Target to $24 from $55
Monday, November 15, 2021
Why EyePoint Shares Are Trading Higher
- EyePoint Pharmaceuticals Inc (Get Free Alerts for EYPT) has announced six-month interim data from the Phase 1 trial of EYP-1901 in wet age-related macular degeneration (wet AMD).
- No reports of ocular SAEs or drug-related systemic SAEs were reported.
- The data showed that 76% and 53% of patients did not require rescue following a single dose of EYP-1901 up to four and six months, stable, respectively.
- The patients sustained BCVA (-2.5 letters) and CST (-2.7 μm), a 79% reduction in treatment burden at six months, and a median time.
- EyePoint plans to initiate a Phase 2 wet AMD trial in 2022.
- The Company has scheduled a Type C meeting with the FDA on December 1, 2021, to discuss specific plans and obtain guidance on potential EYP-1901 registration trials.
- The Company also expects to initiate additional EYP-1901 clinical trials in diabetic retinopathy and retinal vein occlusion.
- “The results of our Phase 1 study in wet AMD are what we had hoped to achieve, and as a result, we will now progress to Phase 2 studies in wet AMD, Diabetic Retinopathy and Retinal Vein Occlusion. These are large, billion-dollar markets with millions of patients who suffer from these potentially blinding eye diseases. Getting over 50% of patients out to 6 months without retreatment is a big deal. Delivering drugs to the eye over an extended period is hard to do. Who wants to get their eye injected every month or every two months (current treatment) for the rest of their lives? I wouldn’t, Nancy Lurker, CEO of EyePoint Pharmaceuticals, told Benzinga.
- “I caution your audience that this is a small (n=17) trial, so we really need to get to much larger (n>150 patients) to be more confident in the results. But, we are very excited!” added Lurker.
Moderna: Positive Data from Phase 2 Study of mRNA Therapeutic in Coronary Artery Bypass Grafting
Phase 2a study met the primary endpoint of safety and tolerability; numerical trends observed in endpoints in the heart failure efficacy domains compared with placebo, including increase in LVEF and patient reported outcomes
Results support further investigation of AZD8601 for efficacy and safety in future larger studies
AZD8601 is being co-developed with AstraZeneca
Moderna, Inc. (Nasdaq: MRNA), a biotechnology company pioneering messenger RNA (mRNA) therapeutics and vaccines today announced positive data from the AstraZeneca-led Phase 2 (EPICCURE) study evaluating the use of an mRNA therapeutic that encodes for vascular endothelial growth factor-A (VEGF-A) (AZD8601) in patients undergoing coronary artery bypass grafting (CABG). These data were presented today at the American Heart Association’s Scientific Sessions 2021 annual meeting.
The Phase 2 study met the primary endpoint of safety and tolerability of AZD8601. In the study of 11 patients, seven were treated with AZD8601 VEGF-A mRNA and four received placebo injections. Numerical trends were observed in endpoints in the heart failure efficacy domains compared with placebo, including increase in left ventricular ejection fraction (LVEF) and patient reported outcomes. In addition, all seven patients treated with AZD8601 had NT-proBNP levels below heart failure (HF) limit at 6 months follow-up compared to one of four patients treated with placebo.
https://finance.yahoo.com/news/moderna-announces-positive-data-phase-133500169.html
Novavax Submits Application in South Korea for Approval of Covid Vax
K bioscience submits application for NVX-CoV2373, the first protein-based COVID-19 vaccine candidate for BLA, to South Korea's MFDS
Novavax, Inc. (Nasdaq: NVAX), a biotechnology company dedicated to developing and commercializing next-generation vaccines for serious infectious diseases, and SK bioscience, Co. Limited (SK bioscience), a biotechnology company in South Korea, today announced the submission of a Biologics License Application (BLA) for Novavax' COVID-19 vaccine to South Korea's Ministry of Food and Drug Safety (MFDS). NVX-CoV2373, Novavax' recombinant nanoparticle COVID-19 vaccine with Matrix-M™ adjuvant, is the first protein-based COVID-19 vaccine to be submitted for BLA in Korea.
https://finance.yahoo.com/news/novavax-announces-submission-biologics-license-134500336.html
Moderna Posts Interim Data From mRNA Triplet Program In Solid Tumors
Moderna Inc (NASDAQ: MRNA) announced interim data from Phase 1 study of mRNA-2752 (Triplet) in patients with accessible solid tumors and lymphomas.
The data showed that the mRNA Triplet program given in combination with AstraZeneca Plc's (NASDAQ: AZN) Imfinzi (durvalumab) was tolerated at all dose levels and elicited evidence of anti-tumor activity.
The recommended dose for expansion (RDE) is up to 8mg mRNA-2752 + durvalumab.
The data were presented at the Society for Immunotherapy of Cancer's (SITC) Annual Meeting.
The study consists of dose escalation and dose confirmation parts, which will occur in Arm A and Arm B, followed by a dose expansion part, which will occur in Arm B, and a Dose Exploration in Arm C as neoadjuvant therapy for cutaneous melanoma.
Enrollment in the dose-expansion part of Arm B and Arm C is currently ongoing.
Britain to extend COVID booster rollout to over-40s
Britain's COVID-19 booster vaccine rollout is to be extended to people between 40 and 49 years old, officials said on Monday, in a bid to boost waning immunity in the population ahead of the colder winter months.
Currently all people other 50, those who are clinically vulnerable and frontline health workers are eligible for boosters, and the Joint Committee on Vaccination and Immunisation (JCVI) said that the rollout would be extended further.
The advice comes as the UK Health Security Agency released data from a real-world study which found the booster gave over 90% protection against symptomatic COVID-19 for people aged 50 years and older.
"Booster vaccine doses in more vulnerable adults, and second vaccine doses in 16–17 year olds are important ways to increase our protection against COVID-19 infection and severe disease," said Wei Shen Lim, the JCVI's Chair for COVID-19 immunisation.
"These vaccinations will also help extend our protection into 2022."
Britain is mainly using the Pfizer-BioNTech and Moderna shots in the booster rollout, with people being eligible 6 months after their second shot.
The real-world study found that protection against symptomatic disease following a booster was 93.1% for people who were initially given AstraZeneca's vaccine, and 94% for people who had been given the Pfizer shot originally.
The JCVI added that the protection given by boosters against severe disease was expected to be higher.
However, the panel declined to recommend boosters for under 40s, saying it had found no robust evidence of a decline in protection against severe COVID-19 from the original vaccine rollout in that age group.
Prime Minister Boris Johnson is leaning on booster vaccines and shots for children to try and withstand winter pressures on hospitals without resorting to another COVID lockdown.
The JCVI also said that all 16 to 17 year olds would be invited to have their second dose of COVID vaccine, having previously advised that they only receive an initial shot unless they had an underlying health condition.
https://finance.yahoo.com/news/britain-extend-covid-booster-rollout-093109655.html
Rhythm gets priority review for weight loss med application
FDA sets PDUFA goal date of March 16, 2022
Rhythm Pharmaceuticals, Inc. (Nasdaq: RYTM), a biopharmaceutical company aimed at developing and commercializing therapies for the treatment of rare genetic diseases of obesity, today announced that the U.S. Food and Drug Administration (FDA) has accepted for filing the company’s supplemental New Drug Application (sNDA) for IMCIVREE® (setmelanotide), a melanocortin-4 receptor (MC4R) agonist, for patients with Bardet-Biedl syndrome (BBS) or Alström syndrome. The FDA granted Priority Review of the sNDA and assigned a Prescription Drug User Fee Act (PDUFA) goal date of March 16, 2022.
“The acceptance for filing of our supplemental application by the FDA marks an important step in our efforts to address the unmet needs and bring IMCIVREE to patients and families living with Bardet-Biedl syndrome and Alström syndrome,” said Linda Shapiro, M.D., Ph.D., Chief Medical Officer of Rhythm Pharmaceuticals. “The FDA’s decision to grant Priority Review to the application aligns with our belief in the potential of IMCIVREE to deliver clinically meaningful and statistically significant reductions in body weight and hunger for patients with BBS and Alström syndrome while also substantially improving quality of life for these patients and their families.”
https://finance.yahoo.com/news/rhythm-pharmaceuticals-announces-fda-acceptance-124500887.html
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