BPC July 02 update

Biotech stock events likely to occur in July (mid-2020); Biotech week in Review

Weekly watchlist

As we enter the third quarter of 2020, eyes now turn toward key biotech stock events slated for the new quarter. We focus this week on events slated for either July or mid-2020. From next week, we will turn to events slated for the quarter as a whole. First, let’s review the week that was with notable biotech stock news.

COVID-19 VACCINE DATA:

Pfizer Inc. (NYSE:PFE) and BioNTech SE (NASDAQ:BNTX) announced preliminary data from one of their vaccine candidates from their BNT162 mRNA-based vaccine program for COVID-19. The company noted that all patients developed SARS-CoV-2 neutralizing antibodies 1.8- and 2.8-times the level of recovered patients. A Phase 2b/3 trial slated to commence in late-July will seek to confirm whether there is sufficient efficacy against preventing COVID-19.

INOVIO (NASDAQ:INO) announced interim data from its Phase 1 trial of its COVID-19 vaccine candidate, INO-4800. Limited data were released, when compared with what was released by Pfizer. The company noted 94% of trial participants demonstrated overall immunological response rates. However, key data regarding the number of patients that produced antibodies were not released. Shares closed the week down 28% to $21.45.

OTHER CLINICAL DATA:

MEI Pharma, Inc. (Nasdaq: MEIP) announced that its Phase 3 trial of pracinostat in combination with azacitidine in patients with AML will be discontinued following analysis which showed it was unlikely to meet the primary endpoint of overall survival. Shares closed Thursday down 18% to $3.49.

Akero Therapeutics, Inc. (Nasdaq: AKRO) shares closed the week up 40% to $33.02 following the release of further data from its Phase 2a BALANCED study of efruxifermin (AKR-001), in patients with nonalcoholic steatohepatitis (NASH).

Zynerba Pharmaceuticals, Inc. (NASDAQ:ZYNE) announced its Phase 2/3 trial of Zygel CBD gel for behavioral symptoms of Fragile X syndrome (FXS), did not meet the primary endpoint and three key secondary endpoints. Shares closed the week down 44% to $3.50.

REGULATORY:

Ultragenyx Pharmaceutical Inc. (NASDAQ:RARE) announced that the FDA approved Dojolvi as a source of calories and fatty acids for the treatment of pediatric and adult patients with molecularly confirmed long-chain fatty acid oxidation disorders (LC-FAOD). Shares closed up 12% to $86.04.

Intercept Pharmaceuticals, Inc. (NASDAQ:ICPT) announced that the FDA issued a Complete Response Letter (CRL) regarding the New Drug Application (NDA) for obeticholic acid (OCA) for the treatment of fibrosis due to nonalcoholic steatohepatitis (NASH). Shares closed the week down 39% to $47.09.

Heron Therapeutics, Inc. (Nasdaq: HRTX) shares closed the week down 22% to $15.53 on news that it also received a CRL from the FDA for its NDA for HTX-011 for the management of post-operative pain, citing non-clinical issues. Pacira BioSciences, Inc. (NASDAQ: PCRX), which has on the market a non-opioid pain management, exparel, the same indication as Heron, saw its shares close the week up 19% to $52.37 in response to the news.

Verrica Pharmaceuticals Inc. (NASDAQ:VRCA) shares closed the week down 27% to $10.30 following news the FDA noted deficiencies that preclude discussion of labelling and post-marketing requirements/commitments for its review of the NDA for VP-102, for the treatment of molluscum contagiosum. The assigned PDUFA date is July 13, 2020.

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Biotech stock events likely to occur in July/mid-2020:

Drug Stage Catalyst Market Cap

ALBO – Albireo Pharma Inc.
Odevixibat (A4250) - PEDFIC- 1
Progressive familial intrahepatic cholestasis (PFIC)

Phase 3 Phase 3 top-line data due mid-2020.
$370 million

ALEC – Alector Inc.
AL001
Frontotemporal Dementia

Phase 3 Phase 3 commencement of dosing announced July 24, 2020.
$1.1 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.
$149.4 billion

BLU – BELLUS Health Inc.
BLU-5937
Chronic cough

Phase 2 Phase 2 trial did not meet primary endpoint - July 6, 2020.
$154.2 million

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

GRTS – Gritstone Oncology Inc.
GRANITE-001 (GO-004)
Colorectal Cancer / Gastric Cancer

Phase 1/2 Phase 2 trial to commence 2H 2020 with data due 2H 2021. Additional Phase 1 data due 2H 2020.
$136.7 million

ITCI – Intra-Cellular Therapies Inc.
Lumateperone ITI-007-402
Bipolar depression

Phase 3 Phase 3 top-line data due mid-September 2020.
$1.3 billion

JAZZ – Jazz Pharmaceuticals plc
Xywav
Cataplexy and Excessive Daytime Sleepiness in Narcolepsy

Approved FDA Approval announced July 22, 2020.
$6.8 billion

LLY – Eli Lilly and Company
LY3127804
COVID-19

Phase 2 Phase 2 enrolling.
$146 billion

MCRB – Seres Therapeutics Inc.
SER-109 - ECOSPOR III
Recurrent C. Difficile infection

Phase 3 Phase 3 data met primary endpoint - August 10, 2020.
$1.6 billion

MESO – Mesoblast Limited
MPC-06-ID
Chronic low back pain

Phase 3 Phase 3 data mid-2020.
$1.4 billion

MRNA – Moderna Inc.
mRNA-1273
COVID-19 vaccine

Phase 2/3 Phase 2 interim efficacy data due 3Q 2020. Phase 3 enrollment to be completed September 2020.
$27.5 billion

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
Upneeq (RVL-1201)
Blepharoptosis

Approved FDA Approval announced July 9, 2020.
$313.2 million

PFE – Pfizer Inc.
BNT162b2
COVID-19 vaccine

Phase 2/3 Phase 2/3 trial initiation announced July 27, 2020. Data due October 2020. On track to seek regulatory review in October 2020.
$213.6 billion