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Portola Pharmaceuticals (PTLA) received a CRL from the FDA, pushing shares down sharply in pre-market trading. PTLA fell more than 10% in regular trading on Wednesday. In the CRL, the FDA has requested information related to manufacturing. The agency also requires more data to support inclusion of edoxaban and enoxaparin in the label. The FDA also said that it requires to complete its review of the clinical amendments to Portola's post-marketing commitments that were submitted recently.

While the CRL is a disappointment for PTLA longs, the issues raised by the FDA have nothing to do with andexanet alfa’s safety or efficacy. Therefore the sell-off post the FDA rejection looks like a buying opportunity. I will be adding PTLA shares to bring my average cost down. While the delay is a setback for PTLA, it does not have a significant impact on the bullish thesis.

Cytokinetics Completes Enrollment in Late-Stage ALS Study- Cytokinetics (CYTK) announced that it has completed enrollment in its Phase 3 clinical trial, VITALITY-ALS. The study will evaluate muscle troponin activator tirasemtiv in patients with amyotrophic lateral sclerosis (ALS). Results from the 700 patient study are expected to be available in the second half of 2017.

Valeant Rallies on Morgan Stanley Upgrade- Valeant Pharmaceuticals International (VRX) shares rallied on Wednesday following a rating upgrade from Morgan Stanley. Morgan Stanley analyst David Risinger raised his rating on the stock from Equal Weight to Overweight. Morgan Stanley has a price target of $42. The analyst cited expectation of successful renegotiation of debt covenants, improved cash flow from operations and the reduction in debt as the reasons for the upgrade.

InVivo Provides Update from INSPIRE Study- InVivo Therapeutics Holdings (NVIV) shares rallied on Wednesday after the company announced that the fifth patient (out of eight in follow-up) in its INSPIRE study who was implanted with its Neuro-Spinal Scaffold has converted from a complete AIS A spinal cord injury to incomplete AIS B status between the two- and three-month evaluations, representing a 62.5% conversion rate. The fifth patient in INSPIRE had a T4-level injury.

Janssen Biotech Files Marketing Application for Expanded Use of Darzalex- Janssen Biotech (JNJ) announced that it has submitted a supplemental Biologics License Application (sBLA) to the FDA seeking approval of the use of DARZALEX (daratumumab), in combination with lenalidomide and dexamethasone or bortezomib  and dexamethasone, for the treatment of multiple myeloma (MM) patients who have received at least one prior line of therapy. The FDA has already granted Breakthrough Therapy status for DARZALEX for this indication last month.

Cerulean Pharma Plunges as Lead Product Candidate Fails in Mid-Stage Study- Cerulean Pharma (CERU) shares plunged more than 60% in after-hours trading on Wednesday after the company announced that its lead product candidate CRLX101 flunked a mid-stage study in kidney cancer. The study evaluated CRLX101, in combination with standard-of-care (SOC) therapy, for the treatment of patients with advanced renal cell carcinoma who progressed through two or three prior lines of therapy. Mean progression-free survival (PFS) for the CRLX101 cohort was 3.7 months versus 3.9 months for SOC. Adding salt to the wound was a 25% higher risk of disease progression or death in the CRLX101 group (hazard ratio = 1.25). The objective response rate (ORR) also favored SOC, 14% versus 5%.

Pfizer Gets Favorable Ruling in Patent Case- A Federal Court has ruled in favor of Pfizer (PFE) in an infringement case related to Remicade patents. The court ruled that PFE’s biosimilar of Johnson & Johnson’s (JNJ) Remicade does not infringe a patent.

No approvals to report.

No patents to report.

Sorrento Therapeutics (SRNE) announced that its subsidiary Scintilla Pharmaceuticals signed a binding term sheet to acquire privately held Semnur Pharmaceuticals. According to the terms of the agreement, Semnur will receive an upfront payment of $60M ($40M in cash + $20M in SRNE common stock) and up to $140M in milestones. Based in Los Altos, California, Semnur’s lead product candidate is Phase 2-stage resiniferatoxin (the active ingredient in chili peppers) a non-opioid pain medication for the treatment of intractable cancer pain.

Perrigo (PRGO) announced that it has agreed to acquire Geiss, Destin & Dunn, a small national distributor of over-the-counter (OTC) healthcare and consumer products to non-chain retail and institutional markets, for an undisclosed sum. The deal is expected to close by the end of the month.

Nymox Pharmaceutical (NYMX) announced that it has secured a $2.2 million in new capital through the direct placement of 965,649 shares of its common stock at $2.32. Proceeds from the offering will be used for general corporate purposes.

Eiger BioPharmaceuticals (EIGR) announced that it has initiated a public offering of common stock. Price, volume and terms have not been announced yet.

No IPOs to report.

Alere (ALR) reported a loss of $0.18 per share in its first quarter. The company reported revenue of $578.21 million, down 5.7% on a year-over-year basis.

Bio-Techne (TECH) reported earnings of $0.92 per share in its fourth quarter, missing consensus forecast by 4 cents. The company reported revenue of $134.6 million, up 14.5% on a  year-over-year basis. Revenue beat consensus forecast by $5.53 million.

ProQr (PRQR) reported a loss of euro 0.43 per share in its second quarter. The company ended the quarter with euro 76.31 million in cash and cash equivalents on its balance sheet.

Innocoll (INNL) reported a loss of $0.62 per share in its second quarter, beating consensus forecast by 11 cents. The company reported revenue of $1.3 million, up 103.1% on a year-over-year basis. Revenue beat consensus forecast by $0.26 million.

Immunomedics (IMMU) reported a loss of $0.17 per share in its fourth quarter, missing consensus forecast by 6 cents. The company reported revenue of $0.93 million, down 61.3% on a year-over-year basis. Revenue missed consensus forecast by $0.27 million.

Guided Therapeutics (GTHP) reported a loss of $0.07 per share in its second quarter. The company reported revenue of $0.13 million, up 30% on a year-over-year basis.

Company (Ticker) Brokerage Action Recommendation Price Target My Price Target
Arbutus Biopharma (ABUS) Leerink Swann Downgrade From Outperform to Market Perform N/A N/A
Aquinox Pharmaceuticals (AQXP) Canaccord Genuity Reiterate Buy

$22

N/A
Arrowhead Pharmaceuticals (ARWR) Cantor Fitzgerald Initiation Buy N/A

$14.40

Aurinia Pharmaceuticals (AUPH) HC Wainwright Price Target Raised Buy From $7 to $10

$4.30

AveXis (AVXS) Wells Fargo & Co. Upgrade From Market Perform to Outperform N/A N/A
Axovant Sciences (AXON) HC Wainwright Reiterate Buy N/A N/A
Biogen (BIIB) Morgan Stanley Price Target Cut Overweight From $385 to $368

$420

BioMarin Pharmaceutical (BMRN) Jefferies Group Reiterate Buy N/A N/A
Concordia Healthcare (CXRX) TD Securities Price Target Cut Hold From $20 to $14 N/A
GlaxoSmithKline (GSK) Shore Capital Reiterate Hold N/A N/A
Heat Biologics (HTBX) Noble Financial Reiterate Buy N/A N/A
Heat Biologics (HTBX) Roth Capital Reiterate Buy

$2.75

N/A
NantKwest (NK) Piper Jaffray Cos. Reiterate Buy N/A N/A
Intellia Therapeutics (NTLA) Jefferies Group Reiterate Buy N/A N/A
Opko Health (OPK) Jefferies Group Reiterate Hold N/A

$20

Regeneron Pharmaceuticals (REGN) Jefferies Group Reiterate Hold N/A

$475

Rigel Pharmaceuticals (RIGL) Piper Jaffray Cos. Reiterate Buy N/A N/A
SCYNEXIS (SCYX) Guggenheim Initiation Buy

$15

N/A
Shire PLC (SHPG) Jefferies Group Reiterate Buy N/A N/A
Valeant Pharmaceuticals International (VRX) Morgan Stanley Upgrade From Equal Weight to Overweight From $33 to $42 N/A

No insider buys to report.

Codexis (CDXS)- VIVO Ventures VII, LLC, a 10% owner, sold 86,894 shares in two separate transactions. VIVO Ventures sold 50,000 shares at $4.27; and 36,894 shares at $4.21. VIVO Ventures still owns 115,321 shares of CDXS.

Atara Biotherapeutics (ATRA)- Christopher Haqq, Chief Medical Officer, sold 1,346 shares at $22.32. Haqq still owns 293,948 shares of ATRA. Gad Soffer, COO, sold 5,356 shares at $22.41. Soffer still owns 145,249 shares of ATRA.

Pacira Pharmaceuticals (PCRX)- David M. Stack, CEO and Chairman, sold 15,000 shares at $45.32. The total value of the transaction was $679,800. Stack still owns 33,637 shares of PCRX. James S. Scibetta, President, sold 25,000 shares at $45.21. The total value of the transaction was approximately $1.13 million. Scibetta still owns 27,084 shares of PCRX.

Alder Biopharmaceuticals (ALDR)- Jeffrey T L Smith, Sr. VP Translational Medicine, sold 3,000 shares at $31.17. The total value of the transaction was $93,512. Smith does not own any shares of ALDR.

Eagle Pharmaceuticals (EGRX)- ProQuest Investments IV, L.P., a 10% owner, sold 99,795 shares in three separate transactions. ProQuest sold 24,949 shares at $60.77; 60,150 shares at $61.67; and 14,696 shares at $61.08. ProQuest still owns 5,387 shares of EGRX.

Jazz Pharmaceuticals (JAZZ)- Rick E. Winningham, Director, sold 633 shares at $136.45. The total value of the transaction was $86,373. Winningham still owns 15,391 shares of JAZZ.

Wave Life Sciences (WVE) announced the appointment of Keith Regnante as Chief Financial Officer. He joins the firm from Shire plc where he was VP of Finance.

NYSE- Valeant Pharmaceuticals International (VRX) shares were among the major gainers on the NYSE. The stock closed 12.78% higher. Puma Biotechnology (PBYI) ended the day 1.85% higher.

NASDAQ- SCYNEXIS (SCYX) shares were among the major gainers on the NASDAQ. The stock closed 25.73% higher. Proteostasis Therapeutics (PTI) ended the day 19.45% higher. Aeglea BioTherapeutics (AGLE) ended the day 13.46% higher. Mirna Therapeutics (MIRN) shares were among the major losers on the NASDAQ. The stock closed 15.19% lower. Portola Pharmaceuticals (PTLA) ended the day 10.97% lower. Histogenics (HSGX) ended the day 10.30% lower.

NYSEMKT- Asterias Biotherapeutics (AST) shares were among the major movers on the NYSEMKT. The stock closed 4.03% lower.

OTC- Amarantus Bioscience Holdings (AMBS) shares were among the major movers on the OTC market. The stock closed 6.38% higher.

Company (Ticker) Short Interest as a % of Float % Change Days to Cover
Paratek Pharmaceuticals (PRTK)

4.9%

30.1%

4

PAREXEL International (PRXL)

7.6%

-9.7%

11

Parnell Pharmaceuticals Holdings (PARN)

0.6%

-9%

1

PDL BioPharma (PDLI)

7%

-2.7%

12

Peregrine Pharmaceuticals (PPHM)

0.5%

-9.1%

2

Pernix Therapeutics (PTX)

11.3%

7.9%

2

Pieris Pharmaceuticals (PIRS)

0.4%

-26.8%

1

Pluristem Therapeutics (PSTI)

0.9%

1.4%

7

Portola Pharmaceuticals (PTLA)

5.6%

-1.3%

5

Progenics Pharmaceuticals (PGNX)

13.4%

1.1%

2