BPC October 13 update

​Gossamer GOSS shares fall on disappointing data -26%; ETON OCUL offerings

Price and Volume Movers

Gossamer Bio, Inc. (Nasdaq: GOSS) announced top-line results from its Phase 2b LEDA trial in patients with moderate-to-severe eosinophilic asthma and its Phase 2 TITAN trial in patients with chronic rhinosinusitis, did not meet the primary endpoints in both trials. Shares fell 26% to close down at $10.09.

Auris Medical Holding Ltd. (NASDAQ:EARS) shares closed up 22% to $1.03. The company announced that the first patient has been randomized in Part B of its Phase 2 trial of AM-125 in acute vertigo. It expects to complete enrolment by the end of the first quarter 2021.

Emergent BioSolutions Inc. (NYSE: EBS) shares closed down 14% to $96.26 following news that Johnson and Johnson (NYSE: JNJ) has paused its COVID-19 vaccine trial due to an unexplained illness in one participant. Earlier this year, Emergent signed a manufacturing agreement with J&J for the vaccine.

United Therapeutics (NASDAQ:UTHR) shares rose 4% to $108.32, while LiquidiaTechnologies (NASDAQ:LQDA) fell 30% to $4.08 following news the US Patent Trial and Appeal Board will review the validity of just one of the two patents of United Therapeutics which protect Tyvaso (treprostinil inhalation solution). Liquidia has been assigned a PDUFA date of November 24 for LIQ861, an inhaled dry powder formulation of treprostinil, for the treatment of pulmonary arterial hypertension (PAH).

Eton Pharmaceuticals, Inc (NASDAQ:ETON) announced after hours that it is offering to sell shares of its common stock in an underwritten public offering.

Ocular Therapeutix, Inc. (NASDAQ:OCUL) also announced after hours that it has commenced an underwritten public offering of its common stock. Shares, which closed normal trading hours up 10%, are currently trading down 8% to $11.17 after hours.

Larimar Therapeutics, Inc. (Nasdaq:LRMR) shares closed up 23% to $18.91. While there was no clinical trial news released to prompt the move, the company did put out a press release noting the formation of its Scientific Advisory Board (SAB).

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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:

Enlivex Therapeutics Ltd. (ENLV): $13.87; +23%.

BiondVax Pharmaceuticals Ltd. (BVXV): $40.79; +20%.

Cogent Biosciences, Inc. (COGT): $2.89; +17%,

Aileron Therapeutics, Inc. (ALRN): $1.90; +15%.

Sol-Gel Technologies Ltd. (SLGL): $8.52; +15%.

DECLINERS:

Avenue Therapeutics, Inc. (ATXI): $3.87; -15%.

Inozyme Pharma, Inc. (INZY): $21.70; -10%.

MorphoSys AG (MOR): $28.40; -6%.

Cardiff Oncology, Inc. (CRDF): $15.58; -6%.

Immunic, Inc. (IMUX): $19.30; -5%.


Pipeline updates below:

Pipeline Database Updates

Drug Stage Catalyst Market Cap

ANAB – AnaptysBio Inc.
ANB019
Generalized pustular psoriasis

Phase 2 Phase 2 data noted 6 of 8 patients achieved primary endpoint of improvement in the clinical global impression scale (CGI) on Day 29 - October 13, 2020.
$781.7 million

CANF – Can-Fite Biopharma Ltd Sponsored ADR (Israel)
Piclidenoson (CF101)
Psoriasis

Phase 3 Phase 3 trial ongoing.
$25.6 million

CLDX – Celldex Therapeutics Inc.
CDX-0159
Chronic spontaneous urticaria (CSU) / Chronic inducible urticaria (CINDU)

Phase 1b Phase 1b trial initiation announced October 13, 2020, with data from the CIndU and CSU due 1Q 2021 and 2H 2021, respectively
$601.4 million

CNCE – Concert Pharmaceuticals Inc.
CTP-543
Alopecia areata

Phase 2 Phase 3 trial to be initiated 4Q 2020. Phase 2 open label data to be presented at EADV meeting October 29, 2020.
$327.3 million

CTIC – CTI BioPharma Corp.
Pacritinib
Myelofibrosis

NDA Filing Rolling NDA filing announced October 13, 2020, to be completed 1Q 2021.
$233.7 million

EARS – Auris Medical Holding Ltd.
AM-125
Vertigo

Phase 2 Phase 2 Part B initiation announced October 13, 2020 with enrollment to be completed 1Q 2021.
$5.9 million

GOSS – Gossamer Bio Inc.
GB001
Nasal polyps / chronic rhinosinusitis

Phase 2 Phase 2 trial did not meet primary endpoint - October 13, 2020.
$642.5 million

GOSS – Gossamer Bio Inc.
GB001
Eosinophilic asthma

Phase 2b Phase 2b trial did not meet primary endpoint - October 13, 2020.
$642.5 million

MBRX – Moleculin Biotech Inc.
WP1066
Glioblastoma

Phase 1 Phase 1 initial data released October 13, 2020.
$44.4 million

OTLK – Outlook Therapeutics Inc.
NORSE 3 ONS-5010 (open-label)
Wet age-related macular degeneration (wet AMD)

Phase 3 Phase 3 trial initiation announced October 13, 2020. To be completed 1H 2021.
$94.1 million

PSTI – Pluristem Therapeutics Inc.
PLX-PAD
Chronic Graft vs Host Disease

Phase 1/2 Phase 1/2 enrollment to move to cohort 2 phase - October 13, 2020.
$236.1 million

QURE – uniQure N.V.
AMT-130
Huntington's disease

Phase 1/2 Phase 1/2 enrollment to be completed mid-2021. DSMB meeting early-2021.
$1.7 billion

REGN – Regeneron Pharmaceuticals Inc.
Dupixent (dupilumab)
Asthma - 6-11 year-olds

Phase 3 Phase 3 trial met primary endpoint - October 13, 2020.
$60.3 billion

VXRT – Vaxart Inc.
VXA-CoV2-1
COVID-19 Vaccine

Phase 1 Phase 1 commencement of dosing announced October 13, 2020. Company noted first data due in a "few weeks".
$547.3 million