BPC February 05 update

​Evolus EOLS shares add further for a 3-day gain of 58%

Price and Volume Movers

Evolus, Inc. (NASDAQ: EOLS) shares closed up 26% to $25.83 for a cumulative three-day gain of 58% following Friday’s announcement of the FDA approval of Jeuveau for the improvement in the appearance of glabellar lines. 

Pain Therapeutics, Inc. (Nasdaq: PTIE) shares closed down 11% to $1.07 following a press release where it launched a stinging attack on the FDA following its meeting held last week regarding the drug candidate, Remoxy, which has received multiple Complete Response Letters (CRLs) from the regulatory agency. A snippet from the press release is noted below:

REMOXY remains an odyssey without a homecoming,” said Remi Barbier, President & CEO of Pain Therapeutics. “We had hoped for a fair, neutral and impartial review of the REMOXY data. Instead, we walked out of this meeting feeling a bit disoriented by FDA’s lack of transparency, clarity or helpfulness.  It’s a rare occasion when two parties can’t agree on simple math.  We can’t work with shambolic regulations.  This is not how you win support for innovation.”

Corcept Therapeutics (Nasdaq: CORT) shares closed up 8% to $11.01. The company released a white paper today against speculators and other traders holding short positions. While not specifically named in the paper, the release appears to be in response to a report filed by Blue Orca Capital

Array BioPharma Inc. (Nasdaq: ARRY) reported positive earnings for 2Q fiscal 2019. The company noted net product sales of Braftovi and Mektovi of $22.7m. The company is due to release interim analysis from its Phase 3 Beacon colorectal cancer trial in (mCRC) during 1H 2019. Shares closed up 11% to $20.96. 

Catabasis Pharmaceuticals, Inc. (NASDAQ:CATB) announced that it intends to offer its securities in an underwritten public offering. Shares are trading after hours down 11% to $5.40. 

Aeglea BioTherapeutics, Inc. (Nasdaq:AGLE) also announced a public offering of $50m of shares of its common stock. Shares closed the after-hours session down 6% to $9.40.

Pulmatrix, Inc. (NASDAQ: PULM) announced a 1-for-10 reverse split of its common stock. Trading on a spit-adjusted basis will commence on February 6, 2019. 

BioLineRx Ltd. (NASDAQ/TASE: BLRX) shares closed down 40% to $0.44 following the pricing of its offering of 28m American Depositary Shares ("ADSs"), each representing one of its ordinary shares, and warrants to purchase 28m ADSs, at a public offering price of $0.55 per ADS and accompanying warrant. Gross proceeds are expected to be $15.4m. 

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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:

Trevena, Inc. (TRVN): $1.35; +21%.

XBiotech Inc. (XBIT): $8.42; +16%.

Aileron Therapeutics, Inc. (ALRN): $1.96; +13%.

BioXcel Therapeutics, Inc. (BTAI): $6.60; +11%.

AVROBIO, Inc. (AVRO): $15.65; +11%.

DECLINERS:

OPKO Health, Inc. (OPK): $2.97; -16%.

Trillium Therapeutics Inc. (TRIL): $1.46; -12%.

Ovid Therapeutics Inc. (OVID): $2.56; -11%.

ProQR Therapeutics N.V. (PRQR): $15.40; -9%.

Jounce Therapeutics, Inc. (JNCE): $4.33; -8%.

 

Pipeline updates below:

Pipeline Database Updates

Drug Stage Catalyst Market Cap

ARRY – Array BioPharma Inc.
Encorafenib and cetuximab - BEACON CRC
BRAF-Mutant Colorectal Cancer

Phase 3 Phase 3 interim analysis 1H 2019.
$5.1 billion

ATNM – Actinium Pharmaceuticals Inc. (Delaware)
Actimab-A and Venetoclax
Relapsed or refractory acute myeloid leukemia (AML)

Phase 1/2 Phase 1/2 trial initiation announced February 5, 2019.
$71.6 million

BCRX – BioCryst Pharmaceuticals Inc.
BCX7353 - ZENITH-1
Angioedema attacks in patients with hereditary angioedema (HAE)

Phase 2 Phase 2 data to be presented February 23, 9:45 a.m. PT at AAAAI meeting.
$986.8 million

ETTX – Entasis Therapeutics Holdings Inc.
ETX2514SUL
Pneumonia

Phase 3 Phase 3 trial to be initiated 1Q 2019 with data due 2020.
$75.8 million

FOLD – Amicus Therapeutics Inc.
ATB200
Pompe Disease

Phase 1/2 Further Phase 1/2 preliminary positive data released February 5, 2019.
$2.6 billion

MRK – Merck & Company Inc. (new)
ZERBAXA(ceftolozane and tazobactam)
Hospital-acquired bacterial pneumonia (HABP)

PDUFA priority review PDUFA date under priority review June 3, 2019.
$210 billion

MRK – Merck & Company Inc. (new)
Imipenem/ cilastatin
Complicated urinary tract infections (cUTI) and Complicated intra-abdominal infections (cIAI)

PDUFA priority review PDUFA date under priority review July 16, 2019.
$210 billion

MRNA – Moderna Inc.
mRNA-1944
Chikungunya Virus Infection

Phase 1 Phase 1 initiation of dosing announced February 5, 2019.
$6.5 billion

NBIX – Neurocrine Biosciences Inc.
Opicapone
Parkinson's disease

NDA Filing NDA filing planned for 2Q 2019.
$7.2 billion

NBIX – Neurocrine Biosciences Inc.
NBI-74788
Congenital Adrenal Hyperplasia (CAH) - adults

Phase 2a Phase 2a data due 1Q 2019.
$7.2 billion

RHHBY – Roche Holding Ltd ADR (Sponsored)
Kadcyla (KATHERINE).
HER2-positive breast cancer - residual invasive disease

BLA Filing BLA filing announced February 5, 2019.
$237.3 billion

SNY – Sanofi
Isatuximab
Refractory Multiple Myeloma

BLA Filing Phase 3 data February 5, 2019 met primary endpoint. BLA filing 2Q 2019.
$102.2 billion

VRTX – Vertex Pharmaceuticals Incorporated
VX-150
Acute pain following bunionectomy surgery

Phase 2b Phase 2b data due 1H 2019.
$47.5 billion

VRTX – Vertex Pharmaceuticals Incorporated
VX-445 in combination with tezacaftor and ivacaftor
Cystic fibrosis (CF) who have two copies of the F508del mutation

Phase 3 Phase 3 data released February 14, 2019 - primary endpoint met.
$47.5 billion

VRTX – Vertex Pharmaceuticals Incorporated
VX-445 in combination with tezacaftor and ivacaftor
Cystic fibrosis (CF) who have one copy of the F508del mutation and one minimal function mutation

Phase 3 Phase 3 data released February 14, 2019 - primary endpoint met.
$47.5 billion