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Exelixis $EXEL announced encouraging results from a Phase 1 study of CABOMETYX (cabozantinib) in combination with nivolumab [Bristol-Myers Squibb’s $BMY Opdivo] in patients with previously treated genitourinary tumors. The data will be presented on Sunday, October 9 at the European Society for Medical Oncology 2016 Congress in Copenhagen.

Mylan Soars after $465mn EpiPen Classification Settlement-Mylan $MYL shares gained sharply in aftermarket hours on Friday after reaching an agreement with government agencies in a $465mn settlement linked to Medicaid rebate classifications for its EpiPen. The settlement -- concerning the question of whether EpiPen Auto-Injectors were correctly classified as a non-innovator drug with Medicaid -- means Mylan admits to no offence.Mylan will take a pretax charge of about $465M for that reason, and has downwardly revised the guidance: It now sees full-year (adjusted) EPS at $4.70-$4.90, compared to earlier forecast of $4.85-$5.15, mainly due to changes in EpiPen access programs and the upcoming generic version. The company maintains that it will book a EPS of $6 in 2018. Q3 results are due on Nov 9.

 Bristol-Myers drug Flunks to meet immunotherapy Expectations-A new lung treatment from Bristol-Myers Squibb $BMY that aimed to make the body into a defence against cancer flunked. The treatment failed to beat chemotherapy in a large head-to-head clinical trial. The outcome is a big setback for the new field of immunotherapy. Those participants taking Opdivo typically survived for just more than four months before the disease aggravated, while those who received chemotherapy survived for six months before the cancer worsened, a clinical trial of 541 patients showed.

 Incyte’s epacadostat and Merck’s Keytruda Shows Encouraging Results in Melanoma Patients-Incyte $INCY announced its updated results from the Phase 1 part of a Phase ½ clinical study, ECHO-202, evaluating the combination of epacadostat and Merck’s $MRK Keytruda (pembrolizumab) in treatment-naive advanced/metastatic melanoma patients. The outcome of the clinical trial is being presented at the European Society for Medical Oncology 2016 Congress in Copenhagen. The enrollment for the Phase 2 is underway.

 Roche’s Triple Combination Therapy Shows Encouraging Results in Advanced Melanoma Patients-Result from a Phase 1b clinical study evaluating the safety and clinical activity of the triple combination of Roche's a $RHHBY COTELLIC (cobimetinib), ZELBORAF (vemurafenib) and TECENTRIQ   (atezolizumab) in treatment-naive patients with BRAF V600-positive advanced melanoma showed a positive treatment benefit although with side effects. The data will be made public on Monday, October 10 at the European Society of Medical Oncology 2016 Congress in Copenhagen.

 Clovis’ rucaparib shows 54% Response Rate in Mid-Stage Study in Treatment-resistant Ovarian Cancer but adverse events persistent-Clovis Oncology $CLVS slumped 20% premarket amid heavy volume trading in response to its announcement of discouraging mid-stage trial data on PARP inhibitor rucaparib in certain patients with treatment-resistant advanced ovarian cancer, an indication that is currently under FDA review (action date is February 23, 2017). The results are being shown at the European Society for Medical Oncology 2016 Congress in Copenhagen.

Alcobra Receives Written Notice From FDA on MDX Clinical Hold-Alcobra $ADHD reported that it has received the written full clinical hold notice from the FDA in relation to its Metadoxine Extended Release (MDX) in adult patients with attention deficit/hyperactivity disorder [ADHD]. Shares had plunged about 60% on September 29, when the company first verbally announced the FDA’s decision.

BeiGene’s Lead-Product Candidate Shows Encouraging Result in non-Hodgkin lymphoma-Updated data from an ongoing Phase 1 Clinical Trial evaluating BeiGene’s $BGNE lead product candidate BGB-3111 in patients with Waldenstrom’s macroglobulinemia (WM), a type of non-Hodgkin lymphoma, demonstrated an encouraging treatment effect. The results were presented today during the 9th International Workshop on Waldenstrom's Macroglobulinemia and Symposium on Advances in Multiple Myeloma in Amsterdam, The Netherlands.

Novartis’ LEE011 Shows Good Results in Late-Stage Breast Cancer Study but with more side effect-Interim results from a Phase 3 study, MONALEESA-2, assessing Novartis’ $NVS LEE011 (ribociclib) for the treatment of postmenopausal women with hormone receptor-positive, human epidermal growth factor receptor-2-negative (HR+/HER2-) advanced/metastatic breast cancer showed pre-eminence over standard-of-care treatment. The data were presented on Saturday at the European Society for Medical Oncology 2016 Congress in Copenhagen and published simultaneously online in The New England Journal of Medicine.

The FDA approved Lundbeck’s $HLUKF, $HLUYY Carnevix (carbamazepine) injection as a temporary replacement for oral carbamazepine formulation in adults with certain seizures types when oral administration is in the short term not possible. This is the first intravenous formulations of the anti-epileptic drug, which has got the approval for sale in the U.S, and it had Orphan Drug Status. The treatment launch will start from early 2017.

The U.S. District Court in Delaware dismissed patent infringement case related to Lipocine’s $LPCN lead product candidate LPCN 1021. Shares vaulted in response to the news on Friday amid extraordinarily high trading volume. The judge dismissed a lawsuit filed by Clarus Therapeutics alleging that LPCN 1021, the company's testosterone replacement therapy candidate, infringed on its U.S. Patent No. 8,828,428.

No deals and collaborations to report.

Idera Pharmaceuticals $IDRA fell sharply amid heavy trading volume in response to its pricing of the secondary offering of 25M shares of common stock at $2. Underwriters will be eligible to purchase an additional 3.75mn shares. The closing date is October 13. The net proceeds will go towards the clinical development of pipeline candidates.

No IPOs to report.

No earnings to report.

Company (Ticker) Brokerage Action Recommendation Price Target My Price Target
Alcobra $ADHD Stifel Nicolaus Downgrade From Buy to Hold N/A N/A
Alnylam Pharmaceuticals $ALNY Morgan Stanley Downgrade/Price Target Cut From Overweight to Equal Weight From $38 to $36 Under Review
Alexion Pharmaceuticals $ALXN FBR & Co. Reiterate Sell N/A N/A
BeiGene $BGNE Cowen and Company Reiterate Buy N/A N/A
Biogen $BIIB JPMorgan Chase & Co. Reiterate Overweight $386 $420
BioMarin Pharmaceutical $BMRN Goldman Sachs Group Upgrade Neutral N/A N/A
Exelixis $EXEL Leerink Swann Reiterate Outperform $15 $12.50
GW Pharmaceuticals $GWPH Goldman Sachs Group Initiation Buy $189 N/A
Intercept Pharmaceuticals $ICPT Wedbush Reiterate Outperform $239 N/A
Idera Pharmaceuticals $IDRA S&P Equity Research Price Target Raised N/A From $1.86 to $2.19 N/A
Illumina $ILMN Canaccord Genuity Price Target Set Hold $165 N/A
Incyte $INCY BMO Capital Markets Price Target Raised N/A $121 N/A
Jazz Pharmaceuticals $JAZZ BMO Capital Markets Reiterate Outperform $195 N/A
Karyopharm Therapeutics $KPTI Leerink Swann Reiterate Outperform $18 N/A
Lexicon Pharmaceuticals $LXRX HC Wainwright Initiation Buy $26 $23.21
Merrimack Pharmaceuticals $MACK JPMorgan Chase & Co. Downgrade From Overweight to Neutral $5.75 $14
The Medicines Company $MDCO Jefferies Group Reiterate Buy $43 $50
Pacira Pharmaceuticals $PCRX Brean Capital Initiation Hold N/A N/A
RedHill Biopharma $RDHL HC Wainwright Price Target Set Buy $33 N/A
Reata Pharmaceuticals $RETA Piper Jaffray Cos. Price Target Set Buy $33 N/A
Scynexis $SCYX WBB Securities Upgrade From Buy to Strong Buy $8 N/A
Syndax Pharmaceuticals $SNDX Guggenheim Initiation Buy N/A N/A
Teva Pharmaceutical Industries $TEVA Leerink Swann Price Target Set Buy $57 N/A
Zynerba Pharmaceuticals $ZYNE HC Wainwright Initiation Buy $22 N/A

Aerie Pharmaceuticals $AERI- Foresite Capital Management II, a 10% owner, sold 50,000 shares at $40.34. The total value of the transaction was $2.02 million. Foresite Capital still owns 1,647,901 shares of AERI.

Ionis Pharmaceuticals $IONS- Stanley T. Crooke, Chairman and CEO, sold 11,000 shares in two separate transactions. Crooke sold 10,000 shares at $36.61; and 1,000 shares at $36.61. Crooke still owns 2,170 shares of IONS.

United Therapeutics $UTHR- Martine A. Rothblatt, Chairman and CEO, sold 1,260 shares at $121.17. The total value of the transaction was $152,679. Rothblatt still owns 140 shares of UTHR.

Vertex Pharmaceuticals $VRTX- Joshua S. Boger, Director, sold 6,500 shares at $87.44. The total value of the transaction was $568,379. Boger still owns 268,225 shares of VRTX.