BPC March 17 update

​BioNTech BNTX shares rally on COVID-19 collaboration with Pfizer; Regeneron REGN to commence trials for treatment this summer

Price and Volume Movers

BioNTech SE (Nasdaq: BNTX) shares closed up 67% to $66.60. The company announced Monday a collaboration with Fosun Pharma to develop its mRNA vaccine candidate BNT162 in China for the prevention of COVID-19 infections, with trials to commence in late April 2020. The company followed this up with news Tuesday of an agreement with Pfizer Inc (NYSE: PFE) for development outside of China.

Moderna, Inc., (NASDAQ:MRNA), which announced Monday that the first participant has been dosed in its Phase 1 trial of its mRNA vaccine (mRNA-1273) for the coronavirus (COVID-19), added a further 6% to $28.18 following Monday’s rise of 24%.

Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) provided an update regarding its potential future treatment for SARS-CoV-2 virus. Scientists have isolated virus-neutralizing, fully human antibodies from their VelocImmune mice, which have been genetically-modified to have a human immune system. Regeneron will select the top two antibodies for a 'cocktail' treatment. The company is working toward the goal of producing hundreds of thousands of prophylactic doses per month by the end of summer and hopes to have smaller quantities available for initial clinical testing at the beginning of the summer.

Blueprint Medicines Corporation (NASDAQ: BPMC) shares closed up 20% to $57.77 on the back of several analysts upgrades. BMO Capital raised their rating from Market Perform to Outperfrom and their price target from $74 to $89, while Deutsche Bank upgraded their rating from Hold to Buy.

DBV Technologies (Nasdaq: DBVT) shares closed down 56% to $2.33 following Monday’s news the FDA has identified questions regarding efficacy of its Biologics License Application (BLA) for Viaskin Peanut in patients with peanut allergy. As a result, the Allergenic Products Advisory Committee (APAC) meeting to discuss the BLA will no longer take place as previously scheduled.

Merck (NYSE:MRK) announced that its two Phase 3 trials (COUGH-1 and COUGH-2) evaluating gefapixant (MK-7264) for the treatment of refractory or unexplained chronic cough, met the primary endpoint in the high dose (45mg), demonstrating a statistically significant decrease in 24-hour coughs per hour versus placebo. The 15 mg dose did not meet the primary endpoint.

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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:

Genprex, Inc. (GNPX): $3.33; +111%.

Synlogic, Inc. (SYBX): $2.62; +64%.

Vaxart, Inc. (VXRT): $1.93; +64%.

Wave Life Sciences Ltd. (WVE): $12.30; +53%.

Neon Therapeutics, Inc. (NTGN): $2.62; +43%.

DECLINERS:

Alpine Immune Sciences, Inc. (ALPN): $2.15; -23%.

Cellectar Biosciences, Inc. (CLRB): $1.22; -20%.

Bicycle Therapeutics plc (BCYC): $11.15; -17%.

Rubius Therapeutics, Inc. (RUBY): $3.75; -16%.

Caladrius Biosciences, Inc. (CLBS): $1.53; -12%.

Pipeline updates below:

Pipeline Database Updates

Drug Stage Catalyst Market Cap

ABEO – Abeona Therapeutics Inc.
EB-101
Recessive dystrophic epidermolysis bullosa (RDEB)

Phase 3 Phase 3 initiation of dosing announced March 17, 2020.
$172.3 million

DFFN – Diffusion Pharmaceuticals Inc.
Trans sodium crocetinate (TSC)
Glioblastoma (GBM)

Phase 3 Phase 3 commencement of enrolment in the randomization portion is contingent upon entering into a strategic partnership.
$10.4 million

DFFN – Diffusion Pharmaceuticals Inc.
Trans sodium crocetinate (TSC) - PHAST-TSC
Ischemic or hemorrhagic stroke

Phase 2 Company noted March 24, 2020 that it expects delays in enrolment due to COVID-19. Previous guidance for data release was for 2022.
$10.4 million

ETON – Eton Pharmaceuticals Inc.
ET-101
Oral solution of topiramate

NDA Filing NDA filing due 3Q 2020.
$78 million

MNK – Mallinckrodt plc
Terlipressin
Hepatorenal syndrome (HRS) Type 1

NDA Filing Completion of NDA filing announced March 17, 2020.
$187.8 million

MRK – Merck & Company Inc. (new)
MK-7264
Chronic cough

Phase 3 Phase 3 data released March 17, 2020. 45 mg arm met primary endpoint; 15 mg arm did not meet the primary efficacy endpoint.
$181.9 billion

NGM – NGM Biopharmaceuticals Inc.
NGM282 - ALPINE 2/3
Non-alcoholic steatohepatitis (NASH)

Phase 2b Phase 2b top-line data due 1H 2021.
$886.2 million

NVUS – Novus Therapeutics Inc.
OP0201 - C-006
Acute Otitis Media - children

Phase 2a Phase 2a data due by early-June 2020.
$6.3 million

REGN – Regeneron Pharmaceuticals Inc.
COVID-19 antibody cocktail
Coronavirus COVID-19

Phase 1 Human trials to commence summer of 2020.
$49.5 billion

SURF – Surface Oncology Inc.
SRF617
Solid tumors

Phase 1 Phase 1 trial initiation announced March 17, 2020 with initial data due by the end of 2020.
$50.8 million