Tiger Money 2 months ago
      Great color!  Time for the fda to let this run
      👍️0
      roadkilll roadkilll 3 months ago
      Department of Defense's priority designation is a strong tell about the future of civilian use.
      "Humacyte is currently evaluating the HAV in a phase 2/3 clinical trial in vascular trauma for use as a vascular replacement to restore blood flow to a limb when saphenous veins or synthetic grafts are not feasible. The HAV has received priority designation for the treatment of vascular trauma by the United States Secretary of Defense."
      Sept 22, 2023 article
      .
      after approval expect a quick order from DOD
      👍️0
      roadkilll roadkilll 3 months ago
      A RMAT designation allows for accelerated approval based surrogate or intermediate endpoints. RMAT goes beyond breakthrough therapy features by allowing for accelerated approval of drugs based on surrogate endpoints. A surrogate endpoint is a biomarker that substitutes for a direct endpoint, such as clinical benefit.
      .
      FDA has awarded Humacyte for two indications.
      👍️0
      Monksdream Monksdream 3 months ago
      HUMA under $6
      👍️0
      FooBarAndGrill FooBarAndGrill 3 months ago
      Has ANYTHING changed?
      August 9, 2024 “We received a call from FDA CBER leadership this afternoon apologizing to us and stating that additional time was required for review.”
      👍️0
      Tiger Money Tiger Money 4 months ago
      This company has a lot going for it, that is for sure
      👍️0
      FooBarAndGrill FooBarAndGrill 4 months ago
      Humacyte up today on genuinely positive SA piece.
      https://seekingalpha.com/article/4722917-humacyte-navigating-the-fda-uncertainty-and-atevs-potential
      👍️0
      Tiger Money Tiger Money 4 months ago
      Very nice!
      👍️0
      Sirpeter Sirpeter 4 months ago
      Wynn for the win...my horse is coming in
      👍️0
      Tiger Money Tiger Money 4 months ago
      Great to hear from you. I bought a bunch of calls for 5 cents here for he t week expiry. I can only hope Christmas comes early…
      👍️0
      Sirpeter Sirpeter 4 months ago
      How are ya bud...been busy...Sept sucks for stocks...only holding some WYNN calls until interest rate cuts on the 18th...have to remember to ck in once in here a while lol...hope all is good with you...talk again soon
      👍️0
      Tiger Money Tiger Money 4 months ago
      You still around? I have a feeling go time could be soon but fda always has em all by the balls ….
      👍️0
      Tiger Money Tiger Money 4 months ago
      Likey or dislikey? Just waiting on fda. Tech is there, proven and safe. A lot of limbs/lives saved in Ukraine because of humacyte
      👍️0
      Monksdream Monksdream 4 months ago
      HUMA under $7

      👍️0
      Tiger Money Tiger Money 5 months ago
      Their product is amazing. Will help so many people
      👍️0
      Tiger Money Tiger Money 5 months ago
      Great stuff and that is what I see too. Thanks!
      👍️0
      Sirpeter Sirpeter 5 months ago
      I sold my options here and bought shares...they're cheap
      👍️0
      Stern is Bald Stern is Bald 5 months ago
      Very promising stock and the is an opportunity to buy the dip big time..
      👍️0
      Tiger Money Tiger Money 5 months ago
      Ok, now that is cleared up. In all seriousness, looking for your thoughts on huma . Thanks and appreciate and hope we can work together to make some $
      👍️0
      Stern is Bald Stern is Bald 5 months ago
      Just nonsensical jibberish about deep state blah blah blah… either wat i am 90% of tuning out the knuckleheads on this site… glad you put it out there like that easier to know not to take anything from you very seriously…
      👍️0

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