The Daily Biotech Pulse: Midatech Shelves Sale Plan, G1 Therapeutics Out-Licenses, Entera Bio Jumps On Survey Results

Scaling The Peaks

(Biotech Stocks Hitting 52-week Highs July 22)

ABIOMED, Inc. ABMD
Bio-Rad Laboratories, Inc. Class A Common Stock BIO
Bio-Rad Laboratories, Inc. Class B Common Stock BIO
BioLife Solutions Inc BLFS
CALLIDITAS THER/S ADR CALT
Catalent Inc CTLT
GENMAB A/S/S ADR GMAB
Hologic, Inc. HOLX
Horizon Therapeutics PLC HZNP
Immunic Inc IMUX
Intuitive Surgical, Inc. ISRG (reported forecast-beating second-quarter results)
Medpace Holdings Inc MEDP
Novo Nordisk A/S NVO
Ocular Therapeutix Inc OCUL
Otonomy Inc OTIC
Penumbra Inc PEN
Qiagen NV QGEN
Quest Diagnostics Inc DGX
ResMed Inc. RMD
TFF Pharmaceuticals Inc TFFP
West Pharmaceutical Services Inc. WST

Down In The Dumps

(Biotech Stocks Hitting 52-week Lows July 22)
Akouos Inc AKUS
AnPac Bio-Medical Science Co Ltd – ADR ANPC
Forma Therapeutics Holdings Inc FMTX
Fusion Pharmaceuticals Inc FUSN
Gritstone Oncology Inc GRTS
Nkarta Inc NKTX
RENALYTIX AI ADR RNLX (went public Friday)
Tricida Inc TCDA

Stocks In Focus

Midatech Terminates Sale Process, Strategic Review to Continue

Midatech Pharma PLC-ADR MTP, a drug delivery technology company, said it has terminated the formal sale process initiated in late April after it failed to receive any proposals from third parties.

The company said the wider strategic review announced March 31 continues, as it is considering all potential options for extracting value from its technologies and providing working capital.

As part of the ongoing strategic review process, the company said it is evaluating early stage proposals and expressions of interest from third parties for the potential acquisition of certain assets and/or a transaction that would constitute a reverse takeover under the AIM Rules.

G1 Therapeutics Out-Licenses Cancer Drug For Up To $310M

G1 Therapeutics Inc GTHX announced the out-licensing of lerociclib to EQRx. Under the terms of the agreement, EQRx will gain exclusive rights for lerociclib in the U.S., Europe, Japan and all other global markets, excluding the Asia-Pacific region.

G1 will in turn receive an upfront cash payment of $20 million and will be eligible to receive development and commercial milestone payments of up to $290 million, plus tiered royalties ranging from the mid-single digits to mid-teens based on the annual net sales of lerociclib.

Lerociclib is a differentiated oral CDK4/6 inhibitor being developed for use in combination with other targeted therapies in certain types of breast and lung cancer.

The stock was trading 4.71% higher to $19 premarket Thursday.

Sanofi Begins Influenza Vaccine Shipment To US For 2020-21 Flu Season

Sanofi SA SNY said it has shipped the first of its influenza vaccine doses to healthcare providers in the U.S. for the upcoming 2020-2021 flu season. The company said shipments will continue through the beginning of November in alignment with customer requests and in time for the start of vaccination efforts.

The stock was down 0.69% at $52.96 premarket.

Entera Bio Rallies On Survey Findings Regarding Uptake of Oral Parathyroid Hormone

Entera Bio Ltd ENTX said results from two primary third-party market research studies of clinicians who treat osteoporosis patients regarding an oral parathyroid hormone, showed that about 85% of clinicians surveyed said they are likely to prescribe oral parathyroid hormone to treat moderate to severe osteoporosis.

The positive opinion was driven by expected improvements in patient compliance, ease of administration, and without injection site discomfort. Physicians also considered reduced costs to patients and payers to be important features, the company said.

Entera's EB613 oral PTH is in Phase 2 clinical development for the treatment of osteoporosis, a multibillion-dollar global market.

The stock jumped 53.4% to $2.93 premarket.

Brainstorm Announces Positive Preclinical Results For COVID-19 Treatment

Brainstorm Cell Therapeutics Inc BCLI said it has successfully completed its first milestone in developing an innovative exosome-based platform-technology for the treatment of severe COVID-19 infection.

Results from a study in a mouse model of lipopolysaccharide-induced ARDS showed that intratracheal administration of NurOwn-derived exosomes resulted in a statistically significant improvement in multiple lung parameters.

The stock was rising 6.03% to $16.70 premarket Thursday.

Aravive Completes Phase 1 Ovarian Cancer Study

Aravive Inc ARAV said it has successfully completed the Phase 1b trial of its AVB-500 drug candidate in platinum resistant ovarian cancer and selection of the recommended Phase 2 dose.

"The information we have obtained from the clinical data together with some informal preliminary feedback from the FDA have helped inform our Phase 2/3 trial strategy. We look forward to formally discussing these results and our development plan with the FDA by the end of 2020," the company said.

In premarket trading Thursday, the stock was advancing 5.87% to $11.

Milestone Announces Positive Regulatory Guidance For Etripamil

Following recent interactions with the FDA regarding Etripamil, Milestone Pharmaceuticals Inc's MIST said the agency outlined an efficient path to registration for etripamil that eliminates the need to start a new Phase 3 study.

Etripamil is a nasal spray investigational novel short-acting calcium channel blocker for patients with paroxysmal supraventricular tachycardia.

"The FDA agreed with our plan to modify the ongoing NODE-301B study to highlight the unique pharmacology of etripamil, including a primary endpoint of time to conversion within 30 minutes. This study, together with our recently completed NODE-301 study, which will also now use a 30 minute endpoint, will serve to fulfill the efficacy requirements for a New Drug Application (NDA) for etripamil in PSVT," the company said.

In premarket trading Thursday, the stock was rallying 69.46% to $5.66.