BPC March 20 update

Axsome AXSM brings forward data release due to COVID19 - shares rise 17%

Price and Volume Movers

Axsome Therapeutics, Inc. (NASDAQ: AXSM) shares closed up 17% to $54.40 following news that it will be bring forward its release of top-line data from its Phase 2/3 trial of AXS-05 in Alzheimer’s Disease Agitation with data now due early in the second quarter, compared with previous guidance of a third quarter release. The company noted it was accelerating the completion of the trial “to ensure the safety of this vulnerable patient population during the COVID-19 pandemic.”

Eli Lilly and Company (NYSE: LLY) announced the FDA issued a complete response letter for the supplemental New Drug Application (sNDA) of empagliflozin as an adjunct to insulin for adults with type 1 diabetes.

Biofrontera AG (NASDAQ:BFRA) announced that it has implemented measures to reduce costs during the global COVID-19 pandemic following declining demand for its product Ameluz due to current measures and regulations implemented by governments worldwide in an attempt to control the COVID-19 pandemic. As a result, the company will implement short-time work for all employees in Germany. Similar measures are currently being assessed for its subsidiaries in Spain, UK and the US, where all employees will be required to take temporary periods of unpaid time off.

Tonix Pharmaceuticals Holding Corp (NASDAQ: TNXP) announced in a SEC filing that it will present certain information regarding its product candidate, TNX-1800, being developed as a potential COVID-19 vaccine, to the World Health Organization on March 20, 2020. Shares closed up 72% to $0.97.

Bellerophon Therapeutics, Inc. (NASDAQ:BLPH) jumped on the COVID-19 bandwagon when the nano-cap company announced the FDA granted emergency expanded access allowing its inhaled nitric oxide (iNO) delivery system, INOpulse, to immediately be used for the treatment of COVID-19. With less than 5m shares in the stock float, shares were traded multiple times, closing up 431% to $18.00 on volume of $9.3m shares.

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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:

Satsuma Pharmaceuticals, Inc. (STSA): $35.00; +113%.

Viela Bio, Inc. (VIE): $44.19; +39%.

Arcutis Biotherapeutics, Inc. (ARQT): $33.32; +32%.

Menlo Therapeutics Inc. (MNLO): $3.49; +31%.

BridgeBio Pharma, Inc. (BBIO): $26.62; +30%.

DECLINERS:

Evelo Biosciences, Inc. (EVLO): $3.42; -25%.

BioNTech SE (BNTX): $46.50; -22%.

PLx Pharma Inc. (PLXP): $2.16; -21%.

Odonate Therapeutics, Inc. (ODT): $20.86; -20%.

Arbutus Biopharma Corporation (ABUS): $1.44; -18%.

Pipeline updates below:

Pipeline Database Updates

Drug Stage Catalyst Market Cap

AXSM – Axsome Therapeutics Inc.
AXS-05 ADVANCE-1
Agitation in patients with Alzheimer’s disease (AD)

Phase 2/3 Phase 2/3 top-line met primary endpoint - April 27, 2020.
$2.8 billion

LLY – Eli Lilly and Company
Empagliflozin
Type 1 Diabetes

CRL CRL announced March 20, 2020.
$145.9 billion

MNLO – Menlo Therapeutics Inc.
Serlopitant
Pruritus associated with prurigo nodularis

Phase 3 Phase 3 data did not meet primary endpoint - April 6, 2020.
$290.2 million

MNLO – Menlo Therapeutics Inc.
FCD105
Acne

Phase 2 Phase 2 data released June 2, 2020.
$290.2 million

MRSN – Mersana Therapeutics Inc.
XMT-1536
Ovarian Cancer, Non Small Cell Lung Cancer

Phase 1 Phase 1 interim dose expansion data May 27, 2020 noted 35% objective response rate, including 10% complete response rate.
$1.2 billion

SRNE – Sorrento Therapeutics Inc.
STI-4398
Coronavirus COVID-19

Phase 1 Phase 1 IND filing due to be filed in the coming months - noted March 20, 2020.
$868.1 million