FDA OKs Avadel’s Nouress; shares down 17% on launch uncertainty

The FDA approves Avadel Pharmaceuticals’ (AVDL -16.8%) Nouress (cysteine hydrochloride injection) (AV001) for neonates requiring total parenteral nutrition (TPN) (method of feeding that bypasses the GI tract).

The company says the U.S. market could be greater than $50M.

On another note, the USPTO recently issued a new patent to the company covering cysteine solutions, including Nouress.

Investors appear to be reacting to its statement that it is “evaluating” the timing and process for commercial launch, adding that a competitor’s product (Exela Pharma Service’s Elcys approved in April) was approved in the U.S. earlier this year and has also received a U.S. patent.

https://seekingalpha.com/news/3526436-fda-oks-avadels-nouress-shares-down-17-on-launch-uncertainty

Amgen prevails in Epogen patent dispute with Hospira

An appeals court has affirmed a lower court verdict that Pfizer (PFE +2.7%) unit Hospira’s proposed Epogen biosimilar infringes on Amgen’s (AMGN +2.3%) U.S. Patent No. 5,856,298, upholding $70M in damages awarded in September 2017.

https://seekingalpha.com/news/3526465-amgen-prevails-in-epogen-patent-dispute-hospira

Guggenheim Starts Relmada Therapeutics Inc (RLMD) at Buy

Guggenheim analyst Yatin Suneja initiates coverage on Relmada Therapeutics Inc.

https://www.streetinsider.com/New+Coverage/Guggenheim+Starts+Relmada+Therapeutics+Inc+%28RLMD%29+at+Buy/16244905.html

Mirum Completes Successful Pre-NDA Meeting with FDA for Maralixibat

FDA Requested Change from Type-C Meeting to pre-NDA Meeting

Company Plans to Initiate Rolling NDA Submission in Third Quarter 2020

Rare Pediatric Disease Designation Granted for Maralixibat for Alagille Syndrome

Conference Call and Webcast today at 8:30 a.m. ET / 5:30 a.m. PT

https://www.businesswire.com/news/home/20191216005174/en/Mirum-Pharmaceuticals-Completes-Successful-Pre-NDA-Meeting-FDA

Salarius Pharma’s seclidemstat Fast Track’d for Ewing sarcoma

Thinly traded nano cap Salarius Pharmaceuticals (NASDAQ:SLRX) is up 12% premarket on increased volume in reaction to Fast Track designation in the U.S. for lead candidate seclidemstat for the treatment of a rare pediatric bone cancer called Ewing sarcoma.

Fast Track status provides for more frequent interaction with the FDA review team and a rolling review of the marketing application.

Phase 1-stage seclidemstat is a small molecule inhibitor of an epigenetic enzyme called lysine-specific demethylase 1 (LSD1), highly expressed in certain cancers and associated with aggressive disease and poor prognosis.

https://seekingalpha.com/news/3526428-salarius-pharmas-seclidemstat-fast-trackd-for-ewing-sarcoma-shares-up-12-pm

Anixa Bio launches Cchek Prostate Cancer Confirmatory Test

Anixa Biosciences (NASDAQ:ANIX) has commercially launched Cchek Prostate Cancer Confirmation test (Cchek PCC), the first test developed with the Cchek artificial intelligence driven, flow cytometry based, liquid biopsy technology platform.

This test is designed to confirm the need for prostate biopsy, as a means to minimize unnecessary invasive procedures and reduce healthcare costs associated with traditional methods of prostate cancer diagnosis and the associated adverse events.

The Company expects Cchek PCC to be broadly available throughout the U.S. by April 2020.

https://seekingalpha.com/news/3526369-anixa-bio-launches-cchek-prostate-cancer-confirmatory-test

BeiGene’s zanubrutinib fails to beat Imbruvica in lymphoma study

BeiGene (NASDAQ:BGNE) is down 9% premarket on modest volume in reaction to results from a Phase 3 clinical trial, ASPEN, comparing BTK inhibitor Brukinsa (zanubrutinib) to AbbVie’s (NYSE:ABBV) Imbruvica (ibrutinib) in patients with a type of lymphoma called Waldenström’s macroglobulinemia (WM).

The study failed to achieve the primary endpoint of demonstrating zanubrutinib’s superiority to ibrutinib as measured by the proportion of patients experiencing either a complete response (CR) or very good partial response (VGPR) in up to three years.

In the overall patient population, the VGPR rate for zanubrutinib was 28.4% compared to 19.2% for ibrutinib.

In the relapsed/refractory population, the major response rate (partial response or better) was 78.3% for zanubrutinib and 80.2% for ibrutinib.

The safety profiles were generally similar.

Complete data will be submitted for presentation at a future medical conference.

ABBV is up a fraction premarket.

Related ticker: Johnson & Johnson (NYSE:JNJ)

https://seekingalpha.com/news/3526409-beigenes-zanubrutinib-fails-to-beat-imbruvica-in-wm-study-shares-down-9-pm