BPC February 15 update

Editas (EDIT) scores patent win - shares +29%; Ardelyx (ARDX) jumps on tenapanor data; Acura (ACUR) delist to OTC

Price and Volume Movers

The US Patent and Trademark Office ruled today that patents awarded to the Broad Institute CRISPR-Cas9 technology will remain. This follows a patent battle between Broad and the University of California over rights to the technology. News of the patent win saw shares of Editas Medicine Inc (NASDAQ:EDIT) close up $29% to $24.30. In 2014, the company formed a license agreement with the Broad Institute to access intellectual property and technology related to the CRISPR/Cas9 genome editing systems. On the other side, shares of Crispr Therapeutics (NASDAQ:CRSP) closed down 8% to $15.90 while shares of Intellia Therapeutics Inc (NASDAQ:NTLA) dropped 9% to $12.50, paring earlier losses in the the early afternoon session. Both companies were founded using CRISPR/Cas9 biology based on research carried out at the University of California.

Acura Pharmaceuticals, Inc. (NASDAQ:ACUR) announced after hours that its shares will begin to trade on the OTCQB Market under the same ticker from February 23, 2017. Shares are currently down 34% to $1.16.

Ardelyx, Inc. (NASDAQ: ARDX) announced that it met the primary endpoint in its Phase 3 trial of tenapanor for the treatment for hyperphosphatemia in patients with end-stage renal disease (ESRD) who are on dialysis. The company noted a 39% diarrhea rate which resulted in 7.8% of patients discontinuing the trial, lower than its previous Phase 2 trial. Shares rose 14% to $13.00.

Auris Medical Holding AG (NASDAQ: EARS) announced the pricing of its previously announced public offering of 10m shares and 10m warrants, with each warrant entitling its holder to purchase 0.70 of a common share (one unit).  The offering will be priced at $1 per unit for gross proceeds of $10m. Shares closed down 19% to $0.934.

Celsion Corporation (NASDAQ:CLSN) also announced the pricing of a public offering with expected total gross proceeds of approximately $5m. The offering, priced at $0.23 per share included warrants to purchase 0.75 of a share of common stock, at an exercise price of $0.23 per share. Shares closed down 33% to $0.22.

Evoke Pharma, Inc. (NASDAQ:EVOK) shares spiked at the open and closed up 30% to $3.40 following notice that it has received a letter from FDA exempting its late stage product, Gimoti from a Human Factors (HF) Validation study requirement prior to submission of a New Drug Application (NDA), slated for filing by the end of 2017.

Other major price movers:


Zosano Pharma Corp (NASDAQ:ZSAN): $2.85; +41%.

Novan Inc (NASDAQ:NOVN): $6.44; +34%.

AVEO Pharmaceuticals, Inc. (NASDAQ:AVEO): $0835; +15%.

Dicerna Pharmaceuticals Inc (NASDAQ:DRNA): $3.22; +14%

Novavax, Inc. (NASDAQ:NVAX): $1.62; +14%.


Delcath Systems, Inc.(NASDAQ:DCTH): $0.156; +21%.

Galectin Therapeutics Inc (NASDAQ:GALT): $1.47; -18%.

Bellerophon Therapeutics Inc (NASDAQ:BLPH): $0.90; -12%.

Neothetics Inc (NASDAQ:NEOT): $1.41; -10%.

BioDelivery Sciences International, Inc.(NASDAQ:BDSI): $1.90; -7%.


Full pipeline updates:

Pipeline Database Updates

Drug Stage Catalyst Market Cap

ALKS – Alkermes plc
ALKS 5461
Major depressive disorder

PDUFA NDA filed but Refusal To File Letter announced April 2, 2018. However, company announced April 16, 2018 that the NDA has been accepted with a PDUFA date of January 31, 2019. Advisory Committee Meeting November 1, 2018.
$6.4 billion

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

Phase 3 Phase 3 released February 15, 2017 - primary endpoint met. Data from second Phase 3 trial due 2019.
$243.9 million

EVOK – Evoke Pharma Inc.
Gimoti - EVK-001
Female diabetic gastroparesis

PDUFA PDUFA date April 1, 2019.
$44.7 million

MNOV – MediciNova Inc.
Progressive multiple sclerosis (progressive MS)

Phase 2b Phase 2b top-line data released October 28, 2017 at Joint ECTRIMS – ACTRIMS meeting. Primary endpoint met.
$470.7 million

NVCR – NovoCure Limited
Tumor Treating Fields (TTFields) LUNAR
Non-small cell lung cancer (NSCLC)

Phase 3 Phase 3 commencement of enrollment announced February 15, 2017. Data due 2021.
$4.2 billion

PRTA – Prothena Corporation plc
AL Amyloidosis

Phase 3 Phase 3 trial discontinued due to futility - April 23, 2018.
$519.1 million

PRTA – Prothena Corporation plc
Previously-treated patients with AL amyloidosis and persistent cardiac dysfunction

Phase 2b Phase 2b trial did not meet primary endpoint - April 23, 2018.
$519.1 million

PRTA – Prothena Corporation plc
Psoriatic Arthritis

Phase 1b Phase 1b data released September 28, 2017 - insufficient meaningful clinical effect for further development.
$519.1 million

PRTA – Prothena Corporation plc
Parkinson's disease

Phase 2 Phase 2 data due 2020.
$519.1 million

SBPH – Spring Bank Pharmaceuticals Inc.
Inarigivir - ACHIEVE
Hepatitis B (HBV)

Phase 2a Phase 2 data from third cohort met primary endpoint - August 2, 2018. Other cohort data due by end of 2018.
$189.7 million

VNDA – Vanda Pharmaceuticals Inc.
HETLIOZ (tasimelteon)
Jet Lag Disorder

Phase 2 Phase 2 data released March 5, 2018 - primary endpoint met.
$1.2 billion

VNDA – Vanda Pharmaceuticals Inc.
HETLIOZ (tasimelteon)
Smith-Magenis Syndrome

Phase 3 Phase 3 initiated 4Q 2016. Data due by the end of 2018.
$1.2 billion

VNDA – Vanda Pharmaceuticals Inc.
Atopic dermatitis

Phase 3 Phase 3 trial initiated June 2018.
$1.2 billion

VNDA – Vanda Pharmaceuticals Inc.
HETLIOZ (tasimelteon) - pediatric formulation

Phase 1 PK trial initiated with full enrollment completed 4Q 2017.
$1.2 billion