The Week Ahead In Biotech: Conferences, PDUFA Dates And Clinical Trials

Biotech stocks staged a modest comeback this week ending along with the broader market. The week saw a spate of clinical trial results releases, sending stocks moving in either direction. The tally of new molecular entity approvals stands steady at last week's level of 55.

Here's what biotech investors will be focusing on in the coming week.

Conferences

• 3rd World Liver Congress: Dec. 17-18, in Abu Dhabi, UAE.
• World Congress on Polycystic Ovarian Syndrome and Fertility: Dec. 17-18 in Abu Dhabi.
• 8th World Conference on Women's Health and Breast Cancer: Dec. 17-18 in Abu Dhabi.

PDUFA Dates

ADMA Biologics Inc ADMA awaits approval for its Prior Approval Supplement (PAS) filing for Bivigam, which is an intravenous immune globulin indicated for the treatment of primary humoral immunodeficiency.

The FDA granted approval to Bivigam to Biotest Pharma in December 2012, but production was halted in December 2016. Subsequently in June 2017, ADMA obtained ownership and all rights, title and interest in Bivigam through its Biotest Therapy Business unit asset acquisition.

ADMA then optimized the production process and submitted the PAS to amend the BLA for Bivigam in June and the PDUFA date was initially set at Oct. 25. This was extended by two months, as the FDA deemed the company's response to its information request a major amendment. The decision date is Tuesday, Dec. 18.

The FDA is set to rule Thursday, Dec. 20, on Jazz Pharmaceuticals PLC JAZZ's NDA for JZP-110, chemically solriamfetol, which is being evaluated for the treatment of excessive sleepiness in adult patients with narcolepsy or obstructive sleep apnea. The company's shares have come significantly off their year's high of $184, trending around $140.

Clinical Trial Results

Achillion Pharmaceuticals, Inc. ACHN is scheduled to present interim Phase 2 data for its lead candidate ACH-447, which is being evaluated for two indications, namely C3 glomerulopathy, or C3G, and paroxysmal nocturnal hemoglobinuria, or PNH. C3G leads to decline in kidney function over time, while PNH is a rare acquired blood disorder resulting in lethal hemolysis. The company will also release interim Phase 1 data from separate trials evaluating its next-gen oral factor D inhibitors ACH-5228 and ACH-5548.

Apellis Pharmaceuticals Inc APLS is scheduled to announce an update on APL-2 in the first half of December. APL-2 is being evaluated for geographic atrophy associated with age-related macular degeneration.

IPO Quiet Period Expiry

Taiwan Liposome Company, Ltd. TLC

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