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Novartis Announces Dissolution of Internal Cell and Gene Therapy Unit- Novartis (NVS) announced that it has dissolved its internal cell and gene therapy unit. The company plans to redeploy ~280 of the 400 employees in the group to other positions in the company while 120 will be let go. The company believes that a dedicated unit no longer makes sense. The action will not affect the company's support of the Novartis-Penn Center for Advanced Cellular Therapeutics, unveiled in February on Penn Medicine's campus. Novartis' seed investment of $20M helped build the center which will employ 100 cell therapy specialists. It entered into a global research and licensing agreement with UPenn in August 2012 to study CAR therapies. It will also not affect Novartis' plan to file a marketing application with the FDA in early 2017 seeking approval of CTL019 for the treatment of pediatric relapsed/refractory acute lymphoblastic leukemia.

MannKind Surges on Update About EpiPen Alternative- MannKind (MNKD) shares rallied on Wednesday after the company announced that it is working on a less-costly alternative to Mylan’s (MYL) EpiPen (epinephrine injection, USP). MYL has come under scrutiny from lawmakers over the pricing of EpiPen. MannKind CEO Matt Pfeffer said that his company is working on an inhalable formulation of the allergic reaction medication that will be "much cheaper" than Mylan's branded product. Pfeffer further said that MNKD has been working on the project for some time and it considers it its lead program.

Novartis (NVS) announced that the FDA has approved its ARZERRA (ofatumumab), in combination with the chemo agents fludarabine and cyclophosphamide, for the treatment of patients with relapsed chronic lymphocytic leukemia (CLL). ARZERRA was previously approved for the treatment of CLL patients who have not responded to fludarabine and Sanofi’s (SNY) LEMTRADA (alemtuzumab), in treatment-naive CLL patients not treated with fludarabine and maintenance treatment of CLL in partial/complete responders treated with at least two prior lines of therapy.

Pfizer (PFE) announced that the European Commission (EC) has approved the use of its XALKORI (crizotinib) for the treatment of patients with non-small cell lung cancer (NSCLC) whose tumors are ROS1 mutation-positive. XALKORI was previously approved in the EU for the first/second line treatment of NSCLC that expresses the enzyme anaplastic lymphoma kinase (ALK).

Ignyta (RXDX) announced that the FDA has approved its IDE (investigational device exemption) for its companion diagnostic next-generation sequencing (NGS) assay, Trailblaze Pharos. The company intends to use it to identify patients with NTRK1/2/3-, ROS1- or ALK-positive solid tumors to determine eligibility in its Phase 2 STARTRK-2 clinical trial evaluating lead product candidate entrectinib in a range of cancers, particularly non-small cell lung cancer (NSCLC) and metastatic colorectal cancer (mCRC).

Allergan (AGN) and Adamas Pharmaceuticals (ADMS) announced that they have settled their patent litigation against Amneal Pharmaceuticals related to Alzheimer's med NAMZARIC (memantine HCl extended release and donepezil HCl) capsules. Amneal filed an abbreviated New Drug Application (ANDA) seeking approval to market a generic version of the drug. Allergan's Forest Laboratories, LLC and Adamas sued Amneal a year ago claiming its ANDA infringed on certain patents.

Hemispherx (HEB) announced a private placement of $5 million with two institutional investors. The deal consists of common stock at $1.50, with each share being paired with one five-year warrant to purchase 3/4 of a share of common at $2.00. Net proceeds from the private placement will be used to fund technology transfer opportunities, expenses related to Ampligen manufacturing, working capital and general corporate purposes.
Elite Pharmaceuticals (ELTP) announced that it has entered into a collaboration and license agreement with privately held SunGen Pharma, LLC to develop and commercialize four generic products. According to the terms of the agreement, the companies will share responsibilities and costs and the products will be jointly owned after regulatory approval. SunGen will have exclusive rights to market two of the products under its own label and Elite will have exclusive rights to market the other two under its label. Elite will manufacture all four on a "cost plus" basis. Financial terms are not disclosed.

Cynapsus Therapeutics (CYNA) announced that it has reached an agreement under which privately-held Sunovion Pharmaceuticals will acquire it for $40 per share in cash. Sunovion would acquire CYNA's APL-130277 product candidate, which is designed to be an easy-to-use, on-demand treatment option for Parkinson’s disease.

Atossa Genetics (ATOS) shares tumbled on Wednesday after the company announced the pricing of its secondary offering of 1.15 million shares of its common stock at $2.50 per share. Underwriters to the offering have been granted an option to purchase an additional 172,500 shares to cover for over-allotment if any.

No IPOs to report.

Ascendis Pharma (ASND) reported second quarter loss of euro 0.53 per share. The company’s revenue for the quarter was euro 1.94 million, up 70.2% on a year-over-year basis.

Company (Ticker) Brokerage Action Recommendation Price Target My Price Target
Alcobra (ADHD) Cantor Fitzgerald Reiterate Buy

$16

N/A
Celgene Corp. (CELG) Morgan Stanley Reiterate Equal Weight

$120

$140

Gilead Sciences (GILD) Jefferies Group Price Target Cut Hold From $93 to $91

$130

Gilead Sciences (GILD) Piper Jaffray Cos. Reiterate Overweight

$108

$130

The Medicines Company (MDCO) Jefferies Group Reiterate Buy

$43

$50

MannKind (MNKD) S&P Equity Research Price Target Cut N/A From $0.84 to $0.70 N/A
Qiagen (QGEN) Commerzbank AG Reiterate Buy N/A N/A
Rigel Pharmaceuticals (RIGL) HC Wainwright Price Target Raised Buy From $6 to $7 TBA
Teva Pharmaceutical Industries Ltd. (TEVA) Leerink Swann Price Target Cut Outperform From $66 to $61 N/A

No insider buys to report.

Ophthotech (OPHT)- Samir Chandrakant Patel, President, sold 20,000 shares at $52.80. The total value of the transaction was approximately $1.06 million. Patel still owns 31,531 shares of OPHT.

Zosano Pharma (ZSAN)- James M. Barrett, a 10% owner, sold 50,000 shares at $1.01. The total value of the transaction was $50,440. Barrett still owns 2,070,276 shares of ZSAN.

Oasmia Pharmaceutical AB (OASM) announced the appointment of Fredrik Gynnerstedt as Chief Financial Officer effective December 1. Previously, he was Director of Collaboration at Karnov Group.

NYSE- Valeant Pharmaceuticals (VRX) shares were among the major movers on the NYSE. The stock closed 4.03% lower.

NASDAQ- Oncobiologics (ONS) shares were among the major gainers on the NASDAQ. The stock closed 18.50% higher. Gemphire Therapeutics (GEMP) ended the day 17.17% higher. Protagonist Therapeutics (PTGX) ended the day 9.78% higher. Rigel Pharmaceuticals (RIGL) shares were among the major losers on the NASDAQ. The stock closed 14.25% lower. Ocera Therapeutics (OCRX) ended the day 10.92% lower. Proteon Therapeutics (PRTO) ended the day 9.26% lower.

NYSEMKT- Palatin Technologies (PTN) shares were among the major movers on the NYSEMKT. The stock closed     1.94% higher.

OTC- Amarantus Bioscience Holdings (AMBS) shares were among the major movers on the OTC market. The stock closed 3.47% higher.

Company (Ticker) Short Interest as a % of Float % Change Days to Cover
XBiotech (XBIT)

26.2%

-1.8%

21

Xencor (XNCR)

5.9%

-2.6%

7

XOMA Corporation (XOMA)

6.8%

-4.8%

15

Zafgen (ZFGN)

9.4%

-12.5%

4

ZIOPHARM Oncology (ZIOP)

33.1%

0.3%

20

Zogenix (ZGNX)

13.7%

-3%

22

Zosano Pharma (ZSAN) -

-90.9%

0

Zynerba Pharmaceuticals (ZYNE)

15.6%

-0.6%

5