The Daily Biotech Pulse: Lilly COVID-19 Antibody Cocktail Approved for Emergency Use, Gamida, Genfit Jump On Data, 2 IPOs

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 Feb. 10)

• 9 Meters Biopharma Inc NMTR
• Agios Pharmaceuticals Inc AGIO
• Amneal Pharmaceuticals Inc AMRX
• AngioDynamics, Inc. ANGO
• argenx SE – ADR ARGX
• Arcus Biosciences Inc RCUS
• Aslan Pharmaceuticals Ltd ASLN
• Assertio Holdings Inc ASRT
• Bausch Health Companies Inc BHC
• BridgeBio Pharma Inc BBIO
• Celcuity Inc CELC
• Cellular Biomedicine Group Inc CBMG
• ChemoCentryx Inc CCXI
• Chimerix Inc CMRX
• Clearpoint Neuro Inc CLPT
• Collegium Pharmaceutical Inc COLL
• Corcept Therapeutics Incorporated CORT
• DarioHealth Corp DRIO
• Edap Tms SA EDAP
• Eton Pharmaceuticals Inc ETON
• Evogene Ltd EVGN
• Eyenovia Inc EYEN
• Glaukos Corp GKOS
• Guardion Health Sciences Inc GHSI
• Haemonetics Corporation HAE
• Fulgent Genetics Inc FLGT
• Halozyme Therapeutics, Inc. HALO
• Ideaya Biosciences Inc IDYA
• Illumina, Inc. ILMN
• Immunocore Holdings PLC – ADR IMCR (IPOed Friday)
• Inari Medical Inc NARI
• Inspire Medical Systems Inc INSP
• Intra-Cellular Therapies Inc ITCI
• iTeos Therapeutics Inc ITOS
• Jazz Pharmaceuticals PLC JAZZ
• Kalvista Pharmaceuticals Inc KALV ( reacted to a positive mid-stage readout for an oral investigational therapy for hereditary angioedema)
• Karuna Therapeutics Inc KRTX
• Kintara Therapeutics Inc KTRA
• Landos Biopharma Inc LABP
• Ligand Pharmaceuticals Inc. LGND
• Marker Therapeutics Inc. common stock MRKR
• Medpace Holdings IncMEDP
• MiMedx Group Inc MDXG
• Morphic Holding Inc MORF
• Nantkwest Inc NK
• Neubase Therapeutics Inc NBSE
• Novan Inc NOVN
• Novavax, Inc. NVAX
• Novocure Ltd NVCR
• Opiant Pharmaceuticals Inc OPNT
• Organogenesis Holdings Inc ORGO
• Outlook Therapeutics Inc OTLK
• Paratek Pharmaceuticals Inc PRTK
• PDS Biotechnology Corp PDSB
• Prelude Therapeutics Inc PRLD
• Prothena Corporation PLC PRTA
• Qiagen NV QGEN
• Radius Health Inc RDUS
• Regulus Therapeutics Inc RGLS
• Salarius Pharmaceuticals Inc SLRX
• Seelos Therapeutics Inc SEEL
• Sesen Bio Inc SESN
• SpringWorks Therapeutics Inc SWTX
• SurModics, Inc. SRDX
• Synlogic Inc SYBX
• Terns Pharmaceuticals Inc TERN (IPOed Friday)
• TherapeuticsMD Inc TXMD
• Vanda Pharmaceuticals Inc. VNDA
• Veracyte Inc VCYT
• Vericel Corp VCEL
• Verrica Pharmaceuticals Inc (NASDAQ: VRCA
• Veru Inc VERU
• Xencor Inc XNCR
• Zosano Pharma Corp ZSAN

Down In The Dumps

None of the biopharma/medical device/diagnostic stocks hit 52-week lows Tuesday.

Stocks In Focus

Lilly's Antibody Combo Gets Emergency Use Authorization For Treating Mild-to-moderate COVID-19

Eli Lilly And Co LLY said FDA granted emergency use authorization for investigational bamlanivimab, 700 mg, and etesevimab 1400 mg together. This therapy is authorized for the treatment of mild to moderate COVID-19 in patients aged 12 and older who are at high risk for progressing to severe COVID-19 and/or hospitalization.

Bamlanivimab and etesevimab should be administered together via a single intravenous infusion as soon as possible after a positive COVID-19 test and within 10 days of symptom onset, Lilly said.

Lilly had licensed bamlanivimab from AbCellera Biologics Inc ABCL.

In after-hours trading, AbCellera rose 0.85% to $47.40 and Lilly was up a more modest 0.045% at $201.80.

Genfit Announces Publication of Positive Phase 2 Data For Elafibranor In Treating Liver Disease

Genfit SA GNFT announced publication in the Journal of Hepatology, positive results from the Phase 2 study of elafibranor in patients with primary biliary cholangitis with incomplete response to ursodeoxycholic acid.

These data show a clinically relevant improvement on the primary and composite biochemical endpoints, a positive trend on pruritus improvement, while maintaining a favorable tolerability profile, all of which are supportive of the conduct of ELATIVE, a longer term, larger scale pivotal Phase 3 study to evaluate elafibranor in patients with PBC, the company said.

The stock soared 150% to $13 in after-hours trading.

Gamida Presents Positive Late-stage Data For Omidubicel In Treating Hematologic Malignancies In Transplant Patients

Gamida Cell Ltd GMDA announced presentation at the Transplantation & Cellular Therapy Meetings, results of the Phase 3 study of omidubicel in patients with hematologic malignancies undergoing allogeneic bone marrow transplant.

The results of the study showed that omidubicel resulted in faster hematopoietic recovery, fewer bacterial and viral infections and fewer days in hospital, all of which are meaningful results and represent potentially important advancements in care when considering the patient experience following transplant," said Mitchell Horwitz, principal investigator of the study.

In after-hours trading, the stock rallied 67.85% to $16.60.

Related Link: Attention Biotech Investors: Mark Your Calendar For February PDUFA Dates

Regeneron, Sanofi Gets Label Expansion For Libtayo

The FDA approved an expansion in the label for Regeneron Pharmaceuticals Inc REGN and Sanofi SA's SNY immunotherapy Libtayo for treating patients with advanced basal cell carcinoma previously treated with a hedgehog pathway inhibitor, HHI, or for whom an HHI is not appropriate.

Full approval was granted for patients with locally advanced BCC and accelerated approval was granted for patients with metastatic BCC.

Moderna Strikes Vaccine Supply Agreements With Taiwan and Columbia

Moderna Inc MRNA announced two supply agreements for its COVID-19 Vaccine - one with the government of Taiwan for 5 million doses and another with the government of Colombia for 10 million doses. Under the terms of the agreements, deliveries would begin in mid-2021.

The vaccine is not currently approved for use in Taiwan or Colombia, and Moderna said it will work with regulators to pursue necessary approvals prior to distribution.

Aptevo Confirms Activist Investor's Intention to Nominate Its Slate of Directors

Aptevo Therapeutics Inc APVO confirmed that it has received a notice from Tang Capital Partners regarding the latter's intention to nominate two candidates to stand for election to the Aptevo's board. Tango also intends to submit an advisory stockholder proposal at the company's 2021 annual shareholder meeting.

Aptevo said its board will review the nominations and proposal notice of Tang and will present its recommendations to stockholders in its proxy statement with respect to the 2021 annual meeting.

The stock gained 2.02% to $39.35 in after-hours trading.

Offerings

Iterum Therapeutics PLC ITRM said it has entered into definitive agreements with several healthcare-focused institutional investors for the purchase and sale of 17.5 million of its ordinary shares at a purchase price of $2 per ordinary share in a registered direct offering priced at-the-market.

Enlivex Therapeutics Ltd ENLV announced an increase in the size of the previously announced offering and purchase on a firm commitment basis of 2.296 million shares at a price of $20 per ordinary share, for raising gross proceeds of $46 million.

The stock slid 7.83% to $22.12 in after-hours trading.

Assertio said it has entered into a securities purchase agreement with certain institutional investors to purchase 35 million shares of its common stock at a price of 98 cents per share.

SQZ Biotechnologies Co SQZ said it has commenced an underwritten public offering of 3 million shares of common stock. All of the shares of common stock are being offered by the company.

Codiak BioSciences Inc CDAK said it has commenced an underwritten public offering of 2.5 million shares of its common stock. All the shares to be sold in the proposed offering will be sold by Codiak.

The stock slid 1.96% to $24 in after-hours trading.

KalVista said it intends to offer and sell 4.5 million shares of its common stock in an underwritten public offering. All of the shares will be offered and sold by KalVista.

The stock added 7.49% to $36.01 in after-hours trading.

Mereo BioPharma Group ADR Representing 5 Ord Shs MREO said it intends to offer ADSs in an underwritten public offering. All of the ADSs in the offering are to be sold by Mereo, with net proceeds to be used to fund ongoing clinical development of product candidates and for working capital and other general corporate purposes.

In after-hours trading, the stock was down 0.33% to $3.04.

Cassava Sciences Inc SAVA said has entered into a definitive agreement with several healthcare-focused and other institutional investors for the purchase of 4.082 shares of its common stock, at a purchase price per share of $49 apiece, for gross proceeds of about $200 million, in a registered direct offering.

The stock was sliding 13.74% to $49.65 in premarket trading Wednesday.

On The Radar

Clinical Readouts

Protalix Biotherapeutics Inc PLX is scheduled to present at the 17th Annual WORLDSymposium, one year of treatment data from BRIDGE, a phase 3 open-label study of pegunigalsidase alfa to treat patients with Fabry disease.

Earnings:

Polypid Ltd PYPD (before the market open)
Veru Inc VERU (before the market open)
Kamada Ltd. KMDA (before the market open)
Teva Pharmaceutical Industries Ltd TEVA (before the market open)
Vanda Pharmaceuticals Inc. VNDA (after the market close)
Pacific Biosciences of California Inc PACB (after the market close)
Fluidigm Corporation FLDM (after the market close)
Exelixis, Inc. EXEL (after the market close)
Aethlon Medical, Inc. AEMD (after the market close)

IPOs

French clinical-stage biotech Biophytis S.A., which focuses on development of therapeutics that slow the degenerative processes associated with aging, priced its initial public offering of 1.2 million ADSs at $16.75 apiece, below the estimated price range of $15-$18. Each ADS represents the right to receive 10 ordinary shares. The ADSs will begin trading on the Nasdaq under the ticker symbol BPTS.

Vallon Pharma, a clinical-stage biopharma focusing on therapies for central nervous system disorders, priced its IPO of $2.25 million shares of its common stock at $8 per share, for gross proceeds of $18 million. The shares are expected to begin trading on the Nasdaq under the ticker symbol VLON.