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Related links

3/20/2017 (Humacyl):
https://www.businesswire.com/news/home/20170320005777/en/Humacyte-Receives-FDA-Regenerative-Medicine-Advanced-Therapy-RMAT-Expedited-Review-Designation-for-HUMACYL®-in-Vascular-Access-for-Hemodialysis

4/17/2017 (RVT-802:
https://enzyvant.com/enzyvant-receives-fda-designations/

5/2/2017 (jCell):
https://www.biospace.com/article/jcyte-receives-regenerative-medicine-advanced-therapy-designation-/

5/10/2017 (Ixmyelocel-T):
https://investors.vcel.com/news-releases/news-release-details/vericel-receives-fda-regenerative-medicine-advanced-therapy-rmat

7/18/2017 (approved as StrataGraft):
https://www.prnewswire.com/news-releases/us-fda-designates-mallinckrodts-stratagraft-as-regenerative-medicine-advanced-therapy-300489200.html

2017 (UD):
https://www.globenewswire.com/en/news-release/2017/08/22/1091116/0/en/Mustang-Bio-Commences-Trading-on-the-NASDAQ-Global-Market.html

9/20/2017 (ATIR101):
https://www.businesswire.com/news/home/20170919006698/en/Kiadis-Pharma-Receives-FDA-Regenerative-Medicine-Advanced-Therapy-RMAT-Designation-for-ATIR101™

10/1/2017 (LentiGlobin approved as Zynteglo for the treatment of beta thalassaemia):
https://www.raps.org/news-and-articles/news-articles/2019/5/regulatory-intelligence-update-on-regenerative-me

10/2/2017 (AST-OPC1):
https://www.globenewswire.com/news-release/2017/10/02/1138619/0/en/Asterias-Announces-Two-Significant-Developments-for-Spinal-Cord-Injury-Program.html

10/5/2017 (MultiStem):
https://seekingalpha.com/news/3299585-fda-designates-athersys-multistem-cell-therapy-for-accelerated-approval-shares-ahead-8

11/1/2017 (JCAR017):
https://www.businesswire.com/news/home/20171101006552/en/Juno-Therapeutics-Reports-Third-Quarter-2017-Financial-Results

11/8/2017 (CEVA101):
https://www.fortressbiotech.com/news-media/press-releases/detail/42/fortress-biotech-announces-cellvations-ceva101-granted

12/21/2017 (MPC-150-IM):
https://www.globenewswire.com/news-release/2017/12/21/1268818/0/en/Mesoblast-Receives-FDA-Regenerative-Medicine-Advanced-Therapy-Designation-for-Its-Cell-Therapy-in-Heart-Failure-Patients-With-Left-Ventricular-Assist-Devices.html

1/29/2018 (EB-101):
https://investors.abeonatherapeutics.com/press-releases/detail/109/abeona-receives-fda-regenerative-medicine-advanced-therapy

2/5/2018 (CAP-1002):
https://www.globenewswire.com/news-release/2018/02/05/1333106/29467/en/Capricor-Receives-FDA-Regenerative-Medicine-Advanced-Therapy-RMAT-Designation-for-Duchenne-Muscular-Dystrophy-Therapy.html

3/9/2018 (AminoFix Injectable):
https://mimedx.gcs-web.com/news-releases/news-release-details/amniofixr-injectable-granted-regenerative-medicine-advanced

4/23/2018 (ABO-102):
https://investors.abeonatherapeutics.com/press-releases/detail/123/abeona-announces-fda-grants-rmat-designationto-abo-102

May 2018 (VM-202):
https://www.raps.org/news-and-articles/news-articles/2019/5/regulatory-intelligence-update-on-regenerative-me

2000 (US$53 M):
https://www.fool.com/investing/2018/05/17/sangamo-therapeutics-stock-history.aspx

6/14/2018 (NSR-REP1):
https://www.globenewswire.com/en/news-release/2018/06/14/1524448/0/en/Nightstar-Therapeutics-Receives-Regenerative-Medicine-Advanced-Therapy-RMAT-Designation-for-NSR-REP1-in-Choroideremia.html

6/19/2018 (CLBS14):
https://www.globenewswire.com/news-release/2018/06/19/1526396/18623/en/Caladrius-Receives-FDA-Regenerative-Medicine-Advanced-Therapy-Designation-for-CD34-Cell-Therapy-for-Treating-Refractory-Angina.html

6/21/2018 (VY-AADC):
https://www.globenewswire.com/en/news-release/2018/06/21/1527729/36461/en/Voyager-Therapeutics-Announces-FDA-Regenerative-Medicine-Advanced-Therapy-RMAT-Designation-Granted-for-VY-AADC-for-the-Treatment-of-Parkinson-s-Disease.html

7/2/2018 (Romyelocel-L):
https://www.businesswire.com/news/home/20180702005248/en/Cellerant-Therapeutics-Inc.-Announces-FDA-Grants-Regenerative-Medicine-Advanced-Therapy-RMAT-Designation-for-Romyelocel-L-to-Prevent-Infections-During-Neutropenia

8/21/2018 (AT132):
https://www.prnewswire.com/news-releases/audentes-announces-regenerative-medicine-advanced-therapy-rmat-designation-granted-by-the-fda-to-at132-for-the-treatment-of-x-linked-myotubular-myopathy-300699224.html

10/11/2018 (Lifileucel):
https://www.globenewswire.com/news-release/2018/10/11/1620273/0/en/Iovance-Biotherapeutics-Reports-Results-from-FDA-End-of-Phase-2-meeting-and-Provides-Updates-About-the-Company-s-Clinical-Program.html

10/29/2018 (Avance Nerve Graft):
https://ir.axogeninc.com/press-releases/detail/849/avance-nerve-graft-receives-regenerative-medicine

11/5/2018 (P-BCMA-101):
https://investors.poseida.com/news-releases/news-release-details/poseida-therapeutics-receives-regenerative-medicine-advanced/

11/27/2018 (RP-L102):
https://ir.rocketpharma.com/news-releases/news-release-details/rocket-pharmaceuticals-receives-fda-regenerative-medicine/

4/18/2019 (FCR-001):
https://talaristx.com/2019/04/talaris-therapeutics-inc-announces-promising-phase-2-data-of-novel-allogeneic-cell-therapy-in-living-donor-kidney-transplant-recipients/

4/23/2019 (ECT-001):
https://www.globenewswire.com/news-release/2019/04/23/1807869/0/en/ExCellThera-s-lead-technology-ECT-001-receives-FDA-Regenerative-Medicine-Advanced-Therapy-RMAT-designation.html

May 2019 (Alofisel):
https://www.takeda.com/newsroom/newsreleases/2022/alofisel-darvadstrocel-shows-clinical-remission-rate-at-six-months-in-the-real-world-inspire-study-interim-analysis-consistent-with-the-pivotal-clinical-admire-cd-study/

5/29/2019 (FCX-007):
https://www.globenewswire.com/en/news-release/2019/05/29/1856272/33272/en/Fibrocell-Receives-FDA-Regenerative-Medicine-Advanced-Therapy-Designation-for-FCX-007-Gene-Therapy-for-the-Treatment-of-RDEB.html

6/11/2019 (Posoleucel):
https://ir.allovir.com/news-releases/news-release-details/allovir-announces-viralym-m-granted-regenerative-medicine/

6/24/2019 (KB103):
https://ir.krystalbio.com/news-releases/news-release-details/krystal-biotech-announces-positive-results-phase-2-clinical

7/5/2019 (SB-525):
https://investor.sangamo.com/news-releases/news-release-details/sangamo-and-pfizer-announce-updated-phase-12-results-sb-525

7/29/2019 (OTL-103):
https://ir.orchard-tx.com/news-releases/news-release-details/orchard-therapeutics-announces-fda-regenerative-medicine/

8/22/2019 (MB-107):
https://ir.mustangbio.com/news-events/press-releases/detail/68/mustang-bio-and-st-jude-childrens-research-hospital

9/4/2019 (MGTA-456):
https://investor.magentatx.com/news-releases/news-release-details/magenta-therapeutics-announces-fda-regenerative-medicine/

9/20/2019 (SB623):
https://www.pharmaceutical-business-review.com/news/sanbio-rmat-sb623-cell-therapy/

10/28/2019 (CT053):
https://www.prnewswire.com/news-releases/carsgen-announces-investigational-car-t-therapy-ct053-granted-rmat-designation-by-the-us-fda-for-rr-multiple-myeloma-300945966.html

12/3/2019 (ADP-A2M4):
https://www.adaptimmune.com/investors-and-media/news-center/press-releases/detail/11/regenerative-medicine-advanced-therapy-designation-granted

2/27/2020 (TT11):
https://www.thepharmaletter.com/article/tessa-picks-up-rmat-designation-for-novel-car-t-cell-candidate

4/16/2020 (TTAX02):
https://www.prnewswire.com/news-releases/tissuetech-receives-regenerative-medicine-advanced-therapy-rmat-designation-from-us-food-and-drug-administration-301042276.html

4/22/2020 (FDA-approved as Kymriah):
https://www.novartis.com/news/media-releases/novartis-kymriah-receives-fda-regenerative-medicine-advanced-therapy-designation-follicular-lymphoma

5/6/2020 (Ilixadencel):
https://www.globenewswire.com/news-release/2020/05/06/2028129/0/en/Immunicum-AB-publ-Receives-Regenerative-Medicine-Advanced-Therapy-Designation-from-FDA-for-Ilixadencel-in-Kidney-Cancer.html

5/11/2020 (CTX001):
https://crisprtx.com/about-us/press-releases-and-presentations/crispr-therapeutics-and-vertex-pharmaceuticals-announce-fda-regenerative-medicine-advanced-therapy-rmat-designation-granted-to-ctx001-for-the-treatment-of-severe-hemoglobinopathies

9/22/2020 (MDR-101):
https://www.medeortx.com/news/pr-2020-09-22.php

9/23/2020 (MultiStem):
https://www.athersys.com/investors/press-releases/press-release-details/2020/FDA-Grants-RMAT-Designation-to-MultiStem-Cell-Therapy-for-the-Treatment-of-Acute-Respiratory-Distress-Syndrome/default.aspx

10/14/2020 (Orca-T):
https://www.globenewswire.com/news-release/2020/10/14/2108307/0/en/Orca-Bio-Receives-Regenerative-Medicine-Advanced-Therapy-RMAT-Designation-for-Orca-T.html

11/11/2020 (AB205):
https://angiocrinebioscience.com/news-events/news/

12/17/2020 (AMDC-USR):
https://www.biospace.com/article/fda-grants-rmat-designation-for-cook-myosite-s-investigational-autologous-muscle-derived-cells-for-urinary-sphincter-repair/

1/11/2021 (ReNu):
https://organogenesis.com/news-events/press-release-01112021.html

3/8/2021 (valoctocogene roxaparvovec):
https://investors.biomarin.com/2021-03-08-BioMarin-Announces-FDA-Regenerative-Medicine-Advanced-Therapy-RMAT-Designation-Granted-to-Valoctocogene-Roxaparvovec-Investigational-Gene-Therapy-for-Hemophilia-A

3/9/2021 (RP-L201):
https://ir.rocketpharma.com/news-releases/news-release-details/rocket-pharmaceuticals-receives-fda-regenerative-medicine-0/

4/21/2021 (ALLO-715):
https://ir.allogene.com/news-releases/news-release-details/allogene-therapeutics-announces-fda-regenerative-medicine/

Oct 2021 (REACT):
https://investors.prokidney.com/news-releases/news-release-details/prokidney-corroborates-mechanism-action-reacttm-cell-marker

11/22/2021 (CTX110):
http://ir.crisprtx.com/news-releases/news-release-details/crispr-therapeutics-announces-fda-regenerative-medicine-advanced/

12/13/2021 (FT516):
https://ir.fatetherapeutics.com/news-releases/news-release-details/fate-therapeutics-highlights-positive-durability-response-data

2022 SPAC merger (UD):
https://medcitynews.com/2022/01/regenerative-med-biotech-prokidney-inks-825m-merger-to-back-ckd-cell-therapy/

1/5/2022 (Posoleucel):
https://ir.allovir.com/news-releases/news-release-details/fda-grants-regenerative-medicine-advanced-therapy-rmat/

1/10/2022 (CT041):
https://www.prnewswire.com/news-releases/carsgen-announces-ct041-car-t-cell-product-candidate-granted-rmat-designation-by-the-fda-301456859.html

1/12/2022 (C-CAR039):
https://www.cellbiomedgroup.com/newsroom/fda-rmat?lang=en

2/14/2022 (AProArt):
https://www.ucsf.edu/news/2022/02/422276/ucsf-gene-therapy-deadly-mutation-fast-tracked-fda-review

4/12/2022 (Exoflo):
https://directbiologics.com/fda-grants-direct-biologics-regenerative-medicine-advanced-therapy-rmat-designation-for-the-use-of-exoflo-in-covid-19-related-ards/

4/20/2022 (Posoleucel):
https://ir.allovir.com/news-releases/news-release-details/fda-grants-regenerative-medicine-advanced-therapy-rmat-0/

4/25/2022 (Obe-cel):
https://autolus.gcs-web.com/news-releases/news-release-details/fda-grants-regenerative-medicine-advanced-therapy-rmat/

5/13/2022 (SkinTE):
https://www.prnewswire.com/news-releases/polarityte-announces-fda-regenerative-medicine-advanced-therapy-designation-granted-to-skinte-301546677.html

5/24/2022 (NeoCart):
https://ir.ocugen.com/news-releases/news-release-details/ocugen-announces-new-cell-therapy-program-following-fda/

6/8/2022 (ALLO-501A):
https://ir.allogene.com/news-releases/news-release-details/allogene-therapeutics-announces-fda-granted-regenerative/

9/28/2022 (CTX130):
https://crisprtx.com/about-us/press-releases-and-presentations/crispr-therapeutics-announces-fda-regenerative-medicine-advanced-therapy-rmat-designation-granted-to-ctx130-for-the-treatment-of-cutaneous-t-cell-lymphomas-ctcl

11/8/2022 (ADP-A2M4CD8):
https://www.adaptimmune.com/investors-and-media/news-center/press-releases/detail/234/adaptimmune-reports-increased-response-rate-and-durability

11/29/2022 (CB-010):
https://investor.cariboubio.com/news-releases/news-release-details/caribou-biosciences-announces-fda-granted-regenerative-medicine/

1/26/2023 (rebonuputemcel):
https://www.discgenics.com/news-posts/2023/1/26/discgenics-announces-fda-regenerative-medicine-advanced-therapy-rmat-designation-granted-to-idct-for-degenerative-disc-disease

2/7/2023 (RP-A501):
https://ir.rocketpharma.com/news-releases/news-release-details/rocket-pharmaceuticals-receives-fda-regenerative-medicine-1/

2/8/2023 (rexlemestrocel-L):
https://www.globenewswire.com/en/news-release/2023/02/08/2604535/0/en/FDA-Grants-Regenerative-Medicine-Advanced-Therapy-Rmat-Designation-for-Rexlemestrocel-L-in-Chronic-Low-Back-Pain.html

2/11/2023 (CT103A):
https://www.iasobio.com/phone/info.php?id=215

3/21/2023 (NTLA-2002):
https://ir.intelliatx.com/news-releases/news-release-details/intellia-therapeutics-announces-fda-regenerative-medicine

5/4/2023 (HAV):
https://www.globenewswire.com/news-release/2023/05/04/2661452/0/en/Humacyte-s-Human-Acellular-Vessel-HAV-Receives-FDA-s-Regenerative-Medicine-Advanced-Therapy-RMAT-Designation-for-Urgent-Arterial-Repair-Following-Vascular-Trauma.html

5/23/2023 (RP-L301):
https://ir.rocketpharma.com/news-releases/news-release-details/rocket-pharmaceuticals-receives-fda-regenerative-medicine-2/

5/24/2023 (RGX-121):
https://www.prnewswire.com/news-releases/regenxbio-receives-fda-regenerative-medicine-advanced-therapy-rmat-designation-for-rgx-121-gene-therapy-for-hunter-syndrome-301831944.html

1997 (US$20 M):
https://investors.vcel.com/node/11886/html

1999 (US$58 M):
https://www.bioworld.com/articles/392839-biomarin-completes-58m-ipo-as-first-product-nears-market?v=preview

2004 (US$21 M):
https://www.intelligentinvestor.com.au/shares/asx-msb/mesoblast-limited/float

2007 (US$56 M):
https://www.pehub.com/tigenix-ipo-prices-in-brussels/

2007 Reverse merger (UD):
https://www.cleveland.com/business/2007/06/athersys_goes_public_in_revers.html

2008 (UD):
https://roic.ai/company/IOVA

2008 Reverse merger (UD):
https://www.biospace.com/article/mimedx-announces-post-split-name-change-/

2011 Reverse merger (UD):
https://www.cfodive.com/news/reverse-merger-helped-recession-hit-axogen-regain-footing/602531/

2013 (SEK 21 M):
https://www.marketscreener.com/quote/stock/MENDUS-AB-PUBL-17946401/news/Immunicum-AB-has-completed-an-IPO-in-the-amount-of-SEK-21-40-million-39111826/

2013 (US$116 M):
https://investor.bluebirdbio.com/news-releases/news-release-details/bluebird-bio-announces-closing-initial-public-offering-and

2013 (US$40 M):
https://www.fiercebiotech.com/r-d/fate-ipo-flop-raises-fresh-concerns-about-investors-appetite-for-biotech

2013 Reverse merger (UD):
https://www.biospace.com/article/china-s-b-cellular-biomedicine-group-b-announces-reverse-merger-/

2013 Reverse merger (UD):
https://www.businesswire.com/news/home/20131121005377/en/Capricor-and-Nile-Therapeutics-Complete-Merger-to-Form-Capricor-Therapeutics-Inc.

2014 (US$265 M):
https://www.fiercebiotech.com/r-d/updated-juno-banks-a-265m-ipo-pushing-next-big-thing-oncology

2015 (US$124 M):
https://www.businesswire.com/news/home/20150408005269/en/SanBio-Announces-Pricing-of-Initial-Public-Offering-on-Tokyo-Stock-Exchange

2015 (US$159 M):
https://www.globenewswire.com/news-release/2015/09/22/770163/10150220/en/REGENXBIO-Announces-Closing-of-Initial-Public-Offering-and-Full-Exercise-of-Underwriters-Option-to-Purchase-Additional-Shares.html

2015 (US$191 M):
https://www.nasdaq.com/articles/adaptimmune-therapeutics-prices-upsized-ipo-17-high-end-range-2015-05-05

2015 (US$36 M):
https://www.fiercebiotech.com/r-d/kiadis-banks-36m-a-euro-ipo-to-fund-its-stem-cell-r-d

2015 (US$5.5 M):
https://www.prnewswire.com/news-releases/asterias-biotherapeutics-completes-public-offering-and-private-placement-of-common-stock-300033976.html

2015 (US$81 M):
https://ir.voyagertherapeutics.com/news-releases/news-release-details/voyager-therapeutics-announces-closing-initial-public-offering/

2016 (US$113 M):
https://ir.intelliatx.com/news-releases/news-release-details/intellia-therapeutics-announces-closing-initial-public-offering

2016 (US$56 M):
https://www.fiercebiotech.com/biotech/crispr-therapeutics-raises-a-56m-ipo-but-patent-battles-potential-stock-drops-loom

2016 (US$75 M):
https://pitchbook.com/newsletter/audentes-raises-75m-in-ipo

2016 Acquired by Mallinckrodt (UD):
https://www.fiercebiotech.com/medical-devices/mallinckrodt-acquires-regenerative-medicine-company-stratatech

2017 (US$46 M):
https://www.globenewswire.com/en/news-release/2017/09/22/1131592/0/en/Krystal-Biotech-Announces-Closing-of-Initial-Public-Offering-and-Full-Exercise-of-Underwriters-Option-to-Purchase-Additional-Shares.html

2017 (US$77 M):
https://www.globenewswire.com/en/news-release/2017/10/02/1139020/0/en/Nightstar-Announces-Closing-of-Initial-Public-Offering-and-Full-Exercise-of-Underwriters-Option-to-Purchase-Additional-American-Depositary-Shares.html

2017 Reverse merger (UD):
https://www.globenewswire.com/news-release/2017/04/07/1052850/0/en/PolarityTE-TM-Inc-Announces-Completion-of-Merger-and-Acquires-Important-Intellectual-Property-for-Regenerative-Medicine-Programs.html

2018 (US$100 M):
https://www.businesswire.com/news/home/20180625006210/en/Magenta-Therapeutics-Announces-Closing-of-Initial-Public-Offering

2018 (US$160 M):
https://autolus.gcs-web.com/news-releases/news-release-details/autolus-announces-closing-initial-public-offering-and-full/

2018 (US$225 M):
https://ir.orchard-tx.com/news-releases/news-release-details/orchard-therapeutics-announces-closing-225-million-initial/

2018 (US$373 M):
https://ir.allogene.com/news-releases/news-release-details/allogene-therapeutics-announces-closing-initial-public-offering/

2018 Acquired by Celgene (US$9,000 M):
https://www.geekwire.com/2018/juno-therapeutics-acquired-celgene-9b-dramatic-deal-rising-biotech-star/

2018 Acquired by Takeda Pharmaceutical Company (US$608 M):
https://www.pharmaceutical-technology.com/news/takeda-tigenix-acquisition-608m/

2018 Reverse merger (UD):
https://endpts.com/gene-therapy-startup-rocket-pharma-reverse-merges-with-troubled-inotek-after-25m-raise/

2018 Reverse merger (UD):
https://organogenesis.com/news-events/press-release-12102018.html

2019 Acquired by Biogen (US$800 M):
https://investors.biogen.com/news-releases/news-release-details/biogen-completes-acquisition-nightstar-therapeutics

2019 Acquired by BioTime (UD):
https://www.spglobal.com/marketintelligence/en/news-insights/trending/dgy96s7WowE7oCnW-Mu7KA2

2019 Acquired by Castle Creek Pharmaceutical (US$63 M):
https://www.globenewswire.com/en/news-release/2019/09/12/1915187/33272/en/Castle-Creek-Pharmaceutical-Holdings-to-Acquire-Fibrocell.html

2019 Acquired by Sumitomo Dainippon Pharma (UD):
https://enzyvant.com/sumitomo-dainippon-pharma-completes-the-formation-of-the-strategic-alliance-with-roivant-sciences/

2019 Reverse merger (UD):
https://www.nbcphiladelphia.com/news/local/malvern-gene-therapy-company-completes-reverse-merger/219782/

2020 (US$224 M):
https://investors.poseida.com/news-releases/news-release-details/poseida-therapeutics-announces-pricing-initial-public-offering/

2020 (US$318 M):
https://www.globenewswire.com/en/news-release/2020/08/03/2072010/0/en/AlloVir-Announces-Closing-of-Upsized-Initial-Public-Offering-and-Full-Exercise-of-the-Underwriters-Option-to-Purchase-Additional-Shares.html

2020 Acquired by Astellas Pharma (US$3,000 M):
https://www.spglobal.com/marketintelligence/en/news-insights/trending/VpqpVltOd5YKifSvTvBf2A2

2021 (US$150 M):
https://ir.talaristx.com/news-releases/news-release-details/talaris-therapeutics-announces-closing-initial-public-offering/

2021 (US$304 M):
https://www.businesswire.com/news/home/20210727006010/en/Caribou-Biosciences-Announces-Closing-of-Upsized-Initial-Public-Offering

2021 (US$400 M):
https://www.bioworld.com/articles/508424-car-t-developer-carsgen-debuts-on-hkex-with-400m-ipo-targets-bcma-first?v=preview

2021 Acquired by consortium (US$411 M):
https://www.prnewswire.com/news-releases/cellular-biomedicine-group-inc-announces-completion-of-merger-301231873.html

2021 Acquired by Sanofi (US$358 M):
https://www.fiercebiotech.com/biotech/sanofi-inks-358m-kiadis-takeover-to-acquire-nk-cell-platform

2021 Reverse merger (UD):
https://www.marketscreener.com/quote/stock/HUMACYTE-INC-126300449/news/Humacyte-Inc-completed-the-acquisition-of-Alpha-Healthcare-Acquisition-Corp-from-a-group-of-share-36263997/

2022 Acquired by Canaria Bio (UD):
https://www.koreabiomed.com/news/articleView.html?idxno=20085

2022 Merger with Cend Therapeutics (UD):
https://www.globenewswire.com/en/news-release/2022/09/15/2516989/18623/en/Caladrius-Biosciences-and-Cend-Therapeutics-Announce-Closing-of-Merger-and-the-Emergence-of-Lisata-Therapeutics.html

20 cellular and gene therapy products:
https://www.fda.gov/vaccines-blood-biologics/cellular-gene-therapy-products/approved-cellular-and-gene-therapy-products

21 CFR 312:
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRsearch.cfm?CFRPart=312

525 non-regenerative-medicine drugs:
https://www.fda.gov/drugs/development-approval-process-drugs/new-drugs-fda-cders-new-molecular-entities-and-new-therapeutic-biological-products

7% in bank fees for a US$100 million IPO:
https://news.crunchbase.com/public/want-to-take-your-startup-public-heres-what-it-actually-costs-to-ipo/

86 RMAT designations:
https://www.fda.gov/vaccines-blood-biologics/cellular-gene-therapy-products/cumulative-cber-regenerative-medicine-advanced-therapy-rmat-designation-requests-received-fiscal

a list and ranking of incubators and accelerators worldwide:
https://www.andeglobal.org/publication/the-ubi-global-world-rankings-of-business-incubators-and-accelerators/

a US$20 million award from the California Institute for Regenerative Medicine (CIRM):
https://www.fiercebiotech.com/biotech/stemcells-inc-awarded-20-million-from-california-institute-for-regenerative-medicine-for

Abecma (2021):
https://www.fda.gov/news-events/press-announcements/fda-approves-first-cell-based-gene-therapy-adult-patients-multiple-myeloma

Accelerators:
https://www.feedough.com/accelerator-vs-incubator/

acquired by Celgene:
https://www.geekwire.com/2018/juno-therapeutics-acquired-celgene-9b-dramatic-deal-rising-biotech-star/

acquired by Mallinckrodt Pharmaceuticals:
https://www.fiercebiotech.com/medical-devices/mallinckrodt-acquires-regenerative-medicine-company-stratatech

acquired by Novartis:
https://www.novartis.com/news/media-releases/novartis-enters-agreement-acquire-avexis-inc-usd-87-bn-transform-care-sma-and-expand-position-gene-therapy-and-neuroscience-leader

acquired in a reverse merger:
https://www.businesswire.com/news/home/20190930005241/en/Ocugen-Announces-Completion-of-its-Merger-with-Histogenics-to-Create-Nasdaq-Listed-Clinical-Stage-Company-Developing-Novel-Ocular-Gene-Therapies-and-Biotherapeutics

acquired through a reverse merger:
https://www.massdevice.com/stemcells-soars-on-reverse-merger-with-israels-microbot-medical/

Adstiladrin (2022):
https://www.ferring.com/ferring-receives-approval-from-u-s-fda-for-adstiladrin-for-high-risk-bcg-unresponsive-non-muscle-invasive-bladder-cancer/

Amgen:
https://sciencebusiness.net/news/74714/UCL-spin-out-sold-to-Amgen-in-%241-billion-deal

amount for a seed round:
https://www.paddle.com/resources/guide-to-seed-funding-for-startups

Analysts consider:
https://www.statnews.com/2016/06/01/stem-cell-company-shutters

approved as Breyanzi:
https://news.bms.com/news/details/2021/U.S.-Food-and-Drug-Administration-Approves-Bristol-Myers-Squibbs-Breyanzi-lisocabtagene-maraleucel-a-New-CAR-T-Cell-Therapy-for-Adults-with-Relapsed-or-Refractory-Large-B-cell-Lymphoma/default.aspx

approved as Rethymic):
https://endpts.com/after-three-decades-and-a-surprise-rejection-first-treatment-for-babies-born-without-a-thymus-secures-fda-approval/

approved by the US Food and Drug Administration:
https://www.fda.gov/vaccines-blood-biologics/zolgensma

approved:
https://www.fda.gov/vaccines-blood-biologics/stratagraft

AProArt:
https://www.cirm.ca.gov/our-progress/awards/ex-vivo-transduction-human-artemis-dclre1c-cdna-lentiviral-vector-aproart-cd34

ATIR101:
https://www.cancer.gov/publications/dictionaries/cancer-drug/def/allodepleted-t-cell-immunotherapeutic-atir101

averages for VC series A, B, and C:
https://www.evaluate.com/vantage/articles/insights/venture-financing-ipo/venture-financing-holds-steady-device-makers

AveXis:
https://www.novartis.com/news/media-releases/novartis-enters-agreement-acquire-avexis-inc-usd-87-bn-transform-care-sma-and-expand-position-gene-therapy-and-neuroscience-leader

Baylor College of Medicine: https://elevate.bio/press-releases/elevatebio-announces-that-allovir-joins-its-portfolio-of-highly-innovative-cell-and-gene-therapy-companies/; https://www.tessacell.com/about-tessa-therapeutics/

BioVex:
https://mergr.com/amgen-acquires-biovex-group

BLA clinical review:
https://www.fda.gov/vaccines-blood-biologics/stratagraft

BLA pharmacology/toxicology review of StrataGraft:
https://www.fda.gov/vaccines-blood-biologics/stratagraft

Bluebird Bio (founded as Genetix Pharmaceuticals):
https://investor.bluebirdbio.com/news-releases/news-release-details/genetix-pharmaceuticals-renamed-bluebird-bio-announces

Breyanzi (2021):
https://news.bms.com/news/details/2021/U.S.-Food-and-Drug-Administration-Approves-Bristol-Myers-Squibbs-Breyanzi-lisocabtagene-maraleucel-a-New-CAR-T-Cell-Therapy-for-Adults-with-Relapsed-or-Refractory-Large-B-cell-Lymphoma/default.aspx

California Institute for Regenerative Medicine (CIRM):
https://www.cirm.ca.gov/

cartilage repair products:
https://www.fda.gov/regulatory-information/search-fda-guidance-documents/preparation-ides-and-inds-products-intended-repair-or-replace-knee-cartilage

Carvykti (2022):
https://www.jnj.com/u-s-fda-approves-carvykti-ciltacabtagene-autoleucel-janssens-first-cell-therapy-a-bcma-directed-car-t-immunotherapy-for-the-treatment-of-patients-with-relapsed-or-refractory-multiple-myeloma

Case Western Reserve University:
https://case.edu/medicine/about/newsroom/our-latest-news/case-western-reserve-center-stem-cell-and-regenerative-medicine-and-athersys-receive-1m-third-frontier-grant-support-research-spinal-cord-injury

cellular immunotherapy product Provenge:
https://stanmed.stanford.edu/pioneering-cancer-drug-provenge-fresh-look

CFR Title 21:
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/cfrsearch.cfm

CGT products: https://www.fda.gov/regulatory-information/search-fda-guidance-documents/preclinical-assessment-investigational-cellular-and-gene-therapy-products

Children’s Hospital of Philadelphia University of Pennsylvania:
https://www.chop.edu/news/childrens-hospital-philadelphia-celebrates-fda-approval-gene-therapy-inherited-blindness

City of Hope National Medical Center:
https://www.cityofhope.org/news/phase-1-clinical-trial-of-mb-101

clinical trials:
https://www.fda.gov/patients/clinical-trials-what-patients-need-know/what-are-different-types-clinical-research

completed an initial public offering (IPO):
https://www.globenewswire.com/en/news-release/2016/02/11/809635/0/en/AveXis-Announces-Pricing-of-Initial-Public-Offering.html

considered safety data generated from the phase I/IIa and phase II trials for an alternate indication:
https://www.fda.gov/vaccines-blood-biologics/stratagraft

convertible note:
https://www.investopedia.com/terms/s/senior-convertible-note.asp

Cooperative Patent Classification system:
https://www.cooperativepatentclassification.org/about

current Good Manufacturing Practice (cGMP) regulations:
https://www.fda.gov/drugs/pharmaceutical-quality-resources/current-good-manufacturing-practice-cgmp-regulations

Dilution of equity:
https://www.svb.com/startup-insights/startup-equity/startup-equity-dilution

Duke University, Massachusetts Institute of Technology:
https://wraltechwire.com/2021/02/18/a-blooming-success-the-rise-of-humacyte-from-humble-beginnings-to-1-1b-valuation/

Duke University:
https://endpts.com/after-three-decades-and-a-surprise-rejection-first-treatment-for-babies-born-without-a-thymus-secures-fda-approval/

Duke University:
https://endpts.com/after-three-decades-and-a-surprise-rejection-first-treatment-for-babies-born-without-a-thymus-secures-fda-approval/

‘End of Phase’ meetings:
https://www.fda.gov/vaccines-blood-biologics/cellular-gene-therapy-products/otp-ind-milestone-type-b-meetings

Enzyvant Therapeutics GmbH licenced the technology from Duke University:
https://www.prnewswire.com/news-releases/enzyvant-to-develop-novel-biologic-therapy-for-complete-digeorge-syndrome-300386922.html

established IP:
https://patents.justia.com/assignee/histogenics-corporation

exceeding US$20 billion in 2021:
https://alliancerm.org/sector-report/2021-annual-report/

excess of these amounts:
https://grants.nih.gov/grants/guide/notice-files/NOT-HL-22-065.html

FDA approval of JCAR017:
https://news.bms.com/news/details/2021/U.S.-Food-and-Drug-Administration-Approves-Bristol-Myers-Squibbs-Breyanzi-lisocabtagene-maraleucel-a-New-CAR-T-Cell-Therapy-for-Adults-with-Relapsed-or-Refractory-Large-B-cell-Lymphoma/default.aspx

Ferring Pharmaceuticals:
https://ferringusa.com/?press=ferring-and-blackstone-life-sciences-invest-over-570-million-usd-in-novel-gene-therapy-for-bladder-cancer-patients

Financial exit strategies:
https://www.investopedia.com/terms/b/business-exit-strategy.asp

founded in 2013:
https://www.prnewswire.com/news-releases/spark-therapeutics-launched-with-50-million-in-financing-to-advance-late-and-mid-stage-gene-therapy-programs-with-clinical-proof-of-concept-228752221.html

Fred Hutchinson Cancer Center, St Jude Children’s Research Hospital:
https://ir.mustangbio.com/news-events/press-releases/detail/68/mustang-bio-and-st-jude-childrens-research-hospital

Fred Hutchinson Cancer Research Center Memorial Sloan-Kettering Cancer Center Seattle Children’s Research Institute:
https://www.forbes.com/sites/matthewherper/2014/08/05/why-this-cancer-fighting-company-has-raised-300-million-in-just-12-months/

Fred Hutchinson Cancer Research Center Memorial Sloan-Kettering Cancer Center Seattle Children’s Research Institute University of California, San Francisco St Jude Children’s Research Hospital:
https://www.businesswire.com/news/home/20171101006552/en/Juno-Therapeutics-Reports-Third-Quarter-2017-Financial-Results

funding caps:
https://www.sbir.gov/about

Genesis Seed Fund:
https://research.rutgers.edu/researcher-support/commercialize-your-innovation/launch-startup/new-ventures/genesis-seed-fund

Gilead Sciences:
https://www.gilead.com/news-and-press/company-statements/kite-pharma

Harvard University, Massachusetts Institute of Technology:
https://news.mit.edu/2001/sicklecell

Harvard University, Washington University in St Louis, Stanford University, San Raffaele Telethon Institute for Gene Therapy, University of Basel:
https://investor.magentatx.com/news-releases/news-release-details/magenta-therapeutics-announces-485m-series-financing-transform/

Harvard University:
https://hsci.harvard.edu/company-startups

Harvard University:
https://hsci.harvard.edu/company-startups

Hemgenix (2022):
https://www.fda.gov/news-events/press-announcements/fda-approves-first-gene-therapy-treat-adults-hemophilia-b

highly competitive:
https://grantengine.com/sbir-sttr-paylines-by-nih-institute/

Imlygic (2015):
https://www.amgen.com/newsroom/press-releases/2015/10/fda-approves-imlygic-talimogene-laherparepvec-as-first-oncolytic-viral-therapy-in-the-us

INitial Targeted Engagement for Regulatory Advice on CBER/CDER ProducTs (INTERACT) meeting:
https://www.fda.gov/vaccines-blood-biologics/cellular-gene-therapy-products/otp-interact-meeting

interpretations of Section 506(g)(8) by the US Food and Drug Administration (FDA):
https://www.fda.gov/vaccines-blood-biologics/cellular-gene-therapy-products/resources-related-regenerative-medicine-therapies

‘inventive step’:
https://www.wipo.int/pct/en/texts/ispe/13_01_02.html

Investigational New Drug application:
https://www.fda.gov/vaccines-blood-biologics/stratagraft

IPO:
https://pitchbook.com/blog/ipo-process-explained

JLABS:
https://jnjinnovation.com/home

Johns Hopkins University:
https://www.sdbj.com/technology/capricor-therapeutics-relocates-la-jolla/

Johnson & Johnson:
https://johnsonandjohnson.gcs-web.com/news-releases/news-release-details/johnson-johnson-announces-completion-merger-centocor-inc/

Juno Therapeutics (founded as FC Therapeutics):
https://pitchbook.com/profiles/company/60580-27#overview

Juno Therapeutics:
https://www.geekwire.com/2018/juno-therapeutics-acquired-celgene-9b-dramatic-deal-rising-biotech-star/

Katholieke Universiteit Leuven Ghent University:
https://www.flandersinvestmentandtrade.com/invest/en/news/tigenix-raise-20-million-euro-product-trials

Kymriah (2017):
https://www.novartis.com/news/media-releases/novartis-receives-first-ever-fda-approval-car-t-cell-therapy-kymriahtm-ctl019-children-and-young-adults-b-cell-all-refractory-or-has-relapsed-least-twice

Kymriah:
https://www.fda.gov/vaccines-blood-biologics/cellular-gene-therapy-products/kymriah-tisagenlecleucel

Luxturna (2017):
https://sparktx.com/press_releases/fda-approves-spark-therapeutics-luxturna-voretigene-neparvovec-rzyl-a-one-time-gene-therapy-for-patients-with-confirmed-biallelic-rpe65-mutation-associated-retinal-dystrophy/

Luxturna to be approved by the US Food and Drug Administration:
https://sparktx.com/press_releases/fda-approves-spark-therapeutics-luxturna-voretigene-neparvovec-rzyl-a-one-time-gene-therapy-for-patients-with-confirmed-biallelic-rpe65-mutation-associated-retinal-dystrophy/

M&A:
https://www.sba.gov/business-guide/grow-your-business/merge-acquire-businesses

MACI (2016):
https://investors.vcel.com/news-releases/news-release-details/fda-approves-maci-treatment-symptomatic-cartilage-defects-knee

Mallinckrodt Pharmaceuticals:
https://mallinckrodt.gcs-web.com/news-releases/news-release-details/mallinckrodt-announces-us-fda-approval-stratagraftr-allogeneic/

Massachusetts Institute of Technology:
https://organogenesis.com/about-us/

Massachusetts Institute of Technology:
https://organogenesis.com/about-us/

MGTA-456:
https://investor.magentatx.com/news-releases/news-release-details/magenta-therapeutics-announces-updated-phase-2-data-mgta-456/

National Cancer Institute:
https://www.stocktitan.net/news/IOVA/iovance-biotherapeutics-announces-first-patient-randomized-in-phase-1fnhlejx69wn.html

Nationwide Children’s Hospital Ohio State University:
https://www.nationwidechildrens.org/newsroom/news-releases/2013/10/avexis-biolife-licenses-spinal-muscular-atrophy-sma-patent-portfolio-from-nationwide-childrens

Nationwide Children’s Hospital:
https://www.prnewswire.com/news-releases/abeona-therapeutics-and-nationwide-childrens-hospital-receive-prestigious-global-genes-champions-of-hope-award-for-patient-advocacy-227092241.html

NIH Data Management and Sharing Policy:
https://oir.nih.gov/sourcebook/intramural-program-oversight/intramural-data-sharing/2023-nih-data-management-sharing-policy

NIH’s Commercialization Readiness Pilot (CRP) programme:
https://seed.nih.gov/support-for-small-businesses/commercialization-enhancement-programs/crp

no major safety concerns were generated from the preclinical studies:
https://www.fda.gov/vaccines-blood-biologics/stratagraft

NSF-funded Innovation-Corps (I-Corps):
https://beta.nsf.gov/funding/initiatives/i-corps/about-i-corps

obtained Regenerative Medicine Advanced Therapy designation:
https://www.prnewswire.com/news-releases/us-fda-designates-mallinckrodts-stratagraft-as-regenerative-medicine-advanced-therapy-300489200.html

only the phase Ib and phase III trials were considered for efficacy:
https://www.fda.gov/vaccines-blood-biologics/stratagraft

Orca-T:
https://ashpublications.org/blood/article/140/Supplement1/654/487614/Precision-Engineered-Cell-Therapy-Orca-T

OTL-103:
https://ir.orchard-tx.com/news-releases/news-release-details/orchard-therapeutics-announces-fda-regenerative-medicine/

over 1,000 new devices:
https://www.fda.gov/about-fda/center-devices-and-radiological-health/cdrh-reports

University of Oxford, University of Pennsylvania:
https://www.adaptimmune.com/our-company

Patent Cooperation Treaty (PCT):
https://www.wipo.int/pct/en/faqs/faqs.html

peak sales forecast:
https://www.europeanpharmaceuticalreview.com/news/179320/cd19-car-t-agents-to-boost-blood-cancer-market/

Phase 0 grants:
https://www.sbir.gov/sites/default/files/SBIR-Table_StateMatchingPhase0_Sept2020.pdf

pledged a US$50 million commitment from the Children’s Hospital of Philadelphia:
https://www.prnewswire.com/news-releases/spark-therapeutics-launched-with-50-million-in-financing-to-advance-late-and-mid-stage-gene-therapy-programs-with-clinical-proof-of-concept-228752221.html

pre-IND meeting:
https://www.fda.gov/vaccines-blood-biologics/cellular-gene-therapy-products/otp-pre-ind-meetings

private equity (PE):
https://www.investopedia.com/terms/p/privateequity.asp

product revenue of Breyanzi:
https://bioprocessintl.com/bioprocess-insider/therapeutic-class/bms-sees-car-t-sales-rocket-in-line-with-increased-capacity/

Promotion and Tenure-Innovation and Entrepreneurship (PTIE) coalition:
https://ptie.org/

Provenge (2010):
https://stanmed.stanford.edu/pioneering-cancer-drug-provenge-fresh-look/

quality management system:
https://www.nidcr.nih.gov/sites/default/files/2017-12/quality-management-of-clinical-research-brief-overview.doc

raised a total of US$310 million:
https://www.crunchbase.com/organization/juno-therapeutics/company_financials

raised an additional US$72.8 million in series B funding:
https://www.prnewswire.com/news-releases/spark-therapeutics-raises-728-million-in-oversubscribed-financing-260806381.html

raised US$304 million through its initial public offering:
https://www.nasdaq.com/articles/juno-therapeutics-prices-upsized-ipo-24-largest-2014-biotech-ipo-22-billion-market-cap

reason for noncompliance:
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?CFRPart=312&showFR=1

Regenerative Medicine Advanced Therapy (RMAT) designation:
https://www.fda.gov/vaccines-blood-biologics/cellular-gene-therapy-products/regenerative-medicine-advanced-therapy-designation

Regenerative Medicine Minnesota:
https://www.regenmedmn.org/

Rethymic (2021):
https://enzyvant.com/enzyvant-receives-fda-approval-for-rethymic-allogeneic-processed-thymus-tissue-agdc-a-one-time-regenerative-tissue-based-therapy-for-pediatric-congenital-athymia/

reverse merger:
https://www.investopedia.com/terms/r/reversetakeover.asp

Rexlemestrocel-L:
https://go.drugbank.com/drugs/DB17606

Risk Evaluation and Mitigation Strategy programme:
https://www.fda.gov/drugs/drug-safety-and-availability/risk-evaluation-and-mitigation-strategies-rems

Roche:
https://technical.ly/startups/spark-therapeutics-acquired-roche-bill-marrazzo-university-city-science-center-gene-therapy/

Roughly 90% of applications filed are utility patents:
https://www.uspto.gov/web/offices/ac/ido/oeip/taf/data/patdesc.htm

San Raffaele-Telethon Institute for Gene Therapy:
https://ir.orchard-tx.com/news-releases/news-release-details/orchard-therapeutics-announces-fda-regenerative-medicine/

SBA loans:
https://www.sba.gov/funding-programs/loans

SBIR and STTR programmes:
https://www.sbir.gov/node/2120519

secondary public offerings:
https://www.cbinsights.com/research-what-is-a-secondary-offering

section 361:
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?CFRPart=1271

Section 506(g)(8) of the United States (US) Federal Food, Drug, and Cosmetic Act:
https://www.congress.gov/114/plaws/publ255/PLAW-114publ255.htm

Seoul National University:
https://www.koreabiomed.com/news/articleView.html?idxno=20085

settled a legal dispute:
https://www.wsj.com/articles/juno-therapeutics-settles-patent-dispute-with-novartis-1428326691

Several expedited programmes:
https://www.fda.gov/patients/learn-about-drug-and-device-approvals/fast-track-breakthrough-therapy-accelerated-approval-priority-review

SkinTE:
https://www.woundsource.com/product/skinte

Skysona (2022):
https://investor.bluebirdbio.com/news-releases/news-release-details/bluebird-bio-receives-fda-accelerated-approval-skysonar-gene

Spark Therapeutics:
https://sparktx.com/press_releases/spark-therapeutics-enters-into-definitive-merger-agreement-with-roche/

Stanford University:
https://orcabio.com/who-we-are/

Stanford University:
https://www.medeortx.com/about-us.php

StrataGraft (2021):
https://mallinckrodt.gcs-web.com/news-releases/news-release-details/mallinckrodt-announces-us-fda-approval-stratagraftr-allogeneic/

StrataGraft:
https://www.stratagraft.com/

Stratatech:
https://www.fiercebiotech.com/medical-devices/mallinckrodt-acquires-regenerative-medicine-company-stratatech

subsequently approved:
https://www.ns-healthcare.com/news/breyanzi-large-b-cell-lymphoma/

Sumitomo Pharma:
https://endpts.com/after-three-decades-and-a-surprise-rejection-first-treatment-for-babies-born-without-a-thymus-secures-fda-approval/

Tecartus (2020):
https://www.gilead.com/news-and-press/press-room/press-releases/2020/7/us-fda-approves-kites-tecartus-the-first-and-only-car-t-treatment-for-relapsed-or-refractory-mantle-cell-lymphoma

technology for Brenyanzi:
https://www.forbes.com/sites/matthewherper/2014/08/05/why-this-cancer-fighting-company-has-raised-300-million-in-just-12-months/?sh=449f6d8b50d5

technology for StrataGraft:
https://pathology.wisc.edu/2021/06/21/stratagraft-approved-by-fda/

technology of Zolgensma:
https://www.nationwidechildrens.org/newsroom/news-releases/2013/10/avexis-biolife-licenses-spinal-muscular-atrophy-sma-patent-portfolio-from-nationwide-childrens

three FDA-approved products:
https://www.fda.gov/vaccines-blood-biologics/cellular-gene-therapy-products/cber-regenerative-medicine-advanced-therapy-rmat-approvals

three types of patent:
https://www.uspto.gov/patents/basics/general-information-patents

“treat, modify, reverse, or cure a serious or life-threatening condition”:
https://www.fda.gov/vaccines-blood-biologics/cellular-gene-therapy-products/regenerative-medicine-advanced-therapy-designation

TT11:
https://www.tessacell.com/pipeline/

UniQure (founded as Amsterdam Molecular Therapeutics):
https://www.biopharmadive.com/news/hemophilia-gene-therapy-fda-approval-hemgenix-csl-uniqure/636999/

Université de Montréal University of Toronto:
https://www.signalsblog.ca/catching-up-with-excellthera-and-co-founder-guy-sauvageau/

University College London:
https://www.uclb.com/portfolio/our-spinouts/orchard-theapeutics-plc/

University of California San Diego (UCSD):
https://innovation.ucsd.edu/commercialize/licensing.html

University of California, Berkeley:
https://ipira.berkeley.edu/caribou-biosciences-inc

University of California, Berkeley:
https://ipira.berkeley.edu/intellia

University of California, Irvine:
https://innovation.uci.edu/2016/11/20161129special-feature-stem-cell-strides-asterias-biotherapeutics/

University of California, Irvine:
https://innovation.uci.edu/2020/06/uci-startup-company-jcyte-partners-with-santen-pharmaceutical/

University of California, Los Angeles:
https://labusinessjournal.com/news/arie-belldegrun/

University of California, Los Angeles:
https://www.biopharmadive.com/news/Kite-Pharma-UCLA-tcell-allogeneic/423263/

University of California, San Francisco:
https://www.ucsf.edu/news/2022/02/422276/ucsf-gene-therapy-deadly-mutation-fast-tracked-fda-review

University College London:
https://www.autolus.com/about-us/

University of Colorado University of Illinois at Chicago:
https://www.fiercebiotech.com/biotech/eye-specialist-ocugen-looks-east-for-second-round-fundraising

University of Eastern Finland:
https://www.uef.fi/en/article/university-of-eastern-finland-and-ferring-ventures-to-continue-collaboration-in-gene-and-cell

University of Florida:
https://ir.axogeninc.com/press-releases/detail/811/axogen-inc-receives-david-j-gury-company-of-the-year

University of Florida:
https://news.drgator.ufl.edu/2013/09/26/uf-teams-with-company-to-advance-gene-therapy-treatments/

University of Louisville:
https://www.uoflnews.com/post/uofltoday/uofl-born-company-secures-100-million-to-advance-cell-therapy/

University of Massachusetts University of California, San Francisco Stanford University:
https://www.umassmed.edu/es/news/news-archives/2014/02/voyager-therapeutics-targets-novel-gene-therapies-to-combat-diseases/

University of Minnesota:
https://www.nytimes.com/2002/12/11/business/technology-politically-correct-stem-cell-is-licensed-to-biotech-concern.html

University of Oxford:
https://www.ox.ac.uk/news/2015-11-09-£23-million-boost-oxford-spinout-company

University of Pennsylvania:
https://pci.upenn.edu/regenxbio-receives-fda-fast-track-designation-for-its-novel-gene-therapy-candidate/

University of Pennsylvania:
https://www.novartis.com/news/media-releases/novartis-kymriah-receives-fda-regenerative-medicine-advanced-therapy-designation-follicular-lymphoma

University of Pennsylvania:
https://www.pennmedicine.org/news/news-releases/2019/september/university-pennsylvania-announces-exclusive-alliance-novartis-development-new-focused-relationship

University of Washington, Children’s Hospital Boston Mass General Hospital for Children:
https://iscrm.uw.edu/fate-therapeutics-a-company-started-in-seattle-with-intellectual-property-from-iscrm-has-announced-its-first-clinical-trials/

University of Wisconsin:
https://pathology.wisc.edu/2021/06/21/stratagraft-approved-by-fda/

University of Wisconsin — Madison:
https://news.wisc.edu/gov-evers-state-leaders-tour-uw-biotech-spinoff-stratatech/

updated the US policy guidance:
https://www.whitehouse.gov/ostp/news-updates/2022/08/25/ostp-issues-guidance-to-make-federally-funded-research-freely-available-without-delay/

US$10 million in series C:
https://www.wsj.com/articles/DJFVW00120150109eb19ozrd9

US$13.1 million:
https://www.pehub.com/histogenics-adds-131-million/

US$34 million:
https://www.massdevice.com/histogenics-raises-34-million-after-prochon-biotech-merger/

US$49 million:
https://www.fiercebiotech.com/biotech/histogenics-closes-49-million-series-a-fundraising-to-support-commercial-development-of-0

US$5.35 million:
https://www.prweb.com/releases/2008/05/prweb908944.htm/

US$65 million in series D:
https://www.fiercebiotech.com/biotech/avexis-secures-65-million-financing

US$65 million through an initial public offering:
https://www.bizjournals.com/boston/blog/bioflash/2014/12/with-65m-offering-histogenics-becomes-states-17th.html

US$9.0 million:
https://www.fiercebiotech.com/biotech/histogenics-secures-9-million-second-round-of-financing

Vyjuvek (2023):
https://www.fda.gov/vaccines-blood-biologics/vyjuvek

Weizmann Institute:
https://www.haaretz.com/israel-news/2017-08-31/ty-article/kite-pharmas-success-is-nothing-compared-to-tevas-failure/0000017f-dbae-df9c-a17f-ffbef7f70000

Weill Cornell Medicine:
https://angiocrinebioscience.com/about-us/our-story/

Western New York Incubator Network SBIR/STTR assistance programme:
https://www.wnyincubators.com/sbir-sttr-assistance

Y Combinator Management:
https://www.ycombinator.com/

Yescarta (2017):
https://www.gilead.com/news-and-press/press-room/press-releases/2020/7/us-fda-approves-kites-tecartus-the-first-and-only-car-t-treatment-for-relapsed-or-refractory-mantle-cell-lymphoma

Zolgensma (2019):
https://www.novartis.com/news/media-releases/avexis-receives-fda-approval-zolgensma-first-and-only-gene-therapy-pediatric-patients-spinal-muscular-atrophy-sma

Zynteglo (2022):
https://investor.bluebirdbio.com/news-releases/news-release-details/bluebird-bio-announces-fda-approval-zynteglor-first-gene-therapy