1/ US biotech is in crisis, right before AI should be saving millions.
China is stealing away our industry and has surpassed the US in blockbuster pharma deals.
The next FDA Commissioner must be a fighter, and have a plan to overhaul the agency, beat China, and unleash cures.
🇺🇸 🇨🇳 I was on @foxnewsnight tonight discussing something that should concern every American in the context of the U.S.-China summit.
For decades, the United States has led the world in biotechnology. Cell & gene therapies & advanced biologics — the medicines of the future — are finally delivering real hope to patients with diseases that were once untreatable or incurable. These are not incremental improvements. They are transformative.
But here’s the reality we can no longer ignore: roughly half of the global investment capital in advanced biotechnology is now flowing to China.
This isn’t just about money or market share. It’s about who will control the next generation of life-saving treatments. When capital, talent, & manufacturing shift overseas, American patients lose access, American innovation slows, and our strategic position in one of the most important industries of the 21st century erodes.
China is not playing by the same rules. They are moving aggressively to dominate cell and gene therapy, while we continue to tie ourselves in regulatory knots and send mixed signals to the companies trying to develop these therapies here at home.
We cannot afford to watch this happen. The patients who are waiting — children with rare genetic diseases, adults facing terminal conditions, families desperate for options — don’t care about bureaucracy or politics. They care about whether these treatments reach them in time.
The FDA has an essential role to play in this moment. We must modernize our approach so that we can accelerate safe and effective innovation here in America, while maintaining the rigorous standards that have made our system the global gold standard. If we fail to do this, we will not only lose our leadership — we will fail the very patients we are supposed to serve.
In my career, I’ve seen what’s possible when regulation keeps pace with science, and I’ve seen what happens when it doesn’t.
The video of my appearance is below 👇 . I’d love to hear your thoughts.
𝐂𝐨𝐦𝐩𝐚𝐧𝐲 𝐍𝐞𝐰𝐬: @Solid_Bio's CEO @bocumbo discusses recent DMD data for the company's microdystrophin gene therapy, and explains the development and regulatory steps ahead. $SLDB
Full video: https://t.co/kiJnhdJ52O
One of our nation’s soldiers has fallen in service to our country. Behind every uniform is a family who now carries the weight of that sacrifice.
Your generosity will help ensure they know their loved one’s sacrifice will never be forgotten. #WarEagle
https://t.co/rbfrbtulxn
Just out in @NeurosurgeryCNS, a study led by @MarkD_Jr (@NeurosurgeryOSU), demonstrates the feasibility, effectiveness and efficiency of robot-assisted placement of convection-enhanced delivery cannulas in the brain. This advance can streamline and enhance direct infusion of therapeutics to the brain.
#neurosurgery #CED #GeneTherapy @OhioStateMed@OSUWexMed@Solid_Bio@CNS_Update@OSUGeneTherapy
https://t.co/3foM9shapb
Any help would be appreciated. I have known Paul for decades and this must have been tough to ask for help.
Paul is facing a tough time with health issues and housing challenges. His car is essential for medical visits and job searches. https://t.co/0aArbcsrHq
I will pay this young man to come to Jordan-Hare next week to watch @AuburnFootball play, and he must cheer for the @GeorgiaFootball team. This could be our key to victory. #WarEagle Go Tigers!
We mourn the loss of 2000 SEC Player of the Year Rudi Johnson.
One of the best to ever wear the orange and blue.
Rudi's family, friends & teammates are in our prayers.
#WarEagle🦅
NEW: Man has been charged with k*lling a retired Auburn University professor who was found dead at dog a park
Auburn Police arrested Harold Rashad Dabney III of Montgomery
Dabney is charged with two counts of capital m*rder
Dr. Julie Gard Schnuelle, 59, was found dead in a wooded area of Kiesel Park on Saturday, September 6
Dr. Schnuelle taught at Auburn University’s College of Veterinary Medicine
Police said her injuries indicate she was assaulted
Breaking News: The FDA has granted Fast Track designation to SGT-501, our novel, AAV-based investigational gene therapy for the treatment of catecholaminergic polymorphic ventricular tachycardia (#CPVT).
Read the full release: https://t.co/w07NsaJfuy
$SLDB
Solid is pleased to share the approval of our Investigational New Drug application by the FDA and clinical trial application by Health Canada for SGT-501, a novel gene therapy approach for the treatment of catecholaminergic polymorphic ventricular tachycardia (CPVT).
Learn more: https://t.co/pPFZTHMeHp
#CPVT $SLDB
Fundraiser by Aunt JeaJea : In Memory of Antonio: Easing the Financial Burden. Any help for this family in need would be appreciated. https://t.co/fR5k4B7JEZ
🧪 The Most Miserable Place on Earth: Biotech
Preclinical?
🗣️ “It’s just an idea.”
Phase 1?
🗣️ “Sell the dream.”
Phase 2?
🗣️“Sample’s too small. Biomarkers don’t count. Comparator’s weak. etc etc ”
Phase 3?
🗣️ “It’ll never be a product. Market’s too crowded..”
FDA approval?
🗣️ “Payers won’t cover it.”
Launch?
🗣️ “The sales force is weak. Label’s too narrow. Competitors are coming.”
$1B in sales?
🗣️ “Growth is capped. Margins are falling. Patent cliff incoming.”
📉 Welcome to biotech investing:
Where skepticism compounds faster than revenue.
$CLYM welcomes biotech veterans Kim Cobleigh Drapkin, CPA and Bo Cumbo to BOD. Their insights will be instrumental as we evolve into a late-stage, pre-commercial company committed to transforming the lives of patients with immune-mediated diseases.
Read: [Insert Link]
𝐂𝐨𝐦𝐩𝐚𝐧𝐲 𝐍𝐞𝐰𝐬: @Solid_Bio's CEO @bocumbo discusses today's data release of the company's microdystrophin gene therapy candidate for Duchenne muscular dystrophy. $SLDB
Full video: https://t.co/UOFyzVzMJZ
@Gantosj I am very sorry for your loss @jennmcnary and Max. Austin was a radiant spirit that touched so many lives. May he rest in peace. My thoughts are with you and your family.
Many of us who have been long-time and dedicated $SRPT investors have experienced numerous events over the years, but we all remember the first FDA Adcom meeting vividly. Families and their children took center stage, fighting passionately for their lives and the DMD community.
We all recall the seven kids, including @jennmcnary, who fought tirelessly for many years alongside her two sons, Austin and Max, leaving a lasting impression in our hearts.
We understand the harsh reality of #DMD, a cruel disease that often takes these young men in their 20s, leaving behind hope for a cure.
This weekend, I learned that the DMD community lost a bright light—Austin. The sweet, smiling kid who grew into a mature young man and a strong, vocal advocate for DMD. Austin dedicated himself to helping other kids and families navigate the tough road that every DMD patient faces.
We will always remember Austin as the kid with a smile and the fighter young man who made a difference in the lives of many.
Jenn, words cannot express how sorry I am for the loss of Austin, stay strong for Max & remember the good years Austin gave your family.
Rest in peace, Austin.
ICYMI: The FDA has granted Fast Track designation to SGT-212, our gene therapy candidate for Friedreich's ataxia (FA). SGT-212 is the first and only dual-route FA gene therapy designed to address the underlying cause of the disease by restoring frataxin protein levels through both intradentate nucleus (IDN) and intravenous (IV) infusions.
Read the full release: https://t.co/anbHBzModL
Solid was founded by those directly impacted by rare diseases, and a decade later, our passion for patient-centricity remains strong. To those living with #FriedreichsAtaxia, your courage drives us. We're excited to advance SGT-212 to the clinic later this year, with hopes it will make a difference for FA patients.
Learn more: https://t.co/imahxioHtw
@CureFA_org #SlowStopReverse #CureFA