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Two replicate Phase 3 studies evaluating AbbVie’s $ABBV Elagolix for the treatment of premenopausal women with endometriosis showed statistically valid treatment effects in lowering menstrual pain (dysmenorrhea of DYS) and non-menstrual pelvic pain (NMPP). The data was shown at the 72nd American Society for Reproductive Medicine Scientific Congress & Expo in Salt Lake City, UT. In the two trials, both oral doses of Elagolix showed a statistically improvement in the percentage of DYS and NMPP responders.

Kite Pharma says it all-set to launch KTE-C19-Addressing the audience during its Investors Day, Kite Pharma $KITE gave an update on its preparedness for the U.S. launch of KTE-C19 and its development activities.  The drug-maker said it can produce KTE-C19, a CAR-T therapy for the treatment of certain blood cancers, in commercial quantities. It added that its manufacturing process is very efficient with yields as high as 99% and will be able to supply treatments for more than 4,000 patients a year with the ability to quickly expand its capacity. Next generation automation will enter feasibility testing next year. Clinical trials are lined-up or are in process for six new blood cancer indications for KTE-C19.

 Mid-stage Clinical Trial of Eiger Pharma’s hepatitis D candidate in-progress- The first patient got dosed in a Phase 2 clinical study, LIMT HDV, evaluating Eiger BioPharmaceuticals’ (EIGR) pegylated interferon lambda 1a (lambda) for the potential treatment of chronic hepatitis delta (D) virus (HDV) infection. The 30-participant open label clinical trial will assess the safety, tolerability, and efficacy of two dose levels of lambda over the next 48 weeks of treatment.

 Merck’s letermovir effective in preventing CMV infection in late-stage study- A Phase 3 study evaluating Merck’s $MRK letermovir (MK-8228) for preventing clinically significant cytomegalovirus (CMV) infection in CMV-seropositive adults who have undergone an allogeneic hematopoietic stem cell transplant (HSCT) met its primary endpoint of a statistically valid percentage of patients with clinically significant CMV infection up to 24 weeks after HSCT. Final results will be presented at a future scientific conference.

 Omeros’ cocaine addiction candidate shows encouraging results in mid-stage trial- Results from Phase 2 clinical study showed patients with cocaine use disorder (CUD) who were treated with Omeros’ $OMER OMS405 experienced  a drastic time-dependent reduction in cocaine craving compared to placebo. The trial was conducted at the Center for Neurobehavioral Research on Addition, University of Texas Health Science Center in Houston.

The FDA, under its Priority Review Process, approved Eli Lilly’s $LLY LARTRUVO (olaratumab), in combination with chemo agent doxorubicin, for the treatment of patients with advanced soft tissue sarcoma (STS), who are incurable with radiotherapy or surgery. The complication occurs with roughly 12K Americans every year. The treatment is a monoclonal antibody designed to disrupt the platelet-derived growth factor receptor alpha (PDGF Receptor-alpha) pathway on tumor cells and on cells in the tumor microenvironment. Marketing application is under review in Europe following a positive Ad Comm vote a month earlier.

No patents to report.

Cerulean $CERU soared on Wednesday in response to two encouraging developments. First, it signed a $200 million stock purchase agreement with Aspire Capital Fund LLC under which Aspire purchased 800K shares of common stock at $1.25. Cerulean has the right to sell up to the remaining $19 million to Aspire over a 24-month period based on a formula linked to then-current market prices. It has also issued 700K commitment shares to Aspire. In another story, Cerulean has entered into a strategic partnership with Novartis $NVS to develop nanoparticle drug conjugate (NDC) product candidates for up to five targets. Cerulean will leverage its proprietary Dynamic Tumor Targeting technology with Novartis' proprietary compounds. It will be in charge for creating the NDC candidates while Novartis will be responsible for further development and commercialization.

Nektar Therapeutics $NKTR announced its equity offering of 13 million shares of common stock at $13.50. Underwriters will have the option to purchase an additional 1.95 million shares. The net proceeds from the offering will fund R&D activities, working capital requirements and other general corporate purposes. The stock closed at $14.08 on Wednesday.

Ascendis Pharma A/S $ASND priced its secondary offering of 6,315,789 American Depository Shares (ADS) at $19. Each ADS equals to one ordinary share. Underwriters will have an option to purchase an additional 947,368 ADSs. The closing date of offer is October 24. The net proceeds from the offering will be about $120 million. It will be used to fund clinical development and regulatory approval of Transcon Growth Hormone, the development of other lead candidates, working capital requirement and other general corporate purposes. The stock closed at $20.09 on Tuesday.

 

CRISPR Therapeutics (pending) $CRSP scaled down its IPO to 4 million common shares from 4.7 million and lowered the price to $14, down from the original range of $15-17. Underwriters will have an option to purchase an additional 600k shares. The closing date is October 24. Trading commences today. The company was co-founded by one of the CRISPR/Cas9 discoverers, Emmanuelle Charpentier. The technology is labelled as the next big thing in biotech. Therefore the stock will be on investors’ radar along with Editas Medicine $EDIT and Intellia Therapeutics $NTLA.

No earnings to report.

Company (Ticker) Brokerage Action Recommendation Price Target My Price Target
ACADIA Pharmaceuticals $ACAD Roth Capital Reiterate Neutral $25 $94.25
Amarin Corp. $AMRN Citigroup Initiation Buy $5 N/A
Can-Fite Biopharma $CANF Roth Capital Reiterate Buy N/A N/A
Cerulean Pharma $CERU Leerink Swann Reiterate Market Perform N/A N/A
Corcept Therapeutics $CORT Piper Jaffray Cos. Price Target Set Buy $12 N/A
GlaxoSmithKline $GSK JPMorgan Chase & Co. Reiterate Neutral N/A N/A
Kite Pharma $KITE Maxim Group Price Target Set Buy $77 N/A
Kite Pharma $KITE Canaccord Genuity Price Target Set Buy $75 N/A
Kite Pharma $KITE Cowen and Company Price Target Set Buy N/A N/A
Pacira Pharmaceuticals $PCRX Wedbush Price Target Cut Outperform From $109 to $93 N/A
Pfizer $PFE Sanford C. Bernstein Price Target Set Buy $36 N/A
Proteon Therapeutics $PRTO Cowen and Company Initiation Outperform N/A N/A
Sangamo Biosciences $SGMO Piper Jaffray Cos. Downgrade From Overweight to Neutral $5 N/A
XOMA Corp. $XOMA Wedbush Reiterate Outperform $17 N/A

Opko Health $OPK- Dr. Phillip Frost, CEO & Chairman, bought 14,700 shares at $9.26. The total value of the transaction was $136,131. Dr. Frost now owns 160,235,643 shares of OPK.

Tobira Therapeutics $TBRA- Pentwater Capital Management, a 10% owner, bought 31,700 shares at $40.07. The total value of the transaction was approximately $1.27 million. Pentwater Capital now owns 3,734,900 shares of TBRA.

FibroGen $FGEN- Thomas B. Neff, CEO, sold 37,798 shares in two separate transactions. Neff sold 18,899 shares at $17.56; and 18,899 shares at $17.94. Neff still owns 3,341,588 shares of FGEN.

Alder Biopharmaceuticals $ALDR- Mark James Litton, Chief Business Officer, sold 6,000 shares at $27.50. The total value of the transaction was $164,998. Litton still owns 26,000 shares of ALDR.

Spark Therapeutics $ONCE- Jeffrey D. Marrazzo, CEO, sold 5,000 shares at $54.66. The total value of the transaction was $273,306. Marrazzo still owns 230,000 shares of ONCE.

SciClone Pharmaceuticals $SCLN- Wilson Wai-Shun Cheung, CFO & Senior VP, Finance, sold 1,475 shares at $10. The total value of the transaction was $14,750. Cheung still owns 15,134 shares of SCLN.

No management changes and additions to report.

NYSE- Puma Biotechnology $PBYI shares were among the major movers on the NYSE. The stock closed 18.90% lower.

NASDAQ- XBiotech $XBIT shares were among the major gainers on the NASDAQ. The stock closed 9.38% higher. Roka Bioscience $ROKA ended the day 9.25% higher. InVivo Therapeutics Holdings $NVIV ended the day 8.14% higher. XOMA shares were among the major losers on the NASDAQ. The stock closed 14.90% lower. Eleven Biotherapeutics $EBIO ended the day 8.61% lower. PTC Therapeutics $PTCT ended the day 7.81% lower.

NYSEMKT- Palatin Technologies $PTN shares were among the major movers on the NYSEMKT. The stock closed 8.91% lower.

OTC- Amarantus Bioscience Holdings $AMBS shares were among the major movers on the OTC market. The stock closed 10.61% lower.

Company (Ticker) Short Interest as a % of Float % Change Days to Cover
Argos Therapeutics $ARGS 10.7% 11.4% 12
ARIAD Pharmaceuticals $ARIA 15.6% -0.5% 3
ArQule $ARQL 0.2% 7.6% 1
Array Biopharma $ARRY 12% 29.9% 1
Arrowhead Pharmaceuticals $ARWR 17.9% 0.9% 8
Ascendis Pharma $ASND 2.1% -6.3% 9
Atara Biotherapeutics $ATRA 18.5% 9.3% 22
Athersys $ATHX 8.5% -4.6% 15
Atossa Genetics $ATOS 1.8% 13.5% 3
aTyr Pharma $LIFE 6% -2.7% 7