The Week Ahead In Biotech: Smid-Cap Earnings Deluge, SITC Conference In The Spotlight

Biotech stocks extended their gains last week amid earnings news flow and the broader market strength. Large-cap pharma stocks saw particular strength.

Here are the key catalytic event a biotech investor should keep a tab on in the unfolding week.

Conferences

American Society of Nephrology Kidney Week – Nov. 5-10, in Washington D.C.
Wolfe Research Healthcare Conference – Nov. 6, in New York
Society for Immunotherapy of Cancer, or SITC, – Nov. 6-10, in National Harbor, Maryland

PDUFA Dates

The FDA is set to rule on Lipocine Inc (NASDAQ:LPCN)'s NDA for Tlando, or LPCN 1021 to treat hypogonadism in adult males. The PDUFA date is set for Saturday, Nov. 9.

Clinical Trial Readouts

SITC Presentations

Alkermes Plc (NASDAQ:ALKS) – Phase 1/2 data for ALKS 4230 in solid tumors and ALKS 4230 in combination with Merck & Co., Inc. (NYSE:MRK)'s Keytruda in solid tumors.

Celldex Therapeutics, Inc. (NASDAQ:CLDX) – Phase 1 data for CDX-1140 in solid tumors (Friday, Nov. 8).

Pieris Pharmaceuticals Inc (NASDAQ:PIRS) – Phase 1/2 data for PRS-343 in HER2-positive solid tumors.

CELYAD SA/ADR (NASDAQ:CYAD) – Phase 1 data for CYAD-01 and FOLFOX in colorectal cancer (Friday, Nov. 8) and Phase 1 data for CYAD-101 in colorectal cancer (Saturday, Nov. 9).

Heat Biologics Inc (NASDAQ:HTBX) – Phase 2 data for HS-110 and Bristol-Myers Squibb Co (NYSE:BMY)'s Opdivo in non-small cell lung cancer (Friday).

Oncolytics Biotech, Inc. (NASDAQ:ONCY) - interim Phase 1b data for Pelareorep and Roche Holdings AG Basel ADR Common Stock (OTC:RHHBY)'s Tecentriq in breast cancer (Friday).

Nektar Therapeutics (NASDAQ:NKTR) – updated Phase 1/2 data for NKTR-214 + Opdivo in multiple cancers (urothelial carcinoma, melanoma, renal cell carcinoma, and non-small cell lung cancer) (Saturday).

Mirati Therapeutics Inc (NASDAQ:MRTX) – initial Phase 2 data for sitravatinib in urothelial carcinoma (Saturday).

ASN Kidney Week Presentations

Allena Pharmaceuticals Inc (NASDAQ:ALNA) – Phase 2 data for reloxaliase, or ALLN-177, in primary hyperoxaluria and Phase 3 data for reloxaliase in enteric hyperoxaluria (Friday).

Earnings

The earnings list is not comprehensive

Monday

Karyopharm Therapeutics Inc (NASDAQ:KPTI) (before the market open)
Tandem Diabetes Care Inc (NASDAQ:TNDM) (after the market close)
Myriad Genetics, Inc. (NASDAQ:MYGN) (after the market close)
Neurocrine Biosciences, Inc. (NASDAQ:NBIX) (after the market close)
Deciphera Pharmaceuticals Inc (NASDAQ:DCPH) (after the market close)

Tuesday

Mylan NV (NASDAQ:MYL) (before the market open)
Regeneron Pharmaceuticals Inc (NASDAQ:REGN) (before the market open)
Mallinckrodt PLC (NYSE:MNK) (before the market open)
Ligand Pharmaceuticals Inc. (NASDAQ:LGND) (after the market close)
GW Pharmaceuticals PLC- ADR (NASDAQ:GWPH) (after the market close)

Wednesday

MannKind Corporation (NASDAQ:MNKD) (before the market open)
Elanco Animal Health Inc (NYSE:ELAN) (before the market open)
Horizon Therapeutics PLC (NASDAQ:HZNP) (before the market open)
Aimmune Therapeutics Inc (NASDAQ:AIMT) (after the market close)
Sangamo Therapeutics Inc (NASDAQ:SGMO) (after the market close)

Thursday

Clovis Oncology Inc (NASDAQ:CLVS) (before the market open)
Axsome Therapeutics Inc (NASDAQ:AXSM) (before the market open)
Viveve Medical Inc (NASDAQ:VIVE) (after the market close)
Sarepta Therapeutics Inc (NASDAQ:SRPT) (after the market close)
Pfenex Inc (NYSE:PFNX) (after the market close)

Friday

Obalon Therapeutics Inc (NASDAQ:OBLN)
Ocugen Inc (NASDAQ:OCGN)
PLx Pharma Inc (NASDAQ:PLXP)

IPOs

Galera Therapeutics has filed to offer 5 million shares in an IPO, with an estimated price range of $14-$16. The company has applied for listing its shares on the Nasdaq under the ticker symbol "GRTX."

89bio, a biotech company focusing on therapies for NASH and other metabolic disorders, is planning a 4.375-million IPO at an estimated price range of $15-17. The company has applied for listing its shares on the Nasdaq under the ticker symbol "ETNB."

Gene testing company Centogene is proposing to offer 4 million shares in an IPO, which are to be priced between $14 and $16. The company has applied to list the shares on the Nasdaq under the ticker symbol "CNTG."

CNS Pharmaceuticals, which develops therapies for brain cancer and other CNS tumors, has filed for a 2.125-million share IPO. The shares, which are likely to be priced in the range of $4-$5, are to be listed on the Nasdaq under the ticker symbol "CNSP."

Tela Bio, which sells soft tissue implants used in hernia repair and reconstructive surgery, is set to offer 4 million shares in an IPO, with each share to be priced between $14 and $16. The company seeks to list the shares on the Nasdaq under the ticker symbol "TELA."