BPC August 06 update

Preview of final week of biotech earnings; Biotech week in review

Weekly watchlist

The final full week of the second quarter earnings season lies ahead with Monday looking at being the busiest day of the week. We highlight a selection of companies set to report while also looking at a few other catalysts slated for the upcoming week.

First let’s review the week that was with price-moving events.

REGULATORY:

Spectrum Pharmaceuticals NASDAQ:SPPI) announced Friday receipt of a Complete Response Letter (CRL) from the FDA regarding its Biologics License Application (BLA) for ROLONTIS (eflapegrastim). The CRL cited deficiencies related to manufacturing and indicated that a reinspection will be necessary. A decision was initially scheduled for October 2020 but was delayed due to the COVID-19 pandemic. Shares fell Friday 22% to $2.55.

CLINICAL UPDATES:

BeyondSpring (NASDAQ: BYSI) announced its Phase 3 DUBLIN-3 trial of plinabulin in combination with docetaxel to treat 2nd and 3rd line NSCLC (non small lung cancer) met the primary endpoint of increasing overall survival (mean OS, p = 0.04; HR=0.82) compared with docetaxel alone. Questions were raised regarding the patient demographics, however, with only around 20% of patients enrolled from the US. Shares closed the week up 182% to $26.87.

Dicerna Pharmaceuticals, Inc. (NASDAQ:DRNA) shares closed Friday down 28% to $27.25 following the release of data from its Phase 2 PHYOX2 pivotal clinical trial of nedosiran, as a once-monthly treatment for primary hyperoxaluria (PH). The trial achieved the primary endpoint, demonstrating a statistically significant reduction from baseline in urinary oxalate (Uox) excretion compared to placebo (p<0.0001). However, the company noted that reductions, while significant in participants with a subtype called PH1, were not favorable in patients with the PH2 subtype, the population of most focus for investors.

OTHER:

Translate Bio (NASDAQ:TBIO) announced it will be acquired by Sanofi (NASDAQ: SNY) for $38.00 per share in cash, which represents a total equity value of approximately $3.2 billion. Shares closed Tuesday up 29% to $37.67.

Gene editing stocks Editas Medicine, Inc. (NASDAQ: EDIT) and Intellia Therapeutics, Inc. (NASDAQ: NTLA) rallied following their respective earnings releases. Editas, which is due to report initial data in late-September, saw its share climb to close the week up 33% to $55.59, while Intellia, which will also deliver further data later this year, added 18% to $167.31.

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Selection (15) of companies scheduled to report earnings week of August 9-13, 2021 (PREMIUM members see BioPharmCatalyst earnings calendar for full list and details)

Mon: AMPH ARCT AXSM BHVN BNTX CCXI CPRX FGEN HALO OCUL

Tue: BTAI MRNS

Wed: TCON

Thu: PDSB PROG

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Other events penned in for rest of August (CWBR by Labor Day):

Drug Price Stage Catalyst Market Cap

AXSM – Axsome Therapeutics Inc.
Dextromethorphan-bupropion (AXS-05)
Major Depressive Disorder

$29.72
+1.19  +4%
PDUFA priority review PDUFA date under priority review August 22, 2021. Noted August 9, 2021 that the FDA has identified deficiencies that preclude discussion of labeling and post-marketing requirements/commitments. Updated August 22, 2021 that the FDA informed the company that its decision has been delayed. No further details provided.
$1.1 billion

CARA – Cara Therapeutics Inc.
KORSUVA (CR845/difelikefalin) injection
Chronic kidney disease (CKD) on hemodialysis (HD) with Moderate-to Severe Pruritus

$15.25
+0.32  +2%
Approved FDA approval announced August 23, 2021.
$763.9 million

CWBR – CohBar Inc.
CB4211
Nonalcoholic Fatty Liver Disease / Obesity / Nonalcoholic steatohepatitis

$1.15
+0.03  +3%
Phase 1b Phase 1b top-line data met primary endpoint - August 10, 2021.
$74.1 million

FATE – Fate Therapeutics Inc.
FT516
Acute Myelogenous Leukemia / B-cell Lymphoma

$71.60
+5.09  +8%
Phase 1 Phase 1 interim data presented August 19, 2021. 8/11 (73%) achieved an objective response, 6/11 (55%) complete responses. 5 patients (45%) maintained their response without further therapeutic intervention.
$6.8 billion

JAZZ – Jazz Pharmaceuticals plc
XYWAV
Idiopathic Hypersomnia

$133.22
+1.48  +1%
Approved FDA approval announced August 12, 2021.
$8.2 billion

LPCN – Lipocine Inc.
LPCN 1144 (LiFT)
Non-alcoholic fatty liver disease (NAFLD) / Non-alcoholic steatohepatitis (NASH)

$1.16
+0.02  +2%
Phase 2 Phase 2 top-line change in liver fat data met primary endpoint January 12, 2021. 36-week data released August 25, 2021.
$102.4 million

SESN – Sesen Bio Inc.
Vicinium
Non-muscle invasive bladder cancer (NMIBC)

$0.91
-0.02  -2%
CRL CRL announced August 13, 2021.
$178 million

TVTX – Travere Therapeutics Inc.
Sparsentan (PROTECT)
IgA nephropathy

$22.51
+0.07  +0%
Phase 3 Phase 3 initial data released August 16, 2021. Primary efficacy endpoint met. Topline results from the confirmatory endpoint analysis are expected 2H 2023.
$1.4 billion