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The Week Ahead In Biotech: Conference Presentations, IPO News Flow Take The Spotlight

Shanthi Rexaline

The holiday-shortened week saw a few huge moves by individual stocks.

Abeona Therapeutics Inc (NASDAQ: ABEO) was among the biggest gainers after the biopharma announced plans to explore strategic alternatives. On the other hand, Mallinckrodt PLC (NYSE: MNK) came under intense selling following reports of a potential bankruptcy filing.

Here are they key events for the upcoming week.

Conferences

  • International Association for the Study of Lung Cancer (IASLC) 2019 World Conference - Sept. 7-10, in Barcelona, Spain
  • 32nd European College of Neuropsychopharmacology (ECNP) Congress – Sept. 7-10, in Copenhagen, Denmark
  • 19th Congress of the International Headache Society – Sept. 5-8, in Dublin, Ireland
  • World Congress on Pain Medicine and Management – Sept. 9-10, in Singapore City, Singapore
  • 31st International Conference on Cancer Research and Therapy – Sept. 9-10, in Zurich, Switzerland
  • H.C. Wainwright Annual Healthcare Conference 2019 – Sept. 9-10, in Lotte New York Palace Hotel, New York
  • Morgan Stanley 17th Annual Healthcare Conference – Sept. 9-11, in Grand Hyatt, New York City, New York
  • 35th Congress of the European Committee For Treatment and Research In Multiple Sclerosis (ECTRIMS) – Sept. 11-13, in Stockholm, Sweden
  • Society for Research in Nicotine and Tobacco Europe 10th Annual Conference – Sept. 12-14, in Oslo, Norway
  • 17th International Myeloma Workshop – Sept. 12-15, in Boston, Massachusetts
  • 12th World Congress on Cell & Tissue Science – Sept. 13-14, in Singapore City, Singapore
  • Heart Failure Society of America 23rd Annual Scientific Meeting – Sept. 13-15, in Philadelphia

PDUFA Dates

Xeris Pharmaceuticals Inc (NASDAQ: XERS) awaits FDA verdict on its NDA for Gvoke – a ready-to-use glucagon injection – for treating severe hypoglycaemia. The PDUFA action date is scheduled for Tuesday.

The FDA is set to rule on Ardelyx Inc (NASDAQ: ARDX)'s NDA for tenapanor in treating irritable bowel syndrome with constipation. The decision date is set for Thursday.

FDA's Allergenic Products Advisory Committee is scheduled to meet Tuesday to discuss and make recommendations on the safety and efficacy of Aimmune Therapeutics Inc (NASDAQ: AIMT)'s Allergen Powder indicated for the treatment to reduce the risk of anaphylaxis after accidental exposure to peanut in patients aged 4 to 17 years with a confirmed diagnosis of peanut allergy.

See Also: Biotech Stock On The Radar: Ardelyx Gears Up For FDA Decision Day

Clinical Trial Readouts

Adverum Biotechnologies Inc (NASDAQ: ADVM) is due on Thursday to release 24-week data from the first cohort of a Phase 1 study evaluating its ADVM-022 in wet age-related macular degeneration.

IASLC World Conference Presentations

Beyondspring Inc (NASDAQ: BYSI) – presentation of already-released Phase 3 data for plinabulin in chemotherapy-induced neutropenia (Sept. 8)

Seattle Genetics, Inc. (NASDAQ: SGEN) & GENMAB A/S/S ADR (NASDAQ: GMAB) – initial Phase 1/2 data for enapotamab vedotin in solid tumors (Sept. 8)

Eli Lilly And Co (NYSE: LLY) – updated Phase 1/2 data for LOXO-292 in RET-fusion non-small cell lung cancer (Sept. 8)

Amgen, Inc. (NASDAQ: AMGN) – Updated Phase 1 data for AMG 510 in solid tumors (Sept. 8)

AstraZeneca plc (NYSE: AZN) – already-released interim Phase 3 data for imfinzi and tremelimumab in small cell lung cancer (Sept. 9)

IHC Congress Presentations

Zosano Pharma Corp (NASDAQ: ZSAN) – long-term safety data from a Phase 3 study of Qtrypta in migraine (Sept. 8)

ECNP Congress Presentations

Concert Pharmaceuticals Inc (NASDAQ: CNCE) – Phase 1 data for CTP-692 in schizophrenia (Sept. 10)

ECTRIMS Congress Presentations

Atara Biotherapeutics Inc (NASDAQ: ATRA) – initial Phase 1 data for ATA188 in multiple sclerosis (Sept. 11)

Roche Holdings AG Basel ADR (OTC: RHHBY) – Phase 3 data for satralizumab in neuromyelitis optica spectrum disorder (Sept. 11)

TG Therapeutics Inc (NASDAQ: TGTX) - Phase 2 long term follow up data for TG-1101 in relapsing form of multiple sclerosis.

Novartis AG (NYSE: NVS) and Genmab – already released Phase 3 data for OMB158 in relapsing multiple sclerosis.

Other Conference Presentations

Achieve Life Sciences Inc (NASDAQ: ACHV) – already-released Phase 2b data for Cytisine in smoking cessation at the SRNT conference (Sept. 13)

Cytokinetics, Inc. (NASDAQ: CYTK) – Phase 1 data from healthy volunteers for CK-3773274 in hypertrophic cardiomyopathy

Cellectar Biosciences Inc (NASDAQ: CLRB) - Poster presentation of Phase 1 data for CLR 131 in multiple myeloma at the International Myeloma Workshop (Sept. 14)

IPOs

10x Genomics, a provider of single-cell sequencing platform for biomedical research, is planning to offer 9 million shares in an IPO at an estimated price range of $31-$35. The company is seeking to list its shares on the Nasdaq under the ticker symbol TXG.

Satsuma Pharmaceuticals, which is developing, a fast-acting dry powder nasal spray for migraines, is planning a 5-million share IPO to be priced between $14 and $16. The shares are to be listed on the Nasdaq under the ticker symbol STSA.

SpringWorks Therapeutics, a developer of small-molecule therapies for rare cancers, is planning to offer 7.353 million shares in an IPO. The company expects to price the offering in the $16-$18 range, with the shares to be listed on the Nasdaq under the ticker symbol SWTX.

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