BPC August 04 update

​Novavax NVAX releases early-stage COVID-19 vaccine data; DBVT issued CRL for peanut allergy

Price and Volume Movers

Novavax, Inc. (NASDAQ: NVAX) shares fell sharply in the after-hours session before recovering just has swiftly to a point where shares are currently trading up 9% to $172.00 after hours. The company released initial Phase 1 data from its trial of its COVID‑19 vaccine noting that it “was generally well-tolerated and elicited robust antibody responses numerically superior to that seen in human convalescent sera.” Shares initially fell as much as 34% following an article from a media publication that erroneously reported that eight participants in the trial had been hospitalised following severe reactions. Novavax noted in its conference call that the report was not correct and the media publication edited its article to reflect this.

DBV Technologies (NASDAQ: DBVT) announced the FDA issued a Complete Response Letter regarding its Biologics License Application (BLA) for Viaskin Peanut to treat peanut allergies in children ages 4 to 11 years. The FDA identified concerns regarding the impact of patch-site adhesion on efficacy and indicated the need for patch modifications, and subsequently a new human factor trial. Supplementary clinical data will also need to be generated to support the modified patch. In addition, the FDA requested additional Chemistry, Manufacturing and Controls data. Shares slid to close down 43% to $2.34.

Mallinckrodt plc (NYSE:MNK) shares fell 28% to $1.62 following the release of second quarter earnings. The company reported a net loss of $933.1 million, or $11.04 a share. The company noted that “due to pressures from the Acthar Gel Medicaid matter, the ongoing opioid litigation and the Company's existing debts and the related risk of non-compliance with its financial debt covenant over the next twelve months, the company has been working with external advisors to explore a range of options and engage in dialogue with financial creditors and litigation claimants and their advisors, including the possibility of a filing for reorganization in bankruptcy under Chapter 11 by Mallinckrodt Plc and most of its subsidiaries in the near-term.”

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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:

Alterity Therapeutics Limited (ATHE): $3.43; +154%.

Sorrento Therapeutics, Inc. (SRNE): $12.84; +31%.

Aileron Therapeutics, Inc. (ALRN): $1.10; +21%.

Proteostasis Therapeutics, Inc. (PTI): $1.76; +18%.

Personalis, Inc. (PSNL): $21.10; +17%.

DECLINERS:

Epizyme, Inc. (EPZM): $12.30; -14%.

Immunic, Inc. (IMUX): $19.43; -12%.

BioSig Technologies, Inc. (BSGM): $8.22; -10%.

Aduro Biotech, Inc. (ADRO): $2.66; -9%.

Atara Biotherapeutics, Inc. (ATRA): $12.32; -9%.

Pipeline updates below:

Pipeline Database Updates

Drug Stage Catalyst Market Cap

ARPO – Aerpio Pharmaceuticals Inc.
Razuprotafib (I-SPY_COVID)
Acute Respiratory Distress Syndrome (ARDS) in COVID-19 patients

Phase 2 Phase 2 commencement of dosing announced September 1, 2020.
$63.1 million

BMRN – BioMarin Pharmaceutical Inc.
Vosoritide
Achondroplasia

NDA Filing NDA filing announced August 20, 2020.
$14.4 billion

CLRB – Cellectar Biosciences Inc.
CLR 131 (CLOVER-2)
Solid tumors

Phase 1 Phase 1 presentation at the International Symposium on Pediatric Neuro-Oncology (ISPNO) annual meeting December 13-16, 2020.
$32.2 million

CORT – Corcept Therapeutics Incorporated
Miricorilant (GRATITUDE 2)
Long-standing antipsychotic-induced weight gain (APIWG)

Phase 2 Phase 2 trial to be initiated 3Q 2020.
$2.1 billion

CRIS – Curis Inc.
CA-4948
Relapsed or Refractory Non-Hodgkin Lymphoma

Phase 1 Phase 1 data due later in 2020.
$60.3 million

DBVT – DBV Technologies S.A.
Viaskin Peanut
Peanut allergy - ages 4 to 11 years

CRL CRL issued August 4, 2020
$214 million

ENTA – Enanta Pharmaceuticals Inc.
EDP-297
Non-alcoholic steatohepatitis (NASH)

Phase 1 Phase 1 initiation announced September 14, 2020 with data due 2Q 2021.
$926.5 million

KPTI – Karyopharm Therapeutics Inc.
Selinexor - SEAL
Dedifferentiated liposarcoma

Phase 2/3 Phase 3 top-line data due in 2H 2020.
$1.2 billion

NVAX – Novavax Inc.
NVX-CoV2373
COVID-19 vaccine

Phase 2 Phase 2 trial initiation in U.S. and Australia announced August 24, 2020. Interim immunogenicity and safety data data due 4Q 2020.
$6.6 billion

OPTN – OptiNose Inc.
XHANCE
Chronic sinusitis

Phase 3 Phase 3 data due 2H 2021.
$198.7 million

OTIC – Otonomy Inc.
OTIVIDEX
Ménière's disease

Phase 3 Phase 3 data due 1Q 2021.
$190.5 million

PCRX – Pacira BioSciences Inc.
EXPAREL - pediatric patients
Postoperative Pain Management

PDUFA PDUFA date March 22, 2021.
$2.6 billion

RGNX – REGENXBIO Inc.
RGX-314
Wet AMD using using subretinal delivery

Phase 2 Phase 2 trial to commence enrollment 3Q 2020 with interim data from first cohort due by the end of 2020.
$1.1 billion

RIGL – Rigel Pharmaceuticals Inc.
Fostamatinib
Warm Autoimmune hemolytic anemia (WAIHA)

Phase 3 Phase 3 enrollment sites are back open following pause due to COVID-19.
$429.1 million