| Yesterday | ||||
Wedbush analyst Laura… Wedbush analyst Laura Chico raised the firm's price target on PepGen to $22 from $17 and keeps an Outperform rating on the shares. PepGen's Q4 report was largely in line with expectations, and Wedbush continues to hold a positive bias as execution continues and multiple clinical readouts are on track for 2024, the analyst tells investors in a research note. | ||||
| Thursday | ||||
Biotech Analysts Chen… Biotech Analysts Chen & Agrawal and Biopharma Analyst Kim, along with Drs Galimberti & Jegasothy discuss key data readouts, debates and takeaways in medical and aesthetic dermatology from the recently-held American Academy of Dermatology (AAD) Meeting on an Analyst/Industry conference call to be held on March 23 at 11 am. Webcast Link | ||||
Dyne Therapeutics… Dyne Therapeutics announced that DYNE-251, an investigational therapeutic for Duchenne muscular dystrophy mutations amenable to exon 51 skipping, was granted U.S. Food and Drug Administration, FDA, orphan drug and rare pediatric disease designations. DYNE-251 is being evaluated in the Phase 1/2 DELIVER clinical trial. "These regulatory designations highlight the urgent and critical need for new and better therapeutic options for people living with this fatal disease," said Wildon Farwell, M.D., MPH, chief medical officer of Dyne. "We are excited about DYNE-251 which we believe has the potential to transform the lives of people with DMD. We continue to advance our DELIVER clinical trial and look forward to sharing initial clinical data later this year." | ||||
Meetings to be held in… Meetings to be held in Boston on March 27 and in New York on March 28 hosted by Piper Sandler. | ||||
Biotech Analysts Chen… Biotech Analysts Chen & Agrawal and Biopharma Analyst Kim, along with Drs Galimberti & Jegasothy discuss key data readouts, debates and takeaways in medical and aesthetic dermatology from the recently-held American Academy of Dermatology (AAD) Meeting on an Analyst/Industry conference call to be held on March 23 at 11 am. Webcast Link | ||||
| Wednesday | ||||
PepGen will be presenting… PepGen will be presenting nonclinical and clinical data of its Enhanced Oligonucleotide Delivery EDO platform at the Muscular Dystrophy Association MDA Clinical and Scientific Conference in Dallas, Texas.PepGen's preclinical data of PGN-EDO51, the company's lead product candidate for the treatment of people living DMD whose mutations are amenable to an exon 51 skipping approach, showed in the mdx mouse model that a single, 30 mg/kg dose of PGN-EDO23 resulted in 52.5% exon 23 skipping and dystrophin production of 22.5% that was sustained for up to four weeks..."Our preclinical and Phase 1 clinical data that is being presented at MDA highlight the observed ability of PepGen's EDO technology platform to drive encouraging levels of exon 51 skipped transcripts following a single-dose in NHPs and in humans. Our repeat-dose NHP data we will present here further support the potential stacking of exon 51 skipped transcripts with monthly PGN-EDO51 dosing," stated Jaya Goyal, PhD, Executive Vice President, Research and Preclinical Development at PepGen. "We look forward to sharing our PGN-EDO51 clinical development plan in the near future." Based on the encouraging nonclinical data, PepGen is planning to initiate two clinical trials to assess the safety and efficacy of repeat doses of PGN-EDO51 in young men living with DMD. CONNECT1-EDO51 is a Phase 2 open-label MAD clinical trial to be initiated in Canada in the first half of 2023 that is expected to report dystrophin protein data in 2024. Additionally, CONNECT2-EDO51, a Phase 2, global, randomized placebo-controlled clinical trial is expected to be initiated in the second half of 2023 to support a potential accelerated approval pathway, subject to alignment with regulators. The corresponding poster presentation and slides referenced during the oral presentations are available on the Events and Presentations page in the Investor Relations section of the company's website. | ||||
| Tuesday | ||||
The FDA granted Dyne… The FDA granted Dyne Therapeutics orphan status for its treatment of Duchenne muscular dystrophy. Reference Link | ||||
"In 2022, we made… "In 2022, we made considerable progress in advancing VGL101 and our small molecule TREM2 agonist program through significant clinical and preclinical milestones, respectively. We shared important data for VGL101 including encouraging interim topline data from our ongoing Phase 1 healthy volunteer trial and informative interim data from ILLUMINATE, our natural history study of ALSP patients. We also initiated IGNITE, our Phase 2 proof-of-concept trial of VGL101 in patients with ALSP, which is the first interventional clinical trial in this indication. We look to continue to build upon that momentum with several anticipated milestones in 2023, including the full data readout from our VGL101 Phase 1 trial and six-month interim data from IGNITE," said Ivana Magovevi-Liebisch, Ph.D., J.D., President and Chief Executive Officer of Vigil. "Furthermore, we made great strides in advancing our small molecule TREM2 agonist program and are on track to submit an IND for our lead small molecule candidate and initiate clinical development, with an initial focus on Alzheimer's disease in genetically defined subpopulations, in the second half of 2023." | ||||
| Monday | ||||
Oppenheimer notes that… Oppenheimer notes that Nurix (NRIX) announced that Gilead (GILD) has exercised its option to exclusively license GS-6791, a targeted degrader of IRAK4, from Nurix. While not expecting the associated $20M option exercise payment from Gilead to materially impact Nurix's operational runway, the firm sees Gilead's decision as an important external validation of the latter's DELigase discovery platform-and puts '6791 on a path to potentially compete against other IRAK4 degraders. With a second partnered program approaching drug candidate nomination, Oppenheimer thinks Nurix could potentially receive a second option exercise payment within the next 12 months, and expects to see updates from the company's wholly-owned clinical-stage programs later this year. The firm reiterate an Outperform rating on Nurix shares. | ||||
