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 (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.
The following are key catalysts that could sway biotech stocks in the upcoming week.
- 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.
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).
- 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).
- 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)
- AngioDynamics, Inc. NASDAQ: ANGO) (before the market open, Thursday, Oct. 3).
- 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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