BPC October 12 update

Avenue Therapeutics ATXI receives CRL -59%; Surface SURF spikes on buyout reports +32%

Price and Volume Movers

Avenue Therapeutics, Inc. (NASDAQ: ATXI) and Fortress Biotech, Inc. (NASDAQ:FBIO) announced the receipt of a Complete Response Letter (“CRL”) from the FDA regarding the New Drug Application for IV tramadol. The CRL stated IV tramadol, intended to treat patients in acute pain who require an opioid, is not safe for the intended patient population. Avenue shares closed down 59% to $4.53, while Fortress shares closed 24% lower to $3.17.

Surface Oncology, Inc. (NASDAQ: SURF) shares spiked in early afternoon trading to close up 32% to $9.39 following reports by StreetInsider that the company has received a takeover approach from GlaxoSmithKline (GSK).

Mallinckrodt plc (NYSE:MNK) announced that it has initiated Chapter 11 proceedings in the U.S. Bankruptcy Court to modify its capital structure, including restructuring portions of its debt, and resolve several billion dollars of potential legal liabilities.

Voyager Therapeutics, Inc. (NASDAQ:VYGR) announced after hours that the FDA has placed on clinical hold its Investigational New Drug (IND) submission for VY-HTT01 for the treatment of Huntington's disease. The hold was placed pending the resolution of certain chemistry, manufacturing and controls (CMC) matters. Shares are trading down 17% to $10.01 after hours.

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Major price movers (stocks priced > $1.00, volume > 50k listed on NASDAQ/NYSE):

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

ADVANCERS:

Five Prime Therapeutics, Inc. (FPRX): $6.09; +13%.

Tracon Pharmaceuticals, Inc. (TCON): $5.45; +11%.

Immuron Limited (IMRN): $8.50; +9%.

Inozyme Pharma, Inc. (INZY): $24.05; +9%.

Poseida Therapeutics, Inc. (PSTX): $9.80; +8%.

DECLINERS:

TFF Pharmaceuticals, Inc. (TFFP): $15.27; -17%.

Aclaris Therapeutics, Inc. (ACRS): $4.05; -15%.

Precigen, Inc. (PGEN): $5.02; -12%.

Opko Health, Inc. (OPK): $4.08; -12%.

Xeris Pharmaceuticals, Inc. (XERS): $5.25; -10%.

Pipeline updates below:

Pipeline Database Updates

Drug Stage Catalyst Market Cap

ALRN – Aileron Therapeutics Inc.
ALRN-6924
Small Cell Lung Cancer (SCLC)

Phase 1b Phase 1b/2 final data due 1Q 2021.
$49.8 million

CLSN – Celsion Corporation
ThermoDox - OPTIMA
Hepatocellular carcinoma - liver cancer

Phase 3 Phase 3 second analysis July 13, 2020 recommends trial be stopped due to futility. Company noted October 12, 2020 that it intends to continue trial with findings from further statistical analyses due before the end of 2020.
$18.7 million

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

CRL CRL announced October 12, 2020.
$203.7 million

RVMD – Revolution Medicines Inc - Ordinary Shares
RMC-4630 and cobimetinib - RMC-4630-02
Solid tumors

Phase 1/2 Phase 1b/2 presented at ENA meeting October 24, 2020.
$2.1 billion

SGEN – Seagen Inc.
Enfortumab Vedotin - EV-201
Urothelial Cancer

Phase 2 Phase 2 data released October 12, 2020 - ORR 52%.
$33.9 billion

UBX – Unity Biotechnology Inc.
UBX1325
Diabetic macular edema / Age-related macular degeneration

Phase 1 Phase 1 initiation of dosing announced October 12, 2020 with safety and tolerability data expected 1H 2021.
$207.1 million