BPC September 08 update

Big moves on late-stage data from Albireo ALBO +45% Spero SPRO +46% Corbus CRBP -76%

Price and Volume Movers

AstraZeneca PLC (NYSE:AZN) shares are trading down 6% to $51.50 after hours following a report from STAT News that its Phase 3 COVID-19 vaccine trial has been placed on hold due to a suspected adverse reaction in a participant in the U.K. trial. No details regarding the type of reaction were reported.

Albireo Pharma, Inc. (Nasdaq: ALBO) shares closed up 45% to $39.62 on news its Phase 3 PEDFIC 1 trial evaluating odevixibat in patients with progressive familial intrahepatic cholestasis (PFIC) met its two primary endpoints, demonstrating that odevixibat reduced serum bile acid responses (sBAs) (p=0.003) and improved pruritus assessments (p=0.004) with a single digit diarrhea rate. The company took advantage of the positive news when it announced after hours an underwritten public offering of 3m shares.

Spero Therapeutics, Inc. (NASDAQ:SPRO) also announced positive top-line results from its Phase 3 ADAPT-PO trial evaluating tebipenem HBr, for the treatment of adults with complicated urinary tract infection (cUTI) and acute pyelonephritis (AP). Top-line data from the trial demonstrated that oral tebipenem HBr was statistically non-inferior to intravenous (IV) ertapenem in the treatment of patients with cUTI and patients with AP. Shares closed up 46% to $13.07.

Corbus Pharmaceuticals Holdings, Inc. (NASDAQ: CRBP) shares slid to close down 76% to $2.23 following its announcement its Phase 3 RESOLVE-1 study of lenabasum in patients with diffuse cutaneous systemic sclerosis (SSc) failed to meet both primary and secondary endpoints.

Moderna, Inc. (NASDAQ:MRNA) shares closed down 13% to $54.34. Analysts at SVB Leerink cut their rating to underperform from market perform and reduced their price target to $41 from $58 on concerns about competition for a COVID-19 vaccine.

Trillium Therapeutics Inc. (NASDAQ: TRIL) announced after hours that Pfizer Inc. (NYSE:PFE) will purchase 2,297,794 shares at a price of $10.88 per share for gross proceeds of $25m. The company also announced updated data from its early-stage trial of TTI-622 in patients with multiple myeloma saw 6/18 (33%) objective responses at 0.8 to 8 mg/kg dose levels. Shares are trading up 32% after hours to $12.50.

Strongbridge Biopharma plc, (Nasdaq: SBBP) announced its Phase 3 LOGICS study evaluating Recorlev (levoketoconazole) for the treatment of endogenous Cushing’s syndrome met its primary endpoint. At the end of the randomized-withdrawal phase of the trial 54.5% more patients who were withdrawn to placebo had a loss of mUFC response as compared with those who remained on the Recorlev. Shares, however, fell 20% to close down at $2.82.

Athenex, Inc. (NASDAQ:ATNX) announced after hours that it intends to offer 10m shares of its common stock in an underwritten public offering. Shares are trading down 10% after hours to $12.89.

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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:

TRACON Pharmaceuticals, Inc. (TCON): $3.74; +21%.

HOOKIPA Pharma Inc. (HOOK): $10.22; +19%.

BeyondSpring Inc. (BYSI): $13.59; +15%.

Precision BioSciences, Inc. (DTIL): $5.33; +15%.

RedHill Biopharma Ltd. (RDHL): $8.41; +13%.

DECLINERS:

Innate Pharma S.A. (IPHA): $4,45; -27%.

Checkmate Pharmaceuticals, Inc. (CMPI): $10.71; -13%.

Evofem Biosciences, Inc. (EVFM): $3.11; -11%.

CureVac N.V. (CVAC): $56.91; -10%.

Avadel Pharmaceuticals plc (AVDL): $5.77; -10%.

Pipeline updates below:

Pipeline Database Updates

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 met primary endpoints - September 8, 2020.
$738.7 million

ANNX – Annexon Inc.
ANX007
Geographic atrophy

Phase 2 Phase 2 trial to be initiated in 2021.
$858.3 million

ARQT – Arcutis Biotherapeutics Inc.
ARQ-151
Atopic dermatitis

Phase 3 Phase 3 trial to be initiated late-2020 or early-2021.
$1 billion

BLU – BELLUS Health Inc.
BLU-5937
Chronic pruritus associated with atopic dermatitis

Phase 2b Phase 2b trial to commence 4Q 2020 with interim analysis due mid-2021 and top-line data due 2H 2021.
$146.9 million

CGEN – Compugen Ltd.
COM701, Opdivo and BMS-986207
Solid tumors

Phase 1/2 Phase 1/2 initiation of dosing announced September 8, 2020.
$1.6 billion

CRBP – Corbus Pharmaceuticals Holdings Inc.
Resunab - RESOLVE-1
Systemic Sclerosis

Phase 3 Phase 3 top-line data did not meet endpoints - September 8, 2020.
$155.3 million

FLXN – Flexion Therapeutics Inc.
FX201
Osteoarthritis (OA)

Phase 1 Phase 1 treatment of first patient in second cohort announced September 8, 2020 with data due in 2021.
$590.6 million

GRTX – Galera Therapeutics Inc.
GC4419
Pancreatic cancer

Phase 1/2 Phase 1b/2a data to be presented at ASTRO meeting October 27, 2020.
$204.3 million

HRTX – Heron Therapeutics Inc.
HTX-011
Post operative pain

NDA Filing CRL announced June 29, 2020. NDA to be refiled 4Q 2020.
$1.5 billion

IPHA – Innate Pharma S.A.
IPH5401 STELLAR-001
Non-small-cell lung cancer (NSCLC) and hepatocellular carcinoma (HCC)

Phase 1 Phase 1/2 enrollment stopped following review of data from cohort expansions - noted September 8, 2020.
$311.8 million

SPRO – Spero Therapeutics Inc.
SPR994 (ADAPT-PO)
Complicated urinary tract infections (cUTI)

Phase 3 Phase 3 data released September 8, 2020 showed non-inferiority versus intravenous ertapenem.
$262.2 million

TBIO – Translate Bio Inc.
MRT5005
Cystic fibrosis

Phase 1/2 Phase 1/2 resumption of enrollment announced September 8, 2020. Data readout timelines to be announced at a later date.
$1.1 billion

TRIL – Trillium Therapeutics Inc.
TTI-622
Refractory lymphoma or multiple myeloma

Phase 1b Phase 1 updated data noted 6/18 (33%) objective responses at 0.8 to 8 mg/kg dose levels.
$1.4 billion