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).


Major price movers (stocks priced > $1.00, volume > 50k):

Refer to the BioPharmCatalyst Biotech Stocks page for Top 10 Gainers/Losers/Unusual Volume


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%.


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.
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.
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.
Treatment resistant depression

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

AXSM – Axsome Therapeutics Inc.

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
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.
Solid tumors

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

PGNX – Progenics Pharmaceuticals Inc.
Prostate Cancer

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

PTN – Palatin Technologies Inc.
Ulcerative colitis

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