Ionis down 6% after Biogen posts Q2 Spinraza sales

Ionis Pharmaceuticals (NASDAQ:IONS) slips 6% premarket on light volume following licensee Biogen’s Q2 report that included a relatively modest 15% jump in Spinraza (nusinersen) sales, an increase that appears to disappoint investors considering the company’s statement that it has not yet encountered a competitive threat from Novartis’ gene therapy Zolgensma (onasemnogene abeparvovec-xioi).

Spinraza sales were up 42% in Q1 and up 30% in Q4 2018.

https://seekingalpha.com/news/3480080-ionis-6-percent-biogen-posts-q2-spinraza-sales

Chiasma’s Mycapssa successful in late-stage acromegaly study

Thinly traded micro cap Chiasma (NASDAQ:CHMA) is up 30% premarket on increased volume in response to positive results from a Phase 3 clinical trial, OPTIMAL, evaluating Mycapssa (octreotide) for the maintenance treatment of adults with acromegaly, a hormone disorder characterized by enlarged bone growth in the hands, feet and face.

The study met the primary end of a statistically significant proportion of patients in the treatment group maintaining biochemical response at week 36 compared to placebo. Specifically, 58% of patients receiving Mycapssa maintained their IGF-1 response versus 19% for control (p=0.008).

All secondary endpoints were also met.

The company expects to file a U.S. marketing application by year-end under accelerated review status.

Management will host a conference call this morning at 8:30 am ET to discuss the results.

https://seekingalpha.com/news/3480085-chiasmas-mycapssa-successful-late-stage-acromegaly-study-shares-30-percent-premarket

Myovant’s relugolix successful in late-stage study

Thinly traded Myovant Sciences (NYSE:MYOV) is up 9% premarket on light volume following its announcement of positive results from a second Phase 3 clinical trial, LIBERTY 2, evaluating once-daily relugolix in women with uterine fibroids and heavy menstrual bleeding.

The study met the primary endpoint and six key secondary endpoints. As far as the primary endpoint was concerned, 71.2% of women in the treatment group achieved the responder criteria versus 14.7% in the placebo group (p<0.0001). A response was defined as menstrual blood loss volume of less than 80 mL and a 50% or greater reduction from baseline in menstrual blood loss volume during the last 35 days of treatment measured using the alkaline hematin method.

The company plans to file a U.S. marketing application by year-end.

Management will host a conference call this morning at 8:30 am ET to discuss the results.

https://seekingalpha.com/news/3480107-myovants-relugolix-successful-late-stage-study-shares-9-percent-premarket

Keytruda + Lenvima Breakthrough Therapy for first-line liver cancer

The FDA designates the combination of Merck’s (NYSE:MRK) Keytruda (pembrolizumab) and Eisai’s (OTCPK:ESALY) Lenvima (lenvatinib) a Breakthrough Therapy for the first-line treatment of advanced unresectable hepatocellular carcinoma not amenable to locoregional treatment.

Breakthrough Therapy status provides for more intensive guidance from the FDA on development, the involvement of more senior agency personnel and a rolling review of the marketing application.

https://seekingalpha.com/news/3480067-keytruda-lenvima-breakthrough-therapy-first-line-liver-cancer

Biogen Q2 revenues up 8%; earnings up 72%

Biogen (NASDAQ:BIIB) Q2 results ($M): Revenues: 3,617 (+7.7%).

Net income: 1,494 (+72.3%); non-GAAP net income: 1,742 (+44.9%); EPS: 7.85 (+87.8%); non-EPS: 9.15 (+57.8%).

Key product sales: Tecfidera: 1,150 (+5.8%); Spinraza: 488 (+15.4%); Tysabri: 475 (+1.7%); Avonex: 438 (-12.7%); Rituxan/Gazyva: 394 (+4.5%); Ocrevus royalties: 183 (+61.9%).

Previously: Biogen EPS beats by $1.61, beats on revenue (July 23)

https://seekingalpha.com/news/3480044-biogen-q2-revenues-8-percent-earnings-72-percent

Shaheen introduces bill to cut insulin prices

U.S. Senator Jeanne Shaheen (D-NH) has introduced a bipartisan bill, the Insulin Price Reduction Act, that she says will rein in skyrocketing costs of insulin while holding pharmacy benefit managers to account for their role in surging prices, adding that the cost of the most popular insulin should drop by more than 75% (based on estimated 2020 prices).

The legislation would create a new pricing model that would restrict the use of rebates for any insulin product that the manufacturer reduces the price to a level no higher than that in 2006. The rebate restrictions would apply in Medicare Part D and private insurance. For all products that meet the list price reduction criteria, private insurance plans would also be required to waive the deductible. Future price increases would be limited to the amount of medical inflation.

She introduced the bill with Senators Susan Collins (R-ME), Tom Carper (D-DE) and Kevin Cramer (R-ND).

ETFs: BIB, GRX, THW, BME, BIS, IXJ, ARKG, CHNA, IDNA, XLV

Selected tickers: Eli Lilly (LLY +0.4%), Novo Nordisk (NVO +1%), Sanofi (SNY +0.7%)

https://seekingalpha.com/news/3479829-u-s-senator-introduces-bill-cut-insulin-prices

Acadia Pharma’s pimavanserin flunks late-stage schizophrenia study

ACADIA Pharmaceuticals (NASDAQ:ACAD) is poised for a down move in response to its announcement that adding lead drug pimavanserin to existing antipsychotic therapy in schizophrenia patients failed to demonstrate enough of a treatment effect compared to placebo in a Phase 3 study called ENHANCE.

Specifically, a measure of psychotic symptoms, a scale called PANSS, showed a “consistent trend in improvement” in the pimavanserin + current therapy cohort, but the separation from the placebo + existing therapy group fell short of statistical significance (p=0.0940).

Results from a subgroup of European patients were statistically valid as were measures of negative symptoms.

A Phase 2 trial, ADVANCE, in schizophrenia patients with predominantly negative symptoms should be completed shortly.

Management will host a conference call today at 5:00 pm ET to discuss the Phase 3 data.

Update: Shares are down 12% after hours.

https://seekingalpha.com/news/3479882-acadia-pharmas-pimavanserin-flunks-late-stage-schizophrenia-study