David Nierengarten, Ph.D., is Managing Director and Head of Healthcare Equity Research at Wedbush Securities.
He mainly covers development-stage therapeutic companies. He began his career on the financial side of biotechnology at a venture capital firm that focused on early-stage therapeutic and medical device companies.
Additionally, prior to joining Wedbush, he worked in a clinical-stage, venture-backed biotechnology company, in business development and clinical trial operations. He received his bachelor’s degree in biochemistry from the University of Wisconsin-Madison and his Ph.D. in molecular and cell biology from the University of California-Berkeley.
In this 3,444 word interview, exclusively in the Wall Street Transcript, Dr. Nierengarten details his current biotech sector investment forecast.
“…There’s also been a resurgence in what I would call the next generation of cell therapies for cancer.
So moving beyond the initial approved autologous T cell, engineered T-cell therapies of Yescarta and Kymriah, and moving into allogeneic or more broadly applicable engineered cell technologies that could potentially treat a wider variety of cancers.
For example, Fate Therapeutics (NASDAQ:FATE) is working with pluripotent-derived natural killer cells — NK cells — in this area.
The other trend or noticeable events over the last few months are perhaps the little bit more scrutiny the FDA has applied to gene therapies, particularly ones where there are existing alternative therapies, such as the CRL — complete response letter — that was given to BioMarin (NASDAQ:BMRN) for Roctavian, their gene therapy for hemophilia.
That was a bit of a surprise to the industry generally. And I think probably speaks to a little bit more scrutiny specifically for diseases where there are existing therapies, and the FDA might want to have a bigger body of evidence for durable, lasting, meaningful clinical benefit for those kinds of therapies.”
Despite the greater FDA scrutiny for genetic therapies, Dr. Nierengarten sees potential in many biotech stocks:
“There are several throughout the space. First, on the genetic-medicine side, there are a couple of earlier stage, a couple of later stage, depending on investors’ appetites.
But one of the later-stage companies — it actually is going to be reporting data on September 9 — is AGTC (NASDAQ:AGTC), and they have a gene therapy for a rare retinal disease, X-linked retinitis pigmentosa, that should be progressing into a Phase III study by the end of the year.
It’s a pretty small market cap given the opportunity of several thousand patients with this rare form of disease that causes blindness in a relatively advanced stage of development.
Other genetic medicines, again, maybe more broadly applied, are some of the earlier-stage companies like Beam Therapeutics (NASDAQ:BEAM) that has a new gene-editing technology that they’re putting into the preclinical experiments right now.
And one that has a really broad potential: Generation Bio (NASDAQ:GBIO). That’s a recent IPO. And Generation Bio is really looking at eliminating a significant bottleneck in gene therapy, and that’s the virus sector.
So to deliver gene therapy, you need to genetically engineer a virus to deliver the genetic material to the cells. Generation Bio is looking to avoid that completely by packaging up the DNA and lipid nanoparticles, these little particles that they inject, and it gets into the cells, puts the genetic material in the cells to make a protein of interest that’s either defective in the patient or has other therapeutic value.
On the oncology side, a couple of names in the small-molecule-targeted therapies. One is Epizyme (NASDAQ:EPZM).
They have an approved drug actually. I think it’s a very good value for their approved drug, Tazverik. That’s approved in both a rare epithelioid sarcoma indication but more broadly or a larger indication of follicular lymphoma. They’re just launching that drug right now. And I think it has potential to outperform expectations.
And also, on the targeted side of things, Blueprint Medicines (NASDAQ:BPMC) just got their drug approved for RET fusion-positive lung cancers.”
Get the complete detail on these and other biotech stocks, exclusively in this 3,444 word interview with David Nierengarten, Ph.D., Managing Director and Head of Healthcare Equity Research at Wedbush Securities.
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