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FDA Nod For BHC, Third Rituxan Biosim In The Offing, CBIO Soars, NERV Depressed


Today's Daily Dose brings you news about FDA approval of Bausch Health's acne drug; licensing deal between Catalyst Biosciences and Biogen; disappointing MDD trial results of Minerva and Urogen's upcoming regulatory catalyst.

Read on…

Amgen (AMGN) and Allergan plc. (AGN) have submitted a Biologics License Application to the FDA for ABP 798, a biosimilar candidate to Rituxan.

Rituxan, developed by Roche, is indicated for the treatment of patients with non-Hodgkin's lymphoma, chronic lymphocytic leukemia, rheumatoid arthritis, granulomatosis with polyangiitis, microscopic polyangiitis, and pemphigus vulgaris. The drug generated sales of $4.29 billion in the U.S. for Roche in 2018.

There are already two FDA-approved biosimilars for Rituxan - Teva/Celltrion's Truxima and Pfizer's RUXIENCE.

AMGN closed Thursday's trading at $241.84, down 0.04%.

The FDA has approved Bausch Health Companies Inc.'s (BHC) (BHC.TO) ARAZLO Lotion, 0.045%, for the topical treatment of acne vulgaris in patients nine years of age and older.

ARAZLO becomes the first tazarotene acne treatment available in a lotion form. Tazarotene, a member of the acetylenic class of retinoids, is already available as a cream, gel, or foam.

ARAZLO is expected to be launched in the first half of 2020.

BHC closed Thursday's trading at $29.90, up 2.68%.

Catalyst Biosciences Inc. (CBIO) has entered into a global license and collaboration agreement with Biogen Inc. (BIIB) for the development and commercialization of pegylated CB 2782 for the potential treatment of geographic atrophy associated dry age-related macular degeneration.

In preclinical study, Catalyst Bio's pegylated CB 2782-PEG has demonstrated the potential for efficacy and improved convenience.

The agreement entitles Catalyst Bio to receive from Biogen a $15 million upfront payment and up to $340 million in clinical, regulatory, and commercial milestone payments plus future tiered royalties based on net sales.

Conduction of pre-clinical and manufacturing activities are the responsibilities of Catalyst Bio while funding for these activities and performing Investigational New Drug (IND)-enabling activities, worldwide clinical development, and commercialization will rest with Biogen.

CBIO closed Thursday's trading at $7.91, up 65.83%.

Shares of Minerva Neurosciences, Inc. (NERV) plunged more than 17% on Thursday, following disappointing results from its phase 2b trial of MIN-117 in adult patients suffering from moderate to severe major depressive disorder with symptoms of anxious distress.

Neither the primary endpoint of reduction in the symptoms of major depressive disorder over the 6-week treatment period as measured by the change in the Montgomery-Åsberg Depression Rating Scale (MADRS) nor the key secondary endpoint of reduction of symptoms of anxiety as measured by Hamilton Anxiety Rating Scale (HAM-A) over the 6-week treatment period were met.

The Company has decided to halt the clinical development of MIN-117 in major depressive disorder.

NERV closed Thursday's trading at $5.66, down 17.85%.

Another stock that gained by signing a licensing deal is Selecta Biosciences Inc. (SELB), which climbed more than 45%.

Selecta Biosciences has entered into a partnership with privately-held Asklepios BioPharmaceutical Inc., under which AskBio has exercised its option to exclusively license rights to develop and commercialize Selecta's immune tolerance platform, ImmTOR, for use in adeno-associated virus (AAV) gene therapy for the treatment of Pompe disease.

Under the terms of this new license agreement, Selecta is eligible to receive upfront and milestone payments of over $240 million plus royalties on product sales. The two companies already have a strategic partnership in place that was signed in August 2019 to jointly develop, manufacture, and commercialize targeted therapeutics for next-generation AAV gene therapies in areas of high medical need.

SELB closed Thursday's trading at $2.12, up 45.21%.

UroGen Pharma Ltd.'s (URGN) New Drug Application for UGN-101 for instillation as a potential treatment for patients with low-grade upper tract urothelial cancer has been accepted for priority review by the FDA, with a decision expected on April 18, 2020.

If approved, UGN-101 would be the first non-surgical treatment option for low-grade upper tract urothelial cancer (LG UTUC).

UGN-101 is bestowed with the tags of Orphan Drug, Fast Track, and Breakthrough Therapy by the FDA for the treatment of LG UTUC.

URGN closed Thursday's trading at $34.86, up 3.08%.

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