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 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 ALKS – Phase 1/2 data for ALKS 4230 in solid tumors and ALKS 4230 in combination with Merck & Co., Inc. MRK's Keytruda in solid tumors.

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

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

CELYAD SA/ADR 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 HTBX – Phase 2 data for HS-110 and Bristol-Myers Squibb Co BMY's Opdivo in non-small cell lung cancer (Friday).

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

Nektar Therapeutics 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 MRTX – initial Phase 2 data for sitravatinib in urothelial carcinoma (Saturday).

ASN Kidney Week Presentations

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

See Also: BTIG: Crispr Could Be A Takeover Target For Vertex

Earnings

The earnings list is not comprehensive

Monday

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

Tuesday

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

Wednesday

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

Thursday

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

Friday

• Obalon Therapeutics Inc OBLN
• Ocugen Inc OCGN
• PLx Pharma Inc 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."

IPO Quiet Period Expiry

BioNTech SE – ADR BNTX
Vir Biotechnology Inc VIR