BPC June 26 update

Shares sell off following FDA Approval decisions for Chiasma CHMA and Zogenix ZGNX; ​Vaxart VXRT continues surge +28%

Price and Volume Movers

Vaxart, Inc. (NASDAQ: VXRT) shares surged to close up 28% to $8.04 following news that its COVID-19 vaccine has been selected to participate in a non-human primate (NHP) challenge study, organized and funded by Operation Warp Speed, a new national program aiming to provide substantial quantities of vaccine by January 2021. Unlike most other vaccines, Vaxart is developing a tablet to be taken by mouth instead of by needle injection. Shares of the company were trading as low as $0.29 just last December.

Axsome Therapeutics, Inc. (NASDAQ:AXSM) shares closed up 12% to $85.79 on news the FDA has granted Breakthrough Therapy designation for AXS-05 for the treatment of Alzheimer's disease (AD) agitation. The company announced in late-April that its pivotal Phase 2/3 trial met its primary endpoint. Breakthrough Therapy Designation is granted to potentially expedite development and review timelines for a promising investigational medicine when preliminary clinical evidence indicates it may demonstrate substantial improvement over available therapies for a serious or life-threatening condition.

Zogenix, Inc. (NASDAQ:ZGNX) announced late-Thursday that the FDA approved Fintepla for the treatment of seizures associated with Dravet syndrome in patients 2 years of age and older. Shares sold off on the news, closing down 9% to $25.47.

Chiasma, Inc. (NASDAQ:CHMA) announced the FDA approved Mycapssa (octreotide) capsules for long-term maintenance treatment in acromegaly patients who have responded to and tolerated treatment with octreotide or lanreotide. After spiking as high as $7.75 during afternoon trading following the intra-day approval, shares also sold off on the news, closing down 7% to $6.08. Such stock behaviour is often seen in biotech stocks following the approval of a drug, in particular during speculative trading conditions.

Allergan, an AbbVie company (NYSE:ABBV) announced that the FDA issued a Complete Response Letter for the Biologics License Application (BLA) for Abicipar pegol for patients with neovascular (wet) age-related macular degeneration (nAMD). The letter from the FDA indicates that the rate of intraocular inflammation observed following administration of Abicipar pegol results in an unfavorable benefit-risk ratio.

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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:

Cleveland BioLabs, Inc. (CBLI): $4.26; +148%.

iBio, Inc. (IBIO): $2.15; +34%.

Citius Pharmaceuticals, Inc. (CTXR): $1.38; +28%.

PDS Biotechnology Corporation (PDSB): $1.38; +28%.

Altimmune, Inc. (ALT): $10.60; +15%.

DECLINERS:

CohBar, Inc. (CWBR): $1.86; -23%.

Translate Bio, Inc. (TBIO): $19.48; -21%.

Viela Bio, Inc. (VIE): $42.54; -20%.

Passage Bio, Inc. (PASG): $28.41; -19%.

Adverum Biotechnologies, Inc. (ADVM): $18.95; -19%.

Pipeline updates below:

Pipeline Database Updates

Drug Stage Catalyst Market Cap

ABBV – AbbVie Inc.
ABICIPAR
Age-related macular degeneration (AMD)

CRL CRL issued June 26, 2020.
$174.3 billion

ACIU – AC Immune SA
Semorinemab (Anti-Tau RO7105705)
Alzheimer’s disease

Phase 2 Phase 2 top-line data due 2H 2020.
$507.3 million

ASND – Ascendis Pharma A/S
TransCon hGH
Growth hormone deficiency in children

BLA Filing BLA filing announced June 26, 2020.
$7.3 billion

CHMA – Chiasma Inc.
Mycapssa - OPTIMAL
Acromegaly

Approved FDA approval announced June 26, 2020.
$190.6 million

DBVT – DBV Technologies S.A.
Viaskin Peanut (EPITOPE)
Peanut allergy - ages 1 to 3 years

Phase 3 Phase 3 (Part B) enrolment expectations due 2H 2020.
$490.5 million

SRPT – Sarepta Therapeutics Inc.
Casimersen
Duchenne muscular dystrophy

NDA Filing Rolling NDA has been completed - June 26, 2020.
$12.7 billion

ZGNX – Zogenix Inc.
FINTEPLA (ZX008)
Dravet syndrom

Approved FDA approval announced June 25, 2020.
$1.6 billion