BPC February 22 update

Biotech week in review; Key biotech stock earnings dates + other catalysts for next week

Weekly watchlist

 Next week is likely to be the busiest week for biotech 4Q earnings, with both Wednesday and Thursday setting up to be stacked with earnings news flow. As earnings will no doubt dominate headlines next week, this week’s watch list focuses on some of the key companies reporting. Listed below are 20 companies reporting while also noting a handful of other events slated for next week. 

First, let’s review the week that was: 

Immune Design (NASDAQ:IMDZ) announced that it will be acquired by Merck (NYSE:MRK) for $5.85 per share in cash for an approximate value of $300m. Shares closed Thursday up 310% to $5.82. 

Voyager Therapeutics, Inc. (Nasdaq: VYGR) shares closed Friday up 23% to $13.12 on news of a collaboration with AbbVie (NYSE: ABBV) to develop antibodies for the potential treatment of Parkinson’s disease and other diseases. Voyager will receive an upfront cash payment of $65m and has the potential to earn up to $245m in preclinical and Phase 1 option payments. Voyager is also eligible to receive up to an additional $728min potential development and regulatory milestone payments for each compound.   

Intercept Pharmaceuticals, Inc. (Nasdaq:ICPT) announced mixed data from its Phase 3 trial of obeticholic acid (OCA) in patients with liver fibrosis due to nonalcoholic steatohepatitis (NASH), meeting one of two primary endpoints. It met the primary endpoint of fibrosis improvement with no worsening of NASH at the planned 18-month interim analysis but didn not meet the primary endpoint of NASH resolution with no worsening of liver fibrosis. The most common adverse event reported was dose-related pruritus (19% in placebo, 28% in OCA 10 mg and 51% in OCA 25 mg). Shares closed the week down 16% to $93.35.

Xencor, Inc. (NASDAQ: XNCR) shares closed the week down 13% to $31.63. The company announced earlier in the week that the FDA has placed a partial clinical hold on its Phase 1 trial of XmAb14045 in patients with relapsed or refractory acute myeloid leukemia. The partial clinical hold was initiated following two patient deaths that were considered at least possibly related to XmAb14045.  

Karyopharm Therapeutics Inc (NASDAQ: KPTI) shares dropped Friday 43% to $5.07 following the release of briefing documents for Tuesday afternoon’s FDA Advisory Committee meeting, which will discuss the New Drug Application of selinexor. The negative tone of the documents noted that treatment with selinexor is associated with significant toxicity. In its conclusion the FDA noted: 

“Given the limited efficacy and significant toxicity demonstrated in this population, it is unclear whether treatment with selinexor-dexamethasone provides a clinically meaningful benefit that outweighs the risks of treatment. The limitations of interpreting safety and efficacy from a single arm trial, and lack of single agent activity of selinexor coupled with historical data showing activity of dexamethasone in RRMM, add to the challenges in interpreting the results of the pivotal study in NDA 212306 ODAC Briefing Document Selinexor 50 support of the proposed indication.” 

4Q Biotech Stock Earnings to watch next week (20): 

Mon: CORT XNCR

Tue: CLVS ACAD AKCA DERM JAZZ MYL

Wed: AMRN FGEN IONS MDCO BGNE SRPT

Thur: AIMT FOLD ICPT PCRX PBYI PTCT RIGL 

Shares of Karyopharm (KPTI ) will likely be halted Tuesday afternoon. Most advisory committee meetings commence in the morning resulting in shares being halted from the pre-market session. However, Karyopharm’s meeting commences later at 12:30pm, meaning that the halt might be for the entire session or just from late-morning.

Drug Stage Catalyst Market Cap

BHC – Bausch Health Companies Inc.
Loteprednol Gel 0.38%
Ocular Inflammation

Approved FDA approval announced February 25, 2019.
$8.6 billion

HTBX – Heat Biologics Inc.
HS-110 and nivolumab (Opdivo)
Non-small cell lung cancer (NSCLC)

Phase 2 Phase 2 additional data due 4Q 2019.
$28.6 million

KPTI – Karyopharm Therapeutics Inc.
Selinexor
Quadruple Refractory Multiple Myeloma

PDUFA priority review PDUFA date under priority review extended by three months to July 6, 2019. Advisory Committee February 26, 2019 voted 8-5 recommending that approval decision is held off until after the release of data from BOSTON trial, late-2019/2020.
$318.3 million

SRPT – Sarepta Therapeutics Inc.
MYO-101
Duchenne muscular dystrophy - LGMD2E

Phase 1/2 Phase 1/2 data February 27, 2019 noted mean of 51% beta-sarcoglycan positive fibers.
$9 billion