BPC May 09 update

Earnings releases see Flexion FLXN +19% and Dynavax DVAX + 18% rally while Puma PBYI slides 32%

Price and Volume Movers

Puma Biotechnology, Inc. (NASDAQ: PBYI) shares have slumped after hours following the report of first quarter earnings. Net Nerlynx revenue for the quarter was $46m, compared to $36m for the same period last year, however, well down on consensus of approximately $66m, with the company noting an increase in patients discontinuing treatment. Shares are currently trading after hours down 32% to $20.55.

Flexion Therapeutics, Inc. (NASDAQ: FLXN) shares closed up 19% to $11.55 following its announcement of first quarter earnings. Revenue of $10.6m for the quarter was slightly down on consensus. However, it did note that revenue just for April is estimated at $5.1m, suggesting for a much-improved performance for the current quarter (2Q).

Dynavax Technologies (NASDAQ: DVAX) shares closed up 18% to $7.69, also on the back of its report of earnings. The company noted first quarter revenue for its Hepatitis B vaccine, Heplisav, of $5.6m, compared to $3.9m during the previous quarter (4Q 2018).

FibroGen, Inc. (NASDAQ:FGEN) and AstraZeneca (NYSE:AZN) announced after hours top-line results from the pooled safety analyses of the global Phase 3 program for roxadustat, for treatment of anemia in chronic kidney disease (CKD) patients. The trial measured roxadustat vs. placebo in non-dialysis-dependent (NDD) patients and roxadustat vs epoetin alfa in dialysis-dependent (DD) patients. The companies noted that the data indicated that patients on roxadustat do better than those who are on epoetin alfa. In NDD patients, no clinically-meaningful difference was shown between roxadustat and placebo. This appears to have caused the stock to trade down after hours with investors debating that “no clinically-meaningful difference” might mean that there was a difference but not clinically meaningful. Shares of Fibrogen are currently trading down 12% to $40.00 after hours.

Chimerix (NASDAQ:CMRX) announced the discontinuation of all ongoing human clinical trials for oral and intravenous brincidofovir (BCV) due to low patient accrual across all active trials. As a result, the company will reduce its staff by more than 50%, resulting in a significantly lower cash burn. Shares closed up 7% to $2.87 in response to the news.

Bristol-Myers Squibb Company (NYSE: BMY) announced its Phase 3 CheckMate-498 trial evaluating Opdivo (nivolumab) plus radiation versus temozolomide plus radiation in patients with glioblastoma multiforme (GBM) did not meet its primary endpoint of overall survival (OS).

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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:

Protagonist Therapeutics, Inc. (PTGX): $10.85; +14%.

Tyme Technologies, Inc. (TYME): $1.70; +10%.

resTORbio, Inc. (TORC): $8.71; +9%.

Paratek Pharmaceuticals, Inc. (PRTK): $5.54; +8%.

Agenus Inc. (AGEN): $2.88; +8%.

DECLINERS:

Provention Bio, Inc. (PRVB): $2.96; -27%.

Atara Biotherapeutics, Inc. (ATRA): $27.22; -21%.

Avid Bioservices, Inc. (CDMO): $3.73; -16%.

Amneal Pharmaceuticals, Inc. (AMRX): $11.04; -16%.

Sangamo Therapeutics, Inc. (SGMO): $9.64; -15%.

Pipeline updates below:

Pipeline Database Updates

Drug Stage Catalyst Market Cap

ACHN – Achillion Pharmaceuticals Inc.
ACH-4471
Paroxysmal nocturnal hemoglobinuria (PNH)

Phase 2 Phase 2 final data presented at EHA June 15, 2019.
$342.7 million

ALBO – Albireo Pharma Inc.
Odevixibat (A4250) - PEDFIC- 1
Liver disease

Phase 3 Phase 3 top-line data due mid-2020.
$347.2 million

ATRA – Atara Biotherapeutics Inc.
ATA188
Multiple sclerosis

Phase 1 Initial data presented at EAN June 30, 2019 - well tolerated with no dose-limiting toxicities.
$837.9 million

AXSM – Axsome Therapeutics Inc.
AXS-05 STRIDE-1
Treatment resistant depression

Phase 3 Phase 3 data due 2H 2019.
$865.9 million

AXSM – Axsome Therapeutics Inc.
AXS-12
Narcolepsy

Phase 2 Phase 2 top-line data due 2H 2019.
$865.9 million

BMY – Bristol-Myers Squibb Company
CM-498 Opdivo
Phase 3 data due 2H 2019.

Phase 3 Phase 3 data released May 9, 2019 did not meet primary endpoint.
$72.3 billion

BPMC – Blueprint Medicines Corporation
BLU-667 - ARROW
RET-altered solid tumors

Phase 1 Phase 1 updated data at ASCO 2019 - 60% ORR in post-platinum RET-fusion NSCLC and 63% ORR in RET-mutant MTC patients. NDA filing due 1Q 2020.
$4.7 billion

CMRX – Chimerix Inc.
Oral Brincidofovir - AdAPT Study
Allogeneic hematopoietic stem cell transplant (HCT) recipients with adenovirus (AdV)

Phase 2 Phase 2 trial discontinued - May 9, 2019.
$188.5 million

MRUS – Merus N.V.
MCLA-145
Solid tumors

Phase 1 Phase 1 dosing has commenced - May 9, 2019.
$368.2 million

PGNX – Progenics Pharmaceuticals Inc.
1095
Prostate Cancer

Phase 2 Phase 2 initiation of dosing announced June 13, 2019.
$469 million

PTN – Palatin Technologies Inc.
PL-8177
Ulcerative colitis

Phase 2 Phase 2 trial to commence 1Q 2020.
$226.3 million