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Sunday, September 29, 2019

Biotech week ahead, Sept. 30

Biotech stocks came under selling pressure in the week ended Sept. 27 amid clinical data readouts and a handful of FDA decisions.
AIM ImmunoTech Inc AIM 6.28% was the worst decliner of the week, as the actively traded nano-cap biotech announced a common stock offering. Incidentally, the shares had rallied the previous week on a $6.42-million breakthrough award win for the clinical development of its drug to treat brain-metastatic breast cancer.
On the other hand, Marinus Pharmaceuticals Inc MRNS 10.06% and Ovid Therapeutics Inc OVID 8.31% were among the biggest gainers, reacting to data releases.
The following are key catalysts that could sway biotech stocks in the upcoming week.

Conferences

  • European Society for Medical Oncology, or ESMO, 2019 Conference:  Sept. 27-Oct. 1 in Barcelona, Spain.
  • European Respiratory Society, or ERS, 2020 International Congress 2019: Sept. 28-Oct. 2 in Madrid, Spain.
  • 24th International Annual Congress of the World Muscle Society, or WMS: Oct. 1-5 in Copenhagen, Denmark.
  • Annual Cell & Gene Meeting on the Mesa: Oct. 2-4 in Carlsbad, California.
  • 2019 Cantor Global Healthcare Conference: Oct 2-4 in New York City.
  • IDWeek 2019: Oct. 2-6 in Washington, D.C.
  • Foundation for Prader-Willi Research, or FPWR’s, PWS Research Symposium : Oct. 3-4 in New Orleans, Louisiana.

PDUFA Dates

The FDA is set to rule on Gilead Sciences, Inc. GILD 0.63%‘s sNDA for Descovy — emtricitabine 200 mg and tenofovir alafenamide 25 mg tablets — as pre-exposure prophylaxis for HIV-1 infection.
The PDUFA action date is estimated to be Friday, Oct. 4, assuming a six-month review period due to the priority voucher submitted with the application.

Clinical Readouts

ESMO Conference Presentations

  • Novartis AG (NYSE: NV: Phase 3 data for Kisqali plus fulvestrant in breast cancer (Sept. 29).
  • Incyte Corporation INCY 1.27% and Calithera Biosciences Inc CALA 0.91%: Phase 1/2 data for INCB001158 in solid tumors (Sept. 29).
  • Athenex Inc ATNX 3.49%: poster presentation of Phase 1b data for Oraxol and Cyramza in gastric cancer (Sept. 29).
  • G1 Therapeutics Inc GTHX 0.92%: additional Phase 2 data for Trilaciclib plus Roche Holdings AG Basel ADR RHHBY 0.61%‘s Tecentriq in first-line small-cell lung cancer; preliminary Phase 1/2 data for GIT48 in ER+, HER2- breast cancer (both due Sept. 29).
  • AstraZeneca plc AZN 0.46%: presentation of already released Phase 3 final overall survival data for Tagrisso in non-small cell lung cancer.
  • Merck & Co., Inc. MRK 1.14%: Phase 3 data for Keytruda in triple negative breast cancer (Sept. 29).
  • ImmunoGen, Inc. IMGN 2.16%: initial Phase 1b/2 data for mirvetuximab soravtansine in ovarian and relapsed endometrial cancers (Sept. 29).
  • Clovis Oncology Inc CLVS 0.25%: updated Phase 2 data for Rucaparib in castrate-resistant prostate cancer (Sept. 29).
  • Seattle Genetics, Inc. SGEN 4.64%: poster presentation of Phase 2 data for tucatinib in HER2 amplified metastatic colorectal cancer (Sept. 29).
  • Roche: updated Phase 3 data for Alecensa in anaplastic lymphoma kinase, or ALK-positive non-small cell lung cancer.
  • Tyme Technologies Inc TYME 0.33%: Phase 2 data for SM-88 in pancreatic cancer (Sept. 29).
  • Five Prime Therapeutics Inc FPRX 0.71%: initial Phase 1 data for FPA150 in solid tumors (Sept. 30).
  • Agios Pharmaceuticals Inc AGIO 1.29%: already released Phase 3 data for AG-120 Ivosidenib in IDH1 mutant positive cholangiocarcinoma (Sept. 30).
  • AVEO Pharmaceuticals, Inc. AVEO 0.67%: final Phase 2 data for Tivozanib in combination with Bristol-Myers Squibb Co BMY 0.47%‘s Opdivo for renal cell cancer (Sept. 30).
  • Oragenics Inc OGEN 3.21%: interim Phase 2 data for AG013 in oral mucositis (Sept. 30).
  • Arcus Biosciences Inc RCUS 15.65%: initial Phase 1 data for AB928 + mFOLFOX in colorectal cancer (Sept. 30).
  • Imv Inc IMV 3.51%: preliminary Phase 2 data for DPX-Survivac and Merck’s Keytruda in solid tumors (Sept. 30).
  • Deciphera Pharmaceuticals Inc DCPH 0.94% and Zai Lab Ltd ZLAB 4.41%: already released Phase 3 data for Ripretinib DCC-2618 in gastrointestinal stromal tumors (Sept. 30).
  • Merck: Phase 3 data for Keytruda vs. chemotherapy in malignant pleural mesothelioma (Sept. 30).
  • AstraZeneca and Merck: Phase 3 data for Lynparza in castration-resistant prostate cancer (Sept. 30).
  • Tyme Technologies: Phase 2 data for SM-88 in prostate cancer (Sept. 30).
  • X4 Pharmaceuticals Inc XFOR 0.99%: Phase 2a data for mavorixafor and axitinib in renal cell carcinoma (Sept. 30).

ERS International Conference Presentations

  • Pieris Pharmaceuticals Inc PIRS 21.52%: Phase 1 data for PRS-060 in asthma (Oct. 1).
  • Savara Inc SVRA 0.53%: already released Phase 3 data for molgradex in autoimmune pulmonary alveolar proteinosis (Oct. 2).

WMS Congress

  • Audentes Therapeutics Inc BOLD 0.3%: Phase 1/2 data for AT132 in x-linked myotubular myopathy (Oct. 1).
  • Capri Holdings Ltd CPRI 0.37%: expanded interim Phase 2 data CAP-1002 in Duchenne muscular dystrophy (Oct. 5).

ID Week Presentations

  • ContraFect Corp CFRX 8.21%: Phase 2 data for CF-301 exebacase in serious infections caused by Staph aureus, including MRSA (Oct. 3).
  • Enanta Pharmaceuticals Inc ENTA 0.38%: New Phase 2a data for EDP-938 in respiratory syncytial virus (Oct. 3).
  • resTORbio, Inc. TORC 3.76%: Phase 2b data for RTB101 in respiratory tract infections (Oct. 3).

FPWR, PWS Research Symposium Presentations

  • Millendo Therapeutics Inc MLND 0.43%: Phase 2b progress report on livoletide in Prader-Willi syndrome (Oct. 3).

Standalone Releases

  • Jaguar Health Inc NASDAQ: JAGX) and Roche: interim analysis of Phase 2 update for Mytesi in cancer-related diarrhea (Oct. 3).
  • Sarepta Therapeutics Inc NASDAQ: SRPT): Phase 1/2, nine-month data for MYO-101 in Duchenne muscular dystrophy (Oct. 4).
  • Minerva Neurosciences Inc NASDAQ: NERV): Phase 2 update for MIN-202 vs. quetiapine in major depressive disorder, Phase 3 update on roluperidone in schizophrenia, Phase 2 update on MIN-117 in major depressive disorder (all due Oct. 1)

Earnings

  • AngioDynamics, Inc. NASDAQ: ANGO) (before the market open, Thursday, Oct. 3).

IPOs

  • ADC Therapeutics, which develops antibody therapies for cancer, plans to offer 8.164 million shares in an IPO to be priced between $23-$26 per share. The shares are likely to be listed on the NYSE under the ticker symbol “ADCT.”
  • Aprea Therapeutics has filed to offer 5 million shares in an estimated price range of $14-$16. The shares of the biotech that develops targeted therapies for cancer are to be listed on the Nasdaq under the ticker symbol “APRE.”
  • Frequency Therapeutics, which focuses on therapies for degenerative diseases, is planning a 6.7-million share IPO to be priced between $14 and $16. The company seeks to list the shares on the Nasdaq under the ticker symbol “FREQ.”
  • Cancer biotech Monopar Therapeutics is set to offer 4.44 million shares in an IPO to be priced in the range of $8-$10. The company expects to list its shares on the Nasdaq under the ticker symbol “MNPR.”
  • Viela Bio has filed to offer 7.5 million shares at an estimated price range of $19-$21. The company, which develops antibodies, seeks to list the shares on the Nasdaq under the ticker symbol “VIE.”
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