OncoSec Medical Inc. (NASDAQ:ONCS

OncoSec Medical Inc. (NASDAQ:ONCS) Hits Record Highs after Trial Results

OncoSec Medical Inc. (NASDAQ:ONCS)

Shares of OncoSec Medical Inc. (NASDAQ:ONCS) hit a new record high after the company reported positive follow-up data from its Phase 2 OMS 1-102 combination study of ImmunoPulse IL-12 and Keytruda. The stock was up by 60% in Monday’s trading session to end the day at $2 a share.

OncoSec Medical Inc. (NASDAQ:ONCS

ONCS Stock Performance

OncoSec Medical Inc. (NASDAQ:ONCS) is currently trading in an uptrend, after being in consolidation for the better part of the year. For the full year, the stock is up by more than 60%. Following the rally, Maxim analyst Jason Kolbert has assigned a ‘Buy’ rating on the stock with a share price target of $5. The price target represents a 146% potential upside from current trading levels.

Renewed investor interest on the stock follows the announcement that a combination of ImmunoPulse il-12 and Keytruda demonstrated a 57% progression-free survival at 15 months.

Trial Results

According to OncoSec Medical Inc. (NASDAQ:ONCS), the new data demonstrates that a combination of the two therapies can prime a coordinated innate and adaptive immune response. The findings also suggest that the approach can reshape the tumor microenvironment yielding a robust anti-tumor response.

“The robust PFS benefit and tolerability observed with ImmunoPulse IL-12 plus pembrolizumab is the first demonstrating efficacy in a predicted PD-1 non-responder population and shows that the combination represents a potentially important addition to the treatment landscape for metastatic melanoma patients who have progressed or are progressing on anti-PD-1 therapy,” said CEO Dan O’Connor.

OncoSec Financial Results

Separately, OncoSec Medical Inc. (NASDAQ:ONCS) reported fourth-quarter financial results that indicated a significant improvement in operational efficiencies. For the three months ended July 31, 2017, the company generated a net loss of (-$5.8) million or (-$0.28) a share. The performance was an improvement from a net loss of (-$6.6) million reported last year.

OncoSec Medical Inc. (NASDAQ:ONCS) full-year net loss came in at (-$21.4) million or (-$1.06) a share, compared to a net loss of (-$26.9) million reported last year. The company attributes the decrease in net loss to a $2.2 million reduction in non-stock-based compensation. Research and development expenses also dropped from $14.7 million as of last year to $$12 million.

OncoSec Medical Inc. (NASDAQ:ONCS) exited the FY2017 with a total of $11.4 million in cash and cash equivalent compared to $28.7 million as of July 31, 2016.

I have no positions in any of the stocks mentioned, and have no plans to initiate any positions within the next 72 hours. All information, including any data, is provided without any guarantees of accuracy.

Don’t miss out! Stay informed on $ONCS and receive breaking news on other hot stocks by signing up for our free newsletter!

About the author: Monica has an undergraduate degree in Accounting and an MBA she earned – with Honors. She has six years of experience in the financial markets and has been an analyst for the past two years.

AcelRx Pharmaceuticals Inc. (NASDAQ:ACRX)

AcelRx Pharmaceuticals Inc. (NASDAQ:ACRX) Implodes After FDA Rejection

AcelRx Pharmaceuticals Inc. (NASDAQ:ACRX)

AcelRx Pharmaceuticals Inc. (NASDAQ:ACRX) shares fell 59.8% after the U.S. Food and Drug Administration declined to approve its opioid painkiller Dsuvia. The agency raised a number of issues that the company needs to address pending any future consideration.

AcelRx Pharmaceuticals Inc. (NASDAQ:ACRX)

FDA Recommendation

One of the recommendations requires AcelRx Pharmaceuticals Inc. (NASDAQ:ACRX) to collect additional data on at least 50 patients, assessing the safety of DSUVIA at the maximum amount described in the labeling. The company will also have to ensure proper administration of the tablet with the single dose applicator.

The regulator is also demanding changes to the “Directions for Use” instructions that come with the drug, to address issues of tablets that may need to be disposed of.

The FDA decision rattled investors as most of them were expecting the painkiller to achieve regulatory approval. Analysts were optimistic about the drug gaining regulatory approval on its limited abuse potential. The stock consequently suffered its biggest one-day sell-off since it went public in 2011.

AcelRX Defense

AcelRx Pharmaceuticals Inc. (NASDAQ:ACRX) has sought to quash investor concern and prevent a further slide in the stock price by insisting that the recommendations by the FDA are manageable. In a statement, the company says it will request a meeting with the FDA to discuss topics in the Complete Response Letter.

“We believe the recommendations stated in the CRL are manageable and plan to fully cooperate with the FDA. We remain focused on the NDA resubmission and our mission to provide physicians and patients with precise and efficient non-invasive pain management options for moderate-to-severe acute pain within medically supervised settings,” said CEO Vincent J. Angotti.

The Chef Executive Officer says they have a sufficient cash runway of $67.9 million to complete the Dsuvia marketing application resubmission. The company also plans to make a marketing submission application for its other drug, Zalviso.

Opioid Epidemic

The FDA decision comes at a time when the United States is grappling with a major opioid epidemic. The agency has become cautious in recent years in issuing new approvals on heavy-duty painkillers after more than 33,000 deaths were reported in 2015.

Last month the regulator rejected another opioid painkiller from Intellipharmaceutics as it requested additional data to prove the drug’s ability to prevent abuse.

I have no positions in any of the stocks mentioned, and have no plans to initiate any positions within the next 72 hours. All information, including any data, is provided without any guarantees of accuracy.

Don’t miss out! Stay informed on $ACRX and receive breaking news on other hot stocks by signing up for our free newsletter!

About the author: Monica has an undergraduate degree in Accounting and an MBA she earned – with Honors. She has six years of experience in the financial markets and has been an analyst for the past two years.

Catalyst Biosciences Inc (NASDAQ:CBIO) Stock Surges On Hemophilia B Trial

Catalyst Biosciences Inc (NASDAQ:CBIO)

Catalyst Biosciences Inc (NASDAQ:CBIO) stock jumped 11.50% after announcing positive clinical data from an ongoing Phase ½ proof-of-concept in people suffering from severe hemophilia B. According to the biopharmaceutical company, top line potency results support the use of CB 2679d as a subcutaneous therapy for the prevention of bleeding in patients with Hemophilia B.

The positive factor IX clinical data helped push the stock to a key resistance level at the $4.00 a share level before it retreated to the $3.78. The stock continues to trade in a year-long downward trend, but investors are waiting to see if the news will help CBIO reverse direction.

Catalyst Biosciences Inc (NASDAQ:CBIO)
One month CBIO stock price chart

Positive CB 2679d Trial Results

Clinical trial results indicate that an intravenous dose of CB 2679d is about 22 times more potent than a case of BeneFIX. The factor IX protease was also found to have the ability to stay in circulation much longer – for up to 34 hours compared to BeneFIX which remains for up to 25 hours.

“We believe that CB 2679d will have advantages over the currently approved intravenous prophylactic treatments that are known to have a prolonged period of low activity levels with increased risk of spontaneous bleeding,” said Nassim Usman, Ph.D., Catalyst Biosciences Inc (NASDAQ:CBIO)’s President and Chief Executive Officer.

Catalyst Biosciences Inc (NASDAQ:CBIO) has already received $0.7 million from ISU Abxis to be used on development of the intravenous prophylactic treatment. It has also received Orphan Medicine Designation from the European Commission for the use of SQ CB 2679d on hemophilia B patients.

Financial stability

Positive CB 2679D trial results come on the heels of Catalyst Biosciences making significant progress in the second quarter in both its clinical programs and balance sheet. The company raised $26 million for the first six months of the year with $2.7 million coming from the underwritten public offering and $5.3 million from its Capital in demand program.

Catalyst Biosciences Inc. (NASDAQ:CBIO) had a total of $32.4 million in cash and a cash equivalent as of the end of the quarter which it believes is sufficient to finance all projects going forward. The company exited the second quarter with a net loss of (-$9.8) million double a net loss of (-$4.8) million reported last year.

I have no positions in any of the stocks mentioned, and have no plans to initiate any positions within the next 72 hours. All information, including any data, is provided without any guarantees of accuracy.

Don’t miss out! Stay informed on $CBIO and receive breaking news on other hot stocks by signing up for our free newsletter!

About the author: Marc has a degree in economics and a MSc. in Finance. Over his 20-year career, Marc has worked for global investment firms in Europe and the United States as an analyst, fund manager, and consultant.

Verastem Inc. (NASDAQ:VSTM)

Verastem Inc (NASDAQ:VSTM) Blood Cancer Drug Meets Primary Endpoints

Verastem Inc (NASDAQ:VSTM)

Shares of Verastem Inc (NASDAQ:VSTM) rallied 28.13% after the company announced positive Phase 3 trial results for its blood cancer drug. The stock had initially jumped 50.3% after the company announced that Duvelisb met its primary endpoints in the late stage trial.

Duvelisib is an oral inhibitor of phosphoinositide-3-kinase (PI3K)-delta and PI3K-gamma under trial for the treatment of hematologic cancers such as indolent non-Hodgkin lymphoma (iNHL) and other T cell lymphomas. Verastem Inc (NASDAQ:VSTM) tested the drug on 319 patients suffering from chronic lympocytic leukemia or small lymphocytic lymphoma

In addition to the positive Phase 2 trial results, the drug is also supported by compelling Phase 1 results that demonstrated a 50% investigator-assessed response rate.

VSTM Investor Reaction

The positive clinical trial results saw the stock gap higher to highs of $5.50 a share before retreating to end the day at $4.92 a share. The stock has already broken key resistance levels of $4.00 and $4.50 a share, further affirming a bullish run that began in July. Verastem Inc (NASDAQ:VSTM) shares are already up by more than 300% for the year.

Verastem Inc. (NASDAQ:VSTM) is currently trading near all-time highs. Renewed investor interest on the stock comes on the biopharmaceutical company saying that Duvelisib reduced the risk of disease progression or death by 48%, compared to standard care Arzerra.

Fuelling investor interests are reports that the Duvelisib, if approved, could generate as much as $400 million in sales for the company. Equity firms have already taken note of Duvelisib potential, with analysts at Oppenheimer initiating coverage of the stock with a ‘buy’ rating.

One month VSTM stock price chart

Regulatory Push

Verastem Inc (NASDAQ:VSTM) plans to share the clinical data with the U.S Food and Drug Administration (FDA) with the goal of filling a New Drug Application (NDA). The filling is to be supported by results from DUO study and CLL/SLL and the DYNAMO study – all of which achieved primary endpoints. The company has also confirmed plans to file for a marketing application for the drug.

Verastem Inc (NASDAQ:VSTM) is also planning to expand Duvelisb development program with a view of carrying out trials on its ability to treat Peripheral T-Cell Lymphoma. Duvelisib has already been granted Fast Track Designation by the FDA for the treatment of PTCL.

“Expansion of the Duvelisib clinical development program, and the accompanying receipt of Fast Track designation from the FDA are important steps in Verastem’s strategy to efficiently develop the potential of duvelisib in additional cancers such as T-cell malignancies,” said Robert Forrester, President and Chief Executive Officer of Verastem Inc (NASDAQ:VSTM).

Board Appointment

Following the positive Duvelisib trial results, Verastem Inc. (NASDAQ:VSTM) has confirmed the appointment of Brian Stuglik to the board of directors. He joins the company with over 30 years’ experience in Pharmaceutical and oncology commercialization.

“Brian Stuglik is an accomplished executive with significant oncology commercialization expertise who can bring immediate value to Verastem as we now move towards commercializing duvelisib,” said Mr. Forrester.

I have no positions in any of the stocks mentioned, and have no plans to initiate any positions within the next 72 hours. All information, including any data, is provided without any guarantees of accuracy.

Don’t miss out! Stay informed on $VSTM and receive breaking news on other hot stocks by signing up for our free newsletter!

About the author: Monica has an undergraduate degree in Accounting and an MBA she earned – with Honors. She has six years of experience in the financial markets and has been an analyst for the past two years.

Capricor Therapeutics Inc (NASDAQ:CAPR)

FDA Transcript Boosts Capricor Therapeutics Inc (NASDAQ:CAPR)

Capricor Therapeutics Inc (NASDAQ:CAPR)

Capricor Therapeutics Inc (NASDAQ:CAPR) gained almost 24% today after the biotech company released the minutes of their meeting with the U.S. Food and Drug Administration. The meeting’s subject was the development of Capricor’s intravenous drug candidate CAP-1002 for the treatment of Duchenne muscular dystrophy (DMD).

Capricor Therapeutics Inc (NASDAQ:CAPR)
One month daily candlebar graph for Capricor Therapeutics Inc (NASDAQ:CAPR)

According to Linda Marbán, Ph.D., President and CEO of Capricor Therapeutics Inc (NASDAQ:CAPR), “The FDA’s response to our proposed clinical development plan supports our near-term objective of submitting an IND for intravenous CAP-1002 as well as provides us with clarity on a path to potential product registration. We look forward to commencing a randomized, double-blind, placebo-controlled Phase II clinical trial of intravenous, repeat-dose CAP-1002 in boys and young men with DMD in the second half of 2017, subject to regulatory approval.”

Capricor’s CAP-1002 consists of allogeneic cardiosphere-derived cells, or CDCs, that have been shown to exert potent immuno-modulatory activity. CDCs have been the subject of over 100 peer-reviewed scientific publications and have been administered to approximately 140 human subjects across several clinical trials.

Duchenne muscular dystrophy (DMD) is a genetic disorder characterized by progressive muscle degeneration and weakness. The incidence of DMD is estimated to be one in every 3,600 live male births, and DMD is believed to afflict approximately 15,000 to 20,000 boys and young men in the U.S.

Shareholders of Capricor Therapeutics Inc (NASDAQ:CAPR) could use some good news. Prior to today’s trading, CAPR shares are down YTD over 60% and down over 70% for the year. The biotech firm has not posted a profit ever. In 2012 the loss was (-$0.23) per shares. That was the smallest loss in the past five years and in 2016 the loss was (-$1.01). Sales have not been a particularly bright spot either. In 2015 sales were reported at $5.5 million but last year that figure dropped to $4 million. The only two investment firms that follow Capricor Therapeutics Inc (NASDAQ:CAPR) rate the shares as a “Strong Buy”.

I have no positions in any of the stocks mentioned, and have no plans to initiate any positions within the next 72 hours. All information, including any data, is provided without any guarantees of accuracy.

Don’t miss out! Stay informed on $CAPR and receive breaking news on other hot stocks by signing up for our free newsletter!

About the author: Monica has an undergraduate degree in Accounting and an MBA she earned – with Honors. She has six years of experience in the financial markets and has been an analyst for the past two years.

Tetraphase Pharmaceuticals Inc (NASDAQ:TTPH)

Bad News Follows Good for Tetraphase Pharmaceuticals Inc (NASDAQ:TTPH) Shareholders

Tetraphase Pharmaceuticals Inc (NASDAQ:TTPH)

Tetraphase Pharmaceuticals Inc (NASDAQ:TTPH) announced positive top line results for its Phase 3 clinical trial and saw its shares rise by over 14%. However, after today’s close, Tetraphase Pharmaceuticals Inc(NASDAQ:TTPH) announced a dilutive $60 million offering of its common shares. Shares are down over 7% in the after-hours market on news of the offering.

Tetraphase Pharmaceuticals Inc (NASDAQ:TTPH)
1 Month Daily Candle Bar Graph for $TTPH

On Tuesday, Tetraphase Pharmaceuticals Inc (NASDAQ:TTPH) announced that its lead experimental antibiotic for serious bacterial infections met its primary endpoints in a late-stage study. Tetraphase said the antibiotic, eravacycline, was being studied in a pivotal 500 patient late-stage study for intra-abdominal infections. Tetraphase said the drug showed statistically significant improvement in curing patients with intra-abdominal infections, compared to patients who were treated with Medicines Co’s drug, meropenem. Eravacycline is a synthetic tetracycline derivative for drug-resistant bacterial infections administered intravenously in hospital. The company plans to submit a marketing application for the drug to the U.S. Food and Drug Administration by the first quarter of 2018. Tetraphase expects to also apply for European approval by the third quarter of this year.

Today, after the market closed, Tetraphase Pharmaceuticals Inc (NASDAQ:TTPH) announced that it has commenced an underwritten offering of $60,000,000 of shares of its common stock. All of the shares of common stock to be sold in the offering will be offered by the company. Piper Jaffray, BMO Capital Markets and Stifel are acting as joint bookrunning managers for the offering, SunTrust Robinson Humphrey is acting as lead manager and H.C. Wainwright & Co. is acting as manager for the offering. Tetraphase intends to grant the underwriters a 30-day option to purchase up to an additional $9,000,000 of shares of its common stock on the same terms and conditions as the offering. The offering is subject to market conditions, and there can be no assurance as to whether or when the offering may be completed, or as to the actual size or terms of the offering.

Despite rather consistent annual losses exceeding (-$2.00) per share, TTPH shares have performed well in the market. Shares have gained over 95% YTD, and are up nearly 90% for the year. Fie investment firms have their analysts follow Tetraphase Pharmaceuticals Inc (NASDAQ:TTPH). Four rate the shares as a “Hold” and one rates the shares as a “Strong Buy”.

I have no positions in any of the stocks mentioned, and have no plans to initiate any positions within the next 72 hours. All information, including any data, is provided without any guarantees of accuracy.

Don’t miss out! Stay informed on $TTPH and receive breaking news on other hot stocks by signing up for our free newsletter!

About the author: Monica has an undergraduate degree in Accounting and an MBA she earned – with Honors. She has six years of experience in the financial markets and has been an analyst for the past two years.

Novavax, Inc. (NASDAQ:NVAX)

Positive News from Novavax, Inc. (NASDAQ:NVAX) Underwhelms Market

Novavax, Inc. (NASDAQ:NVAX)

Novavax, Inc. (NASDAQ:NVAX) shares dropped over 27% after the company released news concerning their drug candidates that clearly underwhelmed the market. NVAX shares closed Monday at $1.51, then gapped down to open at $1.27 which was also its high for the day. After hitting a lot of $1.05, shares rebounded slightly to close at $1.10 on a volume about five times their average.

NASDAQ:NVAX
Daily Candle Graph $NVAX

Novavax, Inc. (NASDAQ:NVAX), based in Gaithersburg, MD, is a clinical-stage biotechnology company that develops vaccines to prevent a broad range of infectious diseases. Yesterday, Novavax, Inc. (NASDAQ:NVAX) announced topline data from its safety and immunogenicity Phase 2 trial of their RSV F Vaccine in older adults, new preclinical data on its RSV F Vaccine construct, additional findings from the prior Phase 2 and Phase 3 clinical trials in older adults (E201 and E301), and an operational update on the Phase 3 clinical trial of the RSV F Vaccine for infants via maternal immunization, known as Prepare. The data supports a positive view regarding the inclusion of adjuvant and the administration of a second dose.

Regardless of the positive news, the market clearly was disappointed. Last year Novavax, Inc. (NASDAQ:NVAX) had a reduction in force of almost a third of its employees and still posted a loss over $40 million for Q1 2017.  Expanding losses have been normal for Novavax, Inc. (NASDAQ:NVAX). In 2012 the company posted a small per share loss of (-$0.22) but that losss increased in each of the following years and in 2016 Novavax posted the loss at (-$1.03). On top of that, sales decreased from $36.3 million in 2015 to $5.4 million in 2016. Six investment firms follow Novavax, Inc. (NASDAQ:NVAX). Five rate NVAX shares as a “Hold” while only one rates the shares as a “Strong Buy”.

I have no positions in any of the stocks mentioned, and have no plans to initiate any positions within the next 72 hours. All information, including any data, is provided without any guarantees of accuracy.

Don’t miss out! Stay informed on $NVAX and receive breaking news on other hot stocks by signing up for our free newsletter!

About the author: Monica has an undergraduate degree in Accounting and an MBA she earned – with Honors. She has six years of experience in the financial markets and has been an analyst for the past two years.

AEterna Zentaris Inc. (USA) (NASDAQ:AEZS)

AEterna Zentaris Inc. (USA) (NASDAQ:AEZS) Explodes After Macrilen NDA Milestone

AEterna Zentaris Inc. (USA) (NASDAQ:AEZS)

Shares of AEterna Zentaris Inc. (USA)(NASDAQ:AEZS) more than doubled in value after the U.S. Food and Drug Administration (FDA) accepted its New Drug Application (NDA) for Macrilen. The stock ended the day at $2.34 a share after rallying by 129.41% on volumes exceeding 38.9 million shares.

AEterna Zentaris Inc. (USA) (NASDAQ:AEZS)
AEterna Zentaris Daily Candle Bar Graph July 20 2017

AEterna Zentaris Inc. (USA) (NASDAQ:AEZS) is a specialty biopharmaceutical company focused on the development and commercialization of novel pharmaceutical therapies. Its principal product candidates are Zoptrex in oncology and Macrilen in endocrinology. Both drugs are currently in Phase III development.

AEterna Zentaris Inc. (USA)(NASDAQ:AEZS) made a NDA resubmission for Macrilen last month after receiving a Complete Response letter in November of 2014. The letter laid out the FDA’s request for the company to carry out additional clinical trials on the drug, pending its review as a novel treatment for growth hormone deficiency in adults.

“We are pleased that the FDA has formally accepted our resubmitted NDA and that it is under active review with an end-of-year PDUFA date. We remain confident that the FDA will approve our NDA and, therefore, we are moving forward with our preparations to launch the product in the first quarter of 2018,” said CEO, David A. Dodd.

Macrilen Approval Odds

The FDA review period for the drug is six months long which sets the stage for approval early next year or late this year. AEterna Zentaris Inc. (USA) (NASDAQ:AEZS) remains confident on Macrilen achieving regulatory approval for assessing adult growth hormone deficiency. If approved, it will be the first and only FDA approved drug for assessing AGHD.

AEterna Zentaris Inc. (USA)(NASDAQ:AEZS) has already started to develop a commercialization infrastructure for Macrilen in anticipation of FDA approval. The company remains confident of launching Macrilen in the first quarter of 2018.

Macrilen is a ghrelin agonist oral active molecule designed to stimulate the secretion of growth hormone. The candidate drug has already achieved orphan drug designation for the diagnosis of AGHD. AEterna Zentaris Inc. (USA)(NASDAQ:AEZS) owns rights to the patented compound.

AGHD is a medical condition that affects 75,000 adults across the U.S, Canada and Europe. The condition is mostly caused by damage to the pituitary gland characterized by a reduction in bone mineral density, and lean body mass.

In the wake of the NDA milestone, Maxim analyst, Jason Kolbert has initiated coverage of AEterna Zentaris Inc. (USA) (NASDAQ:AEZS) stock with a buy rating. The analyst currently has a $4 share price target on the stock.

I have no positions in any of the stocks mentioned, and have no plans to initiate any positions within the next 72 hours. All information, including any data, is provided without any guarantees of accuracy.

Don’t miss out! Stay informed on $AEZS and receive breaking news on other hot stocks by signing up for our free newsletter!

About the author: Marc has a degree in economics and a MSc. in Finance. Marc worked for global investment firms in Europe and the United States as an analyst, fund manager, and consultant.

Massive Volumes Propel Proteon Therapeutics Inc (NASDAQ:PRTO) Up Over 30%

Proteon Therapeutics Inc (NASDAQ:PRTO)

Waltham, MA-based Proteon Therapeutics Inc (NASDAQ:PRTO) shares are up over 35% in early trading on massive volumes. Yesterday the biopharmaceutical firm closed at $1.30. However, this morning the company released positive financial news as well as news of an approved U.S. Food and Drug Administration (FDA) “Breakthrough Therapy” designation. PRTO shares gapped up to open at $1.85 and reached $1.95 before slightly pulling back in early trading. The shares have a 30-day daily average figure of just over 75,000 but less than an hour into trading over 2.7 million PRTO shares have been exchanged.

Proteon Therapeutics Inc (NASDAQ:PRTO) is a late-stage biopharmaceutical firm addresses the needs of patients suffering from kidney and vascular ailments. Proteon’s lead product candidate is Vonapanitase. Vonapanitase is being developed to address blood vessel injuries that cause blockage and restricted blood flow. This morning Proteon Therapeutics Inc (NASDAQ:PRTO) announced that Vonapanitase has been granted the designation of “Breakthrough Therapy” by the FDA for increasing arteriovenous fistula secondary patency (i.e., survival of the fistula without abandonment) and use for hemodialysis in patients on or expected to initiate hemodialysis. These conditions represent the primary endpoints for Proteon’s Phase 3 clinical trial PATENCY-2. The FDA’s Breakthrough Therapy designation is given to treatments that address a serious or life-threatening condition in combination with evidence that the treatment may represent a substantial improvement over existing therapies. PATENCY-2 trial patient enrollment is expected to be complete in the first quarter of 2018 and Proteon expects to report top-line data in the first quarter of 2019.

This morning Proteon Therapeutics Inc (NASDAQ:PRTO) also announced Q1 20917 financial results. The company lost (-$6.5) million which translates into a per share loss of (-$0.39). The loss was smaller than analysts expected. Expectations were for a per share loss of (-$0.45). Still, PRTO shares are trading well below their 52-week high of $11.45. One point of interest is that PRTO shares are currently trading at a discount to “Book Value per share” ($2.32) as well as “Cash per share” ($2.42). Analysts seem content to wait for further developments before offering a definitive opinion on PRTO shares. Eight firms follow Proteon Therapeutics Inc (NASDAQ:PRTO) and seven rate the shares as a “Hold” while just one rates them as a “Strong Buy”. Currently, their consensus price target is $3.00.

I have no positions in any of the stocks mentioned, and have no plans to initiate any positions within the next 72 hours. All information, including any data, is provided without any guarantees of accuracy.

About the author: Marc has a degree in economics and a MSc. in Finance. Over his 20-year career, Marc has worked for global investment firms in Europe and the United States as an analyst, fund manager, and consultant.

Despite Oncoming Class Action Lawsuit, TG Therapeutics, Inc. (NASDAQ:TGTX) Shares Rocket

TG Therapeutics, Inc. (NASDAQ:TGTX)

Most of this year’s press for TG Therapeutics involved announcements of law firms asking clients who had held the shares between September, 2014 and October 2016, to contact them about joining in a class action lawsuit against the biotech company. But today TG Therapeutics Inc. (NASDAQ:TGTX) is making news for all the right reasons and TGTX is up almost 100% in mid-morning trading.

TG Therapeutics has been accused of making misleading or false public statements regarding an FDA Phase 3 clinical trial regarding the firm’s proprietary combination of TG-1101 (ublituximab), its glycoengineered anti-CD20 monoclonal antibody, plus TGR-1202, the company’s once-daily PI3K-delta inhibitor, for the treatment of Chronic Lymphocytic Leukemia (“CLL”). The Phase III clinical trial, is referred to by the Company as “GENUINE”.

It is alleged by the law firms that TG Therapeutics Inc. made false and/or misleading statements and/or omitted material information concerning the GENUINE Phase III trial, assuring investors it was a “best-in-class treatment” that would be “successful” and “offer patients a novel chemo-free treatment option”. The deadline to become a plaintiff in the case is March 7, 2017.

Today, however, TG Therapeutics Inc. (NASDAQ:TGTX) saw its share price more than double when they released news that positive topline results from its Phase 3 GENUINE clinical trial of TG-1101 (ublituximab) plus ibrutinib achieved positive topline results in patients with previously treated high risk Chronic Lymphocytic Leukemia (CLL).

The clinical study involved adult patients with high-risk chronic lymphocytic leukemia (CLL) who have undergone at least one prior therapy. The Phase 3 trial was designed to assess whether adding ublituximab would induce a statistically significant improvement in overall response rate – defined as at least 20 percent between the two groups of patients. TG Therapeutics reported the absolute difference between the two groups was about 30 percent.

Shares of TG Therapeutics Inc. (NASDAQ:TGTX) have gained since the beginning of the year despite the threats posed by the class action lawsuit. Over the past year, and prior to today, TGTX shares had lost over 40% but were actually up over 15% YTD. On Friday TGTX closed at $5.35 and have reached an inter-day high of $11.6 – representing a gain of over 115%.

Complete results are expected to be presented at a future medical meeting in the first half of 2017. TG Therapeutics Inc. (NASDAQ:TGTX) is expected to meet with the FDA to pursue accelerated approvals.

3/6/2017
Ticker Symbol TGTX
Last Price a/o 11:08 AM EST  $                    10.60
Average Volume                    423,500
Market Cap (mlns)  $                  306.50
Sales (mlns) $0.20
Shares Outstanding (mlns) 57.29
Share Float (mlns) 40.91
Shortable Yes
Optionable Yes
Inside Ownership 19.50%
Short Float 14.15%
Short Interest Ratio 13.67
Quarterly Return -6.96%
YTD Return 15.05%
Year Return -41.78%

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.

About the author: Marc has a degree in economics and a MSc. in Finance. Over his 20-year career, Marc has worked for global investment firms in Europe and the United States as an analyst, fund manager, and consultant.