The Week Ahead In Biotech: Adcom Test For Amarin's Fish Oil Pill, Agile Awaits FDA Verdict

After the previous week's strong gains, biotech stocks experienced a slight loss of momentum this week. The week saw a few clinical trial readouts and a slew of earnings reports from small- to mid-sized biotechs.

The FDA approved Sanofi SA's SNY Fluzone for older adults and Novartis AG's NVS Sandoz unit's Neulasta biosimilar. REDHILL BIOPHAR/S ADR RDHL's H. Pylori treatment was also OK'ed by the regulatory agency.

The following are the key catalytic events scheduled for the unfolding week.

Conferences

  • American Society of Nephrology, or ASN, Kidney Week 2019: Nov. 5-10 in Washington, D.C.
  • Society for Immunotherapy of Cancer, or SITC: Nov. 6-10 in National Harbor, Maryland
  • American Association for the Study of Liver Diseases, or AASLD, Liver Meeting: Nov. 8-12 in Boston, Massachusetts
  • American College of Rheumatology, or ACR, /ARP 2019 Annual Meeting: Nov. 8-13 in Atlanta, Georgia
  • 12th International Conference on Tissue Engineering & Regenerative Medicine: Nov. 11-12 in Madrid, Spain
  • 28th Annual Credit Suisse Healthcare Conference: Nov. 11-13 in Scottsdale, Arizona
  • 13th International Congress on Autoimmunity: Nov. 12-13 in London
  • 2019 Connective Tissue Oncology Society, or CTOS, Annual Meeting: Nov. 13-16 in Tokyo
  • European Congress on Nephrology & Urology: Nov.14-15 in Zagreb, Croatia
  • 13th International Conference on Alzheimer's Disease & Dementia: Nov. 14-15 in Paris, France
  • 33rd European Ophthalmology Congress: Nov. 14-15 in Madrid
  • American Heart Association Scientific Sessions 2019: Nov. 16-18 in Philadelphia, Pennsylvania

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PDUFA Dates

The FDA on Monday is expected to rule on Allergan plc's AGN NDA for Ubrogepant in the treatment of migraines. 

Agile Therapeutics Inc AGRX awaits word from the FDA on Saturday on its contraceptive patch Twirla. The odds of approval have increased since the Adcom gave a positive verdict in favor of approving the patch.

The stock, which lost about 67% in three sessions following the release of the briefing document Oct. 28, has added over 560% since the Adcom verdict.

Adcom Meeting

FDA's Endocrinologic and Metabolic Drugs Advisory Committee will meet Thursday to discuss Amarin Corporation plc's AMRN sNDA for Vascepa for reducing the risk of cardiovascular events, as an adjunct to statin therapy in adult patients with elevated triglycerides levels and other risk factors for cardiovascular disease.

Clinical Trial Readouts

AASLD Presentations

Cocrystal Pharma Inc COCP: new Phase 2a data for CC-31244 in hepatitis C (Sunday).

Mallinckrodt PLC MNK: already-released Phase 3 data for terlipressin in hepatorenal syndrome Type 1 (Monday).

VBI Vaccines Inc VBIV: already-released Phase 3 data for Sci-B-Vac, a hepatitis B vaccine (Monday).

Assembly Biosciences Inc ASMB: Phase 2a data for ABI-H0731 for hepatitis B virus and Phase 1b data for ABI-H2158 also for hepatitis B virus (Monday).

Mirum Pharmaceuticals Inc MIRM: Phase 2 data for Maralixibat in Algaille syndrome (Monday).

Eiger Biopharmaceuticals Inc EIGR: Phase 2 data for pegylated interferon lambda + ritonavir-boosted lonafamib for hepatitis delta virus (Tuesday).

DURECT Corporation DRRX: Phase 2a data for DUR-928 in alcoholic hepatitis (Tuesday).

CTOS Presentations

Deciphera Pharmaceuticals Inc DCPH: initial Phase 1 data for DCC-3014 in solid tumors (Wednesday).

Oncternal Therapeutics Inc ONCT: Phase 1 data for TK216 and vincristine in relapsed or refractory Ewing sarcoma (Saturday).

Adaptimmune Therapeutics PLC – ADR ADAP: updated Phase 1 data for MAGE-A4 in solid tumors (Saturday).

ACR Presentations

Corbus Pharmaceuticals Holdings Inc CRBP: Phase 2 open label data for lenabasum in systemic sclerosis (Sunday). 

Kezar Life Sciences Inc KZR: Updated Phase 1b data for KZR-616 in lupus (Tuesday). 

Unity Biotechnology Inc UBX: Phase 1b data for UBX0101 in osteoarthritis (Tuesday).

AHA Presentations

The Medicines Company MDCO and Alnylam Pharmaceuticals, Inc. ALNY – Detailed Phase 3 data for inclisiran from the ORION-10 study evaluating the asset for atherosclerosis cardiovascular disease (Saturday). 

Caladrius Biosciences Inc CLBS: Phase 2 data for CLBS16 in coronary microvascular dysfunction (Saturday). 

Eidos Therapeutics Inc EIDX and BridgeBio Pharma Inc BBIO: Phase 2 data for AG10/BBP-265 in transthyretin amyloid cardiomyopathy, or ATTR-CM (Saturday). 

Kiniksa Pharmaceuticals Ltd KNSA: Phase 2 open label data for rilonacept in pericarditis (Saturday). 

Earnings

The earnings list is not comprehensive. 

Monday, Nov. 11

Amicus Therapeutics, Inc. FOLD (before the market open)

Foamix Pharmaceuticals Ltd FOMX (after the market close)

ICU Medical, Incorporated ICUI (after the market close)

Tuesday, Nov. 11

Akebia Therapeutics Inc AKBA (before the market open)

Applied Genetic Technologies Corp AGTC (after the market close)

Adamis Pharmaceuticals Corp ADMP (after the market close)

Tetraphase Pharmaceuticals Inc TTPH (after the market close)

Paratek Pharmaceuticals Inc PRTK (after the market close)

Wednesday, Nov. 13

Alpine Immune Sciences Inc ALPN (after the market close)

Biocept Inc BIOC (after the market close)

DiaMedica Therapeutics Inc DMAC (after the market close)

Gamida Cell Ltd GMDA (after the market close)

Edap Tms SA EDAP (after the market close)

Thursday, Nov. 14

Altimmune Inc ALT (before the market open)

Vascular Biogenics Ltd VBLT (before the market open)

Aytu Bioscience Inc AYTU (after the market close)

Dare Bioscience Inc DARE (after the market close)

Tricida Inc TCDA (after the market close)

IPO Quiet Period Expiry

INNATE PHARMA S/S ADR IPHA

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