BPC October 05 update

MyoKardia MYOK to be acquired by ​Bristol Myers BMY +58%; Y-mAbs YMAB issued Refusal to File letter -23% AH

Price and Volume Movers

Bristol Myers Squibb (NYSE:BMY) announced it will acquire MyoKardia, Inc. (NASDAQ:MYOK) for $13.1 billion, or $225 per share in cash. The transaction is anticipated to close during the fourth quarter of 2020. Shares of MyoKardia closed up 58% to $220.24.

Axovant Gene Therapies Ltd. (NASDAQ:AXGT) shares closed up 24% to $5.61 following news the company will announce six-month safety and efficacy data from the second cohort of its AXO-Lenti-PD program on the morning of Tuesday, October 6, 2020.

BridgeBio Pharma, Inc. (NASDAQ:BBIO) announced it will acquire all of the outstanding common stock of Eidos Therapeutics, Inc. (NASDAQ:EIDX) it does not already own, representing approximately 36.3% of Eidos' outstanding shares. Eidos stockholders will have the right to receive either 1.85 shares of BridgeBio common stock or $73.26 in cash per Eidos share in the transaction. Eidos shares closed up 42% to $73.78.

Iovance Biotherapeutics, Inc. (NASDAQ: IOVA) shares are trading down 18% after hours to $26.40 following news its BLA filing for lifileucel in metastatic melanoma will be delayed until 2021, from previous guidance of a filing this year. The company noted it had not been able to agree with the FDA “on the required potency assays to fully define its TIL therapy, which is required as part of a BLA submission.”

Y-mAbs Therapeutics, Inc. (NASDAQ:YMAB) announced that it received a Refusal to File letter from the FDA regarding the Biologics License Application for omburtamab for the treatment of pediatric patients with CNS/leptomeningeal metastasis from neuroblastoma. The FDA determined that certain parts of the Chemistry, Manufacturing and Control ("CMC") module and the clinical module require further detail. The company plans to refile its BLA later this year. Shares are trading down 23% to $32.12 after hours.

miRagen Therapeutics, Inc. (NASDAQ: MGEN) shares have slid after hours, currently trading down 41% to $0.45 on news it will discontinue development of cobomarsen following data from its Phase 2 SOLAR clinical trial in patients with Cutaneous T-Cell Lymphoma (CTCL) which showed lack of efficacy.

Unum Therapeutics Inc. (NASDAQ:UMRX) announced a name change to Cogent Biosciences, Inc. and will trade under a new ticker from October 6, 2020 of "COGT".

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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:

Enlivex Therapeutics Ltd. (ENLV): $14.30; +38%.

Corvus Pharmaceuticals, Inc. (CRVS): $4.86; +19%.

Cytokinetics, Incorporated (CYTK): $28.61; +19%.

Protara Therapeutics, Inc. (TARA): $21.47; +17%.

Vir Biotechnology, Inc. (VIR): $39.11; +17%.

DECLINERS:

Immunome, Inc. (IMNM): $12.10; -10%.

Repare Therapeutics Inc. (RPTX): $27.30; -9%.

Tenax Therapeutics, Inc. (TENX): $1.25; -9%.

Akouos, Inc. (AKUS): $20.00; -6%.

Inozyme Pharma, Inc. (INZY): $19.95; -5%.

Pipeline updates below:

Pipeline Database Updates

Drug Stage Catalyst Market Cap

AMGN – Amgen Inc.
AMG 510
Non-small cell lung cancer (NSCLC)

Phase 2 Phase 2 data released October 5, 2020. Objective response rate (primary end point) consistent with previously reported Phase 1 data. Detailed data at IASLC meeting January 26-29, 2021.
$126.7 billion

APLS – Apellis Pharmaceuticals Inc.
Pegcetacoplan
Amyotrophic lateral sclerosis (ALS)

Phase 2 Phase 2 trial to commence by the end of 2020.
$2.4 billion

ARCT – Arcturus Therapeutics Holdings Inc.
ARCT-810
Ornithine Transcarbamylase (OTC) deficiency

Phase 1 Phase 1 data due following study completion 4Q 2020.
$1.2 billion

AXGT – Axovant Gene Therapies Ltd.
AXO-Lenti-PD - SUNRISE-PD
Parkinson's disease

Phase 1/2 Phase 1/2 6-month data released October 6, 2020. Two evaluable patients in Cohort 2 demonstrated a 21-point mean improvement in the UPDRS Part III “OFF” score, representing a 40% improvement from baseline average score. Two other patients not evaluated. Further data due at R&D Day October 30, 2020. Randomized trial to commence 2021.
$170.1 million

CRVS – Corvus Pharmaceuticals Inc.
CPI-006
COVID-19

Phase 1 Phase 1 initial data noted that all patients recorded increased levels of antibodies. Data to be presented at at SITC November 10-14, 2020
$106.5 million

DRRX – DURECT Corporation
DUR-928
Nonalcoholic steatohepatitis (NASH)

Phase 1b Phase 1b top-line data released May 26, 2020. Additional data to be presented at AASLD November 13-16, 2020.
$357 million

FULC – Fulcrum Therapeutics Inc.
FTX-6058
Sickle Cell Disease

Phase 1 Phase 1 trial initiation announced October 5, 2020.
$268.8 million

HSTO – Histogen Inc.
HST 001
Androgenic Alopecia

Phase 1/2 Phase 1b/2 top-line data due 4Q 2020.
$22 million

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

BLA Filing BLA filing due 2021.
$5.2 billion

KOD – Kodiak Sciences Inc
KSI-301 - GLEAM and GLIMMER
Diabetic macular edema (DME) / wet AMD

Phase 3 Phase 3 first patients dosed - October 5, 2020.
$4.3 billion

KOD – Kodiak Sciences Inc
KSI-301 - BEACON
Retinal vein occlusion (RVO)

Phase 3 Phase 3 trial initiation announced October 5, 2020.
$4.3 billion

MGEN – Miragen Therapeutics Inc.
Cobomarsen - SOLAR
Cutaneous T-Cell Lymphoma

Phase 2 Development to be discontinued following insufficient efficacy - October 5, 2020.
$71.3 million

YMAB – Y-mAbs Therapeutics Inc.
Omburtamab
CNS/Leptomeningeal Metastases from Neuroblastoma

BLA Filing Refusal to file letter issued October 5, 2020. Expects to refile by end of 2020.
$1.7 billion