Biotech: The Week Ahead (June 3rd through June 9th)

We preview the potential major trial milestones, presentations and FDA calendar for the biotech sector in the week ahead

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The market posted good overall results in the holiday shortened week. Impressively, the rise occurred despite escalating trade tensions and the announcement of additional tariffs by the administration. A robust Jobs Report on Friday triggered a nice rally in the markets to end the week. The biotech sector has a solid week of trading despite the continued dearth of M&A activity across the industry of note.

The big ASCO conference in Chicago kicked off on Friday and will run through Tuesday keeping oncology names in focus early in the coming week. Another big focus area of market this week on the industry was on NASH as MadrigalPharmaceuticals (MDGL) soared over 150% on the week after a mid-stage trial for its primary drug compound show a ‘sustained benefit’ against this widespread liver affliction. The stock has risen by 2,000% off its 52-week lows. The shares are now pretty much back to the levels they sold for a decade ago in a remarkable round trip.

So what is ahead for the biotech sector in the week ahead? We take a look at the potential trial milestones, presentations and FDA action that could move individual small and mid-cap biotech stocks in the week ahead below.

ASCO will continue to see myriad presentations through Tuesday. Yesterday, a slew of oncology companies presented trial data including Karyopharm Therapeutics (KPTI), Clovis Oncology (CLVS) and Advaxis (ADXS). As we are submitting this article, Tesaro (TSRO) is presenting Phase 1/2 data around is compound Niraparib combined with Keytruda against Triple-negative Breast Cancer. Preliminary data presented in late March showed an Overall Response Rate or ORR of 25%. There will be more than a dozen companies making presentations at ASCO today. Among the small cap names I will be watching are Fibrogen (FGEN), Tyme Technologies (TYME), Syndax Pharmaceuticals (SNDX) and Spectrum Pharmaceuticals (SPPI).

Tomorrow at the conference, Acceleron Pharma (XLRN) will be providing updated data from its Phase 2 Luspatercept Extension Study for the treatment of Myelodysplastic Syndromes. Agenus (AGEN), Nektar Therapeutics (NKTR) and Stemline Therapeutics (STML) will all be among the companies presenting abstracts that day as well. Verastem (VSTM) will also have a Phase 2 presentation around its primary compound Duvelisib for the treatment of Peripheral T-Cell Lymphoma. Duvelisib has an October 5th PDUFA to be approved for Chronic lymphocytic leukemia (CLL)//Small Lymphocytic Lymphoma (SLL)/Follicular Lymphoma.

That is a very condensed view of this huge event, for a more detailed calendar just click here.

There are no PDUFA dates on the FDA calendar this week, but we do have some non-ASCO related events this week. Zealand Pharma (ZEAL) will be presenting new Phase 2 data around its drug candidate Glepaglutide for short bowel syndrome at the Digestive Disease Week or DDW meeting that runs today through Tuesday. Monday, Protalix BioTherapeutics (PLX) will be presenting Phase 2 results for its compound 'OPRX-106**'** for the treatment of Ulcerative Colitis or UC at the same conference. Finally, microcap Ritter Pharmaceuticals (RTTR) will be delivering additional Phase 2/3 data for its drug candidate 'RP-G28**'** against lactose intolerance either Monday or Tuesday at this event.

Rounding out next week's calendar, the ASM Microbe conference runs June 8th through June 10th. Cidara Therapeutics (CDTX) and Vaxart (VXRT) are among the companies scheduled to present early/mid-stage trial results.

And those are some of the schedule events across the industry in the week ahead.

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Bret Jensen
Bret Jensen

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Thinly traded nano cap Vaxart (NASDAQ:VXRT) slumps 28% premarket on average volume in response to its announcement that a Phase 2 clinical trial assessing teslexivir 5% gel for the treatment of condyloma (anogenital warts) failed to achieve the primary efficacy endpoint. Specifically, 30.6% of patients in the treatment group completely cleared baseline condyloma by week 16 compared to 23.3% for placebo. The difference was not statistically significant. In a subgroup analysis, baseline clearance of condyloma in women was higher (37.5%), but the separation from placebo was not statistically significant either. In patients with large condylomas, the total clearance from baseline favored the treatment group over placebo, 30.0% vs. 15.4%, but, again, the results were not statistically valid. On a positive note, the safety profile was favorable.



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