BPC August 09 update

​AstraZeneca AZN reaches new all time high on positive data; Puma PBYI +21% on earnings

Price and Volume Movers

AstraZeneca (NYSE: AZN) set new record highs, closing up 1.4% to $44.77 following more positive news that its Phase 3 FLAURA trial of Tagrisso (osimertinib) in previously-untreated patients with locally-advanced or metastatic non-small cell lung cancer (NSCLC), met the secondary endpoint of a statistically significant improvement in overall survival. The trial had already previously met the primary endpoint in 2017 of an improvement in progression-free survival (PFS).

Puma Biotechnology, Inc. (NASDAQ: PBYI) shares closed up 21% to $11.16 on the back of second quarter earnings. Investors responded positively to better than expected sales revenue from Nerlynx of $53.8m for the quarter compared to $50.8m for the same quarter last year. Nonetheless, shares are still well down since March when it traded as high as $43 and in 2017 when it reached over $135.

Assertio Therapeutics, Inc. (NASDAQ: ASRT) announced it has entered into exchange agreements where it will exchange $200m of outstanding notes for new notes, cash and shares of its common stock. Shares closed down 46% to $1.52.

Nektar Therapeutics (NASDAQ: NKTR) shares closed down 29% to $20.92. As mentioned late-Thursday, the company announced that suboptimal batches of the drug were given to some patients in its trial of NKTR-214, in combination with Bristol-Myers’ Opdivo, which caused a softening of responses.

Amarin Corporation plc (NASDAQ: AMRN) shares closed down 17% to $14.77, also on news noted yesterday when it surprised the market by announcing the FDA plans to hold an Advisory Committee on November 14, 2019 to discuss its supplemental new drug application (sNDA) of Vascepa.

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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:

Atreca, Inc. (BCEL): $12.93; +24%.

Corvus Pharmaceuticals, Inc. (CRVS): $4.32; +21%.

Prevail Therapeutics Inc. (PRVL): $9.70; +21%.

Lexicon Pharmaceuticals, Inc. (LXRX): $1.53; +20%.

Karuna Therapeutics, Inc. (KRTX): $22.08; +18%.

DECLINERS:

Melinta Therapeutics, Inc. (MLNT): $2.85; -19%.

Miragen Therapeutics, Inc. (MGEN): $1.06; -18%.

Precision BioSciences, Inc. (DTIL): $9.19; -16%.

Mallinckrodt plc (MNK): $5.31; -14%.

Autolus Therapeutics plc (AUTL): $11.33; -13%.

Pipeline updates below:

Pipeline Database Updates

Drug Stage Catalyst Market Cap

APVO – Aptevo Therapeutics Inc.
APVO436
Acute myeloid leukemia (AML)

Phase 1 Phase 1 data from higher cohorts due in next several months.
$27.2 million

ARDX – Ardelyx Inc.
Tenapanor - PHREEDOM
Hyperphosphatemia in end-stage renal disease (ESRD) patients

Phase 3 Phase 3 data met primary endpoint - December 3, 2019.
$429.6 million

ARDX – Ardelyx Inc.
Tenapanor - AMPLIFY
Hyperphosphatemia - adjunctive therapy to phosphate binders

Phase 3 Phase 3 trial met primary endpoint.
$429.6 million

AXGT – Axovant Gene Therapies Ltd.
AXO-Lenti-PD - SUNRISE-PD
Parkinson's disease

Phase 1/2 Phase 1/2 three-month data due 1H 2020.
$111.2 million

AXGT – Axovant Gene Therapies Ltd.
AXO-AAV-GM2
GM2 gangliosidosis

Phase 1 Phase 1 data presented October 23, 2019.
$111.2 million

AXGT – Axovant Gene Therapies Ltd.
AXO-AAV-GM1
GM1 gangliosidosis

Phase 1 Phase 1 six-month translational data due mid-2020.
$111.2 million

AZN – Astrazeneca PLC
Tagrisso - FLAURA
Non-small cell lung cancer (NSCLC)

Phase 3 Phase 3 final OS data released August 9, 2019. Endpoint met. Presentation at ESMO September 2019 noted OS of 38.6 months versus 31.8 months for comparator arm; PFS HR 0.48.
$125.1 billion

CASI – CASI Pharmaceuticals Inc.
CID-103
Multiple myeloma

Phase 1 Phase 1 trial to commence in 2020.
$309.3 million

EPZM – Epizyme Inc.
Tazemetostat
Follicular lymphoma

Phase 2 NDA filing due December 2019. Updated Phase 2 data due at ASH 2019.
$1.7 billion

FENC – Fennec Pharmaceuticals Inc.
Pedmark (sodium thiosulfate)
Cisplatin-induced ototoxicity

NDA Filing Rolling NDA to be completed early 2020.
$126.1 million

PLXP – PLx Pharma Inc.
Aspertec
Aspirin - cardiovascular and stroke patients patients

sNDA Filing sNDA filing due late 2019.
$41.5 million

VYGR – Voyager Therapeutics Inc.
VY-AADC01
Advanced Parkinson’s disease

Phase 1b Phase 2 trial ongoing. Phase 1b longer term data due 2020.
$518.3 million