BPC November 10 update

Five Prime FPRX shares surge after hours on cancer data +250%; Amgen AMGN AstraZeneca AZN shares rally on asthma data

Price and Volume Movers

Five Prime Therapeutics, Inc. (NASDAQ: FPRX) shares have surged after hours, currently trading up 256% to $19.50 following the release of top-line results from its Phase 2 FIGHT trial comparing mFOLFOX6 chemotherapy in combination with bemarituzumab (FPA144), in patients with front-line advanced gastric or gastroesophageal junction (GEJ) cancer. The company said that the trial met all three primary endpoints (PFS, OS and ORR). Median overall survival (OS) improved from 12.9 months to not reached (HR 0.58; p=0.027). Median progression-free survival (PFS) improved from 7.4 months to 9.5 months (Hazard ratio 0.68; p=0.073) and the overall response rate (ORR) improved by 13.1% (p=0.106). Of note, the trial used a cutoff of p=0.20 to measure pre-specified statistical significance.

Amgen (NASDAQ:AMGN) and AstraZeneca (NASDAQ:AZN) announced positive top-line results from their Phase 3 NAVIGATOR trial in which tezepelumab met the primary endpoint, demonstrating a statistically significant reduction in exacerbations compared to placebo in patients with severe asthma. Amgen shares closed up 4% to $241.60, while AstraZeneca shares closed up 5% to $56.57.

Applied Genetic Technologies Corporation (Nasdaq: AGTC) announced that it plans to release data from its Phase 1/2 clinical trial in patients with X-linked Retinitis Pigmentosa (XLRP) on November 11, 2020, with a conference call to be held at 8am EST.

Esperion (NASDAQ:ESPR) shares are trading down 7% after hours to $26.85 on news of an offering of $200m of convertible notes.

Oric Pharmaceuticals, Inc. (NASDAQ:ORIC) announced after hours that it has commenced an underwritten public offering of 4m shares of its common stock.

Keros Therapeutics, Inc. (NASDAQ:KROS) also announced after hours it has filed a registration statement relating to a proposed underwritten public offering of 2,250,000 shares of common stock.

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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:

Inovio Pharmaceuticals, Inc. (INO): $11.51; +35%.

Aptevo Therapeutics Inc. (APVO): $44.32; +35%.

Vaccinex, Inc. (VCNX): $2.30; +26%.

DBV Technologies S.A. (DBVT): $2.59; +19%.

Altimmune, Inc. (ALT): $9.25; +18%.

DECLINERS:

Voyager Therapeutics, Inc. (VYGR): $8.60; -23%.

Praxis Precision Medicines, Inc. (PRAX): $27.98; -22%.

Arena Pharmaceuticals, Inc. (ARNA): $70.25; -20%.

Supernus Pharmaceuticals, Inc. (SUPN): $21.07; -16%.

Neurocrine Biosciences, Inc. (NBIX): $87.58; -15%.

Pipeline updates below:

Pipeline Database Updates

Drug Stage Catalyst Market Cap

ALEC – Alector Inc.
AL001 (INFRONT-2)
Frontotemporal Dementia

Phase 2 Phase 2 open-label additional data due 2021.
$1 billion

AMGN – Amgen Inc.
Tezepelumab - NAVIGATOR
Asthma

Phase 3 Phase 3 trial met primary endpoint - November 10, 2020.
$129.3 billion

BCDA – BioCardia Inc.
CardiAMP (BCDA-01)
Heart Failure

Phase 3 Phase 3 DSMB review 4Q 2020
$29.2 million

CRBP – Corbus Pharmaceuticals Holdings Inc.
Lenabasum (resunab) - DETERMINE
Dermatomyositis

Phase 3 Phase 3 data due 2Q 2021.
$102.5 million

FPRX – Five Prime Therapeutics Inc.
FPA144 + chemo (FIGHT)
Gastric and gastro-esophageal junction cancer

Phase 2 Phase 2 data released November 10, 2020. All three efficacy endpoints met.
$870.8 million

GOSS – Gossamer Bio Inc.
GB002 (TORREY)
Pulmonary arterial hypertension (PAH)

Phase 2 Phase 2 enrollment to commence 4Q 2020 with top-line data due 1H 2022.
$671.2 million

GRTX – Galera Therapeutics Inc.
GC4419
COVID-19

Phase 2 Phase 2 top-line data due 1H 2021.
$272.5 million

GSK – GlaxoSmithKline PLC
VIR-7831 / GSK418213
COVID-19 antibody

Phase 2/3 Initial Phase 3 results may be available January 2021; results for the primary endpoint are expected 1Q 2021.
$92.3 billion

HEPA – Hepion Pharmaceuticals Inc.
CRV431 - AMBITION
Non-alcoholic steatohepatitis

Phase 2a Phase 2a to continue to next dose cohort following interim independent Data Safety Monitoring Board review November 18, 2020.
$15.1 million

IVA – Inventiva S.A.
Odiparcil
MPS VI

Phase 1/2 Development suspended (deprioritized) as of November 10, 2020.
$491.2 million

LPCN – Lipocine Inc.
LPCN 1144
Non-alcoholic fatty liver disease (NAFLD) / Non-alcoholic steatohepatitis (NASH)

Phase 2 Phase 2 top-line change in liver fat data due January 2021. 36-week biopsy and MRI-PDFF data are expected mid-2021.
$105.1 million

LRMR – Larimar Therapeutics Inc.
CTI-1601
Friedreich’s ataxia (FA)

Phase 1 Phase 1 top-line data due 1H 2021.
$341.2 million

MRK – Merck & Company Inc. (new)
Keytruda (pembrolizumab) and Lenvima (lenvatinib)
Renal Cell Carcinoma

Phase 3 Phase 3 trial met PFS and OS endpoints versus Sunitinib - November 10, 2020.
$203.4 billion