BPC July 20 update

​BioXcel BTAI releases positive late-stage data +14%; AstraZeneca AZN promising early COVID-19 vaccine data

Price and Volume Movers

BioXcel Therapeutics, Inc.(Nasdaq: BTAI) shares closed up 14% to $60.42 following its announcement that its two Phase 3 trials (SERENITY I and SERENITY II) of BXCL501 met the primary and secondary endpoints demonstrating a robust treatment effect in patients with schizophrenia (SERENITY I) and bipolar disorder (SERENITY II).

AstraZeneca PLC (NYSE:AZN) announced interim data from its Phase 1/2 trial of its COVID-19 vaccine, AZD1222. The vaccine was well tolerated and generated robust immune responses against the virus, with 91% of subjects exhibiting neutralising antibody responses one month following a single AZD1222 dose, and in 100% of participants who received a second dose. Data from non-U.S. Phase 3 trials to test the efficacy of the vaccine are due later this quarter. Trials in the U.S. are slated to commence soon.

Novavax, Inc. (NASDAQ: NVAX) announced that it will present progress of NVX-CoV2373, its Phase 1 COVID-19 vaccine candidate, at the International Society for Vaccines Virtual Congress at July 21, 9:55 a.m. ET. The company previously guided that preliminary immunogenicity and safety data are expected in late-July 2020. However, it did not mention in its press release whether the data would be included in Tuesday's presentation.

Genocea Biosciences, Inc. (NASDAQ:GNCA) announced that its Phase 1/2 Investigational New Drug Application (IND) for GEN-011 has been placed on clinical hold until it receives additional information pertaining to certain third-party reagents used in the GEN-011 manufacturing process. It also announced that it will be presenting data from its Phase 1/2 trial of GEN-009 on July 30, 2020. Shares closed up 16% to $2.47.

ACADIA Pharmaceuticals Inc. (Nasdaq: ACAD) announced top-line data from its Phase 3 trial of pimavanserin as an adjunctive treatment for major depressive disorder (MDD) failed to meet the primary endpoint. Shares are trading down 11% to $49.40 after hours.

Pieris Pharmaceuticals, Inc. (NASDAQ:PIRS) shares are trading down 11% to $2.91 after hours on news its Phase 1 trials of PRS-343 have been placed on partial clinical hold by the FDA while Pieris conducts an additional in-use and compatibility study requested by the agency.

Kiniksa Pharmaceuticals, Ltd. (NASDAQ:KNSA) announced that it is commencing a public offering of $100m of its common shares. Shares are trading down 7% to $22.25 after hours.

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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:

Tonix Pharmaceuticals Holding Corp. (TNXP): $1.55; +91%.

iBio, Inc. (IBIO): $6.41; +64%.

Immuron Limited (IMRN): $10.41; +63%.

Heat Biologics, Inc. (HTBX): $3.62; +47%.

PDS Biotechnology Corporation (PDSB): $4.19; +39%.

DECLINERS:

AcelRx Pharmaceuticals, Inc. (ACRX): $1.08; -14%.

I-Mab (IMAB): $28.55; -13%.

Moderna, Inc. (MRNA): $82.68; -13%.

resTORbio, Inc. (TORC): $2.63; -12%.

Allena Pharmaceuticals, Inc. (ALNA): $1.91; -12%.

Pipeline updates below:

Pipeline Database Updates

Drug Stage Catalyst Market Cap

ACAD – ACADIA Pharmaceuticals Inc.
Pimavanserin - Harmony
Alzheimer’s disease psychosis

PDUFA PDUFA date April 3, 2021.
$6.2 billion

ACAD – ACADIA Pharmaceuticals Inc.
Pimavanserin - CLARITY-2 and CLARITY-3
Adjunctive Treatment in Patients With Major Depressive Disorder

Phase 3 Phase 3 trial did not meet primary endpoint - July 20, 2020.
$6.2 billion

AZN – Astrazeneca PLC
AZD1222 (ChAdOx1 nCoV-19)
COVID-19 vaccine

Phase 3 Phase 1 data July 20, 2020 noted neutralising activity was seen in 91% of participants one month and in 100% of participants who received a second dose. Phase 3 data from non-U.S. trials due 3Q 2020. Phase 3 U.S. trial to start soon.
$148.8 billion

BTAI – BioXcel Therapeutics Inc.
BXCL501 (SERENITY I)
Schizophrenia - Agitation

Phase 3 Phase 3 data met primary and secondary endpoints - July 20, 2020.
$1.1 billion

BTAI – BioXcel Therapeutics Inc.
BXCL501 (SERENITY II)
Bipolar disorder - agitation

Phase 3 Phase 3 data met primary and secondary endpoints - July 20, 2020.
$1.1 billion

EXEL – Exelixis Inc.
Cabozantinib and Atezolizumab (CONTACT-03)
Renal Cell Carcinoma

Phase 3 Phase 3 trial is enrolling.
$6.8 billion

GNCA – Genocea Biosciences Inc.
GEN-009
Various cancers

Phase 1/2 Phase 1/2 Part B initial data noted 3/5 responses - July 30, 2020.
$81.8 million

GNCA – Genocea Biosciences Inc.
GEN-011
Various tumors

Phase 1/2 Phase 1/2 IND placed on clinical hold - July 20, 2020.
$81.8 million

KPTI – Karyopharm Therapeutics Inc.
Selinexor
Multiple myeloma

PDUFA PDUFA date estimate March 19, 2021.
$1.1 billion

LRMR – Larimar Therapeutics Inc.
CTI-1601
Friedreich’s ataxia (FA)

Phase 1 Phase 1 top-line data due 1H 2021.
$174.4 million

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

Phase 1/2 Phase 1 preliminary data released August 4, 2020. Well-tolerated and elicited robust antibody responses.
$7.5 billion

OSMT – Osmotica Pharmaceuticals plc
Ontinua ER (arbaclofen)
Spasticity resulting from multiple sclerosis

PDUFA PDUFA date December 29, 2020.
$313.2 million

PIRS – Pieris Pharmaceuticals Inc.
PRS-343
HER2-positive solid tumors

Phase 1/2 Phase 1 partial clinical hold announced July 20, 2020. Phase 2 gastric cancer trial to commence later in 2020.
$170.6 million

SRNE – Sorrento Therapeutics Inc.
Abivertinib
COVID-19

Phase 2 Phase 2 trial to be initiated.
$3 billion