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The Week Ahead In Biotech: Adcom Test For Agile; Pfizer, Merck Lead Earnings

Shanthi Rexaline

Earnings, clinical trial readouts and positive FDA verdicts catalyzed fairly robust performances by biotech stocks last week.

Biogen Inc (NASDAQ: BIIB)'s about-face with respect to its Alzheimer's drug aducanumab headlined the biotech news, while Seattle Genetics (NASDAQ: SGEN) shares touched record highs in reaction to a positive mid-stage readout related to its breast cancer drug.

The following are key catalysts expected in the unfolding week.

Conferences

  • American College of Gastroenterology, or ACG, Annual Scientific Meeting: Oct. 25-30 in San Antonio, Texas.
  • American Association for Cancer Research, or AACR-NCI-EORTC International Conference on Molecular Targets and Cancer Therapeutics: Oct. 26-30 in Boston, Massachusetts.
  • World Vaccine Congress Europe: Oct. 29-31 in Barcelona, Spain.
  • North American Cystic Fibrosis Conference: Oct. 31-Nov. 2 in Nashville, Tennessee.

PDUFA Dates

The FDA is set to rule Thursday on Adamis Pharmaceuticals Corp (NASDAQ: ADMP)'s NDA for higher-dose naloxone spray, which is being evaluated as a treatment option for opioid overdose.

The regulatory body on Saturday will issue its verdict on REDHILL BIOPHAR/S ADR (NASDAQ: RDHL) NDA for RHB-105, which is being evaluated for H. Pylori infection.

Adcom Meeting

The Bone, Reproductive and Urologic Drug Advisory Committee is scheduled to meet Tuesday to discuss AMAG Pharmaceuticals, Inc. (NASDAQ: AMAG)'s sNDA for Makena, which is being evaluated for reducing the risk of recurrent preterm birth or improving neonatal mortality and morbidity.

The committee will also discuss Wednesday Agile Therapeutics Inc (NASDAQ: AGRX)'s NDA for Twirla — a low-dose combo hormonal contraceptive patch — to be used for birth control.

Biotech Stock On The Radar: Immunomedics' Long Wait For Redemption

Clinical Trial Readouts AACR-NCI-EORTC Presentations

ArQule, Inc. (NASDAQ: ARQL): Phase 1b data for ARQ 751 in solid tumors (Sunday).

View more earnings on IBB

Agios Pharmaceuticals Inc (NASDAQ: AGIO): Phase 1 data for AG-270 in solid tumors (Sunday).

Deciphera Pharmaceuticals Inc (NASDAQ: DCPH): Preliminary Phase 1b/2 data for rebastinib and paclitaxel in solid tumors (Monday); Phase 1 data for DCC-3014 in solid tumors or hematologic malignancies and updated Phase 1 data for DCC-2618 in the second- to fourth-line setting for gastrointestinal stromal tumors (Tuesday).

Mirati Therapeutics Inc (NASDAQ: MRTX): Phase 1/2 data for MRTX849 in solid tumors (Monday).

Sutro Biopharma Inc (NASDAQ: STRO): initial safety data from a Phase 1 trial of STRO-002 in ovarian and endometrial cancer (Tuesday).

Kura Oncology Inc (NASDAQ: KURA): Phase 2 data for Tipifarnib in head and neck squamous cell carcinomas with HRAS Mutations (Tuesday).

ACG Meeting

Protagonist Therapeutics Inc (NASDAQ: PTGX): Phase 1 data for PTG-200 in Crohn's disease and Phase 1 data for PN-943 in ulcerative colitis (Monday).

World Vaccine Congress Presentations

VBI Vaccines Inc (NASDAQ: VBIV): Phase 1/2a Part A immuno-oncology data for VBI-1901 in recurrent glioblastoma multiforme (Tuesday).

NACF Conference

Translate Bio Inc (NASDAQ: TBIO): interim single-ascending dose data for MRT5005 in cystic fibrosis (Friday).

Standalone Releases

Actinium Pharmaceuticals Inc (NYSE: ATNM) is due to present interim results from the pivotal Phase 3 SIERRA trial for its lead asset lomab-B, which is being evaluated in comparison with the physician's choice of salvage chemotherapy in patients ages 55 and above with active, relapsed or refractory acute myeloid leukemia (Monday).

Earnings

Tuesday, Oct. 29

  • Merck & Co., Inc. (NYSE: MRK) (before the market open)
  • Pfizer Inc. (NYSE: PFE) (before the market open)
  • Amgen, Inc. (NASDAQ: AMGN) (after the market close)
  • EXACT Sciences Corporation (NASDAQ: EXAS) (after the market close)
  • Seattle Genetics (after the market close)

Wednesday, Oct. 30

  • United Therapeutics Corporation (NASDAQ: UTHR) (before the market open)
  • ACADIA Pharmaceuticals Inc. (NASDAQ: ACAD) (after the market close)
  • Vertex Pharmaceuticals Incorporated (NASDAQ: VRTX) (after the market close)

Thursday, Oct. 31

  • Alnylam Pharmaceuticals, Inc. (NASDAQ: ALNY) (before the market open)
  • Bristol-Myers Squibb Co (NYSE: BMY)(before the market open)
  • Celgene Corporation (NASDAQ: CELG)
  • Ironwood Pharmaceuticals, Inc. (NASDAQ: IRWD) (before the market open)
  • Bio-Rad Laboratories, Inc. Class A (NYSE: BIO) (after the close)

Friday, Nov. 1

  • AMAG Pharmaceuticals, Inc. (NASDAQ: AMAG) (before the market open)
  • AbbVie Inc (NYSE: ABBV) (before the market open)
  • ImmunoGen, Inc. (NASDAQ: IMGN) (before the market open)

IPOs

Oyster Point Pharma, a biotech developing a nasal spray formulation to treat dry eye disease, is planning a 5-million-share IPO, estimated to be priced between $16 and $18. The company seeks to list the shares on the Nasdaq under the ticker symbol "OYST."

IPO Quiet Period Expiry

Viela Bio Inc (NASDAQ: VIE)

Frequency Therapeutics Inc (NASDAQ: FREQ)

Aprea Therapeutics Inc (NASDAQ: APRE)

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