Join Now - it is FREE

Basic level includes our interactive biotech chatroom, forum, biotech stock screener; you also receive the biotech digest in your email everyday.

[/toggle]

Alkermes $ALKS reported encouraging top-line results from FORWARD-5, a third phase 3 efficacy trial to read out from the FORWARD pivotal program for ALKS 5461, a once-daily, oral investigational medicine with the novel mechanism of action of the adjunctive treatment of major depressive disorder (MDD) in patients with an inadequate response to standard antidepressant therapies. The trial met its pre-determined primary endpoint, showing treatment with ALKS 5461 significantly reduced symptoms of depression in patients with MDD compared to placebo. The treatment, in general, was well tolerated.

Amgen’s Xgeva shows Mixed results compared to Zoledronic Acid-Results from a Phase 3 study evaluating Amgen’s $AMGN XGEVA (denosumab) compared to zoledronic acid (ZA) for the prevention of bone complications in a newly diagnosed multiple myeloma (MM) patients, succeeded in attaining primary endpoints. Full results of the clinical trial will presented at the future medical conference and for publication. The data will also be submitted to regulatory authorities. The primary endpoint was a non-inferiority test defined by the time to the first skeletal-related event (SRE).  However, the treatment failed to show any superiority over ZA as the secondary endpoints were not met.

Gilead triple combo pill for genotypes 1-6 chronic hepatitis c virus show high cure rate-Gilead Sciences $GILD reported strong results from four international Phase 3 clinical studies (POLARIS-1, -2, -3, -4) evaluating its investigational once-daily, fixed-dose combination of sofosbuvir, velpatasvir, and voxilaprevir (SOF/VEL/VOX) for the treatment of genotypes 1-6 chronic hepatitis c virus (HCV) infection. Complete results will be submitted in November at The Liver Meeting in Boston.

Gilead Sciences’ $ open label Phase 2 clinical trial evaluating GS-4997 (selonsertib), taken alone or in combination with simtuzumab (SIM) for the treatment of patients with non-alcoholic steatohepatitis (NASH) with moderate-to-severe liver fibrosis showed a positive treatment benefit. The top-line data will be submitted at the Liver Meeting in Boston, between November 11 and 15, 2016.

Omeros’ OMS721 successful in mid-stage trial in HSCT-associated small vessel blood clots-Omeros $OMER announced positive results from a Phase 2 clinical development study evaluating lead product candidate, OMS721 for the treatment of patients who have thrombotic microangiopathy (TMA) associated with a hematopoietic stem cell transplant (HSCT), a condition with a high mortality rate. TMA signals that there is a damage in the smallest blood vessel and blood clots are involved.

NHS Issues Positive appraisal for Celgene’s Otezla-England’s National Institute for Health and Care Excellence (NICE), an advisory group to the National Health Service (NHS) on costs and quality, issued a positive final appraisal determination providing patient access to Celgene’s $CELG OTEZLA (apremilast) for the treatment of chronic plaque psoriasis. As a result, patients in England and Wales will now have access to OTEZLA. The drug was available in Scotland since June 2015.

Theravance and Mylan announce encouraging results from late-stage COPD candidate- Theravance $TBPH and development partner Mylan N.V. $MYL reported a successful results from two replicate Phase 3 study evaluating revefenacin (TD-4208) for the treatment of chronic obstructive pulmonary disease (COPD). Both trails met their primary endpoint of a statistically valid improvement versus placebo in trough forced expiatory volume in one second (FEV1) after 12 weeks of treatment with each dose studied (88 mcg once-daily and 176 mcg once-daily). The drug-maker plans U.S. marketing application by end of the next year.

FDA to consider Teva’s resubmitted application for deutetrabenazine- The FDA accepted Teva Pharmaceutical Industries’ $TEVA request to review a resubmitted New Drug Application (NDA) seeking approval of deutetrabenazine (SD-809) for the treatment of chorea (involuntary movements) associated with Huntington’s disease, an Orphan Drug indication. The action date is April 3, 2017. The drug-maker received a Complete Response Letter (CRL) in May regarding its original filing, requiring to re-analyze blood levels of certain metabolites.

Rigel’s fostamatinib fails late-stage trial in thrombocytopenia-Rigel Pharmaceuticals $RIGL nosedived more than 25% amid heavy trading volume in response to its announcement of failed results in the second of two Phase 3 study evaluating fostamatinib for the treatment of adult patients with chronic/persistent immune thrombocytopenia (low blood platelets). The trial, FIT 2 (Study 048), was unsuccessful in achieving its primary endpoint of a statistically valid response rate compared to placebo.

No approvals to report.

No patents to report.

No deals and collaborations to report.

Puma Biotechnology $PBYI announced pricing of its equity offering of 3.75mn shares of common stock at $40. Underwriters have an option to purchase an additional 562.5K shares. The closing date of the offering is October 25. The stock closed at $42.70.

No IPOs to report.

Roche’s $RHHBY Q3 revenue rose 4.5% to 12.48 billion Swiss francs (12.6b). The topline fell a tad short of the company forecast, which was for 12.55b francs. Sales were lifted by the strong performance of the company’s cancer and immunotherapy treatments. It included Roche’s trio of drugs for treating the HER2-positive form of breast cancer, Gazya for chronic lymphocytic leukemia, Acterma for rheumatoid arthritis, and Esbriet for the lung disease idiopathic pulmonary fibrosis. The drug-makers overall pharmaceutical sales rose to 9.68b from 9.34b francs. Diagnostic unit’s revenue rose to 2.8b francs from 2.6b francs. The company maintained FY sales to grow at a low-to-mid single-digit range at constant exchange rate.

Revive Therapeutics $RVVTF reported net loss of $2.74 million. Cash and equivalents stood at $1.33 million. Shares sunk in response to the announcement. Revive Therapeutics Ltd. is a Canada-based clinical-stage company. It is focused on commercializing treatments for gout and orphan drug indications, such as cystinuria, Wilson disease and Rett syndrome.

Company (Ticker) Brokerage Action Recommendation Price Target My Price Target
Dimension Therapeutics $DMTX Jefferies Group Reiterate Buy $12 N/A
Eiger Biopharmaceuticals $EIGR Jefferies Group Reiterate Buy $33 N/A
SCYNEXIS $SCYX HC Wainwright Initiation Buy $14 N/A

Opko Health $OPK- Dr. Phillip Frost, CEO & Chairman, bought 2,700 shares at $9.26. The total value of the transaction was $24,989. Dr. Frost now owns 160,238,343 shares of OPK.

No insider sells to report.

No management changes and additions.

NYSE- Intrexon $XON shares were among the major movers on the NYSE. The stock closed 4.24% higher. Axovant Sciences $AXON shares ended the day 3.28% higher.

NASDAQ- Concordia International $CXRX shares were among the major movers on the NASDAQ. The stock closed 11.52% higher. Tetraphase Pharmaceuticals $TTPH shares ended the day 10.92% higher. Eiger Biopharmaceuticals $EIGR ended the day 10.35% higher. Rigel Pharmaceuticals $RIGL shares were among the major losers on the NASDAQ. The stock closed 15.22% lower. Organovo Holdings $ONVO ended the day 15.19% lower. Aurinia Pharmaceuticals $AUPH ended the day 6.59% lower.

NYSEMKT- Actinium Pharmaceuticals $ATNM shares were among the major movers on the NYSEMKT. The stock closed 5.41% lower.

OTC- Amarantus Bioscience Holdings $AMBS shares were among the major movers on the OTC market. The stock closed 15.23% higher.

Company (Ticker) Short Interest as a % of Float % Change Days to Cover
Array BioPharma $ARRY 12% 29.9% 1
Arrowhead Pharmaceuticals $ARWR 17.9% 0.9% 8
Ascendis Pharma $ASND 2.1% -6.3% 9
Assembly Biosciences $ASMB 1.2% -3.9% 8
Atara Biotherapeutics $ATRA 18.5% 9.3% 22
Atossa Genetics $ATOS 1.8% 13.5% 3
aTyr Pharma $LIFE 6% -2.7% 7
Aurinia Pharmaceuticals $AUPH 4.1% -26.9% 0
AVEO Pharmaceuticals $AVEO 1.8% 6.1% 6
AveXis $AVXS 9.3% 4.5% 3