Overall it was a red week for biotech whereas the greater market (S&P, NASDAQ, and DOW) gained a little under +1% each. In the past 30-days the healthcare sector (represented by the XLV) marginally underperformed the market. However, the biotech industry (as represented by the XBI) posted nearly double the gains. That said, investors should expect a continuation of above average volatility. Several factors that have accompanied previous recessions are seen now. Specifically, oil bonds reaching maturity, interest rate cuts, and an inverted yield curve on U.S treasuries. It would behoove investors to buy protection in the form of SPY 2020/2021 $280 puts or something similar.
Winners of the Week
Karyopharm Therapeutics (Nasdaq: KPTI) gained nearly +50% closing at $8.81 last week! On Wednesday the FDA approved its new drug application (NDA) for oral Xpovio in combo with dexamethasone in patients with relapsed or refractory multiple myeloma (RRMM) who tried at least 4-prior treatments. The market sentiment was that the FDA would not approve Xpovio until more mature data was available. The continuation of approval depends on said mature data in the company’s BOSTON-1 trial slated to announce results in 2020.
Amarin Corporation (Nasdaq: AMRN) rallied nearly +20% closing at $23.16 on Friday. The catalyst was increased full-year 2019 revenue guidance. AMRN further said it plans to expand its commercial operation for its lead product Vascepa by doubling its sales force. Investors were already excited about the possibility of label expansion for Vascepa to” reduce residual cardiovascular risk in patients with statin-managed LDL-C cholesterol, but persistent elevated triglycerides…“. Vascepa would be the first FDA approved drug for this indication.
Of note, Corvus Pharmaceuticals (Nasdaq: CRVS) gained over +70% throughout the week closing on Friday at $6.50
Loser of the Week
Unum Therapeutics (Nasdaq: UMRX) dropped -8% to $2.40 after the FDA placed its Phase 1 trial (ATTCK-20-2) on hold. The study was investigating ACTR087 as a combo therapy with rituximab in patients with relapsed/refractory CD20+ B cell non-Hodgkin lymphoma. One patient experienced several serious adverse events that included: Grade 4 respiratory distress, as well as grade 3 neurotoxicity and cytomegalovirus (CMV) infection.
Clinical Stage With a Catalyst
- Amarin (Nasdaq: AMRN) $23.16
- PDUFA date on September 28th, 2019
- Ardelyx (Nasdaq: ARDX) $2.70
- PDUFA date September 12th, 2019
- Avadel Pharmaceuticals (Nasdaq: AVDL)
- PDUFA date September 15th, 2019 $2.22
- IntelliPharmaCeutics International (OTCMKTS: IPCIF) $.24
- CRL was issued in September 2017. A new PDUFA date is on August 28th, 2019.
- Intra-Cellular Therapies (Nasdaq: ITCI) $13.46
- Top-line data from two phase 3 studies testing Lumateperone in Bipolar Depression due this week.
- ADCOM on July 31st evaluating Lumateperone as a treatment for schizophrenia.
- PDUFA date on September 27th, 2019.
- Kala Pharmaceuticals (Nasdaq: KALA) $6.37
- PDUFA date on August 15th, 2019
- Nabriva Therapeutics (Nasdaq: NBRV) $2.43
- PDUFA date (priority review) on August 19th, 2019.
- Vanda Pharmaceuticals (Nasdaq: VNDA) $13.93
- PDUFA date on August 16th, 2019.
- Xeris Pharmaceuticals (Nasdaq: XERS) $12.16
- PDUFA date extended to September 10th, 2019.