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 (ClarIDHy)
IDH1 mutant positive cholangiocarcinoma - cancer

Phase 3 sNDA filing due to be filed following final overall survival analysis between the end of 2020 and mid-2021. Mature data due mid-2020, but anticipates delays in collecting the data due to COVID-19.
$3.8 billion

AVEO – AVEO Pharmaceuticals Inc.
Tivozanib
Third line treatment of patients with renal cell cancer

PDUFA PDUFA date March 31, 2021.
$124.6 million

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

NDA Filing NDA filing due mid-2020.
$3.9 billion

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

Phase 3 Phase 3 second analysis due following IDMC meeting first half of July 2020. Final readout 1Q 2021.
$126.4 million

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

CRL CRL announced December 24, 2019.
$

ERYP – Erytech Pharma S.A.
Eryaspase (Trybeca-1)
Pancreatic cancer

Phase 3 Phase 3 interim superiority analysis expected around end of 2020; final analysis due 2H 2021.
$143.5 million

HALO – Halozyme Therapeutics Inc.
HALO-301
Pancreatic cancer

Phase 3 Phase 3 data November 4, 2019 did not meet primary endpoint.
$3.9 billion

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

Phase 2 Phase 2 new cohort 2 interim data presented at ASCO May 29, 2020. 36.4% Overall Response Rate (ORR) maintained
$4.3 billion

KPTI – Karyopharm Therapeutics Inc.
Selinexor - BOSTON
Multiple myeloma

Phase 3 sNDA filing announced May 20, 2020.
$1.5 billion

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

Phase 2 Phase 2 top-line data met primary endpoint.
$4.4 billion

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

Approved FDA Approval announced November 4, 2019.
$245.8 million

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

PDUFA PDUFA date November 25, 2020.
$1.5 billion

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

PDUFA PDUFA date August 7, 2020.
$182.2 million

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

Phase 1 Phase 1 dose escalation suspended - noted November 4, 2019.
$67.9 million