Biotech stocks are the most dangerous stocks to trade in the kind of risk-off market we are in as 2018 comes to an end. Personally I am not trading in and out of any biotechnology stocks as this time. Nevertheless, we do have some data releases coming up next week that you should know about if you are a looking for biotech penny stocks to buy. PLEASE NOTE: Do not be surprised if some of the scheduled data releases below are pushed into January 2019.
Biotech Stocks List For Week of December 24, 2018 – December 28, 2018
Sesen Bio Inc. (SESN) Vicinium for non-muscle invasive bladder cancer (NMIBC). Phase 3 6-month data is due in December 2018.
“2018 has been a year of focused execution for Sesen Bio, led by the advancement of the Phase 3 program for Vicinium for patients with NMIBC,” said Dr. Thomas Cannell, president and chief executive officer of Sesen Bio. “NMIBC is a devastating disease and there remains just one recommendation for patients who do not respond or become refractory to today’s standard-of-care treatment: complete bladder removal. Our goal is to help save this essential organ and provide a meaningful treatment option for patients with BCG-unresponsive NMIBC. Our Phase 3 registration clinical trial is well-designed and preliminary data reported earlier this year suggest that Vicinium is active and has a favorable safety profile, consistent with our Phase 2 experience. We look forward to assessing six-month data from the trial next month and twelve-month data in mid-2019. If the VISTA Trial is successful, we believe Viciniumcould change the treatment outlook for patients with NMIBC, bringing us closer to achieving our mission of saving and renewing the lives of patients with cancer.”
Sesen Bio anticipates reporting six-month data from the ongoing Phase 3 VISTA Trial in December 2018. A conference call will be held to review the data, with details to follow.
I do not like the chart of SESN stock. It’s in a free-fall like most biotech stocks. It is too volatile to establish support and resistance areas. It is better to wait for consolidation before taking an entry.
ContraFect Corporation (CFRX) CF-301 for serious infections caused byStaph aureus including MRSA. Phase 2 data is due in Q4 2018.
Exebacase (CF-301) is a recombinant bacteriophage-derived lysin with potent bactericidal activity against Staph aureus, a major cause of blood stream infections, or bacteremia. Exebacase has the potential to be a first-in-class treatment for Staph aureus bacteremia. It has a novel, rapid, and specific mechanism of bactericidal action against Staph aureus and does not impact the body’s natural bacterial flora. By targeting a conserved region of the cell wall that is vital to bacteria, resistance is less likely to develop to exebacase. Combinations of exebacase with standard of care antibiotics significantly increased bacterial killing and survival in animal models of disease when compared to treatment with antibiotics or exebacase alone. In addition, in vitro and in vivo experiments have shown that exebacase is highly active against biofilm infections. Exebacase was licensed from The Rockefeller University and is being developed at ContraFect. It is the first lysin to enter clinical studies in the U.S.
“We made meaningful steps this past quarter in both the clinical and corporate sides of our business, including completing enrollment in our ongoing Phase 2 clinical trial of exebacase and securing funding that extends our cash runway into the first quarter of 2020,” said Steven C. Gilman, Ph.D., Chairman and Chief Executive Officer of ContraFect. “In addition to these key milestones, our R&D team presented data on our lysins at scientific meetings and on a panel at a recent FDA-sponsored workshop during the quarter. This progress across our business gives us strong momentum as we look towards topline data from our study of exebacase later this year.”
In September 2018, the Company completed enrollment in its multi-center, multi-national Phase 2 clinical trial of its lead lysin product candidate, exebacase, for the treatment of bacteremia and endocarditis caused by Staph aureus, including MRSA. As of the end of the third quarter, there have been no serious adverse events which we have determined are related to study drug. The Company continues to expect topline data from the study in the fourth quarter of 2018.
CFRX stock does not look like a good long entry right now. The stock price is too volatile to find a good entry or target price. It is better to wait for a consolidation first.
Marinus Pharmaceuticals (MRNS) Ganaxolone for refractory status epilepticus. Phase 2 data is due in Q4 2018.
“This is an exciting time for Marinus,” commented Christopher M. Cashman, chairman and chief executive officer of Marinus. “With enrollment complete in our Magnolia study last quarter, we are on-track to report data shortly. This is our first data readout for ganaxolone in women suffering from postpartum depression, a devastating condition with few treatment options. We will learn how ganaxolone performs in this patient population at various doses and apply these learnings to ongoing and future development as we lay the foundation for later-stage studies.”
The Company is enrolling patients with refractory status epilepticus (RSE) in its Phase 2 study with ganaxolone IV. Initial data from this proof-of-concept study are expected in the fourth quarter of 2018.
MRNS stock chart looks bad like most biotech stocks. I do not see a good setup entry in this stock. It is better to wait for consolidation as the stock could continue to fall.
Portola Pharmaceuticals announced on September 11, 2018, that the FDA has acknowledged receipt of the Company’s Prior Approval Supplement (PAS) filing for the large-scale Generation 2 manufacturing process for Andexxa® [coagulation factor Xa (recombinant), inactivated-zhzo]. The PAS has been assigned a Prescription Drug User Fee Act (PDUFA) date of December 31, 2018. If accepted and approved, the PAS will allow for the broad commercial launch of Andexxa in the United States.
Andexxa received both U.S. Orphan Drug and FDA Breakthrough Therapy designations, and was approved on May 3, 2018 under the FDA’s Accelerated Approval pathway. It is the first and only antidote indicated for patients treated with rivaroxaban and apixaban, when reversal of anticoagulation is needed due to life-threatening or uncontrolled bleeding.
Once again, the stock chart of PTLA looks bad. Price movement has been too volatile to find a good entry and exit point. We need a consolidation at the very least to consider taking a long position.
If I had to pick the strongest looking stock chart above, it would be CFRX.
Disclosure: I do not hold a position in any stock mentioned in this article.