BPC February 03 update

Insmed INSM releases positive mid-stage data - shares rally 41%

Price and Volume Movers

Insmed Incorporated (NASDAQ:INSM) shares rallied to close Monday up 41% to $28.88 on news its Phase 2 Willow trial evaluating INS1007 administered once daily in adults with non-cystic fibrosis bronchiectasis (NCFBE), met its primary endpoint of time to first pulmonary exacerbation over the 24-week treatment period for both the 10 mg and 25 mg dosage groups of INS1007 compared to placebo (p=0.027, p=0.044, respectively).

Anavex Life Sciences Corp. (NASDAQ:AVXL) announced that the FDA has granted Fast Track designation for ANAVEX 2-73 clinical development program for the treatment of Rett syndrome. Shares closed up 15% to $3.28.

United Therapeutics Corporation (NASDAQ:UTHR) announced that its Phase 2/3 Distinct clinical trial evaluating Unituxin (dinutuximab) Injection added to irinotecan compared to irinotecan or topotecan alone in patients with relapsed or refractory small cell lung cancer (SCLC), did not meet its primary efficacy objective of extending the overall survival with Unituxin and irinotecan versus using irinotecan alone. Shares closed down 2% to $95.56, paring back most of its losses after trading down 6% early in the session.

Rockwell Medical, Inc. (NASDAQ:RMTI) announced an underwritten public offering of its common stock. Shares are currently trading down 12% to $2.44 after hours after closing the normal trading session up 7%.

InVivo Therapeutics Holdings Corp. (NASDAQ:NVIV) announced a 1-for-30 reverse stock split of its common stock will become effective and trade on a post-split basis at the market open on February 12, 2020.

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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:

Vaxart, Inc. (VXRT): $1.59; +27%.

AIM ImmunoTech Inc. (AIM): $1.25; +25%.

Acer Therapeutics Inc. (ACER): $4.58; +21%.

Surface Oncology, Inc. (SURF): $3.18; +16%.

Sutro Biopharma, Inc. (STRO): $11.83; +16%.

DECLINERS:

Cleveland BioLabs, Inc. (CBLI): $2.91; -31%.

Evelo Biosciences, Inc. (EVLO): $4.81; -18%.

Miragen Therapeutics, Inc. (MGEN): $1.44; -18%.

Clearside Biomedical, Inc. (CLSD): $3.18; -16%.

Vir Biotechnology, Inc. (VIR): $22.80; -14%.

Pipeline updates below:

Pipeline Database Updates

Drug Stage Catalyst Market Cap

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

Phase 3 Phase 3 enrolment 50% complete - noted February 3, 2020.
$10.9 million

CTIC – CTI BioPharma Corp.
Pacritinib - PACIFICA
Myelofibrosis

Phase 3 Phase 3 Spleen Volume Reduction (SVR) data due by the end of 2021.
$63.2 million

GILD – Gilead Sciences Inc.
Remdesivir GS-5734
Coronavirus

Phase 2 Clinical trials have been initiated in China. Data due April 2020.
$92.2 billion

GWPH – GW Pharmaceuticals Plc
Epidiolex
Tuberous Sclerosis Complex

sNDA Filing sNDA filing announced January 3, 2020.
$3.7 billion

INSM – Insmed Inc.
INS1007
Bronchiectasis

Phase 2 Phase 2 trial met primary endpoint - February 3, 2020.
$2.7 billion

LNTH – Lantheus Holdings Inc.
DEFINITY (BENEFIT 1)
Left Ventricular Ejection Fraction

Phase 3 Phase 3 trial did not meet primary endpoint - February 3, 2020.
$632.3 million

MESO – Mesoblast Limited
Remestemcel-L (MSC-100-IV)
acute graft versus host disease (aGVHD) in children

BLA Filing BLA rolling submission filed January 31, 2020.
$843.6 million

MRK – Merck & Company Inc. (new)
Imipenem/ cilastatin
Hospital-Acquired and Ventilator-Associated Bacterial Pneumonia (HABP/VABP)

PDUFA priority review PDUFA date under priority review June 4, 2020.
$207.1 billion

UTHR – United Therapeutics Corporation
Unituxin - DISTINCT
Small cell lung cancer

Phase 2/3 Phase 2/3 trial did not meet primary endpoint - February 3, 2020.
$5.1 billion

ZYNE – Zynerba Pharmaceuticals Inc.
Zygel ZYN002
Fragile X syndrome

Phase 2/3 Phase 2/3 data due late-2Q 2020.
$107.4 million