Biopharma Stock Watch June 10th-14th

Last Updated on June 23, 2019 by Sultan Beardsley

Last week the markets found its footing after a sharp sell-off in May. Looking at our MS Performance Tracker it appears that tech rebounded marginally more than biotech, and on par with the rest of the healthcare sector.

The Nasdaq gained +5.58% while the XBI (S&P Bio ETF), IBB, and XLV gained +3.09%, +2.74%, and +4.02%, respectfully. The DOWJ and S&P500 closed the week up +4.69% and +4.70%, respectfully. However, when we slide over and look at the 30-day change, we see that healthcare and biotech outperformed all 3 of the major indices. Big pharmaceutical companies performed well overall too. The ones followed by our tracker gained a cumulative 15.06% in the last 30-days while the Nasdaq, DOWJ, and S&P 500 lost a couple percentage points.

I expect healthcare and biotech to continue to outperform the greater markets. On Friday June 7th president Trump tweeted the U.S. would not be hitting Mexico with tariffs on Monday. I expect the markets to be green on Monday and because of this makes it a great opportunity to day-trade.

Notable Developments

Winners

Shares of Amgen (AMGN) closed up +3.4% on Monday after releasing positive data at the American Society of Clinical Oncology (ASCO). A phase 1 trial evaluating a KRAS G12C inhibitor in patients with Non-Small Cell Lung Cancer (NSCLC) or Colorectal Cancer (CRC), achieved favorable partial and overall response rates. Mirati Therapeutics (MRTX), which is developing the same class of drug, closed the week up +47% at $99.77. Their data is not due until later in 2019.

La Jolla Pharmaceutical Company (LJPC) had a stellar week running 139% to $12.86. An interim analysis of a phase 2 study in patients with hereditary hemochromatosis (HH) hit its primary endpoint. A full data readout is expected later this year.

Biohaven Pharmaceutical Holding Company Ltd. (BHVN) closed the week up +20% at $67.01 because of buyout rumors.

Losers

Motif Bio plc (MTFB) share price tumbled -43% to $1.13 on Thursday. The FDA has requested additional clinical trials for the company’s lead candidate for treating acute bacterial skin and skin structure infections (ABSSSI). MTFB previously received a complete response letter (CRL) in February of this year.

InflaRx (IFRX) had its valuation slashed -91% on news that its phase 2 trial in patients with moderate to severe Hidradenitis Suppurativa (HS) missed its primary endpoint. As a result, ChemoCentryx, Inc. (CCXI), who is developing a similar compound for the same indication, fell -23%. CCXI has phase 2b top-line data expected next year.

Xeris Pharmaceuticals, Inc. (XERS) dropped -22% to $8.51 after the FDA extended the company’s PDUFA 3-months to September. This came on the heels of an information request from the FDA.

My number one clinical stage bio pick ADMA Biologics (ADMA) had a rough week in particular. All-in-all, ADMA’s share price shed -10% of its value closing the week at $3.78. What looked at first to be a knee-jerk reaction to an “investigation into a breach of fiduciary duties by the board of directors”, as discussed by Zion in this article, turned out to be the selling of 4.2 million shares by the Biotest Divestiture Trust. On a positive note, ADMA president and CEO presented at the Jefferies 2019 Investor Healthcare Conference which I covered in this article.

Clinical Stage With A Catalyst

• Achieve Life Sciences (ACHV) $3.64
  • Phase 2b data expected 2Q19 for the companies smoking cessation drug.
  • My outlook is discussed here.
• Acer Therapeutics (ACER) $16.40
  • Priority review PDUFA date on June 25th.
  • Very low float (3.5M) making it highly susceptible to volatile swings up, and down.
• Aclaris Therapeutics (ACRS) $4.74
  • Phase 2b data expected in the 2Q19.
• ArQule (ARQL) $6.51
  • Phase-1 data presentation at the European Hematology Association (EHA).
• Intra-Cellular Therapies (ITCI) $11.34
  • Top-line phase 3 data due 2Q19
• AMAG Pharmaceuticals (AMAG) $9.69
  • PDUFA June 23rd for AMAG treatment for female sexual dysfunction disorder (FSD).
• CymaBay Therapeutics (CBAY) $11.51
  • Phase 2b NASH data expected 2Q19.
• Dova Pharmaceuticals (DOVA) $9.05
  • PDUFA June 30th for sNDA for a drug to treat Immune Thrombocytopenic Purpura (ITP).
• Minerva Neurosciences (NERV) $5.21
  • Phase 2b data due 2Q19 for primary insomnia drug.
• Sunesis Pharmaceuticals, Inc (SNSS) $.76
  • Phase 1/2 data due at EHA June 13-16th for Advanced B-Cell Malignancies.
• Krystal Biotech (KRYS) $31.52
  • Top-line phase 2 data expected 2Q19.
  • Very low float (7.5 M) making it highly susceptible to volatile swings up, and down
• Sesen Bio (SESN) $2.32
  • BLA meeting between SESN and FDA happened on June 6th to discuss a BLA (biologics license application) for Vicinium.
  • The company is hosting a conference call Monday morning 8 AM EST to discuss the outcome of the meeting.
• Savara Inc (SVRA) $10.13
  • Phase 3 data due June 2019.
• Verrica Pharmaceuticals (VRCA)
  • Phase 2 data due 2Q19