The Week Ahead In Biotech (Sept. 29-Oct. 5): Conference Presentations, IPOs Hit Top Gear

Shanthi Rexaline

Sun, Sep 29, 2019, 1:01 PM

AIM ImmunoTech Inc (NYSE: AIM) 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 (NASDAQ: MRNS) and Ovid Therapeutics Inc (NASDAQ: OVID) 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. (NASDAQ: GILD)'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 (NASDAQ: INCY) and Calithera Biosciences Inc (NASDAQ: CALA): Phase 1/2 data for INCB001158 in solid tumors (Sept. 29).
Athenex Inc (NASDAQ: ATNX): poster presentation of Phase 1b data for Oraxol and Cyramza in gastric cancer (Sept. 29).
G1 Therapeutics Inc (NASDAQ: GTHX): additional Phase 2 data for Trilaciclib plus Roche Holdings AG Basel ADR (OTC: RHHBY)'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 (NYSE: AZN): presentation of already released Phase 3 final overall survival data for Tagrisso in non-small cell lung cancer.
Merck & Co., Inc. (NYSE: MRK): Phase 3 data for Keytruda in triple negative breast cancer (Sept. 29).
ImmunoGen, Inc. (NASDAQ: IMGN): initial Phase 1b/2 data for mirvetuximab soravtansine in ovarian and relapsed endometrial cancers (Sept. 29).
Clovis Oncology Inc (NASDAQ: CLVS): updated Phase 2 data for Rucaparib in castrate-resistant prostate cancer (Sept. 29).
Seattle Genetics, Inc. (NASDAQ: SGEN): 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 (NASDAQ: TYME): Phase 2 data for SM-88 in pancreatic cancer (Sept. 29).
Five Prime Therapeutics Inc (NASDAQ: FPRX): initial Phase 1 data for FPA150 in solid tumors (Sept. 30).
Agios Pharmaceuticals Inc (NASDAQ: AGIO): already released Phase 3 data for AG-120 Ivosidenib in IDH1 mutant positive cholangiocarcinoma (Sept. 30).
AVEO Pharmaceuticals, Inc. (NASDAQ: AVEO): final Phase 2 data for Tivozanib in combination with Bristol-Myers Squibb Co (NYSE: BMY)'s Opdivo for renal cell cancer (Sept. 30).
Oragenics Inc (NYSE: OGEN): interim Phase 2 data for AG013 in oral mucositis (Sept. 30).
Arcus Biosciences Inc (NYSE: RCUS): initial Phase 1 data for AB928 + mFOLFOX in colorectal cancer (Sept. 30).
Imv Inc (NASDAQ: IMV): preliminary Phase 2 data for DPX-Survivac and Merck's Keytruda in solid tumors (Sept. 30).
Deciphera Pharmaceuticals Inc (NASDAQ: DCPH) and Zai Lab Ltd (NASDAQ: ZLAB): 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 (NASDAQ: XFOR): Phase 2a data for mavorixafor and axitinib in renal cell carcinoma (Sept. 30).

ERS International Conference Presentations

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

WMS Congress

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

ID Week Presentations

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

FPWR, PWS Research Symposium Presentations

Millendo Therapeutics Inc (NASDAQ: MLND): 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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