BPC December 11 update

AstraZeneca AZN releases positive breast cancer data; Novartis terminates agreement with Intec NTEC

Price and Volume Movers

Intec Pharma Ltd. (NASDAQ:NTEC) announced the termination of the Feasibility and Option agreement with Novartis for the development of a custom-designed Accordion Pill (AP). Novartis agreed to pay Intec Pharma $1.5m on conclusion of the program. Shares closed down 11% to $0.53.

AstraZeneca (NYSE: AZN) and Daiichi Sankyo Company, Limited presented positive data from their Phase 2 single-arm DESTINY-Breast01 trial of trastuzumab deruxtecan in patients with HER2-positive metastatic breast cancer who received two or more prior HER2-targeted regimens. An objective response rate (ORR) of 60.9% and a disease control rate (DCR) of 97.3% were recorded.

Bellicum Pharmaceuticals, Inc. (NASDAQ:BLCM) announced that The University of Texas MD Anderson Cancer Center exercised its option to license its CaspaCIDe safety switch technology. Bellicum will receive an upfront payment of $5m and future milestone payments and royalties on sales. Shares closed up 41% to $1.13.

Forty Seven, Inc. (NASDAQ:FTSV) announced after hours that it has commenced an underwritten public offering of $140m of shares of its common stock.

Assembly Biosciences, Inc. (NASDAQ:ASMB) also announced it intends to offer and sell shares of its common stock in an underwritten public offering. Shares are trading down 3% to $17.20 after hours.

Marinus Pharmaceuticals, Inc. (NASDAQ: MRNS) announced the pricing of an underwritten public offering of 28m shares at a public offering price of $1.25 per share for gross proceeds of $65m. Despite the pricing, shares closed up 38% to $1.78.

Madrigal Pharmaceuticals, Inc. (NASDAQ:MDGL) shares closed down 16% to $99.08 following the announcement of the pricing of its underwritten secondary offering by investment funds affiliated with Bay City Capital LLC, of 1.2m shares at the public offering price of $107.85 per share.

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Major price movers (stocks priced > $1.00, volume > 50k):

Refer to the BioPharmCatalyst Biotech Stocks page for Top 10 Gainers/Losers/Unusual Volume

ADVANCERS:

Forward Pharma A/S (FWP): $9.60; +70%.

Neon Therapeutics, Inc. (NTGN): $1.36; +24%.

Immunic, Inc. (IMUX): $8.82; +23%.

Abeona Therapeutics Inc. (ABEO): $4.02; +23%.

CTI BioPharma Corp. (CTIC): $1.21; +22%.

DECLINERS:

Iterum Therapeutics plc (ITRM): $3.12; -36%.

Relmada Therapeutics, Inc. (RLMD): $34.04; -15%.

Rocket Pharmaceuticals, Inc. (RCKT): $20.84; -14%.

Momenta Pharmaceuticals, Inc. (MNTA): $15.71; -13%.

Surface Oncology, Inc. (SURF): $1.84; -11%.

Pipeline updates below:

Pipeline Database Updates

Drug Stage Catalyst Market Cap

ARWR – Arrowhead Pharmaceuticals Inc.
ARO-HIF2
Clear Cell Renal Cell Carcinoma

Phase 1b Phase 1b trial to commence dosing 1H 2020.
$3.7 billion

BCRX – BioCryst Pharmaceuticals Inc.
Berotralstat BCX7353
Reduce or eliminate attacks in HAE patients

PDUFA PDUFA date December 3, 2020
$370.5 million

BTAI – BioXcel Therapeutics Inc.
BXCL701 and pembrolizumab
Malignant Solid Neoplasm

Phase 2 Phase 2 trial to be initiated.
$582.4 million

DARE – Dare Bioscience Inc.
Sildenafil Cream, 3.6%
Female Sexual Arousal Disorder (FSAD)

Phase 2b Phase 2b trial planned for 2020.
$33.6 million

FBIO – Fortress Biotech Inc.
Intravenous (IV) tramadol
Postoperative pain following bunionectomy surgery

PDUFA PDUFA date October 10, 2020.
$181.9 million

GILD – Gilead Sciences Inc.
Axicabtagene ciloleucel - (ZUMA-2)
Relapsed or Refractory Mantle Cell Lymphoma (r/r MCL) - cancer

PDUFA priority review PDUFA date under priority review August 10, 2020.
$92.2 billion

KNSA – Kiniksa Pharmaceuticals Ltd.
Mavrilimumab and Yescarta
Relapsed or Refractory Large B-Cell Lymphoma

Phase 2 Phase 2 trial to be initiated.
$1 billion

KZIA – Kazia Therapeutics Limited
GDC-0084
Glioblastoma

Phase 2/3 Phase 2/3 trial to be initiated 2Q / 3Q 2020.
$25.7 million

LLY – Eli Lilly and Company
Selpercatinib (LOXO-292)
Treatment-naïve RET fusion-positive non-small cell lung cancer (NSCLC)

Phase 3 Phase 3 trial initiation announced December 11, 2019.
$132.1 billion

MGEN – Miragen Therapeutics Inc.
Cobomarsen - SOLAR
Cutaneous T-Cell Lymphoma

Phase 2 Phase 2 data due 3Q 2020.
$27.7 million

ONCT – Oncternal Therapeutics Inc.
TK216 and vincristine
Relapsed or refractory Ewing sarcoma

Phase 1b Phase 1b expansion cohort data due 2H 2020.
$63.5 million

PRQR – ProQR Therapeutics N.V.
QR-1123
autosomal dominant retinitis pigmentosa (adRP)

Phase 1/2 Phase 1/2 initiation of dosing announced December 11, 2019. Data due 2021.
$417.7 million

SYBX – Synlogic Inc.
SYNB1618
Phenylketonuria (PKU)

Phase 2 Phase 2 trial to commence 1H 2020.
$82.3 million

VIE – Viela Bio Inc.
VIB4920
Sjögren’s syndrome

Phase 2b Phase 2b trial initiation announced December 11, 2019.
$2.1 billion