The Daily Biotech Pulse: Hookipa Leaps, Illumina Dims On Q2 Warning, Novartis-Amgen Halt Alzheimer's Study

Here's a roundup of top developments in the biotech space over the last 24 hours:

Scaling The Peaks

(Biotech stocks hitting 52-week highs on July 11)

• Enlivex Therapeutics Ltd ENLV
• GALAPAGOS NV/S ADR GLPG
• Insulet Corporation PODD
• Masimo Corporation MASI
• Novocure Ltd NVCR
• Penumbra Inc PEN
• SAGE Therapeutics Inc SAGE

Down In The Dumps

(Biotech stocks hitting 52-week lows on July 11)

• Aimmune Therapeutics Inc AIMT(fell on a release from the Institute for Clinical and Economic Review, which expressed skepticism about peanut allergy drug vis-à-vis avoiding the food altogether)
• Amneal Pharmaceuticals Inc AMRX
• China SXT Pharmaceuticals Inc SXTC
• Intercept Pharmaceuticals Inc ICPT
• Iradimed Corp IRMD

See Also: Attention Biotech Investors: Mark Your Calendar For These July PDUFA Dates

Stocks In Focus

FDA Clears Hookipa's IND Application For HPV+ Cancer Drug

Hookipa Pharma Inc HOOK announced the FDA cleared its IND application for a Phase 1/2 clinical trial of HB-201 – a TheraT-based immunotherapy for the treatment of HPV-positive cancers. The application is now effective.

The company, which IPOed April 18, said it intends to start the Phase 1/2 trial in the second half of 2019, with the preliminary efficacy and safety data expected in late 2020 or early 2021.

The stock jumped 40.57% to $9.39 in after-hours trading.

Illumina Warns Of Q2 Revenue Shortfall, Lowers Revenue Guidance

Genomic sequencing company Illumina, Inc. ILMN announced preliminary second-quarter results, expecting revenues of about $835 million, below the consensus estimate of $880.63 million. The company blamed the predicament on weakness in population genomics initiatives, direct-to-consumer market and non-high-throughput sequencing systems and consumables.

The company also lowered its 2019 revenue growth forecast from 13%-14% to 6%.

The stock fell 16.13% to $304.99 in after-hours trading.

Ritter Regains Compliance With Nasdaq Listing Standards

Ritter Pharmaceuticals Inc RTTR received written notice from the Nasdaq that its minimum bid price deficiency has been rectified, and it's now in compliance with all applicable listing standards.

The stock rose 6.86% to $1.09 in after-hours trading.

Novartis, Amgen Halts Alzheimer's Prevention Drug Study

Novartis AG NVS, Amgen, Inc. AMGN and Banner Alzheimer's Institute announced their decision to discontinue the clinical trials of CNP520, a BACE1 inhibitor that was being evaluated for preventing Alzheimer's disease. in two pivotal Phase 2/3 studies.

The decision follows an assessment of the unblinded data during a regular pre-planned review that identified worsening in some measures of cognitive function.

The sponsors, therefore, concluded that the "potential benefit for participants in the studies did not outweigh the risk."

Novartis shed 1.48% to $89 in after-hours trading.