BPC July 23 update

Phase 1/2 clinical events to watch this quarter; Biotech earnings calendar; Biotech week in Review

Weekly watchlist

Last week we previewed key companies undergoing COVID-19 vaccine trials and their respective development timelines. At the time of publication Novavax (NVAX) had guided for data release later this month. The company provided an update Thursday that data are now due during the first week of August.

This week we look ahead at Phase 1/2 readouts due this quarter. This follows our preview of Phase 3 events we noted two weeks ago. First, let's review the week that was with notable events.

COVID-19 VACCINE:

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. A U.S. Phase 3 trial is slated to commence soon.

OTHER CLINICAL:

BioXcel Therapeutics, Inc.(Nasdaq: BTAI) shares closed the week up 15% to $60.76 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).

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 closed the week down 21% to $43.46.

Pieris Pharmaceuticals, Inc. (NASDAQ:PIRS) shares closed the week 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.

REGULATORY:

Jazz Pharmaceuticals plc (Nasdaq: JAZZ) announced Thursday that the FDA approved Xywav oral solution for the treatment of cataplexy or excessive daytime sleepiness (EDS) in patients 7 years of age and older with narcolepsy. Shares closed Thursday up 4% to $110.26.

Milestone Pharmaceuticals Inc. (NASDAQ:MIST) announced an update on its Etripamil nasal spray program for patients with paroxysmal supraventricular tachycardia (PSVT) following meetings with the FDA. The company noted that the FDA indicated that its recently completed NODE-301 and ongoing NODE-301B trials could be used as two efficacy studies supporting a future New Drug Application (NDA). Data from the NODE-301B trial (renamed the RAPID study) are due late-2021/early 2022. The company also announced a $25m private placement. Shares closed the week up 133% to $8.28.
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Biotech earnings for the upcoming week (selection of 15):

Tue: PFE AMGN

Wed: ALKS GSK SNY

Thur: AZN ALXN EBS EXAS GILD LLY

Fri: ABBV MRK SGEN VRTX

Phase 1/2 events to watch this quarter:

Drug Stage Catalyst Market Cap

ALBO – Albireo Pharma Inc.
Elobixibat
Nonalcoholic steatohepatitis (NASH)

Phase 2 Phase 2 data due mid-2020.
$375.2 million

ASND – Ascendis Pharma A/S
TransCon
Hypoparathyroidism

Phase 2 Phase 2 six-month data from the open-label extension portion due 3Q 2020. Phase 3 trial to commence 4Q 2020.
$7.5 billion

BLRX – BioLineRx Ltd.
BL-8040 in combination with KEYTRUDA - COMBAT trial
Pancreatic cancer

Phase 2 Phase 2 PFS and OS data due 2H 2020.
$40 million

CCXI – ChemoCentryx Inc.
Avacopan -AURORA
Hidradenitis Suppurativa (HS)

Phase 2b Phase 2b data due early-4Q 2020.
$3.6 billion

CRBP – Corbus Pharmaceuticals Holdings Inc.
Lenabasum
Cystic Fibrosis

Phase 2b Phase 2b data due 3Q 2020.
$578.1 million

CYCN – Cyclerion Therapeutics Inc.
Olinciguat (IW-1701) - STRONG-SCD
Sickle Cell disease

Phase 2 Phase 2 data due late-3Q 2020.
$178.4 million

FIXX – Homology Medicines Inc.
HMI-102
Phenylketonuria (PKU)

Phase 1/2 Phase 1/2 update due 3Q/4Q 2020.
$495.6 million

FULC – Fulcrum Therapeutics Inc.
Losmapimod
Facioscapulohumeral muscular dystrophy (FSHD)

Phase 2b Phase 2b interim data did not show separation from placebo - August 11, 2020. Top-line data 1Q 2021.
$220.9 million

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.
$82.3 million

IMVT – Immunovant Inc.
IMVT-1401
Myasthenia Gravis (MG)

Phase 2 Phase 2 top-line data due late-3Q 2020 or early-4Q 2020.
$2.2 billion

SELB – Selecta Biosciences Inc.
SEL-212 (COMPARE) - Head to head trial vs Krystexxa
Tophaceous gout

Phase 2 Phase 2 top-line data due 3Q 2020.
$277.5 million

TCRR – TCR2 Therapeutics Inc.
TC-210
Mesothelin-positive solid tumors

Phase 1/2 Phase 1 interim update 2H 2020.
$559.3 million

TPTX – Turning Point Therapeutics Inc.
Repotrectinib (TPX-0005) - TRIDENT-1
Non-small-cell lung cancer (NSCLC) and solid tumors

Phase 2 Phase 2 interim data due 3Q 2020.
$2.5 billion

TRIL – Trillium Therapeutics Inc.
TTI-621-01
Diffuse Large B-cell Lymphoma (DLBCL), Cutaneous T-cell lymphoma (CTCL)

Phase 1 Phase 1 update due at ASH December 2020.
$690 million