FDA OKs Cerecor application for CERC-802

The FDA has accepted Cerecor’s (NASDAQ:CERC) IND application for  CERC-802 and informed that the proposed study can begin immediately.

CERC-802, an oral formulation of D-mannose is currently in development for the treatment of Mannose Phosphate Isomerase (MPI) Deficiency, also known as MPI-CDG or CDG-1b.

The clinical program for CERC-802 will commence with a Phase I study in healthy volunteers. The goals will be to assess the single dose tolerability and pharmacokinetics of CERC-802.

https://seekingalpha.com/news/3482656-fda-oks-cerecor-s-ind-cercminus-802

Euro panel backs Merck’s Keytruda + Pfizer’s Inlyta in first-line kidney cancer

The European Medicines Agency’s advisory group CHMP has adopted a positive opinion recommending approval of the combination of Merck’s (NYSE:MRK) Keytruda (pembrolizumab) and Pfizer’s (NYSE:PFE) Inlyta (axitinib) for the first-treatment of advanced renal cell carcinoma.

A final decision from the European Commission usually takes ~60 days.

MRK is up 1% premarket. This morning is also announced positive data from a late-stage study of Keytruda in triple-negative breast cancer.

https://seekingalpha.com/news/3482653-european-advisory-group-backs-mercks-keytruda-pfizers-inlyta-first-line-kidney-cancer

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FDA grants advanced status for Orchard med

Orchard Therapeutics (NASDAQ:ORTX) has received Regenerative Medicine Advanced Therapy (RMAT) designation from the FDA for OTL-103, its ex vivoautologous hematopoietic stem cell-based gene therapy for the treatment of Wiskott-Aldrich Syndrome (WAS) developed at the San Raffaele-Telethon Institute for Gene Therapy (SR-Tiget) in Milan, Italy.

RMAT is akin to Breakthrough Therapy status for drugs/biologics. It provides for the accelerated review of the marketing application and more intensive guidance from the FDA on development.

https://seekingalpha.com/news/3482694-fda-grants-rmat-status-orchards-otlminus-103-treatment

EMA grants PRIME access to ProQr’s sepofarsen for LCA10

ProQR Therapeutics (NASDAQ:PRQR) announces that its sepofarsen (QR-110) drug candidate for the treatment of Leber’s congenital amaurosis 10 (LCA10), was granted access to the PRIority MEdicines (PRIME) program by the European Medicines Agency (EMA).

This is the first EMA PRIME access received by the Company for its portfolio of RNA product candidates for inherited retinal diseases.

Shares are up 5% premarket.

https://seekingalpha.com/news/3482715-ema-grants-prime-access-proqr-s-sepofarsen-lca10

Pfizer down 1% premarket after Q2 result; 2019 guidance lowered

Pfizer (PFE) Q2 results: Revenues: $13,264M (-1.5%); Biopharma: $9,595M (+1.7%); Upjohn: $2,807M (-10.8%); Consumer Healthcare: $862M (-2.7%).

Internal Medicine: $2,330M (+2%); Vaccines: $1,375M (-2%); Oncology: $2,236M (+18%); Hospital: $1,913M (-8%); Inflammation & Immunology: $1,219M ; Rare Disease: $521M (-9%).

Key Product Sales: Ibrance: $1,261M (+22.8%); Eliquis: $1,085M (+22.0%); Prevnar 13/Prevenar 13 : $1,179M (-5.7%); Xeljanz: $613M (+32.4%); Enbrel: $420M (-23.8%); Lyrica: $1,175M (-3.9%); Lipitor: $407M (-21.9%); Norvasc: $216M (-20.9%).

Net Income: $5,046M (+30.3%); EPS: $0.89 (+36.9%); Non-GAAP Net Income: $4,520M (-1.6%); Non-GAAP EPS: $0.80 (+3.9%).

2019 Guidance: non-GAAP EPS: $2.76 – 2.86 from $2.83 – 2.93; Revenues: $50.5B – 52.5B from $52B – 54B.

Shares are down 1% premarket.

Previously: Pfizer EPS beats by $0.05, misses on revenue (July 29)

https://seekingalpha.com/news/3482614-pfizer-1-percent-premarket-q2-result-2019-guidance-lowered

Merck’s Keytruda shows positive effect in late-stage breast cancer study

Merck (NYSE:MRK) perks up 1% premarket on light volume in response to positive results from a Phase 3 clinical trial, KEYNOTE-522, evaluating Keytruda (pembrolizumab), combined with chemo, compared to placebo + chemo as neoadjuvant therapy followed by Keytruda compared to placebo as adjuvant therapy in patients with triple-negative breast cancer (TNBC).

The dual primary endpoints are pathological complete response (pCR) rate up to week 30 and event-free survival up to ~eight years. The estimated completion date is September 2025.

Interim data showed a statistically significant improvement in pCR in the Keytruda cohort compared to chemo alone regardless of PD-L1 status. The study will continue unchanged to assess the survival endpoint.

https://seekingalpha.com/news/3482662-mercks-keytruda-shows-positive-effect-late-stage-tnbc-study-shares-1-percent-premarket

Bausch Health to pay down another $100M of debt

Bausch Health Companies (NYSE:BHC) announces that it plans to pay down an additional $100M of its outstanding secured term loans this week from cash generated from operations.

After the payment, it will have satisfied all mandatory amortization through Q2 2020.

Shares are up 2% premarket on light volume, stoked, in part, by the Mylan/Pfizer deal.

https://seekingalpha.com/news/3482697-bausch-health-pay-another-100m-debt