Ocular Therapeutix, Inc (Nasdaq: OCUL) Shares up in Pre-Market on Phase 3 Results

OcularTherapeutix, Inc. – Nasdaq: OCUL

Bedford, MA-based Ocular Therapeutix, Inc. shares are up over 8% in pre-market trading. Traded on the Nasdaq under ticker OCUL, the shares are benefitting from positive news that additional positive secondary endpoint results were reached from its most recent successful phase 3 clinical trial of Dextenza™ (dexamethasone insert) 0.4 mg, for the treatment of post-surgical ocular inflammation and pain.

Dextenza is a product candidate administered by a physician as a bioresorbable intracanalicular insert and designed to release drug to the ocular surface for up to 30 days. Dextenza successfully met the trial’s two primary efficacy endpoints, absence of ocular pain on day 8 and absence of ocular inflammation on day 14 when compared to placebo. In this Phase 3 clinical trial, for which the complete safety assessment will be available in the first quarter of 2017, no treatment-related serious adverse events were observed. Dextenza has exhibited a favorable safety profile and has been well tolerated in all clinical trials, regardless of indication.

“The positive results for the secondary endpoint of absence of ocular flare build upon the successful topline results from this trial which we announced last month,” said Jonathan H. Talamo, M.D., Chief Medical Officer of Ocular Therapeutix.

Ocular Therapeutix, Inc. (NASDAQ: OCUL) is a biopharmaceutical company focused on the development and commercialization of innovative therapies for diseases and conditions of the eye using its proprietary hydrogel platform technology. Ocular Therapeutix plans to resubmit an NDA in the first quarter of 2017 for post-surgical pain for its lead product candidate, Dextenza™.

OCUL shares had an EPS loss of $2.69 in 2014 and a loss of $1.71 in 2015. Sales were $0.8 million in 2014 and $1.8 million in 2015. Four firms follow Ocular Therapeutix, Inc. Two give OCUL shares a “Strong Buy” rating and Two give OCUL a rating of “Buy”. Consensus price tagrte is $26.50.

I have no positions in any stocks mentioned, and no plans to initiate any positions within the next 96 hours. All information, or data, is provided with no guarantees of accuracy.

1/4/17
Ticker Symbol OCUL
Last Price a/o 8:37 AM EST $9.09
Average Volume 1.06 million
Market Cap $206 milion
Sales 1.8 million
Shares Outstanding 24.76 million
Share Float 21.79 million
Shortable Yes
Optionable Yes
Inside Ownership 2.70%
Short Float 23.45%
Short Interest Ratio 4.83
Quarterly Return 21.46%
YTD Return -0.60%
Year Return -6.52%

CymaBay Therapeutics Inc (Nasdaq: CBAY) Inks Licensing Deal with Kowa

CymaBay Therapeutics, Inc. – Nasdaq: CBAY

Shares of California-based CymaBay Therapeutics, Inc. are rocketing in pre-market trading. Traded on the Nasdaq under ticker symbol CBAY, the shares closed Tuesday at $1.90. In today’s pre-market trading CBAY has hit $3.00 on very heavy volumes.

Investors appear to be reacting to news that CymaBay has entered into a licensing deal with Kowa Pharmaceuticals for development and commercialization of CymaBay’s drug Arhalofenate – an oral, once-daily dual-acting drug candidate for the treatment of gout. Arhalofenate has been licensed to Kowa Pharmaceuticals America, Inc. for the U.S.A. market only – CymaBay Pharmaceuticals retains full development and commercialization rights for arhalofenate outside the U.S.A.

Under the terms of the agreement, CymaBay will receive up to $15 million in upfront and near-term milestone payments and is eligible to receive up to an additional $190 million in payments based upon the achievement of specific development, regulatory and sales milestones.  CymaBay is also eligible to receive tiered, double digit royalties on future sales of arhalofenate products.  Kowa will be responsible for all development and commercialization costs.

Harold Van Wart, Ph.D., President and CEO of CymaBay commented on the deal “We are extremely pleased to enter into this agreement with Kowa to develop and market arhalofenate in the U.S. Kowa has proven development capabilities as well as the resources to carry out a large Phase 3 development program. They also have an established primary care sales force to market arhalofenate products. As arhalofenate is a potential novel therapy for gout, a disease most often treated by primary care physicians, it is a very good fit with Kowa’s established strength in this area…”

Three firms cover CymaBay Pharmaceuticals Inc. Two analysts give CBAY a “”Strong Buy” rating while one rates CBAY as a “Hold”. Their consensus price target is $5.00.

I have no positions in any stocks mentioned, and no plans to initiate any positions within the next 96 hours. All information, or data, is provided with no guarantees of accuracy.

1/4/17
Ticker Symbol CBAY
Last Price a/o 8:00 AM EST $2.77
Average Volume 88,500
Market Cap $45 million
Sales
Shares Outstanding 23.7 million
Share Float 23.13 million
Shortable Yes
Optionable No
Inside Ownership 0.10%
Short Float 1.29%
Short Interest Ratio 3.36
Quarterly Return -0.52%
YTD Return 9.83%
Year Return 4.40%

Titan Pharmaceuticals (Nasdaq: TTNP) Up 15%

Titan Pharmaceuticals Inc. – Nasdaq: TTNP

Titan Pharmaceuticals Inc. trades on the Nasdaq under ticker symbol TTNP. Shares are up almost 15% on heavy volumes. Shares closed on Friday at $4.00 and have reached $4.60 in today’s early trading.

Titan Pharmaceuticals develops proprietary therapeutics for the treatment of select chronic diseases utilizing its innovative, long-term, continuous drug delivery platform, ProNeura. ProNeura implants enhance patient care by providing non-fluctuating, stable levels of medication in the blood for up to one year. Titan is in the early stages of product development programs utilizing ProNeura for the treatment of Parkinson’s disease and hypothyroidism. It’s also evaluating the feasibility of additional product candidates that would be suitable for the treatment of several chronic diseases, including certain hormonal deficiencies; type 2 diabetes, attention deficit hyperactivity disorder, benign prostate hyperplasia and others.

One form covers Titan Pharmaceuticals and gives TTNP a rating of “Strong Buy” with a price target of $11. TTNP reached its highs in EPS ($0.65) and sales ($10.5 million) in 2013. It progressively posted worse figures in 2014 and 2015.

I have no positions in any stocks mentioned, and no plans to initiate any positions within the next 96 hours. All information, or data, is provided with no guarantees of accuracy.

Interpace Diagnostics (Nasdaq: IDXG) Shares Soar on BC/BS Agreement

Interpace Diagnostics Corp. – Nasdaq: IDXG

Interpace Diagnostics Corp. (Nasdaq: IDXG), announced today that it has entered in to an agreement with the Blue Cross Blue Shield (BCBS) Association’s Center for Clinical Effectiveness “Evidence Street”. This program provides the company with the opportunity to support further coverage determinations among Blue Cross Blue Shield and other health plans. Blue Cross Blue Shield’s 36 independent plans and Companies account for approximately 106 million covered lives in the U.S.

IDXG is trading up over 160% on the news. Jack E. Stover, President and CEO of Interpace Diagnostics stated, “We are excited about our evolving relationship with Blue Cross and Blue Shield’sEvidence Street which, we believe, will help ensure that we continue to develop and provide the information and data necessary to support and secure broader based insurance coverage and reimbursement for all of our products.  This relationship is another important milestone in our reimbursement strategy and, when added to our recent AETNA insurance approval for ThyraMIR  and New York State approval to market ThyGenX, bodes well for our commercial prospects in 2017 and beyond.”

Interpace Diagnostics provides diagnostic tests and pathology services for evaluating rancer risk. The Company currently has three commercialized molecular tests; PancraGen for the diagnosis and prognosis of pancreatic cancer from pancreatic cysts; ThyGenX, for the diagnosis of thyroid cancer from thyroid nodules utilizing a next generation sequencing assay and ThyraMIR, for the diagnosis of thyroid cancer from thyroid nodules utilizing a proprietary gene expression assay.

I have no positions in any stocks mentioned, and no plans to initiate any positions within the next 96 hours. All information, or data, is provided with no guarantees of accuracy.

1/3/17
Ticker Symbol IDXG
Last Price a/o 11:47 AM EST $11.31
Average Volume 47,000
Market Cap $11.1 million
Sales $12.5 million
Shares Outstanding 2.52 million
Share Float 1.33 million
Shortable Yes
Optionable No
Inside Ownership 1.00%
Short Float
Short Interest Ratio
Quarterly Return 2650.00%
YTD Return 836.17%
Year Return 836.17%

Tracon Pharmaceuticals Inc. (Nasdaq: TCON) Reaches FDA Agreement

Tracon Pharmaceuticals Inc. – Nasdaq: TCON

Shares of San Diego, CA-based Tracon Pharmaceuticals Inc. are trading at their daily highs on heavy volumes. TRACON develops targeted therapies for cancer, ophthalmic and fibrotic diseases.

Traded on the Nasdaq under ticker symbol TCON, the shares gapped up from their previous close of $4.90 on news that the biotechnology firm reached an agreement with the U.S. Food and Drug Administration (FDA) under a Special Protocol Assessment (SPA) for the protocol design, clinical endpoints, and statistical analysis approach for the Company’s Phase 3 study evaluating TRC105 for the treatment of patients with advanced angiosarcoma. The SPA process is one in which a sponsor asks the FDA to evaluate the proposed design and size of Phase 3 clinical trials that are intended to form the primary basis for determining a drug product’s efficacy. An SPA agreement indicates concurrence with the adequacy and acceptability of specific critical elements of protocol design, endpoints and analysis.

Three firms cover Tracon Pharmaceuticals Inc. and all three assign TCON shares a “Strong Buy” with a consensus price target of $12. In 2015 Tracon reported their strongest sales figures yet – $7.9 million but had a EPS loss of $2.20. TCON shares have never experienced positive EPS.

I have no positions in any stocks mentioned, and no plans to initiate any positions within the next 96 hours. All information, or data, is provided with no guarantees of accuracy.

1/3/17
Ticker Symbol TCON
Last Price a/o 11:30 AM EST $5.75
Average Volume 47,000
Market Cap $69.78 million
Sales $4.2 million
Shares Outstanding 14.24 million
Share Float 13.51 million
Shortable Yes
Optionable No
Inside Ownership 37.69%
Short Float 0.70%
Short Interest Ratio 2.01
Quarterly Return -26.54%
YTD Return -46.97%
Year Return -46.97%

Depomed Inc. (Nasdaq: DEPO) Buyout Imminent?

Depomed Inc. – Nasdaq: DEPO

A New York Post article is sending shares of Depomed Inc. higher in pre-market trading. Depomed Inc. trades on the Nasdaq under ticker DEPO. The article claims that famed Wall St buy-out firm KKR is interested in purchasing Depomed. Previous reports had put any buyout offer would be around $25 a share. At 9:00 AM EST trading for DEPO was under $20.

Newark, CA-based Depomed had previously rejected attempts to purchase the company before finally putting itself out for sale to the market. The moves to reject potential suitors brought scorn for Depomed’s board from shareholders who threatened to remove several board members.

Depomed Inc. specializes in the production of painkillers. Cambria is a drug that addresses migraine headaches but Nucynta, an opiod that carries addiction risks, is their largest source of revenue – $72 million in the last quarter. In addition to its ability to develop and commercialize new drugs, Depomed also has successfully developed and licensed its unique drug-delivery technology, Acuform®. This patented oral-delivery technology allows for the targeted, extended release of pharmaceutical compounds into the upper gastrointestinal tract.

Eight firms follow Depomed Inc. Shares of DEPO have been rated by five analysts as a “Strong Buy”; two as a “Hold”; and one rates it a “Sell”. Revenues and EPS both suffered in 2015 from their 2014 highs.

I have no positions in any stocks mentioned, and no plans to initiate any positions within the next 96 hours. All information, or data, is provided with no guarantees of accuracy.

1/3/17
Ticker Symbol DEPO
Last Price a/o 9:00 AM EST $19.87
Average Volume 1.68 million
Market Cap 1.11 Billion
Sales $443.2 million
Shares Outstanding 61.42 million
Share Float 60.98 million
Shortable Yes
Optionable Yes
Inside Ownership 0.40%
Short Float 20.61%
Short Interest Ratio 7.46
Quarterly Return -27.83%
YTD Return -0.61%
Year Return -0.61%

Inotek Pharmaceuticals Corporation (Nasdaq: ITEK) Reports Failed Phase 3 Results

Inotek Pharmaceuticals Corporation – Nasdaq: ITEK

Shares of Inotek Pharmaceuticals Corporation plunged over 65% in heavy trading this morning after the company announced disappointing results from their Phase 3 trial. Inotek Pharmaceuticals Corporation trades on the Nasdaq under the ticker symbol ITEK.

Lexington, MA-based Inotek Pharmaceuticals is a clinical-stage biopharmaceutical company focused on the discovery, development and commercialization of therapies for glaucoma and other eye diseases.

From the press release:

“The trial did not achieve its primary endpoint of superiority in reduction of intraocular pressure compared with placebo at all 12 time points. This was, in part, due to a placebo response that was 2-3 mmHg greater than that observed in Phase 2.”

David P. Southwell, President and Chief Executive Officer of Inotek stated, “We are disappointed that the primary endpoint of superiority at all 12 time points was not achieved. This result was driven primarily by the unexpectedly stronger placebo response at the 8AM time point.”

Five firms followed Inotek Pharmaceutical Corporation. All five gave shares of ITEK a rating of “Strong Buy” with a consensus price target of $22. ITEK has never reported any revenues and since 2012 ITEK has reported increasing negative EPS: 2012: -$0.52; 2015: -$3.72.

Inotek Pharmaceuticals Corporation ( ITEK ) will host a conference at 8:30 AM ET on January 3, 2017, to discuss the results from the MATrX-1 Phase 3 trial.

To access the live webcast, log on at www.inotekpharma.com

To listen to the call, dial (844) 358-9183 (US) or (478) 219-0400 (International)

I have no positions in any stocks mentioned, and no plans to initiate any positions within the next 96 hours. All information, or data, is provided with no guarantees of accuracy.

1/3/17
Ticker Symbol ITEK
Last Price a/o 7:48 AM EST $2.10
Average Volume 313,210
Market Cap $175 million
Sales
Shares Outstanding 28.69 million
Share Float 26.59 million
Shortable Yes
Optionable Yes
Inside Ownership 5.17%
Short Float 9.00%
Short Interest Ratio 7.65
Quarterly Return -25.65%
YTD Return -46.16%
Year Return -46.16%

Fortress Biotech Inc. (Nasdaq: FBIO) Soaring in Pre-Market

Fortress Biotech, Inc. – Nasdaq: FBIO

Shares of Fortress Biotech Inc. are up over 50% on heavy volume in pre-market trading. FBIO, traded on the Nasdaq, closed Wednesday at $2.29, but Thursday pre-market trading has seen the shares hit $3.50. Investors appear to be flocking to FBIO based on reports that a cancer-stricken patient had responded favorably to a treatment developed by Fortress’s Mustang Bio Inc. unit using T-Cells. The reports suggest that the patient had not experienced improvement with traditional approaches.

Dr. Lindsay A. Rosenwald, Fortress Biotech’s Chairman, President and Chief Executive Officer, said, “We are excited to share this unprecedented research conducted by Mustang’s partners at City of Hope, which confirms the potential of MB-101 to be a breakthrough immunotherapeutic targeted against GBM, an almost universally fatal brain tumor. MB-101’s compelling clinical activity adds to the growing pipeline of therapies developed by our Fortress Companies that have the potential to transform the treatment of life-threatening diseases.”

Michael S. Weiss, Mustang Bio’s Executive Chairman, commented, “We are extremely encouraged by the response seen in this patient.  As the first patient ever to receive intraventricular delivery of CAR T cells for brain tumors, we see this as proof of concept that CAR T cells can be delivered safely and with remarkable effect to patients with GBM.  This robust response has prompted the expansion of our Phase 1 study to evaluate intraventricular administration in a larger cohort of patients.  Given the poor outcomes for patients with GBM, we believe if we see additional patients with this type of response that we can explore a possible accelerated approval pathway, similar to that proposed by some of the other CAR T companies, which are targeting different forms of cancer.”

The sole analyst that covers FBIO rates it a “Strong Buy” with a price target of $11. FBIO had traded above $12 in 2013 and Fortress Biotech has never had a positive year of EPS. However, 2015 was the first year Fortress Biotech reported any sales – $900,000. FBIO appears to be a favored target of short-sellers and investors should perform their own due diligence prior to making any investment decisions as biotech shares are notoriously volatile.

I have no positions in any stocks mentioned, and no plans to initiate any positions within the next 96 hours. All information, or data, is provided with no guarantees of accuracy.

12/29/2016
Ticker Symbol FBIO
Last Price a/o 7:22 AM EST  $                      3.45
Average Volume 90,600
Market Cap $104.84 million
Sales $4.2 million
Shares Outstanding 45.78 million
Share Float 29.28 million
Shortable Yes
Optionable Yes
Inside Ownership 0.80%
Short Float 12.45%
Short Interest Ratio 40.23
Quarterly Return -22.11%
YTD Return -17.92%
Year Return -17.03%

 

Ocera Therapeutics Inc. (Nasdaq: OCRX) Up Big in Pre-Market

Ocera Therapeutics Inc. – Nasdaq: OCRX

Shares of Ocera Therepeutics Inc are up over 25% in pre-market trading. Shares are traded on the Nasdaq under the ticker symbol OCRX. Ocera Therapeutics is a clinical stage biopharmaceutical company focused on the development and commercialization of novel therapeutics for patients with serious diseases in areas of high unmet medical need.

Ocera’s lead drug candidate, OCR-002, is an ammonia scavenger which aims to remove ammonia from the blood. Elevated ammonia is believed to be one of the primary causes of hepatic encephalopathy (HE). OCR-002 is the subject of STOP-HE, a Company-sponsored Phase 2b trial, a Company-sponsored Phase 1 trial, and two externally-sponsored Phase 2a trials. OCR-002 has received Orphan Drug designation in both the U.S. and Europe and has been granted Fast Track status by the U.S. Food and Drug Administration.

Four firms follow Ocera Therapeutics. All four of their analysts rate OCRX a “Strong Buy” with a consensus price target of $10. Analyst confidence may be rewarded as OCRX has experienced increasing, though negative, EPS every year since 2011. However sales have been minimal and interested investors should view OCRX and all biotech companies with extreme caution and perform their own due diligence.

I have no positions in any stocks mentioned, and no plans to initiate any positions within the next 96 hours. All information, or data, is provided with no guarantees of accuracy.

12/28/2016
Ticker Symbol OCRX
Last Price a/o 8:13 AM EST  $               3.00
Average Volume 266,900
Market Cap $50.95 million
Sales $0.1 million
Shares Outstanding 23.2 million
Share Float 22.7 million
Shortable Yes
Optionable Yes
Inside Ownership 0.40%
Short Float 0.74%
Short Interest Ratio 0.63
Quarterly Return -15.38%
YTD Return -29.49%
Year Return -30.60%

 

Synergy Pharmaceutical Inc. (Nasdaq: SGYP) Soars on Positive Results

Synergy Pharmaceuticals Inc.; Nasdaq: SGYP

Shares of Synergy Pharmaceuticals Inc jumped more than 20% today in heavy trading. The New York City-based biotechnology firm trades on the Nasdaq under the ticker symbol SGYP. SGYP ended Thursday’s trading session at $4.74 and closed today up over 21% at $5.77.

Synergy Pharmaceuticals Inc. (NASDAQ:SGYP) today announced on December 22, 2016 (after market close) that positive top-line results from the second of two pivotal phase 3 clinical trials evaluating the efficacy and safety of plecanatide, an investigational once-daily orally-administered compound, in 1,054 adult patients with irritable bowel syndrome with constipation (IBS-C).

Preliminary analysis of the data indicates that both plecanatide 3 mg and 6 mg doses met the study’s primary endpoint and showed statistical significance in the percentage of patients who were Overall Responders compared to placebo during the 12-week treatment period

Synergy Pharmaceuticals has pioneered discovery, research and development efforts around analogs of uroguanylin, a naturally occurring human GI peptide, for the treatment of GI diseases and disorders. Synergy Parmaceuticals has research, technical operations, and commercial offices in suburban Philadelphia. They have discovered, are developing, and control 100% worldwide rights to our proprietary uroguanylin analog platform that includes two lead product candidates – plecanatide and dolcanatide.

Plecanatide is their first uroguanylin analog currently being evaluated for use as a once-daily tablet for chronic idiopathic constipation (CIC) and irritable bowel syndrome with constipation (IBS-C). Dolcanatide is their second uroguanylin analog currently being explored for ulcerative colitis.

Synergy Pharmaceuticals is covered by two firms and both give SGYP a “Strong Buy” rating. However the biotech company has yet to announce any revenues and has had negative EPS since it was listed on the Nasdaq in 2008.

I have no positions in any stocks mentioned, and no plans to initiate any positions within the next 96 hours. All information, or data, is provided with no guarantees of accuracy.

12/23/2016
Ticker Symbol SGYP
Last Price a/o 4:00 PM EST  $               5.77
Average Volume 3.05 million
Market Cap $852.2 million
Sales
Shares Outstanding 179.8 million
Share Float 172.1 million
Shortable Yes
Optionable Yes
Inside Ownership 7.01%
Short Float 13.77%
Short Interest Ratio 7.78
Quarterly Return -15.50%
YTD Return -16.40%
Year Return -18.13%