Oculis Holding AG announced positive top line results from the Phase 3, Stage 1 DIAMOND trial of OCS-01 eye drops in DME, & met the primary efficacy endpoint of demonstrating a statistically significant improvement in the mean BCVA ETDRS score. Read more: hubs.la/Q01R4t6R0

Spherix would like to acknowledge Huntington's Disease Awareness Month and share some resources available: Cleveland Clinic: hubs.la/Q01RfYdn0 Huntington's Disease Society of America: hubs.la/Q01RfPBb0 Massachusetts General Hospital: hubs.la/Q01RfQYq0

With summer right around the corner, be sure to take the proper precautions! The sun is powerful and diseases like pterygium (growths on the eye), photokeratitis, and eye cancers can develop over time. Follow these helpful tips to stay safe for Summer 2023!

Today, Akebia Therapeutics received a response from the FDA's Office of New Drugs denying their appeal but offering guidance for resubmitting the new drug application for vadadustat, intended for the treatment of anemia in dialysis-dependent patients with chronic kidney disease.

Spherix Global Insights would like to acknowledge World Multiple Sclerosis Day and highlight the importance of connecting Multiple Sclerosis patients to treatments through research and innovation. #multiplesclerosis

Satsuma Pharmaceuticals' announced the FDA accepted to review the new drug application (NDA) for STS101, an innovative and investigational therapeutic product candidate designed for the acute treatment of migraine. Read more: hubs.la/Q01RM5sv0 #treatment #trial #NDA #US

Today, Novartis received European Commission (EC) approval for Cosentyx, an IL-17A inhibitor, for adults with active moderate to severe hidradenitis suppurativa (HS) and an inadequate response to conventional systemic HS therapy. Read More: hubs.la/Q01RZwls0

Sanofi announced positive Phase 2 data of their novel second-generation investigational anti-CD40L antibody, frexalimab, significantly reduced disease activity of patients with relapsing MS & met the primary endpoint. Read more hubs.la/Q01R-Zmd0

CMS unveiled their intentions to offer extensive coverage for Alzheimer's drugs once the medications receive full approval from the U.S. FDA. Eisai's Leqembi is a potential contender & could obtain full FDA approval as early as this summer. Read more: hubs.la/Q01S4ZSY0

This week is Hidradenitis Suppurativa Awareness Week! Join us in spreading awareness and support for individuals living with HS. See below for different ways you can get involved and make a difference! To donate: hubs.la/Q01SvH6h0 #HSAwarenessWeek #HidradenitisSuppurativa

Spherix Global Insights would like to recognize Diabetes Week this week! Join us in raising awareness and advocating for advancements in treatment options. By coming together, we can empower those affected by diabetes and strive for a brighter and healthier future.

Spherix's Neurology team will be attending the American Headache Society Annual Scientific Meeting (AHS) beginning today and extending until June 18th in Austin, Tx. We can't wait to see you there! #ASN #Neurology #Pharma

Friday, Pfizer Inc. announced the U.S. FDA approved LITFULO for patients 12+ with severe alopecia areata, making it the first available treatment for adolescents with AA. Read more: hubs.la/Q01V_kb20 #hairloss #alopeciaareata #pfizer #lilly

UCB announced that the Biologics License Application for bimekizumab remains under review with the anticipated FDA approval date extending to Q3 2023. There are no open Information Requests from the FDA regarding the BLA for bimekizumab. Learn More: hubs.la/Q01V_xMF0

Yesterday, Regeneron announced it received a CRL from the U.S. FDA for its BLA of 8mg aflibercept in wAMD, DME, and DR due to an ongoing review of inspection findings at a third-party filler setting back the highly anticipated launch of the Eylea follow-on agent.

Yesterday, the U.S. FDA granted full regulatory approval of Biogen / Eisai US's Leqembi - now becoming the only approved disease modifying treatment shown to reduce Alzheimer's Disease (AD) progression (slowed cognitive and functional decline) in mild AD patients.

Yesterday, 4D Molecular Therapeutics, Inc. announced a license agreement with Astellas Pharma US, granting Astellas rights to deliver their unique genetic payloads with the use of 4DMT proprietary R100 vector technology for the treatment of rare ophthalmic diseases. #opthalmology

Eli Lilly and Company released phase 3 trial data for donanemab with results that suggest more slowing of cognitive decline than has been seen with prior Alzheimer’s therapies, including the recently approved Leqembi (from Eisai/Biogen). Read More: hubs.la/Q01Y9S3q0

On Friday, Horizon announced that daxdilimab’s Phase II clinical trial in SLE failed to achieve its primary endpoint of BICLA and glucocorticoid reduction. Read More: hubs.la/Q01YHHcm0

Spherix Global Insights would like to congratulate Pfizer Inc. on the launch of Zavzpret™ (zavegepant) for the acute treatment of migraine. Zavzpret is the first and only anti-CGRP nasal spray. #migraine #pfizer #zavzpret #ubrelvy #reyvow #nurtec #trudhesa