The Daily Biotech Pulse: Clinical Hold Lifted Off Crispr's Gene-Edited Therapy, Endra To Offer Shares

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 Oct. 10)

• Merck & Co., Inc. MRK
• Kezar Life Sciences Inc KZR
• RA Medical Systems Inc RMED

Down In The Dumps

(Biotech stocks hitting 52-week lows on Oct. 10)

• Abeona Therapeutics Inc ABEO
• Achieve Life Sciences Inc ACHV
• Aerpio Pharmaceuticals Inc ARPO
• Aquestive Therapeutics Inc AQST
• Assembly Biosciences Inc ASMB
• Avenue Therapeutics Inc ATXI
• BioSig Technologies Inc BSGM
• BioXcel Therapeutics Inc BTAI
• Capricor Therapeutics Inc CAPR
• Clovis Oncology Inc CLVS
• CytomX Therapeutics Inc CTMX
• CytRx Corporation CYTR
• Erytech Pharma SA ERYP
• Evelo Biosciences Inc NASDAQ: (EVLO)
• Fennec Pharmaceuticals Inc FENC
• Fortress Biotech FBIO
• IntelliPharmaCeutics Intl Inc IPCI
• Iterum Therapeutics PLC ITRM
• Magenta Therapeutics Inc MGTA
• Mersana Therapeutics Inc MRSN
• Miragen Therapeutics Inc MGEN
• MORPHOSYS AG/S ADR MOR
• MoSys Inc. MOSY
• Mustang Bio Inc MBIO
• Neos Therapeutics Inc NEOS
• Novelion Therapeutics Inc NVLN
• Nymox Pharmaceutical Corp NYMX
• Oncolytics Biotech, Inc. ONCY
• Oramed Pharmaceuticals, Inc. ORM
• Pulse Biosciences Inc PLSE
• RXi Pharmaceuticals Corp RXII
• Surface Oncology Inc SURF
• TRACON Pharmaceuticals Inc TCON
• Translate Bio Inc TBIO
• Trevena Inc TRVN
• Unity Biotechnology Inc UBX
• XOMA Corp XOMA

See Also: Dow Falls 800 Points As Markets Experience Worst Day In Months

Stocks In Focus

FDA Lifts Clinical Hold On Crispr-Vertex Combine's Sickle Cell Disease Therapy

Crispr Therapeutics AG CRSP and Vertex Pharmaceuticals Incorporated VRTX said the FDA has lifted the clinical hold and accepted the investigational new drug application, or IND, for CTX001, their gene-edited hematopoietic stem-cell therapy for treating sickle cell disease, or SCD.

The companies said they have already obtained approvals of Clinical Trial Applications for CTX001 in multiple countries outside the U.S. for both beta-thalassemia and SCD.

The companies also said they remain on track to initiate Phase 1/2 clinical study in SCD by the end of 2018, while they are currently enrolling patients with transfusion-dependent beta-thalassemia in a Phase 1/2 trial in beta-thalassemia in Europe.

Crispr shares jumped 14.14 percent to $41.82 in after-hours trading.

FDA Approves K2M's Dual Differential Correction Technique

K2M Group Holdings Inc KTWO announced FDA approval as well as surgical guidance that enhances Mesa platform using patient-specific rods and rails. The approval provides for dual differential correction, or DDC, philosophy & technique.

"The DDC philosophy combines rod rigidity and degree of bend with the MESA Platform Technology to help achieve quality outcomes in patients with sagittal imbalance," the company said.

The stock rallied 4.17 percent to $28.50 in after-hours trading.

Endra To Offer Shares

ENDRA Life Sciences Inc NDRA said it's planning to offer common shares in an underwritten public offering. All shares are being offered by the company.

The stock slipped 9.8 percent to $2.30 in after-hours trading.

On The Radar

Adcom Meeting

The Anesthetic and Analgesic Drug Products Advisory Committee of the FDA will discuss Trevena's NDA for oliceridine 1 milligram/milliliter injection for the management of moderate-to-severe acute pain in adult patients for whom an intravenous opioid is warranted. Following the release of the committee's briefing document Tuesday, the stock plunged.

Clinical Trial Results

TG Therapeutics Inc TGTX is scheduled to release final Phase 2a data for its relapsing multiple sclerosis treatment candidate TG-1101 at the European Committee for Treatment and Research In Multiple Sclerosis 2018 Congress held in Berlin, Germany.

IPO

Allogene Therapeutics, which develops CAR T cell cancer therapies, priced its upized IPO of 18 million shares at $18, at the upper end of the estimated price range of $16-$18. The shares are to be listed on the Nasdaq under the ticker symbol ALLO.