BPC April 09 update

​Chimerix CMRX shares add 31% on appointment of former Endocyte CEO

Price and Volume Movers

Chimerix (NASDAQ: CMRX) shares closed up 31% to $2.74 following Monday’s news of the appointment of Michael A. Sherman, former Chief Executive Officer of Endocyte, Inc., as Chief Executive Officer of Chimerix, effective immediately. Endocyte was acquired by Novartis late last year.

Amgen (NASDAQ: AMGN) announced the FDA approved Evenity for the treatment of osteoporosis in postmenopausal women at high risk for fracture.

Provention Bio, Inc. (Nasdaq: PRVB) announced that it has dosed the first patient in its Phase 3 PROTECT clinical trial of PRV-031 (teplizumab) in patients with recent onset type 1 diabetes (T1D). While the company had previously announced that such news would be released this quarter, shares still reacted positively, closing up 16% to $2.84.

PhaseBio Pharmaceuticals, Inc. (Nasdaq: PHAS) closed up 16% to $14.61 on the back of Monday’s news that the FDA has granted Breakthrough Therapy designation (BTD) for PB2452. The company took advantage of investor interest when it announced after hours Tuesday that it has commenced an underwritten public offering of 3m shares of its common stock. Shares have pulled back 6% to $13.75 after hours on the news.

Zosano Pharma Corporation (Nasdaq:ZSAN) shares closed down 27% to $3.67 following Monday’s news of a public offering. Other stocks that announced offerings after-hours yesterday, which closed lower Tuesday, include Autolus Therapeutics plc (Nasdaq: AUTL) down 14% to $26.75 and Daré Bioscience, Inc. (NASDAQ:DARE) shares which closed down 23% to $1.06.

Zogenix, Inc. (NASDAQ: ZGNX) shares closed down 23% to $39.96 following Monday’s news the FDA issued a Refusal to File (RTF) letter regarding its New Drug Application (NDA) for Fintepla (ZX008), for the treatment of seizures associated with Dravet syndrome.

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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:

Onconova Therapeutics, Inc. (ONTX): $3.95; +13%.

SELLAS Life Sciences Group, Inc. (SLS): $1.18; +8%.

EDAP TMS S.A. (EDAP): $5.19; +8%.

InflaRx N.V. (IFRX): $43.77; +7%.

ARCA biopharma, Inc. (ABIO): $5.75; +6%.

DECLINERS:

Outlook Therapeutics, Inc. (OTLK): $3.15; -34%.

Selecta Biosciences, Inc. (SELB): $2.74; -10%.

Arbutus Biopharma Corporation (ABUS): $3.96; -10%.

Minerva Neurosciences, Inc. (NERV): $7.41; -10%.

AVROBIO, Inc. (AVRO): $24.68; -10%.

Pipeline Database Updates

Drug Stage Catalyst Market Cap

ALDX – Aldeyra Therapeutics Inc.
ADX-102 - topical ocular reproxalap
Dry eye syndrome

Phase 2 Phase 3 initiation announced April 2, 2019. Phase 2 data to be presented at ARVO May 1, 2019, 3PM.
$212.6 million

ALKS – Alkermes plc
Aristada and Invega Sustenna
Schizophrenia

Phase 3 Phase 3 data released April 9, 2019 - primary endpoint met.
$5.2 billion

AMGN – Amgen Inc.
EVENITY (Romosozumab)
Osteoporosis

Approved FDA Approval announced April 9, 2019.
$108.8 billion

GLMD – Galmed Pharmaceuticals Ltd.
Aramchol - ARMOR
Non-Alcoholic Steatohepatitis (NASH)

Phase 2b Phase 3 trial to commence 3Q 2019.
$167.8 million

NVAX – Novavax Inc.
RSV vaccine - prepare trial
Respiratory Syncytial Virus (RSV) in healthy pregnant women - protect infants via maternal immunization

Phase 3 Phase 3 top-line data released March 28, 2019 - primary endpoint not met.
$242.8 million

PRVB – Provention Bio Inc.
PRV-031 (teplizumab)
Type 1 diabetes

Phase 3 Phase 3 trial initiation announced April 9, 2019. Enrollment to be completed in 2020.
$110.8 million

SNGX – Soligenix Inc.
SGX942 (dusquetide)
Oral Mucositis in Patients with Head & Neck Cancer

Phase 3 Phase 3 interim analysis due September 2019 with top-line data due 1H 2020.
$12.9 million