Allena Pharma down 47% on ‘positive’ reloxaliase data

Thinly traded nano cap Allena Pharmaceuticals (ALNA -46.7%) is getting roughed up on a 22x surge in volume in reaction to results from two clinical trials evaluating lead candidate reloxaliase (ALLN-177) in patients with a fat malabsorption disorder called enteric hyperoxaluria (EH), both positive outcomes according to the company.

The Phase 3 URIROX-1 study met the primary endpoint of percent change from baseline in 24-hour urinary oxalate excretion (UOx) during weeks 1-4. Specifically, the mean reduction was 22.6% in treated patients compared to 9.7% for placebo (p=0.004), a separation of 12.9%.

Preliminary data from Study 206, a Phase 2 trial in EH patients with advanced chronic kidney disease (CKD), showed UOx reductions of 29% and 42%, respectively, over weeks 4-12 in two patients with Stage 3 CKD. Significant reductions in plasma oxalate (POx) were also observed (19 – 68%) across eight participants.

Investors appear to be reacting to the lower effect on UOx levels in the late-stage study.

The data analyses are ongoing.

Another Phase 3, URIROX-2, is currently recruiting patients. The estimated completion date is January 2023.

https://seekingalpha.com/news/3516515-allena-pharma-47-percent-positive-reloxaliase-data

Quanterix up 26% on Q3 revenue beat

Thinly traded small cap Quanterix (QTRX +26.1%) is up on modestly higher volume after its Q3 report released after the close yesterday. Highlights:

Revenue: $14.9M (+41%); product sales: $10.7M (+80%) driven by the launch of its HD-X Analyzer and accelerated adoption of its Simoa technology.

Net loss: ($9.9M) (-28.9%).

Previously: Quanterix beats on revenue (Nov. 6)

https://seekingalpha.com/news/3516548-quanterix-26-percent-q3-revenue-beat

Bellicum down 25% on potential T cell confusion issue with BPX-501

Bellicum Pharmaceuticals (BLCM -25%) slumps on 20% higher volume in apparent reaction to an ASH abstract related to T cell therapy rivogenlecleucel (rivo-cel) (formerly BPX-501).

A 10 year-old leukemia patient who received a hematopoietic stem cell transplant (HSCT) and rivo-cel relapsed after six months. An analysis of T cell purity showed an aberrant cell population expressing both surface CD3 and CD19 proteins while lacking additional B cell surface markers (excluding T cells with leukemia origin). Investigators believe that the dual-positive cells were BPX-501 cells derived from the patient’s paternal donor and were still circulating despite the leukemia relapse.

They suggest considering alternative markers to CD19 as a synthetic identifier for post-transplant add-back products (like rivo-cel) since CD19 expression on effector T cells could complicate treatment with CD19-directed therapy.

Rivo-cel is designed to treat immunodeficiency following allogeneic HSCT aimed at preventing problems from relapse and infection.

https://seekingalpha.com/news/3516500-bellicum-25-percent-potential-t-cell-confusion-issue-bpxminus-501

Invacare up 31% on improved fundamentals in Q3

Invacare (IVC +31.1%) is up in early trade on the heels of its Q3 report released after the close yesterday. Highlights:

Sales down 4% to $235.8M, operating income up 145% to $2.4M.

Non-GAAP EBITDA up 773% to $9.6M, free cash flow up 592% to $12.3M.

Loss/share: ($0.24) (+33%).

2019 and 2020 guidance reaffirmed.

Previously: Invacare EPS beats by $0.05, misses on revenue (Nov. 6)

https://seekingalpha.com/news/3516463-invacare-31-percent-improved-fundamentals-q3

Collegium Pharma up 31% on Xtampza ER prospects

Collegium Pharmaceuticals (COLL +30.9%) is up on more than a 4x surge in volume in early trade in reaction to its Q3 results released after the close yesterday. Highlights:

Revenues: $72.9M (+4%).

Sales of Xtampza ER (oxycodone) extended-release capsules up 56% to $26.5M (+2% sequentially), prescriptions up 44%.

Net loss: ($6.1M) (+63%); loss/share: ($0.18) (+64%).

Non-GAAP net income: $1.7M (+121%).

Effective January 1, 2020, Xtampza ER will have exclusive formulary positions across 15 healthcare plans covering more than 35M additional lives (up from 50M presently).

Previously: Collegium Pharmaceutical EPS misses by $0.03, misses on revenue (Nov. 6)

https://seekingalpha.com/news/3516473-collegium-pharma-31-percent-xtampza-er-prospects

Nevro up 22% on Q3 beat, revenue guidance boost

Nevro (NVRO +22.3%) is up on double normal volume on the heels of its Q3 results released after the close yesterday. Highlights:

Revenue: $100.2M (+5%).

Net loss: ($17.6M) (-57%); loss/share: ($0.58) (-57%).

Non-GAAP EBITDA: ($2.0M) (-139%).

Senza Omnia SCS device launched yesterday.

CFO Andrew Galligan to retire.

2019 guidance: Revenue: $383M – 386M from $368M – 374M.

Previously: Nevro EPS beats by $0.26, beats on revenue (Nov. 6)

https://seekingalpha.com/news/3516489-nevro-22-percent-q3-beat-revenue-guidance-boost

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Mixed Reaction To Weight Watchers: Concerning Quarter, But 2020 Is Key

Weight Watchers International, Inc. WW 0.08% reported mixed third-quarter results. Here is a summary of how some of the Street’s top analysts reacted to the print and management’s outlook.

The Analysts

UBS analyst Michael Lasser maintains a Neutral rating on Weight Watchers with a $38 price target.

Bank of America analyst Olivia Tong maintains at Buy, unchanged $40 price target.

DA Davidson analyst Linda Bolton Weiser downgraded from Buy to Neutral, price target lowered from $44 to $33.

UBS: ‘Fine’ Quarter But Street Expected More

Weight Watchers reported a “fine” quarter but the level of growth but the Street was likely expecting “a bit more,” Lasser said.

Subscriber growth accelerated from 1.5% in the second quarter to 5.7%, partly due to a marketing campaign and extended discounts. As such, total revenue fell slightly short of expectations and gross margins of 55.9% fell 300 basis points despite faster digital growth.

The stock will likely be determined after next Monday’s new program launch, the sustainability of top-line performance, and contribution margin.

BofA: 2020 A Catalyst Year

Weight Watchers’ management team deserves credit for showing an “improved focus” versus last, Tong said. Specifically, management is better emphasizing the weight loss component of its programs after learning from past mistakes.

Heading into 2020, Tong said the innovation at Weight Watchers “screens fundamentally sound,” especially in terms of personalization. The company can also see benefits from Oprah’s 2020 tour and notably easier year-over-year comps. As such, the company has the potential to see “outsized” earnings growth, even if it spends more to support innovation.

DA Davidson: ‘Concerning’ Metric

Bolton Weiser said while subscriber metrics came in better than expected, there was no corresponding gross margin upside, which is “concerning” given the “dampening effect” on sales from a digital shift.

Near-term uncertainty related to uncertainty over the upcoming diet season and execution related to the new program takes precedence. As such, the research firm could re-evaluate its stance on the stock after results are made clear.

https://www.benzinga.com/analyst-ratings/analyst-color/19/11/14745842/the-streets-mixed-reaction-to-weight-watchers-concerning-quarter-but-2020-is-key