Dyne Therapeutics (DYN)

Dyne Therapeutics (DYN)Next up is small-cap biotech firm Dyne Therapeutics. This early clinical-stage biopharma company is working on new treatments for genetically driven muscle diseases, treatments designed to halt disease progression and potentially reverse damage already accrued. The company’s work is currently focused on three conditions, all various forms of muscular dystrophy, including myotonic dystrophy type 1 (DM1), Duchenne muscular dystrophy (DMD) and facioscapulohumeral muscular dystrophy (FSHD).

Dyne is developing a set of modern therapeutics, based on targeted oligonucleotides, through a proprietary platform, FORCE. The therapeutics are antibody based, designed to precisely deliver the active agent directly to the genetic basis of the disease. Dyne currently has two clinical trials underway, along with multiple preclinical research tracks.

On the first clinical trial, Dyne is continuing enrollment in ACHIEVE, a Phase 1/2 global trial of DYNE-101, a proposed treatment for adults suffering from DM1. The ACHIEVE trial will have three stages, a 24-week multiple ascending dose (MAD) randomized, placebo-controlled period, a 24-week open-label extension and a 96-week long-term extension. The company is on track to release initial data in 2H23.

Also on track for an initial data release in 2H23 is the DELIVER trial. This is another Phase 1/2 global trial, testing DYNE-251 as a treatment for DMD. The DELIVER trial is planned to follow the same 3-stage structure as ACHIEVE.

Both of these drug candidates have received Orphan Drug Designation. DYNE-251 received the designation in March of this year, and DYNE-101 in May. The designation will have tax benefits for Dyne Therapeutics.

Analyst Francois Brisebois covers this stock for Oppenheimer, and sees plenty of upcoming catalysts that should encourage investors.

“We recently spent time at DYN’s headquarters with a key opinion leader and come away incrementally more positive. Management’s clear and consistent messaging was comforting, given historical difficulties in the space. In addition to the KOL’s acknowledgment of the importance of a targeted approach that crosses the BBB, DYN reiterated clear expectations of success for the upcoming, potentially registrational P1/2 early cohorts’ readouts in DM1 and DMD. Finally, we believe recent ASGCT pre-clinical data showing FORCE’s ability to deliver to the CNS is a testament to the platform’s potential. As DYN remains our top pick, the event only strengthens our conviction.”

To this end, Brisebois rates DYN an Outperform (i.e. Buy), and his price target, at $34, suggests just how much he expects that outperformance: up to 181% in the coming year.

Like Brisebois, other analysts also take a bullish approach. DYN’s Strong Buy consensus rating breaks down into 6 Buys and zero Holds or Sells. Given the $27.83 average price target, the upside potential lands at 130%.

 

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