In this risk-off market, I’m not playing any biotech stocks next week; however, I wanted to alert you to two important data releases coming next week.
Achillion Pharmaceuticals (ACHN) ACH-4471 for paroxysmal nocturnal hemoglobinuria. Phase 2 interim data due December 17, 2018.
“In the third quarter we completed enrollment in our Phase 2 PNH monotherapy trial of ACH-4471, initiated ten additional clinical trial sites to support our C3G development program, and commenced development of a comprehensive portfolio strategy that we plan to communicate to investors in December 2018. We also plan to provide interim data on all open-label ACH-4471 clinical trials as well as Phase 1 safety and pharmacokinetics interim data from the single ascending dose trials with our second-generation factor D compounds, ACH-5228 and ACH-5548,” Truitt noted. “We believe our innovative and differentiated factor D inhibitors have the potential to address unmet medical needs in patients with PNH and C3G as well as additional complement mediated diseases, together representing significant value-creation opportunities.”
ACHN does present a nice setup opportunity. We see reduced volatility while prices have been consolidating in the most recent period. There is a very little resistance above the current price. There is a support zone below the current price at $3, a stop order could be placed below this zone.
BIVIGAM® is an intravenous immune globulin indicated for the treatment of primary humoral immunodeficiency. This includes, but is not limited to, agammaglobulinemia, common variable immunodeficiency, Wiskott-Aldrich syndrome and severe combined immunodeficiency. These primary immunodeficiencies (PI) are a group of genetic disorders. Initially thought to be very rare, it is now believed that as many as 250,000 people in the U.S. have some form of PI. BIVIGAM® contains a broad range of antibodies similar to those found in normal human plasma. These antibodies are directed against bacteria and viruses, and help to protect PIDD patients against serious infections. BIVIGAM® is a purified, sterile, ready-to-use preparation of concentrated polyclonal Immunoglobulin (IgG) antibodies. Antibodies are proteins in the human immune system that work to defend against infections and disease. FDA approval for BIVIGAM® was received by Biotest Pharmaceuticals Corporation (BPC or Biotest) on December 19, 2012, and production of BIVIGAM® was halted by Biotest in December 2016. ADMA Biologics obtained ownership and all rights, title and interest in BIVIGAM® on June 6, 2017 as part of the Biotest Therapy Business Unit (“BTBU”) asset acquisition. ADMA optimized the production process for BIVIGAM® and submitted a Prior Approval Supplement (PAS) to the FDA to amend the Biologics License Application (BLA) for BIVIGAM® in June of 2018, with a target action date of December 18, 2018 under the Prescription Drug User Fee Act (PDUFA). If the PAS is approved by the FDA, ADMA expects to be able to relaunch the product for commercial sale during the first half of 2019.
ADMA is not a good setup right now for an entry. Price movement has been a little bit too volatile to find a nice entry and exit point. It is a good idea to wait for a consolidation first.
Disclosure: I do not hold any position in any stocks mentioned in this article.