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 ... Read More...

<p class="canvas-atom canvas-text Mb(1.0em) Mb(0)–sm Mt(0.8em)–sm" type="text" content="Biotech stocks extended their gains last week amid earnings news flow and the broader market strength. Large-cap pharma stocks saw particular strength.” data-reactid=”18″>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

<p class="canvas-atom canvas-text Mb(1.0em) Mb(0)–sm Mt(0.8em)–sm" type="text" content="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.” data-reactid=”26″>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

<p class="canvas-atom canvas-text Mb(1.0em) Mb(0)–sm Mt(0.8em)–sm" type="text" content="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.” data-reactid=”28″>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.

<p class="canvas-atom canvas-text Mb(1.0em) Mb(0)–sm Mt(0.8em)–sm" type="text" content="Celldex Therapeutics, Inc. (NASDAQ: CLDX) – Phase 1 data for CDX-1140 in solid tumors (Thursday, Nov. 7).” data-reactid=”29″>Celldex Therapeutics, Inc. (NASDAQ: CLDX) – Phase 1 data for CDX-1140 in solid tumors (Thursday, Nov. 7).

<p class="canvas-atom canvas-text Mb(1.0em) Mb(0)–sm Mt(0.8em)–sm" type="text" content="Pieris Pharmaceuticals Inc (NASDAQ: PIRS) – Phase 1/2 data for PRS-343 in HER2-positive solid tumors.” data-reactid=”30″>Pieris Pharmaceuticals Inc (NASDAQ: PIRS) – Phase 1/2 data for PRS-343 in HER2-positive solid tumors.

<p class="canvas-atom canvas-text Mb(1.0em) Mb(0)–sm Mt(0.8em)–sm" type="text" content="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).” data-reactid=”31″>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).

<p class="canvas-atom canvas-text Mb(1.0em) Mb(0)–sm Mt(0.8em)–sm" type="text" content="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).” data-reactid=”32″>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).

<p class="canvas-atom canvas-text Mb(1.0em) Mb(0)–sm Mt(0.8em)–sm" type="text" content="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).” data-reactid=”33″>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).

View more earnings on IBB

<p class="canvas-atom canvas-text Mb(1.0em) Mb(0)–sm Mt(0.8em)–sm" type="text" content="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).” data-reactid=”35″>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).

<p class="canvas-atom canvas-text Mb(1.0em) Mb(0)–sm Mt(0.8em)–sm" type="text" content="Mirati Therapeutics Inc (NASDAQ: MRTX) – initial Phase 2 data for sitravatinib in urothelial carcinoma (Saturday).” data-reactid=”36″>Mirati Therapeutics Inc (NASDAQ: MRTX) – initial Phase 2 data for sitravatinib in urothelial carcinoma (Saturday).

ASN Kidney Week Presentations

<p class="canvas-atom canvas-text Mb(1.0em) Mb(0)–sm Mt(0.8em)–sm" type="text" content="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).” data-reactid=”38″>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).

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

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

<p class="canvas-atom canvas-text Mb(1.0em) Mb(0)–sm Mt(0.8em)–sm" type="text" content="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."” data-reactid=”76″>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.”

<p class="canvas-atom canvas-text Mb(1.0em) Mb(0)–sm Mt(0.8em)–sm" type="text" content="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."” data-reactid=”77″>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.”

<p class="canvas-atom canvas-text Mb(1.0em) Mb(0)–sm Mt(0.8em)–sm" type="text" content="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."” data-reactid=”78″>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.”

<p class="canvas-atom canvas-text Mb(1.0em) Mb(0)–sm Mt(0.8em)–sm" type="text" content="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."” data-reactid=”79″>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.”

<p class="canvas-atom canvas-text Mb(1.0em) Mb(0)–sm Mt(0.8em)–sm" type="text" content="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."” data-reactid=”80″>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 (NASDAQ: BNTX)
Vir Biotechnology Inc (NASDAQ: VIR)

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