BPC November 04 update

FibroGen FGEN shares fall 8% on short report; ​RedHill RDHL FDA approval +6%

Price and Volume Movers

RedHill Biopharma Ltd. (Nasdaq: RDHL) announced the FDA approved approved Talicia for the treatment of Helicobacter pylori (H. pylori) infection in adults. Shares closed up 6% to $7.35.

FibroGen, Inc. (NASDAQ: FGEN) shares closed down 8% to $37.01 following a short report published by Plainview, LLC titled “The Next Biotech Blow-Up”. The authors noted that they believe a presentation of key major adverse cardiac events (MACE) data of its lead drug, roxadustat at the ASN meeting on November 8, will be negative.

Agile Therapeutics, Inc. (Nasdaq: AGRX) shares added a further 32% to $1.78 following last week’s positive vote from an FDA Advisory Committee meeting which delivered a 14 to 1 vote supporting approval of the New Drug Application (NDA) for its contraceptive patch, Twirla.

AVEO Oncology (NASDAQ: AVEO) shares closed down 37% to $0.57 following an update regarding its pipeline candidate tivozanib for the treatment of refractory renal cell carcinoma (RCC). The FDA recommended that the company not submit an NDA at this time due to concerns regarding overall survival data from its TIVO-3 Phase 3 trial. The company will now file a NDA in 1Q 2020 but will withdraw the filing if overall survival data to be released in June 2020 yields a hazard ratio above 1.00.

Halozyme Therapeutics, Inc. (NASDAQ: HALO) announced that the HALO-301 Phase 3 trial of PEGPH20 as a first-line therapy for treatment of patients with pancreatic cancer failed to reach the primary endpoint of overall survival. Shares recovered from losses early in the session to close flat on the day at $15.44.

Merus N.V. (Nasdaq: MRUS) announced after hours a proposed underwritten public offering of up to $60m of its common shares. Shares are trading down 3% after hours to $14.40 after closing the normal trading session down 7%.

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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:

Bellicum Pharmaceuticals, Inc. (BLCM): $1.28; +20%.

Celldex Therapeutics, Inc. (CLDX): $2.80; +17%.

Oncolytics Biotech Inc. (ONCY): $1.33; +16%.

Ovid Therapeutics Inc. (OVID): $2.83; +15%.

BioNTech SE (BNTX): $18.97; +15%.

DECLINERS:

Omeros Corporation (OMER): $13.60; -16%.

Tonix Pharmaceuticals Holding Corp. (TNXP): $3.03; -16%.

Seneca Biopharma, Inc. (SNCA): $1.22; -13%.

Rexahn Pharmaceuticals, Inc. (REXN): $1.84; -12%.

Forty Seven, Inc. (FTSV): $6.90; -9%.

Pipeline updates below:

Pipeline Database Updates

Drug Stage Catalyst Market Cap

AGIO – Agios Pharmaceuticals Inc.
AG-120 Ivosidenib
IDH1 mutant positive cholangiocarcinoma - cancer

Phase 3 sNDA filing due to be filed following final overall survival analysis mid-2020.
$2.2 billion

AVEO – AVEO Pharmaceuticals Inc.
TIVO-3 - tivozanib
Third line treatment of patients with renal cell cancer

NDA Filing NDA to be filed in 1Q 2020. Will withdraw if overall survival data in 2Q 2020 yields an OS HR above 1.00.
$98.1 million

CCXI – ChemoCentryx Inc.
Avacopan - CCX168 (ADVOCATE)
Associated vasculitis (AAV)

Phase 3 Phase 3 data due 4Q 2019.
$487.1 million

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

Phase 3 Phase 3 interim efficacy November 4, 2019 - trial to continue as planned. Second analysis 2Q 2020.
$29.8 million

CORV – Correvio Pharma Corp.
Brinavess
Atrial fibrillation (AF)

PDUFA PDUFA date December 24, 2019. FDA Advisory Committee meeting December 10, 2019.
$111.1 million

ERYP – Erytech Pharma S.A.
Eryaspase (GRASPA)
Pancreatic cancer

Phase 3 Phase 3 trial to continue as planned following IDMC review.
$88 million

HALO – Halozyme Therapeutics Inc.
HALO-301
Pancreatic cancer

Phase 3 Phase 3 data November 4, 2019 did not meet primary endpoint.
$2.8 billion

IOVA – Iovance Biotherapeutics Inc.
LN-144 - lifileucel
Refractory metastatic melanoma

Phase 2 Phase 2 pivotal cohort enrolment to be completed 1Q 2020. Cohort 2 data noted 41% ORR in patients refractory to anti-PD1/L1 - November 21, 2019.
$2.8 billion

KPTI – Karyopharm Therapeutics Inc.
Selinexor - BOSTON
Multiple myeloma

Phase 3 Phase 3 data due early 2020.
$1 billion

MYOK – MyoKardia Inc.
Mavacamten (MYK-461) - MAVERICK-HCM
Hypertrophic cardiomyopathy (HCM)

Phase 2 Phase 2 top-line data met primary endpoint. 5 patients exhibited ejection fraction reductions below 45% - November 11, 2019.
$2.7 billion

RDHL – Redhill Biopharma Ltd.
Talicia RHB-105
H. pylori

Approved FDA Approval announced November 4, 2019.
$203.2 million

RVNC – Revance Therapeutics Inc.
DAXI (RT002)
Moderate to severe glabellar (frown) lines

BLA Filing BLA filing due November 2019.
$737.5 million

TRVN – Trevena Inc.
Oliceridine (TRV130)
Moderate to severe acute pain

NDA Filing CRL issued November 2, 2018. NDA to be resubmitted 1Q 2020.
$57.6 million

UMRX – Unum Therapeutics Inc.
ACTR087 + SEA-BCMA (ATTCK-17-01)
Multiple Myeloma

Phase 1 Phase 1 dose escalation suspended - noted November 4, 2019.
$19.3 million