APLS To Report Data In 2H, CUR Abuzz, Shire Discontinues NASH Trial

(RTTNews) - Today's Daily Dose brings you news about Apellis Pharma's pipeline progress; licensing agreement between Knight Therapeutics and TherapeuticsMD; anticipated milestones of Progenics Pharma, and discontinuation of Shire's phase II NASH trial.

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Apellis Pharmaceuticals Inc. (APLS) expects to commence a phase III program consisting of two trials of APL-2 in Geographic Atrophy in the second half of 2018.

Data from phase II proof of concept monotherapy trial of APL-2 in four types of complement-dependent nephropathies (IgA nephropathy, C3 glomerulonephropathy, primary membranous nephropathy and lupus nephritis) are also expected in the second half of 2018.

A phase III trial of APL-2 in Paroxysmal Nocturnal Hemoglobinuria, dubbed PEGASUS, initiated in June 2018, is underway.

APLS closed Tuesday's trading at $18.40, up 3.78%.

Knight Therapeutics Inc. (GUD.TO) and TherapeuticsMD Inc. (TXMD) have entered into a licensing agreement that grants Knight the rights to commercialize TX-004HR and TX-001HR in Canada and Israel.

TX-004HR is TherapeuticsMD's FDA-approved product, marketed as Imvexxy in the U.S., for the treatment of moderate-to-severe dyspareunia (vaginal pain associated with sexual activity), a symptom of vulvar and vaginal atrophy (VVA), due to menopause. It was approved in the U.S. on May 30, 2018.

TX-001HR is TherapeuticsMD's investigational bio-identical hormone therapy combination of estradiol and progesterone in a single, oral softgel for the treatment of moderate-to-severe vasomotor symptoms due to menopause.

Under the terms of the licensing agreement, Knight will pay TherapeuticsMD a milestone fee upon first regulatory approval in Canada of each of TX-004HR and TX-001HR, sales milestone fees based upon certain aggregate annual sales in Canada and Israel and royalties based on aggregate annual sales.

As part of the deal, Knight has agreed to invest $20 million in TherapeuticsMD common stock concurrently with closing of the first public offering of TherapeuticsMD common stock.

In related news, the Company announced the launch of a $65 million underwritten public offering.

TXMD closed Tuesday's trading at $5.22, down 5.43%.

Neuralstem Inc. (CUR) has initiated a phase II clinical trial evaluating NSI-566, its lead neural stem cell candidate, as a potential treatment for ischemic stroke.

The trial will be taking place at Bayi Brain Hospital in Beijing, China, commencing on August 1, 2018, noted the Company.

The Company will be allotting $3 million toward this trial.

CUR closed Tuesday's trading at $1.13, down 5.04%. In after-hours, the stock was up 11.50% to $1.26.

Progenics Pharmaceuticals Inc. (PGNX) has a couple of catalysts to watch out for in the coming months.

A phase III study of 1404, a PSMA-targeted small molecule SPECT/CT imaging agent in patients with newly-diagnosed or low-grade prostate cancer, dubbed ProSPECT-AS, is underway. Top-line data from this study is expected in the third quarter of 2018.

A phase II/III study evaluating the diagnostic accuracy of its PSMA-targeted PET/CT imaging agent, PyL (18F-DCFPyL), in prostate cancer, dubbed OSPREY, has completed enrollment. Top-line data are anticipated in the fourth quarter of 2018.

Progenics expects its partner Bayer to initiate a Phase 1 study of PSMA-Targeted Thorium Conjugate (PSMA-TTC) in patients with metastatic castration-resistant prostate cancer (mCRPC) by year end 2018.

On July 30, the Company received FDA approval for its radio-therapeutic Azedra, proposed for the treatment of patients with malignant, recurrent and/or unresectable pheochromocytoma and paraganglioma, which are rare neuroendocrine tumors.

Analysts expect Azedra to rake in peak sales of between $200 million and $300 million.

PGNX closed Tuesday's trading at $7.98, down 3.91%.

Shire plc (SHPG) has pulled the plug on its phase II trial of SHP626, an investigational treatment for adults with nonalcoholic steatohepatitis (NASH) with liver fibrosis.

No further details have been given by the Company other than announcing that it is evaluating other options for the program.

The study was initiated in July 2016, and was expected to be completed in July 2020.

NASH refers to liver inflammation due to fat buildup in the liver. Also called a "silent" liver disease, since the symptoms are not manifested in early stages, in some patients, NASH can also progress to fibrosis and cirrhosis over the years, with a high risk for liver failure and hepatocellular cancer.

Related Reading The Race To Find A Treatment For NASH